Part I Overview Information

Department of Health and Human Services

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

Components of Participating Organizations
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), (http://www.niddk.nih.gov)
Office of Dietary Supplements (NIH/ODS), (http://ods.od.nih.gov)

Title: NIDDK Career Transition Award (K22) in Patient-Oriented Research 

Announcement Type
This Program Announcement (PA) is a re-issue of PAR-02-151 that was published in the NIH Guide on August 21, 2002.

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

Program Announcement (PA) Number: PAR-06-002

Catalog of Federal Domestic Assistance Number(s)
93.847, 93.848, 93.849

Key Dates
Release Date: October 13, 2005
Letter of Intent Receipt Dates: Not Required
Application Receipt Dates: Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm  
Peer Review Dates: Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm  
Council Review Dates: Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm  
Earliest Anticipated Start Dates: Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: November 2, 2008  (now January 8, 2009 per NOT-OD-07-093)

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

The NIDDK Career Transition Award, which uses the K22 mechanism, is a five-year mentored career development award whose goal is to attract outstanding physician-scientists to a clinical research training program that will endow them with the fundamental skills and investigational tools necessary for successful careers in patient-oriented research, and to facilitate their successful transition to an extramural environment as independent researchers.

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
  1. Research  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
  3. Reporting

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

Purpose

The overall aim of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Career Transition Award (K22) is to enable outstanding physician-scientists to obtain clinical research training experiences in the NIDDK Intramural Research Program and to facilitate their successful transition to an extramural environment as independent researchers. The award will provide up to three years of support for research training in an NIDDK intramural clinical laboratory followed by two years of support for an independent research program at an extramural institution.  The combined duration may not exceed five years.  It is anticipated that awardees will subsequently obtain research project grants, such as the R01, to support the continuation of their research.

NIDDK Intramural Research Program

The NIDDK intramural research environment provides a rich and unique opportunity for the training of postdoctoral fellows and early career scientists.  The Intramural Research Program at the NIDDK conducts basic biomedical, translational, and clinical research in the broad areas of diabetes, endocrinology, metabolism, transplantation, hepatitis, digestive and kidney diseases, hematopoiesis and hemoglobinopathies. 

Eligibility for, and receipt of this award is dependent upon  participation in the NIDDK Senior Clinical Research Fellowship Program (http://fellowshipoffice.niddk.nih.gov/scrfp/).  The three-year program is built on a solid foundation of the NIH-Duke University Clinical Research Program that offers didactic courses in research design and management, statistical analysis, and bioethics.  Enrollment in the NIH-Duke University Program is required of all participants in the NIDDK Senior Clinical Research Fellowship Program.  There is also direct, hands-on practical experience in clinical investigation through an individualized research project as part of the thesis requirement. The combined course of study ultimately leads to the awarding of a Masters Degree in Clinical Research.

Detailed information about programmatic areas in clinical, translational, and patient-oriented research as well as potential intramural NIDDK mentors, clinical protocols, and laboratories may be obtained at http://fellowshipoffice.niddk.nih.gov/scrfp/ and http://intramural.niddk.nih.gov.

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

Section II. Award Information

1. Mechanism(s) of Support
 
This Program Announcement will use the National Institutes of Health (NIH) Career Transition Award (K22) mechanism.  Responsibility for the planning, direction, and execution of the proposed project will reside with the applicant and the proposed mentor (co-mentor).

The total period of support is a maximum of five years (three years of intramural funding and two years of extramural funding).  Awards are not renewable.  Total direct costs for Phase I (intramural) are based on the candidate's experience; those for Phase II (extramural) may not exceed $175,000 per year (for salary and research support) plus fringe benefits (specific allowable costs are described below).

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

This funding opportunity uses just-in-time concepts.

2. Funds Available

Phase I (Intramural Support)

Support during the intramural phase will include a fellowship stipend as well as research and travel expenses based on the candidate's years of postdoctoral experience and commensurate with the NIDDK intramural salary structure.  

Phase II (Extramural Support)

Total direct costs for salary and research support may not exceed $175,000 per year plus fringe benefits. 

Activating the Extramural Support Phase

The candidate must receive approval in writing from the NIDDK and must be accepted by an extramural institution in a tenure-track or equivalent position 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 398  (http://grants.nih.gov/grants/funding/phs398/phs398.html.  The application should include a letter from the department or division chairman describing the institution's plan for career development and commitment to the candidate as described later in this announcement. The application submitted by the awardee and the extramural institution will be evaluated by NIDDK extramural staff for completeness and responsiveness to the program.

Total Funding

It is anticipated that between three and five new awards will be made each year through this announcement.  Start dates for the Award will generally be about nine months after the published application submission deadline.

Facilities and administrative costs: Facilities and administrative costs will be reimbursed at 8 percent of modified total direct costs, or at the actual facilities and administrative costs rate, whichever is less.

Because the nature and scope of the proposed research 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 IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Section III. Eligibility Information

 1. Eligible Applicants

1.A. Eligible Institutions

Phase I (Intramural Support)

Applications may only be submitted for research to be conducted within the NIDDK intramural program at the National Institutes of Health (Bethesda, MD or Phoenix, AZ sites).

Phase II (Extramural Funding)

Applications for transition to Phase II require that the extramural domestic institution falls within one or more of the following categories:

Foreign institutions are not eligible.
 
1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with a scientist within the Intramural Research Program at NIDDK 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.

Qualified physician-scientists from either the extramural community or the intramural research program at the NIH are encouraged to apply.  Applicants must have a medical degree or its equivalent, and must have some research experience, during which the potential for highly productive clinical research has been demonstrated.  Individuals who have had more than five years of postdoctoral research training at the time of application are not eligible to apply; however, clinical training does not count against the five-year rule limit.  The required research experience may have been completed in an intramural NIH laboratory or at an extramural institution.  During the intramural phase of the award, the candidate will spend full time on clinical research and coursework.  To obtain support for the extramural phase, candidates must be in a formal tenure-track (or equivalent) position in an extramural institution.  During the extramural phase, the candidate must spend a minimum of 75 percent of full-time professional effort conducting research and research career development activities.  Individuals from groups underrepresented in the sciences as well as individuals with disabilities are especially encouraged to apply.

Eligibility for this Award is predicated on acceptance and participation in the NIDDK Senior Clinical Research Fellowship Program.  These Fellowships are tailored to physician-scientists who have already completed two-three years of specialty training in Internal Medicine, Pediatrics, Surgery, Pathology, or Radiology or subspecialty training in either Adult or Pediatric Endocrinology and Metabolism, Gastroenterology and Hepatology, Nephrology, or Hematology and who are, therefore, Board-certified or Board-eligible.

At the time of award, candidates must be U.S. citizens or non-citizen nationals, or must have been lawfully admitted for permanent residence and possess an Alien Registration Receipt Card (I-551) or some other verification of legal admission as a permanent resident.  Non-citizen nationals are generally persons born in outlying possessions of the U.S. (i.e., American Samoa and Swains Island).  Individuals on temporary or student visas are not eligible.

Applicants should also be aware that they may be eligible to apply for up to five years of support via the Mentored Research Scientist Development Award (K01), the Mentored Clinical Scientist Development Award (K08), or the Mentored Patient-Oriented Research Career Development Award (K23).  Consultation with NIDDK Program Staff is strongly encouraged since receipt of a K22 Award will render the awardee ineligible for other K-series Awards.

Former principal investigators on NIH research projects (R01), FIRST Awards (R29), former NIH career development (K) awardees, SBIR/STTR awards, sub-projects of program projects (P01) or center grants (P50), or the equivalent, are not eligible. 

Former principal investigators of an NIH Small Grant (R03) or Exploratory/Development Grants (R21) remain eligible.  Consultation with NIDDK Program Staff is strongly encouraged. 

2. Cost Sharing or Matching
 
Cost sharing is not required.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria

Acceptance into the NIDDK Career Transition Award Program does not convey any commitment or intent of NIDDK to consider the awardee for a tenure-track position within the NIDDK.  The NIDDK Career Transition Award is specifically intended to help develop physician-scientists who will pursue their careers in the extramural biomedical research community.  However, NIDDK K22 awardees are not explicitly precluded from applying for available tenure-track positions at the NIH.  If an awardee obtains an NIH staff or tenure-track position, the NIDDK Career Transition Award will be terminated.

The award of Phase I, the intramural segment, does not necessarily guarantee the transition to Phase II, the extramural segment.  All awardees will be evaluated on a yearly basis.  The second annual scientific review will also constitute the formal review to determine suitability for transition to the extramural phase of the award.

Section IV. Application and Submission Information

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 must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

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

Individuals interested in applying for the NIDDK K22 Award should contact Dr. Louis Simchowitz, Director of the Fellowship Office, as early as conveniently possible.  This contact is recommended to initiate the process of identifying a mentor within the NIDDK Intramural Program, if one has not already been selected by the candidate, and to facilitate the application process. 

Louis Simchowitz, M.D., M.B.A.   
Director, Office of Fellow Recruitment and Career Development
Division of Intramural Research
National Institute of Diabetes and Digestive and Kidney Diseases
Building 12A, Room 3011
12 South Drive
Bethesda, MD  20892-5632
Telephone: 301-451-9808
FAX: 301-402-7461
Email: LS347F@nih.gov

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 Dun & Bradstreet 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.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.
 
The application must include information regarding the candidate's long-term research career plan, including descriptions of any proposed formal course work, a research training plan for the intramural phase, and the intramural mentor's statement of support.

Note that new and revised applications responding to this announcement must include at least three sealed letter of reference following the instructions and using the CDA Reference Guidelines Format Page found in Section III of the PHS 398 application 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
See Section IV.3.A for details.

3.A. Submission, Review and Anticipated Start Dates
 
Applications submitted in response to this program announcement will be accepted at the standard application deadlines for Research Career Awards (K series).

Letter of Intent Receipt Date: Not required.
Application Receipt Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date: http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Date: http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date: http://grants.nih.gov/grants/funding/submissionschedule.htm

3.A.1. Letter of Intent
A letter of intent is not required for this funding opportunity.

3.B. Sending an Application to the NIH
 
Applications must be prepared using the research grant application forms found in the PHS 398, using the Supplementary Instructions Part III section. 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)

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

At the time of submission, two additional copies of the application and all Appendix materials must be sent to:

Francisco O. Calvo, Ph.D.
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Rm. 752
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)

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. 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.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

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.

For Phase I - Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation 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 or competing continuation award.   For Phase II - Pre-Award Costs are allowable but only applicable if/ when the applicant obtains an extramural position at an eligible domestic institution (see Section III. A. Eligible Institutions) and the grantee, at its own risk, complies with this policy.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
 
A recent NIH policy change (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html) now allows K-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.  The K-award recipient must be the named Principal Investigator on a competing NIH research project grant (R01, R03, R15, R21, R34, etc.), or the recipient must be the sub-project director on a competing multi-component research or center grant or cooperative agreement (P01, P50, U01, etc.).

6. Other Submission Requirements

Using the Supplementary Instructions in the PHS 398 for Research Career Awards (Instructions, Part III), the following information must be included in the application:

Candidate

Career Development Plan

Applicants should describe their overall career goals and plans for continued scientific development in their research career, including the need for any courses, research techniques or methodology.  The career development plan must be tailored to particular needs and the ultimate goal of achieving independence as a researcher.

Letters of Reference

Three sealed letters of reference addressing the candidate's potential for a research career from well-established basic or clinical scientists must be included.  One letter should be from the most recent mentor in a postdoctoral research setting and one letter from the applicant's dissertation/thesis advisor, if applicable.  The letters should address the following issues:

Research Plan

Describe the research plan as outlined in Form PHS 398 including sections on the Specific Aims, Background and Significance, Preliminary Studies, Research Design and Methods.  The research plan should describe the use of a clinical approach to a biomedical question.  The scientific objectives and specific aims should describe research plans that are sufficient to justify the requested number of years of support during Phase I of the award (i.e., 1-3 years).  However, candidates are encouraged to make a convincing case that the proposed initial research plan being conducted during the initial phase will substantially enhance his/her capability to pursue a novel or promising approach to a particular research problem in the second phase of the award, which would encompass a total of five years.   Applicants should also provide future research directions for the extramural support phase, i.e., what are the broad research goals and potential avenues of research that would be enhanced by the specific research project. 

Mentor's Training Plan (Intramural Phase)

The intramural NIDDK mentor working in collaboration with the candidate must describe the elements of research training planned for the candidate, including formal course-work, and specify how the candidate's scientific independence and professional development will be promoted.

Statement(s) by Mentor(s):

Specific Instructions

Applicants for Phase I (Intramural phase) must follow the instructions for PHS 398(http://grants.nih.gov/grants/funding/phs398/phs398.pdf), and pay particular attention to Part III. Preparing an Individual Career Development Award (CDA) Application, “K” Series on pages 45-54.

Training in the Responsible Conduct of Research

Applications must include a description of a program to provide formal or informal instruction in scientific integrity or the responsible conduct of research. Applications without plans for instructions 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 regard 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://www.nih.gov/sigs/bioethics/researchethics.html) for additional guidance.

Budget for Intramural Phase

Cost justifications should be developed in accordance with the Budget instructions in form PHS 398.  Do not provide any dollar figures in the application.  The candidate should work with the proposed NIDDK mentor to devise a reasonable budget for the intramural phase.  The final budget will be negotiated when a selected candidate accepts a position and will be within the allowable costs specified above.

Budget for Extramural Phase

For candidates who receive approval for transition to the Extramural Phase, a budget will be submitted at that time as part of Form PHS 398.

Plan for Sharing Research Data
 Not Applicable

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information

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

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

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

Applications will compete for available funds with all other approved career development award applications. The following will be considered in making funding decisions:

Intramural Support Phase

The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application. 

The application does not need to be strong in all categories to be judged likely to have a major impact and thus to merit a high priority score. These criteria are listed in logical order and not in order of priority. 

Candidate

Letters of Reference

Career Development Plan

Research Plan

Statement(s) by Mentor(s):

Training in the Responsible Conduct of Research:

Extramural Support Phase

The following review criteria will be applied to the evaluation that will take place at the end of the second year of intramural support:

 2.A. Additional Review Criteria:

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

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, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

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

2.C. Sharing Research Data
Not Applicable 

2.D. Sharing Research Resources

NIH policy requires that grant awardee 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 funding opportunity 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 resource sharing plans with the awardee before recommending funding of an application. The final version of the 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. Reporting.

3. Anticipated Announcement and Award Dates
Not Applicable

Section VI. Award Administration Information

1. Award Notices

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).

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization.

(An NoA will not be issued for the Phase I ). The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 14 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.  

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the Notice of Grant Award. 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 begin requesting 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 for Phase II

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 that 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. Special Leave for Phase II

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 institute or center 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.) 

Leave without award support may not exceed 12 months.  Such leave requires the prior written approval of the NIH component institute 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 percent.  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 percent effort as soon as possible.  During the period of reduced effort, the salary and other costs supported by the award will be reduced accordingly.

D. Changes in Research or Career Development Program for Phase II

See http://grants.nih.gov/grants/guide/contacts/pa-05-143_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.  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, program staff could recommend that the award be terminated.

E. Change of Institution or Termination for Phase II

Consultation with the applicable NIH program staff is strongly encouraged when either a change of institution or termination is being considered, see http://grants.nih.gov/grants/guide/contacts/pa-05-143_contacts.htm.

A change of 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, and the qualifications of the proposed new mentor. 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 Principal Investigator 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 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 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 therefore, the effective date, and the right to appeal the decision. 

3. Reporting
 
Evaluation During Phase I (Intramural Support)

Each awardee will be evaluated for progress on an annual basis by the mentor, Laboratory or Branch Chief, and Scientific Director/Advisory Committee within the Intramural Research Program. 

The second annual scientific review will also constitute the formal review to determine suitability for transition to the extramural phase of the award.  Awardees will be expected to provide a description of their research and career progress within four months of the start of the third year of the award including:

Evaluation During Phase II (Extramural Funding)

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (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 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 progress will depend on the following:

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 will be solicited from awardees by NIDDK’s Intramural Fellowship Office.

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial reports as required in the NIH Grants Policy Statement.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Direct questions about the intramural phase, including the initial application process and opportunities for scientific research within the intramural program to:

Louis Simchowitz, M.D., M.B.A.
Director, Office of Fellow Recruitment and Career Development
Division of Intramural Research
National Institute of Diabetes and Digestive and Kidney Diseases
Building 12A, Room 3011
12 South Drive
Bethesda, MD  20892-5632
Telephone: 301-451-9808
Fax: 301-402-7461
E-mail: LS347F@nih.gov

Direct questions about the extramural phase to:

Judith Podskalny, Ph.D.
Program Director for Training and Career Development
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 667
Bethesda, MD  20892-5450
Telephone: 301-594-8876
Fax: 301-480-8300
E-mail: JP52S@nih.gov

Mary Frances Picciano, Ph.D.
Senior Nutrition Research Scientist
Office of Dietary Supplements
National Institutes of Health
6100 Executive Boulevard, Suite 3B01
Bethesda, MD  20892-7517
Telephone: 301-435-3608
Fax: 301-480-1845
E-mail: MP288D@nih.gov

2. Peer Review Contacts:

Francisco O. Calvo, Ph.D.
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 752
Bethesda, MD  20892-5452
Telephone: 301-594-8897
Fax: 301-480-3505
E-mail: FC15Y@nih.gov

3. Financial or Grants Management Contacts:

Mrs. Sharon Bourque
Grants Management Specialist
Grants Management Branch, DEA
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 719
Bethesda, MD  20892-5456
Telephone: 301-594-8846
Fax: 301-480-3504
E-mail: SB114M@nih.gov

Section VIII. Other Information

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

Human Subjects Protection:
Federal regulations (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.

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.

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.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://www.nih.gov/about/publicaccess/ and view the Policy or other Resources and Tools including the Authors' Manual (http://www.nih.gov/about/publicaccess/publicaccess_Manual.htm).

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 PA 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.

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


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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