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
This Funding Opportunity Announcement is a reissue of RFA-MD-09-001.

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

• August 16, 2010 - IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.
• May 19, 2010 - See Notice NOT-MD-10-004 The purpose of this Notice is to modify the CFDA number.
• March 2, 2010 - See Notice NOT-MD-10-003 Extension of Application Receipt Date.

Request for Applications (RFA) Number: RFA-MD-10-001

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.

A compatible version of Adobe Reader is required for download. For assistance downloading this or any Grants.gov application package, please contact Grants.gov Customer Support at http://grants.gov/CustomerSupport.

Catalog of Federal Domestic Assistance Number(s)
93.307 (Changed from 93.308, Per Notice NOT-MD-10-004)

Key Dates - New Dates (Per Notice NOT-MD-10-003)
Letter of Intent Receipt Date: April 24, 2010
Application Receipt Date: May 24, 2010
Peer Review Date: June/July 2010
Council Review Date: August 2010
Earliest Anticipated Start Date: September 2010
Expiration Date: May 25, 2010

Key Dates - Old Dates
Release/Posted Date: December 4, 2009
Opening Date: January 11, 2009 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): January 11, 2010
Application Due Date(s): February 11, 2010
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).
Peer Review Date(s): March-April 2010
Council Review Date(s ): May 2010
Earliest Anticipated Start Date(s): July 2010
Additional Information To Be Available Date (URL Activation Date): Not Applicable
Expiration/Closing Date: February 12, 2010

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

• Purpose: This purpose of the NCMHD DREAM Career Transition Award (K22) is to facilitate the transition of early stage investigators working in health disparities or areas that address health disparity conditions and populations from the mentored stage of career development to the independent stage of investigator-initiated health disparities research. The program will provide an opportunity for investigators to develop solid research skills during the initial period of up to two years of study and research within the environment of the NIH Intramural Research Programs located at the NIH. The award may also include a follow-on period of up to three years of salary and mentored research support at the candidate’s current institution or organization or an academic or research grantee institution of the candidate's choice. This period of extramural support will facilitate the transition to independence as a researcher in health disparities research.
• Mechanism of Support: This FOA will utilize the NIH Career Transition Award (K22) mechanism. The intramural phase is under the NIH Intramural Research Program. Awardees approved to proceed with the second phase of support will receive notification of approval in writing from the NCMHD. 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.
• Funds Available and Anticipated Number of Awards: The total amount to be awarded by the NCMHD and the number of awards will depend upon the quality and merit of applications received. However, the total amount of funding NCMHD anticipates to award through this FOA is approximately $1,000,000 with 5 awards up to $200,000 per individual.
• Budget and Project Period: 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. Awards pursuant to this funding opportunity are contingent upon the receipt of a sufficient number of meritorious applications. The award is intended to provide up to 5 years of support including a 2-year intramural phase followed by up to 3 years of support in an extramural phase.
• Research Strategy Page Limit: Section 2-5 within the Candidate Information Section and 11 (Research Strategy are limited to 12 pages collectively).
• Eligible Institutions/Organizations: Institutions/organizations listed in Section III are eligible to apply. Applications may only be submitted for the intramural phase for research to be conducted within NIH intramural programs in or near Bethesda, Maryland.
• Eligible Project Director/Principal Investigator (PD/PI): Also referred to as the Applicant or Candidate, individuals with the skills, knowledge, and resources necessary to enter into the mentored training experience and career development activities are invited to work with their mentor and sponsoring institution to develop an application for support or to contact the NCMHD regarding the development of an application for support. Individuals from underrepresented racial and ethnic groups, as well as individuals with disabilities are always encouraged to apply for NIH support.
• Number of PDs/PIs: Only one PD/PI may be designated on the application.
• Number of Applications: Candidates may only have one individual Career Development Award application pending peer review at any time
• Resubmissions: See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016).
• Renewals: K22 awards are not renewable and are not transferable from one PD/PI to another.
• Special Date(s): This FOA uses non-standard due dates. See Receipt, Review and Anticipated Start Dates.
• Application Materials: See Section IV for application materials. All applications, including resubmission, revision and renewal, submitted for due dates January 25, 2010 and beyond, must utilize the current forms and instructions.
• General Information: For general information on SF424 (R&R) Application and Electronic Submission, see these Web sites:
• SF424 (R&R) Application and Electronic Submission Information: http://grants.nih.gov/grants/funding/424/index.htm
• General information on Electronic Submission of Grant Applications: http://era.nih.gov/ElectronicReceipt/
• Hearing Impaired: Telecommunications for the hearing impaired are available at: TTY 301-451-5936.

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research 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

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

Background

The overall goal of the NIH Research Career Development Award program is to prepare promising and qualified individuals or investigators for careers that have a significant impact on the health-related research needs of the Nation. The NCMHD is committed to building a pipeline of investigators that are working to ensure significant progress towards eliminating health disparities.

The major objective of the NCMHD DREAM Career Transition Award (K22) program is two-fold: 1) to provide a mechanism for facilitating the career transitions of the most promising individuals while they are establishing their first independent research programs in health disparities research and 2) to create a diverse, multi-disciplinary pool of health disparities investigators with exposure to a extramural and intramural mentored career development opportunities and training in translational and transdisciplinary health disparities science and 3) to further the mission of the NCMHD by ensuring that health disparities research is coordinated and conducted through a successful transition by qualified independent investigators that will conduct work that positively impacts health disparities communities and settings.

NCMHD DREAM Transition Award

Over the past couple of decades, the country has become increasingly aware that the health of minorities and other health disparity populations has not benefited from our nation’s progress in scientific discovery due to a wide range and variety of health disparities. Research has demonstrated significant disparities for minorities, rural populations, and those with low socioeconomic status. It should be noted that a recent Census Bureau report states that US minorities will be the majority by 2042. Therefore, what we now know as minority health will become majority health in just about three decades. Without our full efforts and focused attention, the disproportionate burden of disease that health disparity populations currently bear will become an albatross for not only our children, but also the majority of our entire nation.

It is clear that the American people are deeply concerned about health inequities. A survey by Research! America found that over 90% of the American public advocates concerted research efforts to overcome these health disparities. Much of this concern led the Congress to pass Public Law 106-525, which created the National Center on Minority Health and Health Disparities (NCMHD) in 2000. Within this law, 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. The same legislation states that the Director of NCMHD is the primary Federal official with responsibility for coordinating all minority health disparities research and other health disparities research conducted or supported by the National Institutes of Health. Within these capacities of leading and coordinating health disparities efforts, NCMHD sees a unique opportunity to transform the dialogue and research and looks to supporting a cadre of researchers to help to champion this effort.

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 1) to provide a mechanism for stabilizing the careers of the most promising investigators while they are establishing their first independent research programs in health disparities research and 2) to create a diverse, multi-disciplinary pool of health disparities investigators with exposure to extramural and intramural mentored career development opportunities in translational and transdisciplinary health disparities science.

The NCMHD highly encourages applications for the DREAM Career Transition program from former or current NCMHD LRP recipients, who meet the eligibility criteria at the time of application submission.

Nature of the career/research transition opportunity

Intramural Research at the NIH

The total period of support for the NCMHD Career Transition Award is up to five years. The program begins with up to two years of support for research training in an NIH intramural research environment. NCMHD will help to facilitate the appropriate intramural research environment for the candidate at the time of award. However, each applicant is encouraged to be familiar with the scientific research programs at the NIH institutes or centers to ensure that their proposed research is relevant to at least one intramural research activity currently offered at the NIH. See below the link to the NIH Intramural Scientific Programs.

Intramural Research Scientific Programs

During the intramural research phase, the candidate will spend full time on acquiring basic scientific, translational or transdisciplinary research skills within the appropriate intramural institute, consistent with the level of research development and career objectives. During the intramural phase, pertinent didactic experiences designed to facilitate the critical skills and scientific perspectives for pursuing an independent research career in health disparities research will be provided. 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

Extramural Support Phase

Transition from the intramural phase of support to the extramural phase is NOT AUTOMATIC. (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.

The K-22 award will support salary and research for a second phase of up to three years of extramural mentored career training within a sponsoring eligible institution or organization. For this second phase of the award, research and salary support will be provided by NCMHD in the form of an extramural career development award (K22). The career development award may be activated when the candidate has assumed a suitable tenure-track faculty position at an extramural academic institution or an independent research investigator position at a research institution/organization.

The award will be made on behalf of the candidate to the extramural institution in which the candidate secures a suitable research position. During the extramural phase, the investigator is required to apply for additional independent research support. The K22 Career Transition Award is not renewable at the end of the three years and not transferable to another investigator.

SPECIAL RESTRICTIONS

The Transitional Award is specifically intended to help develop scientists who will pursue careers in the extramural scientific research community in health disparities. The expectation is that the transitional career awardee will move to a tenure-track or equivalent position in the extramural research community for the final three years. However, the awardee is not explicitly precluded from applying for available positions at the NIH. If the awardee obtains an NIH tenure-track or other NIH position, the transitional award will be terminated.

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 responsible for planning, directing, and executing the proposed project on behalf of the NIH Intramural Research Program in the first phase of the program. Planning, direction and execution of the program will be the responsibility of the candidate in collaboration with the extramural institution on behalf of the candidate in the second phase.

Transition from Phase I (the intramural period of support) to Phase II (the extramural period) is not automatic. Approval of the transition will be based on the success of the awardee's research program as determined by yearly scientific review and by the evaluation of a research and career development plan to be carried out at the extramural institution. Additionally, the extramural institution must demonstrate a commitment to the candidate by providing a minimum of nine person months (75%) protected research time, space and resources needed to perform the proposed research project and appropriate scientific mentoring. A plan for career development that will lead to research independence and the ability to successfully compete for research support is essential. Awardees approved to proceed with the second phase of support will receive notification of approval in writing from the NCMHD.

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 SF424 R&R 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. The total amount of funding NCMHD anticipates to award through this FOA is approximately $1,000,000 with 5 awards up to $200,000 per individual.

2.A. Allowable Costs

Salary and Professional Effort: Intramural Phase: Salary and research costs for the intramural phase is covered by NCMHD, but negotiated at time of award based on the individual’s background/experience and research plans and the commitment of a minimum of 75% of full time effort to the conducting health disparities research with remaining effort being devoted to activities related to the research career development.

Extramural Phase: The salary requested for the candidate in the extramural phase 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. The NCMHD will provide salary for the award recipient up to $125,000 (plus fringe benefits) for a minimum of 9 person months (75% effort) of full-time professional effort. Although a greater effort may be proposed, the award will provide up to 3 years of salary (up to $125, 000 per annum plus fringe benefits) and up to $75,000 in direct costs per annum for research and development expenses for the extramural phase. For information regarding NIH policy on determining full-time professional effort for career awards, see NOT-OD-04-056. 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 extramural institution may supplement the NIH contribution up to a level that is consistent with the institutional or organizational salary scale over the $125,000 cap during the extramural phase; 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 and Research-Related 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. 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 extramural 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:

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education
• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Other(s):
  • Faith-based or Community-based Organizations

Foreign institutions are not eligible to apply.

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

Project Director/Principal Investigator (PD/PI): Also referred to as the Applicant or Candidate, individuals with the skills, knowledge, and resources necessary to carry out the proposed research and career development activities are invited to work with their sponsoring to develop an application for support. Current and former NCMHD LRP recipients are eligible to be candidates for this award.

Citizenship and Residency: Only U.S. citizens or non-citizen nationals, or an individual lawfully admitted for permanent residence who have a currently valid Permanent Resident Card (USCIS Form I-551), or some other verification of legal admission as a permanent resident, 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.S., Pharm.D., or equivalent doctoral degree, or a combined clinical and research doctoral degree. In addition, the candidate must have postdoctoral research experience, during which the potential for highly productive basic or clinical research was demonstrated.

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 with VA appointments should contact the NCMHD 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:

• have more than 10 years of related postdoctoral research training at the time of initial application, or
• have been or are currently a PI on NIH research grants (such as R01, R29, P01), NIH career development awards, other peer reviewed NIH or non-NIH research grants over $100,000 direct costs per year intended for faculty members, or a subproject leader on a Program Project (P01) and Center Grant (P20, P50, or P60), or a non-NIH equivalent to these grants/awards; or
• Have pending an application for any other PHS career award (e.g., K01, K08, K23), an NIH institute-specific K22, or a Pathway to Independence Award (K99/R00).

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

NCMHD will review the responsiveness of the application based on the following criteria:

• Eligibility of the candidate for the K-22 award and evidence of current or prior work in health disparities or research areas that address health disparity conditions

K22 award recipients are expected to apply for NIH or other independent research grant support during the independent phase 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.

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.

Number of Applications: Candidates may have only one individual career award application pending peer review at any time.

Resubmissions: Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications are permitted only a single amendment (A1). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016). Original new and competing renewal applications that were submitted prior to January 25, 2009 are permitted two amendments (A1 and A2). For these grandfathered applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date.

Renewals: K22 applications are not renewable and are not transferable from one PD/PI to another.

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.

Registration:

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

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

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

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

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

2) Organizational/Institutional Registration in the eRA Commons

• To find out if an organization is already Commons-registered, see the "List of Grantee Organizations Registered in NIH eRA Commons.
• Direct questions regarding the Commons registration to:
  eRA Commons Help Desk
  Phone: 301-402-7469 or 866-504-9552 (Toll Free)
  TTY: 301-451-5936
  Business hours M-F 7:00 a.m. 8:00 p.m. Eastern Time
  Email commons@od.nih.gov

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

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

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

Note: The registration process is not sequential. Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number. Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.

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 301-710-0267, 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 - New Dates
Letter of Intent Receipt Date: April 24, 2010
Application Receipt Date: May 24, 2010
Peer Review Date: June/July 2010
Council Review Date: August 2010
Earliest Anticipated Start Date: September 2010
Expiration Date: May 25, 2010

3.A. Submission, Review, and Anticipated Start Dates - Old Dates
Opening Date: December 11, 2009 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): January 11, 2010
Application Due Date(s): February 11, 2010
Peer Review Date(s): March-April 2010
Council Review Date(s): May 2010
Earliest Anticipated Start Dates(s): July. 2010

3.A.1. Letter of Intent

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

• Descriptive title and background information of proposed research
• Name, address, and telephone number of the Principal Investigator
• Participating institution or organization
• Number and title of this funding opportunity

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

3.C.1 Submitting On-Time

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application due date(s). (See Section IV.3.A for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed. All applications must meet the following criteria to be considered on-time :

• All registrations must be complete prior to the submission deadline
• The application must receive a Grants.gov tracking number and timestamp (or eRA help desk ticket confirming a system issue preventing submission) by 5:00 p.m. local time on the submission deadline date.
• Any system identified errors/warnings must be corrected and the submission process completed within the error correction window.

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

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

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

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

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

Please note that the following caveats apply:

• Initial application submission must be on-time.
• The AOR/institutions is expected to enforce that application changes made within the error correction window are restricted to those necessary to address system-identified errors/warnings. NIH may reject any application that includes additional changes.
• Proof of on-time submission (e.g., Grants.gov timestamp and tracking number) and description of all changes made within the window must be documented in the PHS 398 Cover Letter component of the application.

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

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

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

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 the application status in the Commons.

The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. However, the NIH will accept a resubmission application, but such application must include an Introduction (1 page maximum) 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: 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

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 PHS 398 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: Sections 2-5 (within the Candidate Information Section) and 11 (Research Strategy) are limited to a total of 12 pages.

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. 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:

• Describe the Candidate’s potential to develop into a successful independent investigator.
• Describe the Candidate’s commitment to a career in a biomedical or behavioral research field relevant to the mission of NCMHD.

Career Goals and Objectives:

• Describe a systematic plan that shows a logical progression from prior research and training experiences to the training and research experiences that will occur during the K22 award period and then to independent investigator status.
• Describe the candidate’s current as well as long-term research and career objectives.

Career Development/Training Activities:

(Please note that this career development and training activity is in reference to those training and development activities that will be developed during the extramural phase)

• The candidate and the sponsoring mentor or sponsoring organization are jointly responsible for the preparation of the career development plan
• A timeline including a publication plan is strongly encouraged.
• Describe the career development plan and how it fits with the candidate’s goals and prior experience. A systematic plan should be presented for obtaining the necessary biomedical, bio-behavioral, behavioral or clinical science background and research experience to launch an independent research career. The career development plan must be specifically tailored to meet the needs of the candidate and the ultimate goal of achieving independence as a researcher.
• The applicant should describe how the career development plan will promote the candidate’s success and scientific independence. This plan should describe activities such as those that will lead to new and/or enhanced research, grant-writing, communication and laboratory management skills and knowledge. The candidate should also describe how these skills will contribute to research productivity and facilitate the development of new approaches and directions for investigation. Courses or other activities that might allow the candidate to expand the scope of his/her research in order to improve the potential for success in gaining further independent funding is particularly encouraged.

Training in the Responsible Conduct of Research:

Applications must include a plan to obtain instruction in the responsible conduct of research. This section should document prior instruction in responsible conduct of research during the applicant’s current career stage (including the date of last occurrence) and propose plans to receive instruction in responsible conduct of research. Such plans must address five instructional components, format, subject matter, faculty participation, duration of instruction, and frequency of instruction, as outlined and explained in NOT-OD-10-019. The plan may include career stage-appropriate, individualized instruction or independent scholarly activities that will enhance the applicant s understanding of ethical issues related to their specific research activities and the societal impact of that research. The role of the sponsor/mentor in responsible conduct of research instruction must be described. Applications lacking a plan for instruction in responsible conduct of research will be considered incomplete and may be delayed in the review process. The background, rationale and more detail about instruction in the responsible conduct of research can be found in NOT-OD-10-019.

6.B. Research Plan

• A sound research project that is consistent with the candidate’s level of research development and objectives of his/her career development plan must be provided.
• The application must also describe the relationship between the mentor’s research and the candidate’s proposed research plan.
• When the K22 award includes two phases, the application must include a description of how the mentored phase research will lead to the independent phase research.
• Data and Safety Monitoring: Candidates proposing to conduct clinical trials should consult with the Office of Innovation and Program Coordination staff (Section VII). Plans for data and safety monitoring must be included in Research Strategies involving Phase I or Phase II clinical trials (see Federal Citations in Section VIII): Generally, this requirement may be satisfied in the submitted application by providing documentation that the sponsoring institution has an approved plan in place and providing a brief description of the key elements of the plan.

6.C. Statement of Support

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

• The candidate must name a primary mentor who, together with candidate is responsible for planning, directing, and executing the program.
• The mentor should be recognized as an accomplished investigator in the proposed research area and have a track record of success in training and placing independent investigators.
• Where feasible, women, individuals from diverse racial and ethnic groups, and individuals with disabilities should be involved as mentors to serve as role models.
• The application must include a statement from the mentor providing: 1) information on his/her research qualifications and previous experience as a research supervisor; 2) a plan that describes the nature of the supervision and mentoring that will occur during the proposed award period, including how the Candidate’s scientific and professional independence will be promoted; 3) a description of the elements of the planned research training, including any formal course work.
• Consultant(s)/Collaborator(s): Signed statements must be provided by each consultant/collaborator confirming his/her participation in the project and describing his/her specific roles. Collaborators and consultants generally do not need to provide their biographical sketches. However, information should be provided clearly documenting the appropriate expertise in the proposed areas of consulting/collaboration. Collaborators/consultants are generally not directly involved in the development of the career of the candidate as an independent investigator.
• The mentor must agree to provide annual evaluations of the candidate’s progress for the mentored phase as required in the annual progress report, PHS 2590 (see Section VI.3 Reporting).

6.D. Environment and Institutional Commitment to the Candidate

Description of Institutional Environment:

• The application must include evidence that the scientific environment will contribute to the probability of success for the Candidate.
• Assurance must be provided that the research facilities, resources and training opportunities will be available for the Candidate’s planned career development and research programs.

Institutional Commitment to Candidate’s Research Career Development:

• The sponsoring extramural institution must provide a statement of commitment to the candidate s development into a productive, independent investigator and to meeting the requirement of this award. It should be clear that the institutional commitment to the candidate is not contingent upon receipt of the K22 award.
• The sponsoring institution must provide the candidate with appropriate facilities and other resources to carry out the proposed Research Strategy.
• An assurance must be provided that the candidate will be able to devote the minimum amount or professional effort required for the K22 program.

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.

For extramural candidates applying for both the mentored and non-mentored phases of this award, a budget will be required as part of the original application, as follows:

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.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

Review 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:

• Undergo a selection process in which only those applications deemed to have the highest scientific and technical merit, generally the top half of applications under review, will be discussed and assigned an impact/priority score;
• Receive a written critique; and
• Receive a second level of review by the NCMHD Advisory Council.

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 impact/priority score, weighting them as appropriate for each application.

Overall Impact/Priority Score: Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the research education program to exert a sustained, powerful influence on the activities involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the proposed program).

Core Review Criteria: Reviewers will consider each of the five review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

• Candidate
• Career Development Plan
• Research Strategy
• Mentor, Co-Mentor(s), Consultant(s), and Collaborator(s) (Extramural)
• Environment and Institutional Commitment to the Candidate (Extramural sponsoring institution)

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

Candidate:

• Does the candidate have the potential for becoming a successful independent investigator who will contribute significantly to a chosen health-related research field?
• Will the research experiences in the mentored phase prepare the candidate to implement successfully the independent phase research project?
• Do the letters of reference from at least three well-established scientists address the above review criteria, and do they demonstrate evidence that the candidate has a high potential for becoming an independent investigator?

Career Development Plan:

• Is the career development plan appropriate, and is the award like to contribute substantially to the scientific development of the Candidate?
• Is the career development plan consistent with the candidate’s prior research experience and current research career goals?
• Are the content, phasing, and proposed duration of the career development plan appropriate for achieving scientific independence?

Research Strategy:

• Is the proposed research project appropriate for the candidate’s stage of research development and as a vehicle for development of research skills described in the career development plan?
• Are the scientific and technical merits of the research question, design, and methodology appropriate in the context of prior training and experience?
• Is the proposed research relevant to stated career objectives?

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

• Are the mentor s research qualifications, scientific stature, experience and mentoring track record appropriate for the candidate’s career development needs?
• Do the mentor(s) adequately address the above review criteria including the candidate s potential and his/her strengths and areas needing improvement?
• Are the nature and extent of proposed supervision that will occur during the mentored phase period of support adequate, and is the commitment of the mentor to the candidate’s continued career development appropriate?
• Is the mentor s description of the elements of the research training plan and career development activities, including formal course work adequate?
• Does the mentor have a history of research productivity and support, and previous experience in fostering the development of new investigators?
• Are there adequate plans for monitoring and evaluating the career development awardee s progress toward independence?

Environment and Institutional Commitment to the Candidate:

• Are there adequate and appropriate research facilities and educational opportunities, including collaborating faculty?
• Is there clear commitment of the sponsoring institution to ensure that the required effort of the candidate will be devoted directly to the research training, career development, and research activities described in the proposed career development and Research Strategies?
• Is there strong institutional commitment to fostering the career development of the candidate?
• Are there unique features of the scientific environment that benefit the proposed research; e.g., useful collaborative arrangements or subject populations?
• Is the environment of high quality and relevance for scientific and professional development of the candidate?

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.

Resubmissions: Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?

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.

Additional Review Considerations

Training in the responsible conduct of research: Reviewers will evaluate plans for instruction in responsible conduct of research as well as the past record of instruction in responsible conduct of research, where applicable. Reviewers will specifically address the Format, Subject Matter, and Frequency of instruction as detailed in NOT-OD-10-019. Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE.

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 impact/priority score should not be affected by the evaluation of the budget.

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 impact/priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.

• Data Sharing Plan: Not Applicable.
• Sharing Model Organisms. Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042
• Genome Wide Association Studies (GWAS). Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, and http://grants.nih.gov/grants/gwas/.

Selection Process

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

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

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.

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:

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

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

C. Leave Policies: See Also NOT-OD-09-036: NIH Policy Concerning Career Development (K) Awards: Leave, Temporary Adjustments to Percent Effort, and Part-Time Institutional Appointments.

Leave to another institution, including a foreign laboratory, may be permitted if the proposed experience is directly related to the purpose of the award. Only local institutional approval is required if such leave does not exceed 3 months. For longer periods, prior written approval of the NIH funding component is required. Details on the process for submission of prior approval requests can be founds in the NIHGPS (rev. 12/03), Requests for Prior Approval, at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600130. 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:

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

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

3. Reporting

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 demonstration of scientific progress toward the aims of the research as described in a brief summary of the studies and results obtained during the prior funding period;
• A description of career development and research-related activities undertaken during the prior funding period;
• A list of accomplishments such as publications, scientific presentations, new collaborations, inventions, or project-generated resources made during the prior funding period;
• A brief explanation of plans to address the specific aims during the next year of support;
• A description of proposed career development and research-related activities for the next year of support with a clear indication of number of person-hours (percent effort) devoted to research/research training and other activities;
• A description of the resources sharing plan as described in Section IV.6 (Sharing Research Resources) of this announcement, or an explanation why resource sharing is not possible;
• An annual evaluation statement of the candidate's progress, as required in the PHS 2590 continuation application instructions (Item J. Sponsor's Report). The intramural training director must include a statement documenting the awardee’s progress.

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. Approval of the transition will be based on the success of the awardee’s research program as determined by annual scientific reviews and by the evaluation of a research and career development plan to be carried out at the extramural institution. Additionally, the sponsoring institution must demonstrate a commitment to the candidate by providing a minimum of 75% protected research time, space and resources needed to conduct the proposed research project and appropriate scientific mentoring. A plan for career development that will lead to research independence and the ability to successfully compete for research support is essential. In addition, 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. However, should the individual accept such a position, 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 pre-doctoral and post-doctoral 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, generally two months before the end of the mentored phase, 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 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):

Nathan Stinson, Jr., PhD, MD
Acting Scientific Director, Intramural Research Program
National Center on Minority Health and Health Disparities
6707 Democracy Boulevard, Suite 800
MSC 5465
Bethesda, MD 20892-5465
Telephone: (301) 594-8704
Fax: (301) 480-4049
E-mail: stinsonn@mail.nih.gov

Irene Dankwa-Mullan, MD, MPH
Acting 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) 594-8758
Fax: (301) 480-4049
E-mail: dankwamullani@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.

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-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

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

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

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

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

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

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

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

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