Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Funding Opportunity Title

Career Development Programs in Diabetes Research for Pediatric Endocrinologists (K12)

Activity Code

K12 Physician Scientist Award (Program) (PSA)

Announcement Type

Reissue of RFA-DK-11-006

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-DK-15-006

Companion Funding Opportunity

None

Number of Applications

Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.847

Funding Opportunity Purpose

To foster the development of a diverse and highly trained workforce of pediatric endocrinologists to assume leadership roles related to the Nation’s biomedical and behavioral research efforts in the area of pediatric diabetes, This Funding Opportunity Announcement (FOA) invites applications for institutional career development programs in diabetes research for pediatric endocrinologists.  The NIDDK will award physician scientist career development program (K12) grants to eligible institutions to provide a program to prepare pediatricians, selected by the institution, for careers in pediatric endocrinology research related to diabetes.

Key Dates
Posted Date

April 21, 2015

Open Date (Earliest Submission Date)

November 2, 2015

Letter of Intent Due Date(s)

November 2, 2015

Application Due Date(s)

December 2, 2015, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.  No late applications will be accepted for this Funding Opportunity Announcement.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

March/April 2016

Advisory Council Review

May 2016

Earliest Start Date

July 2016

Expiration Date

December 3, 2015

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide including the Supplemental Instructions to the SF424 (R&R) for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement
Section I. Funding Opportunity Description

The overall goal of the NIH Research Career Development programs is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation’s biomedical, behavioral, and clinical research needs.  More information about Career programs may be found at the NIH Extramural Training Mechanisms website.

This FOA encourages applications from organizations that propose creative and innovative institutional career development programs for pediatric endocrinologists in research related to diabetes.

The proposed institutional research career development program may complement other, ongoing research training and career development programs at the applicant institution, but the proposed career development experiences must be distinct from those career development programs currently receiving Federal support.

Pediatric diabetes, including type 1 diabetes, type 2 diabetes (formerly almost exclusively a disease of adults that is now being reported with increasing frequency in children), and other rarer forms of diabetes in youth, subjects children to the risk of devastating complications over time, including accelerated cardiovascular disease, kidney failure, blindness, neuropathy, and amputation. Management of diabetes in children is particularly arduous, with suboptimal glycemic control increasing the risk of long-term complications and intensive therapy to optimize glucose levels associated with substantial risk of hypoglycemia. Effective therapy for pediatric diabetes requires an exceptional level of effort from the children, their families, and their healthcare providers. These extraordinary clinical care demands make it particularly challenging for pediatric endocrinologists involved in diabetes care to pursue research careers. Although there has been considerable recent progress in understanding the etiology and pathogenesis of pediatric diabetes and in developing improved therapies, we still cannot prevent or cure these disorders. Thus, it is imperative to enhance the diabetes research training and career development of pediatric endocrinologists to create the cadre of skilled investigators needed to build upon the foundation of current basic and clinical knowledge and to develop new approaches to the treatment, prevention and cure of pediatric diabetes.

The NIDDK intends to provide support for career development programs in pediatric diabetes at institutions that have environments, mentors and programs that will make them particularly effective in enhancing the number of independent investigators contributing to research in pediatric diabetes.

To foster the development of a diverse and highly trained workforce of pediatric endocrinologists to assume leadership roles related to the Nation’s biomedical and behavioral research efforts in the area of pediatric diabetes, the NIDDK invites applications for the establishment of institutional career development programs in diabetes research for pediatric endocrinologists. The NIDDK will award physician scientist career development program (K12) grants to eligible institutions to provide an integrated program to prepare pediatricians, selected by the institution, for careers in pediatric endocrinology research related to diabetes.  In combination with existing training programs and grants, these awards will establish multilevel (fellow and junior faculty) training and career development programs. Attracting, training and retaining the best and brightest new researchers to the study of diabetes are included in the recommendations of the NIH Diabetes Strategic Plan.

Physician scientist career development programs (K12) assist in the transition of clinical investigators to an independent research career. These institutional mentored research career development awards will allow participants up to three years of supervised research experience that may combine didactic studies with laboratory or patient-oriented research.

The K12 programs will provide an opportunity for research career development after the clinical fellowship years to facilitate the transition to a fully-trained independent investigator.  Moreover, the institutions receiving these awards are encouraged to interact with one another and to provide opportunities for career development pathways involving more than one institution.

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Renewal

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIDDK intends to commit approximately $2.5 million in support of 4-5 awards in FY 2016.  Although the financial plans of the NIDDK provide full support for the first two years of this program, awards pursuant to this FOA, particularly in years 3 to 5 of the awards, are contingent upon the availability of funds.

Award Budget

Application budgets are not limited, but need to reflect the actual needs of the proposed project.

Award Project Period

The maximum project period is 5 years.

Other Award Budget Information
Personnel Costs

Individuals designing, directing, and implementing the career development program may request salary and fringe benefits appropriate for the person months devoted to the program.  Salary for the PD/PI will be provided for levels of effort up to 1.2 person months (10% of full-time professional effort).  For applications with multiple PD/PIs, salary support for the combined levels of effort of the PD/PIs will be provided up to 1.2 person months.  Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap.  If mentoring interactions and other activities with scholars are considered a regular part of an individual's academic duties, then mentoring and other interactions with scholars are non-reimbursable from grant funds.

Limited (typically no more than 1.2 person months) program-related administrative and clerical salary costs associated distinctly with the program that are not normally provided by the applicant organization may be direct charges to the grant only when they are in accordance with applicable cost principles.  For institutions covered by Uniform Guidance 45 CFR Part 75, this type of training program may qualify as a “major project” where administrative salaries are allowable as a direct cost.  When specifically identified and justified, these expenses must be itemized in Sections A and B, as appropriate, of the R&R Budget.

Items that may NOT be supported with K12 grant funds include:

Salaries and fringe benefits for the program mentors.

Direct support of the mentors' laboratories beyond those expenses directly attributable to the scholar's project.

Salary and support for central institutional administrative personnel (e.g., budget officers, grant assistants, and building maintenance personnel), which are usually paid from institutional overhead charges.

Salary and support for administrative activities such as institutional public relations or health and educational services. 

Scholar Costs

Scholars are those individuals who benefit from the proposed activities and experiences involved in the career development program. Scholar costs must be justified as specifically required for the proposed career development program and based on institutional policies for salaries paid to individuals in similar positions, regardless of the source of funds.  Salary support of up to $90,000 each year, plus the appropriate fringe benefits, may be requested for each K12 scholar. The total salary requested must be based on a full-time, 12-month staff appointment and requires Scholars to devote a minimum of 9 person months (equivalent to 75 percent) of full-time professional effort toward health-related research and career development activities, with the remaining effort being devoted to activities related to the development of a successful career as a physician-scientist.  The institution may supplement the NIDDK contribution; however, the 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 salary supplementation may not require extra duties or responsibilities that would interfere with the purpose of this award.  The applicant institution may request support for up to three scholars in each budget period.

Scholar Research and Development Support: Up to $50,000 per scholar may be requested for the following types of expenses: (a) research supplies, small equipment and technical personnel; (b) tuition and fees related to didactic courses or career development workshops; (c) travel to research meetings or training; and, (d) statistical and computational services including personnel and computer time. All expenses must be directly related to the proposed research career development program; they cannot be pooled and used for other programs unrelated or indirectly related to the research activities of individual Scholars.

Other Program Related Expenses

Consultant costs, equipment, supplies, travel for key persons, and other program-related expenses may be included in the proposed budget.  These expenses must be justified as specifically required by the proposed program and must not duplicate items generally available at the applicant institution.

These expenses must be itemized in the proposed budget.

Items that may NOT be supported with K12 funds include:

Travel of the PD/PI, Program Director, or program faculty/mentors to scientific meetings.

Patient care costs such as inpatient bed days or outpatient visits, except for clinical laboratory analyses essential for the research of the Scholars.

Alterations and renovations.

Indirect Costs

Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees, consortium costs in excess of $25,000, and expenditures for equipment), rather than on the basis of a negotiated rate agreement.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

Higher Education Institutions

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

    • Hispanic-serving Institutions
    • Historically Black Colleges and Universities (HBCUs)
    • Tribally Controlled Colleges and Universities (TCCUs)
    • Alaska Native and Native Hawaiian Serving Institutions
    • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

Governments

  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)
  • U.S. Territory or Possession

Other

  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations

The sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program..

The applicant institution must have a strong and high quality program in diabetes research and must have the requisite faculty and facilities on site to conduct the proposed institutional program. In many cases, it is anticipated that the proposed program will complement other ongoing career development programs occurring at the applicant institution and that a substantial number of program faculty will have active research projects in which participating scholars may gain relevant experiences consistent with their research interests and goals.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

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

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

The PD/PI should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program.  It is expected that the PD/PI will be a pediatric endocrinologist with a strong record in biomedical research and mentoring.  If the PD/PI is not a pediatric diabetologist, a senior investigator with expertise in pediatric diabetes research must be included as a part of the leadership in the K12 program.  The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required.  The PD/PI at the institution will be responsible for the appointment of the K12 scholars and for the overall direction, management and administration of the program.  In addition to the day to day administration of the program, the PD/PI will also be responsible for appointing members of the Advisory Committee and using their recommendations to determine the appropriate allotment of funds for research and career development.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility
Number of Applications

 Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).
Preceptors/Mentors

Program faculty should have strong records as researchers, including recent publications and successful competition for research support in the area of the proposed career development program.  Program faculty should also have a record of research training, including successful, former trainees/scholars who have established productive careers relevant to the NIH mission.  Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as mentors.

The mentors should be recognized as accomplished investigators in the proposed research area, which should be directly relevant to diabetes, and have a track record of success in training and mentoring individuals who are now independent investigators in diabetes.  The mentors should have sufficient independent research support to cover the costs of the proposed research projects in excess of the allowable costs of this award.  

Participants/Scholars

Scholars to be supported by the institutional career development program must be at the career level for which the planned program is intended.  Scholars are expected to devote a minimum of 9 person-months (75% of full-time professional effort) during the appointment on the K12 award.

Details on citizenship requirements are available in the NIH Grants Policy Statement.

Scholars appointed to the K12 program must have the opportunity to carry out supervised basic or clinical biomedical or behavioral research relevant to diabetes with the primary objective of developing or extending their research skills and knowledge in preparation for an independent research career in pediatric diabetes.

Scholars appointed to the K12 career development program must 1) have full-time appointments at the grantee institution, and 2) be physician scientists who have completed their pediatric endocrinology fellowship training.  NIDDK anticipates that all physician scientist scholars appointed to the K12 career development program will be either board-certified or board eligible.  The scholars may spend up to three years in the K12 career development program, but are strongly encouraged to apply for either an individual Mentored Clinical Scientist Research Career Development Award (K08; https://grants.nih.gov/grants/guide/pa-files/PA-14-046.html) or an individual Mentored Patient-Oriented Research Career Development Award (K23; https://grants.nih.gov/grants/guide/pa-files/PA-14-049.html) after 1-2 years of support through the K12 program.  Through NIDDK, the physician scientist scholars may receive up to a total of 6 years of combined support through K12/KL2 and K08/K23 grant mechanisms.

At the time of initial K12 appointment, scholars may have no more than six years of research or research training experience beyond their last doctoral degree.  Time spent in clinical training is not considered postdoctoral research training.  Mid-career and senior faculty are not eligible to be appointed as scholars.

Individuals who are or were PD/PIs on NIH Small Research Grants (i.e., R03s) or Exploratory/Developmental Research Grants (i.e., R21s) are eligible for K12 support providing they do not have more than 6 years of postdoctoral research experience and not more than 10 years has elapsed since the granting of the terminal doctoral degree as described above.  However, individuals who are or were PDs/PIs on NIH research projects grants (R01), sub-projects of program projects (P01) or Center grants (P50) or the equivalent are not eligible for appointment under this K12 program.  Individuals who have been previously supported by NIH or non-NIH career development awards are not eligible.  Scholars may not concurrently hold any other PHS award that duplicates the provisions of this award.

Section IV. Application and Submission Information
1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Letter of Intent

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.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

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 (NIDDK)
6707 Democracy Boulevard, Room 752
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone: 301-594-8897
Email: calvof@mail.nih.gov

Page Limitations

All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA). 

SF424(R&R) Project/Performance Site Locations

Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA).

SF424 (R&R) Other Project Information

Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA), with the following additional modifications:

Substitute the term “scholars” for all references to “trainees” in the SF424 (R&R) Application Guide, and substitute the term “career development” for all references to “training” in the SF424 (R&R) Application Guide.

Project Summary/Abstract. Provide an abstract of the entire application. Include the objectives, rationale and design of the research career development program, as well as key activities in the training plan. Indicate the planned duration of appointments, the projected number of scholars including their levels (i.e., , postdoctoral, junior faculty), and intended scholar outcomes.

Other Attachments.  A plan must be provided for the appointment of an Advisory Committee to monitor progress of the career development program. The composition, roles, responsibilities, and desired expertise of committee members, frequency of committee meetings, and other relevant information should be included.  Describe how the Advisory Committee will evaluate the overall effectiveness of the program.  Proposed Advisory Committee members should be named in the application if they have been invited to participate at the time the application is submitted.  Renewal applications with Advisory Committees should include the names of all committee members during the past project period.  Please name your file “Advisory_Committee.pdf”.

The filename provided for each “Other Attachment” will be the name used for the bookmark in the electronic application in eRA Commons.

SF424(R&R) Senior/Key Person Profile Expanded

Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA).

PHS 398 Cover Page Supplement

Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA).

PHS 398 Training Subaward Budget Attachment(s)

Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA).

Research and Related (R&R) Budget

Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:

  • Include all personnel other than the Training PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff. Also include proposed salary costs for planned scholars.
  • Do not complete the section on Participant/Trainee Support Costs.
  • The applicant institution may request support for up to three scholars in each budget period.   Appointments of scholars may occur at any point during the current budget period, but scholar appointments that are not filled during the current budget period may not be carried forward into a subsequent budget period.  Institutions are encouraged to design a program that is appropriate for their pool of potential scholars and participating faculty/mentors.  The award provides support to institutions for up to five consecutive 12-month periods.  Appointments are provided in 12-month increments; scholar appointments of less than 9 months require prior approval from NIDDK.
  • Salary requests for the Program Faculty/Mentors are not allowed.
PHS 398 Research Training Program Plan

All Supplemental Instructions to the SF424 (R&R) for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application must be followed, with the following additional instructions:

Substitute the term “scholars” for all references to “trainees” in the SF424 (R&R) Application Guide, and substitute the term “career development” for all references to “training” in the SF424 (R&R) Application Guide.

Program Plan

Program Administration. Describe the acknowledged strengths, leadership and administrative skills, training experience, scientific expertise, and active research of the PD/PI. Relate these strengths to the proposed management of the training program. Describe the planned strategy and administrative structure to be used to oversee and monitor the program. If there are multiple PDs/PIs, then the plan for Program Administration is expected to synergize with the “Multiple PD/PI Leadership Plan” section of the application.

Institutions with existing programs must explain what distinguishes this program from the others, how their programs will synergize with one another, if applicable, and make it clear that the pool of faculty, potential scholars, and resources are robust enough to support additional programs. When a program administrator position is planned, a description of the scientific expertise, leadership, and administrative capabilities essential to coordinate a program for developing investigators must be included in the application.

Program Faculty. The application must include information about the program faculty who will be available to serve as preceptors/mentors and provide guidance and expertise appropriate to the level of scholars proposed in the application. Describe the complementary expertise and experiences of the proposed Program Faculty, including active research and other scholarly activities in which the faculty are engaged, as well as experience mentoring and training individuals at the proposed career stage(s). For any proposed Program Faculty lacking research training experience, describe a plan to ensure successful scholar guidance by these individuals. Describe the criteria used to appoint and remove faculty as Program Faculty and to evaluate their participation.

Proposed Career Development. Provide an overview of the proposed program. Outline the objectives of the program and the program activities that will be used to meet these objectives. Describe for whom the career development program is intended, including the training level(s) of the scholars, the academic and research background needed to pursue the proposed training, and, as appropriate, plans to accommodate differences in preparation among scholars. Include information about planned courses, mentored research experiences, and any activities designed to develop specific technical skills or other skills essential for the proposed research training. Describe how scholars will be educated in the human health- and disease-related aspects of their research training.

Describe the immediate and long-term objectives of the program, including training or career development activities that will be used to ensure that the objectives of the program are met.  Include information about planned seminars, workshops, or tutorials that will be incorporated into the career development program and activities, such as individual development plans. The PD/PI should also describe past track records in research training/career development including those of mentors, documenting the probability of success of the program.

Applicants should include a plan describing selection procedures for recruiting scholars.

Programs should provide all scholars with additional professional development skills and career guidance including instruction and training in writing grant applications for research funding, in order to apply successfully for future career development and independent research support

For renewal applications, highlight how the career development program has evolved in response to changes in relevant scientific and technical knowledge, educational practices, program evaluations and feedback from current and former scholars.

Program Evaluation. Describe a plan to review and determine the quality and effectiveness of the training program. This plan should include the metrics to be evaluated (including program activities completed, degree completion (if applicable), publications, fellowships/honors, and subsequent positions) as well as plans to obtain feedback from current and former scholars to help identify weaknesses and to provide suggestions for program improvements. Specified evaluation metrics should be tied to the goals of the program.

Scholar Candidates. Describe, in general terms, the size and qualifications of the pool of trainee candidates including information about the types of prior clinical and research training and career level required for the program. Do not name prospective Scholars. Describe specific plans to recruit candidates and explain how these plans will be implemented (see also section on Recruitment and Retention Plan to Enhance Diversity). Describe the nomination and selection process to be used to select candidates who would be offered admission to the program and criteria for scholars’ reappointment to the program.

Institutional Environment and Commitment to the Program.

The sponsoring institution must assure support for the proposed program including assurance that sufficient time will be allowed for the PDs/PIs and other Program Faculty to contribute to the proposed program, and that there will be protected time for scholars (9 person months, equivalent to 75%) selected for the program. The application must include a signed letter, on institutional letterhead, that describes the applicant institution’s commitment to the planned program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program. This commitment may also include features such as PD/PI salary, salary or tuition support for individuals involved in the proposed career developmentprogram, or other commitments essential to a successful career development program. Institutions with ongoing research training, student development, or career development programs that receive external funding should explain what distinguishes the proposed program from existing ones at the same trainee level, how the programs will synergize, if applicable, whether scholars are expected to transition from one support program to another, and how the training faculty, pool of potential scholars, and resources are sufficiently robust to support the proposed program in addition to existing ones.

Recruitment and Retention Plan to Enhance Diversity

Individuals are required to comply with the instructions for Recruitment and Retention Plan to Enhance Diversity as provided in Chapter 8 of the SF424 (R&R) Application Guide, and with reference to NOT-OD-15-053, Notice on NIH's Interest in Diversity. 

Plan for Instruction in the Responsible Conduct of Research

Individuals are required to comply with the instructions for Plan for Instruction in the Responsible Conduct of Research as provided in Chapter 8 of the SF424 (R&R) Application Guide. 

Progress Report

Renewal applications should follow the instructions in Chapter 8 of the SF424 (R&R) Application Guide, with the exceptions described below.

Renewal applications must provide brief summaries of the overall career development program that has been successful in preparing scholars for careers as independent investigators. Include information on the career outcomes of all scholars that have entered your program over the course of the award. The summary should contain information on their promotions, publications, support from research grants or contracts, honors and awards, and other relevant professional activities. Include measures of success consistent with the nature and duration of the training period, and additional information helpful in evaluating the impact of your Career Development Programs in Diabetes Research for Pediatric Endocrinologists.

Data Tables

Particular attention must be given to the required Training Data Tables.  These tables are not counted toward the page limits of the Program Plan.  Please read the Introduction to the Data Tables linked on the above web site before starting to prepare the tables.

New Applications must include the following tables: Table 2, Table 4, Table 6B, Table 9B and Table 10.  All other data tables listed in the SF424 (R&R) Application Guide do not apply.

Renewal applications must include the following tables: Table 2, Table 4, Table 6B, Table 10, and Table 12B. All other data tables listed in the SF424 (R&R) Application Guide do not apply.

Please summarize the data in the body of the application and provide any explanatory notes at the bottom of the data tables themselves.  Use the data to support the presentation of your career development program as described in the body of the application.

Additional custom tables may be included in the Research Training Program Plan.  However, such tables will count as part of the page limit.

Letters of Support

Applicants from institutions that have an NIDDK Diabetes Research Center, Center for Diabetes Translation Research or a Clinical and Translational Science Award (CTSA) may wish to identify these as resources for conducting the proposed research.  In such a case, a letter of support from the PD/PI should be included with the application. Letter(s) of support may also be provided by the PD/PI of any affiliated NIDDK-supported T32 training grant, if applicable.  Letters of support are not counted toward the page limits of the Program Plan.

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.  

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NIDDK Referral Office by email at calvof@mail.nih.gov when the application has been submitted.  Please include the FOA number and title, PD/PI name, and title of the application.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information
1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood that the proposed career development program will prepare individuals for successful, productive scientific research careers and thereby exert a sustained influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of the merit of the career development program, and give a separate score for each. When applicable, the reviewers will consider relevant questions in the context of proposed short-term training. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

Career Development Program and Environment

  • Does the proposed program clearly outline a plan to recruit and develop well-qualified junior investigators for successful careers as biomedical or clinical researchers?
  • Is there evidence of an adequate pool of potential scholars who could benefit from receiving career development support?
  • Are the content and duration of any proposed didactic, career development-related and research-related activities of the program appropriate?
  • Are appropriate timelines indicated for career progression and transition to independence?
  • Does the institutional environment (e.g., research facilities and other relevant resources) in which the program will be conducted contribute to the probability of success?
  • Does the proposed career development program benefit from unique features of the scientific environment, subject populations, or employ useful collaborative arrangements?
  • Is the institutional commitment to the proposed program appropriate?
  • If multiple sites are participating, is this adequately justified in terms of the career development and research experiences provided?
  • Is there sufficient assurance that the required effort of the PD/PI, mentors and scholars will be devoted directly to the research training, career development, and related activities?
  • When applicable, is there adequate documentation describing the responsibilities of the advisory committee with regard to the provision of input, guidance and oversight of the program?

 Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))

  • Do the PD/PI and Research Administrator (if applicable) have the experience to develop, direct and administer the proposed program? 
  • Does the leadership team bring complementary and integrated expertise to the program? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure program objectives?
  • Are the research qualifications, scientific stature, previous leadership and mentoring experience, and track record(s) appropriate for the proposed career development program?
  • Are the PD(s)/PI(s) currently engaged in research relevant to the scientific area of the proposed program?
  • For applications designating multiple PDs/PIs:
    • Is a strong justification provided that the multiple PD/PI leadership approach will benefit the career development program and the scholars?
    • Is a strong and compelling leadership approach evident, including the designated roles and responsibilities, governance, and organizational structure consistent with and justified by the aims of the career development program and the complementary expertise of the PDs/PIs?

Mentors

  • Do the mentors have appropriate expertise and experience, as well as track records of past mentoring and career development?
  • Are the quality and extent of the mentors’ roles in providing guidance and scientific advice to the scholars acceptable? Are the mentors currently engaged in relevant research?
  • Do the research/career development experiences provided by the program mentors focus on diabetes research?

Candidates/Scholars

  • Is a recruitment plan proposed with strategies likely to attract high quality scholar candidates?
  • Are there well-defined and well justified recruitment and selection strategies?
  • Is there evidence of a sufficiently large, competitive scholar pool to warrant the proposed size of the career development program?
  • Are the content, phasing, and proposed duration of the career development plan appropriate for achieving scientific independence of the scholar candidates?
  • What is the likelihood that the career development plan will contribute significantly to the scientific development of the scholars?
  • Does the plan for selection of the scholars include all of the eligibility criteria stated in the FOA?

Training Record

Is there evidence of a successful past training record of the PD/PI and mentors, including the success of former scholars in seeking independent support and establishing productive scientific careers? Does the program have a rigorous evaluation plan to assess the quality and effectiveness of the career development?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.  

Inclusion of Women, Minorities, and Children 

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Vertebrate Animals

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Biohazards

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Resubmissions

Not Applicable 

Renewals

For Renewals, the committee will consider the progress made in the last funding period, including on the Recruitment and Retention Plan to Enhance Diversity, and Training in the Responsible Conduct of Research.  Does the application describe the program’s accomplishments over the past funding period(s)?  Are changes proposed that would improve or strengthen the career development experience?  Is there evidence of a successful past training record of the PD/PI and mentors, including the success of former scholars in seeking independent support and establishing productive scientific research careers?

Revisions

Not Applicable

Additional Review Considerations

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

Recruitment & Retention Plan to Enhance Diversity

Peer reviewers will separately evaluate the recruitment and retention plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented groups. The plan will be rated as ACCEPTABLE or UNACCEPTABLE, and the consensus of the review committee will be included in an administrative note in the summary statement.

Training in the Responsible Conduct of Research

All applications for support under this FOA must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR).  Taking into account the specific characteristics of the career development program, the level of scholar experience, and the particular circumstances of the scholars, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - Does the plan satisfactorily address the format of instruction, e.g. lectures, coursework and/or real-time discussion groups, including face-to-face interaction?  (A plan involving only on-line instruction is not acceptable.); 2) Subject Matter – Does the plan include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics? 3) Faculty Participation - Does the plan adequately describe how faculty will participate in the instruction?  For renewal applications, are all career development faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period named in the application?  4) Duration of Instruction - Does the plan meet the minimum requirements for RCR, i.e., at least eight contact hours of instruction? 5) Frequency of Instruction – Does the plan meet the minimum requirements for RCR, i.e., at least once during each career stage (undergraduate, post-baccalaureate, predoctoral, postdoctoral, and faculty levels) and at a frequency of no less than once every four years? 

For renewal applications, does the progress report document acceptable RCR instruction in the five components described above? Does the plan describe how participation in RCR instruction is being monitored? Are appropriate changes in the plan for RCR instruction proposed in response to feedback and in response to evolving issues related to responsible conduct of research?

Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including (1) the Select Agent(s) to be used in the proposed research, (2) the registration status of all entities where Select Agent(s) will be used, (3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and (4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by NIDDK in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

  • May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
  • Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Diabetes and Digestive and Kidney Diseases Advisory Council. The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.
3. Anticipated Announcement and Award Dates

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

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 as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. 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.      

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually. Continuation support will not be provided until the required forms are submitted and accepted.

Failure by the grantee institution to submit required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Other Reporting Requirements
  • The institution must submit a completed Statement of Appointment (PHS Form 2271) for each scholar appointed or reappointed to the career development grant.  Grantees must submit the PHS 2271 data electronically using the xTrain system.  More information on xTrain is available at xTrain (eRA Commons).  An appointment or reappointment may begin any time during the budget period, but not before the budget period start date of the grant year.
  • A notarized statement verifying possession of permanent residency documentation must be submitted with the Statement of Appointment (PHS Form 2271). Individuals with a Conditional Permanent Resident status must first meet full (non-conditional) Permanent Residency requirements before receiving support.
  • Termination Notice: Within 30 days of the end of the total support period, the institution must submit a Termination Notice (PHS Form 416-7) via xTrain for each scholar appointed for eight weeks or more.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award as described in the NIH Grants Policy Statement. Evaluation results should be included as part of the final Progress Report.

4. Evaluation

In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants 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.

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)

Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: https://grants.nih.gov/support/index.html
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

Scientific/Research Contact(s)

James F. Hyde, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7692
Email: James.Hyde@mail.nih.gov

Peer Review Contact(s)

Carol Goter-Robinson, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7791
Email: goterrobinsonc@mail.nih.gov

Financial/Grants Management Contact(s)

Tommy Gunter
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-451-3447
Email: gunterto@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75. This FOA is supported under the authority of PL 114-10, "The Medicare Access and CHIP Reauthorization Act of 2015;” “Section 213. Extension of special diabetes program for type I diabetes and for Indians.”

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