Part I Overview Information

Department of Health and Human Services

Participating Organizations
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: Mentored Clinical Scientist Research Career Development Award (K08)

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

Announcement Type
This Funding Opportunity Announcement (FOA) is a re-issue of PAR-07-443.

Update: The following updates relating to this announcement have been issued:

• February 7, 2012 - See Notice NOT-HS-12-006. Re-Activation of AHRQ Individual Career Development (K) Funding Opportunity Announcements (FOAs) for June 5, 2012 Receipt Date.
• December 15, 2011 - See Notice NOT-HS-12-003. Suspension of AHRQ Individual Career Development (K) Funding Opportunity Announcements (FOAs) for February 5, 2012 Receipt Date.
• October 6, 2011 - See Notice NOT-HS-12-001. This Notice extends the expiration date as indicated below by one year.
• February 22, 2011 - See Notice NOT-HS-11-011 Time Limitations for AHRQ Individual Career Development Award Support (K01 and K08).
• January 20, 2011 - Please see NOT-OD-11-036 informing applicants that the Letters of Reference are due by the application receipt deadline date.
• September 29, 2010 (NOT-OD-11-008) - Updated Electronic Application Forms Required for F, K, T and D Submissions with Due Dates of January 25, 2011 and Beyond. Adobe B1 forms are required for due dates on or after January 25, 2011.
• August 16, 2010 - IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.
• November 5, 2010 - See Notice NOT-HS-11-003 Special Emphasis Notice (SEN): AHRQ Announces Interest in Career Development (K01, K02, K08) Grants Focused on Healthcare-Associated Infections.
• January 20, 2010 - This FOA has been updated to reflect the new requirements from NIH’s Enhancing Peer Review Initiative. The new requirements are effective for submissions intended for due dates January 25, 2010 and beyond. If submitting an application intended for a due date of January 25, 2010 and beyond, follow the guidance below and be sure to use the Adobe-Forms-B version of the application forms and instructions. If applying for a due date before January 25, 2010, follow the guidance in the archived version of this FOA and be sure to use the Adobe-Forms-A version of the application forms and instructions.

Program Announcement (PA) Number: PAR-09-085

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: January 23, 2009
Opening Date: February 9 2009 (Earliest date an application may be submitted to Grants.gov)
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Due Date(s): March 9, 2009 is the first application due date for new K08 applications, then standard dates apply will apply for all applications, please see
http://grants1.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s): Generally four months after receipt date
Earliest Anticipated Start Date(s): Generally four months after peer review date
Expiration Date: (New Date January 08, 2013 per NOT-HS-12-001), Originally January 8, 2012

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

The overall goal of AHRQ-supported career development programs is to help ensure that a diverse pool of highly trained health services researchers are available in adequate numbers and in appropriate research areas to address the mission and priorities of AHRQ.

• Purpose: The primary purpose of the AHRQ Mentored Clinical Scientist Research Career Development Awards (K08) program is to prepare qualified individuals for careers that have a significant impact on the quality, safety, efficiency, and effectiveness of health care for all Americans. This program represents the continuation of an AHRQ program that provides support and protected time to individuals with a clinical doctoral degree for an intensive, supervised research career development experience in health services research. The award can be used both by individuals who propose to newly embark in heath services research training and those who had a hiatus in their research careers because of illness or family circumstances. The award is also available to promote research workforce diversity by providing enhanced research career development opportunities. Candidates interested in pursuing careers in patient-oriented research are eligible to apply for this award at AHRQ.
• Mechanism of Support: This Funding Opportunity Announcement (FOA) will utilize the Mentored Clinical Scientist Research Career Development Award (K08) mechanism.
• Funds Available and Anticipated Number of Awards: The total amount to be awarded 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 the proposed career award program will vary from application to application, it is anticipated that the size and duration of each award will also vary. Awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.
• PHS 398 Career Development Award Supplemental Form Component Sections: Items 2-5 (Candidate Information) and Item 11 (Research Strategy) are limited to a combined total of 25 pages, including tables, graphs, figures, diagrams and charts.
• Eligible Institutions/Organizations: Institutions/organizations listed in Section III are eligible to apply.
• Eligible Project Director/Principal Investigator (PD/PI). Also referred to as the Applicant or Candidate, individuals with the skills, knowledge, and resources necessary to carry out the proposed research and career development activities are invited to work with their mentor and sponsoring institution to develop an application for support. Individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds are always encouraged to apply for AHRQ support. Applicants must be U.S. citizens, non-citizen nationals, or permanent residents and hold a clinical doctoral degree (e.g., M.D., D.D.S., D.M.D., O.D, Pharm.D., D.O., D.C., N.D. (Doctor of Naturopathy), D.V.M.). Individuals with the Ph.D. or other doctoral degree in clinical disciplines such as clinical psychology, nursing, speech-language pathology, audiology or rehabilitation are also eligible to apply. They must commit a minimum of 75% of full-time professional effort conducting research and relevant career development activities specified in the application. See Section III.
• Number of PDs/PIs: Only one PD/PI may be designated on the application.
• Number of Applications: Applicants may only have one individual Career Development Award application pending peer review at any time.
• Resubmissions: Up to one resubmission is allowed.
• Renewals: Awards are not renewable and are not transferable from one PD/PI to another.
• Application Materials: See Section IV for application materials.
• General Information: For general information on SF424 (R&R) Application and Electronic Submission, see these Web sites:
  • SF424 (R&R) Application and Electronic Submission Information: http://grants.nih.gov/grants/funding/424/index.htm
  • General information on Electronic Submission of Grant Applications: http://era.nih.gov/ElectronicReceipt/
• Hearing Impaired: Telecommunications for the hearing impaired are available at: TTY 301-451-5936.

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. Submission, Review, and Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application Electronically to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information

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 Career Objectives

The objective of the AHRQ Mentored Clinical Scientist Research Career Development Award (K08) program is to provide support for a sustained period of protected time for intensive research career development under the guidance of an experienced mentor, or sponsor, in health services research leading to research independence.

The award may be used by candidates with different levels of prior research training and at different stages in their career development. For example, a candidate with limited experience in health services research may use an award to support a career development experience that includes a designated period of didactic training followed by a period of closely supervised research experience. A candidate with previous health services research experience and training may not require extensive additional didactic preparation, and may use an award to support a career development experience that focuses on an intensive, supervised research experience.

Applications must be responsive to AHRQ’s mission. The mission of the Agency is to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. Within the mission, specific areas of current AHRQ research interest include the following six priority areas:

Value: AHRQ seeks to support research to develop, disseminate, and translate rigorous evidence that can be used by public and private policymakers, by health system and community leaders, and by managers of healthcare organizations who want to reduce unnecessary healthcare costs (waste) while maintaining or improving healthcare quality, i.e., who want to increase value and efficiency in the organization, delivery, and financing of health care for all Americans. We encourage qualitative and mixed-methods research as well as quantitative methods.

AHRQ is also interested in supporting applicants interested in conducting research to provide appropriately generalizable findings about the consequences of value-driven experimentation for health care quality and costs, including how such issues relate to AHRQ priority populations. This also includes encouraging experimentation and the spread of promising strategies for reducing waste and improving value. Thus, AHRQ seeks both to facilitate and quickly learn from this rich body of natural experiments, focusing on: changes in the organization of health care (e.g., alliances and mergers, regionalization of trauma or other services, use of physician assistants); payment (e.g., tiering, no payment for hospital-acquired conditions); insurance and benefits redesign (e.g., value-based benefits design, coverage expansions); healthcare delivery redesigns (e.g., open scheduling; redesigning emergency room throughputs, Lean redesigns); and cultural competency and literacy programs.

Health Information Technology: Health information technology (IT) is broadly defined as the use of information and communication technology in health care to support the delivery of patient or population care or to support patient self-management. Health IT can support patient care related activities such as order communications, results reporting, care planning and clinical or health documentation.

Health IT-related grants will support research in one of three priority health IT research areas. Applications which are self-identified as health IT related must clearly identify one of these areas as the primary research area to be addressed and the specific element of the area being addressed. The three health IT research areas are:

• Health IT to improve the quality and safety of medication management; this includes the utilization of medication management systems and technologies; ambulatory health care providers and out-patient pharmacists use of electronic prescribing systems and/or medication management technologies; integration of evidence-based decision support for priority conditions within electronic prescribing systems; and, providing patients electronic tools to support medication self-management.
• Health IT to support patient-centered care; this includes, but is not limited to, a focus on the coordination of care across transitions in care settings and the use of electronic exchange of health information to improve quality of care. Patient-centered care is responsive to the needs and preferences of individual patients, provides patients and/or their caregivers with access to their medical information, facilitates communication between patients, caregivers and providers, and empowers patients to be active participants in care decisions and in the daily management of their health and illnesses.
• Health IT to improve health care decision making; this includes the development, implementation, and integration of health information tools, products or systems through the use of integrated data and knowledge management. AHRQ encourages research projects that will use health IT applications that apply principles to evidence based medicine including the use of the best available evidence, health care providers ability to execute their best judgment, and consideration of patients expressed treatment preferences.

Comparative Effectiveness: AHRQ is interested in supporting grants focusing on comparative effectiveness of different clinical treatments and services, as authorized in the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) Section 1013. The focus is on the generation and translation of new scientific evidence and analytic tools in an accelerated format and the integration of evidence into practice and decision-making in the health care system.

Applicants can have either a clinical or methodological emphasis, but must focus tightly on the study and/or the use of comparative effectiveness research. For grants with methodological emphasis, the goals should be to advance study designs and methods to fill specific knowledge gaps and to enhance the consistency, applicability, and generalizability of the comparative effectiveness studies. For grants with clinical emphasis, the goals should be to develop new scientific evidence that fills important knowledge gaps and to generate critical insights on the clinical effectiveness and comparative clinical effectiveness of health care interventions. For studies in which randomized controlled trails may not be feasible or timely, or would raise ethical concerns that are difficult to address, novel or alternative study designs may be proposed. Such clinical research projects also need to be informed by the information needs and inputs from various stakeholders (e.g., policy-makers, providers, and patients) to ensure the most appropriate outcome measures for assessing the effectiveness of the interventions and outcomes of importance to stakeholders are included in the study. Research projects should also be organized around a set of priority conditions of importance to the Medicare, Medicaid, and SCHIP programs as mandated by the MMA section 1013. The current list of conditions includes:

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

Prevention/Care Management: The mission of the Prevention/Care Management Portfolio is to improve the quality, safety, efficiency, and effectiveness of evidence-based preventive services and chronic care management in ambulatory care settings. We are interested in career development grants that will support two broad strategic goals. The first goal focuses on preventive services. Grants awarded in this strategic area should complement the work of the U.S. Preventive Services Task Force in terms of advancing methods for assessing the benefits and harms of preventive services, and improving the implementation of evidence-based recommendations on preventive services. We are interested in funding areas that have not traditionally been the focus of funding initiatives, such as:

• the harms associated with preventive services;
• the overuse of preventive services; and
• the delivery of preventive services for the patient with multiple co-morbidities.

Examples of grant applications that would be considered under this strategic area include, but are not limited to, research on:

• the effectiveness of preventive services in improving health and quality of life in complex patients;
• the development of new methodologies for assessing the harms of preventive services; and
• evidence gaps identified by the U.S. Preventive Services Task Force for specific preventive services.

A second strategic area of interest is based on the Care Model (Wagner 1998; Barr, et. al.; 2002). AHRQ is interested in supporting grants with the aim of improving primary care and clinical outcomes through health care redesign, clinical-community linkages, self management support, and care coordination. We are less interested in funding research on specific conditions, but rather seek to support grants that are focused on system redesign in ambulatory care, the results of which would be generalizable across health conditions. Examples of grant applications that would be considered under this strategic area include, but are not limited to, research on the effectiveness, efficiency, and/or implementation of:

• new models of delivering primary care, especially for individuals with multiple chronic conditions;
• methods of linking primary care practices with community resources to improve the delivery of preventive services and care management;
• the effectiveness and implementation of models of self management support;
• care coordination methods, especially during transitions among care settings;
• system and organizational policy change that support the Care Model; and,
• interventions to stimulate practice change, including practice coaching, training, toolkits, and collaboratives.

Generally, we are very interested in research that involves non-traditional ambulatory health care sites that serve the uninsured, Medicaid, and other vulnerable populations. Vulnerable populations, as defined by the IOM in 2002, include the uninsured, low-income, under-insured, Medicaid beneficiaries, minority population, immigrant populations and geographically or economically disadvantaged communities.

Patient Safety: Patient safety research initiatives can be considered to occur in three different stages:

• identification of the risks and hazards;
• design, implementation, and evaluation of patient safety practices; and
• maintaining vigilance to ensure that a safe environment continues and patient safety cultures remain in place.

The Patient Safety Portfolio will support research projects that seek to create new knowledge by identifying the risks and hazards encountered by patients as a result of health care. Proposals in this area may investigate important topics such as the impact of human performance and working conditions on patient safety. Examples of other topics of interest include the role consumers can play and how they can contribute to protecting patient safety, organizational characteristics and the structure of care delivery organizations. Additional factors that relate to patient safety such as diagnostic error, communication and teamwork, and the challenges inherent in transitions of care and handoffs between health care providers.

AHRQ encourages an interdisciplinary approach to research that is related to Patient Safety, so that the perspectives not only from the field of health care services but also from the social and behavioral sciences (such as organizational psychology) education, industrial engineering, human factors, and others are incorporated in such a way so that they contribute meaningfully to research plans.

Additionally, AHRQ supports the inclusion of approaches that address risks and hazards across various dimensions of patient characteristics and priority populations (e.g., the elderly, children, individuals with low health literacy, patients with multiple chronic conditions) settings of care (hospital, long-term care, ambulatory, home health care), and health-related conditions.

Innovations and Emerging Areas Portfolio: The Innovations Portfolio was created to identify and support researchers and institutions with ideas that have the potential for high impact. These ideas will be novel and span a diverse (and perhaps non traditional) array of disciplines. The portfolio will foster and nurture ideas and projects that have the potential to lead to highly innovative solutions that may lead to significant advances in healthcare practice, organization, delivery, and management. Research and activities supported under the Innovations Portfolio will reflect ideas substantially different from those already being pursued elsewhere. The portfolio will fund transformative research with a focus on projects that transform existing conditions and that solve pressing healthcare problems. The main focus of the portfolio is problem solving in order to accelerate improvement in healthcare.

Research areas of interest include, but are not limited to:

• Methological innovations for evaluation and research in healthcare quality and safety improvement implementation;
• Modeling of implementation taking into consideration the nature of quality and safety improvement implementation, variations in implementation context, and account for resource availability;
• Development of valid and feasible measures of organizational context (e.g., resource availability, readiness to change, leadership, teamwork) for use in implementation of quality and safety improvement implementation and their evaluation; and
• Development of research designs and analytical methods for assessing the effectiveness and safety of what works in quality and safety improvement implementation for use by implementers, evaluators and by researchers. The research designs and analytical methods must address external validity, generalizability, and ability to provide context-specific results.

Innovations for financing and organizing healthcare and related systems to improve quality (including safety, timeliness, effectiveness, efficiency, equity, patient-centeredness) for individuals with complex healthcare needs (e.g., children with special healthcare needs, people with disabilities, frail elderly people). Studies of other countries or systems approaches to financing and organization may be studied for possible adaptation to the United States. The innovation proposed must be one that can be implemented either nationally or in a representative region of the U.S.

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

Section II. Award Information

1. Mechanism of Support

This Funding Opportunity Announcement (FOA) will use the Mentored Clinical Scientist Research Career Development Award (K08) mechanism. The Project Director/Principal Investigator (PD/PI) (also referred to as the Applicant or Candidate) and his/her mentor will be solely responsible for planning, directing, and executing the proposed project.

The candidate should follow the instructions for budget information described in Section IV (6.F) 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.

The program must be tailored to meet the individual needs of the candidate. Applicants may request 3 to 5 years of support. The actual duration of the award will depend upon the number of years of prior research experience and the demonstrated need for additional mentored experience to achieve research independence. Awards are not renewable and are not transferable from one PD/PI to another.

AHRQ is not using the Modular Grant Application and Award Process. Applications submitted in modular format will be returned without review.

2. Funds Available

Because the nature and scope of the proposed award will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of AHRQ provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. Funding beyond the first year will be contingent upon a review and acceptance by Agency staff of the progress report. An application with a project period that exceeds five years will not be reviewed.

2.A. Allowable Costs

Salary: AHRQ will provide salary and fringe benefits for the award recipient for a requested portion of the candidate’s institutional salary, of up to $90,000 annually plus associated fringe benefits. The total salary requested must be based on a full-time, 12-month staff appointment. The K08 award requires the candidate to devote a minimum of 9 person-months (75% of full-time professional effort) to conducting health services research. 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, see NOT-OD-04-056.

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. Fringe benefits, based on the sponsoring institution’s rate and the percent of effort, are provided in addition to the salary.

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.

K08 award recipients are encouraged to obtain funding from AHRQ or other Federal sources either as a named PD/PI on a competing research grant award or cooperative agreement or as sub-project director on a competing multi-project award (see NOT-OD-08-065). At the time the research grant is awarded the effort required on the K08 award may be reduced to no less than 6 person-months (50% full-time professional effort) at the grantee organization and replaced by effort from the research award so that the total level of research commitment remains at 9 person-months (75% full-time professional effort) or more for the duration of the award. To be eligible for salary support from peer-reviewed research awards from any Federal agency:

• The K08 award recipient must be the PD/PI on a competing AHRQ or NIH research grant application (R01, R03, R15, R21, R34, or equivalent application from another Federal agency) or a sub-project director on a competing multi-component research or center grant or cooperative agreement application (P01, P50, U01, etc. or an equivalent application from another Federal agency).
• The K08 award must be active when the competing research grant application is submitted.
• The K08 award must be in its final two years before the reduction in effort to 6 person-months (50% full-time professional effort) is permitted. If a reduction in effort is proposed, the awarded and committed levels of funding will be adjusted accordingly.

Research Development Support: AHRQ will provide up to a total of $25,000 in direct costs per year for the following expenses: a) tuition and fees related to career development; b) research expenses such as supplies, equipment, and technical personnel working with research data; c) travel to research meetings or training; d) statistical services including personnel and computer time. All expenses must be directly related to the proposed research career development.

In Section F.1, Other Direct Costs/Materials and Supplies, the total amount requested for Research Development Support costs should be entered. A budget justification is required which should include a detailed list, description and justification for the specific Research Development Support costs requested, such as those pertaining to travel, equipment, supplies, and additional personnel that will be used to help achieve the career development and research objectives of the award. Applicants should review the supplemental K instructions found in Part 1.7.4 of the SF424 (R&) Application Guide for Adobe applications.

Ancillary Personnel Support: Salary for mentors, secretarial and administrative assistance, etc., is not allowed.

Indirect Costs: These 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 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, hospital, 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. Foreign institutions may participate in projects as members of consortia or as subcontractors only. Applications submitted by for-profit organizations and foreign institutions will be returned without review. Organizations described in section 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible.

Applicants requesting foreign training must show in the application that the foreign institution and sponsor offer unique opportunities that are not currently available in the United States. Only if there is a clear scientific advantage will foreign training be considered for support.

1.B. Eligible Individuals

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

Project Director/Principal Investigator (PD/PI): Also referred to as the Applicant or Candidate, individuals with the skills, knowledge, and resources necessary to carry out the proposed research and career development activities are invited to work with their mentor and sponsoring institution to develop an application for support. Individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds are always encouraged to apply for AHRQ support.

Citizenship and Residency: Only U.S. citizens or non-citizen nationals, or individuals lawfully admitted for permanent residence who have a currently valid Permanent Resident Card (USCIS Form I-551), or some other verification of legal admission as a permanent resident prior to the time of award, are eligible for this award. Non-citizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S. They are usually born in lands that are not states but are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible.

Degree and Research: Candidates for this award must have a clinical doctoral degree. Such degrees include but are not limited to the M.D., D.O., D.D.S., D.M.D., O.D., D.C., Pharm.D., N.D. (Doctor of Naturopathy), D.V.M. Individuals with the Ph.D. or other doctoral degree in clinical disciplines such as clinical psychology, nursing, speech-language pathology, audiology or rehabilitation are also eligible. Candidates with a clinical doctoral degree interested in pursuing a career in patient-oriented research are eligible to apply for this award at AHRQ.

Level of Effort: Candidates must be able to commit a minimum of 9 person-months (75% of full-time professional effort) conducting research career development activities associated with this award. The remaining 3 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. For information regarding policy on determining full-time professional effort for career awards, see NOT-OD-04-056.

At the time of award, the candidate must have a full-time appointment at the academic institution that is the applicant institution. Candidates who have VA appointments may not consider part of the VA effort toward satisfying the full time requirement at the applicant institution. Candidates with VA appointments should contact the staff person at AHRQ prior to preparing an application to discuss their eligibility.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Number of Applications: Candidates may only have one individual Career Development Award application pending peer review at any time.

Resubmission(s): Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) are permitted only a single amendment (A1). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016). Original new applications that were submitted prior to January 25, 2009 are permitted two amendments (A1 and A2). For these grandfathered applications, AHRQ expects that any A2 will be submitted no later than January 7, 2011, and AHRQ will not accept A2 applications after that date.

Renewals: Awards are not renewable and are not transferable from one PD/PI to another.

Individuals are eligible for a K08 award 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 if they:

• Have simultaneously submitted or have an application pending peer review for any other PHS career 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 been or are currently a PD/PI on any other AHRQ or NIH mentored career development awards, or any equivalent PHS or non-PHS grant. Individual scholars supported on institutional K12 grants are eligible to apply for a K08 award provided that the support is not concurrent. However, in such instances the combined support requested for the K08 award and the total time spent on the K12 grant cannot exceed 5 years.
• Have been or are currently a PD/PI on AHRQ or NIH research grants (such as R01, R29, P01) or subproject leaders on Program Project (P01) and Center Grants (P50), or non-AHRQ/NIH equivalents to these grants/awards;
• Have been or are currently a PD/PI on peer-reviewed non-AHRQ/NIH or other PHS research grants or cooperative agreements over $100,000 in direct costs per year intended for independent investigators.

3.A. Special Requirements

Mentor(s): The candidate must name a primary sponsor/mentor who, together with the applicant, is responsible for the planning, direction, and execution of the program. The mentor should be recognized as an accomplished investigator in the proposed research area and have a track record of success in training independent health services researchers. The mentor should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of this award. Candidates may also nominate co-mentors as appropriate to the goals of the program. Where feasible, women, individuals from diverse racial and ethnic groups, and individuals with disabilities should be involved as mentors to serve as role models.

Reference letters must be submitted directly by the mentor through the eRA Commons and not as part of the electronic application that goes through Grants.gov. Reference letters are still an integral part of the application and they will be joined with the electronic application within the eRA system once an application completes the submission process. Applications that are missing the required letters may be delayed in the review process or not accepted at all. Information about these critical letters is in each application FOA, and complete instructions for candidates and mentors are found in Part I, Section 7.3 of the SF 424 (R&R) Application Guide for Adobe Applications.

Institutional Environment: The applicant institution must have a strong, well-established record of research and career development activities and faculty qualified in health services research to serve as mentors. The institution must demonstrate a commitment to the development of the candidate as a productive, independent investigator and be willing to allow the protected time needed by the applicant. The candidate, mentor, and institution must describe a research career development program that will maximize the use of this environment, including available facilities and resources.

Applicants may have only one individual career development award application pending peer review at any time.

Section IV. Application and Submission Information

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

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

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

The PD/PI 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 support@grants.gov

Note: If a PD/PI is also an NIH/AHRQ peer-reviewer the DUNS number obtained and used in the reviewer role may NOT be used and is not applicable to any Grant Application to the Federal Government. This DUNS number is different from the DUNS number used by the applicant organization. The individual DUNS number should be used only for the purposes of personal reimbursement.

2) Organizational/Institutional Registration in the eRA Commons

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

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

• The individual designated as PD/PI on the application must be registered also in the NIH eRA Commons prior to the submission of the application.
• The PD/PI must hold a PD/PI account in the Commons. The applicant 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 Internet Assisted Review (IAR) role, both roles should exist under one Commons account.
• This registration/affiliation must be done by the AOR/SO or his/her designee who is already registered in the Commons.

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

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

1. Request Application Information

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

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

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

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

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms 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 NIH. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by NIH (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 Research Plan
PHS398 Career Development Award Supplemental Form
PHS398 Checklist

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: February 9, 2009 (Earliest date an application may be submitted to Grants.gov)
Application Due Date(s): March 9, 2009 is the first application due date for new K08 applications, then standard dates apply will apply for all applications, please see
http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s): Generally four months after receipt date
Earliest Anticipated Start Date(s): Generally four months after peer review date

3.A.1. Letter of Intent

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

3.B. Submitting an Application Electronically to AHRQ

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp and follow Steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED. All attachments must be provided to AHRQ in PDF format, filenames must be included with no spaces or special characters, and a pdf extension must be used.

3.C. Application Processing

3.C.1 Submitting On-Time

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

• All registrations must be complete prior to the submission deadline
• The application must receive a Grants.gov tracking number and timestamp (or eRA help desk ticket confirming a system issue preventing submission) by 5:00 p.m. local time on the submission deadline date.
• Any system identified errors/warnings must be corrected and the submission process completed within the error correction window.

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

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

3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings

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

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

Please note that the following caveats apply:

• Initial application submission must be on-time.
• The AOR/institutions is expected to enforce that application changes made within the error correction window are restricted to those necessary to address system-identified errors/warnings. NIH may reject any application that includes additional changes.
• Proof of on-time submission (e.g., Grants.gov timestamp and tracking number) and description of all changes made within the window must be documented in the PHS 398 Cover Letter component of the application.

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

Once any eRA identified errors have been addressed and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.

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

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

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

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

AHRQ will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. AHRQ will not accept any application that is essentially the same as one already reviewed. However, AHRQ will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.

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

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

Use of CMS Data

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

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

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

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

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

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

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

Citizenship: Applicants must meet the citizenship requirements as described in the Eligibility section of this announcement (see Section III) at the time of award.

Concurrent Awards: Applicants must be aware of the AHRQ policies associated with other federally sponsored support as described in Section III.3 above

Pre-Award Costs: Pre-award costs are allowable. A grantee may, at its own risk and without AHRQ prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing renewal award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without AHRQ prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain AHRQ approval before incurring the cost. AHRQ prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing renewal award.

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

6. Other Submission Requirements and Information

All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements (see http://grants.nih.gov/grants/funding/424/index.htm):

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

Cover Letter: The PHS398 cover letter must include the list of referees (including name, department affiliation, and institution).

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) are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:

• Introduction (required for a resubmission or revision application) is limited to 1 page.
• Specific Aims is limited to 1 page.
• PHS 398 Career Development Award Supplemental Form Component Sections: 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 25 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, applicants 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 applicants to better monitor formatting requirements such as page limits.

The following information must be included in the application in accordance with the Supplementary Instructions for Research Career Awards in the SF424 (R&R) Application Guide (See Part I.7.5).

Ongoing and Completed Research: Candidates are required to include descriptions of ongoing and completed research projects that are relevant to the research proposed in the application as part of their Biosketch.

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

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

Priority Populations

The Healthcare Research and Quality Act of 1999, in amending the Public Health 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 include two nationwide databases, the Nationwide Inpatient Sample (NIS) and the Kids Inpatient Database (KID), 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.

The following information must be included in the application in accordance with the Supplementary Instructions in the R&R 424 for Research Career Awards (Instructions, Part 7, Section 5).

6.A. Candidate Information and Career Development Plan

Candidate s Background:

• Describe the candidate's commitment to a career in health services research. 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 award.
• Describe prior training and how it relates to the immediate objectives and long-term career plans of the candidate.
• Describe the candidate’s research efforts to this point in his/her research career, including any publications, prior research interests and experience.
• Provide evidence of the candidate’s potential to develop into an independent health services research investigator.
• Include a statement that the candidate will commit at least 9 person-months (75% of full-time professional effort) to the mentored research scientist development program and related career development activities.

Career Goals and Objectives:

• Describe a systematic plan: (1) that shows a logical progression from prior research and training experiences to the training and research experiences that will occur during the career award period and then to independent investigator status; (2) that justifies the need for further career development to become an independent investigator; and (3) that utilizes the relevant research and educational resources of the institution.

Career Development/Training Activities:

• The candidate and the mentor are jointly responsible for the preparation of the career development plan. A timeline is often helpful. The sponsor/mentor may form an advisory committee to assist with the development of the program of study or to monitor the candidate’s progress through the career development program.
• The didactic (if any) and the research aspects of the plan must be designed to develop the necessary knowledge and research skills in scientific areas relevant to the candidate’s health services research goals. Specific research competencies to be gained from both planned coursework and experiential activities relative to career development goals should be demonstrated.
• Describe the professional responsibilities/activities including other research projects beyond the minimum required 75% effort commitment to the career award. Explain how these responsibilities/activities will help ensure career progression to achieve independence as an investigator.

Training in the Responsible Conduct of Research:

• Document prior instruction in or propose plans to receive instruction in the responsible conduct of research in terms of subject matter and duration of instruction. An award cannot be made if an application lacks this component.
• Applications not providing documentation of prior instruction in the responsible conduct of research must include a description of a program to receive formal or informal instruction in scientific integrity or the responsible conduct of research.
• Applications without plans for instruction in the responsible conduct of research will be considered incomplete and may be returned to the applicant without review.
• Although the AHRQ does not establish specific curricula or formal requirements, all programs are encouraged to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, policies regarding the use of human subjects, and data management.
• Applicants must follow the application instructions found in PHS 398 Career Development Award Supplemental form Section 7.5.1, and refer to the NIH web site (http://www.nih.gov/sigs/bioethics/researchethics.html) for additional guidance.

6.B. Research Plan

The research plan should follow instructions outlined in PHS 398 Career Development Award Supplemental form, including sections on Specific Aims, Background and Significance, Preliminary Studies/Progress Report, Research Design and Methods. The candidate should consult with the mentor(s) regarding the development of this section.

• A sound research project that is consistent with the candidate’s level of research development and objectives of his/her career development plan must be provided. The research description should demonstrate not only the quality of the applicant’s research thus far but also the novelty, significance, creativity and approach, as well as the ability of the applicant to carry out the research.
• The application must also describe the relationship between the mentor’s research and the candidate’s proposed research plan.
• If more than one mentor is proposed, the respective areas of expertise and responsibility should be described.

6.C. Statement of Support

Statement by Mentor, Co-Mentors, Consultants, Contributors (All statements/letters should be appended to each other and uploaded as a single pdf document):

• The candidate must name a primary mentor who, together with the applicant, is responsible for the planning, directing, monitoring, and executing the program. The candidate may also nominate co-mentors as appropriate to the goals of the program.
• The mentor should be recognized as an accomplished investigator in the proposed health services research area and have a track record of success in training and placing independent investigators.
• The mentor should have sufficient independent health services research support to cover the costs of the proposed research project in excess of the allowable costs of this award.
• 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 health services research qualifications and previous experience as a research supervisor; 2) a plan that describes the nature of the supervision and mentoring that will occur during the proposed award period; 3) a plan for career progression for the candidate to move from the mentored stage of his/her career to the independent health services research investigator status during the project period of the award; and 4) a plan for monitoring the candidate’s research, publications, and progression towards independence.
• Similar information must be provided by any co-mentor. If more than one co-mentor is proposed, the respective areas of expertise and responsibility of each should be described. Co-mentors should clearly describe how they will coordinate the mentoring of the candidate. If any of the co-mentors are not located at the sponsoring institution, a statement should be provided describing the mechanism(s) and frequency of communication with the candidate, including the frequency of personal meetings.
• Signed statements must be provided by each consultant/collaborator confirming their participation in the project and describing their specific roles. Collaborators and consultants generally do not need to provide their biographical sketches. However, information should be provided clearly documenting the appropriate expertise in the proposed areas of consulting/collaboration. Collaborators/consultants are generally not directly involved in the development of the career of the candidate as an independent investigator.
• The mentor must agree to provide annual evaluations of the candidate’s progress as required in the annual progress report, PHS 2590 (see Section VI.3. Reporting).

6.D. 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 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.

Institutional Commitment to Candidate’s Research Career Development:

• The sponsoring institution must provide a statement of commitment to the candidate's development into a productive, independent investigator and to meeting the requirements of this award. It should be clear that the institutional commitment to the candidate is not contingent upon receipt of the K08 award.
• Provide assurances that the candidate will be able to devote a minimum of 9 person-months (75% of full-time professional effort) to the development of their research program. The remaining effort should be devoted to activities related to the development of the candidate s career as an independent health services researcher, e.g. clinical responsibilities, teaching and administration, and/or additional research activities.
• Provide the candidate with appropriate office and laboratory space, equipment, and other resources and facilities (including access to clinical and/or other research populations) to carry out the proposed research plan.
• Provide appropriate time and support for any proposed mentor(s) and/or other staff consistent with the career development plan.

6.E. Letters of Reference

[ January 20, 2011 - Please see NOT-OD-11-036 informing applicants that the Letters of Reference are due by the application receipt deadline date. ]

Electronic submission of reference letters is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons and do not use Grants.gov. Therefore, candidates must follow the Supplemental Instructions in the SF424 R&R Application Guide for Research Career Awards (Instructions, Part 7.3) (see http://grants.nih.gov/grants/funding/424/index.htm).

Letters of reference are an additional important component of the application for the Mentored Clinical Scientist Development Award (K08). Applicants for the must arrange to have at least three (but no more than five) letters of reference submitted on their behalf to the NIH eRA Commons Web site at https://public.era.nih.gov/commons/public/reference/submitReferenceLetter.do?mode=newThe letters should be from well-established scientists (referees) addressing the qualities of the candidate as well as their potential for becoming an independent investigator. These letters should be from individuals not directly involved in the application, but who are familiar with the candidate s qualifications, training, and interests, including advisory committee members (if applicable).

The mentor/co-mentor(s) should also submit letters of reference, but these letters will be considered independently of the three required reference letters. Revised applications must include new letters of reference. Reference letters must be submitted directly by the mentor through the eRA Commons and not as part of the electronic application that goes through Grants.gov. Reference letters are still an integral part of the application and they will be joined with the electronic application within the eRA system once an application completes the submission process. Applications that are missing the required letters may be delayed in the review process or not accepted at all. Information about these critical letters is in each application FOA, and complete instructions for candidates and mentors are found in Part I, Section 7.3 of the SF 424 (R&R) Application Guide for Adobe Applications.

Applications that are missing letters of reference may be delayed in the review process or not accepted at all.

6.F. Budget for the Entire Proposed Period of Support

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.

6.G. 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.

Section V. Application Review Information

1. Criteria

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

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

2. Review and Selection Process

Review Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with standard AHRQ peer review procedures that are described in 42 CFR Part 67, Subpart A. Incomplete and/or 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.

Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the candidate to maintain a strong research program, in consideration of the following five core review criteria, and additional review criteria). An application does not need to be strong in all categories to be judged likely to have major impact.

Reviewers recognize that an individual with limited research experience is less likely to be able to prepare a research plan with the breadth and depth of that submitted by a more experienced investigator. Nevertheless, a fundamentally sound research plan must be provided.

Scored Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each.

Candidate:

• Does the candidate have the potential to develop as an independent and productive health services researcher?
• Is the candidate’s academic, clinical (if relevant), and research record of high quality?
• Is there evidence of the candidate s commitment to meeting the program objectives to become an independent investigator in health services research?
• Do the letters of reference from at least three well-established scientists address the above review criteria, and do they demonstrate evidence that the candidate has a high potential for becoming an independent investigator?

Career Development Plan:

• What is the likelihood that the plan will contribute substantially to the scientific development of the candidate leading to scientific independence?
• Is the content, scope, phasing, and duration of the career development plan appropriate when considered in the context of prior training/research experience and the stated training and research objectives for achieving research independence?
• Are specific research competencies to be gained from both planned coursework and experiential activities relative to career development goals adequately demonstrated?
• Are there adequate plans for monitoring and evaluating the candidate’s research and career development progress?

Research Plan:

• Are the proposed research question(s), design, and methodology of significant scientific and technical merit?
• Is the research plan relevant to the candidate’s research career objectives?
• Is the research plan appropriate to the stage of research development and as a vehicle for developing the research skills described in the career development plan?
• Are there adequate plans to include both genders, minorities, and children and their subgroups as appropriate for the scientific goals of the research when human subjects are used? Are there adequate plans for the recruitment and retention of subjects, when applicable? Are other AHRQ priority populations are included in the planned research?

Mentor(s), Consultant(s), Collaborator(s):

• Are the mentor's research qualifications in the area of the proposed health services research appropriate?
• Do the mentor(s) adequately address the candidate’s potential, his/her strengths, and areas needing improvement?
• Is there adequate description of the quality and extent of the mentor’s proposed role in providing guidance and advice to the candidate?
• Is the mentor’s description of the elements of the research career development activities, including formal coursework, auditing, and experiential activities adequate?
• Is there evidence of the mentor s, consultant s, collaborator’s previous experience in fostering the development of independent health services research investigators?
• Is there evidence of previous research productivity and peer-reviewed support?
• Is there active/pending support for the proposed research project appropriate and adequate?
• Are there adequate plans for monitoring and evaluating the career development awardee’s progress toward independence?

Environment and Institutional Commitment to the Candidate:

• Is there clear commitment of the sponsoring institution to ensure that a minimum of 75% of the candidate’s effort will be devoted directly to the research described in the application, with the remaining percent effort being devoted to an appropriate balance of research, teaching, administrative, and clinical responsibilities?
• Is the institutional commitment to the career development of the candidate appropriately strong?
• Are the research facilities, resources and training opportunities, including faculty capable of productive collaboration with the candidate adequate and appropriate?
• Is the environment for scientific and professional development of the candidate of high quality?
• Is there assurance that the institution intends the candidate to be an integral part of its research program?

2.A. Additional Review Criteria

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

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See the Human Subjects Sections of the PHS398 Research Plan component of the SF424 (R&R), part I, 5.5.

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. See the Human Subjects Sections of the PHS398 Research Plan component of the SF424 (R&R) part I, 5.5.

Inclusion: Adequacy of inclusion plans and attention to AHRQ priority populations (see above discussion on Priority Populations in Section IV.6 Other Submission Requirements, and inclusion criteria included in section VIII of Required Federal Citations, below.)

Budget and Period of Support: Is the proposed budget and period of support appropriate in relation to the proposed research and the career development needs of the applicant?

Training in the responsible conduct of research: Does the application include appropriate and adequate documentation in prior instruction, or plans for training

Resubmission Applications: Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?

2.B. Additional Review Considerations

None.

2.C. Resource Sharing Plans

Data Confidentiality

Pursuant to 42 USC 299c-3(c), information obtained in the course of any AHRQ supported-study that identifies an individual or entity must be treated as confidential in accordance with any explicit or implicit promises made regarding the possible uses and disclosures of such data. There are civil monetary penalties for violation of the confidentiality provision of the AHRQ statute 42 USC 299c-3(d). In the Human Subjects section of the application, applicants must describe procedures for ensuring the confidentiality of the identifying information to be collected. The description of the procedures should include a discussion of who will be permitted access to this information, both raw data and machine readable files, and how personal identifiers and other identifying or identifiable data will be restricted and safeguarded. Identifiable patient health information collected by grantees under this FOA will also be obtained and managed in accordance with 45 CFR Parts 160 and 164, the Federal Privacy Rule developed by the Department of Health and Human Services (DHHS) pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA). 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

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

Selection Process

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

• Scientific merit and quality of the proposed project as determined by peer review
• Relevance of the proposed career development program, prior training, and commitment of the applicant to becoming an independent health services researcher
• Relevance to AHRQ program priorities
• Availability of funds

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 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).

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

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 Section IV.5 Funding Restrictions.

2. Administrative and National Policy Requirements

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

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

The following related administrative policies apply to AHRQ Research Career Award ( K ) programs:

A. 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. Such fees must be assigned to the grantee institution for disposition by any of the following methods:

• The funds may be expended by the grantee institution in accordance with the AHRQ policy on supplementation of career award salaries and to provide fringe benefits in proportion to such supplementation. Such salary supplementation and fringe benefit payments must be within the established policies of the grantee institution.
• The funds may be used for health-related research purposes.
• The funds may be paid to miscellaneous receipts of the U.S. Treasury. Checks should be made payable to the Department of Health and Human Services, AHRQ and forwarded to the Director, Division of Financial Management, NIH, 540 Gaither Road, Rockville, Maryland 20850. Checks must identify the relevant award account and reason for the payment.

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 rebudgeted. 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.

B. Leave Policies: Leave to another institution, including a foreign laboratory, may be permitted if the proposed experience is directly related to the purpose of the award. Only local institutional approval is required if such leave does not exceed 3 months. For longer periods, prior written approval of the AHRQ funding component is required. Details on the process for submission of prior approval requests can be founds in the NIH Grants Policy Statement (rev. 12/03), Requests for Prior Approval."

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 of the 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.

C. Policy on Temporary Adjustments to Full-Time Appointments: K awardees may reduce the full-time appointment required at the onset of the K award to less than full-time (but not less than three-quarter time) for a period not to exceed 12 continuous months during the K award project period. However, awardees may not simultaneously request a reduction in appointment status from full-time to part-time AND a reduction in percent effort to less than 75% (see above for existing policy). Note these two options are only available once a K application has been awarded. At the time of application, all candidates must meet the full-time appointment requirement as well as the minimum 75% effort requirement.

If requesting approval to change to a part-time appointment status, the awardee must continue to commit at least 75% effort (of the part-time appointment) to research and career development activities. Ideally, the awardee will increase their percent effort on the K award to greater than 75% (e.g., 85%) to compensate for the anticipated effect of the part-time appointment status on the K awardee’s career progression.

The nature of the circumstances requiring a change in the appointment status or percent effort might include personal or family situations such as parental leave, child care, elder care, medical conditions, or a disability. Permission to change appointment status or percent effort will not be approved to accommodate job opportunities, clinical practice, or clinical training.

The grantee institution must submit written documentation supporting the need for reduced faculty appointment status or percent effort along with assurance of a continuing commitment to the scientific and research career development of the awardee. The K awardee should justify the request to reduce either his/her appointment to less than full-time status or to less than 75% effort and must describe the anticipated impact of the requested change on his/her career progression during the remainder of the K award period. In addition, the awardee must submit assurance of his/her intention to return to a full-time faculty appointment or to at least 75% effort as soon as possible. The mentor must provide a revised plan for mentoring and specifically describe updated milestones for the awardee’s progression to independence. Lastly, a revised statement of institutional commitment to the awardee must ensure continued protected time and describe additional support that will assist the K awardee to continue to make progress toward his/her goals during the requested period of reduced time/effort devoted to the K award. During the period of reduced appointment status or percent effort, the salary and other costs supported by the award will be reduced accordingly. Requests must be submitted by the grantee institution to the awarding component of AHRQ where they will be considered on a case-by-case basis.

D. Changes in Research or Career Development Program: Consultation with AHRQ program staff is strongly encouraged when a change in the approved career development program and/or research plan is being considered.

Individual awards are made for career development in a specific research program. A change in the specified scientific area of the research component of the career development program requires prior approval by AHRQ. A scientific rationale must be provided for any proposed changes in the aims of the original peer-reviewed research plan. The new research plan will be evaluated by AHRQ staff to ensure that the plan remains within the scope of the original peer-reviewed research program. If the new plan does not satisfy this requirement, staff could recommend that the award be terminated.

In rare cases where a mentor must be replaced, the institution must submit a letter from the proposed mentor and awardee documenting the need for substitution, the new mentor's qualifications for supervising the program, and the level of support for the PD/PI’s continued career development. The letter must also document that the specific aims of the research program will remain within the scope of the original peer reviewed research program. AHRQ staff will review the request and will notify the institution of the results of the evaluation.

E. Change of Institution or Termination: Consultation with AHRQ program staff and/or grants management staff is strongly encouraged when either termination or a change of institution is being considered.

A change of grantee institution normally will be permitted only when all of the benefits attributable to the original grant can be transferred, including equipment purchased in whole or in part with grant funds. In reviewing a request to transfer a grant, AHRQ will consider whether there is a continued need for the grant-supported project or activity and the impact of any proposed changes in the scope of the project. A change may be made without peer review, provided the PD/PI plans no significant change in research and career development objectives and the facilities and resources at the new organization will allow for successful performance of the project. If these conditions or other programmatic or administrative requirements are not met, AHRQ may require peer review or may disapprove the request and, if appropriate, terminate the award.

If the K awardee is moving to another eligible institution, career award support may be continued provided:

• A relinquishing statement is submitted by the original institution and a transfer application is submitted by the new institution at least three months prior to the transfer in order to allow the necessary time for administrative review by AHRQ staff.
• The awardee must establish in the transfer application that the specific aims of the research program to be conducted at the new institution are within the scope of the original peer-reviewed research program, and that a new mentor has been identified who has the appropriate research expertise and support to provide adequate guidance to the awardee and research support for the awardee's research program.
• All conditions of the award are met at the new institution.
• The period of support requested is no more than the time remaining within the existing award.

When a grantee institution plans to terminate an award, the Grants Management Specialist listed on the Notice of Award (NoA) must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. The AHRQ may terminate an award upon determination that the purpose or terms of the award are not being fulfilled. In the event an award is terminated, AHRQ shall notify the grantee institution in writing of this determination, the reasons, the effective date, and the right to appeal the decision.

3. Reporting

Awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590). 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.

Section VII. Agency Contacts

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

1. Scientific/Research Contact(s):

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

Kay Anderson, Ph.D.
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) 427-1555
Fax: (301) 427- 1562
E-mail address: Kay.Anderson@ahrq.hhs.gov

2. Peer Review Contact(s):

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

Ali Azadegan, DVM, 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) 427-1869
Fax: (301) 427-1562
E-mail address: Ali.Azadegan@ahrq.hhs.gov

3. Financial/Grants Management Contact(s):

Direct inquiries regarding fiscal matters to:

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

Section VIII. Other Information

Required Federal Citations

Inclusion of Women and Minorities in Research Study Populations:

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

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

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

Human Subjects Protection:

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

Standards for Privacy of Individually Identifiable Health Information:

The Department of Health and Human Services (DHHS) "Standards for Privacy of Individually Identifiable Health Information", regulation was mandated by the Health Insurance Portability and Accountability Act (HIPAA) of 1996 which governs the protection of individually identifiable health information. It is administered and enforced by the DHHS Office for Civil Rights (OCR). The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools that may be used to determine whether a researcher is a staff member of a covered entity. Compliance with the Privacy Rule for those classified under the Rule as "covered entities" is mandatory. Decisions about applicability and implementation of the Privacy Rule reside with covered entities. Project Officers will assist grantees in resolving questions about the applicability of HIPAA requirements.

Access to Research Data through the Freedom of Information Act:

The OMB Circular A-110 has been revised to provide access to research data developed with Federal support through the Freedom of Information Act (FOIA) 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) may be accessed through FOIA. If no Federal action is taken having the force and effect of law in reliance upon an AHRQ-supported research project, the underlying data are not subject to this disclosure requirement. Furthermore, even if a Federal regulatory action is taken in reliance on AHRQ-supported research data under FOIA, 5 USC 552(b), disclosure of confidential identifiable data from such study is statutorily protected under 42 USC 299c-3(c), and thus is exempted from disclosure under "the (b)(3) exemption in FOIA, 5 USC 552(b)(3). It is important for applicants to understand the scope of this requirement and its limited potential impact on data collected with AHRQ support. Proprietary data might also be exempted from FOIA disclosure requirements under "the (b)(4) exemption", 5 USC 552(b)(4) for example, if it constitutes trade secrets or commercial information. NIH has provided general related guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm which does not include discussion of the exception applicable to confidential identifiable data collected under AHRQ's authorities.

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

Healthy People 2010:

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

Authority and Regulations:

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

The Public Health Service 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.