PA-09-110: Career Enhancement Award for Stem Cell Research (K18)

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 update relating to this announcement has been issued:

April 2, 2009 - Change in allowable salary levels on Career Awards supported by the National Cancer Institute (see Notice NOT-CA-09-022).

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.

Purpose. The purpose of the Career Enhancement Award for Stem Cell Research (K18) is to encourage investigators to obtain the training and career development they need to appropriately use stem cells in their research. 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. Prospective applicants are encouraged to contact the relevant Institute or Center (IC) staff for IC-specific programmatic and budgetary information: Table of Institute and Center Contacts.
Mechanism of Support. This Funding Opportunity Announcement (FOA) will utilize the NIH Career Enhancement Award for Stem Cell Research (K18) mechanism.
Funds Available and Anticipated Number of Awards. The total amount to be awarded by the participating ICs and the number of awards will depend upon the quality and merit of applications received and the availability of funds.
Budget and Project Period. Because the nature and scope of the proposed K18 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.
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.
Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply.
Eligible Project Directors/Principal Investigators (PDs/PIs). 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 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. Applicants must be U.S. citizens, non-citizen nationals, or permanent residents who hold a health-professional doctoral degree, and commit a minimum of 6 person-months (equivalent to 50% of full-time professional effort) conducting stem cell research and relevant career development activities during the period of the award. Two types of applicants should consider applying for support: (1) independent junior faculty who wish to expand their research by the use of stem cells, and (2) more senior, established investigators who wish to re-direct their research, in whole or in part, to include the use of stem cells. 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 post-doctoral work prior to applying for this K18. See Section III.
Number of PDs/PIs. Only one PD/PI may be designated on the application.
Number of Applications. Candidates for the K18 award may not have pending or concurrently apply for any other PHS career award.
Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016).
Renewals. Awards are not renewable, nor can they be transferred to another individual.
Application Materials. See Section IV.1 for application materials.
General Information. For general information on SF424 (R&R) Application and Electronic Submission, see these Web sites:
- SF424 (R&R) Application and Electronic Submission Information: http://grants.nih.gov/grants/funding/424/index.htm
- General information on Electronic Submission of Grant Applications: http://era.nih.gov/ElectronicReceipt/
Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY: (301) 451-5936

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research 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 institution’s 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:

Public/State Controlled Institutions of Higher Education
Private Institutions of Higher Education
Hispanic-serving Institutions
Historically Black Colleges and Universities (HBCUs)
Tribally Controlled Colleges and Universities (TCCUs)
Alaska Native and Native Hawaiian Serving Institutions
Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
For-Profit Organizations (Other than Small Businesses)
State Governments
Indian/Native American Tribal Governments (Federally Recognized)
Indian/Native American Tribally Designated Organizations
U.S. Territory or Possession
Indian/Native American Tribal Governments (Other than Federally Recognized)
Regional Organizations
Foreign institutions are not 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

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

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

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

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

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

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

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

2. Organizational/Institutional Registration in the eRA Commons

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

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

The individual(s) designated as PDs/PIs on the application must be registered also in the NIH eRA Commons.
The PD/PI must hold a PD/PI account in the Commons. The applicant should not share a Commons account for both an Authorized Organization Representative/Signing Official (AOR/SO) role and a PD/PI role; however, if they have both a PD/PI role and an Internet Assisted Review (IAR) role, both roles should exist under one Commons account.
This registration/affiliation must be done by the AOR/SO or his/her designee who is already registered in the Commons.

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

Several of the steps of the registration process could take four weeks or more. Therefore, 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/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
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.

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.

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

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 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 a resubmission 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.

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

Concurrent Awards: A candidate for an NIH K18 Award may not simultaneously submit or have an application pending peer review for any other PHS career 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. Confirmation of the actual salary is required prior to the issuance of an award. The candidate is required to devote a minimum of 6 person-months (equivalent to 50% of full-time professional effort) to this program; although a full time commitment for the six to 12-month period of time is encouraged and up to 24 months is allowable. Prospective applicants should contact the applicable NIH component to ascertain amounts associated with this program.

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. The mentor may not receive salary; and, while consultant fees may be considered, such funding must be in accordance with formally established institutional policy and in accordance with the NIH grants policy of funding consultants in the same department. Ancillary Personnel Support: Salary for secretarial and administrative assistance is not allowed. Any research development support costs allowed for this program must be carefully justified annually and must not duplicate funds provided in other funded research support programs. (Refer to Section II, Funds Available.)

Indirect Costs: These costs also know as Facilities and Administrative (F&A) costs, will be reimbursed at 8% of modified total direct costs (exclusive of tuition, fees, and equipment).

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 of a new or renewal award 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 of a new or renewal award.

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.

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

The NIH requires the PD(s)/PI(s) 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.”

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

PHS398 Research Plan Component Sections

Page limitations of the PHS398 Research Plan component must be followed as outlined in the SF424 (R&R) Application Guide. While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct 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.

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:

Appendix Materials

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

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

6.A. Candidate Information and Career Development Plan

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 15 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

The following information must be included in the application:

Candidate’s Background:

Describe the candidate’s commitment to a biomedical research career in an area of interest to the NIH, including immediate and long-term career objectives, and how training in the use of stem cells will further those objectives.
Discuss prior training and how it relates to the objectives and long-term career plans of the candidate.
Present evidence of the candidate's capabilities and support to continue a research career and/or provide leadership as a stem cell researcher.
The candidate must include three letters of reference with the application from individuals familiar with the candidate’s research.

Career Goals and Objectives:

Describe the candidate’s overall plan for developing expertise with stem cell research techniques, tailoring the plan to their own goals, prior experience, and career level as well as to the intent of the K18 award.
Provide details of any coursework to be taken, including any laboratory courses.
Both didactic and laboratory training are appropriate means to acquire experience with the use, maintenance, and application of stem cells.

Training in the Responsible Conduct of Research:

Applications must include a description of a program to provide formal or informal instruction in scientific integrity or the responsible conduct of research. Applications without plans for instruction in the responsible conduct of research will be considered incomplete and may be returned to the applicant without review.
Although the 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 in PHS 398 Career Development Award Supplemental form Section 7.5.1, and refer to the NIH web site (http://www.nih.gov/sigs/bioethics/researchethics.html) for additional guidance.

6.B. Research Plan

The research plan should follow instructions outlined in PHS 398 Career Development Award Supplemental form, including sections on Specific Aims, Background and Significance, Preliminary Studies/Progress Report, Research Design and Methods.

A sound research project that is consistent with the candidate’s level of research experience and objectives of his/her career objectives must be provided. The research description should demonstrate not only the quality of the applicant’s research thus far but also the novelty, significance, creativity and approach, as well as the ability of the applicant to carry out the research.
The candidate should consult with their mentor to develop this section because the proposed project should reflect the expertise of the stem cell expert as well as your own interests and research needs.
Describe plans for the recruitment and retention of subjects (when applicable) and plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research.

6.C. Statement of Support

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

Signed statements must be provided by each consultant/collaborator confirming their participation in the project and describing their specific roles. Collaborators and consultants generally do not need to provide their biographical sketches. However, information should be provided that clearly documents expertise in the proposed area(s) of consulting/collaboration. Any other opportunities for the candidate’s professional growth should also be documented in these statements.

Mentor’s Statement:

The application must include a statement from the stem cell expert describing his/her research qualifications as well as previous experience as a research mentor.
The mentor must provide a description of the nature and extent of supervision that will occur during the proposed award period.
The candidate should also describe any plans for future, ongoing collaborations with the stem cell expert once the K18 award is completed.

6.D. Environment and Institutional Commitment to the Candidate

Description of Institutional Environment:

The sponsoring institution must define and document a strong, well-established research program related to the candidate's area of interest including a high-quality research environment with staff capable of productive collaboration with the candidate.
Describe the facilities, supplies, equipment, and human resources that will be available to the candidate.
Describe how the research environment of the institution is particularly suited to enhance the development of the candidate's research career as an independent scientist and proposed career and research plans.

Institutional Commitment to Candidate’s Research Career:

The sponsoring institution must provide a statement of commitment to the candidate's career goals for as a productive, independent investigator and to meeting the requirements of this award. It should be clear that the institutional commitment to the candidate is not contingent upon receipt of the K18 award.
In a clear statement, provide assurances that the candidate will be released from other duties and be able to devote a minimum of 6 person-months (50% of full-time professional effort) in the development of his/her research program related to stem cell research, with the remaining percent effort being devoted to activities related to the development of his/her career as a research scientist.
The candidate’s institution must agree to the candidate’s plan to obtain additional research training in the techniques necessary for stem cell research either at another institution or the candidate’s current location.
Provide assurance that the candidate is an integral part of the institution’s research and academic program.
Provide assurance that their facilities and the time of the stem cell expert are available to the candidate.

Biographical Sketches:

The candidate must submit a Biographical Sketches as well as their mentor, and any other key personnel, following the Biographical Sketch Format page in the PHS 398.

6.E. 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.

Follow instructions in SF 424 (R&R) supplemental instructions for career development awards, Section 4.7 (R&R Budget Component). Provide only the total direct costs for each year and the entire proposed period of support. In budget sections A, B, and C where a dollar amount is required, enter 0 (zero) in the appropriate box. The total direct cost amount requested for each year will be entered in Section F.1, Materials and Supplies. In Section H enter Modified Total Direct Costs in line 1 of Indirect Cost Type. The Indirect Cost rate is 8% of modified total direct cost. The Indirect Cost amount should be entered under Funds Requested. Totals for Sections F, G, and H will be calculated automatically for each year as well as for the Cumulative Budget. Within the direct cost limitation for research development support, provide a detailed description with justification for all equipment, supplies and personnel that will be used to help achieve the career development and research objectives of this award.

6.F. 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, applicants 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:

Undergo a selection process in which only those applications deemed to have the highest scientific and technical merit, generally the top half of applications under review, will be discussed and assigned a priority score.
Receive a written critique.
Receive a second level of review by the appropriate national advisory council or board.

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

Scientific merit and quality of the proposed project as determined by peer review.
Relevance of the proposed career development program, prior training, and commitment of the applicant to becoming an independent research scientist.
Relevance to the IC program priorities.
Availability of funds.

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.

Candidate
Career Development Plan
Research Plan
Mentor(s), Consultant(s), and Collaborator(s)
Environment and Institutional Commitment to the Candidate

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:

Has the candidate provided evidence of excellence in academic, research, and, if appropriate, clinical activities?
Does the candidate have potential to become, or continue as, an outstanding investigator, teacher, resource person, and leader in research programs related to the mission of the appropriate Institute?
Is there evidence of quality and breadth of prior scientific training and experience?
Is the candidate’s degree and extent of previous research support and publications commensurate with their academic level?

Research Plan:

Is the research plan of high quality, relevant to the candidate’s research interests and does it have potential for advancing the field of study?
Is the scientific and technical merit (research question, design, and methodology) of the proposed research plan of significance?
When applicable for the specific candidate and situation, do the letters from consultant(s) and collaborator(s) adequately document their willingness to participate in the independent scientist award program?
If applicable, are there adequate plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research? Are there adequate plans for the recruitment and retention of subjects?
Is the research plan appropriate for the candidate’s career level and as a vehicle for developing the research skills described in the career development plan?

Career Goals and Objectives:

Is there likelihood that the award will contribute substantially to the continued scientific development and productivity of the candidate?
Are the career goals and objectives consistent with the candidate’s career goals?
Is there evidence that the award will enable the candidate to devote full time (at least the required minimum of 50% of full-time professional effort) to research and related duties by release from teaching, administration, clinical work, and other responsibilities?
Is there an assessment of the value of the proposed training and career development experience as it relates to enhancing the candidate’s capabilities as an independent investigator?

Consultant(s), Collaborator(s) and Stem Cell Expert (Mentor):

Are the proposed collaborations with other active investigators and other opportunities for professional growth appropriate and of high quality?
Is there adequate information provided that clearly documents expertise in the proposed area(s) of consulting/collaboration?
Is there evidence of the stem cell expert’s qualifications as well as prior experience and record of fostering academic growth and productivity?
Is there documentation of the expert’s history of productivity and peer-reviewed research support?
Is there evidence of adequate active support for the proposed research project, if applicable?

Environment and Institutional Commitment to the Candidate:

Is the level of the applicant institution’s commitment to the scientific development of the candidate appropriate?
Is the level of assurance from the institution that they intend the candidate to be an integral part of its research program adequate?
Are the research facilities, resources and appropriate educational opportunities available to the candidate appropriate and adequate?
Are the quality and relevance of the environment for continuing the scientific and professional development of the candidate and for others pursuing research appropriate and adequate?
Is the commitment from the sponsoring institution to provide adequate protected time for the candidate to conduct the research program adequate?
Is the level of commitment from the candidate’s institution adequate in supporting future plans to use stem cells in research?

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 in prior instruction, or plans for training in the responsible conduct of research?

Resubmissions: 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 applicant? 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.

Data Sharing Plan: Not Applicable.
Sharing Model Organisms. [http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html]
Genome Wide Association Studies (GWAS). [http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html]

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 applicant. 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 notification in the form of a Notice of Award (NoA) will be provided to the applicant 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.

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:

The funds may be expended by the grantee institution in accordance with the NIH policy on supplementation of career award salaries and to provide fringe benefits in proportion to such supplementation. Such salary supplementation and fringe benefit payments must be within the established policies of the grantee institution.
The funds may be used for health-related research purposes.
The funds may be paid to miscellaneous receipts of the U.S. Treasury. Checks should be made payable to the Department of Health and Human Services, NIH and forwarded to the Director, Office of Financial Management, NIH, Bethesda, Maryland 20892. Checks must identify the relevant award account and reason for the payment.

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: (See NIH Policy Concerning Career Development (K) Awards: Leave, Temporary Adjustments to Percent Effort, and Part-Time Institutional Appointments).

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.

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. Changes in Research or Career Program: Consultation with the applicable NIH funding Institute or Center Program staff is strongly encouraged when a change in the approved career program and/or research plan is being considered.

Career awards are made for a specific research program. A change in the specified scientific area of the research component of the career 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.

E. 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 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:

A relinquishing statement is submitted by the original institution and a transfer application is submitted by the new institution at least three months prior to the transfer in order to allow the necessary time for administrative review by the NIH awarding Institute or Center.
The awardee must establish in the transfer application that the specific aims of the research program to be conducted at the new institution are within the scope of the original peer-reviewed research program.
All conditions of the award are met at the new institution.
The period of support requested is no more than the time remaining within the existing award.

When a grantee institution plans to terminate an award, the Grants Management Specialist listed on the Notice of Award (NoA) must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. The 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:

A demonstration of scientific progress toward the aims of the research as described in a brief summary of the studies and results obtained during the prior funding period.
A list of accomplishments such as publications, scientific presentation, new collaborations, inventions, or project-generated resources made during the prior funding period.
A brief explanation of plans to address the specific aims during the next year of support.
A description of proposed career development and research-related activities for the next year of support with a clear indication of percent effort devoted to research, research career development and other activities.
An annual evaluation statement of the candidate’s progress, as required in the PHS 2590 continuation application instructions (item J. Sponsor’s Report).

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished, when a recipient changes institutions, or when an award is terminated.

Section VII. Agency Contacts

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

1. Scientific/Research Contact(s):

Applicants should refer to the NIH Web site (Table of Institute and Center Contacts) for information regarding each IC’s scientific/research contact for this program.

2. Peer Review Contact(s):

Not Applicable.

3. Financial/Grants Management Contact(s):

Applicants 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.

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/.

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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