Part I Overview Information

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Department of Health and Human Services

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

Components of Participating Organizations
National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov)
 
Title: NHLBI Career Transition Award (K22)

Announcement Type
This is a reissue PAR-02-154 which was previously released August 26, 2002.

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

• September 17, 2007 - Expiration Date adjusted to accommodate recent changes to standing submission deadlines, per NOT-OD-07-093.

Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government, during FY 2007 the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. Therefore, once the transition is made for a specific grant mechanism, investigators and institutions will be required to submit applications using those mechanisms electronically using Grants.gov. For more information and an initial timeline, see http://era.nih.gov/ElectronicReceipt/. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html). Specific funding opportunity announcements will also clearly indicate if Grants.gov submission and the use of the SF424 (R&R) is required. Investigators should consult the NIH Forms and Applications Web site (http://grants.nih.gov/grants/forms.htm) for the most current information when preparing a grant application.

Program Announcement (PA) Number: PAR-07-317

Catalog of Federal Domestic Assistance Number(s)
93.233, 93.837, 93.838, 93.839

Key Dates
Release Date:  January 22, 2007
Letters Of Intent Receipt Date(s):  Not Applicable
Application Receipt Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date:  January 3, 2010 (now January 8, 2010 per NOT-OD-07-093)

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

• The NHLBI provides leadership for a national program in diseases of the heart, blood vessels, blood, and lungs, and in the use of blood and the management of blood resources.  It plans, conducts, fosters, and supports an integrated and coordinated program of research, investigations, clinical trials, and demonstration and education projects relating to the causes, prevention, methods of diagnosis, and treatment (including emergency medical treatment) of cardiovascular and cardiopulmonary diseases.
• The goal of the NHLBI K22 program is to provide highly qualified postdoctoral fellows with an opportunity to receive mentored research experience in the NHLBI Division of Intramural Research and then to provide them with bridge funding to facilitate the transition of their research programs as new investigators at extramural institutions.
• To achieve these objectives, the NHLBI Career Transition Award will support two phases of research:  an intramural phase and an extramural phase, for a total of four to five years of combined support.  Transition from the intramural phase of support to the extramural phase is not automatic.  Approval of the transition will be based on the success of the awardees research program as determined by an NHLBI progress review, which will take place no later than the end of the second year of the Intramural Support Phase, and the evaluation of a research plan to be carried out at the extramural institution. 
• The extramural institution must demonstrate a commitment to the candidate by providing protected research time and space needed to perform the proposed research.  Matching funds from the extramural institution for equipment and supplies (and if necessary, salary) are encouraged. 
• Awardees approved to proceed with the second phase of support will receive notification of approval in writing from the NHLBI.  An application from the extramural institution on behalf of the candidate will be required for the NHLBI to process the second phase of the K22.
• The NHLBI intramural research environment provides a unique opportunity for the training of new scientists who subsequently enter the extramural biomedical research community and become leaders in their fields of investigation.
• Support for the intramural phase is provided by the candidate’s laboratory or branch.  Total direct costs for the extramural phase cannot exceed $150,000 including fringe benefits per year in direct costs or $300,000 for the two-year period. The total project period for an application submitted in response to this PAR may not exceed five years.
• Five new awards per year are anticipated.
• Citizenship/Immigration Status:  Awardees appointed to this program must be citizens or non-citizen nationals of the United States or must have been lawfully admitted for permanent residence (i.e., in possession of a currently valid Alien Registration Receipt Card I-551, or some other legal verification of such status). Non-citizen nationals are generally persons born in possessions of the United States (i.e., American Samoa and Swains Island).  Individuals on temporary or student visas are not eligible.
• Any eligible individual with the skills and knowledge necessary to enter into the mentored training experience is invited to work with the Division of Intramural Research at NHLBI 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 programs.
• The candidate must have a research or a health-professional doctorate or its equivalent, and must have postdoctoral research experience, during which the potential for highly productive basic or clinical research was demonstrated. During the intramural phase of the award, the candidate will spend full time on research. During the subsequent two-year extramural phase, the candidate must spend a minimum of 75 percent of full-time professional effort conducting research and research career development activities.
• The required research experience may have been completed in an intramural NIH laboratory or at an extramural institution.  To obtain support for the extramural phase, candidates must have a formal tenure- track (or equivalent) offer in an extramural institution.
• For the Extramural phase of the K22 award, applications from the following institutions are eligible:
• For-profit and non-profit organizations
• Public or private institutions, such as universities, colleges, hospitals, and laboratories
• Units of State and local governments
• Eligible agencies of the Federal government
• Domestic institutions
• The application form is available at: http://grants.nih.gov/grants/funding/phs398/phs398.html.  Refer to Section III of PHS 398 application instructions.
• Telecommunications for the hearing impaired is available at: TTY 301-451-0088

Table of Contents

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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(s) 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. Address to Request Application Information
  2. Content and Form of Application Submission
  3. Submission Dates and Times
    A. Receipt and Review and Anticipated Start Dates
      1. Letter of Intent
    B. Sending an Application 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. Sharing Research Data
    D. Sharing Research Resources
  3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
  1. Award Notices
  2. Administrative and National Policy Requirements
    A. Evaluation
    B. Other Income
    C. Special Leave
    D. Changes in Research or Career Development Program
    E. Change of Institution or Termination 
  3. Award Criteria
  4. Reporting

Section VII. Agency Contact(s)
  1. Scientific/Research Contact(s)
  2. Financial/ Grants Management Contact(s)
 
Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

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Section I. Funding Opportunity Description

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1. Research Career Objectives

The overall goals of the National Heart, Lung, and Blood Institute (NHLBI) Career Transition Award (K22) program are to enable outstanding individuals to obtain a research training experience in the NHLBI Division of Intramural Research and to facilitate their successful transition to an extramural environment as independent researchers.

To achieve these objectives, the NHLBI Career Transition Award will support two phases of research. The award will provide up to three years of support for research training in an NHLBI intramural laboratory followed by two years of support for an independent research project in an extramural institution. It is anticipated that awardees will subsequently obtain research project grants such as the R01 to support the continuation of their work.

Transition from the intramural phase of support to the extramural phase is not automatic. Approval of the transition will be based on the success of the awardees research program as determined by an NHLBI progress review, which will take place no later than the end of the second year of the Intramural Support Phase, and the evaluation of a research plan to be carried out at the extramural institution.

The extramural institution must demonstrate a commitment to the candidate by providing protected research time and space needed to perform the proposed research.  Matching funds from the extramural institution for equipment and supplies (and if necessary, salary) are encouraged. 

Awardees approved to proceed with the second phase of support will receive notification of approval in writing from the NHLBI.  An application from the extramural institution on behalf of the candidate will be required for the NHLBI to process the second phase of the K22.

NHLBI DIVISION OF INTRAMURAL RESEARCH

The Division of Intramural Research conducts clinical research on the normal and pathophysiologic functioning of the cardiac, pulmonary, blood, and endocrine systems and basic research on normal and abnormal cellular behavior at the molecular level. The research activities of the laboratories and branches range from structural organic chemistry to cardiology. 

Major areas of interest include:

Mechanisms of gene regulation, viral-mediated gene transfer and gene therapy, the molecular basis of lipoprotein dysfunctions and the atherogenic process, the molecular basis of diseases of the alveolar structures of the lung and the design of new therapeutic modalities, the cellular and molecular events underlying ischemic heart disease and myocardial hypertrophy, biochemical events associated with aging and certain pathologic processes, molecular, structural, and developmental aspects of muscle and nonmuscle contractile systems, cell and organelle movement, molecular and cellular processes for the conversion of metabolic energy into useful work, mechanisms of cardiac development,  the molecular basis of transmembrane signaling, the pathophysiology of renal function at the cellular and molecular levels, the biochemistry of trace nutrients, enzyme kinetics, metabolic regulation, and protein chemistry, the cellular and molecular basis of toxicities induced by drugs and other foreign compounds, molecular immunology and cytokines, hematopoietic stem cell biology and bone marrow transplantation, pathophysiology of vascular diseases with emphasis on molecular genetic interventions, cardiac imaging through ultrasound and magnetic resonance imaging, as well as some aspects of cardiovascular devices, computational biophysics, and mass and optical spectroscopy. Animal medicine and surgery support is provided to both clinical and basic science by full-time NHLBI staff.  Potential candidates are urged to visit the web site for the Division of Intramural Research at NIH: http://dir.nhlbi.nih.gov/

Section II. Award Information

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1. Mechanism(s) of Support

This PAR will use the K22 award mechanism(s). Planning, direction, and execution of the candidate’s individual research and training program will be the responsibility of the candidate and his/her mentor.

This PAR uses the just-in-time budget concepts.  It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 

NHLBI will provide up to a maximum of 6 years combined K12 plus K22 support.

2. Funds Available

• The total period of support is four to five years (two or three years intramural, plus two years extramural).  Awards are not renewable.
• Support for the intramural phase is provided by the candidate’s laboratory or branch.
• Total direct costs for the extramural phase cannot exceed $150,000 including fringe benefits per year in direct costs or $300,000 for the two-year period.  (For information about specific allowable costs, please see ALLOWABLE COSTS under Section IV,6 – Other Submission Requirements).
• The NHLBI anticipates making five awards per year.
• For the anticipated start dates please see: http://grants.nih.gov/grants/funding/submissionschedule.htm 

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

NIH policy allows NIH mentored career development award recipients in the final two years of their award, to receive salary support from both their K award and an NIH research grant or subproject (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html). The K-award recipient must be the named Principal Investigator on a competing NIH research project grant (R01, R03, R15, R21, R34, etc.), or be the sub-project director on a competing multi-component research or center grant or cooperative agreement (P01, P50, U01, etc.). See the Notice for full details.

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

The Notice of Award will provide facilities and administrative costs based on 8% of modified total direct costs exclusive of tuition and fees.

Section III. Eligibility Information

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1. Eligible Applicants

1.A. Eligible Institutions

Phase I:  Only candidates to be supported by the NHLBI’s laboratory or branch are eligible for the mentored phase of the program.  Applicants must contact the NHLBI program staff (Section VII.) for guidance and additional information.

Phase 2:  Following Phase 1 support, eligible institutions for the independent phase of the program are:

For-profit organizations

• Non-profit organizations
• Public or private institutions, such as universities, colleges, hospitals, and laboratories 
• Eligible agencies of the Federal government including Nih intramural laboratories
• Domestic Institutions

1.B. Eligible Individuals

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any eligible individual with the skills and knowledge necessary to enter into the mentored training experience is invited to work with the Division of Intramural Research at NHLBI 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.

Awards under this program are limited to citizens or non-citizen nationals of the United States or to individuals who have been lawfully admitted for permanent residence in the United States (i.e., in possession of an Alien Registration Receipt Card or some other legal evidence of admission for permanent residence at the time of application).

The candidate must have a research or a health-professional doctorate or its equivalent, and must have postdoctoral research experience, during which the potential for highly productive basic or clinical research was demonstrated.  During the intramural phase of the award, the candidate will spend full time on research. During the subsequent two-year extramural phase, the candidate must spend a minimum of 75 percent of full-time professional effort conducting research and research career development activities.

The required research experience must be completed in an intramural NIH laboratory. To obtain support for the extramural phase, candidates must have a formal tenure- track (or equivalent) offer in an extramural institution.

Former principal investigators on NIH research project (R01), FIRST Awards (R29), SBIR/STTR awards, sub-projects of program project (P01) or center grants (P50), K08 awards, the Pathway to Independence Award (K99/R00), or the equivalent, are not eligible. Former principal investigators of an NIH Small Grant (R03) or Exploratory/ Development Grants (R21) remain eligible. A candidate for the NHLBI Career Transition Award may not concurrently apply for any other PHS award that duplicates the provisions of this award nor have another application pending award.

Minorities, women, and persons with disabilities are encouraged to apply:

A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see http://www.nsf.gov/sbe/srs/women/start.htm ). In addition, it is recognized that under-representation can vary from setting to setting and individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution are eligible for support under this program.

B. Individuals with disabilities, which are defined as those with a physical or mental impairment that substantially limits one or more major life activities.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria

Acceptance into the NHLBI Career Transition Award Program does not convey any commitment or intent of the NHLBI to consider the awardee for a tenure track position within the NHLBI. The NHLBI Career Transition Award is specifically intended to help develop scientists who will pursue their careers in the

extramural biomedical research community. However, the NHLBI K22 awardees are not explicitly precluded from applying for available tenure track positions at the NIH. If an awardee obtains an NIH position, the NHLBI Career Transition Award will be terminated.

Once a K22 award is made, the awardee is expected to remain with the NHLBI Intramural Program for at least 18 months.  Exceptions may be reviewed on a case-by-case basis.

SPECIAL REQUIREMENTS.

Phase 1

Mentor(s): The candidate must name a primary sponsor/mentor, who, together with the applicant is responsible for the planning, direction, and execution of the program. The mentor must be an investigator at the NHLBI who is recognized as an accomplished investigator in the proposed research area and have a track record of success in training research scientists. Candidates may also nominate co-mentors as appropriate to the goals of the program. Co-mentors may be NIH investigators or may be full-time faculty at an extramural institution. 

Phase 2

Sponsoring Extramural Institution:  To obtain support for phase 2, the phase 1 awardee must have a formal tenure-track (or equivalent) offer at the extramural institution.  The institution must demonstrate a commitment to the individual by providing protected research time and space needed to conduct the proposed research.

Section IV. Application and Submission Information

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1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format.  Applicants should use the currently approved version of the PHS 398.  Refer to Section IV of PHS 398 application instructions.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov

Telecommunications for the hearing impaired: TTY 301-451-0088.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

SUPPLEMENTARY INSTRUCTIONS for Career Development awards are located in the PHS 398, Section III, starting on page 44. Note that new and revised applications responding to this announcement must include at least three sealed letters of reference following the instructions and using the Career Development Award Reference Guidelines Format Page found in Part 1, Section III of the PHS 398 application.  These letters must be attached to the face page of the original application. Applications submitted without the required number of reference letters will be considered incomplete and will be returned without review.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A).

3.A. Receipt, Review and Anticipated Start Dates
Letters Of Intent Receipt Date(s):  Not Applicable
Application Receipt Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Additional Information To Be Available Date (Url Activation Date): Not applicable

3.A.1. Letter of Intent

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

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional copies of the application and all five collated sets of the appendix material must be sent to:

Chief, Review Branch
Division of Extramural Research Activities, NHLBI
Two Rockledge Center, Room 7214
6701 Rockledge Drive, MSC 7924
Bethesda, MD 20892-7924

Bethesda, MD 20817 (for express mail)

Telephone: (301) 435-0270
FAX:  301-480-0730
Email: nhlbichiefreviewbranch@nhlbi.nih.gov

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).  

3.C. Application Processing

Applications must be submitted on or before the application receipt/submission dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm. Upon receipt, applications will be evaluated for completeness by CSR and responsiveness by the NHLBI. Incomplete applications will not be reviewed.
 
The NIH will not accept any application in response to this funding opportunity 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. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.
 
Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at:  https://commons.era.nih.gov/commons/.

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. The Grants Policy Statement can be found at

http://grants.nih.gov/grants/policy/policy.htm. (See also Section VI.4. Reporting)

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

Concurrent Awards: Applicant must be aware of the NIH policies associated with other federally sponsored support (see: http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html).

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

NIH policy allows NIH mentored career development award recipients in the final two years of their award, to http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html). The K-award recipient must be the named Principal Investigator on a competing NIH research project grant (R01, R03, R15, R21, R34, etc.), or be the sub-project director on a competing multi-component research or center grant or cooperative agreement (P01, P50, U01, etc.). See the Notice for full details.

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

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).

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 K22 award 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.  Prior approval of the NIH funding component Institute or Center 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 at:

http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements

Individuals interested in applying for the NHLBI K22 Award must first identify a mentor within the Division of Intramural Research. The mentor should be in a position to offer a training experience that will enhance the candidate’s ability to conduct independent research. The NHLBI Office of Education can assist in identifying potential mentors within the Division of Intramural Research. Candidates wishing to take advantage of this

assistance should contact the Office of Education at direducation@nhlbi.nih.gov and submit a curriculum vitae and a brief pre-application description of his/her past training, research experience and research interests as well as future research plans. 

Senior DIR staff will review this application for an intramural training position and attempt to identify appropriate mentors in the applicant’s area of interest who are willing to provide research training and provide this information to the applicant.  The Office of Education may then arrange for the applicant to visit the NIH campus and meet with these investigators so that a prospective mentor can be selected.  Once a mentor is identified, the candidate and mentor must work together to complete the application.  The

application must include information regarding the candidate’s long-term career plan, a research training plan, including descriptions of proposed formal course work, a research plan, and the mentor’s statement of support. The application should specifically address how training to be received in the Division of Intramural Research will enhance the candidate’s ability to achieve their career goals of becoming an independent investigator. 

The application must address the following issues:

CANDIDATE

• The candidate’s commitment to a career in biomedical or behavioral research.
• The candidate’s potential to develop into a successful independent investigator.
• The candidate’s immediate and long-term career objectives, explaining how the research training under the award will contribute to their attainment.
• Letters of recommendation.  Three sealed letters of recommendation addressing the candidate’s potential for a research career must be included as part of the application.

RESEARCH PLAN

• Describe the research plan and the use of a basic or clinical approach to a biomedical or behavioral problem.  The candidate must describe the research plan as outlined in form PHS 398 including sections on the Specific Aims, Background and Significance, Progress Report/Preliminary Studies, Research Design and Methods.  The candidate should consult with the mentor(s) regarding the development of this section.
• Training in the Responsible Conduct of Research: Document prior instruction in or propose plans to receive instruction in the responsible conduct of research in terms of subject matter and duration of instruction. An award cannot be made if an application lacks this component. Applications not providing documentation of prior instruction in the responsible conduct of research must include a description of a program to receive formal or informal instruction in scientific integrity or the responsible conduct of research. Applications without plans for instruction in the responsible conduct of research will be considered incomplete and may be returned to the applicant without review. Although the NIH does not establish specific curricula or formal requirements, all programs are encouraged to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, policies regarding the use of human and animal subjects, and data management. Applicants must follow the application instructions found on page 49 of the PHS-398 application package and refer to the NIH web site (http://bioethics.od.nih.gov/) for additional guidance.

CAREER DEVELOPMENT PLAN

• Present a systematic plan that: (1) shows a logical progression from the candidate’s 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; (2) justifies the need for further career development to become an independent research investigator; (3) includes didactic and research components; and (4) utilizes the relevant research and educational resources of the institution. The didactic and research components must be designed to develop the necessary knowledge and research skills in scientific areas relevant to the candidate’s career goals.  The candidate and the mentor are jointly responsible for the preparation of the career development plan.  A timeline including a publication plan is strongly encouraged. 
• NHLBI strongly encourages K22 candidates to include an Advisory Committee composed of the candidate’s mentor(s) and two or three other senior faculty members. If the candidate does not propose an Advisory Committee, she/he should document which individuals are available to cover all areas of expertise that are required for the research plan and career development. An advisory committee may be formed to assist with the development of the program of study and to monitor the candidate’s progress through the career development program.
  

MENTOR TRAINING PLAN

• The candidate must name a primary sponsor (or mentor), who, together with the applicant, is responsible for the planning, direction, monitoring, and execution of the program. The candidate may also nominate co-mentors as appropriate to the goals of 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.
• The mentor should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of this award.
• 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 mentoring plan that describes the elements of research training planned for the candidate, including any formal course-work, the nature of the supervision and mentoring that will occur during the proposed award period; 3) a plan for transitioning the candidate from the mentored phase of their careers to the independent research investigator phase during the project period of the award; and 4) a plan for monitoring the candidate’s research, publications, and transition towards independence.
• Similar information must be provided by any co-mentor. If more than one mentor is proposed, the respective areas of expertise and responsibility of each should be described. Co-mentors should clearly describe how they will coordinate the mentoring of the candidate. If any of the co-mentors are not located at the sponsoring institution, a statement should be provided describing the mechanism(s) and frequency of communication with the candidate, including the frequency of personal meeting.
• The mentor must agree and provide a statement in the application documenting that the candidate will provide 100% of full-time professional effort to devote to research and related activities in order to achieve the research objectives of the award.
• Consultant(s)/Collaborator(s): Signed statements must be provided by each consultant/collaborator confirming their participation in the project and describing their specific roles. Collaborators and consultants generally do not need to provide their biographical sketches. However, information should be provided clearly documenting the appropriate expertise in the proposed areas of consulting/collaboration.

ENVIRONMENT AND INSTITUTIONAL COMMITMENT TO THE CANDIDATE

The NIH mentor must define and document a strong, well-established research and career development program related to the candidate's area of interest, including a high-quality research environment with staff capable of productive collaboration with the candidate. The NHLBI Scientific Director must provide a statement of commitment to the candidate's development into a productive, independent investigator and to meeting the requirements of this award. It should be clear that the commitment to the candidate is not contingent upon receipt of the K22 award.

In addition, the statement should:

• Describe the resources and facilities that will be available to the candidate.
• Describe how NHLBI environment is particularly suited for the development of the candidate's research career and the pursuit of the proposed research plan.
• Provide assurances that the candidate will be able to devote 100% professional effort to the development of a research program. The remaining effort should be devoted to activities related to the development of the candidate’s career as an independent clinician scientist, e.g. clinic responsibilities, teaching and administration, and/or additional research activities.

LETTERS OF REFERENCE

Include with the application three sealed letters of reference from well-established scientists addressing the above areas and any other evidence that the candidate has a high potential for becoming an independent investigator.  The mentor(s) may also submit letters of reference, but these letters will be considered independently of the three required reference letters.  Revised applications must include new letters of reference.  All sealed letters of reference should be attached to the face page of the application. 

BUDGET

The candidate should work with the potential NHLBI mentor to devise a budget for the Intramural Phase. Budget information for TOTAL DIRECT COSTS and cost justifications should be developed in accordance with the Budget Information instructions in form PHS 398.  For candidates who receive approval for transition to the Extramural Phase a budget will be submitted at that time as part of the form PHS 2590 (noncompeting application) as discussed below in EXTRAMURAL SUPPORT PHASE.

ALLOWABLE COSTS

Intramural Support Phase:

Support during the intramural phase will include a fellowship stipend, be based on the candidate’s years of postdoctoral experience, commensurate with the NHLBI intramural salary structure. Research expenses including personnel, consultants, equipment, supplies, and travel will be negotiated with the laboratory chief and will depend on the nature and scope of the research approved by peer review.

Extramural Support Phase:

1. Salary:  The NHLBI will provide salary for the award recipient of up to $75,000 per year plus commensurate fringe benefits for a minimum of 75 percent effort. Although a greater effort may be proposed, the maximum allowable salary is $75,000. 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. The institution may supplement the NHLBI 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.  Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the K22.  If the grant is subject to streamlined non-competing application procedures (SNAP), institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution’s salary scale provided they do not exceed the current legislated maximum salary.

2.  Research Support: The NHLBI will provide up to $75,000 per year for (a) research expenses, such as supplies, equipment, and technical personnel, (b) travel to research meetings or training, and (c) statistical services, including personnel and computer time. Total direct costs, including salary, fringe benefits and research support, may not exceed $150,000 per year.

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

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

Sharing Research Data

A data sharing plan is not required. 

Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this RFA should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Award Criteria.

Section V. Application Review Information

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1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

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

 2. Review and Selection Process

Upon receipt, applications will be reviewed for completeness by the CSR.

Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened by NHLBI in accordance with the review criteria stated below.

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

• Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score.
• Receive a written critique.
• Receive a second level of review by the National Heart, Lung, and Blood Institute Advisory Council.

Applications will compete for available funds with all other approved career development award 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 program priorities.
• Availability of funds.

REVIEW CRITERIA

The goals of NIH-supported career development programs are 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 the following criteria in assigning the application’s overall score, weighting them as appropriate for each application.

• Candidate
• Research Plan
• Career Development Plan
• Training in the Responsible Conduct of Research
• Mentor, Co-Mentor(s), Consultant(s), and Collaborator(s)
• Environment and Institutional Commitment to the Candidate

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

Intramural Support Phase

CANDIDATE:

• Commitment to an independent research career.
• Potential to develop as an outstanding scientist who will make significant contributions to the field.
• All candidates for this award must have had previous research experience. Quality and breadth of prior scientific training and experience including, where appropriate, the record of previous research support and publications.

RESEARCH PLAN:

• A sound research plan that is appropriate for the research training objectives of the candidate must be provided.
• Appropriateness of the research plan as a vehicle for enhancing research skills necessary to fulfill the objectives of the career development plan.
• Scientific and technical merit of the research question, design, and methodology, judged in the context of the candidate’s proposed career objectives.
• Adequacy of plans to obtain instruction in the responsible conduct of research.

CAREER DEVELOPMENT PLAN:

• Appropriateness of the proposed training experience to the candidate’s career development, considering the candidate’s goals and prior experience.

TRAINING IN THE RESPONSIBLE CONDUCT OF RESEARCH

• Quality and appropriateness of the proposed training or instruction in areas related to the responsible conduct of research.

STATEMENTS BY MENTOR/CO-MENTOR (S), CONSULTANTS, AND COLLABORATOR(S):

• Research qualifications and previous experience as a research supervisor.
• Adequacy of the nature and extent of supervision that will occur during the proposed award period.
• Appropriateness of the mentor’s research interests and qualifications to the career development needs of the candidate.
• Adequacy of the proposed mentoring plan.
• Strength of the mentor’s statement.

ENVIRONMENT AND INSTITUTIONAL COMMITMENT TO THE CANDIDATE

For Extramural Phase:

• Clear commitment of the sponsoring institution to ensure that a minimum of 75% of the candidate’s effort will be devoted directly to the research described in the application, with the remaining percent effort being devoted to an appropriate balance of research, teaching, administrative, and clinical responsibilities;
• Strength of the institutional commitment to the career development of the candidate;
• Adequacy of research facilities and training opportunities, including faculty capable of productive collaboration with the candidate;
• Quality and relevance of the environment for scientific and professional development of the candidate; and
• Assurance that the institution intends the candidate to be an integral part of its research program.

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score:

Resubmission Applications (formerly “revised/amended” applications): Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

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 Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, adequacy of the proposed protection will be assessed.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research career development plan. The priority score should not be affected by the evaluation of the budget.

Training in the Responsible Conduct of Research (RCR):  All trainees supported by this award must receive instruction in RCR.  (For more information on this provision, see the NIH Guide for Grants and Contracts, Volume 21, Number 43, November 27, 1992, see http://grants.nih.gov/grants/guide/notice-files/not92-236.html.)  Applications must include a description of a program to provide formal or informal instruction in scientific integrity or RCR. 

2.C. Sharing Research Data

A data sharing plan is not required. 

2.D. Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this RFA should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Award Criteria.

3. Anticipated Announcement and Award Dates

Not applicable.

Section VI. Award Administration Information

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1. Award Notices

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

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

For the intramural mentored phase at the NHLBI laboratory or branch, there will be no formal Notice of Award (NoA).   NHLBI will transmit an approval letter which will include the terms and conditions, and the requirements for the transition phase application for the subsequent independent support sponsored by an extramural institution.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for Phase 2 of the K22 award program. The NoA signed by the awarding Institute or Center grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

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 Also Section IV.5. Funding Restrictions.  

An electronic NGA will be transmitted to the applicant institution’s authorized official by the applicable NIH Grants Management Officer.

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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

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. Special Leave:

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 NHLBI 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 K22 award will continue during such leave.

Leave without award support may not exceed 12 months.  Such leave requires the prior written approval of the NHLBI 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.

Under unusual and pressing circumstances, an awardee may submit a written request to the awarding component requesting a reduction in professional effort below 75%.  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.  The nature of the circumstances requiring reduced effort might include medical conditions, disability, or pressing personal or family situations such as child or elder care.  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% effort as soon as possible.  During the period of reduced effort, the salary and other costs supported by the award will be reduced accordingly.

D. Changes in Research or Career Development Program: 

Consultation with the applicable NIH funding Institute or Center Program staff is strongly encouraged when a change in the approved career development program and/or research plan is being considered. See http://grants.nih.gov/grants/guide/contacts/pa-06-512_contacts.htm.

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 staff of the awarding NIH component institute to ensure that the plan remains within the scope of the original peer-reviewed research program.  If the new plan does not satisfy this requirement, staff could recommend that the award be terminated.

E. Change of Institution or Termination

Consultation with the applicable NHLBI program and/or grants management staff is strongly encouraged when either termination or a change of institution is being considered.  See http://grants.nih.gov/grants/guide/contacts/pa-06-512_contacts.htm.

A change of grantee request 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 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 grantee 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 sponsor 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.    Award Criteria

Facilities and Administrative costs, which were formerly called indirect costs, will be reimbursed at eight percent of modified total direct costs.  

The following will be considered in making funding decisions:

• Scientific and training merit of the proposed project as determined by peer review
• Availability of funds
• Relevance of program priorities

SELECTION PROCEDURES

Intramural Support Phase:

Following peer review, applications will be considered by a NHLBI Selection Committee (NSC) consisting of Senior Scientists from the NHLBI Intramural Program convened by the Division of Extramural Affairs, NHLBI.  Based on priority score ranking and programmatic needs, this committee will determine the final candidates to be selected.

ACTIVATING THE EXTRAMURAL SUPPORT PHASE

The candidate must receive approval in writing from the NHLBI and must be accepted by an extramural institution in order to activate the extramural support phase. The extramural institution will submit an application on behalf of the candidate for the extramural phase of support, using form PHS 2590, the noncompeting application. The application submitted by the awardee and the extramural institution for activation of the extramural phase of the program will be evaluated by NHLBI extramural staff for completeness and responsiveness to the program.

4. Reporting

Intramural Support Phase:

Each awardee will be evaluated for progress on an annual basis by the mentor, Laboratory Chief, and Scientific Director.

Extramural (Transition) Support Phase:

Awardees will be required to submit annually the PHS Non-Competing Grant Progress Report, Form 2590 non-competing continuation application for the final years of extramural support:  Note that the instructions for Research Career Development applications must be followed for this program.

http://grants.nih.gov/grants/funding/2590/2590.htm and financial statements as required in the NIH Grants Policy Statement.

The Progress Report must include Sections (a) through (f) as described on pages 10-14 in the general PHS form 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 encompass the following:

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

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

After the completion of this award, periodic updates on various aspects of 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 may be solicited from awardees.

Section VII. Agency Contacts

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We encourage your inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants.

1. Scientific/Research Contact:

Direct your questions about intramural programmatic issues to:

Herbert M. Geller, Ph.D.
Director, Office of Education
Division of Intramural Research
National Heart, Lung, and Blood Institute
10 Center Drive, Room 2N242, MSC 1754
Bethesda, MD  20892-1754
Telephone:  (301) 451-9440
FAX: (301) 594-8133
Email:  direducation@nhlbi.nih.gov 

Direct your questions about extramural programmatic issues to:

Chitra Krishnamurti, Ph.D.
Deputy Director, Office of Minority Health Affairs
National Heart, Lung, and Blood Institute, NIH 
6701 Rockledge Drive, Room 8186, MSC 7913
Bethesda, MD 20892-7913
Telephone: 301-451-5081
Fax: 301-480-0862
E.mail: krishnac@nhlbi.nih.gov

2. Peer Review Contacts:

Chief, Review Branch
Division of Extramural Research Activities, NHLBI
Two Rockledge Center, Room 7214
6701 Rockledge Drive, MSC 7924
Bethesda, MD 20892-7924
Telephone: (301) 435-0270
FAX:  301-480-0730
Email: nhlbichiefreviewbranch@nhlbi.nih.gov

3. Financial or Grants Management Contact:

Craig Bagdon, MPA
Grants Management Specialist
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, Room 7129, MSC 7926
Bethesda, MD 20892-7926
Telephone:  (301) 435-0480
FAX:  (301) 480-1948
Email: bagdonc@nhlbi.nih.gov

Section VIII. Other Information

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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 (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 priority score.

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 http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, 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.

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

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author’s final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH.  The author’s final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005.  The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies.  The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings.  Publications resulting from non-NIH supported research projects should not be submitted.

Additional information regarding the NIH Public Access Policy can be found at: http://publicaccess.nih.gov/

Additional information regarding the submission process can be found in the Public Access Policy Author’s Manual found at: http://publicaccess.nih.gov/publicaccess_manual.htm.

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.

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. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for 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 PAR 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 or Health Systems Agency review. 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 NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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.