Part I Overview Information

Department of Health and Human Services

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

Components of Participating Organizations
Office of Extramural Research, Education and Priority Populations (OEREP), (http://www.ahrq.gov)

Title: AHRQ Mentored Career Enhancement Award in Patient Centered Outcomes Research (PCOR) for Mid-Career and Senior Investigators (K18)

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

Announcement Type

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

• November 27, 2013 (NOT-OD-14-027) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after January 25, 2014. Forms-C applications are required for due dates on or after January 25, 2014.
• July 2, 2013 - See Notice NOT-HS-13-010. AHRQ Announces Interest in Patient-Centered Outcomes Research (PCOR) Mentored Career Development Grants focused on Methodologies and Research in Translation, Implementation, and Diffusion of Research into Practice and Policy.
• August 17, 2012 - Notice is to inform the scientific community that AHRQ is clarifying the criteria regarding scholar eligibility noted in PAR-12-115. See Notice NOT-HS-12-012.

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

Request for Applications (PA) Number: PAR-12-115

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

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

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

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

Catalog of Federal Domestic Assistance Number(s)
93.226

Key Dates
Release/Posted Date: March 1, 2012
Opening Date: April 2, 2012
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): May 2, 2012, December 18, 2012, December 18, 2013, December 18, 2014
Peer Review Date(s): estimated at two to four months following application receipt
Earliest Anticipated Start Date(s): estimated at two to four months following peer review
Additional Information to Be Available Date (Activation Date): Not Applicable
Expiration Date: December 19, 2014

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Section 6301(b) of the Patient Protection and Affordable Care Act , Public Law 111-148 (the Affordable Care Act ), enacted Section 937(e) of the Public Health Services Act authorizing AHRQ to establish a grant program that provides for the training of researchers in comparative effectiveness methods and states that, at a minimum, such training shall be in methods that meet the methodological standards adopted [by PCORI] under 1181(d)(9) of the Social Security Act. AHRQ is also authorized to sponsor health services research career development programs under section 902(b) of the Public Health Service Act. This FOA addresses the Affordable Care Act’s provision authorizing AHRQ to support the training of researchers in comparative clinical effectiveness research. AHRQ encourages submission of applications from minority serving institutions.

• Purpose. This Funding Opportunity Announcement (FOA) issued by AHRQ, invites applications for Mentored Career Enhancement grant awards (K18) in Patient Centered Outcomes Research (PCOR). The program targets established mid-career and senior investigators who are interested in developing new skills in comparative effectiveness research methodology and applying these methods to patient-centered outcome research (PCOR).
• Mechanism of Support. This Funding Opportunity Announcement (FOA) will utilize the short-term Mentored Career Enhancement Award Mechanism (K18).
• Funds Available and Anticipated Number of Awards. The total amount to be awarded by AHRQ and the number of awards will depend upon the quality and merit of applications received and the availability of funds.
• Budget and Project Period. Because the nature and scope of each application will vary, it is anticipated that the size and duration of each award will also vary. Budget proposals must not exceed $275,000 total costs annually. Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. The total project period for an application submitted in response to this program announcement shall be between six (6) and twenty-four (24) months.
• Research Strategy Page Limit. The K18 application Research Strategy and items 2-5 of the Career Development Supplemental Form component of the application may not exceed 15 pages, including tables, graphs, figures, diagrams, and charts. Items 2-5 of the Career Development Supplemental Form include: Candidate’s Background, Career Goals and Objectives, Career Development/Training Activities during Award Period, and Training in the Responsible Conduct of Research.
• Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply.
• Eligible Project Director/Principal Investigator (PD/PI). Eligible PD/PIs include doctoral level investigators holding the rank of Associate Professor or Professor, or their equivalent, in nonacademic settings. Two types of candidates should consider applying for support: (1) Faculty, providers or investigators without expertise in comparative effectiveness research, who are located at institutions that do not possess intensive CER programs; and (2) faculty, providers or investigators who are located at institutions that possess intensive CER programs, but who do not possess individual expertise in CER. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply. See Section III for details.
• Number of PDs/PIs. Only one PD/PI may be designated on the application.
• Number of Applications. Candidates may have one individual Career Development Award application pending peer review at any time.
• Resubmissions. One resubmission application is permitted in response to this FOA prior to the expiration date of the FOA. Resubmission deadlines are the same as submission deadlines for new K18 applications.
• Renewals. Awards are not renewable and are not transferable from one PD/PI to another.
• 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.

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice published by AHRQ in the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Candidates must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Career Objectives

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

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other-Special Eligibility Criteria

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

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contacts
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

Purpose

Section 6301(b) of the Patient Protection and Affordable Care Act , Public Law 111-148 (the Affordable Care Act ), enacted Section 937(e) of the Public Health Service Act, authorizing AHRQ to build capacity for comparative effectiveness research by establishing grant programs that provide training for researchers in methods used to conduct research.

The overall goal of this FOA is to prepare qualified individuals for careers in patient-centered outcomes research (PCOR). Candidates must hold the rank of Associate Professor or Professor, or their equivalent in non-academic settings. Candidates must commit a minimum of 6 full-time calendar months (equivalent to 50% of full-time professional effort) to their career enhancement in PCOR across a period ranging from six months to two years. The career development experience must involve an intense, mentored career development plan in comparative effectiveness research, which will substantially improve the candidate’s ability to pursue future research in PCOR.

Applications for this award must propose a career enhancement/development plan that: 1) has intrinsic research importance in the area of PCOR (as described below), 2) will serve as a suitable vehicle for learning the comparative effectiveness research methodology, as well as theories and concepts needed for undertaking a research career in PCOR, 3) will ensure high research productivity; and 4) will sufficiently prepare candidates for PCOR research that is responsive to and involves stakeholders in the development of the research and/or in the dissemination and implementation of research findings. Research projects conducted by candidates must be designed to provide a strong foundation for conducting PCOR.

The candidate, mentors and sponsoring institution must propose a research career enhancement/development program that maximizes the use of available research, educational and partnership resources, curriculum, and qualified research faculty as mentors. The entire program should be designed to rigorously monitor and provide well-defined policies and a structure to ensure progress for the candidate. The program, tailored to the individual needs and level of experience of the candidate, would generally incorporate two components: 1) experiential and/or didactic learning (e.g., directed study/tutorials, short courses, seminar series, journal clubs), and 2) a research project conducted in conjunction with and generally at the host research facility.

Research Career Training Objectives

The purpose of PCOR is to improve health outcomes by developing and disseminating evidence-based information to patients, clinicians, policy makers, and health care administrators, responding to their expressed needs about which clinical and health system design interventions are most effective for which patients under specific circumstances. Research career training objectives and candidates must focus the content on health care delivery within the United States.

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

As noted above, Section 937(e) of the Public Health Service Act authorizes AHRQ to establish a grant program that provides for the training of researchers in comparative effectiveness methods and states that, [a]t a minimum, such training shall be in methods that meet the methodological standards adopted [by PCORI] under 1181(d)(9) of the Social Security Act.

The Methodology Committee of PCORI was established to develop and improve the science and methods of comparative clinical effectiveness research. Legislation charges the Committee to develop a translation table that is designed to provide guidance and act as a reference for the Board to determine research methods that are most likely to address each specific comparative clinical effectiveness research question. The Committee is also charged with producing a report by May 2012. Information on this activity can be found at www.pcori.org. Grant applicants must be responsive to recommendations made by the Committee in their grant applications if these are released by the application receipt date (i.e., applicants must, at a minimum, meet PCORI methodological standards that are developed.). If these recommendations are released subsequent to the application receipt date and before the scheduled peer review date, AHRQ will issue notification that the PCORI standards have been released and will include any additional submission requirements.

Note, the Methodology Committee has developed a preliminary translation framework that will inform the development of the translation table. Components include:

• Determining which research methods are best to address specific clinical effectiveness research questions;
• Utilizing a translational framework to provide theoretical underpinnings and organizing structure to help identify appropriate analytical designs and methods most suitable for addressing specific research questions; and,
• As necessary, utilization of any translational tool adopted by PCORI to assist with the dynamic implementation of the translational framework.

Example areas of methodological emphases in applications may include, but are not limited to:

• Aims to help people make informed health care decisions and allows their voice to be heard in assessing the value of health care options;
• Assesses the benefits and harms of preventive, diagnostic, therapeutic, or health delivery system interventions to inform decision-making, highlighting comparisons and outcomes that matter to people;
• Is inclusive of an individual's preferences, autonomy and needs, focusing on outcomes that people notice and care about such as survival, function, symptoms, and health-related quality of life;
• Incorporates a wide variety of settings and diversity of participants to address individual differences and barriers to implementation and dissemination; and
• Investigates (or may investigate) optimizing outcomes while addressing burden to individuals, resources, and other stakeholder perspectives.

AHRQ operationalizes the definition to include any potential medical intervention, whether prognostic, preventive, diagnostic, therapeutic, palliative, or delivery-oriented. PCOR includes assessments of comparative effectiveness and/or safety and the active involvement of stakeholders in defining research questions, thereby establishing a ready audience poised to act upon research findings. PCOR can also include the development and application of methods to assess benefits or harms, or the integration of benefits, harms in therapeutic decision-making and choices. PCOR can include the synthesis of existing evidence, the generation of new evidence, or educational/translational or systems interventions to apply evidence to clinical practices and behaviors. AHRQ is particularly interested in PCOR projects focused on eliminating health care disparities. For all projects, it is important to include populations that are sufficiently large and diverse to allow for sub-group comparative effectiveness analyses.

Candidates also need to engage stakeholders (e.g., providers, consumers, community groups, payers, purchasers, policymakers, administrators) in the formulation of their research, and to the extent necessary, the implementation and dissemination of the research. Also, candidates must demonstrate their ability to collaborate with institutions and networks well versed in systematic review methodologies or with research centers capable of performing accelerated clinical effectiveness and outcomes research and the translation, dissemination and uptake of evidentiary information for health care practice and decision-making.

Special Methodological and Program Objectives for Consideration

Methodological training and career development plans must be proposed within the context of final recommendations made by the Methods Subcommittee of PCORI and adhere to guidance proposed for:

• Determining which research methods are best to address specific clinical effectiveness research questions;
• Utilizing a translational framework to provide theoretical underpinnings and organizing structure to help identify appropriate analytical designs and methods most suitable for addressing specific research questions; and,
• As necessary, utilization of any translational tool adopted by PCORI to assist with the dynamic implementation of the translational framework.

Example areas of methodological emphasis could include, but are not limited to:

• Prospective, longitudinal cohort studies of the effectiveness/comparative effectiveness of health care diagnoses, treatment, and services including pharmaceuticals, devices and other types of interventions or combination of interventions;
• Cluster-randomized or randomized clinical trials of the effectiveness/comparative effectiveness of new or existing health care technologies, involving wide inclusion of patients and health systems that adequately reflect health care provision for the general population;
• Innovative approaches (clinical, methodological, and statistical) in the design as well as analysis of studies that more adequately identify and account for clinical heterogeneity of treatment effects;
• Integration of quantitative and qualitative analytical frameworks and techniques in the screening, synthesis, appraisal, and dissemination/implementation of evidence;
• The identification, role, and assessment of observational studies in the systematic review and synthesis of evidence on comparative effectiveness;
• The design, analytical tools, and statistical techniques for reducing, confounding and mitigating the impacts of potential bias inherent in the observational studies of comparative effectiveness;
• The communication of risk and benefit and contextual information that enhances the use of evidence in decision-making, as well as the comparative effectiveness of different approaches and technologies in accomplishing such objective;
• Implementation science methodology;
• Training in use of registries, combining large-scale longitudinal data sets, and data mining techniques; and
• The ability to conduct subgroup analyses to determine which treatments and interventions work best for specific populations, such as underserved and underrepresented groups.

Required Areas of Emphases

Candidates must focus their career enhancement/development programs in one or both of these areas:

• The reduction of specific and known disparities in health care outcomes and quality among racial and ethnic minority populations and underserved populations.
• Evaluating and comparing health care delivery system designs; developing and evaluating system redesigns; and implementing and disseminating effective, evidence-based design practices. Candidates can focus their research on a wide range of issues within delivery system research, including:
  • the organization and management of health care delivery (e.g., primary care medical home, the development of accountable care organizations, other forms of bundling care);
  • strategies for increasing providers compliance with evidence-based guidelines;
  • transition support for patients with complex health care needs, including ways to reduce unnecessary re-hospitalization;
  • care delivery and coordination for chronic care patients; and
  • payment and reporting strategies for improving access, quality, and/or the value and administration of health care and its delivery.

Candidates are strongly encouraged to emphasize and address the following in their career development programs and applications:

• Novel approaches for engaging stakeholder groups (e.g., clinicians, consumers, policymakers, insurers, buyers, and administrators) in the development of research questions, measurement of outcomes, the design of projects, and, as necessary, participation in the research;
• Specific plans for disseminating the findings and incorporating them into health care delivery at the onset of developing a research project.

Section II. Award Information

1. Mechanism of Support

This FOA will utilize the Short-term Mentored Career Enhancement mechanism for mid-career and senior investigators (K18). The candidate, the Project Director/Principal Investigator (PD/PI), and the candidate’s mentor are jointly responsible for planning, directing, and executing the proposed project and career enhancement activities.

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

The candidate should follow the instructions for budget information described in this FOA as well as in PHS 398 Career Development Award Supplemental form Section 7.4.6 of the R&R 424 instructions, and budget justification information.

2. Funds Available

Because the nature and scope of the proposed career development 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.

Funds may be used only for those expenses that are directly related and necessary to the career development program and must be expended in compliance with applicable OMB Cost Principles (see http://www.whitehouse.gov/omb/circulars_default) and the HHS Grants Policy Statement (see http://www.ahrq.gov/fund/hhspolicy.htm).

Funding beyond the first year will be contingent upon a review and acceptance by Agency staff of the annual progress report (PHS 2590).

Allowable Costs

Budget proposals must not exceed $275,000 annually in total costs for up to two years. Facilities and administrative (F&A) costs requested by applicants are included in the total cost limitation. Facilities and administrative costs are based on 8% of modified total direct costs, or at the actual indirect cost rate, whichever is less (excluding tuition/fees and expenditures for equipment) may be requested. An application that requests more than $275,000 total costs in any given year, or that exceeds two years in duration, will not undergo peer review.

Salary and Professional Effort: AHRQ will provide salary and fringe benefits for the K18 candidate at a rate up to the Congressionally-mandated salary limit in effect at the time of award. The total salary provided by the award will be prorated based on a full-time, 12-month staff appointment and the support period requested. The total project period for an application submitted in response to this FOA shall be six months to two years duration. The K18 requires the candidate to devote a minimum of 6 calendar months (equivalent to 50% of full-time professional effort) to conducting PCOR. The remaining effort may be devoted to clinical, teaching, or other research pursuits and activities consistent with the objectives of the award. For information regarding policy on determining full-time professional effort for career awards, please see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-056.html.

K18 award recipients may hold concurrent Federal and non-Federal grant/contract support as a PD/PI or sub-project director with this award provided the aggregate effort does not exceed 12 calendar months (i.e.100%). Applicants are not required to have active research grant support at the time of application for this award. Candidates to this program may not concurrently apply for any other PHS award that duplicates the provisions of this FOA.

The salary must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure. Confirmation of salary may be required prior to the issuance of an award. Fringe benefits, based on the sponsoring institution’s rate and the percent of effort, are provided in addition to the salary. The total salary may not exceed the legislatively mandated salary cap.

Research Enhancement/Development Support: AHRQ will provide up to a total of $50,000 per year direct costs for the following expenses: a) tuition and fees related to career development; b) research related costs such as supplies, equipment, and technical personnel working with research data; c) travel to research meetings or training (including local or distance travel related to training that takes place at another site); d) statistical services including personnel and computer time; e) mentor salary and fringe benefits (up to $6,000) annually per mentor for a maximum of two mentors per candidate. All expenses must be directly related to the proposed research career development, not to living expenses.

Facilities and Administrative Costs: Facilities and Administrative (F&A) costs will be reimbursed at eight percent of modified total direct costs, or at the actual indirect cost rate, whichever is less.

AHRQ Grants Policy: All AHRQ grant awards are subject to the requirements of the applicable requirements in the HHS grants policy statement (see http://www.hhs.gov/grantsnet/docs/HHSGPS_107.doc), which will apply to the applications submitted and the awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

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

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

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 healthcare 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.

HHS grants policy requires that the grant recipient perform a substantive role in the conduct of the planned project or program activity and not merely serve as a conduit of funds to another party or parties. If consortium/contractual activities represent a significant portion of the overall project, the applicant must justify why the applicant organization, rather than the party(s) performing this portion of the overall project, should be the grantee and what substantive role the applicant organization will play. Justification can be provided in the Specific Aims or Research Strategy section of the PHS398 Research Plan Component sections of the SF424 (R&R) application. There is no budget allocation guideline for determining substantial involvement; determination of substantial involvement is based on a review of the primary project activities for which grant support is provided and the organization(s) that will be performing those activities.

1.B. Eligible Individuals

Program Director/Principal Investigator (PD/PI)

Any individual with the skills, knowledge, scientific expertise, and resources necessary to develop and implement the proposed institutional research training program is invited to work with his/her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for AHRQ support.

This award is intended for mid-career and senior investigators holding a research or health professional doctorate who are at the academic rank of Associate Professor or Professor (or the equivalent in nonacademic settings), who have established records of independent, peer-reviewed Federal or private research grant funding, who seek an intense, mentored career development experience in comparative effectiveness methodology which will substantially improve their ability to pursue future research in PCOR. Targeted candidates are: 1) faculty, providers or researchers without expertise in comparative effectiveness research who are located at institutions that do not possess intensive CER programs; and 2) faculty, providers or researchers who are located at institutions that possess intensive CER programs, but who do not possess individual expertise in CER. The research career enhancement experience shall occur at a host institution, whether in the candidate’s home institution (i.e. in which the candidate holds his/her primary appointment) or in another institution with the appropriate resources to provide the proposed research career development experience. In both cases, the tutelage of well-qualified mentor(s) is required.

Mentor(s)

Candidates must identify one or more mentors with extensive research experience in PCOR, and an active, funded research program in CER, who are well-qualified and willing to sponsor the short term research career enhancement/development experience. The candidate Project Director/Principal Investigator (PD/PI) and his/her mentor are jointly responsible for planning, directing, and executing the proposed project and career enhancement activities. It is expected that the proposed career development plan will represent a novel experience for the candidate.

Where feasible, women, individuals from diverse race and ethnic groups, and individuals with disabilities should be involved as mentors to serve as role models.

Consultant(s)/Collaborator(s)

Signed statements must be provided by each consultant/collaborator confirming their participation in the project and describing their specific roles. A consultant must state his/her daily or hourly consulting rate and specify the number of hours or days to be devoted. Collaborators and consultants generally do not need to provide their biographical sketches. However, information should be provided that clearly documents expertise in the proposed area(s) of consulting/collaboration.

2. Cost Sharing or Matching

This program does not require cost sharing for applications in response to this FOA.

While there is no cost sharing requirement included in this FOA, AHRQ welcomes applicant institutions, including any collaborating institutions, to devote resources to this effort. An indication of institutional support from the applicant and its collaborators indicates a greater potential of success and sustainability of the project. Examples of institutional support would include: donated equipment and space, institutional funded staff time and effort, or other resource investments. Applicant institutions should indicate institutional support by outlining the specific contributions to the project and providing assurances that their organization and any collaborators are committed to providing these funds and resources to the project. This information 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

The K18 award recipients may hold concurrent Federal and non-Federal grant/contract support as a PD/PI or sub-project director with this award provided the aggregate effort does not exceed 12 calendar months (i.e.100%). Candidates are not required to have active research grant support at the time of application for this award. Candidates to this program may not concurrently apply for any other PHS award that duplicates the provisions of this FOA.

Each short term career enhancement program in CER must be tailored to meet the individual needs of the candidate. The candidate and mentor are jointly responsible for the preparation of the career development plan. The sponsoring institution must demonstrate a commitment to provide the environment and resources needed for the candidate to perform the activities included in the career enhancement program that maximize the use of relevant research and educational resources and propose qualified investigators as mentors.

A Resources Format page (PHS 398) for the host institution must be included in the application. Programs which focus on the reduction of disparities, as outlined above, are encouraged to demonstrate they provide health care to economically disadvantaged populations and/or have access to unique data on these populations. They are also expected to demonstrate how candidates in these programs can utilize these opportunities in research projects focusing on the reduction of specific and known disparities.

Degree Requirements. Candidates should have received a Ph.D., M.D., D.D.S., D.M.D., D.C., D.O., D.V.M., O.D., D.P.M., Sc.D., Eng.D., Dr. P.H., D.N.Sc., D.P.T., Pharm.D., N.D., D.S.W., Psy.D., or equivalent doctoral degree from an accredited domestic or foreign institution. It is the responsibility of the grantee institution, not AHRQ, to determine if a foreign degree is equivalent. Research training must emphasize specialized training to meet national research priorities in PCOR.

Applicant Citizenship and Residency. At the time of appointment to the career development program, the candidate selected to be supported by the K18 grants must be a citizen or non-citizen national of the United States, or must have been lawfully admitted to the United States for permanent residence, i.e., in possession of a currently valid Permanent Resident Card (USCIS Form I-551), or some other legal verification of legal admission as a permanent resident. Non-citizen nationals are persons who, although not citizens of the United States, owe permanent allegiance to the United States. They generally are born in outlying possessions of the United States (e.g., American Samoa and Swains Island). Individuals on temporary or student visas are not eligible for K18 support. It is the grantee institution’s responsibility to ensure that a candidate s citizenship status at the time of appointment meets these criteria, and to assure that the individual remains eligible for K18 support for the duration of the appointment.

Level of Effort. The candidate is required to devote at least 6 full-time calendar and not more than 24 full-time calendar months across the duration of the award. The proposed duration of the award can be for a minimum of six continuous and a maximum of 24 continuous months. The amount of effort devoted to the program over the course of each 12-month period can vary, so long as the required minimum level of effort (50% of full-time effort over the duration of the award) is achieved. For example, a candidate could propose 100% effort for a 6 month award, or 50% effort for a 12 month award, or 25% effort for the first 6 months and 75% effort for the final six months of a 12 month award, etc., provided the overall level of effort over the duration of the project is 50%.

The allowance for a part-time commitment of professional effort will enable candidates to hold their ongoing research grants (if applicable) and/or meet their academic responsibilities in a limited capacity, as they pursue the career enhancement program. Applicants should describe any clinical, administrative, teaching, mentoring or grant-related research commitments they intend to maintain during the period of the award, and the arrangements to be made with the home institution and/or the sponsoring institution to ensure the requisite protected time for this award period. Generally, the research experience shall span a contiguous period of six months to two years.

In no case will a reduction of total effort below 50% over the course of the duration of the entire project in order to accept other Federal funding be allowed. In addition, no redistribution of the proposed levels of effort across the duration of the course of the project will be allowed once a grant is awarded.

At the time of award, the candidate must have a full-time appointment at the institution that is the applicant institution. Candidates who have full-time VA appointments and part-time non-VA appointments are not eligible to apply.

Number of Applications. Candidates may submit only one application in response to this FOA.

Resubmissions. One resubmission application is permitted in response to this FOA prior to the expiration date of the FOA. Resubmission deadlines are the same as submission deadlines for new K18 applications.

Renewals. The K18 is not renewable and may not be transferred to another individual. Due to the short-term nature of the award, it may not be transferred to another institution.

Section IV. Application and Submission Information

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

Registration:

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

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

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

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

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

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

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

2) Organizational/Institutional Registration in the eRA Commons

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

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

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

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

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

1. Request Application Information

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

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

For further assistance, contact GrantsInfo -- Telephone 301-710-0267; Email: [email protected].

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

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

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

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

Required Components:

SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
SF424 (R&R) Detailed Budget
PHS398 Cover Letter
PHS398 Cover Page Supplement
PHS398 Career Development Award Supplemental Form
PHS398 Checklist
(See Section IV.6, Special Instructions regarding the appropriate required budget component.)

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

SPECIAL INSTRUCTIONS

Applications Involving a Single Institution

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

Applications Involving Multiple Institutions

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

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review, and Anticipated Start Dates
Release/Posted Date: March 1, 2012
Application Due Date(s): May 2, 2012, December 18, 2012, December 18, 2013, December 18, 2014
Peer Review Date(s): estimated at two to four months following application receipt
Earliest Anticipated Start Date(s): estimated at two to four months following peer review
Additional Information to Be Available Date (Activation Date): Not Applicable
Expiration Date: December 19, 2014

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).

3.A.1. Letter of Intent

A letter of intent is not required for this funding opportunity.

3.B. Submitting an Application Electronically to AHRQ

To submit an application in response to this FOA, applicants must access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp and follow Steps 1-4. Note: Applications must only be submitted electronically.

PAPER APPLICATIONS WILL NOT BE ACCEPTED.

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

3.C. Application Processing

3.C.1 Submitting On-Time

Applications must be received on or before the application receipt date described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed. Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH, and AHRQ. Incomplete and/or non-responsive applications will not be reviewed.

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.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

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

Use of CMS Data

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

Applicants should be aware that for individually identifiable Medicare and Medicaid data, Principal Investigators and their grantee institutions will be required to enter into a Data Use Agreement (DUA) with CMS to protect the confidentiality of data in accordance with the terms of the DUA and applicable law.

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

6. Other Submission Requirements

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

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

Organizational DUNS

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

PHS 398 Career Development Award Supplemental Form Component Sections

All application instructions outlined in the SF424 (R&R) Application Guide (See Supplementary Instructions for Research Career Awards, Part I.7.5) that are not otherwise specified within this Funding Opportunity Announcement are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:

• Specific Aims is limited to 1 page.
• Items 2-5 (Candidate's Background, Career Goals and Objectives, Career Development/Training Activities During Award Period, and Training in the Responsible Conduct of Research) and Item 11 (Research Strategy) are limited to a combined total of 15 pages, including tables, graphs, figures, diagrams, and charts.
• While each section of the Candidate Information and Research Strategy components needs to be uploaded separately as a PDF attachment, candidates are encouraged to construct the Candidate Information component and the Research Strategy component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable candidates to better monitor formatting requirements such as page limits.

The following information must be included in the application:

Candidate Information and Career Enhancement/Development Plan

Candidate’s Background:

• Describe the candidate's commitment to a career in PCOR. Include a description of all of the candidate’s professional responsibilities at the grantee institution and elsewhere and show their relation to the proposed activities on the career development award.
• Describe any clinical, administrative, research, or grant related commitments they intend to maintain during the period of the award, and arrangements which will be made to provide protected release time.
• Describe the candidate’s research efforts to this point in his/her research career, including any publications, prior research interests and experience.
• Present evidence of the candidate’s potential to augment his/her research career through this career development award.
• Include a description of the candidate s professional responsibilities and show their relationship to the proposed activities of the career enhancement award.
• Provide evidence of the candidate’s ability to interact and collaborate with other scientists.

Career Goals and Objectives:

• Provide details of the career development plan, tailoring it to the candidate’s goals, prior experience and career level, as well as the intent of the K18 award.
• Discuss the candidate’s objectives and long term career plans, and how these relate to the proposed activities in the career enhancement award, with a focus on how the proposed work will advance the candidate’s methodological skills in comparative effectiveness research and research career in PCOR.
• Justify the need for further career development in relation to the candidate’s future research goals.

Career Development/Training Activities:

• The candidate and the mentor are jointly responsible for the preparation of the career development plan. A timeline for the phasing of the K18 award should be included.
• Provide a systematic plan for progression of research experiences for the period of the award and beyond to exploit the career development activities provided by the K18, emphasizing the potential to advance knowledge in PCOR.
• Specific mentoring plans and demonstration of qualifications, availability and commitment of major faculty and external non-academic partners in the specific research objective areas proposed.
• Plans for having specific didactic training as well as experiential research opportunities (depending on the various skill levels/needs of the candidate), noting the competencies to be conveyed, how they will be conveyed and how they will be assessed. These plans should also address training required for professional development, communication of research, and translation of research into practice and/or policy.

Research Plan:

• A research project in PCOR that is consistent with the goals of this FOA and the objectives of the career enhancement must be described.
• Organize the research plan as indicated in the Form 398, following instructions for Specific Aims, Research Strategy, (Significance, Innovation, Approach), to the extent possible and appropriate. The candidate should consult with the mentor regarding the development of this section.

Training in the Responsible Conduct of Research:

• Applications must include a plan to obtain instruction in the responsible conduct of research.
• This section should document prior instruction in responsible conduct of research during the applicant’s current career stage (including the date of last occurrence) and propose plans to receive instruction in responsible conduct of research
• Such plans must address five instructional components (format, subject matter, faculty participation, duration of instruction, and frequency of instruction).
• The plan may include career stage-appropriate, individualized instruction or independent scholarly activities that will enhance the applicant’s understanding of ethical issues related to their specific research activities and the societal impact of that research.
• The role of the sponsor/mentor in responsible conduct of research instruction must be described.
• Applications lacking a plan for participation or instruction in responsible conduct of research will be considered incomplete and may be delayed in the review process.

Statement(s) by Mentor(s)/Consultant(s)/Collaborator(s):

• Candidates must name a primary mentor who, together with the applicant, is responsible for the planning, direction, and execution of the program. Candidates may also nominate co-mentors, as appropriate to the goals of the program.
• The mentor should be recognized as an accomplished investigator in his or her scientific domain, and have a track record of success in training independent investigators.
• Where feasible, women, individuals from diverse racial and ethnic groups and individuals with disabilities should be involved as mentors to serve as role models.
• The application must include a statement from the mentor providing: (1) information on his/her research qualifications and previous experience as a research mentor; (2) a mentoring plan describing the content and nature of the mentoring that will occur during the proposed award period; and (3) The ongoing research activities and research grant support of the mentor, along with how the research activities of the candidate will dovetail with these.
• Similar information must be provided by any co-mentor, if more than one mentor is proposed. The respective areas of expertise and responsibility of the primary mentor and co-mentor(s) should be described.
• Signed statements should be provided by each consultant/collaborator confirming his/her role in the project.

Environment and Institutional Commitment to the Candidate

Description of Institutional Environment:

• The sponsoring institution must document a strong, well-established research and career development program related to the candidate's area of interest, including a high-quality research environment with key faculty members and other investigators capable of productive collaboration with the candidate.
• Describe the resources and facilities that will be made available to the candidate.
• The application must describe how the institutional research environment is particularly suited for the development of the candidate's research career and the pursuit of the proposed research plan.
• Explain the collaborative environment and infrastructure available for interdisciplinary training related to PCOR.

Institutional Commitment to Candidate’s Research Career Enhancement/Development:

• The sponsoring institution (e.g., the institution that is providing the training experience for the candidate) must provide a statement of commitment to the candidate’s research career development and to meeting the requirements of this award.
• The sponsoring institution must provide the candidate with appropriate facilities and other resources to carry out the proposed research plan.
• In a separate letter, appropriate administrators/officials at the applicant institution must describe all institutional commitments the candidate will maintain during the research career development period and provisions which will be made to provide appropriate release time. This must be a clear and unambiguous statement of assurance that during the active period of the K18 award the candidate will be released from all administrative, teaching and/or clinical duties that infringe on his/her commitment to the award, and that he/she will be able to devote 6-12 calendar months (i.e. 50-100%) effort to the research career enhancement program.
• Provide appropriate time and support for any proposed mentor(s) and/or other staff consistent with the career development plan.

Letters of Reference:

• Three letters of reference are required. However, the mentor should submit a separate letter outlining his/her support of the application.

Budget Component

Special Instructions for Modular Grant applications

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

Budget Component (Section 4.7): Use the SF424 (R&R) Detailed Budget component and review the instructions found in Part I.4.7(R&R Budget Component) of the Application Guide. However for K applications only limited budget information is required; therefore, candidates will also need to follow the special instructions in Part I.7.4 of the SF 424 (R&R) [Supplemental Instructions for Career Development Awards], noting the special instructions that modify Section 4.7. In budget section A (Senior/Key Persons) include base salary, person months and requested salary and fringe benefit information for only the candidate. Base salary, and requested salary and fringe benefits should reflect actual levels. Any adjustments based on AHRQ policy limits will be made at the time of the award. Sections B-E should be left blank. If a dollar amount is required, enter 0 (zero) in the appropriate box. The total Research Development Support amount requested for each year will be entered in Section F, Materials and Supplies. In Section H enter Modified Total Direct Costs under Indirect Cost Type. The Indirect Cost rate is 8% of modified total direct cost. The Indirect Cost amount should be entered under Funds Requested. Totals for Sections F, G, and H will be calculated automatically for each year as well as for the Cumulative Budget. Within the direct cost limitation for research development support, provide a detailed description with justification for all equipment, supplies and personnel that will be used to help achieve the career development and research objectives of this award.

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

Appendix Materials

Candidates must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).

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

Resource Sharing Plan(s)

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.

Priority Populations

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

Publication Transmittal: General AHRQ Requirements

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

Assessment of AHRQ Grant Programs

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

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

HCUP & MEPS

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

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

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

Health Literacy

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

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

Consumer Products

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

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: Merit Review Criteria, as described below, will be considered in the review process.

2. Review and Selection Process

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

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

Review Criteria

The overall goal of AHRQ-supported career development programs is to help ensure that diverse pools of highly trained scientists are available in adequate numbers and in appropriate research areas to address the Nation’s PCOR needs. The scientific review group will address and consider each of these criteria in assigning the application's overall impact/priority score, weighting them as appropriate for each application.

Overall Impact

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

Scored Review Criteria

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

• Candidate
• Career Enhancement/Development Plan
• Research Plan Strategy
• Mentor, Co-Mentor(s), Consultant(s) and Collaborator(s)
• Environment and Institutional Commitment to the Candidate

Candidate:

• Does the candidate have an established record as an independent and productive researcher, including ongoing and previous research support and publication output?
• Is the candidate a mid-career or senior investigator (Associate Professor or Professor or equivalent in non-academic setting)?
• Is there a discussion of the candidate’s objectives and long-term career plans related to mastering new methods in comparative effectiveness research and applying these skills to PCOR goals?
• Does the candidate have the potential for successfully augmenting his/her research capabilities and/or becoming an outstanding investigator in research relevant to the proposed career development experience?
• Do the statement(s) of the mentor(s) address the above review criteria, and do these demonstrate evidence that the candidate has a high potential for augmenting his research career development?

Career Enhancement/Development Plan:

• Are the content, goals, scope and phasing of the career development plan appropriate, and is there a likelihood that the award will contribute substantially to the development of a new area of research expertise in comparative effectiveness research methods applied to PCOR?
• Is the planned duration (6 months - 24 months) appropriate relative to the stated training and career development goals? Is there a planned progression of research and other career development experiences?
• Is there documentation and commitment to devote a minimum of 50% effort to the career development award plan?
• Will there be adequate preparation in methodologies of CER design, as related to PCOR and translation of research into practice or policy?

Research Plan:

• Is the research plan appropriate for developing or enhancing career development plans, and developing a collaborative, interdisciplinary research program in a new research trajectory?
• Are the scientific and technical merits of the research question, design, and methodology appropriate?
• Is the research project to be conducted in a different institutional setting, or within a different department in the same institutional setting, from the candidate’s primary appointment?
• Is the proposed research project likely to advance knowledge in PCOR?
• Will there be novel methods to engage stakeholder groups (e.g. clinicians, consumers, policymakers, insurers, buyers, and administrators)?
• Are there innovative approaches for rapid and efficient design, and implementation? Will there be production of publicly available PCOR tools?
• Is there consideration at the outset of the research on how to disseminate and incorporate the findings of the study into practice?
• Will there be utilization of study designs and analytical methods that can detect treatment effects and adverse outcomes in patient subgroups?

Mentor/Co-Mentor(s), Consultant(s), and Collaborator(s):

• Are the mentor(s) research qualifications in the area of the proposed research appropriately strong, including evidence of an established, active research program in the relevant domain or discipline?
• Is there evidence of the mentor(s) commitment to provide the proposed training?
• Is a signed statement from each mentor included in the application addressing his/her research qualifications, experience as a mentor, a mentoring plan, an overview of the mentor’s ongoing research activities and grant support, and confirming their role?

Environment and Institutional Commitment:

• Is there a clear commitment of the candidate s institution to ensure that a minimum of 50% of the candidate’s effort will be dedicated to the research career development plan during the active period of the award?
• Does the mentor(s) institution have adequate and appropriate research facilities for the proposed research plan?
• Is there evidence of institutional commitment to the candidate’s career development in the new research trajectory?
• Are the research facilities and training opportunities available to the candidate at the location where the research is to be conducted (i.e., mentor’s institution) of high quality and appropriate to the planned research?

2.A. Additional Review Criteria

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

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

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). For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following:

1) Risks to the subjects, likelihood & seriousness:

• Are all risks identified?
  
• Are all subject pools identified (e.g., are providers subjects)?

2) Adequate protection from risks:

• Is there evidence of adequate data security?
  
• Are there special populations that need protections?

3) Potential benefits to subjects and others:

• Has the PD/PI identified all anticipated benefits?

4) Importance of the knowledge to be gained:

• Does the project propose to provide social benefit?

5) For research involving interventions with human subjects where there is a greater than minimal risk, reviewers will review and comment on:

• Adequacy of the proposed Data and Safety Monitoring plan
  
• Any proposed monitoring function, such as monitoring committees, or boards.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

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, Required Federal Citations below.). In particular, note that reviewers will:

• evaluate the proposed plan and justification for the inclusion of priority populations or evaluate the proposed justification when priority populations are absent.
• evaluate the proposed exclusion of priority populations when a requirement for inclusion would be inappropriate with respect to the purpose of the research.
• evaluate the plans for outreach and recruitment of study participants where appropriate.
• evaluate the proposed plan for conducting subgroup analyses so that study results will be relevant to one or more priority populations where appropriate.
• include these criteria as part of the scientific assessment and assigned score.

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.

2.B. Additional Review Considerations

As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.

Training in the Responsible Conduct of Research. Taking into account the specific characteristics of the career development program, level of candidate experience, and the particular circumstances of the candidate, the reviewers will address the following questions. Does the plan satisfactorily address the format of instruction, e.g., lectures, coursework and/or real-time discussion groups? Do plans include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety? Do the plans adequately describe how faculty will participate in the instruction? Does the plan meet the minimum requirements for RCR, i.e., eight contact hours of instruction every four years? Plans and past record will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

Budget and Period of Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Selection Process

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

• Scientific 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 and programmatic balance
• Portfolio balance within AHRQ and DHHS

2.C Resource Sharing Plan(s)

Data Confidentiality

The AHRQ confidentiality statute, 42 USC 299c-3(c), requires that information that is obtained in the course of AHRQ-supported activities and that identifies individuals or establishments be used only for the purpose for which it was supplied. Information that is obtained in the course of AHRQ-supported activities and that identifies an individual may be published or released only with the consent of the individual who supplied the information or is described in it. There are civil monetary penalties for violation of the confidentiality provision of the AHRQ statute, 42 USC 299c-3(d). In the Human Subjects section of the application, applicants must describe procedures for ensuring the confidentiality of the identifying information to be collected. The description of the procedures should include a discussion of who will be permitted access to this information, both raw data and machine readable files, and how personal identifiers and other identifying or identifiable data will be restricted and safeguarded. Identifiable patient health information collected by grantees under this FOA will also be obtained and managed in accordance with the HIPAA Privacy Rule, 45 CFR Parts 160 and 164. These regulations serve to limit the disclosure of personally identifiable patient information by covered entities and define when and how such information can be disclosed e.g., to researchers. Thus, health care plans ordinarily will require either patient authorization for disclosures of identifiable information to be made to researchers or waivers of such authorizations obtained from an IRB or Privacy Board (defined in the regulations), which will involve review to ensure that identifiable health information will be appropriately safeguarded by the investigators. The DHHS Office of Civil Rights is the enforcement body for this regulation. Additional information about the regulations, their implementation, and alternative methods of permissible disclosures to researchers (limited data sets with data use agreements, de-identified data sets, data about deceased persons, and data use to develop protocols) can be obtained from: http://www.hhs.gov/ocr/hipaa/

The grantee should ensure that computer systems containing confidential data have a level and scope of security that equals or exceeds that established by the HIPAA Security Rules if applicable (see HIPAA website in prior paragraph) and that established by the Office of Management and Budget (OMB) in OMB Circular No. A-130, Appendix III - Security of Federal Automated Information Systems. The National Institute of Standards and Technology (NIST) has published several implementation guides for this circular. They are: An Introduction to Computer Security: The NIST Handbook; Generally Accepted Principals and Practices for Securing Information Technology Systems; and Guide for Developing Security Plans for Information Technology Systems. The circular and guides are available on the web at http://csrc.nist.gov/publications/nistpubs/800-12/. The applicability and intended means of applying these confidentiality and security standards to subcontractors and vendors, if any, should be addressed in the application.

Sharing Research Resources: Rights in Data

Unless otherwise provided in grant awards, AHRQ grantees may copyright, or seek patents for, as appropriate, final and interim products and materials developed in whole or in part with AHRQ support, including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses. Such copyrights and patents are subject to a royalty-free, non-exclusive, and irrevocable AHRQ license to reproduce, publish, use or disseminate for any purpose consistent with AHRQ’s statutory responsibilities and to authorize others to do so for any purpose consistent with AHRQ’s statutory responsibilities. 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), which incorporates additional applicable provisions on Rights in Data, including 45 CFR Part 74 and 37 CFR Part 401.

3. Anticipated Announcement and Award Dates

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

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

2. Administrative and National Policy Requirements Reporting

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.

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

3. Reporting

For multi-year grants, awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually. 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 must include Sections (A) through (F) as described in Section 2.2.6 (Progress Report Summary) in the general PHS form 2590 instructions, as well as sections G through J as described in Section 5 of the 2590 instructions. Evaluation of the awardee’s progress will encompass the following:

• A demonstration of scientific progress toward achieving the aims of the research as described in a brief summary of the studies and results obtained during the prior funding period;
• A description of career development and research-related activities undertaken during the prior funding period.
• A list of accomplishments such as publications, scientific presentation, new collaborations, inventions, or project-generated resources made during the prior funding period;
• A brief explanation of plans to address the specific aims during the next year of support;
• A description of proposed career development and research-related activities for the next year of support with a clear indication of percent effort devoted to research/research training and other activities.
• An annual evaluation statement of the candidate s progress by the mentor, as required in the PHS 2590 continuation application instructions (item J. Mentor’s Report).

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

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

Other Reporting Requirements

Evaluation: In carrying out its stewardship of human resource-related programs, AHRQ may request information essential to an assessment of the effectiveness of this Program. Accordingly, recipients are hereby notified that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the research training program.

Other Income: Awardees may retain royalties and fees for activities such as scholarly writing, service on advisory groups, honoraria from other institutions for lectures or seminars, fees resulting from clinical practice, professional consultation or other comparable activities, provided these activities remain incidental, are not required by the research and research-related activities of this award, and provided that the retention of such pay is consistent with the policies and practices of the grantee institution.

All other income and fees, not included in the preceding paragraph as retainable, may not be retained by the career award recipient.

Usually, funds budgeted in an AHRQ-supported research grant for the salaries or fringe benefits of individuals, but freed as a result of a career award, may not be re-budgeted. The awarding component will give consideration to approval for the use of released funds only under unusual circumstances. Any proposed retention of funds released as a result of a career award must receive prior written approval of the AHRQ awarding component.

Leave Policies: Leave to another institution from which the career development is taking place, including a foreign laboratory, may be permitted if the proposed experience is directly related to the purpose of the award.

A copy of a letter or other evidence from the institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made. Support from the career award will continue during such leave.

Leave without award support may not exceed 12 months. Such leave requires the prior written approval by AHRQ and will be granted only in unusual situations.

Support from other sources is permissible during the period of leave without award support. Such leave does not reduce the total number of months of program support for which an individual is eligible.

Publication and Sharing of Research Results: AHRQ supports the practical application and sharing of outcomes of funded research. Therefore, grantees should make the results and accomplishments of their career development activities available to the research community and to the public at large. The grantee organization should assist grantees in these activities, including the further development of discoveries and inventions for furthering research and benefiting the public. No restrictions should be placed on the publication of results in a timely manner.

Candidates are encouraged to submit reports of their findings for publication to the journals of their choice. For each publication that results from a trainee’s research, AHRQ support must be acknowledged by a footnote in language similar to the following: This investigation was supported by the Agency for Healthcare Research and Quality (AHRQ) under National Research Service Award (number). Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the AHRQ.

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

Section VII. Agency Contacts

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

1. Scientific/Research Contact(s):

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

Mitra Ahadpour, M.D., M.P.H.
Office of Extramural Research, Education and Priority Populations
Division of Research Education
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1012
Email: [email protected]
FAX: (301) 427-1562

2. Peer Review Contact(s):

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

Kishena Wadhwani, Ph.D.
Office of Extramural Research, Education and Priority Populations
Division of Scientific Review
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1556
Fax: (301) 427- 1362
E-mail address: [email protected]

3. Financial/Grants Management Contact(s):

Direct inquiries regarding fiscal matters to:

Galen Gregor
Office of Performance Accountability, Resources and Technology
Grants Management
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1457
Fax: (301) 427-1462
E-mail address: [email protected]

Section VIII. Other Information

Required Federal Citations

Inclusion of Women and Minorities in Research Study Populations:

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

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

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

Human Subjects Protection:

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

Standards for Privacy of Individually Identifiable Health Information:

The 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.

Access to Research Data through the Freedom of Information Act:

OMB Circular A-110 provides access to certain research data developed with Federal support through the Freedom of Information Act (FOIA), 5 U.S.C. 552, in certain circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation or administrative order) may be accessed through FOIA. If no Federal action is taken having the force and effect of law in reliance upon an AHRQ-supported research project, the underlying data are not subject to this disclosure requirement. Furthermore, even if a Federal regulatory action is taken in reliance on AHRQ-supported research data, disclosure of such data is limited in accordance with the AHRQ confidentiality statute, 42 USC 299c-3(c). 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 2020:

The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2020," 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 2020" at http://www.health.gov/healthypeople.

Authority and Regulations:

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

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