Part I Overview Information


Department of Health and Human Services

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

Components of Participating Organizations
National Cancer Institute (NCI) (http://www.nci.nih.gov/)
National Eye Institute (NEI) (http://www.nei.nih.gov/)
National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov/)
National Institute on Aging (NIA) (http://www.nia.nih.gov/)
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov/)
National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov/)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (http://www.niams.nih.gov/)
National Institute of Biomedical Imaging and Bioengineering (NIBIB) (http://www.nibib.nih.gov/)
National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/)
National Institute on Deafness and Other Communication Disorders (NIDCD) (http://www.nidcd.nih.gov/)
National Institute of Dental and Craniofacial Research (NIDCR) (http://www.nidcr.nih.gov/)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov/)
National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov/)
National Institute of Environmental Health Sciences (NIEHS) (http://www.niehs.nih.gov/)
National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov/)
National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov/)
National Institute of Nursing Research (NINR) (http://ninr.nih.gov/ninr/)
National Center for Complementary and Alternative Medicine (NCCAM) (http://www.nccam.nih.gov/)
Office of Dietary Supplements (ODS), (http://ods.od.nih.gov)

Title: Midcareer Investigator Award in Patient-Oriented Research (K24)

Announcement Type
This is a reissue of PA-08-151.

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

Program Announcement (PA) Number: PA-09-037

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

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

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

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

Catalog of Federal Domestic Assistance Number(s)
93.866, 93.271, 93.855, 93.856, 93.846, 93.286, 93.398, 93.865, 93.173, 93.121, 93.847, 93.848, 93.849, 93.279, 93.113, 93.361, 93.867, 93.233, 93.837, 93.838, 93.839, 93.281, 93.853, 93.213

Key Dates
Release/Posted Date: December 11, 2008
Opening Date: January 12, 2009 (Earliest date an application may be submitted to Grants.gov).
Letters of Intent Receipt Date(s): See Section IV3A1.
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Due Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Due Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS.
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional Information To Be Available Date (URL Activation Date): Not Applicable
Expiration Date: (New Expiration Date January 8, 2010 per issuance of PA-10-061) Old Date: January 8, 2012

Due Dates for E.O. 12372

Not Applicable.

Additional Overview Content

Executive Summary

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

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Career Objectives


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

Section III. Eligibility Information
1. Eligible Applicants

A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other-Special Eligibility Criteria

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

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices

2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contacts
1. Scientific/Research Contact(s)

2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Career Objectives

The overall 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. The NIH Midcareer Investigator Award in Patient-Oriented Research (K24) award is designed to enable mid-career clinician scientists to:

The K24 award is intended to provide protected time to mid-career clinical investigators who are typically at the Associate Professor level or the equivalent (see Section III, Eligible Individuals) and who have their own independent peer-reviewed research support to provide mentoring to junior clinical investigators, particularly K23 grantees, in POR and to stabilize the careers of these investigators so that they could continue to conduct POR and be available as mentors in POR. A K24 award recipient who continues to have an independent peer-reviewed patient-oriented research program and continues to provide mentoring to new investigators can continue to contribute to the overall goals of the program after being promoted to Full professor. This award has formed an important part of the NIH initiative to attract and retain talented individuals to the challenges of patient-oriented research. The overall goal is to increase the pool of clinical researchers who can conduct patient-oriented research, who will be able to successfully compete for peer-reviewed grants, and who will mentor the next generation of clinical investigators.

It is expected that K24 recipients will obtain new or additional independent peer-reviewed funding for POR as PD/PI and establish and assume leadership roles in collaborative POR programs. In addition, it is expected that there will be an increased effort and commitment to act as a mentor to beginning clinician investigators in POR to enhance the research productivity of both the K24 investigator and increase the pool of well-trained clinical researchers of the future.

For the purposes of this award, Patient-Oriented Research is defined as research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator directly interacts with human subjects. This area of research includes: 1) mechanisms of human disease; 2) therapeutic interventions; 3) clinical trials, and; 4) the development of new technologies. Studies falling under Exemption 4 for human subjects research are not included in this definition. See also: http://www.oenb.at/de/img/executive_summary--nih_directors_panel_on_clinical_research_report_12_97_tcm14-48582.pdf

For additional historical perspective about the K24 program, see the two previous K24 FOAs: PA-08-151, and PA-04-107.

Note: NIH Institutes and Centers have unique scientific purviews and different program goals and initiatives. Therefore, candidates are strongly encouraged to contact 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 Midcareer Investigator Award in Patient-Oriented Research (K24) mechanism. The Project Director/Principal Investigator (PD/PI) (also referred to as the Candidate) will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses “Just-in-Time” information concepts (see SF424 (R&R) Application Guide). However, since the K24 program requires that the candidate have a track record of research support, independent or otherwise, current, past, and pending research support must be documented in the application as part of the research support section of the biographical sketch attachment. This FOA also uses the non-modular budget format.

The candidate should follow the instructions for budget information described in Section IV (6.F) as well as in PHS 398 Career Development Award Supplemental form Section 7.4.6 of the R&R 424 instructions, and budget justification information.

The K24 program must be tailored to meet the individual needs of the candidate. Candidates may request three to five years of support (at least three years are required). Funding beyond the first year is contingent upon satisfactory progress during the preceding year, as documented in the required progress report (refer to Section VI).

2. Funds Available

Because the nature and scope of the proposed K24 award program will vary from application to application and the amounts provided by the participating ICs are not uniform, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the ICs provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

2.A. Allowable Costs

Salary: The NIH Midcareer Investigator Award in Patient-Oriented Research (K24) will provide salary for levels of effort between 3-6 person-months (or 25 and 50% full-time professional effort). The actual salary provided by the award is based on a full-time, 12-month staff appointment at the sponsoring institution, the PIs institutional salary, and the level of effort requested, up to the maximum legislated salary rate in effect at the time of award (see: http://grants.nih.gov/grants/policy/salcap_summary.htm).

The salary must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members 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. Confirmation of salary may be required prior to the issuance of an award. Fringe benefits, based on the sponsoring institution’s rate and the percent of effort, are provided in addition to the salary.

The sponsoring institution may supplement the NIH salary contribution up to a level that is consistent with the institution's salary scale. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the K24 award.

In addition, the candidate may derive additional compensation for effort associated with other Federal sources or awards provided the total salary derived from all Federal sources does not exceed the maximum legislated salary rate and the total percent effort does not exceed 100%.

Research Support: The NIH will provide up to $50,000 per year for the following expenses: (a) research expenses, such as supplies, equipment and technical personnel for the PD/PI and the mentees; (b) travel to research meetings or training; (c) statistical services including personnel and computer time.

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 eight percent (8%) of modified total direct costs.

NIH Grants Policy: NIH grants policies as described in the Table of Institute and Center Contacts) of this program announcement.

Effort and Other Support: Candidates must be able to demonstrate the need for protected time, 3-6 person months (25-50% of full-time professional effort) for a period of intensive research focus as a means of augmenting their capabilities in POR and act as a mentor to new clinical investigators in the conduct of POR during this period. Candidates for the K24 award may not have pending peer review or concurrently apply for any other PHS career award.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NOT-OD-09-003, NOT-OD-09-016). A candidate who gets promoted to the Full professor level will continue to be eligible for the purposes of resubmission.

Renewals: K24 awardees may apply for a one-time renewal for an additional three to five years of support if the K24 recipient continues to have independent peer-reviewed patient-oriented research support at the time of submission of the renewal application. Candidates should clearly demonstrate their continuing need for protected time to expand their research and mentoring programs. K24 awardees promoted from Associate Professor to Full Professor during the course of the initial award are considered to be eligible to apply for renewal of their support, as long as they meet all other eligibility requirements stated in this FOA. Renewal K24 applications will not be rejected, nor will they be unscored, solely based on the candidate’s academic rank.

Reviewers will continue to apply their professional judgment in assessing the review criteria, and in assigning priority scores to specific K24 grant applications. Individual NIH Institutes and Centers may differ in the programmatic priority that they apply to investigator rank in reaching their funding decisions. Differences in the rates of investigator promotion may mean that a Full Professor may or may not be considered mid-career depending on the discipline.

Program: The K24 award provides three to five years of support. 3-6 person-months (25-50% of full-time professional effort) must be devoted to the patient-oriented research program and mentoring that is a part of the award. The remainder may be devoted to other clinical, teaching, or research pursuits consonant with the objectives of the award.

PD/PI Status: A K24 recipient who is promoted to a higher academic position (viz., Full Professor or equivalent) during the award and continues to have an independent peer-reviewed patient-oriented research program and continues to provide mentoring to new investigators can retain the award and remain eligible to apply for a renewal.

3.A. Special Requirements

Research Support: Candidates are expected to continue to hold independent peer-reviewed support for POR during the period of this award. Candidates losing this support during the award period must document in their annual Progress Reports efforts to replace this support and demonstrate that they continue to meet all other requirements of the K24 award. Candidates may not receive additional compensation from another HHS award (specifically, AHRQ or SAMHSA) that exceeds the maximum allowable salary compensation (See details on current salary limitations at http://grants.nih.gov/grants/policy/salcap_summary.htm).

Institutional Environment: The institution must be able to demonstrate a commitment to the candidate as a productive, independent investigator. The application must describe a program that will use the relevant research and educational resources and facilities available. The institution must certify that the candidate will be released from other duties and be able to devote 25 to 50% effort (at least 25%) to a patient-oriented research program. The applicant institution must document the availability of beginning clinical investigators (including junior clinical faculty) to be mentored. In addition, if there is an NIH institutional career development award (K12); an NIH Clinical Translational Science Award (CTSA) with an institutional career development component; or an NIH Clinical Research Curriculum Award (K30) at the sponsoring institution, a plan should be described for integrating the proposed K24 mentoring activities with activities under these programs.

Section IV. Application and Submission Information


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

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

The PD/PI should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.

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

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

2) Organizational/Institutional Registration in the eRA Commons

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

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

Note: If a PD/PI is also an NIH peer-reviewer the DUNS number obtained and used in the reviewer role may NOT be used and is not applicable to any Grant Application to the Federal Government. This DUNS number is different from the DUNS number used by the applicant organization. The individual DUNS number should be used only for the purposes of personal reimbursement.

Several of the steps of the registration process could take four weeks or more. Therefore, the candidate should immediately check with his/her business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact GrantsInfo -- Telephone 301-435-0714, 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
SF424 (R&R) Detailed Budget
PHS398 Cover Letter
PHS398 Cover Page Supplement
PHS398 Career Development Award Supplemental Form
PHS398 Checklist

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: January 12, 2009 (Earliest date an application may be submitted to Grants.gov)
Letter of Intent Receipt Date(s): See below.
Application Due Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Due Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward

3.A.1. Letter of Intent

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

3.B. Submitting an Application Electronically to the NIH

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

3.C. Application Processing

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

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

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PD/PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

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

The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. However, the NIH will accept resubmission(s) application, but such application must include an Introduction addressing the critique from the previous review.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

Citizenship: Candidates 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 K24 Award may not simultaneously submit or have an application pending peer review for any other PHS career award (e.g., K02, K05). Candidates may submit research project grant (RPG) applications at the same time as the K24 application. However, any concurrent RPG application may not duplicate the provisions of the K24 application.

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

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

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

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement NIH Grants Policy Statement.

6. Other Submission Requirements and Information

All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements (see http://grants.nih.gov/grants/funding/424/index.htm):

PD/PI Credential (e.g., Agency Login): The NIH requires the PD/PI to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component.

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

The following information must be included in the application in accordance with the Supplementary Instructions for Research Career Awards in the SF424 (R&R) Application Guide (See Part I.7.5).

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

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

6.A. Candidate Information and Career Development Plan

Candidate’s Background:

Career Goals and Objectives:

Training in the Responsible Conduct of Research:

6.B. Research Plan

The research plan should follow instructions outlined in PHS 398 Career Development Award Supplemental form, including sections on Specific Aims, Background and Significance, Preliminary Studies/Progress Report, Research Design and Methods. Provide a Research Plan that establishes goals both for the individual’s research career and for mentoring. These goals should be appropriate to the experience level of the candidate, and to the research and training environment. The Research Plan should be presented in two separate parts, and indicate the percent effort committed to the entire research plan:

Additional Elements of the Research Plan:

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):

6.D. Environment and Institutional Commitment to the Candidate

Description of Institutional Environment:

Institutional Commitment to Candidate’s Research Career:

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

Participating NIH ICs will provide salary for the K24 awardee up to the maximum legislated salary rate in effect at the time of award (see: http://grants.nih.gov/grants/policy/salcap_summary.htm). The ICs will also provide up to $50,000 per year to cover research costs.

Budget Component (Section 4.7): Use the SF424 (R&R) Detailed Budget component and review the instructions found in Part I.4.7(R&R Budget Component) of the Application Guide. However for “K” applications only limited budget information is required; therefore, candidates will also need to follow the special instructions in Part I.7.4 of the SF 424 (R&R) [Supplemental Instructions for Career Development Awards], noting the special instructions that modify Section 4.7. In budget section A (Senior/Key Persons) include base salary, person months and requested salary and fringe benefit information for only the candidate. Base salary, and requested salary and fringe benefits should reflect actual levels. Any adjustments based on IC policy limits will be made at the time of the award. Sections B-E should be left blank. If a dollar amount is required, enter 0 (zero) in the appropriate box. The total Research Development Support amount requested for each year will be entered in Section F, Materials and Supplies. In Section H enter Modified Total Direct Costs under “Indirect Cost Type.” The Indirect Cost rate is 8% of modified total direct cost. The Indirect Cost amount should be entered under “Funds Requested.” Totals for Sections F, G, and H will be calculated automatically for each year as well as for the Cumulative Budget. Within the direct cost limitation for research development support, provide a detailed description with justification for all equipment, supplies and personnel that will be used to help achieve the career development and research objectives of this award.

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

Section V. Application Review Information


1. Criteria

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

2. Review and Selection Process

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

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

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

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

Review Criteria

The overall goal of NIH-supported career development programs is to help ensure that diverse pools of highly trained scientists are available in adequate numbers and in appropriate research areas to address the Nation’s biomedical, behavioral, and clinical research needs. The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application. Although it is understood that currently funded research described in K24 applications do not require the level of detail necessary in regular research grant applications, a fundamentally sound research plan must be provided. Research proposed in the K24 application that is not currently funded by a peer-reviewed grant should include a Statement of Hypothesis and Specific Aims; Background, Preliminary Studies and Aims. In addition, the application should outline the general goals for the later years and sufficient detail should be provided to permit evaluation of the scientific merit of the plan.

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:

Plan to Provide Mentoring:

Research Plan:

Consultant(s), Collaborator(s):

Environment and Institutional Commitment to the Candidate:

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 a description of a program to provide formal or informal instruction in scientific integrity or the responsible conduct of research?

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

Progress Assessment (Additional criteria for renewal applications):

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See the “Human Subjects Sections” of the PHS398 Research Plan component of the SF424 (R&R), part I, 5.5.

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. See the “Human Subjects Sections” of the PHS398 Research Plan component of the SF424 (R&R) part I, 5.5.

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

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

2.B. Additional Review Considerations

Budget and Period of Support: Is the proposed budget and period of support appropriate in relation to the proposed research and the career development needs of the candidate? The priority score should not be affected by the evaluation of the budget.

2.C. Resource Sharing Plans

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

3. Anticipated Announcement and Award Dates

Not Applicable.

Section VI. Award Administration Information


1. Award Notices

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

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

Usually, funds budgeted in an NIH supported research grant for the salaries or fringe benefits of individuals, but freed as a result of a career award, may not be rebudgeted. The awarding component will give consideration to approval for the use of released funds only under unusual circumstances. Any proposed retention of funds released as a result of a career award must receive prior written approval of the NIH awarding component.

C. Leave Policies: Leave to another institution, including a foreign laboratory, may be permitted if the proposed experience is directly related to the purpose of the award. Only local institutional approval is required if such leave does not exceed 3 months. For longer periods, prior written approval of the NIH funding component is required. Details on the process for submission of prior approval requests can be founds in the NIHGPS (rev. 12/03), Requests for Prior Approval, at http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600130.

Due to the special nature of the K24, this letter must include a description of the plans to continue meeting the effort commitments of both the research and mentoring components of the K24 award. 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:

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 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 candidates. Inquiries may fall into three areas: scientific/research (program), peer review, and financial or grants management issues:

1. Scientific/Research Contact(s):

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

2. Peer Review Contact(s):

Not Applicable.

3. Financial/Grants Management Contact(s):

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

Section VIII. Other Information


Required Federal Citations

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

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

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

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

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

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

Access to Research Data through the Freedom of Information Act: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are: (1) first produced in a project that is supported in whole or in part with Federal funds; and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

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

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

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

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

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

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

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

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

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

Healthy People 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

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

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


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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