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 Heart, Lung, and Blood Institute (NHLBI), (http://www.nhlbi.nih.gov/)
National Cancer Institute (NCI), (
http://www.cancer.gov/)
National Institute on Alcohol Abuse and Alcoholism (NIAAA), (
http://www.niaaa.nih.gov/)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), (
http://www.niddk.nih.gov/)
National Institute of Environmental Health Sciences (NIEHS), (
http://www.niehs.nih.gov)

Title: Career Enhancement Award for Stem Cell Research (K18)

Announcement Type
This is a reissue of PA-07-359

Program Announcement (PA) Number: PA-09-110

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

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.233, 93.837, 93.838, 93.839, 93.398, 93.271, 93.847, 93.113

Key Dates
Release/Posted Date: February 24, 2009
Opening Date:May 12, 2009 (Earliest date an application may be submitted to Grants.gov).
Letters of Intent Receipt Date(s): See Section IV.
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: May 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 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

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 Objectives

The overall goal of NIH-supported career development programs is to help ensure that a diverse pool of highly trained scientists is available in adequate numbers and in appropriate research areas to address the Nation's biomedical, behavioral, and clinical research needs. The NIH Career Enhancement Award for Stem Cell Research (K18) is intended to enable investigators to change the direction of their research careers or to take time from their regular professional responsibilities to broaden their scientific background by acquiring new research capabilities, specifically in the use of human or animal embryonic, adult, or cord blood stem cells. The use of stem cells in biomedical research offers the potential for significant advances in the next decades, provided investigators not only understand this potential, but are equipped to take advantage of it. Human embryonic stem cells (hESC) have only recently become available and most investigators are not prepared to handle, maintain, or properly study hESCs. Likewise, the potential of human adult or cord blood, and even animal, stem cells for understanding, treating and curing human disease is great. This Career Enhancement Award is meant to provide the opportunity and necessary protected time for investigators to gain experiences that will enable them to take full advantage of stem cells in their research. Applicants must propose a research career development program suitable for their level of experience and scientific interests, and seek an environment where the training and career development can occur. All training and career development should be carefully tailored to meet the individual needs of the applicant and should, usually, include a description of a research project involving stem cells. The proposed training and career development may include both didactic as well as laboratory-based instruction in the growth, management, and application of human, or animal, embryonic stem cells or adult stem cells for the broad areas of interest supported by the NIH.

The project period will typically be six months to one year, although up to two years may be appropriate in some situations. Part-time career development activities can be accommodated. Prospective applicants are advised to discuss the length of the career development period they are proposing with the appropriate Institute contact.

Applicants must hold a doctoral degree, may need to hold independent peer-reviewed research support at the time the award is made (see IC provisions),and commit a minimum of 6 person-months (equivalent to 50% of full-time professional effort) conducting research and relevant career development activities during the period of the award. Depending on the sponsoring Institute or Center (IC), scientists whose work is primarily theoretical may apply for this award in the absence of external research grant support (see Section III and also IC-specific provisions). Receipt of prior support may impact on eligibility for the K18 award. Before submitting an application, investigators should verify that they will be able to pursue stem cell research after their training and career development supported by the K18 ends by familiarizing themselves with the policies governing the use of stem cells at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-014.html. The sponsoring institution must demonstrate a commitment to provide the environment, resources and the protected time required for the candidate to perform the activities included in the proposed research and career development plans.

Note: NIH Institutes and Centers have unique scientific purviews and different program goals and initiatives. Therefore, applicants are strongly encouraged to contact the NIH staff 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 Career Enhancement Award for Stem Cell Research (K18) mechanism. As an applicant, the candidate and his/her mentor will be jointly responsible for planning, directing and executing the proposed project and career development and enhancement activities.

This FOA uses Just-in-Time information concepts (see SF424 (R&R) Application Guide). It also uses non-modular budget format. A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

The applicant should follow the instructions for budget information described in Section IV Other Submission Requirements as well as in PHS 398 Career Development Award Supplemental form Section 7.4.6 of the R&R 424 instructions providing only the total direct costs for each year and for the entire proposed period of support and budget justification information.

The project period will typically be six months to one year, although up to two years may be appropriate in some situations. Prospective applicants are advised to discuss the length of the career development period they are proposing with the appropriate Institute contact: Table of Institute and Center Contacts. Awards are not renewable.

2. Funds Available

The total amount awarded under the K18 program and the number of awards will depend upon the number, scientific merit, overall quality, and costs of the applications received, as well as on the funds available at the participating NIH Institutes/Centers.

Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

2. A. Allowable Costs

Salary: The participating NIH Institute or Center (IC) will provide salary and fringe benefits for the career enhancement award for stem cell research recipient (see Table of Institute and Center Contacts). The total salary requested must be based on a full-time, 12-month staff appointment and the level of effort requested, up to the maximum legislated salary rate in effect at the time of award. For example, in Fiscal Year 2007, the maximum allowable annual salary on an NIH award was $186,600 for a full-time position (see: NOT-OD-07-051). The candidate will be required to devote a minimum of 6 person-months (equivalent to 50% of full-time professional effort) conducting stem cell training and research career development activities, although a full-time commitment for the six to 12-month period of time is encouraged and up to 24 months is allowable. For information regarding NIH policy in determining full-time professional effort for career awards see NOT-OD-04-056.

In all cases, the salary requested must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure. Fringe benefits, based on the sponsoring institutions rate and the percent of effort, are provided in addition to salary.

For K18 awards used to support a sabbatical period, the NIH award will take into account concurrent sabbatical salary support provided by the home institution and any other supplemental support.

K18 award applicants may not concurrently apply for any other PHS award that duplicates the provisions of this award.

K18 award recipients may hold independent research support, either Federal or private, concurrently with this award and may derive additional compensation for effort from other Federal sources or awards. However, the total salary derived from all Federal sources may not exceed the maximum legislated salary rate and the total percent effort cannot exceed 100%.

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 PHS funds be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the K18 award. Under expanded authorities, however, institutions may re-budget funds within the total costs awarded to cover salaries consistent with the institution's salary scale. The total salary, however, may not exceed the legislatively mandated salary cap. See: http://grants.nih.gov/grants/policy/salcap_summary.htm

Research Support: Research Development support of up to $50,000 may be requested to pay for the cost of tuition and fees for courses, allowable research expenses, consultant fees for the mentor, and travel to scientific meetings or to training courses (however, see Table of Institute and Center Contacts).

Ancillary Personnel Support: Salary for 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 8% of modified total direct costs (exclusive of tuition, fees, and equipment).

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

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

1.B. Eligible Individuals

Project Director/Principal Investigator (PD/PI): Also referred to as the Applicant or Candidate, individuals with the skills, knowledge, and resources necessary to carry out the proposed research and career activities are invited to work with their 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: Only U.S. citizens or non-citizen nationals, or individuals lawfully admitted for permanent residence who have a currently valid Permanent Resident Card (USCIS Form I-551), or some other verification of legal admission as a permanent resident prior to the time of award, are eligible for this award. Non-citizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S. They are usually born in lands that are not states but are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible.

Degree and Research: All applicants for this award must have a clinical or research doctoral degree and be actively engaged in research of interest to the NIH. Applicants should have completed at least three years of postdoctoral work prior to applying for this K18. All applicants must identify a stem cell expert with a record of providing the type of supervision required by this award who is willing to serve as mentor. The mentor must have a history of research productivity and peer-reviewed research support and prior recorded experience of fostering academic growth and productivity.

Level of Effort: As a K18 award applicant, you must be able to devote at least 6 person-months (equivalent to 50% full-time professional effort) to your proposed program of didactic and/or research training and career development in stem cell research. You may devote your full-time effort to the award, however.

Renewals: Awards are not renewable.

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

The following special eligibility requirements apply:

3.A. Special Requirements

Research Support: A candidate for an NIH K18 Award may not simultaneously submit or have an application pending for any other PHS career award (e.g., K01, K07, K08, K22, K23) or any PHS or award that duplicates any of the provisions of the K18 award. Current principal investigators on NIH career awards are not eligible.

Candidates for the K18, under some circumstances, may have been principal investigators on NIH research or career development awards, provided the research experience proposed in the K18 application is in a fundamentally new field of study or there has been a significant hiatus in their research career because of family or other personal obligations. Candidates are therefore strongly encouraged to contact the staff person in the relevant IC listed under Section VII prior to preparing an application to discuss issues of eligibility, program relevance, and review the specific provisions of this award.

Institutional Environment: The applicant institution must have a strong, well-established record of research career development activities and demonstrate a commitment to research and to the continuing development of the candidate as a productive independent scientist. The institution must provide assurance that the candidate is an integral part of its research and academic program and must certify that the candidate will be released from other duties and be able to devote at least 6 person-months (equivalent to 50% full-time professional effort) to the research program. The institution must also delineate the duties from which the candidate will be released in order to devote this effort.

Section IV. Application and Submission Information


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

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:

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

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

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

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.

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their 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 301-435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY: (301) 451-5936

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms 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/PIs 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
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:May 12, 2009 (Earliest date an application may be submitted to Grants.gov)
Letter of Intent Receipt Date(s): Not Applicable.
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 Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed. All applications must meet the following criteria to be considered on-time:

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

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

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

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

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

Note that the following caveats apply:

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

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


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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