Part I Overview Information


Department of Health and Human Services

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

Components of Participating Organization
National Institute of Mental Health (NIMH), (http://www.nimh.nih.gov/)

Title: NIMH Career Transition Award for Intramural Investigators (K22)

Announcement Type
New

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

Program Announcement (PA) Number: PAR-09-246

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

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

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

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

Catalog of Federal Domestic Assistance Number
93.281

Key Dates
Release/Posted Date: July 31, 2009
Opening Date: September 12, 2009 (Earliest date an application may be submitted to Grants.gov).
Letters of Intent Receipt Date(s): See Section IV.3.A.1
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization). 
Application Due Date(s):  Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm  
AIDS Application Due Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS.
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward 
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional Information To Be Available Date (URL Activation Date): Not Applicable.
Expiration Date: September 8, 2012

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

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

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Career Objectives

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

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria

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

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 for Phase 2

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
 2. Peer Review Contact(s)
  3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Career Objectives

The National Institutes of Health (NIH) believes that the creativity and innovation of independent investigators at all career stages, plays an integral role in addressing our Nations biomedical, behavioral, and clinical research needs. The intent of the NIMH Career Transition (K22) Program is to assist NIMH Division of Intramural Research Programs (DIRP) investigators in achieving their research career goals.

The specific goals of this initiative are to: 1) support scientists conducting research in the NIMH intramural program who aim to transition to research positions in the extramural community where they intend to continue already successful biomedical careers as independent research scientists; and 2) foster the further development of these independent scientists and enable them to expand their potential to make significant contributions to their field of mental-health-related research.

The NIMHs intramural program has undergone a Blue Ribbon Panel evaluation and the Panels report on this evaluation is available at: http://www.nimh.nih.gov/about/director/updates/nimhbrpreport.pdf. In this report, the Blue Ribbon Panel applauded the numerous vital contributions that NIMH DIRP investigators are making to mental health research and the emphasis on translational research and focus on high risk-high yield projects that spur innovation. In order to maintain and even expand on these contributions and to seek further strength in the innovative research that is conducted, the DIRP must maintain a steady turnover of tenured and tenure-track investigators. In seeking to attract outstanding early-stage scientific talent to the intramural program, there is a need to foster and encourage the movement of DIRP investigators to the extramural community. To foster and aid that transition, this award will provide the resources for these investigators to bring their research programs to the extramural setting with fiscal support for up to 3 years to facilitate the acquisition of traditional R01 or R01-like research grant support from the NIH and other sources. This career transition program should enable intramural investigators to compete successfully for academic positions and make successful career changes.

Nature of the Career/Research Transition Opportunity

Each career transition award must be tailored to meet the individual needs of the Candidate.  The NIMH DIRP will sponsor Phase 1 of the award while Phase 2 will be sponsored by the extramural institution to which the investigator will transition.

The initial (Phase 1) application will be submitted while the investigator is in a tenured or tenure-track position in the NIMH intramural laboratories.  The Phase 1 application is the document that will be submitted for peer review for scientific merit, and the outcome of this review will be the primary determinant of whether the application will be supported. However, it is the Phase 2 application that will be awarded. If the candidate receives a fundable score after the review of Phase 1 of the application, she/he will be notified in writing of NIMHs commitment to make an award.  The candidate will then have a period of up to 18 months to identify a suitable position in research at a domestic research institution/organization and negotiate a start-up package.  As soon as negotiations between the candidate and the institution are complete, the Phase 2 application must be submitted.

Phase 2 of the K22 award will provide up to three years of support to conduct research as an independent scientist at an extramural sponsoring institution/organization to which the individual has been recruited, been offered and has accepted a research position. The sponsoring institution of the Phase 2 award must demonstrate a commitment to provide the environment, resources, and at least 6 person months (equivalent to 50% full-time professional effort) protected time for the candidate to perform the activities included in the proposed research. This support is to allow the individual to continue to work to maintain an independent research program and allow sufficient time for the candidate to prepare a competitive application for regular research grant support (R01). 

The K22 application is thus submitted in two phases in order to allow the candidate to have the project peer reviewed for scientific merit (Phase 1) before entering a research position at an extramural institution. After the review of the Phase 1 application, Phase 2 funding is NOT automatic and is subject to several conditions described in Section VI.4. Once the research position has been secured, NIMH will administratively review the Phase 2 application to ensure that all programmatic requirements are met prior to the award.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism of Support

This funding opportunity will use the NIH Career Transition (K22) award mechanism.  The Project Director/Principal Investigator (PD/PI) (also referred to as the Candidate) will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses the Just-In-Time information concepts (see SF424 (R&R) Application Guide). It also uses the non-modular budget format.

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

2. Funds Available

Because the nature and scope of the proposed K22 award 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 NIMH provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

2.A. Allowable Costs

Phase 1: An Intramural phase of up to 18 months, in which the candidate continues to conduct research within the NIMH intramural laboratory in which he/she works. Initially, the NIMH intramural program will continue to provide support through the NIMH intramural laboratory in which the candidates are conducting their research. There is no additional intramural budget provided by the K22 award.

Phase 2: An extramural phase of up to 3 years sponsored by the extramural institution/organization to which the individual has been recruited. The budget for the three-year extramural transition, Phase 2, may not exceed $300,000 direct costs per year in each of those years.

Salary: NIMH will provide salary and fringe benefits during Phase 2 of the K22 award. In this Phase 2, the NIMH will provide salary and commensurate fringe benefits for the award recipient for up to 6 person months (equivalent to 50% full-time professional effort), up to the level of the current NIH extramural salary cap. The institution may supplement the NIMH contribution up to a level that is consistent with the institution's salary scale. However, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case may PHS funds be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the award. Under expanded authorities, however, institutions may re-budget funds within the total costs awarded to cover salaries consistent with the institution's salary scale. The total salary, however, may not exceed the legislatively mandated salary cap. See http://grants.nih.gov/grants/policy/salcap_summary.htm. The total salary requested must be based on a full-time, 12-month staff appointment. It must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure. Fringe benefits, based on the sponsoring institutions rate and the percent of effort, are provided in addition to salary.

Research-Related Expenses: These include salaries for technical support, consultant costs, equipment, supplies, travel, and other research-related expenses. Salary for secretarial or administrative assistance is not allowed.

Facilities and Administrative (F&A) costs: These costs will be reimbursed at eight percent (8%) of modified total direct costs. .

NIH Grants Policy: NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted

3.  Transition to Phase 2 of the NIMH K22 Award

After the review of the Phase 1 application, funding is NOT automatic and is subject to several conditions described in Section VI.4.

The NIMH K22 award consists of up to three years of support and is based on a successful Phase 1 application review together with the fulfillment of the programmatic requirements set forth in the Phase 2 application. It is the successful submission of the Phase 2 application that will determine whether or not the K22 will be awarded. In each of the three years of the Phase 2 of the K22 award, the PI may request up to $300,000 (direct costs). The PI will have discretion to utilize the award as needed by the research described in the application. The facilities and administrative (F&A) costs will be limited to eight percent of modified total direct costs (exclusive of fees and equipment).

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

Eligible applicant institutions for Phase 2 include:

For Phase 1 of the award, only NIMH intramural laboratories are eligible to apply for this mechanism on behalf of intramural candidates.

Agencies of the federal government and foreign institutions are not eligible to apply for Phase 2. Only successful Phase 1 applicants may proceed to Phase 2.

1.B. Eligible Individuals

An NIMH Intramural Scientist with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with the NIMH intramural Program 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.

The application for Phase 1 of the award will be submitted on behalf of the candidate by the NIMH intramural program where the candidate is currently a tenured or tenure-track investigator. Successful Phase 1 awardees (note that there is no actual award for Phase 1) may submit an application for Phase 2 of the award through the extramural institution/organization at which the individual has been recruited, offered and has accepted an independent research position.

Project Director/Principal Investigator (PD/PI): The PD/PI is also referred to as the Candidate. This is any individual from the NIMH DIRP who is tenured or a tenure-track investigator and has been in that intramural position for at least 5 years. The candidate must also have the skills, knowledge, and resources necessary to carry out the proposed research.

Level of Effort: Phase 2 awardees must devote an effort of at least 6 calendar months (equivalent to 50% full-time professional effort) to mental health-related research. Funding will support salary and fringe benefits for up to 6 person months at the current NIH extramural salary cap. The sponsoring institution may supplement the NIMH contribution up to a level consistent with the institutions salary scale for individuals in comparable positions.

Citizenship and Residency: U.S. citizens or non-citizen nationals, or individuals lawfully admitted for permanent residence who have a currently valid Permanent Resident Card (USCIS Form I-551), or some other verification of legal admission as a permanent resident prior to the time of award, are eligible for this award.  Non-citizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S.  They are usually born in lands that are not states but are under U.S. sovereignty, jurisdiction, or administration.

Degree and Research: This award is intended for career scientists who conduct research within the NIMH intramural program. Eligible PD/PIs include NIMH DIRP investigators (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 degrees) who have been tenured or in tenure-track positions in the NIMH DIRP for at least 5 years.

See further details under Section III.3 - Other Special Eligibility Criteria.

Candidates are encouraged to consult with the appropriate staff person in Section VII - Agency Contacts, prior to submitting an application, to discuss eligibility and program requirements.

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

Number of Applications: Candidates may only have one individual Career Development Award application pending peer review at any time. 

Resubmission(s): See NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016).

Renewals: K22 awards are not renewable and may not be transferred to another individual.

3.A. Special Requirements

At the time of Phase 1 application submission (or any resubmissions), Candidates must be:

Individuals are NOT eligible to submit if they have already accepted an independent research faculty or tenure-track faculty position, or its equivalent, in academia, industry, or elsewhere.

NIMH K22 award recipients are expected to apply for NIH or other independent research grant support during the second year of the extramural phase of the K22 award.  Recipients of a K22 award may hold concurrent research support, and salary support from their K22 award and a competing NIH research project grant when recognized as a PD/PI or subproject Director of the research project grant.  See: NOT-OD-08-065.

Section IV. Application and Submission Information


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

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

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

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

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

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

2) Organizational/Institutional Registration in the eRA Commons

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

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

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

1. Request Application Information

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

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

For further assistance, contact GrantsInfo -- Telephone 301-435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PIs assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
SF424 (R&R) Detailed Budget
PHS398 Cover Letter
PHS398 Cover Page Supplement
PHS398 Career Development Award Supplemental Form
PHS398 Checklist

3. Submission Dates and Times

See Section IV.3.A for details.

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

3. A.1. Letter of Intent

A letter of intent is not required for this funding opportunity; however, candidates are encouraged to contact the scientific research/program contact (Section VII) prior to submitting an application, to discuss eligibility and program requirements.

3. B. Submitting an Application Electronically to the NIH

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

3. C. Application Processing

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

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

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

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

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

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

The incurrence of pre-award costs in anticipation of a 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 for Research Career Awards in the SF424 (R&R) Application Guide (See Part I.7.5).

PHS 398 Career Development Award Supplemental Form Component Sections: Items 2-5 (Candidate's Background, Career Goals and Objectives, Career Development/Training Activities During Award Period, and Training in the Responsible Conduct of Research) and Item 11 (Research Strategy) are limited to a combined 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.

Candidate Information, Career Development Plan, Research Plan

The Supplementary Instructions for Research Career Awards in the SF424 (R&R) Application Guide (See 7.5, PHS398 Career Development Award Supplemental Form) do not fully apply to the special needs of this career investigator award grant program (K22). Letters of Reference, information about the Career Development/Training Activities During Award Period, and Statements by Sponsor(s) are NOT REQUIRED. Therefore, in addition to the required information listed in the instructions for Research Career Awards, all applications MUST include the following information in the respective sections: 

Basic Administrative Data

For the Phase 1 of the application for an NIMH K22, complete ALL sections with the following modifications:

Biographical Sketch

Candidate

Career Goals and Objectives

Research Plan

The research plan should follow instructions outlined in PHS 398 Career Development Award Supplemental form, including sections on Specific Aims, Significance, Preliminary Studies for New Applications and Progress Reports for Renewal and Revision Applications, and Approach.

Statements of Support

Statement by Consultants, Contributors (All statements/letters should be appended to each other and uploaded as a single pdf document – Note that this section must be uploaded using item 7, Statements by Mentor, Co-Mentors, Consultants, Contributors):

Environment and Institutional Commitment to the Candidate

For Phase 1, describe how the intramural program has provided a strong commitment to the Candidate throughout his/her intramural career.  Describe the collaborations and consultations that have occurred throughout his/her career.

For Phase 2 applications, the sponsoring institution must document a strong, well-established research program in biomedical and/or behavioral research. The sponsoring institution must provide a detailed statement of institutional resources committed to supporting the Candidates research.  The sponsoring institution must also demonstrate a commitment to provide at least 6 person months (equivalent to 50% full-time professional effort) protected time for the candidate to perform the activities included in the proposed research. The Candidate and an appropriate official (Dean, Departmental Chair, or equivalent) of the sponsoring institution must satisfactorily describe the elements of a research program that will support a faculty members chances for a successful research career in an academic setting.

Training in the Responsible Conduct of Research

Applications must include a description of a plan for instruction in responsible conduct of research.  This section should document prior instruction in or the nature of the applicant’s participation in responsible conduct of research instruction (lecturer, discussion leader, etc.) during the applicant’s current career stage (including the date of last occurrence) and propose plans to participate in instruction in responsible conduct of research.  Such plans must address four instructional components, format, subject matter, duration of participation, and frequency of participation, as outlined and explained in NOT-OD-10-019.  The plan may include career stage-appropriate, 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.  Applications lacking a plan for participation 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.

Budget for the Entire Proposed Period of Support

Budget Component (Section 4.7): Since the budget will only be required for Phase 2 and will be prepared for a paper PHS398 process, budget figures should be entered only for Phase 2 of the award.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance, 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 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 where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible.  A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as 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, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

Section V. Application Review Information


1. Criteria

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

2. Review and Selection Process

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

As part of the initial merit review, all applications will:

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

Review Criteria

The goal of the NIMH Career Investigator (K22) is to facilitate an intramural investigators transition from the intramural program to an extramural faculty position. The scientific review group will address and consider each of these criteria in assigning the application's impact/priority score, weighting them as appropriate for each application. 

The following review criteria will be applied in Phase 1 of the review process:

Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the candidate to maintain a strong research program, in consideration of the following five core review criteria, and additional review criteria.  An application does not need to be strong in all categories to have a major impact.

Core Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each.

Candidate:

Career Goals and Objectives:

Research Plan:

Consultant(s), and Collaborator(s)

Environment and Institutional Commitment to the Candidate:

2. A. Additional Review Criteria

Additional Review Criteria. As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

Resubmission Applications (formerly revised/amended applications): When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Protections for Human Subjects: For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion of Women, Minorities, and Children: When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals: The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.

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

2. B. Additional Review Considerations

Additional Review Considerations. As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.

Training in the responsible conduct of research: Does the application include appropriate and adequate documentation in prior instruction, or plans for training in the responsible conduct of research?

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

2. C. Resource Sharing Plans

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

3. Anticipated Announcement and Award Dates

Not Applicable.

Section VI. Award Administration Information


1. Award Notices

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

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. 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.

There will not be a formal Notice of Award (NoA) associated with the NIH intramural phase of the K22, Phase 1. The awarding Institute will transmit to the successful applicant 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 extramural Phase 2 of the award.

A formal NoA will be provided as part of Phase 2 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 NIH to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

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

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

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

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

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

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

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

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

D. Changes in Research Program: A change in the specified scientific area of the research component requires prior approval of the NIMH.  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 NIMH staff to ensure that the plan remains within the overall scope of the original peer-reviewed research program.  If the new plan does not satisfy this requirement, staff could recommend that the award be terminated.

E. Change of Institution or Termination: Consultation with the applicable NIH funding Institute or Center program and/or grants management staff is strongly encouraged when either termination or a change of institution is being considered.

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

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

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

3. Reporting for Phase 2

NIMH 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 awardees progress will encompass the following:

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

4. Activating the Award in Phase 2 of the NIMH K22

If the Candidate receives a fundable score after the review of Phase I of the application, she/he will be notified in writing of NIMHs commitment to make an award.  The candidate will then have a period of up to 18 months to identify a suitable position at an extramural domestic research institution/organization and negotiate a start-up package.  As soon as negotiations between the Candidate and the institution are complete, the Phase 2 application must be submitted.

The Phase 2 application must include the following items:

1. A start-up package for an NIMH K22 MUST consist of:

1.     A description of the candidates position at the institution

2.     A description of the institutions research facilities, resources and the intellectual environment relevant to the candidates research program

3.     Funds and resources made available to the candidate to enable successful completion of the proposed research program

4.     Information on the sponsoring institutions commitment to the candidate, including effort

2. Cover Page of the PHS 398 application signed by the extramural institution.

3. Budget- As the Phase 2 application is not electronic, the PHS 398 budget forms are to be used. A detailed budget for the Initial Budget Period should be completed using form page 4 of the PHS 398.

Budget for Entire Proposed Period of Support - complete the categorical budget table on form page 5 in the PHS 398 for up to two additional years of support.

4. Budget Justification

Begin the budget justification on form page 5, using continuation pages as needed.

a.     List the name, role on project and percent effort for all project personnel (salaried or unsalaried) and provide a narrative justification for each person.

b.    Identify all consultants by name and organizational affiliation and describe the services to be performed. Provide letters of support from consultants.

c.     Provide a narrative justification for any major budget items, other than personnel, that are requested for the conduct of the project. Describe specific resources committed by the sponsoring institution to support the Candidates research.

d.    Facilities and administration (F&A) costs will be calculated at the time of the award at an eight percent of modified total direct costs (exclusive of tuition, fees, and equipment).

5. Environment and Institutional Commitment

The sponsoring institution must document a strong, well-established research program in biomedical and/or behavioral research. The sponsoring institution also must provide a detailed statement of institutional resources committed to supporting the Candidates research.  The Candidate and an appropriate official (Dean, Departmental Chair, or equivalent) of the sponsoring institution must satisfactorily describe the elements of a research program that will support a faculty members chances for a successful research career in an academic setting.

6. Training in the Responsible Conduct of Research

The application must include a description of a program to provide formal or informal instruction in scientific integrity or the responsible conduct of research. Although the NIH does not establish specific curricula or formal requirements, all programs are encouraged to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, policies regarding the use of human and animal subjects, and data management. Instructions are found in PHS 398 Career Development Award Supplemental form, and the NIH web site (http://www.nih.gov/sigs/bioethics/researchethics.html) provides additional guidance.

7. Checklist page

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, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Candidates should visit: http://www.nimh.nih.gov/research-funding/training/contacts-for-research-training-and-career-development-programs.shtml for information regarding the scientific/research contacts for this program.

2. Peer Review Contact(s):

David Armstrong, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6138, MSC 9606
Bethesda, MD 20892-9606
Telephone: (301) 443-3534
Email: armstrda@mail.nih.gov

3. Financial/Grants Management Contact(s):

Victoria Carper, MPA
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6118, MSC 9608
Bethesda, MD 20892-9608
Telephone: (301) 443-3538
Email: carpervictoria@mail.nih.gov

Section VIII. Other Information


Required Federal Citations

Vertebrate Animals: 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 (45CFR46) 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 IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the impact/priority score.

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

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

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

Inclusion of Women, Minorities, and Children: 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 new PHS Form 398; 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 Medicines 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 (DHHS) 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 DHHS 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. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

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/ in the following citations: No. 93.855, Immunology, Allergy, and Transplantation Research and No. 93.856, Microbiology and Infectious Diseases Research, 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 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 2 years to the research. For further information, please see: http://www.lrp.nih.gov/.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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