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: AHRQ Individual Awards for Postdoctoral Fellows (F32) National Research Service Awards (NRSA)

Announcement Type

This Funding Opportunity Announcement (FOA) updates and supersedes PA-09-229 which was released on July 2, 2009.

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

• January 12, 2016 - Extension of Expiration Dates for AHRQ Fellowship (F) and Career Development Award (K) Funding Opportunity Announcements (PA-12-261 and PA-13-039). See Notice NOT-HS-16-004.
• October 27, 2015 - Extension of Expiration Dates for AHRQ Fellowship (F) and Career Development Award (K) Funding Opportunity Announcements (PA-12-261 and PA-13-039). See Notice NOT-HS-16-001.
• August 29, 2014- See Notice NOT-OD-14-129. eRA Commons Username Required for Sponsor in Individual Fellowship Grant Applications to NIH and AHRQ.
• January 14, 2014 The application package forms associated with this FOA have been updated. The new forms must be used for due dates on/after April 8, 2014.

Program Announcement (PA) Number: PA-12-261

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 Individual Fellowship 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.

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

Catalog of Federal Domestic Assistance Number(s)

93.225

Key Dates
Release/Posted Date: August 9, 2012
Opening Date: November 8, 2012
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Due Date(s): Standard dates for Individual National Research Service awards apply, 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 to eight months after peer review date
Additional Information to Be Available Date (Activation Date): Not Applicable
Expiration Date:

New Date December 9, 2016 per issuance of NOT-HS-16-004. (Original Expiration Date: May 24, 2016)

New Date May 24, 2016 per issuance of NOT-HS-16-001. (Original Expiration Date: December 9, 2015)

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

• Purpose. The purpose of this individual postdoctoral research training fellowship is to provide support to promising fellows with the potential to become productive, independent investigators in health services research, with a research interest in areas and priorities relevant to the mission of AHRQ.
• Mechanism of Support. This FOA will use the Individual Postdoctoral National Research Service Award (NRSA) grant mechanism (F32).
• Funds Available and Anticipated Number of Awards. The total amount to be awarded and the number of F32 fellowships awarded will depend on the quality and scientific merit of the applications received, their relevance to the program priorities of AHRQ and the availability of funds.
• Budget and Project Period. Aggregate NRSA postdoctoral support normally may not exceed 3 years. See Section III for details.
• Application Research Strategy Length: The F32 Research Strategy section may not exceed 6 pages, including tables, graphs, figures, diagrams, and charts.
• Eligible Institutions/Organizations: Institutions/organizations listed in Section III, 1.A. are eligible to apply.
• Eligible Project Director/Principal Investigator (PD/PI): The PD/PI is the individual Fellowship Applicant. Applicant fellows must be citizens or non-citizen nationals of the United States, or have been lawfully admitted to the United States for permanent residence. See Section III for definitions associated with specific eligibility requirements. Individuals from diverse racial and ethnic groups, individuals with disabilities, and those from disadvantaged backgrounds are encouraged to submit an application.
• Number of PDs/PIs: Only one PD/PI may be designated on the application.
• Number of Applications: Fellowship Applicants may have only one individual fellowship application pending peer review within the Public Health Service (PHS) at any time.
• Resubmissions: Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (summary statement).
• Renewals: Awards are not renewable and are not transferable from one PD/PI to another.
• Application Materials. See Section IV.1 for application materials.
• General Information. For general information on SF424 (R&R) Application and Electronic Submission, see these Web sites:
  • SF424 (R&R) Application and Electronic Submission Information: https://grants.nih.gov/grants/funding/424/index.htm
  • General information on Electronic Submission of Grant Applications: http://era.nih.gov/ElectronicReceipt/
• Hearing Impaired: Telecommunications for the hearing impaired are available at: TTY 301-451-5936.

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

It is critical that applicants follow the instructions in the Individual Fellowship SF424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

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

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

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

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

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

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Training Objectives

The purpose of the postdoctoral fellowship (F32) award is to provide support to promising postdoctoral applicants who have the potential to become productive and successful independent research investigators. The proposed postdoctoral training must offer an opportunity to enhance the applicant’s understanding of health services research and must be responsive to AHRQ’s mission, which is to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. 42 U.SC. 299a(b) authorizes AHRQ to provide training programs in the field of health services research.

The research sponsored and conducted by the Agency develops and presents scientific evidence regarding all aspects of health care in the United States. It addresses issues of organization, delivery, financing, utilization, patient and provider behavior, outcomes, effectiveness and cost. It evaluates both clinical services and the system in which these services are provided. These scientific results improve the evidence base to enable better decisions about health care, including such areas as: disease prevention; appropriate use of medical technologies; care coordination, care management, enhancing access to care, patient self-management; palliative care; improving diagnosis, treatment, patient access, and work flow while reducing costs or holding them constant; long-term care; reducing disparities in health care outcomes and quality among racial, ethnic, and underserved populations; enhancing the transparency and accountability of care delivery practices and outcomes; and contributing to evidence-based decision making by patients, providers, regulators, and payers. AHRQ is especially interested in applications that propose to train researchers to address healthcare disparities and quality measurement and improvement. Applicants are strongly encouraged to focus on topical areas unique to AHRQ, demonstrating how expected results can be used or made available for use to enhance healthcare quality. Results should be directly relevant to stakeholders, such as providers and practitioners, administrators, payers, consumers, policymakers, and insurers. The strategic research goals are:

• Safety/quality Reduce the risk of harm from health care services by promoting the delivery of appropriate care that achieves the best quality outcomes
• Efficiency Achieve wider access to effective health care services and reduce health care costs
• Effectiveness Assure that providers and consumers/patients use beneficial and timely health care information to make informed decision choices.

AHRQ also has specific research portfolio areas of interest which include comparative effectiveness/patient-centered outcomes, health information technology (health IT), value, patient safety, prevention and care management, and healthcare innovations. To learn more about AHRQ’s focus within these portfolios of work, please visit http://www.ahrq.gov/fund/portfolio.htm

Applicants are required to address training in research issues critical to AHRQ priority populations, including: individuals living in inner city and rural (including frontier) areas; low-income and minority groups; women, children, the elderly; and individuals with special health care needs, including those with disabilities and those who need chronic or end-of-life health care.

Trainees must focus their research development and projects on health care delivery in the United States.

Applicant fellows with a health professional doctoral degree may use the proposed postdoctoral training to satisfy a portion of the degree requirements for a master's degree, a research doctoral degree or any other advanced research degree program.

Individuals from diverse racial and ethnic groups and individuals with disabilities and individuals from disadvantaged backgrounds are always encouraged to apply for AHRQ support.

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 will use the NRSA individual postdoctoral fellowship award mechanism (F32). As a fellowship applicant, the individual together with his/her sponsor and institution, are jointly responsible for planning, directing, and executing the proposed research training program.

This mechanism is intended for candidates who will have received a PhD, MD, DO, DC, DDS, DVM, OD, DPM, ScD, EngD, Dr PH, DNSc, ND (Doctor of Naturopathy), PharmD, DSW, PsyD, or equivalent doctoral degree from an accredited domestic or foreign institution prior to activation of the award.

Additional information and detailed requirements for this NRSA award mechanism can be found at: https://grants.nih.gov/training/nrsa.htm.

2. Funds Available

Although the financial plans of AHRQ provide support for this program, awards pursuant to this funding opportunity are contingent upon the receipt of a sufficient number of meritorious applications, the AHRQ program priorities and availability of funds.

2.A. Allowable Costs

Stipends: NRSA awards provide stipends to fellows as a subsistence allowance to help defray living expenses during the research and clinical training experiences. The awards are not provided as a condition of employment with either the Federal government or the sponsoring institution. For the most recent stipend levels, see the following website: http://grants2.nih.gov/training/nrsa.htm.

Fellows with less than one full year of relevant postdoctoral experience at the time of award will receive initial support at the zero level. Relevant experience may include research (including research in industry), teaching, internship, residency, clinical duties, or other time spent in full-time studies in a health-related field beyond that of the qualifying doctoral degree. AHRQ will adjust awards on the anniversary date of the fellowship award to ensure consistency with the stipend schedule in effect at that time. No departure from the published NRSA stipend schedule may be negotiated between the institution and the fellow. The stipend for each subsequent year of NRSA support is the next level of experience using the stipend schedule in effect at that time.

Tuition and Fees: AHRQ will contribute to the combined cost of tuition and fees at the NRSA rate that is in effect at the time of award. Tuition, for the purposes of this policy, means the combined costs of tuition and fees, excluding health insurance. For the most recent tuition/fees rates, see the following website: http://grants2.nih.gov/training/nrsa.htm.

Institutional Allowance: Fellows will receive an institutional allowance to help defray fellowship expenses such as health insurance, research supplies, equipment, books, and travel to scientific meetings. Self-only health insurance (available to fellows without families) or family health insurance is an allowable cost for fellows at the sponsoring institution only if such self or family health insurance is required of all persons in a similar training status and regardless of the source of support. The institutional allowance is intended to cover training-related expenses for the individual fellow and is not available until the fellow officially activates the award. If an individual fellow is enrolled or engaged in training for less than six months of the award year, only one-half of that year's allowance may be charged to the grant. The Notice of Award will be revised and the balance must be returned to AHRQ.

Funds are not to be used to cover the costs of travel between the fellow’s place of residence and a training institution. However, in an individual case of extreme hardship, a one-way travel allowance may be authorized by the sponsoring institution. Such travel must be paid from the institutional allowance.

Additional funds may be requested by the institution for accommodations for fellows who are disabled, as defined by the Americans with Disabilities Act. The funds requested must be reasonable in relationship to the total dollars awarded under a fellowship and must be directly related to the approved research training project. These funds are not meant to relieve the sponsoring institution of its obligation to provide reasonable accommodation as defined by the Americans with Disabilities Act. Such additional funds shall be provided only in exceptional circumstances that are fully justified and explained by the institution in the application.

For the most recent approved institutional allowance levels, see the following website: http://grants2.nih.gov/training/nrsa.htm.

Supplementation of Stipends, Compensation, And Other Income: The sponsoring institution is allowed to provide funds to the fellow in addition to the stipend paid by AHRQ. Such additional amounts either may be in the form of an augmented stipend (supplementation) or in the form of compensation, provided the conditions described below are met. Under no circumstances may the conditions of stipend supplementation or the services provided for compensation interfere with, detract from, or prolong the fellow's approved NRSA training program. See also: https://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part10.htm#_Toc54600200.

Stipend Supplementation: Supplementation, or additional support to offset the cost of living, may be provided by the sponsoring institution. Supplementation cannot require additional effort from the fellow. DHHS funds may not be used for supplementation under any circumstances. Additionally, no funds from other Federal agencies may be used for supplementation unless specifically authorized by AHRQ and the other Federal agency.

Compensation: The sponsoring institution may provide additional funds to a fellow in the form of compensation (as salary and/or tuition remission) for services such as teaching or serving as a research assistant. A fellow may receive compensation for services as a research assistant or in some other position on a Federal research grant, including a DHHS research grant. However, compensated services may only occur on a limited, part-time basis apart from the normal research training activities, which require a minimum of 40 hours per week. In addition, compensation may not be paid from a research grant supporting the fellow's research training experience.

Educational Loans or G.I. Bill: An individual may make use of Federal educational loan funds and assistance under the Veterans Readjustment Benefits Act (G.I. Bill). Such funds are not considered supplementation or compensation.

Indirect Costs: These costs, also known as Facilities and Administrative (F&A) costs, are not allowed on individual fellowship awards.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

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

• Public or non-profit private institution, such as a university, college, or a faith-based or community-based organization;
• Units of local or State government;
• Eligible agencies of the Federal government.
• Indian/Native American Tribal Government (Federally Recognized);
• Indian/Native American Tribal Government (Other than Federally Recognized);
• Indian/Native American Tribally Designated Organizations.

Awards for fellowship training may only be made to domestic institutions.

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

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

1.B. Eligible Individuals

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

Citizenship: On or before the issue date of the award, the individual must be a citizen or a noncitizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status). Non-citizen nationals are generally persons born in outlying possessions of the United States (i.e., American Samoa and Swains Island). Individuals on temporary or student visas are not eligible. Individuals may apply for the F32 in advance of admission to the United States as a Permanent Resident recognizing that no award will be made until legal verification of Permanent Resident status is provided.

Degree Requirements: Before a NRSA postdoctoral fellowship award can be activated, the individual must have received a PhD, MD, DO, DC, DDS, DVM, OD, DPM, ScD, EngD, Dr PH, DNSc, ND (Doctor of Naturopathy), PharmD, DSW, PsyD, or equivalent doctoral degree from an accredited domestic or foreign institution. Certification by an authorized official of the degree-granting institution that all degree requirements have been met is also acceptable. A NRSA fellowship may not be used to support studies leading to the MD, DO, DDS, DVM, or other similar health-professional degrees. Neither may these awards be used to support the clinical years of residency training. However, these awards are appropriate for the research fellowship years of a research-track residency program. Research clinicians must devote full-time to their proposed research training and confine clinical duties to those activities that are part of the research training program.

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. An individual may not have more than one competing NIH or AHRQ fellowship application pending review concurrently.

Resubmission(s): Applicants may submit one resubmission application, but such application must include an Introduction addressing issues raised in the previous critique (Summary Statement).

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

Duration of Support: Individuals may receive up to 3 years of aggregate NRSA support at the postdoctoral level, including any combination of support from institutional training grants (T32) and individual fellowship awards (F32). It is not allowable to have concurrent NRSA support from two different sources (e.g., F32 and T32). Applicants must consider any prior NRSA postdoctoral research training in determining the duration of fellowship support requested. Accurate information regarding previous NRSA support must be included in the application and will be considered at the time of award. Applications not providing this information or showing a combined prior and proposed duration of NRSA postdoctoral support exceeding 3 years by the time of an award are not eligible for this FOA.

Training beyond the 3-year aggregate limit may be possible under certain exceptional circumstances, but a waiver from AHRQ is required. Individuals seeking additional NRSA support beyond the third year are strongly advised to consult with relevant AHRQ staff before preparing a justification. Any waiver will require a detailed justification of the need for additional research training. A waiver request should be made to the program official at AHRQ at least six months prior to the termination date of the fellowship award. A request for a waiver cannot be made prior to the issuance of the initial award.

Fellowship awardees are required to pursue their research training on a full-time basis, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies. Support for subsequent years of the fellowship award beyond the first budget period is based upon evidence of satisfactory progress in the postdoctoral research training program which is determined by the AHRQ Program staff review of information documented in the progress report.

Sponsor: Before submitting a fellowship application, the applicant fellow must identify a sponsor (also called mentor or supervisor) who will supervise the training and research experience. The sponsor should be an active investigator in the area of the proposed research training and be committed both to the research training of the Fellowship Applicant and to the direct supervision the applicant’s research. The sponsor must document the availability of sufficient research support and facilities for high-quality research training. The sponsor, or a member of the mentoring team, should have a successful track record of mentoring. Applicants are encouraged to identify more than one mentor, i.e., a mentoring team, if this is deemed advantageous for providing expert advice in all aspects of the research and training program. In such cases, one individual must be identified as the principal sponsor who will coordinate the applicant’s research training program. The applicant must work with his/her sponsor(s) in preparing the application.

The sponsor must describe the research training plan for the applicant fellow (coordinated with the applicant’s research strategy). The sponsor and any co-sponsors are also expected to provide an assessment of the applicant’s qualifications and potential for a research career. The research environment and the availability and quality of needed research facilities and research resources (e.g., equipment, laboratory space, computer time, available research support, etc.) must also be described. The description should include items such as classes, seminars, and opportunities for interaction with other groups and scientists. Training in career skills, e.g. grant-writing and presentation skills are strongly encouraged.

Sponsoring Institution: Before submitting a fellowship application, the applicant fellow must also identify a sponsoring institution. The sponsoring institution must have appropriate staff and facilities available on site to provide a suitable environment for performing high-quality research training and be demonstrably committed to research training in the particular program proposed by the applicant.

The fellowship is designed to support research training experiences in new settings in order to maximize the acquisition of new skills and knowledge. In most cases, therefore, the sponsoring institution should be a site other than where the applicant fellow has trained as a graduate student. However, if the applicant fellow is proposing postdoctoral training at his/her doctoral institution, the application must carefully document the opportunities for new research training experiences specifically designed to broaden his/her scientific background. In addition, the application should propose research experiences that will allow the fellow to acquire new knowledge and/or technical skills that will enhance the candidate’s potential to become a productive, independent investigator.

Section IV. Application and Submission Information

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

Registration:

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

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

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

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

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

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

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

2) Organizational/Institutional Registration in the eRA Commons

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

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

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

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

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

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) Individual Fellowship 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 301-945-7573; Email: [email protected].

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

2. Content and Form of Application Submission

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

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

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

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS Fellowship Supplemental Form
PHS Cover Letter File

Note: Specific instructions related to each of the components are included in the Individual Fellowship Application Guide SF424 (R &R)

SPECIAL INSTRUCTIONS

Applications Involving a Single Institution

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

Applications Involving Multiple Institutions

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

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: November 8, 2012
Application Due Date(s): Standard dates apply, 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 to eight months after peer review date

3.A.1. Letter of Intent

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

3.B. Submitting an Application Electronically to AHRQ

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

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

3.C. Application Processing

Applications must be received on or before the application receipt date described above (see Section IV.3.A. for all dates). If an application is received after that date, the application may be delayed in the review process or not reviewed.

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.

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

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

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

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

Institutional Review Board (IRB) approval of human subjects is not required prior to peer review of an application (see https://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.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

These awards are also subject to the NRSA Policies. For more information see: http://grants1.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part10.htm.

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

Concurrent Awards: A NRSA fellowship may not be held concurrently with another federally sponsored fellowship or similar Federal award that provides a stipend or otherwise duplicates provisions of this award.

Tax Liability: Internal Revenue Code Section 117 applies to the tax treatment of all scholarships and fellowships. Degree candidates may exclude from gross income (for tax purposes) any amount used for tuition and related expenses such as fees, books, supplies, and equipment required for courses of instruction at a qualified educational organization. Non-degree candidates are required to report as gross income all stipends and any monies paid on their behalf for course tuition and fees required for attendance.

The taxability of stipends in no way alters the relationship between NRSA recipients and sponsoring institutions. NRSA stipends are not considered salaries. In addition, NRSA trainees are not considered to be in an employee-employer relationship with AHRQ or the sponsoring institution solely as a result of the NRSA award. The interpretation and implementation of the tax laws are the domain of the IRS and the courts. AHRQ takes no position on the status of a particular taxpayer, nor does it have the authority to dispense tax advice. Individuals should consult their local IRS office about the applicability of the tax laws to their situation and for information on their tax obligations.

Future Year Support: Funds for continuation beyond the initial year are determined by the progress described in the continuation application (PHS 416-9), the timely submission of all required forms, and the availability of funds.

Service Payback: As required by the NIH Revitalization Act of 1993, postdoctoral fellows incur a service obligation of 1 month for each month of support during the first 12 months of the NRSA postdoctoral support. The 13th and subsequent months of NRSA support are acceptable postdoctoral payback service. Thus, individuals who continue under the award for 2 years will have paid off their first year obligation by the end of the second year.

Individuals accepting an award for the first 12 months of a NRSA postdoctoral support must sign a payback agreement (PHS Form 6031) in which they agree to engage in health-related research training, research, and/or teaching for 12 months.

Those who do not pay back their obligation through continued NRSA supported training may satisfy their obligation by serving in a position in which health- related research, research training, or teaching are the primary activities. Such individuals must engage in research, research training, or teaching at a rate of 20 or more hours per week averaged over a full work-year. Payback service may be conducted in an academic, governmental, commercial, or nonacademic environment, in the United States or in a foreign country. Examples of acceptable payback service include research associateships/assistantships, postdoctoral research fellowships, and college or high school science teaching positions. Examples of unacceptable payback service include clinical practice and administrative responsibilities not directly related to scientific research.

Payback service positions are arranged by the individual, not by AHRQ or NIH. The AHRQ will review and approve the activity at the end of the year in which it occurs. Service to satisfy any outstanding obligation must be initiated within 2 years after termination of NRSA support, and must be performed on a continuous basis. For individuals who fail to fulfill their service obligation, the United States is entitled to recover the total amount of NRSA funds paid to the individual for the obligated period plus interest at a rate determined by the Secretary of the U.S. Department of Treasury. Financial payback must be completed within 3 years, beginning on the date the United States becomes entitled to recover such amount.

Under certain conditions, the Secretary, DHHS, may extend the period for starting service, permit breaks in service, extend the period of repayment, or otherwise waive the payback obligation when compliance would constitute a substantial hardship against equity and good conscience.

Policies regarding the NRSA payback obligation are explained in the NRSA Section of the Policy Statement available at https://grants.nih.gov/grants/policy/policy.htm.

Specific questions may appear in a list of Frequently Asked Questions that appears on the Web at https://grants.nih.gov/training/faq_fellowships.htm. For questions on payback see: http://grants1.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part10.htm.

6. Other Submission Requirements

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

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

Organizational DUNS

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

Cover Letter (Section 5.2 of SF424 Individual Fellowship Application Guide)

Fellowship Applicants are required to attach a cover letter to the PHS Cover Letter component of the application. The cover letter must contain the same list of referees (including name, departmental affiliation, and institution) that is included in the Other Project Information Component Item 12, Other Attachments. In addition, applicants may request assignment (referral) to a particular NIH Institute or Center, as well as a specific Scientific Review Group. See SF 424 Individual Fellowship Application Guide, Section 5.2, for additional information.

PHS Fellowship Supplemental Form (Section 5.3 of SF424 Individual Fellowship Application Guide)

All application instructions outlined in the SF424 (R&R) Individual Fellowship Application Guide are to be followed (see: http://grants2.nih.gov/grants/funding/424/index.htm), taking into consideration the following additional instructions (Note that only selected items are emphasized below). See SF 424 Individual Fellowship Application Guide, Section 5.3, for additional information.

Page Limitations

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

Research Training Plan

Research Strategy (Component of Research Training Plan)

This section, including tables, graphs, figures, diagrams, and charts, is limited to 6 pages. This section should address the Significance of the proposed studies, including the background leading to the present application; and the Approach (including preliminary studies, if any) to provide experimental support of the proposed hypothesis.

Applicant fellows must describe a tailored research training plan, including a description of the research strategy (preferably hypothesis-driven) well-suited to the stage of his/her career development to date. Describe the skills and techniques that the candidate will learn during the award period, and discuss the relationship of the proposed research training to the applicant’s career goals. The applicant’s plan should be coordinated with the sponsor’s plan (see below), and should include substantive detail that adds to the information about time allocations requested. The applicant must describe the background leading to the proposed research, the significance of the research, the research approach (design and methods) for achieving the Specific Aims (see above), the rationale, and expected/alternative outcomes of the proposed studies.

Other Research Experience (Component of Additional Information)

The applicant fellow should discuss how the proposed research training plan will add to the fellowship experience.

Sponsor(s) and Co-Sponsor(s)

Before submitting a fellowship application, the applicant must identify a sponsor (also called mentor or supervisor) who will supervise the training and research experience. The sponsor should be an active investigator in the area of the proposed research training and be committed both to the research training of the Fellowship Applicant and to the direct supervision the applicant’s research. The sponsor must document the availability of sufficient research support and facilities for high-quality research training. The sponsor, or a member of the mentoring team, should have a successful track record of mentoring. Applicants are encouraged to identify more than one mentor, i.e., a mentoring team, if this is deemed advantageous for providing expert advice in all aspects of the research and training program. In such cases, one individual must be identified as the principal sponsor who will coordinate the applicant’s research training program. The applicant must work with his/her sponsor(s) in preparing the application.

The sponsor must describe the research training plan for the applicant (coordinated with the applicant s research strategy). The sponsor and any co-sponsors are also expected to provide an assessment of the applicant’s qualifications and potential for a research career. The research environment and the availability and quality of needed research facilities and research resources (e.g., equipment, computer time, available research support, etc.) must also be described. The description should include items such as classes, seminars, and opportunities for interaction with other groups and scientists. Training in career skills, e.g. grant-writing and presentation skills are strongly encouraged.

Training in the Responsible Conduct of Research

Applications must include the sponsoring institution s plan to provide and the potential fellow’s plans for obtaining instruction in the responsible conduct of research. The rationale, subject matter, appropriateness, format, frequency and duration of instruction must be described. The amount and nature of faculty participation must be described. Although AHRQ has not established specific curriculum or format requirement for this training, it is suggested that the following topics be covered: conflict of interest, data sharing, responsible authorship, policies for handling misconduct, policies regarding the use of human subjects, and data management. Applications without plans for training in responsible conduct of research will be considered incomplete and may not be reviewed. No award will be made if an application lacks this component. This section is limited to 1 page.

Letters of Reference (Section 5.4 of SF424 (R&R) Individual Fellowship Application Guide)

Applicant fellows must carefully follow the SF424 (R&R) Individual Fellowship Application Guide, including the time period for when letters of reference will be accepted. Applications lacking the required reference letters may be delayed in review or not reviewed. Please note that the specified Fellowship Reference Form must be used. This is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons Referee Information link and not through Grants.gov. Note that the sponsor and any co-sponsors may not submit a letter of reference.

Failure to submit all of the required references in the appropriate format may result in the application being returned to you without review.

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

Post Submission Materials

Documentation related to Sponsor(s) funding will be allowed as post-submission material to update the Sponsor(s) funding information in the originally submitted application. Information on the Sponsor(s) funding information must not exceed 1 page, and is limited to the project title, funding source (e,g. AHRQ grant number), a brief description of specific aims, and relevance to the fellowship application under review. The additional material is due no later than 30 days prior to the meeting of the review committee.

Authorized Organizational Representative (AOR) concurrence:

The requirement for concurrence from the Authorized Organizational Representative (AOR) of the applicant organization continues. Although the content of post-submission materials may originate from the PD/PI, Contact PD/PI for multiple PD/PI applications, or organizational officials, the AOR must send the materials directly to the AHRQ Referral Officer, or must send his/her concurrence to the PD/PI who will forward the materials and concurrence to the AHRQ Referral Officer. A communication from the PD/PI only or with a cc to the AOR will not be accepted.

Please direct these post submission materials and related inquiries to:

Gerald E. Calderone, Ph.D.
AHRQ Referral Officer
Agency for Healthcare Research and Quality
[email protected]

Resource Sharing Plan

AHRQ considers the sharing of unique research resources developed through AHRQ-sponsored research an important means to enhance the value and further the advancement of the research. When resources have been developed with AHRQ funds and the associated research findings published or provided to AHRQ, it is important that they be made readily available for research purposes to qualified individuals within the scientific community.

Appendix Materials

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

Do not use the Appendix to circumvent the page limitations of the Research Strategy. 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 Service Act, directed AHRQ, in carrying out its mission, to conduct and support research and evaluations, and to support demonstration projects, with respect to the delivery of health care in inner-city and rural areas (including frontier areas), and health care for priority populations. Priority populations include low income groups; minority groups; women; children; the elderly; and individuals with special health care needs, including individuals with disabilities and individuals who need chronic care or end-of-life health care. This authority is found at 42 USC 299(c). 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. Investigators should review the February 2003 policy entitled AHRQ Policy on the Inclusion of Priority Populations, which is available at: https://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html).

Publication Transmittal: General AHRQ Requirements

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

Assessment of AHRQ Grant Programs

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

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

HCUP & MEPS

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

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

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

Health Literacy

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

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

Consumer Products

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

Plan for Sharing Research Data

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

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

Section V. Application Review Information

1. Criteria

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

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

2. Review and Selection Process

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

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

• Undergo a selection process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score
• Receive a written critique

The purpose of the AHRQ NRSA F32 program is to provide support to promising applicants with the potential to become productive and successful independent research investigators in scientific health-related fields relevant to the mission of AHRQ. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research training will have a substantial impact on the pursuit of this goal. The scientific review group will use information in the letters of reference in consideration of the review criteria. The overall score will reflect the overall evaluation of the entire application.

For this particular announcement, please note that fellowship grants are training awards and are not research awards. Major considerations in the review are the applicant fellow's potential for a productive career, the applicant fellow's need for the proposed training, and the degree to which the research training proposal, the sponsor, and the environment will satisfy those needs.

Overall Impact

Reviewers will provide an overall priority score to reflect their assessment of the likelihood that the fellowship will enhance the candidate’s potential for, and commitment to, a productive independent scientific research career in health services research, in consideration of the scored and additional review criteria .

Scored Review Criteria

Reviewers will consider each of the review criteria below in determining scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have a major impact.

Fellowship Applicant:

• Are the applicant’s fellow academic record and research experience of high quality?
• Does the applicant fellow have the potential to develop as an independent and productive researcher in health services research?

Sponsor(s), Collaborator(s), and Consultant(s):

• Are the sponsor(s) research qualifications (including successful competition for research support) and track record of mentoring appropriate for the proposed fellowship?
• Are there (1) evidence of a match between the research interests of the applicant fellow and the sponsor (including an understanding of the applicant’s research training needs) and (2) a demonstrated ability and commitment of the sponsor to assist in meeting these needs?
• Are the qualifications of any collaborator(s) and/or consultant(s), including their complementary expertise and previous experience in fostering the training of fellows, appropriate for the proposed research project?

Research Training Plan:

• Is the proposed research plan of high scientific quality, and does it relate to the applicant fellow training plan?
• Is the training plan consistent with the applicant fellow’s stage of research development?
• Will the research training plan provide the applicant fellow with individualized and supervised experiences that will develop research skills needed in preparation for his/her independent and productive research career?

Training Potential:

• Does the proposed research training have the potential to provide the applicant fellow with the requisite individualized and supervised experiences that will develop his/her research skills?
• Does the proposed research training have the potential to serve as a sound foundation that will lead the applicant fellow to an independent and productive career?

Institutional Environment and Commitment to Training:

• Are the research facilities, resources (e.g. equipment, laboratory space, computer time, subject populations), and training opportunities adequate and appropriate?
• Is the institutional environment for the scientific development of the applicant of high quality, and is there appropriate institutional commitment to fostering the fellows training?

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.

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

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

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

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

2.B. Additional Review Considerations

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

Training in the Responsible Conduct of Research: Every NRSA fellow must receive instruction in the responsible conduct of research (https://grants.nih.gov/grants/guide/notice-files/not92-236.html). Applications must include the sponsoring institution’s plans to provide and the fellow's plans for obtaining instruction in the responsible conduct of research, including the rationale, subject matter, appropriateness, format, frequency and duration of instruction. The amount and nature of faculty participation must be described. The plan will be discussed after the overall determination of merit, so that the review panel's evaluation of this plan will not be a factor in the determination of the overall impact score. The plan will be judged as acceptable or unacceptable. The acceptability of the plan will be described in an administrative note in the summary statement. Regardless of the overall impact score, an application with an unacceptable plan will not be funded until the applicant provides an acceptable plan. AHRQ staff will judge the acceptability of the revised plan.

Budget and Period of Support: Reviewers will assess the appropriateness of the requested period of support in relation to the proposed fellowship training.

2.C. Resource Sharing Plan(s)

Data Confidentiality

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

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

Sharing Research Resources: Rights in Data

Unless otherwise provided in grant awards, AHRQ grantees may copyright, or seek patents for, as appropriate, final and interim products and materials developed in whole or in part with AHRQ support, including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses. Such copyrights and patents are subject to a royalty-free, non-exclusive, and irrevocable AHRQ license to reproduce, publish, use or disseminate for any purpose consistent with AHRQ’s statutory responsibilities and to authorize others to do so for any purpose consistent with AHRQ’s statutory responsibilities. In accordance with its legislative dissemination mandate, AHRQ purposes may include, subject to statutory confidentiality protections, making project materials, databases, results, and algorithms available for verification or replication by other researchers. In addition, subject to AHRQ budget constraints, final products may be made available to the health care community and the public by AHRQ or its agents if such distribution would significantly increase access to a product and thereby produce substantial or valuable public health benefits. Ordinarily, to accomplish distribution, AHRQ publicizes research findings but relies on grantees to publish research results in peer-reviewed journals and to market grant-supported products. AHRQ's Office of Communications and Knowledge Transfer (OCKT) wishes to be consulted in advance of publication in order to coordinate announcements of new AHRQ-supported research results with other AHRQ dissemination activities. Important legal rights and requirements applicable to AHRQ grantees are set out or referenced in AHRQ's grants regulation at 42 CFR Part 67, Subpart A (available in libraries and from the GPO's website at http://www.gpoaccess.gov/cfr/index.html) which incorporates additional applicable provisions on Rights in Data, including 45 CFR Part 74 and 37 CFR Part 401.

Selection Process

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

• Scientific merit of the proposed project as determined by peer review
• Availability of funds
• Responsiveness to goals and objectives of the FOA
• Relevance to program priorities and programmatic balance
• Portfolio balance within AHRQ and DHHS

3. Anticipated Announcement and Award Dates

Generally, applicants should anticipate eight months between the application submission date and the earliest possible start date.
Section VI. Award Administration Information

1. Award Notices

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

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

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

Selection of an application for award is not an authorization to begin performance. Pre-award costs are NOT allowed on fellowship awards. See also Section IV.5., Funding Restrictions.

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

Activation: No funds may be disbursed until the fellow has started training under the award and an Activation Notice (PHS 416-5) and a Payback Agreement (PHS 6031) have been submitted to AHRQ. A fellow has up to six months from the issue date on the award notice to activate the award. Under unusual circumstances, AHRQ may grant an extension of the activation period upon receipt of a specific request from the fellow.

2. Administrative and National Policy Requirements

NRSA Postdoctoral Fellowships require a payback agreement. For more information see Section IV.5, Funding Restrictions, and https://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part10.htm.

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

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

Fellowships must be administered in accordance with the current NRSA section of the Grants Policy Statement at https://grants.nih.gov/grants/policy/policy.htm), and any terms and conditions specified on the Notice of Award.

Leave Policies: In general, fellows may receive stipends during the normal periods of vacation and holidays observed by individuals in comparable training positions at the sponsoring institution. For the purpose of these awards, however, the period between the spring and fall semesters is considered to be an active time of research and research training and is not considered to be a vacation or holiday. Fellows may receive stipends for up to 15 calendar days of sick leave per year. Sick leave may be used for the medical conditions related to pregnancy and childbirth. Fellows may also receive stipends for up to 60 calendar days of parental leave per year for the adoption or the birth of a child when those in comparable training positions at the grantee institution have access to the same paid leave for this purpose and the use of parental leave is approved by the program director (see NOT-OD-08-064).

A period of terminal leave is not permitted and payment may not be made from fellowship funds for leave not taken. Fellows requiring periods of time away from their research training experience longer than specified here must seek approval from the AHRQ for an unpaid leave of absence.

Part-time training: While NRSA awardees are required to pursue research training full time, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies, under unusual and pressing personal circumstances, a fellow may submit a written request to AHRQ to permit less than full-time training. Such requests will be considered on a case-by-case basis. They must be approved by AHRQ in advance for each budget period. The nature of the circumstances requiring the part-time training might include medical conditions, disability, or pressing personal or family situations such as child or elder care. Permission for part-time training will not be approved to accommodate other sources of funding, job opportunities, clinical practice, clinical training, or for other responsibilities associated with the fellow's position at the institution. In each case, the fellow must submit a written request countersigned by the sponsor and an appropriate institutional business official that includes documentation supporting the need for part-time training. The written request also must include an estimate of the expected duration of the period of part-time training, an assurance that the fellow intends to return to full-time training when that becomes possible, and an assurance that the trainee intends to complete the proposed research training program. In no case will it be permissible for the fellow to be engaged in NRSA supported research training for less than 50 percent effort. Individuals who must reduce their commitment to less than 50 percent effort must take a leave-of-absence from NRSA fellowship support. The fellowship notice of award will be revised and the stipend will be pro-rated during the period of any approved part-time training. Part-time training may affect the rate of accrual or repayment of the service obligation for postdoctoral fellows.

Certification Requirements: Individuals admitted to the United States as Permanent Residents must submit notarized evidence of legal admission prior to the award.

Service Payback: A Payback Agreement Form (PHS 6031) must accompany the Activation Notice for any award that occurs during the individual's initial 12 months of NRSA postdoctoral support. When support ends, the fellow must submit a Termination Notice (PHS 416-7) to the AHRQ. If the fellow has a payback obligation, he or she must notify the AHRQ of any change in address and submit Annual Payback Activities Certification Forms (PHS 6031-1) until the payback service obligation is satisfied. Forms may be found at https://grants.nih.gov/grants/forms.htm

Inventions: Fellowships made primarily for educational purposes are exempted from the PHS invention requirements. F32 awards will not contain any provision giving PHS rights to inventions made by the fellow. 35 U.S.C. 212.

3. Reporting

When multiple years are involved, awardees will be required to submit a NRSA Individual Fellowship Progress Report for Continuation Support (PHS 416-9) annually. The report is due before the beginning date of the next budget period (the terms and conditions of the fellowship award will indicate the actual date the report is due). It must include information describing the current year's progress as well as the research and training plans for the coming year. Note that the instructions request that a listing of all courses and publications completed during the past year be included in the application for continued support.

Other Fellowship Reporting Requirements:

• The fellowship award recipient has up to six months from the issue date on the Notice of Award to activate the award using the Individual Fellowship Activation Notice (PHS 416-5). Under unusual circumstances, AHRQ may grant an extension of the activation period upon receipt of a specific request from the fellow. Such a request must be countersigned by the sponsor and an authorized institutional official.
• For the individual's initial 12 months of NRSA postdoctoral support, a signed, original Payback Agreement Form (PHS 6031) must accompany the Activation Notice.
• Individuals admitted to the United States as Permanent Residents must submit notarized evidence of legal admission prior to issuance of the award.
• At the conclusion of a fellowship, the fellow must submit a Termination Notice (PHS 416-7) via xTrain to the AHRQ within 30 days of termination. Fellows with service payback requirements must notify the AHRQ of any change in address and submit Annual Payback Activities Certification Forms (PHS 6031-1) until the payback service obligation is satisfied.

All forms may be found at: https://grants.nih.gov/grants/forms.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 be written or by telephone, and fall into three areas: scientific/research (program), peer review, and financial or grants management issues.

1. Scientific/Research Contact(s):

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

Shelley M. Benjamin, M.S.W.
Division of Research Education
Office of Extramural Research, Education and Priority Populations
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1528
FAX: (301) 427-1562
E-mail: [email protected]

2. Peer Review Contact(s):

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

Ali Azadegan, D.V.M., 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) 427-1689
Fax: (301) 427-1562
E-mail address: [email protected]

3. Financial/Grants Management Contact(s):

Direct inquiries regarding fiscal matters to:

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

Section VIII. Other Information

Required Federal Citations

Human Subjects Protection:

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

Standards for Privacy of Individually Identifiable Health Information:

The Department of Health and Human Services (DHHS) "Standards for Privacy of Individually Identifiable Health Information", regulation was mandated by the Health Insurance Portability and Accountability Act (HIPAA) of 1996 which governs the protection of individually identifiable health information. It is administered and enforced by the DHHS Office for Civil Rights (OCR). The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools that may be used to determine whether a researcher is a staff member of a covered entity.

Access to Research Data through the Freedom of Information Act:

OMB Circular A-110 provides access to certain research data developed with Federal support through the Freedom of Information Act (FOIA), 5 U.S.C. 552, in certain circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation or administrative order) may be accessed through FOIA. If no Federal action is taken having the force and effect of law in reliance upon an AHRQ-supported research project, the underlying data are not subject to this disclosure requirement. Furthermore, even if a Federal regulatory action is taken in reliance on AHRQ-supported research data, disclosure of such data is limited in accordance with the AHRQ confidentiality statute, 42 USC 299c-3(c). NIH has provided general related guidance at https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm which does not include discussion of the exception applicable to confidential identifiable data collected under AHRQ's authorities.

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

Healthy People 2020:

The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2020," a PHS-led national activity for setting health improvement priorities for the United States. AHRQ encourages applicants to submit grant applications with relevance to the specific objectives of this initiative. Potential applicants may obtain a copy of "Healthy People 2020" at http://www.health.gov/healthypeople.

Authority and Regulations:

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

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