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

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-HD-13-015

Companion Funding Opportunity

None 

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.865  

Funding Opportunity Purpose

This funding opportunity announcement (FOA) issued by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health, invites applications for the Reproductive Scientist Development Program (RSDP).  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.  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. 

Key Dates
Posted Date

July 20, 2012

Open Date (Earliest Submission Date)

October 15, 2012  

Letter of Intent Due Date

October 15, 2012 

Application Due Date(s)

November 15, 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 16, 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.

This FOA encourages applications from organizations that propose creative and innovative institutional research career development programs in the mission area(s) of the NIH.

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.

Purpose

 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.  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.

Background

The RSDP is a national career development program that was launched in 1988 with the goal of developing a cadre of reproductive physician-scientists based in academic departments who could employ cutting-edge cell and molecular technologies to address important problems in the field of Obstetrics and Gynecology (Ob-Gyn).  The mentored research experiences offered by this program seek to assist junior faculty in their transition to productive, independent physician-scientists who are highly competitive for research funding.  As of spring, 2012, approximately 90 clinical fellows (hereafter referred in this FOA as "scholars") have participated in the RSDP.  Of those scholars, nearly 90% are active in academia, 62% have applied for NIH funding (excluding loan repayment applications) and approximately two-thirds of those applying have received at least one grant.  Many of these individuals have also gone on to assume leadership positions in their respective institutions.

The parent award is provided to an academic institution that then provides funds to US-based academic institutions to support scholar career development activities.  Since its inception, the parent award has been based at the University of California, San Francisco and was re-competed by a letter of intent according to NICHD procedures for renewal of this Program.    

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 chairperson of Ob-Gyn) and a world-class mentor(s) at a US institution of their choice.  During this phase, the scholar devotes 100% of their time conducting cutting-edge basic research in cellular/molecular biology.  Following this intensive research training, the scholar enters Phase II training and assumes a junior faculty position in the sponsoring department for three years, as assured by the department chairperson at the time of the prospective scholar’s application for an appointment to the career development award.  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

With funds from this award, the RSDP will provide annual support for up to 15 scholars including up to three scholars for each of the first and second year of Phase I training and for each of the first, second and third 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 Chair of Ob-Gyn, each applicant to the RSDP will be chosen for entry into Phase I and progression to Phase II by the RSDP Selection Committee.

The scope of the research conducted by the scholar includes all areas of Ob-Gyn 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 and molecular biologythat will allow them to answer questions important to reproductive science.  The work should ultimately be relevant to general Ob-Gyn and/or its subspecialties such as maternal-fetal medicine, reproductive endocrinology and infertility (including those interested in contraception), gynecologic oncology and urogynecology. 

The proposed RSDP may complement other, ongoing training and career development programs at the applicant institution, but the proposed RSDP research experiences must be distinct from those of other 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

NICHD intends to commit up to $1,800,000 total costs in FY 2013 to fund one award.  Future year amounts will depend on annual appropriations.

Award Budget

Application budgets are limited to a total cost ceiling of up to $1,800,000 in FY 2013, 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

Applicants 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 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 career development 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. 

Support for personnel and other administrative activities should be limited to no more than $200,000 direct costs per year.

Items that may NOT be supported with K12 funds include:

  • Salaries and fringe benefits for the program mentors;
  • Direct support of the laboratories, salaries, fringe benefits, travel and research projects of the investigators serving as mentors beyond those expenses directly attributable to the Scholar's project;
  • Salary and support for central institutional administrative personnel (e.g., budget officers, grant assistants, and building maintenance personnel), which are usually paid from institutional overhead charges;
  • Salary and support for administrative activities such as institutional public relations or health and educational services. 
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, scholars are provided up to $100,000 for salary support plus associated fringe benefits, annually from the K12 award consistent with their 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 through five of the Program, scholars are provided up to $75,000 for salary support plus associated fringe benefits, annually from the K12 award consistent with their 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' and career development activities.  Allowable expenses include (1) travel to training or 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.

Other Program Related Expenses

The RSDP budget should include adequate funds to permit each scholar to attend the annual RSDP Scholar's Retreat.  

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 by all training sites. This includes assuring that all training sites provide of adequate staff, facilities, and educational resources that can contribute to the success of 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.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Even though non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply, it is permissible during Phase I for Scholars to spend time in a foreign-based laboratory if this experience can enhance the research skills of the Scholar.  The duration of time spent in the foreign laboratory should be no longer than three months.  Also, the experience must be unique in that it cannot be duplicated in a US-based laboratory setting.

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.

Participants (Scholars)

Scholars to be supported by the RSDP 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 on the K12 award.

Phase I Scholars must have 100% of their professional time protected from clinical duties or assignments.  Phase II Scholars must have a minimum of 75% of their professional time protected from clinical duties or assignments.

At the time of entry into the RSDP, a scholar may not be or have been a PD/PI on an R01, R29 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 other eligibility requirements.

By the time of appointment, each scholar must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Care USCIS Form I-551, or other legal verification of such status).  Details on citizenship requirements are available in the NIH Grants Policy Statement.

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, K22, K23, K25, K99) 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 the last two years of their 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

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:

Louis V. DePaolo, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 8B01
Bethesda, MD  20892-7510
Rockville, MD  20852 for courier/non-USPS service
Telephone: 301-435-6970
Fax: 301/480-2389
Email: depaolol@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:

Substitute all references to “trainees” in the SF 424 (R&R) Application Guide with “scholars” and all references to “training” in the SF 424 (R&R) Application Guide with “career development”.

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.

Committees (Uploaded via the Other Attachments section)

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 and 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.

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:

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

Program Administration (Component of Program Plan) 

Describe the strengths, leadership and administrative skills, and scientific expertise of the PD/PI. Include the planned strategy and administrative structure to be used to oversee and monitor the program. For applications with multiple PDs/PIs, address the Leadership Plan and how the combined knowledge, skills and experience of the individual PDs/PIs will enhance the likelihood of success of the program. 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.

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.

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 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.  

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. 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 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 trainees. 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 trainees. Provide brief summaries of training plans that the program will employ. The application should contain a description of how training 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 that the PD/PIs will require that institutions selected by scholars for mentored career development research activities will provide written assurance of 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.

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 or table of scholars who have participated in this K12 program over the past ten years.   Provide scholar data including name, years funded through the K12 program, name of mentor, department, title of research project or research topic area, current professional position (appointment type, department), and research grant awards (e.g., R21, R01).  Optional information may include peer reviewed journal publications based on RSDP-supported research.  Standardized data tables are available to provide some of this information (see below).

Data Tables

Standardized data tables for institutional training programs (e.g., T32 and K12 programs) are located at http://grants.nih.gov/grants/funding/424/index.htm#datatables. The data tables are designed to enable consistent entry and review of data for training program faculty and scholars.  The information provided in these data tables is not counted toward the 25 page limitation for the main body of the application (Items 2.2-2.4 in the SF424 instructions).  

Some or all of the tables may not be appropriate for any given K12 application.  Applicants are encouraged to use those tables that will be useful in describing important aspects of the program.  Additional tables may be included in the Research Training Program Plan.  However, such tables will count as part of the 25 page limit.

Please read the Introduction to the Data Tables linked on the above web site before starting to prepare the tables. The data tables should be numbered consecutively and titled as shown, even if some are not used.  Indicate by table number and title those tables that are intentionally omitted.  Additional tables not specified in these instructions should be identified by letter, rather than number, to avoid confusion with the sequentially numbered required tables.

The information included in the data tables should be used to present a detailed documentation of the proposed K12 Training Program.  For example, renewal applications may include a list of data from past scholars as described in the instructions for Table 12B.  Publications of past scholars resulting from work conducted during the period of K12 training, regardless of when the publication actually appeared, may be listed in Table 6B.  Applicants may provide explanatory notes at the bottom of the standardized data tables. 

Use the data in these tables to support the presentation of the training program as described in the body of the application. Applicants should include the data table attachment (Item 13. Data Tables) even if none of the standardized data tables will be used.  List the data tables by title and indicate that the table is “Not Applicable”.

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.

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? 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? Are the PD(s)/PI(s) currently engaged in research relevant to the scientific area of the proposed program?

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 currently engaged in relevant research?

Candidates/Scholars

Is a recruitment plan proposed with strategies likely to attract high quality scholar candidates 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 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 career development program? Is there evidence of a successful past training record of the PD/PI including the success of former scholars in seeking independent support and establishing productive scientific careers?

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? 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 NICHD, 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:

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:

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.

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)

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

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Ted Williams
Eunice Kennedy Shriver National Institute of Child Health and Human Development
Telephone: 301-435-6996
Email: williate@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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