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Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)

Components of Participating Organizations
National Cancer Institute (NCI), ( http://www.cancer.gov/)
National Eye Institute (NEI), (http://www.nei.nih.gov/)
National Heart, Lung, and Blood Institute (NHLBI), (http://www.nhlbi.nih.gov)
National Human Genome Research Institute (NHGRI), (http://www.nhgri.nih.gov/)
National Institute on Aging (NIA), (http://www.nia.nih.gov/)
National Institute on Alcohol Abuse and Alcoholism (NIAAA), (http://www.niaaa.nih.gov/)
National Institute of Allergy and Infectious Diseases (NIAID), (http://www.niaid.nih.gov/)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), (http://www.niams.nih.gov/)
National Institute of Biomedical Imaging and Bioengineering (NIBIB), (http://www.nibib.nih.gov/)
National Institute of Child Health and Human Development (NICHD), (http://www.nichd.nih.gov/)
National Institute on Deafness and Other Communication Disorders (NIDCD), (http://www.nidcd.nih.gov/)
National Institute of Dental and Craniofacial Research (NIDCR), (http://www.nidcr.nih.gov/)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), (http://www.niddk.nih.gov/)
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov/)
National Institute of Environmental Health Sciences (NIEHS), (http://www.niehs.nih.gov)
National Institute of General Medical Sciences (NIGMS), (http://www.nigms.nih.gov)
National Institute of Mental Health (NIMH), (http://www.nimh.nih.gov/)
National Institute of Neurological Disorders and Stroke (NINDS), (http://www.ninds.nih.gov/)
National Institute of Nursing Research (NINR), (http://ninr.nih.gov/)
National Library of Medicine (NLM), (http://www.nlm.nih.gov/)
Fogarty International Center (FIC), (http://www.fic.nih.gov/ (No longer participating, see NOT-TW-09-002)
National Center for Complementary and Alternative Medicine (NCCAM), (http://www.nccam.nih.gov/)
National Center on Minority Health and Health Disparities (NCMHD), (http://ncmhd.nih.gov/)
National Center for Research Resources (NCRR), (http://www.ncrr.nih.gov/)

Title: NIH Pathway to Independence Award (K99/R00)

Announcement Type
This is a reissue of PA-07-297.

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

Program Announcement (PA) Number: PA-09-036

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 candidates 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)
93.213, 93.389, 93.172, 93.233, 93.837, 93.838, 93.839, 93.271, 93.855, 93.856, 93.173, 93.121, 93.847, 93.848, 93.849, 93.279, 93.859, 93.281, 93.361, 93.853, 93.894, 93.879, 93.989, 93.307, 93.867, 93.866, 93.846, 93.865, 93.286, 93.398

Key Dates
Release/Posted Date: December 12, 2008
Opening Date: January 12, 2009 (Earliest date an application may be submitted to Grants.gov).
Letters of Intent Receipt Date(s): See Section IV3A1.
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 apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Due Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS.
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional Information To Be Available Date (URL Activation Date): Not Applicable.
Expiration Date: (New Expiration Date January 8, 2010 per issuance of PA-10-063) Old Date: January 8, 2012.

Due Dates for E.O. 12372

Not Applicable.

Additional Overview Content

Executive Summary

The overall goal of NIH-supported career development programs is to help ensure that a diverse pool of highly trained scientists are available in adequate numbers and in appropriate research areas to address the Nation's biomedical, behavioral, and clinical research needs.

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
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting
4. Activating the Independent Phase of the Pathway to Independence Award (R00)

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 overall objective of the NIH Research Career Development Award program is to prepare qualified individuals for careers that have a significant impact on the health-related research needs of the Nation. The objective of the NIH Pathway to Independence Award (K99/R00) initiative is to assist postdoctoral investigators in transitioning to a stable independent research position with NIH or other independent research funding. One of the most challenging transitions in any research career is the transition from postdoctoral trainee to independent scientist. Recent reports from the National Research Council of the National Academies of Science (Bridges to Independence: Fostering the Independence of New Investigators in Biomedical Research, and Advancing the Nation’s Health Needs: NIH Research Training Programs) have highlighted the need for enhanced efforts to foster the transition of postdoctoral scientists from mentored environments to independence.

NIH believes that the creativity and innovation of new independent investigators in their early career stages play an integral role in addressing our Nation’s biomedical, behavioral, and clinical research needs. However, the average age of first-time (new) Principal Investigators obtaining R01 research funding from the NIH has risen to 42 years for Ph.D. degree holders and 44 years for M.D. and M.D./Ph.D. degree holders. The intent of the K99/R00 program is to help alleviate this trend and to assist new investigators in transitioning to stable independent research positions at an earlier age and with an enhanced probability of success in obtaining independent NIH or other independent research support.

In addition to this initiative, NIH Institutes and Centers (ICs) support a variety of other mentored career development programs designed to foster the transition of new investigators to research independence, which may be more suitable for particular candidates. Information describing all NIH Career Development Award programs can be found at the K Kiosk - Information about NIH Career Development Awards.

Nature of the career/research transition opportunity

The K99/R00 award will provide up to 5 years of support consisting of two phases. The initial mentored phase will provide support for up to 2 years for the most promising and exceptionally talented new investigators who have no more than 5 years of postdoctoral research training experience at the time of initial application or subsequent resubmission(s) and do not already have a full-time tenure track assistant professor position (or equivalent). This initial phase of mentored support will allow the candidate time to obtain additional training, complete research, publish results, and bridge to an independent research position. The candidate must propose a research project that will be pursued during the K99 phase and transition into an independent project during the R00 phase of the award. The candidate and mentor(s) together will be responsible for all aspects of the mentored (K99 phase) career development and research program. An individual may submit an application from an extramural or intramural sponsoring institution/organization that has a rich and extensive research program in the area of interest as well as the faculty, facilities and resources to support the proposed research endeavor. The individual must select an appropriate mentor with a track record of funded research related to the selected research topic and experience as a supervisor and mentor. The sponsoring institution must ensure that the candidate has the protected time needed to conduct the proposed research.

Following the mentored phase, the individual may request up to 3 years of support to conduct research as an independent scientist at an extramural sponsoring institution/organization to which the individual has been recruited, been offered and has accepted a tenure-track full-time assistant professor position (or equivalent). This support is to allow the individual to continue to work toward establishing his/her own independent research program and prepare an application for regular research grant support (R01). Support for the independent phase, however, is not automatic and is contingent upon being accepted by an appropriate extramural institution and the successful NIH programmatic review of the individual’s mentored phase of the award.

Note: NIH Institutes and Centers have unique scientific purviews and different program goals and initiatives. Therefore, candidates are strongly encouraged to consult the following table for IC-specific programmatic and budgetary information: Table of Institute and Center Contacts.

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 NIH Pathway to Independence Award (K99/R00) mechanism. The Project Director/Principal Investigator (PD/PI) (also referred to as the Candidate) and his/her mentor will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses Just-in-Time information concepts (see SF424 (R&R) Application Guide). It also uses non-modular budget format.

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 K99/R00 program must be tailored to meet the individual needs of the candidate. Candidates may request up to 5 years of support consisting of two phases. The initial phase will provide 1-2 years of mentored support for highly promising, postdoctoral research scientists. This phase will be followed by up to 3 years of independent support contingent on securing an independent tenure-track or equivalent research position. R00 award recipients are expected to apply for additional NIH or other independent research grant support during the independent phase of the award.

2. Funds Available

Because the nature and scope of the proposed K99/R00 award program will vary from application to application and the amounts provided by the participating ICs are not uniform, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the ICs provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

2.A. Allowable Costs

The K99/R00 award has two phases: a mentored K99 phase of up to 2 years at an eligible extramural sponsoring institution/organization or NIH intramural laboratory followed by an independent scientist phase of up to 3 years sponsored by an extramural institution/organization to which the individual has been recruited. Individuals who receive mentored phase support and are subsequently recruited to positions at NIH intramural laboratories will not receive the independent scientist phase of the award.

Mentored Phase of the Pathway to Independence Award Program (K99)

The total cost per year for the initial mentored phase generally should not exceed $90,000 at either an NIH intramural or an extramural sponsoring institution site, but may be higher in the case of individuals with exceptional salary needs. Salary and fringe benefits may be requested up to the level provided by other Mentored Career Awards offered by the awarding Institute or Center. Research support costs will generally be provided up to $20,000 for a 12 month budget period. Some ICs may offer higher research support costs. Candidates are strongly encouraged to consult the following table for IC-specific programmatic and budgetary information (see Table of Institute and Center Contacts).

Candidates (intramural or extramural) are required to commit a minimum of 75% of full-time professional effort (i.e. minimum of 9 person-months) to the pursuit of their career development and research experience during the mentored phase. This experience may also include activities such as completing research publications and searching for an independent research position. Candidates may engage in teaching and/or clinical duties as part of the remaining 25% of the candidate s full-time professional effort not covered by this award, as long as such duties do not interfere with or detract from the proposed career development program.

Intramural: Mentored candidates in the NIH intramural program will be supported by intramural funds provided by the NIH Institute/Center intramural laboratory in which they are conducting their research. Budget details for the mentored phase will be negotiated with the sponsoring intramural laboratory Institute/Center and salary will be consistent with that offered new scientists in similar positions.

Extramural: Mentored candidates in an extramural sponsoring institution/organization will be supported by NIH extramural funds. Salary must be consistent with the established salary structure at the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. Fringe benefits should be requested based on the sponsoring institution’s rate. Research expenses may include (a) tuition and fees related to career development; (b) supplies, equipment and technical personnel; c) travel to research meetings or training; and (d) statistical services including personnel and computer time. Indirect costs will be provided at 8% of modified direct costs to extramural sponsoring institutions, only.

The extramural sponsoring institution may supplement the NIH 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 additional PHS funds beyond those provided in the K99 award be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of this award. Under expanded authorities, however, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution's salary scale. The total salary paid from NIH funds, however, may not exceed the legislatively mandated salary cap. See http://grants.nih.gov/grants/policy/salcap_summary.htm.

Independent Investigator Phase of the Pathway to Independence Award Program (R00)

The total cost for the independent investigator R00 phase may not exceed $249,000 per year. This amount includes salary, fringe benefits, research support allowance and applicable indirect costs. Indirect costs will be reimbursed at the extramural sponsoring institution’s indirect cost rate. Indirect costs requested by consortium participants are included in the total cost limitation.

The salary requested should be based on the person-months effort to be devoted to the R00 project, as is the case for other research grant awards. The candidate is required to devote a total of 75% of their full-time, 12 month professional effort to research (i.e., a full-time 9 person-months). See eligibility below. However, it may not be feasible to support this entire effort through the R00 project alone. Recipients of the R00 phase awards may devote effort to other research projects and may reduce effort on the R00 award if they receive additional independent research support. Please note that a reduction of time devoted to a project by 25% or more from the level in an approved application will require NIH prior approval as described in the NIH Grants Policy Statement.

Applicable to both Mentored and Independent Phases

For information regarding NIH policy on determining full-time professional effort for career awards see NOT-OD-04-056. The requested 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 with 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 related appropriately to the existing salary structure. Confirmation of salary is required prior to the issuance of an award. Fringe benefits based on the sponsoring institution’s rate and the percent of effort are provided in addition to the salary. See also Eligible Individuals below.

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

Indirect Costs: These costs also known as Facilities and Administrative (F&A) costs, will be reimbursed at eight percent (8%) of modified total direct costs for the extramural K99 phase, and at the extramural sponsoring institution’s indirect cost rate for the R00 phase.

NIH Grants Policy: NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

3. Transition from K99 Phase to R00 Phase Award

Transition from the mentored phase (intramural NIH or extramural institution) to the extramural independent scientist phase is NOT automatic and is subject to review of the awardee’s research training/career development accomplishments and an evaluation of the materials (including progress report) submitted in support of the R00 phase application. The candidate must be accepted by an extramural institution in a tenure-track, full-time assistant professor (or equivalent) position in order to activate the extramural support phase. Information on materials to be submitted is located in Section VI.4. Activating the Extramural Independent Investigator Phase of the Pathway to Independence Award (R00).

Acceptance into the K99/R00 Award Program does not imply a commitment on the part of the NIH to consider the awardee for a tenure-track position at an NIH intramural laboratory. The primary intent of this program is to develop outstanding researchers who will pursue extramural research careers related to the mission of the NIH awarding component that provided the support for the program. However, awardees may wish to apply for available tenure-track positions at the NIH. The award will be terminated if the candidate is offered and accepts such a position.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

NIH intramural laboratories are eligible to apply for this mechanism on behalf of intramural candidates.

Foreign institutions are not eligible to apply.

The applicant institution will be the mentored phase K99 institution. All institution/organization types listed above are eligible for both the mentored and independent phase, with one exception: ineligible agencies of the Federal government, such as the NIH intramural program, are eligible only for the mentored phase.

For non-U.S. citizen/permanent residents, the applicant U.S. institution for each phase of the application (K99 or R00) is responsible for determining and documenting in the application that the applicant investigator’s visa will allow him or her to remain in this country long enough to (a) transition to an independent research career in the U.S. during the proposed mentored (K99) phase and/or (b) be productive on the research project in the U.S. for the duration of the proposed independent research (R00) phase.

If a grant is awarded on the basis of this information and the individual's visa does not allow for such a stay, NIH may terminate the grant (see "Administrative Requirements Changes in Project and Budget and "Administrative Requirements Enforcement Actions Suspension, Termination, and Withholding of Support. ) NIH will not intercede on behalf of non-citizens whose stay in the United States may be limited by their visa status.

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 NIH support.

Project Director/Principal Investigator (PD/PI): Also referred to as the 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 NIH support.

Citizenship and Residency: U.S. citizens and non-U.S. citizens with the skills, knowledge, and resources necessary to carry out the proposed research are invited to develop an application for support. Information on citizenship/residency status must be provided in the application as part of section 9. Institutional Commitment to Candidate’s Research Career Development of the PHS398 Career Development Award Supplemental Form. See also Section III.3.A (Institutional Environment).

Degree and Research: Eligible PD/PIs include outstanding postdoctoral candidates who have a clinical or research doctorate (including Ph.D., M.D., D.O., D.C., N.D., D.D.S., D.M.D., D.V.M., Sc.D., D.N.S., Pharm.D. or equivalent doctoral degrees) and who have no more than 5 years of postdoctoral research training at the time of application (resubmissions must also comply with this requirement). Clinicians (including those with M.D., D.D.S, D.V.M. and other licensed health professionals) in a clinical faculty position that denotes independence in clinical responsibilities but not in research may also be eligible for the K99/R00 award. See Other-Special Eligibility Criteria below for more information.

Career Level: This award is intended for and limited to postdoctoral scientists who are in mentored training positions and do not have sufficient research experience or institutional authority to lead an independent research program. Individuals with a full-time tenure track assistant professor position (or equivalent) at the time of application are not eligible.

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 NIH K99/R00 Award, i.e., the candidate’s development into an independent investigator. For information regarding NIH 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 in the relevant Institute or Center prior to preparing an application to discuss their eligibility.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

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): See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016).

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

Individuals are NOT eligible if they:

Ph.D. (or equivalent research doctorate degree) candidates in positions other than postdoctoral fellow positions: It is recognized that some institutions appoint postdoctoral fellows in positions with other titles although they are still in non-independent training positions. Candidates in such positions are encouraged to obtain confirmation of their eligibility before they begin to prepare their applications. It is incumbent upon the candidate to provide evidence that the position he/she is in complies with the intent of this eligibility requirement. Evidence for non-independence may include:

Conversely, evidence for independence, and therefore lack of eligibility, includes:

Clinicians (including those with M.D., D.D.S, D.V.M. and other licensed professionals) in positions not designated as postdoctoral positions: Following clinical training or fellowship training periods, clinicians often obtain a clinical faculty position that denotes independence in clinical responsibilities but not in research. A clinical faculty member who does not hold an independent research faculty position may be eligible for the K99/R00 award, and should contact a Program Director at the relevant NIH Institute for guidance. Clinicians in such positions are encouraged to obtain confirmation of their eligibility before they begin to prepare their applications. Such individuals may also wish to consider other career awards available for junior faculty development. See: K Kiosk - Information about NIH Career Development Awards.

Candidates are strongly encouraged to consult with the scientific/research contact person listed in Section VII of this announcement prior to the submission of an application to discuss eligibility and IC-specific program and budget requirements (See Table of Institute and Center Contacts).

3.A. Special Requirements

Mentor(s): The candidate must name a primary mentor for the K99 phase, who together with the candidate 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 research scientists. 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. Primary mentors (and if at all possible, co-mentors) should be full-time faculty at the sponsoring institution. If they are not (e.g., off-site mentors or co-mentors), strong justification for the appropriateness of the mentoring relationship must be provided in the application. The primary mentor and co-mentors should be committed to the development of the career of the candidate as an independent investigator, as evidenced by the mentor and co-mentor statements.

Institutional Environment: The applicant institution must have a strong, well-established record of research and career development activities and faculty qualified in biomedical, behavioral, or clinical 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 candidate. 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.

For candidates for K99/R00 awards who are non-U.S. citizens with temporary U.S. visas, the sponsoring institution must include information about their visa status, and an assurance that their visas will allow them to remain in the United States long enough to (a) transition to an independent research career in the U.S. during the proposed mentored (K99) phase and (b) be productive on the research project in the U.S. for the duration of the proposed independent research (R00) phase. This information must be included as part of section 9. Institutional Commitment to Candidate’s Research Career Development of the PHS398 Career Development Award Supplemental Form.

Candidates 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:

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

2) Organizational/Institutional Registration in the eRA Commons

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

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

Note: If a PD/PI is also an NIH 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.

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. The NIH 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: [email protected].

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

2. Content and Form of Application Submission

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

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to 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 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: January 12, 2009 (Earliest date an application may be submitted to Grants.gov)
Letter of Intent Receipt Date(s): See below.
Application Due Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Due Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward

3.A.1. Letter of Intent

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

3.B. Submitting an Application Electronically to the NIH

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.

3.C. Application Processing

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

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

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. 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 PD/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.

The NIH 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. The NIH will not accept any application that is essentially the same as one already reviewed. However, the NIH will accept resubmission(s) application, but such application must include an Introduction addressing the critique from the previous review.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

NRSA Support: Ruth L. Kirschstein National Research Service Award (NRSA) recipients who are selected for K99/R00 award funding must terminate their NRSA support prior to receiving support from the K99/R00 award.

Salary Support: The salary requested for the candidate must be consistent with both the established salary structure for full-time staff appointments and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the applicable department.

Research Development Support: The research development support costs allowed for this program must be justified and be consistent with the stage of development of the candidate and the proportion of time to be spent in research or career development activities. Salary for ancillary personnel support, such as mentors, secretarial and administrative assistants is not allowed.

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

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH 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. NIH 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. See NIH Grants Policy Statement NIH Grants Policy Statement.

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 NIH 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.

Other Project Information Component (Section 4.4): For Project Summary/Abstract, briefly describe your current research AND the research you propose to continue in the independent phase.

Senior/Key Person Profile (Section 4.5): Following the standard instructions for this section, delineate under separate headings entitled Mentored K99 Phase and Independent R00 Phase, the key personnel you plan to request for the mentored K99 phase and the projected types of key personnel you plan to request in the independent R00 phase of the Award. Please note that a mentor is required only for the initial K99 mentored phase.

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).

PHS 398 Career Development Award Supplemental Form Component Sections: Items 2-5 (Candidate Information) and 10-13 (Research Plan) are limited to a total of 25 pages. While each section of the Candidate Information and Research Plan components needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Candidate Information component and the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

Appendix Materials: Candidates must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm). Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not comply with the required page limitations may be delayed in the review process.

6.A. Candidate Information and Career Development Plan

Candidate’s Background:

Career Goals and Objectives:

Career Development/Training Activities:

Training in the Responsible Conduct of Research:

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.

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):

6.D. Environment and Institutional Commitment to the Candidate

Description of Institutional Environment:

Institutional Commitment to Candidate’s Research Career Development:

6.E. Letters of Reference

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 important component of the application for the mentored career award. Candidates for this career award 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=new. The 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) may also submit letters of reference, but these letters will be considered independently of the three required reference letters. Resubmission applications must include new letters of reference.

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

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

Allowable costs for this career award program are not uniform throughout the participating Institutes and Centers; therefore the salary amounts as well as the research development costs vary. See: Table of Institute and Center Contacts.

Cover Component (Section 4.2): For Proposed Project (Start and Ending Date) indicate the total period of support being requested including the mentored phase (up to 2 years) and the independent phase (up to 3 years).

Budget Component (Section 4.7): The first year's budget must be the mentored phase budget, and is dependent upon the awarding IC salary policies for mentored K programs.

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 IC 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.

Note: Intramural candidates should not request a budget for the mentored phase of the award. If a dollar amount is required, enter 0 (zero) in the appropriate box. The maximum total cost budget for the independent (R00) phase is $249,000 per year. No detailed budget information is required for the R00 phase at the time of application for the K99 phase.

6.G. Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in the Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.)

(a) Data Sharing Plan: Not Applicable.

(b) Sharing Model Organisms: Regardless of the amount requested, all applications in which the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible (see Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.)

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, candidates seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (e.g., blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (NOT-OD-07-088) and http://grants.nih.gov/grants/gwas/.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Applications submitted for this funding opportunity will be assigned on the basis of established PHS referral guidelines to the ICs for funding consideration.

Applications that are complete will be evaluated for scientific and technical merit by (an) appropriate scientific review group(s) in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/) using the review criteria stated below.

As part of the scientific peer review, all applications will:

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:

Review Criteria

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

The application does not need to be strong in all categories to receive a high priority score. These criteria are listed in logical order and not in order of priority.

Candidate:

Career Development Plan:

Research Plan:

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

Environment and Institutional Commitment to the Candidate (K99 Phase):

2.A. Additional Review Criteria

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

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

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

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.

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the adequacy of the plans for their care and use will be assessed. See the Other Research Plan Sections of the PHS398 Research Plan component of the SF424 (R&R), part I, 5.5.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

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 candidate? The priority score should not be affected by the evaluation of the budget.

2.C. Resource Sharing Plans

When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.

3. Anticipated Announcement and Award Dates

Not Applicable.

Section VI. Award Administration Information

1. Award Notices

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

If the application is under consideration for funding, NIH will request "just-in-time" information from the candidate. JIT includes, but is not limited to, updated salary information and confirmation, current Other Support as well as Human Subjects and Animal certifications. Activation of the JIT link in the eRA Commons is not an indication of a request for Just in Time information. The applicant organization will be contacted by NIH grants administration staff if this information is required. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

A formal NoA will be provided as part of the extramural mentored phase of the K99 award conducted at a domestic, sponsoring extramural institution/organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

There will not be a formal Notice of Award (NoA) associated with the mentored phase of the K99 award conducted in the NIH intramural program. The awarding Institute will transmit to the successful candidate an approval letter which will include the terms and conditions of the NIH intramural K99 award, as well as expectations for the transition to the independent phase (R00) of the award.

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 NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities.

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

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

B. 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:

Usually, funds budgeted in an NIH 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 NIH awarding component.

C. 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 NIH funding component is required. Details on the process for submission of prior approval requests can be founds in the NIHGPS (rev. 12/03), Requests for Prior Approval, at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600130. Note: because of the relatively short duration of the K99 phase of the K99/R00 program, awardees are cautioned about the impact of any leave on their ability to make sufficient progress to warrant transition to the R00.

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 NIH component Institute or Center 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.

D. Percent Effort Policies: Under certain circumstances, an awardee may submit a written request to the awarding component requesting a reduction in professional effort below 75 percent (equivalent to 9 person months). Such requests will be considered on a case-by-case basis during the award period. In no case will it be permissible to work at less than 50 percent effort (equivalent to 6 person months). 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 reduce the level of effort will not be approved to accommodate job opportunities, clinical practice, or clinical training. In each situation, the grantee institution must submit documentation supporting the need for reduced effort along with assurance of a continuing commitment to the scientific development of the awardee. In addition, the awardee must submit assurance of his/her intention to return to at least 75 percent effort as soon as possible. During the period of reduced effort, the salary and other costs supported by the award will be reduced accordingly.

E. Changes in Research or Career Development Program: Consultation with the applicable NIH funding Institute or Center 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 of the awarding NIH Institute or Center. 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 staff of the awarding IC 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.

F. Change of Institution or Termination: Consultation with the applicable NIH funding Institute or Center program 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, NIH 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, the NIH awarding office 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:

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 Director of the NIH awarding component 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, NIH 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) annually and financial statements as required in the NIH Grants Policy Statement. (Note that the instructions for Research Career Development applications must be followed for this program).

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:

4. Activating the Independent Phase of the Pathway to Independence Award (R00)

Transition from the mentored phase to the independent phase is intended to be continuous in time and, except in unusual circumstances, the awarding NIH Institute/Center will not extend the K99 phase beyond the 2-year limit. To activate the independent phase of the grant, individuals must have been offered and accepted a tenure-track, full-time assistant professor position (or equivalent) at an eligible institution with appropriate infrastructure to support the proposed research program and a history of external research funding. Applicants are free to apply for independent phase positions within the NIH intramural research program (IRP). However, should the individual accept such a position in the IRP, the independent phase of the award will not be activated. This is because NIH intramural scientists are supported directly by NIH intramural funds and are not eligible for NIH extramural grant awards. Such outcomes are consistent with the goals of the K99/R00 award initiative.

The application for the R00 phase of the award must be submitted no later than 2 months prior to the proposed activation date of the R00 award by the R00 phase grantee organization. However, to avoid potential problems in activation, applicants are strongly encouraged to contact their NIH program official as soon as plans to assume an independent position develop, and not later than 6 months prior to the termination of the K99 phase of the award, to discuss plans for transition to, and the application for, the R00 phase.

The independent phase institution will submit an application on behalf of the candidate for the R00 award using the PHS 398. The R00 application must include:

In addition, a letter from the R00 Department or Division Chairman describing the R00 institution’s commitment to the candidate and plans for his/her career development should be submitted (see below), as well as a final evaluation statement by the K99 phase mentor, if not already provided.

These materials should be sent directly to the awarding Institute or Center (IC). Details are available at the NIH New Investigator Program website. The original application plus one copy (preferably in a PDF format) are to be mailed to the Financial or Grants Management contact person of the awarding NIH Institute or Center listed in the Notice of Grant Award. The R00 application will be evaluated by extramural program staff of the awarding component for completeness and responsiveness to the program.

An institutional commitment agreement will be required at the time of activation of the independent phase of the award. This agreement should satisfy the criteria described in the Career Development Award Section III of the PHS 398 application kit. In addition to space, facilities, resources, and other support needed to conduct the proposed research, the sponsoring institution must provide protected research time (minimum of 75% effort) at least for the duration of the R00 award. The start-up package and other institutional support must be described and should be comparable to that given to other faculty recently hired into tenure-track or equivalent positions. Institutions must provide a startup and salary package equivalent to that provided to a newly hired faculty member who does not have a grant; R00 funds may not be used to offset the typical startup package or to offset the usual institutional commitment to provide salary for tenure-track (or equivalent) assistant professors who are hired without grant support. The R00 sponsoring institution should describe the candidate’s academic appointment, bearing in mind that it must be tenure-track assistant professor (or equivalent), and confirm that the appointment is not contingent on the transfer of the award to the institution. The R00 phase institution must foster and support the awardee’s ability to apply for and secure independent research grant (R01) support.

The R00 award requires that a minimum of 75% effort be devoted to research activities. Consequently, teaching, clinical duties and other non-research activities should be minimal during the R00 award period. NIH staff may review start-up packages and other commitments between the institution and candidate prior to activating the independent phase of the award. It is suggested that the applicant and/or the hiring institution discuss the institutional commitment with the relevant NIH institute program official prior to submission of the R00 application. NIH will not activate the independent phase if the institutional commitment is deemed inadequate. Applicants who are approved to transition will receive a Notice of Grant Award reflecting the new R00 grant mechanism, the dollar amount, and the new recipient organization (if applicable).

The K99/R00 award is intended to facilitate successful transition to independence. Consequently, a requirement for activation of the R00 phase is successful completion of this transition. Applicants are encouraged (but not required) to apply for independent positions at departments and institutions different from where they conducted their mentored research. It is important for all applicants, but especially so for applicants who intend to stay at the mentored phase institution for the independent phase, to provide a plan by which they will separate from their mentor and advance to independence. Awardees are also encouraged to include a plan and timeline for submitting an independent research grant application in a research area relevant to the mission of an NIH awarding component.

Candidates who are not approved to transition will receive written notification from the awarding component communicating the rationale for the disapproval. This letter typically will be sent within 60 days of receipt of the R00 application.

Although the financial plans of the NIH Institute or Center provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

Termination of the K99 award phase

If transition from the K99 phase at an extramural institution to the R00 phase occurs at the originally scheduled end date of the K99 award, then no specific steps to terminate the K99 award are necessary. If the transition occurs prior to the scheduled end date, then a revised Notice of Award will be issued to terminate the K99 phase award. Carry-over of unspent funds from a partially completed year in the K99 phase into the R00 phase may be permitted.

Section VII. Agency Contacts

Information about the Pathway to Independence award program can be found in the NIH New Investigator website. We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential candidates. Inquiries may fall into three areas: scientific/research (program), peer review, and financial or grants management issues:

1. Scientific/Research Contact(s):

Candidates should refer to the NIH Web site (Table of Institute and Center Contacts) for information regarding each IC-specific programmatic and budgetary information, and scientific/research contact for this program.

2. Peer Review Contact(s):

Not Applicable.

3. Financial/Grants Management Contact(s):

Candidates should refer to the NIH Web site (Table of Institute and Center Contacts) for information regarding each IC’s grants management contact for this program.

Section VIII. Other Information

Required Federal Citations

Use of Animals in Research: Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection: Federal regulations (45 CFR 46) require that applications and proposals involving human subjects must be evaluated 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).

Data and Safety Monitoring Plan: Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants ( NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data: Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing). Investigators should seek guidance from their institutions, on issues related to institutional policies and local institutional review board (IRB) rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Policy for Genome-Wide Association Studies (GWAS): NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/.

Sharing of Model Organisms: NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh-Dole Act (see the NIH Grants Policy Statement. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Access to Research Data through the Freedom of Information Act: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some 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. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Inclusion of Women And Minorities in Clinical Research: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC): Criteria for Federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy Requirement: In accordance with the NIH Public Access Policy, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information: The Department of Health and Human Services (HHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the HHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. 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 on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices: All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, Internet addresses (URLs) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles. Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.

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 priority areas. This FOA is related to one or more of the priority areas. 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 authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

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 PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs: NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.

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