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

National Institutes of Health (NIH)

Components of Participating Organizations

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Funding Opportunity Title

Reproductive Scientist Development Program (RSDP) (K12)

Activity Code

K12 Physician Scientist Award (Program) (PSA)

Announcement Type

Reissue of RFA-HD-13-015

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-HD-18-007

Companion Funding Opportunity

None  

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

93.865  

Funding Opportunity Purpose

The purpose of this FOA issued by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), NIH is to announce the re-competition of the Reproductive Scientist Development Program (RSDP).  This program constitutes a national network of mentors and scholars, in contrast to K12 programs that are based solely at a single applicant institution.  The purpose of the RSDP is to provide career development support for obstetricians and gynecologists who have completed their clinical training, and who are committed to a career conducting basic science research in an academic setting.  The overall goal of the Program is to strengthen the field of obstetrics and gynecology by encouraging the application of contemporary science advances to clinical practice and facilitating the transition to independence of physician-scientists in areas related to obstetrics and gynecology and its subspecialties.

Key Dates
Posted Date

June 7, 2017

Open Date (Earliest Submission Date)

September 30, 2017

Letter of Intent Due Date(s)

September 30, 2017

Application Due Date(s)

October 30, 2017, 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.

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 2018  

Advisory Council Review

May 2018  

Earliest Start Date

July 2018  

Expiration Date

October 31, 2017 

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Training (T) Instructions in the SF424 (R&R) Application Guide, 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.


There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Go to Grants.gov to download an application package to complete the application forms offline or create a Workspace to complete the forms online; submit your application to Grants.gov; and track your application in eRA Commons.
Learn more about the various submission options.

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

Purpose

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.

The purpose of the RSDP is to provide career development support for obstetricians and gynecologists    who have completed their clinical training, and who are committed to a career conducting basic science research in an academic setting.  This program constitutes a national network of mentors and scholars, in contrast to K12 programs that are based solely at a single applicant institution.  The overall goal of the Program is to strengthen the field of obstetrics and gynecology by encouraging the application of contemporary science advances to clinical practice.  It is envisioned that the mentored training experience will assist junior faculty in their transition into independent, productive physician-scientists in areas related to obstetrics and gynecology and its subspecialties.

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.

Background

The RSDP is a national career development program that was launched in 1988 with the goal of developing a cadre of physician-scientists based in academic departments who could employ cutting-edge cell, molecular and genetic technologies to address important problems in Obstetrics and Gynecology (Ob-Gyn).  The mentored research experiences offered by this program seek to assist junior faculty in their transition to productive, independent clinician-scientists who are highly competitive for research funding.

As of spring, 2016, nearly 100 clinical fellows (hereafter referred in this FOA as "scholars") have participated in the RSDP.  Of those scholars, approximately 75% have applied for research grants with half receiving at least one grant award.  Moreover, 78% of former scholars remained in faculty or research-related positions with many assuming leadership positions in their respective institutions. 

The RSDP has distinguished itself from other K12 programs in that scholar career development is done in two phases.  In Phase I, which lasts two, and occasionally, three years, a scholar identifies a sponsor (usually a department chairperson) and a world-class mentor(s) at a US-based institution of their choice.  During this phase, the scholar devotes 100% of their time conducting cutting-edge basic research in cellular/molecular biology, genetics, etc.  Following this intensive research experience, the scholar enters Phase II and assumes a junior faculty position, usually in the sponsoring department.   During Phase II, the scholar spends at least 75% of their effort in mentored laboratory research with the remaining time being spent in teaching or clinical service.  It is during this phase that the scholar attempts to establish an independent research program by applying for extramural grant support generally through the NIH.  An RSDP Selection Committee reviews applications for Phase I and II and makes recommendations to the PD/PI of the K12 award.  An RSDP Evaluation Committee also performs site visit reviews of scholars at the end of their Phase I experience and when issues arise.

Scope of Program

Commencing with this award, the RSDP will provide four years of mentored research experiences.  With funds from this award, the RSDP will provide annual support for up to eight scholars including up to two scholars for each of the first and second year of Phase I training and for each of the first and second year of Phase II training.  These scholars will train in laboratories located at premier research institutions throughout the country.  After having been nominated to the RSDP by a Chairperson, each applicant to the RSDP will be chosen for entry into Phase I and progression to Phase II by an RSDP Selection Committee.

The scope of the research conducted by the scholar can include all areas of Ob-Gyn and related fields with a focus on career development leading to research independence.  Emphasis of scientific projects should be on allowing the scholar to acquire state-of-the-art techniques in cellular/molecular biology, genetics, etc. that will allow them to answer questions important to reproductive science and medicine.  The work should ultimately be relevant to general Ob-Gyn and/or its subspecialties such as maternal-fetal medicine, reproductive endocrinology and infertility, gynecologic oncology and urogynecology.

In order to hasten the transition to independence, a scholar will be expected to submit an R03 application to the NIH in the first year of Phase II.

See Section VIII. Other Information for award authorities and regulations.

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

The NICHD intends to commit up to $1,000,000 total costs in FY 2018 to fund one award.  Future year amounts will depend on annual appropriations.

Award Budget

Application budgets are limited to $920,000 direct costs in FY 2018, and must reflect actual needs of the proposed RSDP.

Award Project Period

The project period duration may not exceed five 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. 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 as F&A costs may be direct charges to the grant only when they are in accordance with applicable cost principles.  For institutions covered by 45 CFR 75.413(c), this type of 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. 

Allowable Costs:

  • Up to $25,000 may be requested for all faculty who are involved in designing, directing, and administering the K12 program.  This may include the PD(s)/PI(s), Training Director, and/or Recruiting Officer, as appropriate to the proposed program. The Cost limit applies to all faculty salaries combined.
  • Up to $100,000 per year may be requested for administrative, clerical, or other staff with responsibilities directly associated with the institutional career development program.  The cost limit applies to all staff salaries combined.

Items that may NOT be supported with K12 funds include:

  • Salaries and fringe benefits for the program mentors;
  • 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.
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.

Salary and Fringe Benefits:

For the first two years of the Program (Phase I), scholars can receive up to $125,000 per year for salary support and fringe benefits, consistent with the host institution's salary scale.  The total salary requested must be based on a full-time, 12-month staff appointment and requires scholars to devote no less than 12 person-months (equivalent to 100%) of full-time professional effort to conducting research and engaging in activities devoted to the development of a successful research career.

For years three and four of the Program (Phase II), scholars can receive up to $100,000 per year for salary support and fringe benefits, consistent with the institution's salary scale.  The total salary requested must be based on a full-time, 12-month appointment and requires scholars in Phase II to devote a minimum of 9 person-months (equivalent to 75%) of full-time professional effort to conducting research.  The remaining effort may be devoted to other activities such as teaching or clinical service.

The institution may supplement the NIH salary contribution up to a level that is consistent with the institution's salary scale; however, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived.  In no case may PHS funds be used for salary supplementation.  Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the Program.

Research and Career Development Support:

All applicants may request up to $25,000 per year for support of scholars' career development activities.  Allowable expenses include (1) travel to attend the annual RSDP Scholars Retreat or other scientific meetings; (2) research supplies and equipment; and (3) technical support and statistical or computer services.  These research and development costs must be specifically documented for each individual candidate and must be specifically related to the scholar's research activities.  They cannot be pooled and used for other programs unrelated or indirectly related to the research activities of individual scholars.

Items that may NOT be supported with each Scholar's Research and Career Development Support category include:

  • Direct support of the laboratories, travel, and research projects of the investigators serving as mentors beyond those expenses directly attributable to the scholar's project.
Other Program Related Expenses

Consultant costs, equipment, supplies, non-Scholar travel for Senior/Key persons, meeting costs, and other program-related expenses may be included in the proposed budget. These Other Program-Related Expenses must be justified as specifically required by the proposed program and must not duplicate items generally available at the applicant institution.

Other Program-Related Expenses are limited to $25,000 per year.  This allowance may be used for the PD(s)/PI(s) or other faculty to attend the annual RSDP Scholars Retreat or other organizational/administrative meetings associated with the K12 program.

Funds may NOT be used to support travel of the PD/PI or scholars to scientific meetings other than K12 program-specific meetings.

Personnel Costs (above) and Other Program Related Expenses should be limited to no more than $150,000 direct costs per year.

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.

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.

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.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
  • 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.

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.

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 research training program.  Program faculty should also have a record of research training, including successful, former trainees 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 hold faculty positions, be supported by NIH or other competitively awarded grants and be acknowledged experts in the application of new advances in basic science or translational research.  The established investigators, as mentors, will make available their expertise, guidance and laboratory facilities to be utilized by scholars for research projects that will enhance their knowledge and skills.  Mentors must have track records in mentoring and training, and must interact closely with the scholar in order to develop a career development plan.  Assigned mentors will provide guidance for the development of each scholar appointed to the RSDP.

Scholars

Scholars to be supported must be at the career level for which the planned program is intended. RSDP Scholars must have an M.D. degree or equivalent and must have completed a postgraduate residency training in general Ob-Gyn or an Ob-Gyn subspecialty area.  Scholars may also have a Ph.D. or other doctoral degree in addition to an M.D.  Scholars are expected to be in a 12 person-month (100% of full-time professional effort) position during the appointment of the K12 award.

Phase I scholars (years 1 and 2) must have 100% of their professional time protected from clinical duties or assignments.  Phase II scholars (years 3 and 4) must have a minimum of 75% of their professional time protected from clinical duties or assignments.

By the time of appointment, scholars must be citizens or noncitizen nationals of the United States or have been lawfully admitted for permanent residence at the time of appointment. Additional details on citizenship requirements are available in the NIH Grants Policy Statement.

At the time of entry into the RSDP, a scholar may not be or have been a PD/PI on an R01 or subproject of a Program Project (P01) or Center (P50, P60, U54) grant, independent mentored career development (K-series) grants or other equivalent research grant awards. Individuals who are or were PD/PIs on NIH Small Grants (i.e., R03s) or Exploratory/Developmental Grants (i.e., R21s) may be eligible providing they meet the eligibility requirements of the RSDP.

During the period of their appointment, scholars may not accept or hold any other PHS award that duplicates the provisions of this career award.  However, scholars may remain eligible for other individual mentored career development awards (e.g., K08, K23, K99/R00) at the conclusion of the K12 appointment if additional training is needed to establish research independence.  Combined support through the K12 and other mentored career development award programs must not exceed six years.  Scholars may also hold concurrent support from their K award and a competing research grant during Phase II training.  According to NIH Policy (NOT-OD-08-065), scholars who are successful in obtaining support from other grants as a PI or subproject Director of a multi-project grant are permitted to reduce the level of effort required for the K award to no less than six person-months (50% full-time professional effort) and replace that effort with effort on an NIH research grant or subproject provided they remain in a mentored situation.

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

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Training (T) 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:

Louis V. DePaolo, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6970
Fax: 301-480-2389
Email: depaolol@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. 

SF424(R&R) Project/Performance Site Locations

Follow all instructions provided in the SF424 (R&R) Application.

SF424 (R&R) Other Project Information

Follow all instructions provided in the SF424 (R&R) Application, 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., , ,  faculty), and intended scholar outcomes.

Other Attachments. A plan must be provided for the appointment of all committees necessary for the operation of the RSDP.  These may include an Executive Committee, Selection Committee and Evaluation Committee.  The composition, responsibilities, frequency of meetings, and other relevant information for each committee should be included.  Describe the composition of each committee, identifying the role and the desired expertise of members.  For example, describe how the Executive 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.  A plan for Selection Committee approval and selection of participants should be included.  Describe the criteria used by the Evaluation Committee in determining the suitability of an applicant for participation in Phase I or Phase II of the RSDP.  Note that proposed committee members should not be named in the application, particularly if they include individuals from outside the institution.  However, renewal applications with committees in place should include names of existing committee members.  Please name your file "Committees.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.

 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 ultimately responsible for the selection and appointment of scholars to the approved research training program, and for the overall direction, management, administration, and evaluation of the program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required. The PD/PI also has responsibility for the day to day administration of the program.  To assist and advise for the above responsibilities, the PD/PI may choose to appoint an Executive Committee, Selection Committee and Evaluation Committee.

When a program administrator position is planned, a description of the scientific expertise, leadership, and administrative capabilities essential to coordinate a national program for developing investigators must be included in the application.

PHS 398 Cover Page Supplement

Follow all instructions provided in the SF424 (R&R) Application.

PHS 398 Training Subaward Budget Attachment(s)

Follow all instructions provided in the SF424 (R&R) Application Guide

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.
PHS 398 Research Training Program Plan

The PHS 398 Research Training Program Plan Form is comprised of the following sections:

  • Training Program
  • Faculty, Trainees, and Training Record
  • Other Training Program Sections
  • Appendix

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

Data Tables:  Particular attention must be given to the required Training Data Tables. For this FOA, applicants should use the following Data Tables only (Data for Scholars should be entered into the Postdoctoral sections of the Data Tables.

Table 2 (New and Renewal applications)

Table 3 (New and Renewal applications)

Table 4 (New and Renewal applications)

Table 5B (Renewal applications only)

Table 7 (Renewal applications only)

Table 8C, Part I only (Renewal applications only)

Applicants should follow all instructions provided in the SF424 (R&R) Application Guide, as well as the specific instructions for the Training Data Tables.  Information presented in the Data Tables should be summarized in the Research Training Program Plan as described in the Instructions and Sample Data Tables Files.

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.

Training Program

Program Plan

a. Program Administration.

For renewal applications, highlight how the program has evolved in response to changes in relevant scientific and technical knowledge, educational practices, and evaluation of the program.

b. Program Faculty

Career development programs developed under this FOA shall be national networks rather than programs based solely at the applicant institution.  Scholars shall choose the most appropriate mentors and institutions which will usually extend beyond those of the applicant organization; the specific expertise of those mentors will depend on the needs of the scholar pool.  Applicants must describe a plan for identifying appropriate mentors, linking candidates with those mentors, and ensuring that mentors will commit to candidate support.  The K12 applicant need not provide a list of potential mentors as this may compromise the review process by creating unnecessary institutional conflicts for the recruitment of peer reviewers.  Applicants should describe how mentors at remote sites will be integrated into the national network of the proposed K12 program in terms of providing guidance and scientific advice to the scholars and supporting their transition to independent status.

e. Scholar Candidates

The application should contain a description of how the career development plan will be tailored to the needs of prospective candidates, taking into account their past experiences and competencies.

Institutional Environment and Commitment to the Program.

The application must include a statement from the applicant institution describing the commitment to the planned program.  The applicant institution must assure that institutions selected by scholars for mentored career development research activities will provide the required protected time for scholars (for Phase I, 12 person-months, equivalent to 100% effort; for Phase II, 9 person-months, equivalent to 75% effort), as well as essential time for faculty involved in mentoring.

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 the SF424 (R&R) Application Guide. 

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.  

PHS Assignment Request Form

All instructions in the SF424 (R&R) Application Guide must be followed. 

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. 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. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. 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. .

7. 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. For assistance with application submission, contact the Application Submission Contacts in Section VII.

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.    

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy.

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 score to reflect their assessment of the likelihood that the proposed training 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 training 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, training-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 various committees (i.e., Executive, Selection and Evaluation) with regard to the provision of input, guidance and oversight of the program?
  • For renewal applications, was institutional support sufficient to allow the program to achieve its objectives?

 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?
  • Is the PD/PI 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

  • For this national K12 program, is there an effective plan for identifying highly-qualified mentors and linking them to potential candidates, and ensuring that those mentors commit to candidate support?
  • Will mentors at remote sites be effectively integrated into the national network of the proposed K12 program in terms of providing guidance and scientific advice to the scholars and supporting their transition to independent status?
  • Are the mentors currently engaged in relevant research?

Scholars

  • Is a recruitment plan proposed with strategies likely to attract high quality scholars with a commitment to research relevant to the objectives of the FOA and the potential to develop as independent researchers?
  • 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 scholars?
  • 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 program?  Are effective mechanisms in place for obtaining feedback from current and former trainees?
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 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 Plan to Enhance Diversity

Peer reviewers will separately evaluate the recruitment plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment 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 training program, the level of trainee experience, and the particular circumstances of the trainees, 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 training 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 NICHD, 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 Advisory Child Health and Human Development (NACHHD) 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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date 

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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements.  FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award.  An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS.  The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

Inventions and Copyrights

Awards made primarily for educational purposes are exempted from the PHS invention requirements and thus invention reporting is not required, as described in the NIH Grants Policy Statement.

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 trainee appointed or reappointed to the training grant for 8 weeks or more. 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 trainee 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.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

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 Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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: 301-945-7573

Scientific/Research Contact(s)

Louis V. DePaolo, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6970
Email: depaolol@mail.nih.gov

Peer Review Contact(s)

Sherry Dupere, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-1485
Email: duperes@mail.nih.gov

Financial/Grants Management Contact(s)

Bryan Clark, M.B.A
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: clarkb1@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 Section 487 of the Public Health Service Act as amended (42 USC 288) and under Federal Regulations 42 CFR 66.

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.

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