Part I Overview Information

Department of Health and Human Services

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

Components of Participating Organizations
National Cancer Institute (NCI), (http://www.cancer.gov/)
National Center for Complementary and Alternative Medicine (NCCAM), (http://www.nccam.nih.gov/)
National Center for Research Resources (NCRR), (http://www.ncrr.nih.gov/)
National Center on Minority Health and Health Disparities (NCMHD), (http://ncmhd.nih.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/)

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

Announcement Type
New

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

NOTE: Questions and answers regarding this announcement can be found at: http://grants1.nih.gov/grants/new_investigators/QsandAs.htm

Program Announcement Number: PA-06-133

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, 93.308, 93.867, 93.866, 93.846, 93.865, 93.286, 93.398

Key Dates
Release Date: January 27, 2006
Letters of Intent Receipt Date(s): Not required
Application Receipt Dates(s): April 7, 2006 then standard dates, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Peer Review Date(s): Summer 2006 then standard dates, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Council Review Date(s): September 2006 then standard dates, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Earliest Anticipated Start Date: October 2006 then standard dates, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: January 12, 2007

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

This initiative will develop and implement a new Pathway to Independence Award Program (PI) designed to facilitate receiving an R01 award earlier in an investigator’s research career. The primary, long-term goal of the PI Award Program is to increase and maintain a strong cohort of new and talented, NIH-supported independent investigators.

Telecommunications for the hearing impaired is available at: TTY 301-451-5936

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) 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. Address to 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. Sending an Application to the NIH
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
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
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 Contact(s)
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

Background and Objective

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 http://books.nap.edu/catalog/11249.html, and Advancing the Nation’s Health Needs: NIH Research Training Program http://www.nap.edu/booksearch.php?term=%22nrc+analysis%22&isbn=0309094275) have highlighted the need for enhanced efforts to foster the transition of postdoctoral scientists from mentored environments to independence.

The NIH data indicate that 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. This trend must be curtailed in order to capture the creativity and innovation of new independent investigators in their early career stages to address our Nation’s biomedical, behavioral and clinical research needs.

The primary goal of this pilot initiative is to facilitate receiving an R01 award earlier in a research career and to assist investigators in securing a stable research position during the critical transition stage of their career.

In addition to this initiative, NIH Institutes and Centers support a variety of mentored career development programs designed to foster the transition of new investigators to research independence. These programs span research career development opportunities for investigators who have made a commitment to focus on patient-oriented research through the Mentored Patient-Oriented Research Career Development Award (K23) http://grants.nih.gov/grants/guide/pa-files/PA-05-143.html to research career development opportunities for individuals with highly-developed quantitative skills seeking to integrate their expertise in research relevant to the mission of NIH (K25) http://grants.nih.gov/grants/guide/pa-files/PA-06-087.html Information describing all NIH Career Development Award programs can be found at http://grants.nih.gov/training/careerdevelopmentawards.htm.

Nature of the career/research transition opportunity

The NIH Pathway to Independence Award will provide up to five years of support consisting of two phases. The initial mentored phase will provide support for salary and research expenses 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). This initial phase of mentored support will allow the candidate time to complete research, publish results, and bridge to an independent research position. As part of the application, the candidate must propose a research project that will also be pursued as an independent investigator during the second phase of the award. The candidate and mentors together will be responsible for all aspects of the mentored 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 transition, as an independent scientist, to an extramural sponsoring institution/organization to which the individual has been recruited. 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 extramural institution and the successful NIH programmatic review of the individual’s mentored phase of the award.

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

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the new combination K99/R00 funding mechanism. As an applicant, the candidate and his/her mentor are jointly responsible for planning, directing, and executing the proposed mentored phase of the research project.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). The applicant should follow the instructions for budget information described in the PHS 398, Section III, providing only the total direct costs requested for each year and the entire proposed period of support and budget justification information.

2. Funds Available

This award has two phases: a mentored phase at an eligible extramural sponsoring institution/organization or NIH intramural laboratory of up to 2 years followed by an independent scientist phase of up to 3 years sponsored by an extramural institution/organization to which the individual has been recruited.

Mentored Phase of the Pathway to Independence Award Program-K99

The total cost per year for the initial mentored mentored phase may not exceed $90,000 at either an NIH intramural or an extramural sponsoring institution site. Salary is limited to $50,000, plus applicable fringe benefits, and up to $20,000 for research support costs for a 12-month budget period. Candidates (intramural or extramural) are required to commit a minimum of 75% of full-time professional effort to pursue 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. F&A costs will be provided at 8% of modified direct costs to an extramural sponsoring institution. Candidates may engage in teaching and/or clinical duties as part of the 25% maximum of the applicant’s full-time professional effort not covered by this award, as long as such duties do not interfere 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. Direct costs are limited to salary (up to $50,000) and up to $20,000 for research support costs and must be consistent with levels provided to new scientists in similar positions at the institution. Fringe benefits may also 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.

The 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 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, however, may not exceed the legislatively mandated salary cap.

Independent Investigator Phase of the Pathway to Independence Award Program-R00

The total cost for the independent investigator phase may not exceed $249,000 per year. This amount includes salary, fringe benefits, research support allowance and applicable F&A costs.

The NIH participating Institutes/Centers will provide salary and fringe benefits for the independent investigator phase of the PI Award, contingent upon the individual’s securing an independent tenure-track, full-time assistant professor position (or equivalent) at an eligible institution. The total salary requested must be based on a full-time, 12-month staff appointment and requires candidates to devote a minimum of 75% of full-time professional effort to conducting health-related research with the remaining effort being devoted to activities related to the development of a successful research career. For information regarding NIH policy on determining full-time professional effort for career awards see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-056.html. 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.

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 NIH Institute or Center prior to preparing an application to discuss their eligibility.

Recipients of the independent phase of the PI Award may reduce effort on the award to a minimum of 50% and hold concurrent support from their PI Award and a competing NIH research grant if recognized as a Principal Investigator or subproject Director of a subsequent research grant. 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 which can be found at http://grants.nih.gov/grants/policy/policy.htm.

Support for secretarial and administrative assistance, etc., is not allowed.

Facilities and Administrative costs: These costs will be reimbursed at 8% percent of modified total direct costs for the initial mentored K99 phase conducted at an extramural site. For the independent R00 phase, these costs will be reimbursed at the extramural sponsoring institution’s F&A rate. Facilities and administrative costs requested by consortium participants are included in the total cost limitation.

Special Pathway to Independence Award Requirements

Independent Phase Evaluation (R00)

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 success of the awardee’s research training/career development accomplishments and the evaluation of a research plan to be carried out at the extramural sponsoring institution at which he/she has been recruited. Reporting information is located in Section VI.3.

Acceptance into the PI 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.

Activating the Extramural Independent Scientist Phase-R00

The candidate must receive approval in writing from the NIH awarding component and 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. The extramural institution will submit an application on behalf of the candidate using Form PHS 398 (http://grants.nih.gov/grants/funding/phs398/phs398.html) and http://grants.nih.gov/grants/funding/phs398/cdafp3.doc. The non-competing application must include a letter from the department or division chairman describing the institution’s commitment to the candidate and plans for career development. The application submitted by the awardee and the extramural institution will be evaluated by extramural program staff of the awarding component for completeness and responsiveness to the program.

Transition from the mentored phase to the independent phase is intended to be continuous in time. The extramural sponsoring institution must demonstrate a commitment to the candidate by providing protected research time (minimum of 75% effort), space, facilities, resources, and other support needed to conduct the proposed research. The sponsoring institution must describe the candidate’s academic appointment, bearing in mind that it must be tenure-track or equivalent, and that the appointment must not be contingent on the transfer of the award to the institution. The independent phase institution must foster and support the awardee’s ability to apply for and secure independent research grant (R01) support, in a research area relevant to the mission of an NIH awarding component. It is expected that such an application will be submitted during the independent phase of the PI Award in order to ensure continued support and a smooth transition to independence.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NIH Institute or Center 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.

It is anticipated that the start dates for the first PI Awards will be in October of 2006.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

Eligible organizations for the PI award include domestic for-profit or non-profit institutions/organizations, or public or private institutions, such as universities, colleges, hospitals and laboratories, and eligible agencies of the federal government, including NIH intramural laboratories. 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: Eligible agencies of the Federal government, such as the NIH intramural program, are eligible for the mentored phase only.

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

Although principal investigators and other personnel under research projects are not required to be U.S. citizens, NIH will not intercede on behalf of non-citizens whose stay in the United States may be limited by their visa status. As a result, NIH requires the applicant institution or organization to determine and indicate, in its application, that such individuals' visas will allow them to remain in this country long enough for them to be productive on the project. 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 http://grants.nih.gov/grants/policy/nihgps_2001/part_iia_5.htm#ChangesinProjectandBudget and "Administrative Requirements—Enforcement Actions—Suspension, Termination, and Withholding of Support http://grants.nih.gov/grants/policy/nihgps_2001/part_iia_7.htm#SuspensionTerminationandWithholding)

1.B. Eligible Individuals

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.

Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.

At time of submission, applicants must:

Individuals are NOT eligible if they:

Former principal investigators of NIH Small Grants (R03), Exploratory/Developmental Grants (R21), and Phase I Small Business Research Grants (SBIR/STTR) remain eligible.

Applicants 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 program requirements (http://grants.nih.gov/archive/grants/guide/contacts/pa-06-133_contacts.htm).

2. Cost Sharing or Matching
Not applicable

3. Other-Special Eligibility Criteria

A candidate for the new PI Award may not simultaneously submit or have an application pending for any other NIH career award (e.g., K01, K07, K08, K22, K23, K25) or any PHS award that duplicates any of the provisions of the PI Award. Ineligible individuals include current and former principal investigators on NIH research project grants, comparable individual career development awards (e.g., K01, K07, K08, K23, K25) equivalent non-PHS peer-reviewed research grants over $100,000 direct costs per year, or project leaders on sub-projects of program project (P01) or center (P50) grants.

PI Award recipients are expected to apply for independent research grant support during the independent phase of the award. Recipients of a PI Award may hold concurrent research support, and under certain circumstances (see Allowable Costs above) salary support from their PI Award and a competing NIH research project grant when recognized as a Principal Investigator or subproject Director of the research project grant; see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-036.html.

Each PI Award application must be tailored to meet the individual needs of the candidate. The candidate and mentor are responsible jointly for the preparation of the plan for the career development program in health-related research. The sponsoring institution must demonstrate a commitment to the development of the candidate as a productive, independent investigator.

Section IV. Application and Submission Information


1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact Grants Info., Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a Dun &Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the “YES” box must be checked.

Please note that applications responding to this announcement must include at least three sealed letters of reference attached to the face page of the original application. Applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The current postdoctoral mentor should not be one of the 3 required references.

2. Submission Dates and Times

See Section IV.3.A for details.

3. A. Submission, Review and Anticipated Start Dates

Application Receipt Date(s): April 7, 2006 then standard dates, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Peer Review Date: Summer 2006 then standard dates, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Council Review Date: September 2006 then standard dates, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Earliest Anticipated Start Date: October 2006 then standard dates, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details

3. A.1. Letter of Intent

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

However, applicants are encouraged to contact the scientific research/program contact at the relevant awarding component (See Section VII), prior to submitting an application, to discuss issues of eligibility and review the specific provisions of this award.

3. B. Sending an Application to the NIH

Applications must be prepared using the research grant application forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

3. C. Application Processing

Applications must be submitted on or before the application receipt/submission dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm. Upon receipt, applications will be evaluated for completeness by CSR.

The NIH 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. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.

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

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement which can be found at http://grants.nih.gov/grants/policy/policy.htm.

Ruth L. Kirschstein National Research Service Award recipients that are selected for PI Award funding must terminate their NRSA support prior to receiving support from the PI Award.

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 of a new award if such costs: are necessary to conduct the project, and 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 of a new award.

The incurrence of pre-award costs in anticipation of a 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 http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements

Applicants should follow the instructions in the PHS 398 application for Individual Research Career Development Awards (Section III) and complete all the required sections with the following modifications:

Section D. Basic Administrative Data: Complete all sections with the following modifications:

Section F. Career Development Plan: Complete ALL the sections with the following modifications:

In addition to the Supplementary Instructions in the PHS 398 for Research Career Awards (Instructions, Part III, starting on page 44), and the modifications stated above, the following information must be included in the application:

Prospective applicants should contact the scientific/research individual at the targeted NIH awarding component (see Section VII; http://grants.nih.gov/archive/grants/guide/contacts/pa-06-133_contacts.htm) to discuss eligibility and determine actions necessary to initiate the process. If the applicant is planning an NIH intramural laboratory for the mentored phase, a mentor will need to be selected with whom the candidate can consult in preparing and submitting the application for the intramural mentored phase of the award. Individuals working at an NIH laboratory may work with their current mentor, or with another intramural investigator, provided the research experience proposed in this application will enhance the candidate’s scientific career. Candidates planning to be sponsored by an extramural institution should consult with the proposed mentor prior to contacting the NIH scientific/research staff to discuss the proposed research training/career development plan for the mentored phase and the research plan to be presented in the application for the subsequent independent scientist phase. In any case, both the candidate and the mentor must collaborate closely in preparing the application and follow the appropriate instructions.

Application Contents

Candidate

Career Development Plan

Research Plan

Mentor

Environment

Training in the Responsible Conduct of Research

Applications must include a description of a program to receive formal or informal instruction in scientific integrity or the responsible conduct of research. Applications without plans for instructions in the responsible conduct of research will be considered incomplete and may be returned to the applicant without review. Although the NIH does not establish specific curricula or formal requirements, all programs are encouraged to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, policies regarding the use of human and animal subjects, and data management. Applicants must follow the application instructions found on page 49 of the PHS-398 application package and refer to the NIH Web site (http://www.nih.gov/sigs/bioethics/researchethics.html) for additional guidance.

Document prior instruction in or propose plans for instruction in the responsible conduct of research in terms of subject matter and duration of instruction. An award cannot be made if an application lacks this component.

Letters of Reference

Include with the application three sealed letters of reference from well-established scientists addressing the application content areas and any other evidence that the candidate has a high potential for becoming a successful candidate for this transition award program. The mentor(s) may also submit letters of reference, but these letters will be considered independently of the three required reference letters. All sealed letters of reference should be attached to the face page of the application.

Plan for Sharing Research Data

A plan for sharing research data is not required.

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication. NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131. Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report. (PHS 2590). See Section VI.3. Reporting.

Section V. Application Review Information


1. Criteria
Not applicable

2. Review and Selection Process

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

Applications that are complete will be evaluated for scientific and technical merit by an appropriate review group in accordance with the review criteria stated below.

As part of the initial merit review, all applications:

The following will be considered in making funding decisions:

The goal of this initiative is to facilitate a new investigator’s ability to transition from a postdoctoral status to an independent scientist capable of applying for and receiving their first R01 award and securing a stable research position. 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 and career development plans will have a substantial impact on the pursuit of these goals.

Candidate

Career Development Plan

Research Plan

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

Mentor

Environment and Institutional Commitment to the Candidate

Plans to Evaluate Progress

Training in the Responsible Conduct of Research

2. A. Additional Review Criteria:

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

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 Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from 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 Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

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: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research transition award program. The priority score should not be affected by the evaluation of the budget.

2. C. Sharing Research Data
A data sharing plan is not required.

2. D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication. NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps and http://ott.od.nih.gov/policy/rt_guide_final.html. Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the resource sharing plans with the Principal Investigator before recommending funding of an application. The final version of the resources sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report. (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates
Not applicable

Section VI. Award Administration Information


1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

There will not be a formal Notice of Award (NoA) associated with the mentored phase of the PI Award conducted in the NIH intramural program. The awarding Institute will transmit to the successful applicant 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.

A formal NoA will be provided as part of the extramural mentored phase of the PI 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.

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

Requirements and guidance for the independent phase-R00

Applicants are encouraged to consider independent positions at departments and institutions different from where they conducted their mentored research. Should an awardee wish to activate the independent phase of the grant award at the same department or institution at which they conducted their mentored research, the individual must provide justification addressing the decision to remain at the same institution.

Transition from the mentored phase to the independent phase of the award is intended to be continuous in time. 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 institution with a history of rigorous research programs and extensive outside research funding. While an institutional commitment agreement from the independent phase institution is not required when the original application is submitted, such an agreement will be required at the time of activation of the independent phase of the award. This agreement must be similar to the institutional agreement described in the CDA Section III (Part F.3.) of the PHS 398 application.

Subsequent to approval for the extramural transition phase, and to activate the independent phase of this grant award, the applicant organization grantee must submit to the appropriate NIH participating Institute/Center a transfer research application, with an updated research and budget plan using the PHS 398 application form, at least six months prior to the termination of the mentored phase. Awardees are encouraged to also include a plan and time-line for subsequently submitting an independent research grant application, in a research area relevant to the mission of an NIH awarding component.

The transfer application must be signed by the appropriate officials at the hiring institution. The transfer application will be administratively reviewed by the NIH Institute/Center. Approval, based on the administrative review, will be required before the independent phase can be activated.

Evidence of institutional commitment to the newly independent investigator

So that the awardee can devote as much time as possible to the development of his/her research career, institutions must confirm that at least 75% of the candidate's time and effort can be devoted to the research proposed in the independent phase of the award. The institution, therefore, must release the candidate from most administrative duties. Candidates may engage in limited teaching and clinical duties as part of the 25% maximum of the applicant's effort not covered by this grant award, as long as such teaching and clinical duties are minimal. In addition, the institution must provide the candidate sufficient resources and salary support to launch his/her research career. The start-up package must be similar to that which is typically offered to other new faculty members. The independent phase institution must foster and support the awardee’s ability to apply for and secure independent research grant (R01) support in a research area relevant to the mission of an NIH awarding component. NIH staff may review start-up packages and other agreements between the institution and candidate prior to activating the second, independent phase of the grant. NIH will not activate independent phase funds if the institutional commitment is deemed inadequate.

Grantee institutions may supplement a candidate’s salary so that the salary is consistent with salaries of individuals in comparable positions at the institution. However, performing or assuming additional responsibilities that would interfere with the required 75% effort on the PI Award is not permitted.

PI awardees will be expected to submit an R01 grant application to the NIH, or a similar application to a Federal government or private funding agency, during the independent phase.

Recipients of the Pathway to Independence Award are free to apply for independent phase positions within NIH's intramural research program (IRP). However, should the individual accept such a position in the IRP, the independent phase of the program will be terminated.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

Evaluation: In carryout its stewardship of human resource-related program, the NIH may begin requesting 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.

Changes in Research Program:

A change in the specified scientific area of the research component 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 NIH component to ensure that the plan remains within the overall 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.

Change of program/transfer of sponsoring institution:

A change of sponsoring institution will be permitted only when all of the terms and benefits attributable to the original award can be assured. Consultation with the NIH Institute or Center scientific/research staff responsible for the programmatic management of the award is strongly encouraged when a change of institution is being considered. A change may be made without peer review, provided the 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 disapprove the request and, if appropriate, terminate the award.

3. Reporting

Each mentored Pathway to Independence awardee will be evaluated for progress by the mentor, in coordination with the NIH awarding component’s extramural program staff. The review will determine suitability for transition to the extramural independent phase of the award. For those awardees conducting their mentored research at an NIH intramural laboratory, the intramural training director will be involved in the review of the awardee’s progress. For awardees sponsored by an extramural institution for the mentored support phase, the mentor and Department or Division Chair must review the awardee’s research training/career development progress and submit a report to the NIH awarding component at least six months prior to the scheduled end of the mentored phase of the award. Individuals approved for the extramural independent scientist transition phase will then be required to submit an application to receive continued support through the non-competing NIH R00 award mechanism using the PHS 398 application form. Transition from the mentored phase to the independent phase is intended to be continuous in time. Delays in transition will be considered in unusual and pressing circumstance such as personal or family situations involving child or elder care, medical conditions or disability.

Pathway to Independence Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

The mentored phase progress report must also include Sections a through f as described in the general PHS form 2590 instructions, as well as sections g through j as described in Section IV of the 2590 instructions. Evaluation of the awardee’s progress will depend on the following:

A final progress report, invention statement, and Financial Status Report are required upon the conclusion or termination of an award.

Section VII. Agency Contacts


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

1. Scientific/Research Contacts:

(http://grants.nih.gov/archive/grants/guide/contacts/pa-06-133_contacts.htm)

2. Peer Review Contacts:

Not applicable

3. Financial or Grants Management Contacts:

(http://grants.nih.gov/archive/grants/guide/contacts/pa-06-133_contacts.htm)

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 (45CFR46) 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 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.

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 http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, 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.

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 new PHS Form 398; 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:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author’s final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author’s final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://www.nih.gov/about/publicaccess/ and view the Policy or other Resources and Tools including the Author’s Manual (http://www.nih.gov/about/publicaccess/publicaccess Manual.htm).

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.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) 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 DHHS 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. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

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 PA 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 or Health Systems Agency review. 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 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 NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.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 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/.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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