Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

Agency for Healthcare Research and Quality (AHRQ)

NOTE: The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH. Where this Funding Opportunity Announcement (FOA) provides specific written guidance that may differ from the general guidance provided in the grant application form, please follow the instructions given in this FOA. Also note that AHRQ may have different page limits than NIH for the application Research Strategy, which can be found within each individual FOA (see Section IV below). AHRQ Grants Policy and Information to applicants regarding Funding Opportunity Announcement procedures can be found at Funding Opportunity Announcement Guidance.

Components of Participating Organizations

Agency for Healthcare Research and Quality (AHRQ)

Funding Opportunity Title

AHRQ Patient Centered Outcomes Research (PCOR) Institutional Mentored Career Development Program (K12)

Activity Code

K12 The Mentored Clinical Scientist Development Program Award

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-HS-13-008

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.226

Funding Opportunity Purpose

The purpose of this solicitation is to support the career development of post-doctoral and junior research and clinical doctorate faculty scholars in comparative effectiveness research methods, applied to patient-centered outcomes.

Key Dates
Posted Date

April 19, 2013

Open Date (Earliest Submission Date)

June 17, 2013

Letter of Intent Due Date(s)

June 7, 2013

Application Due Date(s)

July 17, 2013, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable.

Scientific Merit Review

Generally, four months after receipt date

Advisory Council Review

Not Applicable

Earliest Start Date

Generally, four months after peer review date

Expiration Date

July 18, 2013

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide including the Supplemental Instructions to the SF424 (R&R) for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants 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 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description

Purpose

This program proposes to launch a multi-year large-scale effort to support the development of patient centered outcomes (PCOR) researchers in academic and applied settings (e.g., the health care delivery system, state and local governments, health plans, research networks). Applicant institutions must be well poised to directly provide or partner with those who can provide the needed didactic and experiential opportunities for candidates in sophisticated comparative effectiveness methodologies applied to PCOR. They must also have the capability to expose candidates to accelerated clinical effectiveness and outcomes research and to the translation, dissemination and uptake of evidentiary information for health care practice and decision-making.

Applicants can be academic or non-academic institutions. Academic programs will be expected to partner with applied settings in order to provide experiential research opportunities for candidates. Similarly, non-academic applicants responding to this announcement are expected to partner, with academic institutions for formal, educational training needs. Grantee institutions and the K12 Program Director will be responsible for the recruitment, placement, and mentoring of eligible scholar candidates.

Eligible scholar candidates include post-doctoral fellows and junior faculty or their counterparts in non-academic settings. AHRQ strongly encourages the recruitment of scholars from racial and ethnic minority groups. AHRQ also encourages submission of applications from minority serving institutions and institutions which provide health care to economically disadvantaged populations and/or have access to unique data on these populations.

Applications must propose a career development program that maximizes the use of available research, educational and partnership resources, curriculum, and qualified research faculty as mentors. The entire program must 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, must incorporate two components: 1) experiential and/or didactic learning (e.g., directed study/tutorials, coursework, seminar series, journal clubs), and 2) a research project conducted in conjunction with and normally at the host research facility.

This institutional career development program is intended to provide grant support for five years. Scholar appointments must be based on continuous, full-time, 12-month support. Scholars appointed to the program should be committed to two or three years of mentored training and career development and to a career in applying advanced comparative effectiveness research methods to PCOR, which also aims at the integration of evidence into practice and decision-making in the United States health care system.

The proposed institutional research career development program may complement other, ongoing research training and career development programs at the applicant institution, but the proposed career development experiences must be distinct from those career development programs currently receiving Federal support. Information on other Federally-supported career development programs must be provided within the research training program plan section of the application.

Each proposed program must:

(1) have intrinsic research importance in the area of PCOR;

(2) serve as a suitable vehicle for learning the methodology, theories, and concepts needed for a well-trained PCOR researcher;

(3) ensure high research productivity; and

(4) sufficiently prepare scholars for PCOR research using Comparative Effectiveness Research (CER) methodology that is responsive to, and involves stakeholders in, the development of the research and in the dissemination and implementation of research findings. Research projects conducted by scholars must be designed to provide a strong foundation for conducting PCOR. The entire program should be designed to rigorously monitor and provide well-defined policies and a structure to ensure progress for all scholars.

Research Career Training Objectives:

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. 42 U.S.C. 299b-37(e). Section 937(e) also provides that such training is required to be in methods that meet the methodological standards adopted and updated by the Methodology Committee of the Patient-Centered Outcomes Research Institute (see http://www.pcori.org/what-we-do/methodology/). See also 42 U.S.C. 299a(b), which authorizes AHRQ to provide training grants in the field of health services research.

This FOA solicits applications which apply CER methods to PCOR. For purposes of this FOA, CER 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. AHRQ is interested in applications which propose the utilization of CER methods to address PCOR. The intent is to improve health outcomes by developing and disseminating evidence-based information to patients, clinicians, and other decision-makers. Applicants must respond to needs identified by stakeholders 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.

Example areas of CER 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, randomized, or practical 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;

Meta-analysis and systematic review methodology;

Decision science modeling and analysis;

Design, analytical tools, and statistical techniques for reducing, confounding and mitigating the impacts of potential bias inherent in the observational studies of comparative effectiveness;

Communication of the 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, within a comparative effectiveness framework;

Training in the use of registries, combining large-scale longitudinal data sets, and data mining techniques (as applied to comparative effectiveness research questions);

The ability to conduct subgroup analyses to determine which treatments and interventions work best for specific populations, such as underserved and underrepresented groups, with the intent to focus on reduction of disparities;

Specific plans for disseminating the findings and incorporating them into health care delivery must be developed.

PCOR components include:

Utilization of a translational framework to provide theoretical underpinnings and organizing structure to help identify appropriate analytical designs and methods most suitable for addressing specific PCOR research questions;

Engagement of stakeholders (e.g., providers, consumers, community groups, payers, purchasers, policymakers, administrators) in the formulation of the scholar's research (in the development of research questions, measurement of outcomes, the design of projects, and as necessary , participation in the research), and to the extent necessary, the implementation and dissemination of the research;

Demonstrated 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;

Assessment of the benefits and harms of preventive, diagnostic, therapeutic, palliative, or health delivery system interventions to inform decision making, highlighting comparisons and outcomes that matter to people; and

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.

Section II. Award Information
Funding Instrument

Grant.

Application Types Allowed

New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

AHRQ intends to fund approximately 8-10 awards, for up to a total of $7.5 million. Applications must be five years in duration with a budget supported by AHRQ not to exceed $1,000,000 per year in total costs (combined direct and indirect). Awards issued under this FOA are contingent on the availability of funds and the submission of a sufficient number of meritorious applications.

Award Budget

Total annual costs (combined direct and indirect) for an individual grant awarded under this FOA will not exceed $1,000,000. .

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://dhhs.gov/asfr/ogapa/grantinformation/hhsgps107.pdf).

Award Project Period

The project period may not exceed 5 years.

Other Award Budget Information
Personnel Costs

The PD/PI may request salary and fringe benefits appropriate for the person months devoted to the program. Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap.

It is expected that the PD/PI will devote not less than 10% and no more than 20% effort annually to this K12 program. Salary and fringe benefit support for the PD/PI may not exceed $25,000 direct costs annually, regardless if the PD/PI is a mentor.

Salary and fringe benefit support can be requested for mentors. Total support for mentoring cannot exceed $5,000 in direct costs annually per mentor. The total number of mentors requesting salary support annually cannot exceed the total number of scholars appointed to the grant annually. Salaries requested may not exceed the levels commensurate with the institution s policy for similar positions. If mentoring interactions and other activities with scholars are considered a regular part of an individual's academic duties, then mentoring and other interactions with scholars are non-reimbursable from grant funds

Limited program-related administrative and clerical salary costs associated distinctly with the program that are not normally provided by the applicant organization may be direct charges to the grant only when they are in accordance with applicable cost principles. Total salary and fringe benefit support for administrative and clerical costs cannot exceed $25,000 direct costs annually and must be reasonable and justified. These costs must be specifically identified and justified, and must be itemized in Sections A and B, as appropriate, of the R&R Budget.

Other personnel costs cannot be requested under Sections A and B of the R&R Budget.

The applicant can request up to $1,200 per person for the PD/PI and up to five designated scholar mentors for a one-time meeting with scholars and AHRQ to be convened during the course of the grant.

Participant Costs

Scholars (i.e., participants) are those individuals who benefit from the proposed activities and experiences involved in the career development program. Scholar costs must be justified as specifically required for the proposed career development program and based on institutional policies for salaries paid to individuals in similar positions, regardless of the source of funds. These expenses must be itemized in the proposed budget.

AHRQ will provide salary support for the K12 scholars of up to $90,000 annually plus associated fringe benefits. The K12 requires the appointed scholar to devote a minimum of 75 percent annual effort to the grant. Each scholar must be appointed for a minimum of two and a maximum of three years. Scholars are not allowed to reduce their level of effort over the course of the award. The total salary requested must be based on a full-time, 12-month staff appointment and on institutional policies for salaries paid to individuals in similar positions, regardless of the source of funds. 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.

The sponsoring institution may supplement the AHRQ salary contribution up to a level that is consistent with the institution's salary scale. However, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case may PHS funds be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the K08 award. Under expanded authorities, however, institutions may re-budget funds within the total costs awarded to cover salaries consistent with the institution's salary scale. The total salary, however, may not exceed the legislatively mandated salary cap.

The application must clearly indicate the number and type (postdoctoral fellow or junior faculty) of scholar appointments proposed.

Other Program Related Expenses

Up to $25,000 per scholar per year may be requested as a lump sum under "Other Expenses" for research-development support costs such as: travel to scientific meetings; consultant costs; research supplies; equipment, tuition, fees, and books related to didactic courses or career development; health insurance (self-only or family); and statistical services including personnel and computer time. Costs cannot be pooled and used for advertising, recruitment, or other programs unrelated or indirectly related to the research activities of individual candidates or appointees. These expenses must not duplicate items generally available at the applicant institution. Short-term rotation costs are included in the $25,000. However, costs allowed for the short-term rotation may not duplicate any costs/benefits allowed for the salaried scholars in the K12 program. These expenses need to be specifically identified, reasonable, and justified.

It is anticipated that a meeting of scholars and program directors will be convened once during the course of the grant. Travel costs associated with scholars attending this meeting, which will be held in the Washington D.C area, must be included as part of the research development support costs. If requested, expenses for foreign travel must be exceptionally well justified.

Indirect Costs

Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees and expenditures for equipment), rather than on the basis of a negotiated rate agreement.

All applications submitted and AHRQ grants made in response to this FOA are subject to AHRQ's grant regulations at 42 CFR Part 67, Subpart A, the HHS Grants Policy Statement (see http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html and http://dhhs.gov/asfr/ogapa/grantinformation/hhsgps107.pdf), and the terms and conditions set forth in the Notice of Award.

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

You may submit an application(s) if your institution/organization is a (an):

AHRQ’s authorizing legislation does not allow for-profit organizations to be eligible to lead applications under this research mechanism. 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.

The sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program.

The applicant institution must have a strong and high quality research program in the area(s) proposed under this FOA and must have the requisite faculty/researchers and facilities on site to conduct the proposed institutional program. In many cases, it is anticipated that the proposed program will complement other ongoing career development programs occurring at the applicant institution and that a substantial number of program faculty/researchers will have active research projects in which participating scholars may gain relevant experiences consistent with their research interests and goals. Institutions with existing programs must explain what distinguishes this program from the others, how their programs will synergize with one another, if applicable, and make it clear that the pool of faculty, potential scholars, and resources are robust enough to support additional programs.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

The Program Director/Principal Investigator (PD/PI) must also work with his/her institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

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

The PD/PI must be an established researcher in the area of comparative effectiveness research with a documented record of superior accomplishment, scientific expertise, leadership and administrative skills. The PD/PI must have experience in the design, implementation and management of related research training programs for developing clinical investigators, and must be able to demonstrate a superior record of preparation of post doctoral researchers who conduct clinical comparative effectiveness research and have demonstrated a successful record of involving health system stakeholder input and partners in the conduct of research that has influenced health care delivery beyond the bed-side. The PD/PI must be able to demonstrate access to institutional or other funds for a scholar to complete his /her research project in the event of a gap in his or her mentor’s research funding.

Only one PD/PI may be designated on the application.

2. Cost Sharing

This FOA does not require cost sharing.

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. Additional Information on Eligibility


Number of Applications

Applicant organizations may submit more than one application, provided that each application is programmatically distinct.

AHRQ will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months, except for submission:

Mentors

Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as mentors. Mentors must have research expertise and experience relevant to the proposed program. Mentors must be committed to continue their involvement throughout the total period of the award.

Each scholar appointed to the program must have a primary mentor. All proposed mentors must: (1) be recognized as accomplished investigators in the area of comparative effectiveness research, and/or clinical epidemiology; (2) be actively involved in comparative effectiveness research; (3) have a successful record of providing the type of career development and training activities required under this award; and (4) have a successful record of engendering his or her scholars research careers as evidenced by scholars research productivity, their ability to obtain/participate in a continuing role in independent research, and their ability to work with health system stakeholders in a responsive fashion that has an impact on health care delivery.

Participants

Once selected to the program, candidates/participants will be referred to as scholars. The research experience of the candidates selected for support under this award should resemble those supported by the individual Mentored Clinical Scientist Development Award (K08), the Mentored Research Scientist Development Award (K01), the Mentored Patient-Oriented Career Development Award (K23), or postdoctoral trainees and fellows appointed to F32 or T32 grants or eligible for K99 grants. Scholars to be supported by the institutional career development program must be at the career level for which the planned program is intended and appointed for a two- or three-year period.

It is recognized that not all candidates will be named upon submission of the application or start of the grant. To the extent that individuals and their salary levels and research development costs are known at the time of application, they should be individually included and justified. In lieu of this level of specificity, applicants may provide a more general justification for these costs within the guidelines of allowable components. As much detail as possible, however, is necessary in order to provide reviewers with a sense of anticipated needs/demand (e.g., What are average salary and tuition needs, average mentoring needs, average statistical support and computing needs, average insurance needs, average travel needs, etc.? If these needs vary by the types of scholars anticipated, what is the anticipated mix of the components required for how many of each type of scholar requested in the budget? All of these estimates should be based on the institution s anticipated pool of candidates).

Candidates must be U.S. citizens or non-citizen nationals, or individuals lawfully admitted for permanent residence, and who have earned a clinical or research doctorate, including Ph.D., Sc.D, Dr.P.H., M.D., D.O., D.C., N.D., D.D.S., D.M.D., D.N.S. or equivalent doctoral degree at the time of appointment. As noted above, these candidates must demonstrate commitment to conducting comparative effectiveness research, applied to PCOR. There are no specific requirements that scholars need to be postdoctoral fellows or junior faculty or that persons of differing ranks (e.g., fellow vs. junior faculty) must be provided the same level of salary support.

Candidates must be able to commit a minimum of nine person-months (75% of full-time professional effort) conducting research career development activities associated with this award for a two or three year period. The remaining three months (25% effort) can be divided among other research, clinical, and teaching activities only if these activities are consistent with the goals of the Award, i.e., the candidate’s development into an independent investigator.

At the time of placement on the grant, candidate must have a full-time appointment at the institution that is the applicant institution.

All scholars appointed to this grant can move on to individual mentored career development support grants upon completion of their two- or three-year appointment on the K12 grant. Any scholar appointed to an AHRQ-supported K12 program or an AHRQ-supported individual mentored career development may not exceed a total of five years of AHRQ mentored career development support.

Individuals are eligible for placement as a scholar if they have been, or currently are the PD/PI of an NIH or AHRQ R36, F31, or F32 grant or a Federal or non-Federal award that duplicates the provisions or research goals of these grants and otherwise meet all other eligibility criteria. The scholar will have to terminate the existing award before being appointed to the K12. Individuals are also eligible to be scholar candidates if they have been, or currently are the PD/PI of an NIH or AHRQ R03 or R21 grant or a Federal or non-Federal award that duplicates the provisions or research goals of an R03 or R21 grant.

Individuals are NOT eligible to be scholar candidates if they:

Have simultaneously submitted or have an application pending peer review for any other Federal career development award, or a research project grant (R01). However, individuals may concurrently submit an application for an AHRQ or NIH Small Grant (R03) or Exploratory/Developmental Grants (R21);

Have simultaneously submitted or have an application pending peer review for any non-Federal research grant, contract, or cooperative agreement over $100,000 direct costs per year;

Have been or are currently a PD/PI on any other Federal mentored career development awards;

Have been or are currently supported on an institutional K12 grant or KL2 (or similar grant);

Have been or are currently a PD/PI on a Federal research grant (such as R01, R29, P01) or subproject leaders on Program Project (P01) and Center Grants (P50); and/or

Have been or are currently a PD/PI on peer-reviewed non-Federal research grants, contracts or cooperative agreements over $100,000 direct costs per year.

Note that K12 Scholars should be strongly encouraged to apply for independent research grant support (e.g., R01, R21, R03) by the end of their final year of appointment to the K12 grant.


Details on citizenship requirements are available in the HHS Grants Policy Statement at http://dhhs.gov/asfr/ogapa/grantinformation/hhsgps107.pdf.

Section IV. Application and Submission Information


1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows AHRQ staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

The letter of intent is to be sent electronically to:

Jennifer E. Moore, Ph.D., R.N.
Patient Centered Outcomes Research (PCOR) Service Fellow
Agency for Healthcare Research and Quality (AHRQ)
Office of Extramural Research, Education and Priority Populations (OEREP)
Email: Jennifer.Moore@ahrq.hhs.gov
Office: 301-427-1394

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow the instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

Page Limitations

All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed.

SF424 (R&R) Other Project Information Component

Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA), with the following modification:

Substitute all references to trainees in the SF424 (R&R) Application Guide with scholars and all references to training in the SF424 (R&R) Application Guide with career development .

Project Summary /Abstract

Provide an abstract of the entire application, including the long-term goals and objectives of the program. Include the rationale and design of the program, the planned duration of the program and the projected number of scholars, including their levels (i.e., postdoctoral, faculty).

The filename provided for each Other Attachment will be the name used for the bookmark in the electronic application in eRA Commons.

Research and Related (R&R) Budget Component

Follow all instructions provided in the SF424 (R&R) Application Guide with the following modifications:

PHS 398 Research Training Program Plan

All Supplemental Instructions to the SF424 (R&R) for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application must be followed, with the additional instructions described below:

Substitute all references to trainees in the SF424 (R&R) Application Guide with scholars and all references to training in the SF424 (R&R) Application Guide with career development .

Program Administration (Component of Program Plan)

Describe the strengths, leadership and administrative skills, and scientific expertise of the PD/PI. Include the planned strategy and administrative structure to be used to oversee and monitor the program.

Program Faculty (Component of Program Plan)

Describe in general terms the complementary expertise and experiences of the proposed mentors. This does not need to include all possible mentors, but should focus on key individuals with comparative effectiveness methodological expertise who are likely to serve as mentor for scholars. Provide an overview of their active research and other scholarly activities, as well as track records of mentoring and training.

Proposed Training (Component of Program Plan)

Provide an overview of the proposed program: Describe the immediate and long-term objectives of the program, including activities that will be used to ensure that the objectives of the program are met. Include information about planned courses, curricula, seminars, workshops, or tutorials that will be incorporated into the training program and mentored research experiences and activities (including core competencies to be conveyed, the method they will be conveyed, and how they will be assessed. Institutions with existing career development programs must explain what distinguishes this program from the others, how the programs will synergize, if applicable, and justify that the faculty, pool of potential trainees, and resources are robust enough to support additional programs). The description must include planned strategies to be used to ensure that the objectives are met. The PD/PI must also describe past research career development activities/experiences including those of mentors, documenting the success of former trainees in establishing independent productive scientific careers. Plans should also address training required for professional development, communication of research, and translation of research into practice and/or policy. Specific mentoring plans should be included. The plan should also include descriptions of any proposed rotations/practicum in PCOR, which will be made available for scholars in academic-based programs. These are not required, but highly encouraged for academic-based applicants. They should be designed to take advantage of PCOR career development experiences not available at, but complementary to, those at the applicant institution. Documentation of commitment on the part of the stakeholder group should be included in the application, but does not count toward the research training plan page limitation.

Program Evaluation (Component of Program Plan)

Describe an evaluation plan to review and determine the effectiveness of the program. This should include plans to obtain feedback from current and former scholars to help identify weaknesses and to provide suggestions for program improvements, as well as plans for assessing trainees career development and progression, including metrics such as degree completion (if applicable), publications, and subsequent positions. Specified evaluation metrics should be tied to the goals of the program. Evaluation results should be included in future renewal applications and in the Final Progress Report.

Trainee (Scholar) Candidates (Component of Program Plan)

Describe in general terms the pool of potential candidates including information about the types of prior clinical and research training and the expected career level required for the program. Describe plans to recruit candidates and explain how these plans will be implemented (see also section on Recruitment and Retention Plan to Enhance Diversity). Describe the evaluation criteria to be used in the selection of scholars. Provide brief summaries of career development plans that the program will employ. The application must contain a description of how career development plans will be tailored to the needs of the prospective candidates, taking into account their past experiences and competences. The plan should guarantee existence of an adequate group of highly qualified potential candidates available to embark on a two- to three- year commitment to career development in PCOR that is responsive to stakeholder needs.

Institutional Environment and Commitment to the Program (Component of Program Plan)

The application must include a statement from the applicant institution describing the commitment to the planned program. The institution must assure that essential time will be allowed for the PD/PI, other faculty and mentors, and that the PD/PI will require that institutions selected by scholars for mentored career development research activities will provide written assurance of protected time for, as well as essential time for faculty involved in mentoring. Include documentation of an institution's commitment to the proposed research career development program's goals, and a description of support, financial or otherwise, to be provided to the program. The support could include space, equipment, release time for the PD/PI and participating faculty, support for additional scholars in the program, or any other creative ways to improve and enhance the growth of the research career development program.

Recruitment and Retention Plan to Enhance Diversity

Individuals are required to comply with the instructions for Recruitment and Retention Plan to Enhance Diversity as provided in Chapter 8 of the SF424 (R&R) Application Guide.

Plan for Instruction in the Responsible Conduct of Research

Individuals are required to comply with the instructions for Plan for Instruction in the Responsible Conduct of Research as provided in Chapter 8 of the SF424 (R&R) Application Guide.

Data Tables

Standardized data tables for institutional training and career development programs (e.g., T32 and K12 programs) are located at http://grants.nih.gov/grants/funding/424/index.htm#datatables. The data tables are designed to enable consistent entry and review of data for training program faculty and scholars. The information provided in these data tables is not counted toward the 25 page limitation for the main body of the application (Items 2.2-2.4 in the SF424 instructions). Applicants are required to include only Tables 2, 4, 5B and 6B. Please read the Introduction to the Data Tables linked on the above web site before starting to prepare the tables. The data tables should be numbered consecutively and titled as shown, even if some are not used. Indicate by table number and title those tables that are intentionally omitted. The information included in the data tables should be used to present a detailed documentation of the proposed K12 Program.

Tables 5B and 6B should include both postdoctoral fellows as well as junior faculty supported through individual or institutional mentored career development grants. Publications of past scholars should only include work conducted during their period of training, regardless of when the publication actually appeared, may be listed in Table 6B. Applicants may provide explanatory notes at the bottom of the standardized data tables.

Additional tables may be included as part of the research training program plan. However, such tables will count toward toward the 25-page limit.

Appendix

Do not use the Appendix to circumvent page limits of the research training plan. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

All appendix materials must be submitted as PDF attachments. A summary listing of all appendix materials is required and should be the first PDF file of the appendix. All appendix materials must only include information relative to patient-centered outcomes or comparative effectiveness research,

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application before the deadline in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

4. Intergovernmental Review (E.O. 12372)

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://dhhs.gov/asfr/ogapa/grantinformation/hhsgps107.pdf.

Pre-award costs are not allowable without AHRQ prior approval.

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

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:

The PD/PI must include his/her eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH and for responsiveness by AHRQ. Applications that are incomplete will not be reviewed.

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

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

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

Priority Populations

AHRQ supports research, evaluations, and demonstration projects concerning 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. 42 USC 299(c). 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 is provided that inclusion is inappropriate, e.g. because of the lack of connection between the study and the health of women or particular minorities. Investigators should review the document entitled, AHRQ Policy on the Inclusion of Priority Populations, which is available at http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html.

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 should 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.

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.

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 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.

Section V. Application Review Information


1. Criteria

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.

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:

Administrative Criteria: Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH, and for responsiveness by AHRQ.

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

Overall Impact

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

Scored Review Criteria

Reviewers will consider each of the 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.

Career Development Program and Environment

Does the proposed program clearly outline a plan to recruit and develop well-qualified junior investigators for successful careers as researchers in applying CER methods to PCOR? Is there evidence of an adequate pool of potential scholars who could benefit from receiving career development support? Are the content and duration of any proposed didactic, training-related, and research-related activities of the program appropriate and aligned with CER and PCOR? Are appropriate timelines indicated for career progression and transition to independence? Does the institutional environment (e.g., research facilities and other relevant resources) in which the program will be conducted contribute to the probability of success? Does the proposed career development program benefit from unique features of the scientific environment, subject populations, or employ useful collaborative arrangements? Is the institutional commitment to the proposed program appropriate? If multiple sites are participating, is this adequately justified in terms of the career development and research experiences provided? Is there sufficient assurance that the required effort of the PD/PI, mentors and scholars will be devoted directly to the career development activities? Does the program have a rigorous evaluation plan to assess the quality and effectiveness of the career development program? Additionally, for non-academic institutions, is there evidence of effective partnership with an academic institution to ensure robust formal educational training?

Program Director/Principal Investigator (PD/PI)

Does the PD/PI have the experience to develop, direct and administer the proposed program? Does the leadership team bring complementary and integrated expertise in CER and PCOR to the program? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure program objectives? Are the research qualifications, scientific stature, previous leadership and mentoring experience, and track record(s) appropriate for the proposed career development program? Is the PD/PI currently engaged in research relevant to the scientific area of CER and PCOR as outlined in the proposed program?

Mentors

Do the mentors have CER and PCOR expertise and experience, as well as track records of past mentoring and training? Are the quality and extent of the mentors roles in providing guidance and scientific advice to the scholars acceptable? Are the mentors currently engaged in relevant CER and PCOR scholarly activities?

Candidates/Scholars

Is a recruitment plan proposed with strategies likely to attract high quality scholar candidates? Are there well-defined and well justified recruitment and selection strategies? Is there evidence of a sufficiently large, competitive scholar pool to warrant the proposed size of the career development program? Is there an appropriate plan for the content, the phasing, and the proposed duration of the career development plan for achieving scientific independence for the prospective candidates? What is the likelihood that the career development plan will contribute significantly to the scientific development of the scholars? Does the plan for selection of the scholars include all of the eligibility criteria stated in the FOA?

Training and Career Development Record

Is there evidence of a successful past training and career development record of the PD/PI and mentors, including the success of former scholars in seeking independent support and establishing productive scientific careers?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

The involvement of human subjects and protection from research risk relating to their participation in proposed research will be assessed. See the "Human Subjects Section" of the Research Training Program Plan Component of the SF 424 (R&R).

Degree of Responsiveness

Reviewers will assess how well the application addresses the purpose and objectives of this FOA.

Inclusion of Priority Populations

Although this criterion is generally not applicable, reviewers will articulate any concerns to the attention of the Scientific Review Officer.

Budget and Period of Support

The committee will evaluate whether the proposed budget is reasonable, and whether the requested period of support is appropriate in relation to the proposed research.

Additional Review Considerations

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

Recruitment & Retention Plan to Enhance Diversity

Reviewers will separately evaluate the recruitment and retention plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented groups. The review panel s evaluation will be included in an administrative note in the summary statement. Plans and past record will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

Training in the Responsible Conduct of Research

Taking into account the specific characteristics of the career development program, level of scholar experience, and the particular circumstances of the scholars, 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 training in the responsible conduct of research, 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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group in accordance with AHRQ review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Applications will be assigned on the basis of established AHRQ referral guidelines to the appropriate AHRQ Office or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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 eRA Commons.

Information regarding the disposition of applications is available in the HHS Grants Policy Statement (see http://dhhs.gov/asfr/ogapa/grantinformation/hhsgps107.pdf).

Section VI. Award Administration Information


1. Award Notices

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

Once all administrative and programmatic issues have been resolved, a formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the AHRQ grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions.

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, SAM Registration, and Transparency Act requirements as noted on the AHRQ web site at http://www.ahrq.gov/fund/postawrd.htm#terms.

2. Administrative and National Policy Requirements

All AHRQ grant and cooperative agreement awards are subject to AHRQ’s grants regulations at 42 CFR Part 67, Subpart A, the HHS Grants Policy Statement (see http://www.ahrq.gov/fund/hhspolicy.htm), and the terms and conditions set forth in the Notice of Award.

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

3. Reporting

When multiple years are involved, grantees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually. Chapter 8 of the SF424 (R&R) Application Guide, Additional Instructions for Preparing a Progress Report for an Institutional Research Training Grant, Including Ruth L. Kirschstein National Research Service Awards, must be followed.

The annual progress reports must include Sections 2.2.6 A through F as described in the general PHS form 2590 instructions, as well as sections G through J as described in Section 5.1.4 of the 2590 instructions, and Part 6 of the 2590 instructions entitled, Additional Instructions for Preparing a Progress Report for an Institutional Research Training Grant. For details regarding progress report submission, refer to http://www.ahrq.gov/fund/noncomp.htm. If instructions on the AHRQ website are different from the PHS form 2590 instructions, follow the instructions on the AHRQ website.

The Progress Report is to include descriptive and evaluative comments on both completed activities and plans for the remainder of that year, including any changes foreseen in the future. At a minimum, the reports will include descriptive comments on: progress to date measured against project aims; methodological changes implemented; key preliminary findings; significant problems and resolutions; inclusion of priority populations; and project related publications, presentations, and dissemination activities. AHRQ does not currently limit the length of the progress report to 2 pages. AHRQ will provide the due date for submitting annual progress reports. In addition to the annual progress report, recipients may be required to submit quarterly progress reports to AHRQ. Detailed instructions on reporting requirements will be provided with the grant award. The annual Progress Report for the grant should also include: relevant information on rotations and practicums, including: how they were selected; experiences offered; and a list of the scholars and respective mentors involved.

Please note: The Research Performance Progress Report (RPPR) is a Federal-wide progress report which will eventually replace the PHS 2950. Grantees will be required to follow the new progress report guidelines when they become available.

Expenditure data is to be reported on the Federal Financial Report (FFR; SF 425). AHRQ requires annual financial expenditure reports for ALL grant programs as described in the HHS Grants Policy Statement (see http://www.ahrq.gov/fund/hhspolicy.htm). AHRQ implementation of the FFR retains a financial reporting period that coincides with the budget period of a particular project. However, the due date for annual FFRs will be 90 days after the end of the calendar quarter in which the budget period ends. Note that this is a change in due dates of annual FFRs and may provide up to 60 additional days to report, depending upon when the budget period end date falls within a calendar quarter. For example, if the budget period ends 4/30/2013, the annual FFR is due 9/30/2013 (90 days after the end of the calendar quarter of 6/30/2013).

A final Progress Report, final Federal Financial Report, and Final Invention Statement are required when an award ends. All final reports are due within 90 days of the project period end date. For further details regarding grant closeout requirements, refer to http://www.ahrq.gov/fund/closeout.htm.

Other Reporting Requirements

The institution must submit a completed Statement of Appointment (PHS Form 2271) for each scholar appointed or reappointed to the K12 grant. Grantees must submit the PHS 2271 data electronically using the xTrain system. More information on xTrain is available at xTrain (eRA Commons). An appointment or reappointment may begin any time during the budget period, but not before the budget period start date of the grant year. The institution must also submit the CV and one-page summary of the proposed training and research plan for each scholar to the Program Officer listed in this announcement.

4. 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 from databases and from participants themselves. Participants 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 program.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

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

Jennifer Moore, Ph.D., R.N.
Agency for Healthcare Research and Quality
Office of Extramural Research, Education and Priority Populations
Telephone: (301) 427-1394
E-mail address: Jennifer.Moore@ahrq.hhs.gov

Peer Review Contact(s)

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

Ali Azadegan, D.V.M.
Agency for Healthcare Research and Quality
Office of Extramural Research, Education and Priority Populations
Division of Scientific Review
Telephone: (301) 427-1869
Fax: (301) 427-1562
E-mail address: Ali.Azadegan@ahrq.hhs.gov

Financial/Grants Management Contact(s)

Direct your questions regarding fiscal matters to:

Galen Gregor, C.R.A.
Office of Performance Accountability, Resources and Technology
Grants Management
Agency for Healthcare Research and Quality
Telephone: (301) 427-1457
Fax: (301) 427-1462
E-mail address: Galen.Gregor@ahrq.hhs.gov

Section VIII. Other Information

Recently issued AHRQ policy notices may affect your application submission. A full list of policy notices published by AHRQ is provided in the NIH Guide for Grants and Contracts. Notices can also be found at AHRQ Grants Policy Notices.. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

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.


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