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 (ODS) (http://dietary-supplements.info.nih.gov/)

Title: NIDDK Mentored Clinical Scientist Award to Promote Diversity in Health-Related Research (K08)

Announcement Type
New

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

• January 24, 2007 - See Notice (NOT-DK-08-007) Additional receipt date has been added and Salary Change.
• February 22, 2007 - See Notice (NOT-DK-07-005) The purpose of this notice is correct the November 2008 receipt date.

Request For Applications (RFA) Number: RFA-DK-06-015

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

Key Dates
Release Date: October 5, 2006
Letters of Intent Receipt Date(s): November 21, 2006; October 31, 2007; October 30, 2008
Application Receipt or Submission Date(s): December 20, 2006; November 28, 2007; March 27, 2008; November 26, 2008
Peer Review Date(s): February/March 2007; February/March 2008; February/March 2009
Council Review Date(s): May 2007; May 2008; May 2009
Earliest Anticipated Start Date(s): July 1, 2007; July 1, 2008; July 1, 2009
Expiration Date: November 27, 2008

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

• The Mentored Clinical Scientist Award to Promote Diversity in Health-Related Research is a three year career development award made to clinician scientists from diverse backgrounds including individuals from underrepresented racial and ethnic groups and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds. This award provides an opportunity for specialized study in NIDDK-relevant research areas for clinician scientists committed to a career in laboratory or clinical research.
• NIDDK recognizes the need to promote diversity in the health-related workforce by increasing the number of highly trained clinical researchers from diverse backgrounds with the cultural competence and sensitivity to conduct laboratory or clinical research in health disparities and who possess the ability to successfully recruit and retain a diversity of subjects into clinical research.
• Eligibility is limited to principal investigators from underrepresented racial/ethnic or disadvantaged backgrounds who have a health professional doctoral degree such as the M.D., D.O., D.D.S., D.V.M. , O.D., or equivalent degree AND a recently acquired ( less than 3 years) Master of Science in Clinical Research or Master of Public Health in a clinically relevant area. Detailed eligibility criteria are described in the full announcement (see Section III 1.B.)
• Candidates must be U.S. citizens or non-citizen nationals, or individuals lawfully admitted for permanent residence at the time of award and must have completed their clinical training, and, if applicable, subspecialty training prior to receiving an award. Additionally, candidates should have broad clinical training, must demonstrate competence in clinical activities, and must document a serious intent for a clinical research career in areas of relevance to the mission of NIDDK. High priority NIDDK clinical research areas include diabetes, obesity, nutrition-related disorders, hepatitis C, gallbladder disease, H. Pylori infection, sickle cell disease, kidney diseases, and complications from infection with HIV. ODS/NIH is interested in funding clinical research on dietary supplements with in the context of the mission of NIDDK.
• Individuals who graduated from the NIH-funded Clinical Research Education and Career Development (CRECD) program and received a Master’s degree from the program will receive special consideration.
• It is expected that candidates may have limited clinical research experience. As a result, significant emphasis is placed upon the mentor’s dedication and on-going commitment to the candidate’s career development and progression to independence. The candidate must be able to identify a mentor with extensive research experience in NIDDK mission-specific research areas. Planning, direction, and execution of the proposed career development program and research project will be the responsibility of the applicant and his/her mentors.
• The candidate must be willing to spend a minimum of 75% of full-time professional effort conducting research and research career development.
• This mechanism provides up to $75,000 for salary plus fringe benefits and up to $25,000 in research development support. The total project period for a career award will be 3 years. Applications requesting support for less than three years will not be accepted.
• The estimated annual funds (total costs) available for the program is expected to be $260,000 annually per cohort. The actual amount may vary, however, depending upon the response to the RFA, the availability of funds, and the quality, duration, and total costs of the applications.
• Two new awards per year are expected.
• Eligible institutions include:
  • For-profit organizations
  • Non-profit organizations;
  • Public or private institutions, such as universities, colleges, hospitals, and laboratories;
  • Domestic Institutions/organizations
  • Foreign institutions and organizations are not eligible to apply
• Each applicant may submit one application. An applicant may not concurrently apply for or have an award pending for another NIH career development award.
• The application form is available at: http://grants1.nih.gov/grants/funding/phs398/phs398.html Refer to Section IV, Application and Submission Information , for application instructions.
• Telecommunications for the hearing impaired is available at: TTY 301-451-5936

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research 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 Objectives

• The Healthy People 2010 report, which was released by the Department of Health and Human Services in 2000, is a national health promotion and disease prevention agenda that serves as a roadmap for improving the health of all people in the United States. A copy of Healthy People 2010 may be obtained from (http://www.healthypeople.gov/default.htm). The two overarching goals of Healthy People 2010 are to Increase quality and years of healthy life and to eliminate health disparities among U.S. populations.
• Many of the high-priority research areas for NIDDK such as diabetes, obesity, nutrition-related disorders, hepatitis C, gallbladder disease, H. Pylori infection, sickle cell disease, kidney diseases, and complications from infection with HIV are included in the leading health focus areas identified by Healthy People 2010.
• Although there has been some progress over the past five years in reducing racial and ethnic disparities, Blacks, Hispanics, American Indians, Alaska Natives, Asians, Native Hawaiians, and Other Pacific Islanders continue to bear a disproportionate burden of the many chronic and costly diseases affecting public health in the U.S. compared to non-Hispanic Whites.
• Inequalities in income and education also have a considerable impact on disparities in health status of the U.S. population. In general, population groups that suffer the worst health status also are those that have the lowest socio-economic status. As a result, ethnic minorities and individuals from disadvantaged backgrounds tend to experience a decreased life expectancy and quality of life.
• Clinical research studies designed and conducted with a significant number of participants from disparate U.S. populations are critically needed if the burden of disease on these populations is to be effectively decreased or eliminated. Although the proportion of ethnic minorities is increasing in the United States, and expected to exceed 50% by 2050, the majority of clinical research, however, does not have an adequately diverse participant population.
• Current data suggest a serious shortage of clinically trained racial and ethnic minority researchers and individuals from disadvantaged backgrounds who have the appropriate cultural sensitivity and perspectives needed to recruit and retain a diverse population into clinical research.
• It is notable that many minority clinicians and clinicians from disadvantaged backgrounds lacked the opportunity or resources early in their careers to gain the critical skills and experience necessary to conduct biomedical research.
• This has provided the impetus for the National Institutes of Health to expand opportunities for mentored research training of underrepresented racial and ethnic clinicians and clinicians from disadvantaged backgrounds as one approach to achieving the Healthy People 2010 goals of reducing health disparities and increasing the quality and years of healthy life for all Americans.
• The overall goal of this K08 program is to strengthen the capacity for clinical research focused on eliminating health disparities by increasing the number of clinician scientists from ethnically diverse and disadvantaged backgrounds in the health-related research workforce.

This K08 supports an intensive, mentored research experience that integrates didactic studies with laboratory or clinical research. Considerable emphasis is placed on the experience, training environment, and hands-on involvement and dedication of the mentor to the candidate’s development of independent research potential. Because of the focus on progression to independence, the prospective candidate should propose a closely mentored period of study and development consistent with previous training and her/his career development needs. For example, a candidate with limited experience in a given field of research may find a 3-year phased developmental program that includes a designated period of specialized didactic training followed by a research experience that is very closely monitored by the mentor necessary to insure that he/she will attain independence. A candidate with previous research experience and training may not require extensive additional didactic preparation, and a program that focuses primarily on an intensive, supervised research within NIDDK mission areas may be appropriate.

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

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the Mentored Clinical Scientist Development (K08) award mechanism(s). The candidate and his/her mentor will be solely responsible for planning, directing, and executing the proposed project on behalf of your institution. An unsuccessful application to this RFA for one receipt date may be submitted as an amended application on subsequent receipt dates for this RFA.

This funding opportunity 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). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

2. Funds Available

• NIDDK intends to commit approximately $260,000 dollars in FY 2007 in response to this RFA to support the career development of underrepresented clinician scientists engaged in research in NIDDK-relevant mission areas.

• The total project period for a career development award will be three years. Each award is non-renewable and non-transferable from one Principal Investigator to another.
• Two new awards per year are expected.
• The expected amount for individual awards is from $100,000 to $140,000.
• Funding beyond the first year of the grant is contingent upon satisfactory progress during the preceding year and the availability of funds.
• Although the financial plans of the NIDDK 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.

Allowable Costs

Salary Support: The NIH will provide salary and fringe benefits for the career award recipient. The total salary requested must be based on a full-time, 12-month staff appointment. It must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. If full-time 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure. For information regarding NIH policy on determining full-time professional effort for career awards, see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-056.html.

The NIDDK will provide up to $75,000 annually plus fringe benefits to offset the full-time salary requirements of the candidate. The institution may supplement the NIH salary contribution up to a level that is consistent with the institution's salary scale; however, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case may PHS funds be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the K08 award (e.g., patient care duties, administrative and teaching duties). Under expanded authorities, however, institutions may re-budget funds within the total costs awarded to cover salaries consistent with the institution's salary scale. The total salary, however, may not exceed the legislatively mandated salary cap. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-031.html

Mentored career award recipients in the last 2 years of career award support may reduce effort on the career award to a minimum of 50 percent and hold concurrent support from their career award and a competing NIH research grant if they are recognized as a PI or subproject Director of the research grant. This new policy can be found at the following web site: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html.

Ancillary Personnel Support: Salary support for ancillary personnel, such as mentors, secretaries, and administrative assistants, is not allowed.

Research Development Support: NIDDK will provide generally up to $25,000 per year for the following expenses: (a) tuition and fees related to career development; (b) research expenses, such as supplies, equipment, and under limited special circumstances, technical personnel; (c) travel to research meetings or training; (d) statistical and computational services including personnel and computer time. All expenses must be directly related to the proposed research career development program.

Facilities and Administrative costs: Facilities and administrative (F&A) costs, which were formerly called indirect costs, will be reimbursed at 8 percent of modified total direct costs. F&A costs requested by consortium participants are not included in the direct cost limitation (see NOT-OD-05-004).

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

• For-profit organizations
• Non-profit organizations
• Public or private institutions, such as universities, colleges, hospitals, and laboratories
• Domestic Institutions
• Foreign Institutions and organizations are not eligible to apply for this award.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research and career development activities is invited to work with his/her institution to develop an application for support.

The NIDDK recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences research workforce. The NIDDK expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation's capacity to address and eliminate health disparities.

There is abundant evidence that the biomedical and educational enterprise will directly benefit from broader inclusion. Recent studies have supported the argument that diversity enhances the quality of education in multiple settings. Studies have suggested that racially and culturally concordant scientific staff may be more successful in recruiting individuals from minority groups into clinical trials. Racially similar physician-patient dyads also may be related to greater patient satisfaction in ways that could enhance communication and participation in clinical research settings.

Accordingly, the NIDDK continues to encourage institutions to diversify their student and faculty populations and to identify candidates who will increase diversity on a national or institutional basis. Candidates eligible for support under the NIDDK Mentored Clinical Scientist Development Award to Promote Diversity in Health-Related Research (K08) award include underrepresented minorities and individuals from disadvantaged backgrounds.

A. Underrepresented minorities are defined as:

• Individuals from racial and ethnic groups that have been shown by the National Science Foundation (NSF) (see: http://www.nsf.gov/statistics/) to be underrepresented in health-related sciences on a national basis. These groups include African Americans, Hispanics, Native Americans, Alaska Natives, Natives of Hawaii and non-Asian Pacific Islanders.

B. Individuals from disadvantaged backgrounds are defined as:

• Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size; published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at http://aspe.hhs.gov/poverty/index.shtml. For individuals from low income backgrounds, the institution must be able to demonstrate that such candidates have qualified for Federal disadvantaged assistance or they have received any of the following student loans: Health Professions Student Loans (HPSL); Loans for Disadvantaged Student Program; or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.
• Individuals who come from a social, cultural, and/or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career.

This award provides an intensive, supervised research experience for clinicians from groups that are underrepresented in health-related science and, who are committed to pursuing laboratory or clinical research careers in areas of relevance to the mission of the NIDDK. Applicants must hold health professional degrees (e.g., M.D., D.D.S., D.O., O.D., D.V.M., N.D. [Doctor of Naturopathy], Pharm.D. degrees) or their equivalents AND a recently acquired (less than 3 years) Master of Science in Clinical Research or Master of Public Health in a clinically relevant area. Individuals who graduated from the NIH-funded Clinical Research Education and Career Development (CRECD) program and received a Master’s degree from the program will receive special consideration. Individuals with the Ph.D. or other doctoral degrees in clinical disciplines such as clinical psychology, nursing, clinical genetics, speech-language pathology, audiology, and rehabilitation are also eligible. Individuals holding the Ph.D. in a non-clinical discipline are not eligible to apply for this award.

Only U.S. citizens or non-citizen nationals, or an individual lawfully admitted for permanent residence who possesses an Alien Registration Receipt Card (I-151 or I-551), or some other verification of legal admission as a permanent resident prior to the time of award, are eligible for this award. Non-citizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S. They are usually born in lands that are not states, but are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible.

Ineligible individuals include current and former principal investigators on NIH research project (R01), FIRST Awards (R29), comparable career development awards (K01, K07, K23), sub-projects of program project (P01) or center grants (P50), and the equivalent. Former principal investigators of NIH Small Grants

(R03) or Exploratory/Developmental Grants (R21) remain eligible. A candidate for the K08 may not concurrently apply for or have an award pending for any other NIH career development award, a research project grant (R01), or any PHS award that duplicates any of the provisions of the K08 award.

K08 recipients are encouraged to apply for independent research grant support during the period of this award. K08 award recipients that obtain independent support during the K08 award period may hold concurrent research support, and under certain circumstances salary support from their career award and a competing NIH research project grant when recognized as a PI or subproject Director of the research project grant (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html).

Candidates for the award should have broad clinical training, must demonstrate competence in clinical activities, and must document a serious intent for a laboratory science or clinical research career in areas of relevance to the mission of the NIDDK. The NIDDK supports much of the clinical research on the diseases of internal medicine and related subspecialty fields as well as many basic science disciplines. The Institute's Mission encompasses the broad spectrum of metabolic diseases such as diabetes, inborn errors of metabolism, endocrine disorders, mineral metabolism, digestive diseases, nutrition, urology and renal disease, and hematology. Basic research studies include biochemistry, nutrition, pathology, histochemistry, chemistry, physical, chemical, and molecular biology, pharmacology, and toxicology. ODS/NIH has particular interests in the roles of dietary supplements in preventing and reducing risk factors for disease and in enhancing physical and mental health and performance. ODS is also interested in research exploring the biochemical and physiological effects of supplements and in improved scientific methods for the study of dietary supplements. Research on dietary supplements in the context of the mission of NIDDK is particularly encouraged.

Candidates may have variable academic/clinical appointments with little or no research experience or they may be experienced in basic research studies with a desire to re-direct their research focus and acquire new research capabilities in clinical research areas relevant to NIDDK’s mission. The candidates must be nominated by institutions on the basis of qualifications, interests, accomplishments, motivation, and potential for careers in laboratory science or clinical research. Evidence of the institution's commitment to the applicant's research development must be documented and this documentation should be tailored to the candidate's experience and needs.

Candidates must identify a suitable sponsor (i.e., mentor) with extensive research experience in a NIDDK mission-specific research area and who fully recognizes that many minority clinicians and clinicians from disadvantaged backgrounds may have lacked the opportunity or resources early in their careers to gain the critical skills and experience necessary to pursue successful careers in biomedical research. The mentor, with input from the candidate, will be responsible for the planning, direction, and execution of a tailored career development plan specific to the applicant's particular career development needs.

Candidates must be willing to devote a minimum of 75 percent professional effort conducting research and career development. The remaining 25 percent effort can be divided among other research, clinical, and teaching activities only if these activities are consistent with the goals of the K08 Award, i.e., the candidate’s development into an independent investigator in clinical research. The candidate must have a full-time appointment at the academic institution that is the applicant institution. Candidates who have U.S. Veterans Administration (VA) appointments may not consider part of the VA effort toward satisfying the full-time requirement at the applicant institution. Potential candidates should contact Program staff to discuss their eligibility prior to preparing an application.

Applicants must have completed postgraduate clinical training by the time of the award and hold an active professional license in the U.S.

2. Cost Sharing or Matching

Cost sharing and matching funds are 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

Environment: The applicant institution must have a well-established record of research career development activities and qualified research faculty to serve as mentors. The institution must demonstrate a commitment to the development of the candidate as a productive, independent investigator and allow the protected time needed by the applicant. The candidate, mentor, and institution must describe a career development program with an emphasis on laboratory or clinically-based research that maximizes the use of relevant research, and educational resources, and qualified faculty as mentors in basic research.

Program: Support will be provided for three consecutive 12-month awards. At least 75 percent of the recipient's full-time professional effort must be devoted to the goals of this award. For the purposes of this award, full-time professional effort provides protected time away from normal activities (e.g., standard patient care and on-call duties, and administrative and teaching assignments). The 75 percent effort includes activities consistent with development of the eligible candidate into a competitive independent physician-scientist (e.g., acquisition of laboratory skills and didactic courses). The remainder (25 percent effort) may be devoted to clinical, teaching, or other research pursuits as long as they are consistent with the objectives of the award (i.e., to train a clinical scientist who can compete successfully for NIH support). Both the didactic and the research phases of an award period must be designed to develop the necessary knowledge and research skills in scientific areas relevant to the career goals of the candidate.

Mentor(s): Each applicant must name a primary mentor who is responsible for the planning, direction, and execution of the program. The mentor should be recognized as an accomplished investigator, be sensitive to the individual needs of the minority candidate, have a proven record of success in training independent investigators, and demonstrate a strong, continuous commitment to the candidate throughout the period of training. Candidates may also nominate co-mentors in each area as appropriate to the goals of the program. Where feasible, women, individuals from underrepresented racial and ethnic groups, and individuals with disabilities should be involved as mentors to serve as role models. The mentors should have sufficient independent research support to absorb the costs of the proposed research project in excess of the allowable costs of this award.

Career Development: Because of the focus on progression to independence as researchers, candidates for the K08 should propose, together with their mentor, a period of study and career development consistent with the previous research and clinical experience of the candidate. As appropriate, sensitivity to the individual needs should be considered. For example, a candidate with limited experience in a given field of research may find a 3-year phased developmental program that includes a designated period of specialized didactic training followed by a research experience that is very closely monitored by the mentor necessary to insure that he/she will attain independence. A candidate with previous research experience and training may not require extensive additional didactic preparation, and a program that focuses primarily on an intensive, supervised research within NIDDK mission areas may be appropriate.

All programs must be tailored to meet the individual needs of each candidate to provide the opportunity for him/her to gain the skills and knowledge necessary to carry out high quality research. The candidate and the mentor are jointly responsible for the preparation of the plan for this program. The mentor must carefully monitor the candidate's progress throughout the career development program. If necessary, an advisory committee can be formed to assist with the development of a program that meets the candidate's needs. The didactic and research components of both phases must develop new knowledge and research skills in scientific areas relevant to the career goals of the candidate.

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) 710-0267, Email: [email protected].

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

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.

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.

Supplementary Instructions for Preparing an Individual Career Development Awards (CDA) are located in the PHS 398, Part I, starting on page 45.

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). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date(s): November 21, 2006; October 31, 2007; October 30, 2008
Application Receipt Date(s): December 20, 2006; November 28, 2007; March 27, 2008; November 27, 2008
Peer Review Date(s): February/March 2007; February/March 2008; February/March 2009
Council Review Date(s): May 2007; May 2008; May 2009
Earliest Anticipated Start Date(s): July 1, 2007; July 1, 2008; July 1, 2009

3.A.1. Letter of Intent

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

• Descriptive title of proposed research
• Name, address, and telephone number of the Principal Investigator
• Names of other key personnel
• Participating institutions
• Number and title of this funding opportunity

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

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

Francisco O. Calvo, Ph. D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Room 752
Bethesda, MD 20892-5452
(Courier use Zip 20817)
Telephone: (301) 594-8897
Fax: (301) 480-3505
E-mail: [email protected]

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application. 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 copies of the appendix material must be sent to:

Francisco O. Calvo, Ph. D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Room 752
Bethesda, MD 20892-5452
(Courier use Zip 20817)
Telephone: (301) 594-8897
Fax: (301) 480-3505
E-mail: [email protected]

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the NIDDK. Incomplete and non-responsive 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 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.

Citizenship: Only U.S. citizens or non-citizen nationals, or an individual lawfully admitted for permanent residence who possesses an Alien Registration Receipt Card (I-151 or I-551), or some other verification of legal admission as a permanent resident prior to the time of award, are eligible for this award. Non-citizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S. They are usually born in lands that are not states, but are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible.

Concurrent Awards: A candidate for the K08 may not concurrently apply for or have an award pending for any other NIH career development award, a research project grant (R01), or any PHS award that duplicates any of the provisions of the K08 award. K08 recipients are encouraged to apply for independent research grant support during the latter period of this award.K08 award recipients that obtain independent support during the K08 award period may hold concurrent research support, and under certain circumstances salary support from their career award and a competing NIH research project grant when recognized as a PI or subproject Director of the research project grant (see http://grants.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. The candidate is required to devote a minimum of 75 percent of full time effort to this program, and confirmation of the actual salary is required prior to the issuance of an award.

An NIH policy change (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html) now 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. The K-award recipient must be the named PI 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.).

Salary support for ancillary personnel such as mentors, secretaries, and administrative assistants, is not allowed.

Research Development Support: The research development support costs allowed for this program must be carefully justified annually and must be consistent with the stage of development of the candidate and the proportion of time to be spent in research or career development activities. Support for laboratory personnel/technicians will be permitted only under exceptional circumstances.

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 award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a competing 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.

6. Other Submission Requirements

In addition to the supplementary instructions for preparing an individual Career Development Award (CDA) in the PHS 398 (Part I, page 45), the application must address the following issues:

CANDIDATE

• Describe the candidate's research background and note any issues, as appropriate, that have already affected or may affect the pace of the candidate's career development.
• Describe the candidate's commitment to a laboratory or clinical research career in NIDDK relevant mission areas.
• Establish the candidate's potential to develop into an independent investigator.
• Describe immediate and long-term career objectives, explaining how the award will contribute to their attainment.
• Indicate a minimum commitment of at least 75 percent professional effort to research career development activities. The candidate should give a clear overall description of the types of research/research training activities that he/she will be involved in within the 75 percent effort versus an overall description of "other activities" and the percent effort involved.
• Letters of recommendation. Three sealed letters of recommendation addressing the candidate's potential for a clinical research career must be included as part of the application. Letters must be from individuals other than the designated mentor(s). For amended and new applications submitted for the November 28^th, 2007 and November 27^th 2008, receipt dates, the Letters of Reference will be submitted as a PDF document through Grants.gov.

CAREER DEVELOPMENT PLAN

• The career development plan should be a joint effort between the applicant and his/her mentor and carefully tailored to the candidate's needs demonstrating an appreciation, as appropriate, of the candidates cultural, socioeconomic and research background and the particulars required to develop the applicant into an independent clinical scientist engaged in laboratory or clinical research.
• Describe the career development plan incorporating consideration of the candidate's goals and prior experience. A systematic plan should be presented for obtaining the necessary laboratory or clinical research background to launch an independent research career.
• The plan must include justification for the need for a 3 year period of mentored research experience. Relatively junior candidates with little previous research experience may require a phased developmental period during which the first year(s) of the award are largely of a didactic nature followed by a period of intense, supervised research experience.
• Candidates with more experience at the time of the application may require a shorter development period that includes mostly additional basic research training with little or no didactic component.
• In any case, the career development plan must be tailored to the needs of the candidate and the ultimate goal of the candidate achieving independence as a researcher.

RESEARCH PLAN

The applicant must provide a description of the research plan and the use of a laboratory or clinical science approach to a biomedical or behavioral problem within the NIDDK Mission areas. The research plan must be described as outlined in PHS form 398 include the following sections:

• Specific Aims
• Background and Significance
• Progress Report/Preliminary Studies
• Research Design and Methods

The candidate should consult with the mentors regarding the development of this section.

MENTOR/CO-MENTOR(S) STATEMENT(S)

• The application must include a statement from the mentor(s) including information on their qualifications in the research area proposed by the candidate and previous experience as a research supervisor.
• The application must also include detailed information that describes the nature and extent of supervision that will occur during the proposed award period. This information must detail how the career plan will build upon the candidates unique research background, take into account the unique needs of the candidate, as appropriate, and enhance the candidate's research development toward independence.
• Similar information must be provided by any co-mentor. If more than one mentor is proposed, the respective areas of expertise and responsibility should be described.

ENVIRONMENT AND INSTITUTIONAL COMMITMENT

• The sponsoring institution must document a strong, well-established research and training program related to the candidate's area of interest and a high-quality research environment with staff capable of productive collaboration with the candidate.
• A signed statement from the candidate and an institutional official establishing the eligibility of the candidate for support under this program. The statement must include clearly presented information on citizenship as well as the nature of the candidate's circumstances, background, or characteristics that confer eligibility under this program.
• The sponsoring institution must provide a statement of commitment to the candidate's development into a productive independent investigator.
• The institutional statement also must commit to provision of release time from normal clinical, teaching or administrative duties necessary to meet the 75 percent effort requirement of this award. The institutional statement should clearly indicate activities included within the 75 percent protected time.

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 in clinical research. All sealed letters of reference should be attached to the face page of the application.

For amended and new applications submitted for the November 28^th, 2007 and November 27^th 2008, receipt dates, the Letters of Reference will be submitted as a PDF document through Grants.gov.

TRAINING IN THE RESPONSIBLE CONDUCT OF RESEARCH

Candidates must describe plans to receive instruction in the responsible conduct of research. These plans must detail the proposed subject matter, format, frequency, and duration of instruction. No award will be made if an application lacks this component.

BUDGET

The total direct costs requested must be consistent with this K08 program announcement and the award limits of the NIDDK. Budget requests must be provided according to the instructions in form PHS 398, Part I, Section III, Instructions for the Career Development Awards (CDA). The request for tuition and fees, travel, research development support, etc., must be justified and specified by category. Applicants seeking information on award limits should contact the NIDDK financial representative listed in Section VII (Agency Contacts).

Plan for Sharing Research Data

A plan for sharing research data is not required.

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

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

2. Review and Selection Process

Applications submitted for this funding opportunity will be assigned to a Scientific Review Group on the basis of established PHS referral guidelines.

Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit.

As part of the initial merit review, all applications:

• May 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.
• Will receive a written critique.
• Will receive a second level of review by an appropriate national advisory council or board.

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 applicant to becoming an independent research scientist.
• Relevance to the IC 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
• Career Development Plan
• Research 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.

Candidate

• The candidate’s professional background, scope of clinical training and competence in clinical activities
• Quality of the candidate’s academic and clinical record;
• Potential to develop as an independent and productive researcher;
• Commitment to a laboratory or clinical research career in an NIDDK-relevant mission area; and
• Quality of the letters of reference from three well-established scientists evaluating the candidate’s potential to pursue an independent research career.

Career Development Plan

• Appropriateness of the content, the phasing, and the proposed duration of the career development plan for achieving scientific independence;
• Consistency of the career development plan with the candidate's previous training and career goals; and
• Sensitivity of the plan to the candidate’s previous research experience and his/her career development needs.
• Likelihood that the plan will contribute substantially to the scientific development of the candidate leading to scientific independence.
• Plans for monitoring and evaluating the candidate’s research and career development progress.

Research Plan

Reviewers recognize that applicants will have variable amounts of previous research experience. Those with limited research experience are less likely to be able to prepare a research plan with the breadth and depth of that submitted by a more experienced investigator. All applications must include a fundamentally sound research plan but reviewers will consider the applicant's prior research experience in judging the level of detail provided.

• Scientific and technical merit of the research question, design and methodology;
• Relevance of the proposed research to the candidate's career objectives;
• Appropriateness of the research plan to the stage of research development and as a vehicle for developing the research skills described in the career development plan; and
• Adequacy of the plan's attention to children, gender and minority issues when human subjects are involved.

Mentor/Co-Mentor

• Appropriateness of mentor(s) research qualifications in the area of the proposed research;
• Quality and extent of mentor(s) proposed role in providing guidance and advice to the candidate;
• Evidence that the mentor is sensitive to the research experience and career development needs of the candidate and has participated in the development of the Career Development plan;
• Previous experience in fostering the development of researchers;
• History of research productivity, and
• Adequacy of the mentor’s independent research support to absorb excess costs above the allowable costs of the proposed research project.

Environment and Institutional Commitment

• Adequacy of research facilities and training opportunities;
• Quality and relevance of the environment for scientific and professional development of the candidate;
• Applicant institution's commitment to the scientific development of the candidate and assurances that the institution intends the candidate to be an integral part of its research program; and
• Applicant institution's commitment to an appropriate balance of research and clinical responsibilities including the level of 75 percent effort proposed by the candidate.

Training in the Responsible Conduct of Research

Is the quality of the proposed training or instruction in areas related to the responsible conduct of research appropriate and adequate?

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

A Data Sharing Plan is not required

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.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

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. Reporting.

3. Anticipated Announcement and Award Dates

Not applicable

Section VI. Award Administration Information

1. Award Notices

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

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

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 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:

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.

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.

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 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).

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 K08 award will continue during such leave.

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

Changes in Research or Career Development Program: Since 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. Awardees should contact NIDDK program staff listed in Section VII of this announcement in consideration of any proposed changes in the specified scientific area of the research component of the career development program.

Change of Institution: Consultation with the NIDDK program staff is strongly encouraged when a change of institution is being considered. See Section VII of this announcement for the NIDDK program staff contact information. 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 PI is moving to another eligible institution, career award support may be continued provided that the following conditions are met:

• 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;
• The awardee must establish in the transfer application that the specific aims of the research program to be conducted at the new institution are within the scope of the original peer-reviewed research program, and that a new mentor has been identified who has the appropriate research expertise and support to provide adequate guidance to the awardee and research support for the awardee's research program;
• All conditions of the award are met at the new institution; and
• The period of support requested is no more than the time remaining within the existing award period.

Change of Mentor: When a mentor at the grantee institution is to be replaced, the institution must submit a letter from the proposed mentor documenting the need for substitution, the new mentor's qualifications for supervising the program, and the level of support for the candidate's career development. The letter must also document that the specific aims of the research program will remain within the scope of the original peer reviewed research program. Staff within the NIH funding component will review the request, and will notify the grantee institution of the results of the evaluation.

Termination of Award: Consultation with the NIDDK program staff is strongly encouraged when termination of an award is being considered; see Section VII of this announcement for the NIDDK program staff contact information. 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

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 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.

Non-competing Grant Progress Report

Funding beyond the first year of the award is contingent upon satisfactory progress during the preceding year, as documented in the required Progress Report. 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. The Progress Report (PHS form 2590) will be evaluated based upon and should include:

• Demonstration of scientific progress toward the aims of the research. The candidate is responsible for a brief summary of the studies and results obtained during the prior funding period;
• A list of accomplishments such as publications, inventions, or project-generated resources should be provided;
• A brief explanation of plans to address the specific aims during the next year of support;
• A short description of candidate involvement in research/research training activities during the prior funding period in relation to the content, phasing and duration of the originally proposed Career Development Plan; this description must also address how weaknesses in the plan, as identified by peer reviewers in the Summary Statement, have been addressed and corrected;
• Formal coursework, informal instruction in specific research skills, scientific seminars, etc., and a concise description of the candidate's participation in "other activities" during the report period should be included;
• The percent effort devoted to research/research training and to other activities, respectively, must be clearly stated;
• Similar activities for the next year of support with a clear indication of percent effort devoted to research/research training and other activities respectively should be described; and
• The sponsor's report should briefly detail the candidate's progress and performance during the prior year of support in terms of development into an independent investigator. Progress should be delineated in relation to the originally proposed Career Development Plan and Research Plan and, should describe how weaknesses in these plans as identified by peer reviewers in the Summary Statement have been addressed and corrected. The sponsor should clearly substantiate that the candidate has at least 75 percent protected time toward research/research training.

A final Progress Report, Invention Statement, and Financial Status Report are required when an award is relinquished, when a recipient changes institutions, or when an award is terminated.

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:

Frances E. Ferguson, M.D., MPH
Program Director, Office of Minority Health Research Coordination
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
6707 Democracy Boulevard, Room 648A
Bethesda, MD 20892-5454
Telephone: (301) 594-9652
FAX: (301) 594-9358
Email: [email protected]

2. Peer Review Contacts:

Francisco O. Calvo, Ph. D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Room 752
Bethesda, MD 20892-5452
(Courier use Zip 20817)
Telephone: (301) 594-8897
Fax: (301) 480-3505
E-mail: [email protected]

3. Financial or Grants Management Contacts:

Carolyn Kofa
Grants Management Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 727
Bethesda, MD 20892-5456
Telephone: (301) 594-7687
FAX: (301)480-3504
Email: [email protected]

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://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/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. 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 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.

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