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

Multidisciplinary K12 Urologic Research (KURe) Career Development Program

Activity Code

K12 Physician Scientist Award Program (PSA)

Announcement Type

Reissue of RFA-DK-07-006

Related Notices

  • September 28, 2012 - See Notice NOT-DK-12-023. Technical Assistance Webinar for this RFA.

Funding Opportunity Announcement (FOA) Number

RFA-DK-12-013

Companion Funding Opportunity

None 

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.847

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to solicit applications to support institutional career development programs in urological research that will assist MDs, PhDs, and MD/PhDs with an interest in benign urological disease or urological research to develop the skills necessary to initiate and sustain an independent research career in urological research.  Research areas supported by this initiative must be related to the mission of the NIDDK (http://www2.niddk.nih.gov/Research/ScientificAreas/Urology/)

Key Dates
Posted Date

September 12, 2012

Open Date (Earliest Submission Date)

October 29, 2012

Letter of Intent Due Date

October 29, 2012

Application Due Date(s)

November 29, 2012, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

February/March 2013

Advisory Council Review

May 2013

Earliest Start Date(s)

July 1, 2013

Expiration Date

November 30, 2012

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (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 needs.  More information about Career programs may be found at the NIH Extramural Training Mechanisms website.

The purpose of this Institutional Mentored Urological Research Career Development Program is to assist MDs, PhDs, and MD/PhDs interested in urological research to develop the skills necessary to initiate and sustain an independent research career.  The institutional programs are to include activities and opportunities that will provide candidates with a comprehensive understanding of clinical research, translational, and/or basic science approaches needed to successfully pursue their independent research careers.  These activities may include didactic education, mentored practical research training, and enhancement experiences in areas such as mentorship and grant-writing skills. Programs should also consider the multidisciplinary nature of a successful research career in urological sciences and should select a group of candidates with a variety of scientific, clinical, and/or training backgrounds.  KURe scholars should be exposed to the approaches necessary to foster cross-disciplinary collaborations.

A scholar selected by the institution for the K12 program will work with their mentoring team to propose a thorough, individualized career development program that will prepare the scholar for an independent career in urological research.  Areas of primary focus may include clinical, translational, or basic science research and must be relevant to the research mission of the NIDDK (http://www2.niddk.nih.gov/Research/ScientificAreas/Urology/ ).  Didactic training may take advantage of CTSA resources, or extant MS and/or PhD programs to provide supplemental educational resources for scholars.  Additionally, institutions with O’Brien Centers and large projects supported by the NIDDK are encouraged to take advantage of those resources in ways that benefit their proposed KURe Program. The duration of the career development program should be tailored to fit a scholar’s background and experience.  It is anticipated that candidates selected as scholars for this program would have five years or fewer of research experience beyond a doctoral degree.

The Kidney, Urologic, and Hematologic Diseases Division of NIDDK has convened several workshops and planning sessions over the previous 5-7 years to continually solicit advice and input from the urologic academic community in the area of supporting urologic research.  An over-riding theme of many of the recommendations is to first, maintain the cadre of young investigators committed to a career in urologic research and, second, to expand the research workforce pipeline to include not only clinically-trained urologists, but also basic scientists and clinicians from other scientific and medical disciplines who have an interest in benign urological research and unique skill sets to apply to understanding the etiologies of many symptomatic urologic conditions.  The continued focus of this mentored training program is to recruit qualified clinical and basic researchers to benign urological research and provide mentored support to train them in collaborative, multidisciplinary approaches to urological research questions.  Expertise of interest may include (but are not limited to) the following:

This funding opportunity is intended to address the need for multidisciplinary career development and training at the postdoctoral level and provide a transition to independence. It is hoped that the K12 programs established in response to this announcement will become incubator environments for development of independent researchers able to sustain viable careers and mentor those that follow them.

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.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Renewal

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIDDK intends to commit $2,000,000 in total costs [Direct plus Facilities and Administrative (F & A) costs] in FY 2013 to fund up to four new and/or renewal awards.

Award Budget

Applicants may request up to $600,000 in direct costs per year and need to reflect the scope of the proposed project, considering the applicant's research base and scholar recruitment pool.

Award Project Period

The total project period for an application submitted in response to this FOA may not exceed 5 years.

 
Other Award Budget Information
Personnel Costs

Salary and fringe benefits for a dedicated Administrative Director, if any, up to 0.6 person months (5% effort) may be requested.  This person will be responsible for designing, directing, and implementing the career development program.  Salary and fringe for the PD/PI is not allowed, unless the PD/PI also serves as the Administrative Director.  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 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 OMB Circular A-21, 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.  Administrative salary costs and Other Program Related Expenses may not exceed $65,000 per year.

Items that may NOT be supported with K12 funds include: salaries and fringe for program mentors; direct support of the laboratories, salaries, fringe benefits, travel and research projects of the mentors, except those directly attributable to the scholar's project as described below; salary and support for central institutional administrative personnel (e.g. budget officers, grants assistants), who are usually paid from institutional overhead charges; and salary and support for administrative activities such as institutional public relations of health and educational services. 

Participant 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. These expenses must be itemized in the proposed budget.

NIDDK will provide total salary support of up to $140,000 per year.  This amount includes fringe benefits consistent with the institutional salary scale.  Scholars are required to devote 9 person-months (75%) of full-time professional effort conducting research and research career development activities.  Scholars who are urologic surgeons may request between 6 and 9 person-months (50% to 75%) of full-time professional effort conducting research and career development activities.

The total salary requested for each scholar must be based on a full-time 12-month staff appointment.  It must be consistent 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.

The institution may supplement the NIH salary contribution up to a level consistent with the institution's salary scale, but the supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived.  Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of this Program.

Research and Career Development Support:  Up to $55,000 per year per scholar may be requested for the following types of expenses:  (a) research supplies, equipment and technical personnel; (b) tuition and fees related to didactic courses or career development; and (c) travel to research meetings or training.  Of the funds requested, $35,000 should specifically be used for support of the candidates' research -related activities to generate preliminary data (pilot projects or other research costs). Institutions are encouraged to demonstrate their commitment to the program by contributing additional funds for pilot research projects, where possible.

Other Program Related Expenses

Consultant costs, equipment, supplies, 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.  Minimal costs can be allocated for advertising and recruitment in order to attract the best candidates nationally.  Some laboratory costs for equipment and supplies may be provided to the mentors, , to offset costs directly attributable to the scholar's project.  These costs, together with administrative personnel costs, may not exceed $65,000 per year.

Travel to the annual Urology Program Directors meeting for the PD/PI, the Administrative Director and each Scholar must be requested and is not included in the $65,000 cap, above.

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 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

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

Nonprofits Other Than Institutions of Higher Education

Governments

Other

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 research program in the area(s) proposed under this FOA 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. 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.

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 must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (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 PD(s)/PI(s), 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. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required. 

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

Applicant organizations may submit more than one application, provided that each application is programmatically distinct.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.   

Mentors

Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as mentors. Mentors should have research expertise and experience relevant to the proposed program. Mentors must be committed to continue their involvement throughout the total period of the award.

It is expected that each KURe scholar will have a mentoring team which includes at least two individuals from different disciplines and training backgrounds. These mentors should hold a faculty position and be established investigators in clinical, translational, or basic scientific research with track records in mentoring and training. The mentors must interact closely with the scholar in order to develop a tailored career development plan.

Scholar Participants

Institutions receiving a KURe Program award must recruit and select scholars with the potential to develop into independent investigators capable of interacting with multidisciplinary teams with diverse training and scientific backgrounds.  Scholars must have a doctoral level degree such as an MD, DO, MD/PhD, or PhD degree, must have completed residency training (if required), and be committed to a career in independent research in benign urologic disease.  Scholars should have no more than five years of postdoctoral research experience and not more than 10 years should have elapsed since receiving the terminal doctoral degree.  Time spent in clinical fellowships is not considered postdoctoral research training.  Mid-career and senior faculty are not eligible.  Scholars must be willing to commit a minimum of 9 person-months (equivalent to 75% of full-time professional effort) to the activities of their career development plan.  However, urologic surgeons may devote 6 to 9 person-months (50% to 75% effort) to the activities of their career development plan.

Funds provided by this award may support full or partial completion of an advanced degree in health-related research.  Scholars with fewer than three years of support under this award will remain eligible to compete for individual career development awards such as the K01, K08, and K23.  The maximum duration of support for a scholar under this award is five years.  It is expected that scholars will begin to transition to independent support (either R01 or individual K award) at the end of three years.  Scholars may be eligible for the Loan Repayment Program (LRP) for clinical and pediatric investigators.  More information about LRP can be found at http://lrp.info.nih.gov.  The total period of K12 plus individual mentored K support may not exceed 6 years.

Individuals who are or were Principal Investigators on NIH Small Grants (i.e. R03s) or Exploratory/Developmental Grants (i.e., R21s) are eligible to be appointed as scholars providing they do not have more than 5 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, Principal Investigators who have current or prior support 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 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.

Scholars in this program are encouraged to apply for independent research grant support during the period of support under this award. 

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

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 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:

The letter of intent should be sent to:

Francisco O. Calvo, Ph.D.
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes, Digestive and Kidney Diseases
6707 Democracy Boulevard 
Democracy 2, Room 752 MSC 5452
Bethesda, MD 20892 (Courier service use 20817)
Telephone: 301-594-8897
Email: calvof@mail.nih.gov

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow the instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

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

SF424 (R&R) Other Project Information Component

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 modifications:

Project Summary /Abstract

Provide an abstract of the entire application, including the long-term goals and objectives of the program. Include the rationale and design of the program, the planned duration of the program and the projected number of scholars, including their levels (i.e., predoctoral, postdoctoral, faculty).

Advisory Committee (Uploaded via the Other Attachments section)

A plan must be provided for the appointment of an Advisory Committee to monitor progress.  Composition, responsibilities, frequency of meetings, and other relevant information should be included.  Describe the composition of the Advisory Committee, identifying the role and the desired expertise of members.  A plan for Advisory Committee approval and selection of scholars should be included.  Describe how the Advisory Committee will function in providing oversight of the development, implementation, and evaluation of recruitment strategies, the recruitment and retention of candidates, and the evaluation of the overall effectiveness of the program.  Note that proposed Advisory Committee members should not be named in the application, particularly if they include individuals from outside the institution.  However, renewal applications with Advisory Committees should include names of existing external advisors.  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.

Research and Related (R&R) Budget Component

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

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 additional instructions described below:

Program Faculty (Component of Program Plan)

Describe in general terms the complementary expertise and experiences of the proposed mentors. Provide an overview of their active research and other scholarly activities, as well as track records of mentoring and training.

Proposed Training (Component of Program Plan)

Provide an overview of the proposed program: Describe the immediate and long-term objectives of the program, including activities that will be used to ensure that the objectives of the program are met. Include information about planned courses, curricula, seminars, workshops, or tutorials that will be incorporated into the training program and mentored research experiences and activities. Institutions with existing training or career development programs must explain what distinguishes this program from the others, how the programs will synergize, if applicable, and justify that the faculty, pool of potential trainees, and resources are robust enough to support additional programs. The description should include planned strategies to be used to ensure that the objectives are met. The PD/PI should also describe past research career development activities/experiences including those of mentors, documenting the success of former trainees in establishing independent productive scientific careers. The PD/PI should also provide a description of any formal training and/or guidance provided to mentors to improve their mentoring skills or to orient them to multi-disciplinary approaches.

Program Evaluation (Component of Program Plan)

Describe an evaluation plan to review and determine the effectiveness of the program. This should include plans to obtain feedback from current and former scholars to help identify weaknesses and to provide suggestions for program improvements, as well as plans for assessing trainees’ career development and progression, including metrics such as degree completion (if applicable), publications, and subsequent positions. Specified evaluation metrics should be tied to the goals of the program. The program evaluation should include metrics to assess the effectiveness of the program mentors and the effectiveness of any proposed mentor training plan.   Evaluation results should be included in future competing continuation (renewal) applications and in the Final Progress Report.

Trainee Candidates (Component of Program Plan)

Describe in general terms the pool of potential scholar candidates including information about the types of prior clinical and research training and the expected career level required for the program. Do not name prospective scholar candidates. Describe 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 evaluation criteria to be used in the selection of scholars. Provide brief summaries of career development plans that the program will employ. The application should contain a description of how career development plans will be tailored to the needs of the prospective candidates, taking into account their past experiences and competences.

Institutional Environment and Commitment to the Program (Component of Program Plan)

The application must include a statement from the applicant institution describing the commitment to the planned program. The institution must assure that essential time will be allowed for the PD(s)/PI(s), other faculty and mentors, and the required protected time for scholars (9 person months, equivalent to 75%; 6 to 9 person months, equivalent to 50% to 75% for urologic surgeons) selected for the program.

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. 

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 Only)

Renewal applicants should provide a list of scholars who have participated in this K12 program over the previous funding period.  Provide scholar statistics including name, support years under the K12, department, name of mentor, current professional position and research grant awards.    Optional information may include scholar publications derived from the KURe-supported project and a description of the scholar's subspecialty area of research. Renewal applications should also provide the results of the program evaluation of the previous funding period and describe any program changes resulting from the evaluation data.

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 in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via 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 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 SF 424 (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.

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 SF 424(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 Central Contractor Registration (CCR). 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 by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.  

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

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 for the program to exert a sustained, powerful 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 scientific merit, and give a separate score for each. 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 in urologic research?  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, training-related, and research-related activities of the program appropriate to foster cross-disciplinary collaborations? 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?  If there are NIDDK-supported Centers or other large projects at the applicant institution, are there plans to take advantage of the resources provided for the benefit of the proposed KURe Program?  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 urologic research mission of the NIDDK?

Mentors

Do the mentors have expertise and experience, as well as track records of past mentoring and training?  Are the quality and extent of the mentors’ roles in providing guidance and scientific advice to the scholars acceptable?  Are the mentors engaged in research interests relevant to the NIDDK (http://www2.niddk.nih.gov/Research/ScientificAreas/Urology/)?  Are there formal mechanisms for providing programmatic guidance to mentors who may also be new to multidisciplinary approaches?  Are there plans to provide general mentorship training and feedback to mentors?

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 career development program?  Is there an appropriate plan for the content, the phasing, and the proposed duration of the career development plan for achieving scientific independence for the prospective 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

Does the program have a rigorous evaluation plan to assess the quality and effectiveness of the training?       

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/priority 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? Has the program been adequately evaluated and are proposed changes responsive to the results of this evaluation?  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?

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/priority 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 review panel’s evaluation will be included in an administrative note in the summary statement. Plans and past record will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

Training in the Responsible Conduct of Research

 Taking into account the specific characteristics of the career development program, level of scholar experience, and the particular circumstances of the scholars, the reviewers will address the following questions.  Does the plan satisfactorily address the format of instruction, e.g., lectures, coursework and/or real-time discussion groups?  Do plans include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety?  Do the plans adequately describe how faculty will participate in the instruction?  Does the plan meet the minimum requirements for RCR, i.e., eight contact hours of instruction every four years?  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 the NIDDK, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Appeals of initial peer review will not be accepted for applications submitted in 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 (NDDKAC). The following will be considered in making funding decisions:

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 the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants 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

The Non-Competing Continuation Grant Progress Report (PHS 2590) and financial statements as described in the NIH Grants Policy Statement are required annually. Continuation support will not be provided until the required forms are submitted and accepted. Chapter 8 of the SF424 (R&R) Application Guide, Additional Instructions for Preparing a Progress Report for an Institutional Research Training Grant, including Ruth L. Kirschstein National Research Service Awards, must be followed.

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

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

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Tracy L. Rankin, Ph.D.
Program Director, Career Development and Training
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone:  301-594-4748
Email:  rankint@mail.nih.gov

Peer Review Contact(s)

Francisco O. Calvo, Ph.D.
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone:  301-594-8897
Email:  calvof@mail.nih.gov

Financial/Grants Management Contact(s)

Aricia Ajose
Senior Grants Management Specialist
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone:  301-594-9023
Email:  ajosea@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 Parts 74 and 92.


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