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 Center on Minority Health and Health Disparities (NCMHD), (http://www.ncmhd.nih.gov/)

Title:  NCMHD Disparities Research and Education Advancing Mission (DREAM) Career Transition Award (K22)

Announcement Type
New

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

Request for Applications (RFA) Number: RFA-MD-09-001

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)
93.308

Key Dates
Release/Posted Date: December 12, 2008
Opening Date:  January 12, 2009 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): January 12, 2009 - (Changed to February 13, 2009 per NOT-MD-09-001)
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): February 11, 2009 - (Changed to March 13, 2009 per NOT-MD-09-001)
Peer Review Date(s): May-June 2009
Council Review Date(s): September 2009
Earliest Anticipated Start Dates(s): August 2009
Additional Information To Be Available Date (URL Activation Date): Not Applicable.
Expiration Date: February 12, 2009 - (Changed to March 14, 2009 per NOT-MD-09-001)

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 is 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
3. Transition from Intramural Phase to the Extramural Phase Award

Section III. Eligibility Information
1. Eligible Applicants

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

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

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

Section VI. Award Administration Information
1. Award Notices

2. Administrative and National Policy Requirements
3. Reporting
4. Transition from the Mentored Phase to the Independent Phase.

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 the NIH Research Career Development Award program is to prepare qualified individuals for careers that have a significant impact on the health-related research needs of the Nation.

The objective of the NCMHD DREAM Career Transition Award (K22) program is to support current or former NCMHD loan repayment program (LRP) recipients, who are highly qualified postdoctoral fellows but have no more than 10 years of postdoctoral research training at the time of application submission.

NCMHD DREAM Transition Award

“Of all the forms of inequality, injustice in health care is the most shocking and inhumane.” 

Spoken over forty years ago, these are the words of Dr. Martin Luther King who worked tirelessly to raise awareness about health disparities—health issues that disproportionately affect people of color, low-income, and rural communities.  As articulated and documented in recent watershed documents such as the Institute of Medicine’s Unequal Treatment (2003) and Unfinished Business: Examining the Health Disparities Research Plan of the NIH (2006), there is still much work to be done in order to eliminate health disparities and achieve Dr. King’s vision of equity in health.

Created by Congress through the Minority Health and Health Disparities Research and Education Act of 2000, the National Center on Minority Health and Health Disparities (NCMHD) has a clear mandate for “the conduct and support of research, training, dissemination of information, and other programs with respect to minority health conditions and other populations with health disparities.”

Honoring Dr. King’s vision, this program is named the NCMHD DREAM (“Disparities Research and Education Advancing Mission”) Career Transition Award and its primary purpose is to support the transition phase of NCMHD loan repayment program (LRP) recipients from postdoctoral trainee to independent scientist.  It should be noted that the NCMHD loan repayment program is the largest health disparities program of its kind.  As of 2008, there have been over 1700 NCMHD loan repayment recipients.

The NCMHD invites applications for the DREAM Career Transition program which is to provide former or current NCMHD LRP recipients, who are highly qualified postdoctoral fellows but have no more than 10 years of postdoctoral research training at the time of application submission. The overall goals of this program are to support outstanding individuals to obtain a research training experience at the NIH in the intramural research laboratories and to facilitate their successful transition to an extramural environment as independent researchers.

Intramural scientists and facilities at the NIH provide an infrastructure for the research training and career development of promising new scientists who will subsequently enter the extramural community in relevant health disparities research and have the potential to become leaders in their fields of investigation.  The goal of the NCMHD Career Transition Award program is to provide highly qualified developing scientists with an opportunity to receive research career development experience in an NIH intramural research laboratory or clinical research department.  Transition funding will be provided upon completion of the fellowship and successful review for the continuation of their program of research in an extramural institution.

NCMHD Office of Innovation and Program Coordination

“Knowing is not enough, we must apply.  Willing is not enough; we must do.”

Spoken over two hundred years ago and serving as the motto of the Institute of Medicine, these are the words of German writer Johann Wolfgang von Goethe who identified the need to not only know, but to apply and do.  At NCMHD, the DREAM program is based in the Office of Innovation and Program Coordination (OIPC).  In the spirit of Goethe, OIPC is looking for applications that will: (1) focus on a clearly defined area of health disparities; (2) build and improve on what we know in this area; (3) propose and implement an innovative project or study that could potentially eliminate health disparities in this area.  To support Goethe’s call for both application and action and achieve the goal of elimination of health disparities, OIPC has created the “Triple T model” and encourages scientists to propose preventive-oriented research that is transformational, transdisciplinary, and translational. 

In determining the area of health disparities that you would like to propose and focus on either for your time intramurally at NIH or extramurally at your home institution or organization, one should consider and integrate several documents and paradigms \ into the application: (1) priority populations; (2) diseases and medical conditions; (3) causes; (4) the 3 Ts. 

From the perspective of priority populations, NIH has identified the following groups as health disparity populations: minorities; low-income; rural.  The proposal should address at least one of these priority populations.  For minorities, subgroup research (beyond the Office of Management and Budget or OMB definitions of race and ethnicity) is both encouraged and preferred. 

From the perspective of medical conditions, the Department of Health and Human Services has identified six health disparity focus areas: infant mortality, cancer screening and management, cardiovascular disease, diabetes, HIV infection/AIDS, immunizations.  The researcher could choose one or more of these areas or identify another area that has been confirmed by data from Healthy People 2010 (http://www.healthypeople.gov) and/or the 2006 Agency for Healthcare Research and Quality (AHRQ) Health Care Disparities Report (http://www.ahrq.gov/qual/nhdr06/nhdr06.htm).  The proposal should incorporate current and up-to-date national, state, and local data (if available) when referencing any diseases or medical conditions that are being studied. 

From the perspective of causes, Dr. Michael McGinnis et al. published an article in 2002 in Health Affairs titled “The Case for More Policy Attention to Health Promotion.”  In this article, Dr. McGinnis uses the literature to categorize determinants of health into the following five groupings: social circumstances; environmental conditions; behavioral choices; medical care; genetics.  If the proposal has an intervention, it should indicate which category(ies) of the determinants of health it proposes to address and enlighten.  Interventions that are preventive, address the social determinants of health, and promote behavioral change are encouraged and preferred.

Finally, the proposed research is expected to have the potential to be transformational, transdisciplinary and translational.  “Transformational” refers to research that takes an innovative, creative approach and has the potential to make large (versus incremental) closing of an important health disparity gap area. “Transdisciplinary” means research that builds partnerships across different disciplines and fields, especially bringing in nontraditional partners (e.g., community members, faith leaders).  “Translational” describes research that has the potential to be put into practice in the community immediately.  The proposal should indicate how and why it fits within the “Triple T model”.  More information about the “Triple T model” can be found at www.ncmhd.nih.gov under Office of Innovation and Program Coordination (OIPC). 

Nature of the career/research transition opportunity

Intramural Research at the NIH

The NIH intramural research program is located in or near Bethesda, MD. Research opportunities exist within the intramural institute laboratories. The proposed research must be consistent with the mission of NCMHD. The NCMHD Mission can be accessed through the following website: http://www.ncmhd.nih.gov/about_ncmhd/mission.asp

Potential candidates are encouraged to seek guidance regarding the selection of a research project and mentoring opportunities offered by the NCMHD though this FOA by making an initial contact with the NCMHD’s Office of Innovation and Program Coordination (see Section VII. Agency Contacts).  Subsequently the applicant can and should access http://www1.od.nih.gov/oir/sourcebook/sci-prgms/sci-prgms-toc.htm, which lists all of the NIH intramural and research topics of interest, along with telephone numbers of scientists within the intramural laboratories of the respective Institutes and Centers. 

Extramural Support Phase

Transition from the intramural phase of support to the extramural phase is NOT AUTOMATIC. An application from the extramural institution on behalf of the candidate will be required for the NCMHD to process the second phase of the K22.

(See Section VI.4 for details on transitioning from the intramural to the extramural phases of this award.) The extramural institution must demonstrate a commitment to the candidate by providing protected research time, space needed to perform the proposed research and a plan for career development. Awardees approved to proceed with the second phase of support will receive notification of approval in writing from the NCMHD. 

As stated above and throughout this application, it should be noted that only former and current NCMHD LRP recipients are eligible for this award.

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 utilize the NIH Career Transition Award (K22) mechanism.  The Project Director/Principal Investigator (PD/PI) (also referred to as the candidate) and his/her mentor will be solely responsible for planning, directing, and executing the proposed project.

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

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

2. Funds Available

Because the nature and scope of the proposed K22 award program will vary from application to application, it is anticipated that the size and duration of each award will also vary.  Although the financial plans of the NCMHD 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.  Total amount of funding that NCMHD is expected to award through this announcement is up to $5,000,000 of direct costs ($1,000,000 per year x 5 years); the anticipated number of awards is up to 5 awards for this initial offering.

The DREAM Career Transition Award has two phases: an intramural phase of 2 years at an NIH intramural laboratory followed by an extramural phase of 3 years sponsored by an extramural institution/organization to which the individual has been recruited.  The number of applications funded will be dependent upon the number of meritorious applications received, funds available, and the particular resource needs for the proposed project. Individuals who receive intramural phase support and are subsequently recruited to positions at NIH intramural laboratories will not receive the extramural scientist phase of the award.

Intramural Phase of the Career Transition Award

Funds for the intramural phase will be negotiated with the relevant intramural laboratory, and will be commensurate with the level of training and experience specified by the intramural salary structure at the time of an award. During the NIH intramural phase of the award, the candidate is expected to devote 12 person months (100% effort) on research training for two years.  No grant award is associated with the intramural phase.

Extramural Phase of the Career Transition Award

Salary:  The NCMHD will provide salary for the award recipient up to $125,000 (including fringe benefits) for a minimum of 9 person months (75% effort).  Although a greater effort may be proposed, the maximum allowable salary is $125,000 (including fringe benefits).  The total salary requested must be based on a full-time, 12-month faculty or staff appointment.  It must be consistent with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other faculty or staff members of equivalent qualifications, rank, and responsibilities in the department concerned.  No less than 9 person months (75% effort) should be devoted by the candidate specifically to the proposed program of research.

The institution may supplement the NIH 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 Public Health Service 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 DREAM Career Transition Award.

Under expanded authorities, institutions may re-budget funds within the total costs awarded, but may not re-budget funds involving the salary component of the budget. 

Research Support: The NCMHD will provide up to $75,000 per year for (a) research expenses, such as supplies, equipment, consultants, patient care costs, and technical personnel; (b) travel to research meetings or training; and (c) statistical service, including personnel and computer time.

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

Facilities and Administrative (F&A) Costs: F&A costs will be reimbursed at eight percent of modified total direct costs.  F&A costs requested by consortium participants are not included in the direct cost limitation; see NOT-OD-05-004. 

Applicable to both Intramural and Extramural Phases

For information regarding NIH policy on determining full-time professional effort for career awards see NOT-OD-04-056. The requested salary must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members with equivalent qualifications, rank, and responsibilities in the department concerned.  If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be related appropriately to the existing salary structure.  Confirmation of salary is required prior to the issuance of an award.  Fringe benefits based on the sponsoring institution’s rate and the number of person-months devoted to the project (percent of effort) are provided in addition to the salary.

Candidates who have VA appointments may not consider part of the VA effort toward satisfying the “full time” requirement at the applicant institution (see: Note-OD-04-056). Candidates who have VA appointments should contact the staff person in the relevant NIH Institute or Center prior to preparing an application to discuss their eligibility.  

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.

2.A. Allowable Costs

The salary requested for the candidate must be consistent with both the established salary structure for 12-month 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. 

Salary and Professional Effort: The total salary requested must be based on a full-time, 12-month staff appointment requiring candidates to devote a minimum of 75% effort of full-time professional effort to conducting health-related research with the remaining effort being devoted to activities related to the development of a successful research career.  For information regarding NIH policy on determining full-time professional effort for career awards, see NOT-OD-04-056.  Candidates who have U.S. Veterans Administration (VA) appointments may not consider part of the VA effort toward satisfying the “full-time” requirement at the applicant institution.  Candidates who have VA appointments should contact the Office of Innovation and Program Coordination staff (Section VII) prior to preparing an application to discuss their eligibility, qualifications, rank, and responsibilities in the department concerned.  If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be related appropriately to the existing salary structure. Confirmation of salary 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 salary.

Salary Supplementation: The sponsoring institution may supplement the NIH salary contribution up to a level that is consistent with the institution's salary scale.  However, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case may additional PHS funds be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the K22 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.

Research-Related Expenses: These include salaries for technical support, consultant costs, equipment, supplies, travel to scientific meetings and training, statistical services, and other research-related expenses.  The research development support costs must be justified and be consistent with the stage of development of the candidate and the proportion of time to be spent in research or career development activities. 

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

Indirect Costs: These costs also known as Facilities and Administrative (F&A) costs will be reimbursed at eight percent (8%) of modified total direct costs only for the independent phase of the award.

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:

Foreign institutions are not eligible to apply.

1.B. Eligible Individuals

Applicants are strongly encouraged to consult with the scientific/research contact person listed in Section VII of this FOA prior to the submission of an application to discuss eligibility and program requirements.

Project Director/Principal Investigator (PD/PI): Only current and former NCMHD LRP recipients are eligible to be candidates for this award.  The candidate must have a research or health professional doctorate or its equivalent, and must have no more than 10 years of postdoctoral research experience, during which the potential for highly productive health disparities research was demonstrated.  Parental leave or other well justified leave from postdoctoral research training for pressing personal or family situations of generally less than 12 months duration is not included in the 10-year eligibility limit.  In addition, clinical training time with no research involvement (e.g., residency training) is not counted against the 10-year limit.

At time of submission applicants must:

Ph.D. applicants in positions other than postdoctoral fellow positions: Some institutions appoint postdoctoral fellows in positions with other titles although they are still in non-independent training positions.  Applicants in such positions are encouraged to obtain confirmation of their eligibility before they begin to prepare their applications.  It is incumbent upon the applicant to provide evidence that the position he/she is in complies with the intent of this eligibility requirement. Evidence for non-independence may include: 

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

Citizenship and Residency: Only U.S. citizens or non-citizen nationals, or an individual lawfully admitted for permanent residence who possesses an Alien Registration Receipt Card (I-151 or I-551), or some other verification of legal admission as a permanent resident, 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: Candidates must have earned a terminal clinical or research doctorate (including Ph.D., M.D., D.O. D.C., N.D., D.D.S., D.V.M., Sc.D., D.N.Sc., Pharm.D., or equivalent doctoral degree, or a combined clinical and research doctoral degree.

Level of Effort: Candidates must be able to commit a minimum of 9 calendar months (75% of full-time professional effort) conducting research career development activities associated with this award.  The remaining 3 months (25% effort) can be divided among other research, clinical, and teaching activities only if these activities are consistent with the goals of the K22 award.  For information regarding NIH policy on determining full-time professional effort for career awards, see NOT-OD-04-056. At the time of award, the candidate must have a “full-time” appointment at the academic institution that is the applicant institution.  Candidates who have VA appointments may not consider part of the VA effort toward satisfying the “full time” requirement at the applicant institution. Candidates who have VA appointments should contact the Office of Innovation and Program Coordination staff prior to preparing an application to discuss their eligibility.

Individuals are eligible for a K22 award if they have been, or currently are the PI of an NIH R03 or R21 grant or a PHS or non-Federal award that duplicates the provisions or research goals of an R03 or R21 grant.

Individuals are NOT eligible if they:

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

3.A. Special Requirements

Each K22 career development program must be tailored to meet the individual needs of the Candidate.  The Candidate and mentor are responsible jointly for the preparation of the plan for the career development and research program.  The sponsoring institution for the independent phase must provide an appropriate scientific environment for the Candidate and demonstrate a commitment to the development of the candidate as a productive, independent investigator.

The initial application for the intramural phase (Phase I) may be submitted on behalf of the candidate (principal investigator) by any domestic for-profit or non-profit institution/organization such as universities, colleges, hospitals, and laboratories, and eligible agencies of the Federal government, including NIH intramural laboratories.  The submitting organization is the one where the applicant is located at the time of application. The applicant is expected to relocate from the applicant institution to the NIH for the initial intramural phase.

The subsequent application for the extramural phase (Phase II) may be submitted on behalf of the awardee (principal investigator) by any domestic for-profit or non-profit institution/organization such as universities, colleges, hospitals, and laboratories at which the awardee has been recruited, offered and has accepted a tenure-track, full-time assistant professor position (or equivalent).  Agencies of the Federal Government that are ineligible to apply for NIH research grants (including NIH intramural laboratories) and foreign institutions are not eligible to apply for the extramural phase of the Career Transition award.

During the Phase I of the award, the candidate is expected to devote 12 person months (100% effort) on research training for up to two years.  During the extramural phase, the candidate must spend a minimum of 9 person months (75% effort) conducting research and engaging in research career development activities for the three years of the award.

Candidates must be U.S. citizens or non-citizen nationals, or must have been lawfully admitted for permanent residence and possess an Alien Registration Card (I-151 or I-552) or some other verification of legal admission as a permanent U.S. resident by the time of the initiation of the intramural phase of the 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.

A candidate for the NCMHD DREAM Career Transition award may not simultaneously submit or have an application pending for any other NIH fellowship, career award or research award. Ineligible individuals include current and former principal investigators on NIH R01 research grants, comparable individual NIH career development awards (e.g., K01, K07, K08, K23, K25), equivalent non-PHS peer-reviewed career development awards, or non-PHS peer-reviewed research grants over $100,000 direct costs per year, or project leaders on sub-projects of program project (P01) or center (P50) grants.  

A candidate for the NCMHD DREAM Career Transition Award may not concurrently apply for any other PHS award that duplicates the provisions of this award nor have another application pending award.

K22 award recipients are expected to apply for NIH or other independent research grant support during the independent phase (Phase II) of the award.  Recipients may hold concurrent research support, and under certain circumstances, salary support from the final two years of their K22 award and a competing NIH research project grant when recognized as the PD/PI or subproject Director of the research project grant. See NOT-OD-08-065.

NCMHD will review the responsiveness of the application based on the following criteria and Non-responsive applications will not be reviewed:

1. The application must address how and why it fits the “Triple T model.”

2. Does the study investigate any or all of the following: SUBGROUP research (beyond OMB definitions of race and ethnicity), interventions that are PREVENTIVE, address the SOCIAL DETERMINANTS of health, and/or promote BEHAVIORAL CHANGE?

Applicants may submit more than one application, provided each application is scientifically distinct.

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  

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 for, and is not applicable to, any Grant Application to the Federal Government. This individual 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.

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.

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
Letter of Intent Receipt Date(s): January 12, 2009
Application Due Date(s):  February 11, 2009
Peer Review Date(s): May-June 2009
Council Review Date(s): August 2009
Earliest Anticipated Start Date(s): September 2009

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Prabha Atreya, PhD
Chief, Office of Scientific Review
Division of Extramural Activities and Scientific Programs
National Center on Minority Health and Health Disparities
6707 Democracy Boulevard, Suite 800
MSC 5465
Telephone: (301) 594-8696
Fax: (301) 480-4049
E-mail: atreyapr@mail.nih.gov

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 funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an “Introduction” describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

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:  Candidates must be aware of the NIH policies associated with other federally sponsored support (see NOT-OD-08-065).

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.

6. Other Submission Requirements and Information

Only current and former NCMHD LRP recipients are eligible.

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 in the R&R 424 for Research Career Awards (Instructions, Part 7, Section 5).

Cover Letter: The PHS398 cover letter must include the list of referees (including name, department affiliation, and institution.

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

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

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

PHS 398 Career Development Award Supplemental Form Component Sections: Items 2-5 (Candidate Information) and 10-13 (Research Plan) are limited to a total of 25 pages. While each section of the Candidate Information and Research Plan components needs to be uploaded separately as a PDF attachment, candidates 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 candidates to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

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

6.A. Candidate Information and Career Development Plan

Candidate’s Background:

Career Goals and Objectives:

Career Development/Training Activities:

Training in the Responsible Conduct of Research:

6.B. Research Plan

6.C. Statement of Support

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

6.D. Environment and Institutional Commitment to the Candidate

Description of Institutional Environment:

Institutional Commitment to Candidate’s Research Career Development:

6.E. Letters of Reference

Electronic submission of reference letters is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons and do not use Grants.gov.  Therefore, candidates must follow the Supplemental Instructions in the SF424 R&R Application Guide for Research Career Awards (Instructions, Part 7.3) (see http://grants.nih.gov/grants/funding/424/index.htm).

Letters of reference are an important component of the application for the mentored career award.  Candidates for this career award must arrange to have at least three (but no more than five) letters of reference submitted on their behalf to the NIH eRA Commons Web site at https://public.era.nih.gov/commons/public/reference/submitReferenceLetter.do?mode=new.  The letters should be from well-established scientists (referees) addressing the qualities of the candidate as well as his/her potential for becoming an independent investigator.  These letters should be from individuals not directly involved in the application, but who are familiar with the candidate’s qualifications, training, and interests, including advisory committee members (if applicable).

The mentor/co-mentor(s) may also submit letters of reference, but these letters will be considered independently of the three required reference letters.  Resubmission applications must include new letters of reference. 

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

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

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

Budget Component – Intramural (Section 4.7): Intramural candidates should not request a budget for the mentored phase of the award because the budget will be negotiated with the respective intramural program.  If a dollar amount is required, enter 0 (zero) in the appropriate box.  There will be no extramural grant award associated with intramural phase for the K22 award.

Budget Component – Extramural (Section 4.7): For awardees who receive approval to transition to the non-mentored phase, a budget will be required at that time as part of the application for the extramural phase of the K22 award (see Section VI.4, “Transition to the Independent Phase.”

6.G. Resource Sharing Plan(s)

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

(a) Data Sharing Plan: Not Applicable.

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

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

Section V. Application Review Information


1. Criteria 

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

2. Review and Selection Process

 Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the National Center on Minority Health and Health Disparities and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

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

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

Review Criteria

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

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

Candidate:

Career Development Plan:

Research Plan:

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

Environment and Institutional Commitment to the Candidate:

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:

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

2.C. Resource Sharing Plans

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

3. Anticipated Announcement and Award Dates

Not Applicable.

Section VI. Award Administration Information


1. Award Notices

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

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

A formal NoA will be provided as part of the extramural mentored phase of the K22 award conducted at a domestic, sponsoring extramural institution/organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

There will not be a formal Notice of Award (NoA) associated with the mentored phase of the K22 award conducted in the NIH intramural program.  The awarding Institute will transmit to the successful candidate an approval letter which will include the terms and conditions of the NIH intramural K22 award, as well as expectations for the transition to the independent phase of the award.

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

2. Administrative and National Policy Requirements

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

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

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

B. Other Income: Awardees may retain royalties and fees for activities such as scholarly writing, service on advisory groups, honoraria from other institutions for lectures or seminars, fees resulting from clinical practice, professional consultation or other comparable activities, provided these activities remain incidental, are not required by the research and research-related activities of this award, and provided that the retention of such pay is consistent with the policies and practices of the grantee institution.

All other income and fees, not included in the preceding paragraph as retainable, may not be retained by the career award recipient.  Such fees must be assigned to the grantee institution for disposition by any of the following methods:

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

C. Leave Policies: Leave to another institution, including a foreign laboratory, may be permitted if the proposed experience is directly related to the purpose of the award.  Only local institutional approval is required if such leave does not exceed 3 months.  For longer periods, prior written approval of the NIH funding component is required.   Details on the process for submission of prior approval requests can be founds in the NIHGPS (rev. 12/03), Requests for Prior Approval, at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600130.  However, because of the relatively short duration of the mentored phase of the program, awardees are cautioned about the impact of any leave on their ability to make sufficient progress to warrant transition to independence.

A copy of a letter or other evidence from the institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made.  Support from the career award will continue during such leave.

Leave without award support may not exceed 12 months.  Such leave requires the prior written approval of the NIH component Institute or Center and will be granted only in unusual situations.

Support from other sources is permissible during the period of leave without award support.  Such leave does not reduce the total number of months of program support for which an individual is eligible.

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

E. Changes in Research or Career Development Program: Consultation with the NCMHD Program staff is strongly encouraged when a change in the approved career development program and/or research plan is being considered.

Individual awards are made for career development at a specific institution in a specific research program.  A change in the specified scientific area of the research component of the career development program requires prior approval of the awarding NIH Institute or Center.  A scientific rationale must be provided for any proposed changes in the aims of the original peer-reviewed research plan.  The new research plan will be evaluated by the NCMHD staff to ensure that the plan remains within the scope of the original peer-reviewed research program.  If the new plan does not satisfy this requirement, staff could recommend that the award be terminated.

F. Change of Institution or Termination: Consultation with the NCMHD Program and/or Grants Management staff is strongly encouraged when either termination or a change of institution is being considered. 

A change of grantee institution normally will be permitted only when all of the benefits attributable to the original grant can be transferred, including equipment purchased in whole or in part with grant funds.  In reviewing a request to transfer a grant, NIH will consider whether there is a continued need for the grant-supported project or activity and the impact of any proposed changes in the scope of the project.  A change may be made without peer review, provided the PD/PI plans no significant change in research and career development objectives and the facilities and resources at the new organization will allow for successful performance of the project.  If these conditions or other programmatic or administrative requirements are not met, the NIH awarding office may require peer review or may disapprove the request and, if appropriate, terminate the award.

If the K awardee is moving to another eligible institution, career award support may be continued provided:

When a grantee institution plans to terminate an award, the Grants Management Specialist listed on the Notice of Award (NoA) must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination.  The Director of the NIH awarding component may terminate an award upon determination that the purpose or terms of the award are not being fulfilled.  In the event an award is terminated, NIH shall notify the grantee institution in writing of this determination, the reasons, the effective date, and the right to appeal the decision.

3. Reporting

NCMHD DREAM Career Transition (K22) 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 (see below: “Transition to the Independent Phase”):

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

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

4. Transition to the Independent Phase

Transition from Phase I (Intramural) to the Phase II (Extramural) is intended to be continuous in time but is not automatic. To activate the extramural phase of the grant, individuals must have been offered and accepted a tenure-track, full time assistant professor position (or equivalent) at an eligible institution with appropriate infrastructure to support the proposed research program and a history of external research funding.  Applicants are free to apply for positions within the NIH intramural research program (IRP). However, should the individual accept such a position in the IRP, the second phase of the award will not be activated.  This is because NIH intramural scientists are supported directly by NIH intramural funds and are not eligible for NIH extramural grant awards.  Such outcomes are not inconsistent with the goals of the Career Transition award initiative.

The extramural institution must demonstrate, in writing, a commitment to the applicant by providing protected research time and sufficient space and resources needed to perform the research.  Matching funds from the institution for equipment, supplies, and salary are encouraged.

The NCMHD DREAM Career Transition (K22) award is intended to facilitate the successful transition to status as an extramural scientist.  Applicants are encouraged (but not required) to apply for independent positions at departments and institutions different from where they received prior predoctoral and postdoctoral training.  Awardees are also encouraged to include a plan and timeline for submitting an independent research grant application in a research area relevant to the mission of an NIH awarding component.

The application for Phase II of the award must be submitted 3 months before the end of the second year; i.e., no later than 3 months prior to the proposed activation date of the extramural phase. To avoid potential problems in activation, applicants are strongly encouraged to contact NCMHD program officials as soon as plans to assume an independent position develop. This is especially important if the applicant has any question about the acceptability of a specific position for the extramural phase of the award.

The institution for Phase II will submit an application on behalf of the candidate using the PHS 398.  The application must include a new Face Page signed by the extramural phase institutional representatives, new project description page (Form page 2), budget pages (Form pages 3 and 4), biographical sketches, a new resources page, an updated research plan, and a new checklist.  The abstract and specific aims should be updated to reflect current plans for the extramural phase and the updated research plans should be briefly described in 2-3 pages.  A letter from the Department or Division Chairman describing the institution’s commitment to the candidate and plans for his/her career development should be submitted, including a final evaluation statement by the intramural phase mentor.  These materials should be sent to the Grants Management Office of the NCMHD.  The extramural phase application will be evaluated by extramural program staff of the awarding component for completeness and responsiveness to the program.

Once the application is found to be complete, the NCMHD Office of Review will convene a Special Emphasis Panel (SEP) consisting of experts in the K22 candidate’s research program.  The reviewers will develop a written evaluation based on the criteria detailed in section V.2, but with a focus on (1) progress in the intramural program, and (2) likelihood of successful transition to status as an independent extramural scientist. The results of this formal review will be presented in writing to the applicant.  Approval will result in eligibility for the extramural Faculty Transition Phase of the Career Transition Award (K22).  Disapproval will result in a terminal year of intramural support with no transition funding. 

An institutional commitment agreement will be required at the time of activation of the independent phase of the award. This agreement should satisfy the criteria described in the CDA Section III (Part F.3.) of the PHS 398 application. In addition to space, facilities, resources, and other support needed to conduct the proposed research, the sponsoring institution must provide protected research time (minimum of 75% effort, or 9 person months) at least for the duration of the extramural phase award. The start-up package and other institutional support should be comparable to that given to other recently hired faculty into tenure-track or equivalent positions.  Moreover, institutions may not require the use of K22 funds to offset a typical startup package. The sponsoring institution should describe the candidate’s academic appointment, bearing in mind that it must be tenure-track or equivalent, and confirm that the appointment is not contingent on the transfer of the award to the institution. The independent phase institution must foster and support the awardee’s ability to apply for and secure independent research grant (e.g., R01) support.

Candidates may engage in limited teaching, administrative and clinical duties as part of the 3 person months (25% effort) not required by this grant award, as long as such non-research duties are minimal. In cases where salary commensurate with the required 9 person months (75% effort) cannot reasonably be covered by the $249,000 maximum total cost K 22 extramural phase award, grantee institutions may need to supplement the candidate’s salary so that the salary is consistent with salaries of individuals in comparable positions at the institution.  However, such supplements may not require applicants to engage in additional responsibilities that would interfere with the required 9 person months  (75% effort) on the PI Award is not permitted.  NIH staff may review start-up packages and other commitments between the institution and candidate prior to activating the independent phase of the award. NIH will not activate the independent phase if the institutional commitment is deemed inadequate Applicants that are approved to transition will receive a Notice of Grant Award reflecting activation of the K22 extramural phase, the dollar amount, and the new recipient organization.

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

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

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):

Kyu Rhee, MPP, FAAP, FACP
Director, Office of Innovation and Program Coordination
National Center on Minority Health and Health Disparities
6707 Democracy Boulevard, Suite 800
MSC 5465
Bethesda, MD 20892-5465
Telephone: (301) 594-8731
Fax: (301) 480-4049
E-mail: rheekb@mail.nih.gov

2. Peer Review Contact(s):

Prabha Atreya, PhD
Chief, Office of Scientific Review
Division of Extramural Activities and Scientific Programs
National center on Minority Health and Health Disparities
6707 Democracy Boulevard, Suite 800
MSC 5465
Telephone: (301) 594-8696
Fax: (301) 480-4049
E-mail: atreyapr@mail.nih.gov

3. Financial/Grants Management Contact(s):

Priscilla Grant, JD, CRA
Chief Grants Management Officer
National center on Minority Health and Health Disparities
6707 Democracy Boulevard, Suite 800
MSC 5465
Bethesda, MD  20892-5465
Phone: (301) 594-8412
Fax: (301) 480-4049
E-mail: grantp@mail.nih.gov

Section VIII. Other Information


Required Federal Citations

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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


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