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

Postdoctoral Research Training in Pediatric Clinical Pharmacology (T32)  

Activity Code

T32 Institutional National Research Service Award (NRSA)

Announcement Type

Reissue of RFA-HD-10-005 

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-HD-16-015

Companion Funding Opportunity

None

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

93.865    

Funding Opportunity Purpose

This funding opportunity announcement (FOA) invites grant applications from institutions/organizations that propose to develop clinician-scientists who will be leaders in the field of pediatric clinical pharmacology research. Individuals in these programs should receive training and experience in the methods and conduct of basic and clinical research, in order to qualify them to perform such studies independently.    

Key Dates
Posted Date

April 20, 2015

Open Date (Earliest Submission Date)

June 21, 2015  

Letter of Intent Due Date(s)

June 21, 2015  

Application Due Date(s)

July 21, 2015, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

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

October 2015

Advisory Council Review

January 2016  

Earliest Start Date

April 2016  

Expiration Date

July 22, 2015 

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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


Table of Contents

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


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

The overall goal of the NIH Ruth L. Kirschstein National Research Service Award (NRSA) program 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.  In order to accomplish this goal, NRSA training programs are designed to train individuals to conduct research and to prepare for research careers. More information about NRSA programs may be found at the Ruth L. Kirschstein National Research Service Award (NRSA) website.

Purpose and Background Information

The NRSA program has been the primary means of supporting predoctoral and postdoctoral research training programs since enactment of the NRSA legislation in 1974.  Research training activities can be in basic biomedical or clinical sciences, in behavioral or social sciences, in health services research, or in any other discipline relevant to the NIH mission.

Institutional NRSA programs allow the Training Program Director/Principal Investigator (Training PD/PI) to select the trainees and develop a program of coursework, research experiences, and technical and/or professional skills development appropriate for the selected trainees. Each program should provide high-quality research training and offer opportunities in addition to conducting mentored research. The grant offsets the cost of stipends, tuition and fees, and training related expenses, including health insurance, for the appointed trainees in accordance with the approved NIH support levels.

Program Objective

The objective of the Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Research Training Grant (T32) program is to develop and/or enhance research training opportunities for individuals interested in careers in biomedical, behavioral and clinical research that are relevant to the NIH mission.  The training program should provide:

  • A strong foundation in research design, methods, and analytic techniques appropriate for the proposed research area;
  • The enhancement of the trainees’ ability to conceptualize and think through research problems with increasing independence;
  • Experience conducting research using state-of-the-art methods as well as presenting and publishing their research findings;
  • The opportunity to interact with members of the scientific community at appropriate scientific meetings and workshops; and
  • The enhancement of the trainees’ understanding of the health-related sciences and the relationship of their research training to health and disease.

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


Program Considerations

The duration of training, the transition of trainees to individual support mechanisms, and their transition to the next career stage are important considerations in institutional training programs.  Training PDs/PIs should limit appointments to individuals who are committed to a research career and who plan to remain in training for no less than two years, whether that support comes from a training grant or some combination of NRSA and non-NRSA support programs.  Training PDs/PIs should encourage and make available appropriate skills training so that  trainees are prepared to apply for subsequent independent support for their training or research program (e.g., an individual fellowship award, mentored career development award, or research project grant), as appropriate for their career stage.  In addition, past studies (Lenfant, C. Review of the National Institutes of Health Biomedical Research Training Programs, 1989) have shown that health professional trainees who train in programs with postdoctoral researchers who have intensive research backgrounds are more likely to apply for and receive subsequent research grant support.  Programs that emphasize research training for individuals with the M.D. or other health-professional degrees are therefore encouraged to develop ties to basic science departments and include trainees with research doctorates when this approach is consistent with the goals of the proposed training program. 

Biomedical research and the resulting scientific knowledge are increasingly complex and multidisciplinary in nature. Training PDs/PIs are encouraged to develop institutional training programs that will expose trainees to a diversity of scientific approaches, systems for study, research approaches, and tools and technologies. Consideration of team-based research approaches may also be warranted depending upon the goals of the proposed training program.  

Within the framework of the NRSA program’s longstanding commitment to excellence and the projected need for investigators in particular areas of research, attention must be given to recruiting and retaining trainees from racial or ethnic groups underrepresented in the biomedical, behavioral and clinical sciences, individuals with disabilities, and individuals from disadvantaged backgrounds. See Section IV for background.

The career outcomes of individuals supported by NRSA training programs include both research-intensive careers in academia and industry and research-related careers in various sectors, e.g., academic institutions, government agencies, for-profit businesses, and private foundations. Training programs should make available structured, career development advising and learning opportunities (e.g., workshops, discussions, Individual Development Plans). Through such opportunities, trainees would obtain a working knowledge of various potential career directions that make strong use of the knowledge and skills gained during research training and the steps required to transition successfully to the next stage of their chosen career.  

Institutional research training grants must be used to support a program of full-time research training. Within the full-time training period, research trainees who are also training as clinicians must devote their time to the proposed research training and must confine clinical duties to those that are an integral part of the research training experience. The program may not be used to support studies leading to the M.D., D.D.S., or other clinical, health-professional training except when those studies are part of a formal combined research degree program, such as the M.D./Ph.D. Similarly, trainees may not accept NRSA support for clinical training that is part of residency training leading to clinical certification in a medical or dental specialty or subspecialty. It is permissible and encouraged, however, for clinicians to engage in NRSA-supported, full-time postdoctoral research training even when that experience is creditable toward certification by a clinical specialty or subspecialty board.

Background

Pediatric pharmacology has been the mainstay of pediatric therapeutics, with emphasis on the effect of development on the disposition and response to specific drugs in children. Properly trained pediatric clinical pharmacologists are indispensable for their ability to integrate basic and clinical science including trial design, epidemiology, biostatistics, biomarker qualification and standardization; disease-specific biomarker development; novel clinical trial design and endpoints; and bioinformatics, including clinical trial modeling and simulation. There is unprecedented innovation in biomedicine, juxtaposed with increased public attention to drug safety and accessibility. The explosion in biomedical knowledge and the growing number of disease targets dictate the need to reevaluate traditional approaches to pediatric pharmacology by incorporating new technologies.

At present there is a shortage of scientists who have formal training in pediatric clinical pharmacology.  This is a major human resource gap that could further disadvantage children as advances continue to be enjoyed in adult therapeutics. The current demand for training both physicians and biomedical scientists in pediatric clinical pharmacology far outstrips the available opportunities-a situation that must find a remedy if the opportunities for therapeutic advancement afforded by the provisions of the Best Pharmaceuticals for Children Act of 2012 (BPCA), the Pediatric Research Equity Act (PREA), and similar global initiatives are to be fully realized. Implicit in this legislation is the need to provide trained pediatric pharmacologists to implement the studies required by the Act.

Scope

The purpose of the BPCA-funded T32 program in Pediatric Clinical Pharmacology is to help ensure that a diverse and highly trained workforce is available in an area that has a limited number of researchers. Without an increase in the pool of investigators trained in new 'omics' technologies and pharmacometrics and their application to pediatric therapeutics, the necessary integration and synergistic interaction will not be possible, and the overall goal of personalized pediatric therapeutics will not be realized. The major focus of this program is to train fellows to utilize the most advanced techniques as applied to pediatric drug therapy and rational therapeutics.

Trainees, most of whom would have the MD or PharmD and/or PhD degrees, will be expected to spend at least 2 years in the training program. Trainees should have the opportunity to acquire fundamental scientific knowledge and research techniques in such areas as basic pharmacology, biochemistry, physiology, molecular medicine and gene therapy, biostatistics, pediatric pharmacometrics, trial simulation and design modeling of disease progression, pharmacogenetics/genomics and other biomedical disciplines. Individuals in these programs will receive training and experience in the methods and conduct of basic and clinical research, in order to qualify them to perform such studies independently.

The major focus of this FOA is to train fellows to utilize the most advanced techniques developed in adults and apply them to pediatric drug therapy and rational therapeutics, developmental pharmacology, developmental pharmacogenetics/pharmacogenomics, and pharmacologic biomarker development and validation.

For trainees with an MD, PharmD, or other professional degree, this experience should emphasize rigorous research training and complement their clinical backgrounds. The training program will provide each trainee with two years of full-time postdoctoral research training, including didactic instruction, mentoring and supervised research experience.

Trainees may be recruited from a broad range of pediatric clinical specialties.

There must a synergy between the training plans for PharmD or PhD trainees and those with MDs.

1) Organization and Structure: The PD/PI of the training program must be a clinical pharmacologist, preferably with subspecialty training. A pediatric liaison with pediatric subspecialists should be included as needed to facilitate interactions between the Clinical Pharmacology Division and other pediatric subspecialties divisions within Pediatric Departments. The clinical pharmacology training program should be organized to provide a coherent, integrated, and progressive educational program in clinical pharmacology with emphasis in pediatrics. The training program must be structured to ensure that each trainee acquires the knowledge, the clinical management and interpersonal skills, the professional attitudes and behaviors, and the experience required to become proficient in pediatric clinical pharmacology. The program must be accomplished within a 24-month period of training.

2) Research Experience: The trainee shall obtain research experience relevant to pediatric clinical pharmacology. The research focus can be either laboratory or clinic based. Once a research focus is defined, an ongoing exposure to the complementary area of clinical pharmacology research (i.e., basic, translational or clinical) is recommended. The trainee must also gain experience in oral presentation. This may be accomplished by presenting at scientific meetings, local seminars, conferences, and courses for students or house staff.

3) Formal education:  The program may involve a variety of educational formats, including graduate level courses (including on-line courses). Topics should include, but are not limited to: basic pharmacology (in the non-pediatric component of the program), ontogeny of organ system function, developmental pharmacology, including issues specific to fetuses, pre-term infants, newborns, infants, children, and adolescents; pharmacometrics; principles of compartmental and non-compartmental analysis, population and trial simulation modeling; statistics;  pharmacokinetics, pharmacogenetics / pharmacogenomics; proteomics/ metabolomics; and pediatric clinical trial design; and regulatory science.

4) Other Recommended Experiences:   a) Clinical experience in the domain of Clinical Pharmacology with the specifics determined by the individual program; b) External rotations at clinical pharmacology sites or intramural NIH sites involved in developing new drugs in pediatrics; c) Participation in a clinical pharmacology/toxicology consultation service (hospital-based); d) Participation in the activities of a Pharmacy and Therapeutics Committee; e) Institutional Review Board participation or observation.

In addition to the didactic opportunities offered at each institution, the fellows in the programs funded under this FOA are expected to interact with each other and with other T32 programs in clinical pharmacology that have a pediatric component.  Altogether these T32 programs constitute a “virtual” network of institutions linked by a website (PedPharmHub.org) created by NICHD. PedPharmHub was developed exclusively for the use of faculty and fellows. The site contains training Program updates, lectures, recordings, discussion boards, document libraries, Special Interest Groups, information on active grants in pediatric pharmacology, and a Sharepoint site to facilitate discussions between trainees and to develop research protocols across sites.

All T32 trainees are expected to participate in across-institutions interactions and are also required to attend an annual face-to-face meeting and present their ongoing or completed research.

All trainees are encouraged to enroll in and complete the Core Training program in Pediatric Clinical Pharmacology developed by NICHD (main lecture series at http://www.cvent.com/d/k4qfvg; course schedule at http://www.cvent.com/d/k4qfvg/2K), and participate in monthly journal clubs and Summer Yaffe Memorial Lectures in Pediatric Clinical Pharmacology and other didactic webinars.

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
Revision

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

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

NICHD intends to commit $523,000 in FY2016 to fund three to five awards.

Award Budget

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

Grantees are expected to be familiar with and comply with applicable cost policies and the NRSA Guidelines (NIH Grants Policy Statement - Institutional Research Training Grants). Funds may be used only for those expenses that are directly related to and necessary for the research training and must be expended in conformance with OMB Cost Principles, the NIH Grants Policy Statement, and the NRSA regulations, policies, guidelines, and conditions set forth in this document.

Award Project Period

The scope of the proposed project should determine the project period.  The maximum project period is 5 years.     

Other Award Budget Information
Stipends, Tuition, and Fees
 

Kirschstein-NRSA awards provide stipends as a subsistence allowance to help defray living expenses during the research training experience.

NIH will contribute to the combined cost of tuition and fees at the rate in place at the time of award.

The most recent stipend, tuition, and fee levels are described on the Ruth L. Kirschstein National Research Service Award (NRSA) site. Visit NIH Grants Policy Statement: Ruth L. Kirschstein National Research Service Awards for more information.

Trainee Travel
 

Trainee travel to attend scientific meetings and workshops that the institution determines to be necessary for the individual’s research training experience is an allowable trainee expense for predoctoral and postdoctoral trainees. 

Training Related Expenses
 

NIH will provide funds to help defray other research training expenses, such as health insurance, staff salaries, consultant costs, equipment, research supplies, and faculty/staff travel directly related to the research training program. The most recent levels of training related expenses are described on the Ruth L. Kirschstein National Research Service Award (NRSA) site.  Visit NIH Grants Policy Statement: Ruth L. Kirschstein National Research Service Awards for more information.

Indirect Costs

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

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

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

Governments

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

Other

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

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

The applicant institution must have robust and high-quality research ongoing in the area(s) proposed under this FOA and must have the requisite faculty, staff, students and postdoctorates (as applicable), and facilities on site to conduct the proposed institutional program. It is anticipated that program faculty will have active, funded research projects in which participating trainees may gain relevant experiences consistent with their research interests and goals.

Foreign Institutions

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

Required Registrations

Applicant Organizations

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

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • 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.

The PD/PI of the training program must be a clinical pharmacologist, preferably with subspecialty training, and must be capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The Training PD/PI will be responsible for the selection and appointment of trainees to the approved research training program, and for the overall direction, management, administration, and evaluation of the program. The Training 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.

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.

Trainees

The individual to be trained must be a citizen or a noncitizen national of the United States or have been lawfully admitted for permanent residence at the time of appointment. Additional details on citizenship, training period, and aggregate duration of support are available in the NIH Grants Policy Statement.

All trainees are required to pursue their research training full time, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies. Appointments are normally made in 12-month increments, and no trainee may be appointed for less than 9 months during the initial period of appointment, except with prior approval of the NIH awarding unit, or when trainees are appointed to approved, short-term training positions.

This program is limited to postdoctoral trainees.  Trainees must have received, as of the beginning date of the NRSA appointment, a Ph.D., M.D., D.D.S., or comparable doctoral degree from an accredited domestic or foreign institution. Comparable doctoral degrees include, but are not limited to, the following:  D.M.D., D.C., D.O., D.V.M., O.D., D.P.M., Sc.D., Eng.D., Dr. P.H., D.N.Sc., D.P.T., Pharm.D., N.D. (Doctor of Naturopathy), D.S.W., Psy.D, as well as a doctoral degree in nursing research. Documentation by an authorized official of the degree-granting institution certifying all degree requirements have been met prior to the beginning date of the training appointment is acceptable. Individuals in postgraduate clinical training who wish to interrupt their studies for at least 2 years to engage in full-time research training before completing their formal training programs are also eligible.

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

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

2. Content and Form of Application Submission

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

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

Letter of Intent

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

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

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

The letter of intent should be sent to:

George P. Giacoia, M.D.
Obstetric and Pediatric Pharmacology and Therapeutics Branch
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Suite 4AO1C
Bethesda, MD 20892
Telephone: (301) 496-5589
FAX:  (301) 480-2897
Email:  giacoiag@mail.nih.gov

Page Limitations

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424 (R&R) Other Project Information

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

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

Facilities and Other Resources.  For the Division of Pediatric Pharmacology or other participating departments, describe any experience or track record of doing drug studies in collaboration with pediatric subspecialists.  Include information on whether any of the drug studies resulted in or contributed to FDA labeling of drugs in the pediatric population.  Describe the availability of laboratory facilities using "omics" technologies and the availability of drug and biomarker measurements using microsamples.  Provide evidence that there are sufficient numbers of eligible research patients in the pediatric age groups: newborn, infants, preadolescents, and adolescents. Describe whether the clinical pharmacology division supports or has access to a pharmacometric laboratory staffed with a pediatric pharmacometrician.

Other Attachments. An Advisory Committee is not a required component of a training program.  However, if an Advisory Committee is intended, provide a plan for the appointment of an Advisory Committee to monitor progress of the training program. The composition, roles, responsibilities, and desired expertise of committee members, frequency of committee meetings, and other relevant information should be included. Describe how the Advisory Committee will evaluate the overall effectiveness of the program. Proposed Advisory Committee members should be named in the application if they have been invited to participate at the time the application is submitted.  Renewal applications with Advisory Committees should include the names of all committee members during the past project period.  Please name your file “Advisory_Committee.pdf”.

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

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

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

PHS 398 Cover Page Supplement

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

PHS 398 Training Subaward Budget Attachment(s)

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

Training 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.
PHS 398 Research Training Program Plan

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

Particular attention must be given to the required Training Data Tables.

Program Plan

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

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

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

The PD/PI should describe program activities intended to develop the working knowledge needed for trainees to select among and prepare for the next step in varied research career options available in the biomedical workforce. For example, programs should provide all trainees with instruction and training in oral and written presentation and in skills needed to apply for individual fellowship or grant support. All postdoctoral trainees should also be provided with instruction in laboratory and project management. 

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

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

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

Institutional Environment and Commitment to the Program.

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

Recruitment Plan to Enhance Diversity

Fostering diversity in the scientific research workforce is a key component of the NIH strategy to identify, develop, support and maintain the quality of our scientific human capital (NOT-OD-15-053).

Every facet of the United States scientific research enterprise—from basic laboratory research to clinical and translational research to policy formation–requires superior intellect, creativity and a wide range of skill sets and viewpoints. NIH’s ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds who will help to further NIH's mission.

Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the researchers, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust.

In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. NIH encourages institutions to diversify their student and faculty populations to enhance the participation of individuals from groups identified as underrepresented in the biomedical, clinical, behavioral and social sciences, such as:

A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27) and the report Women, Minorities, and Persons with Disabilities in Science and Engineering). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: Blacks or African Americans, Hispanics or Latinos, American Indians or Alaska Natives, and Native Hawaiians and other Pacific Islanders.

B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities, as described in the Americans with Disabilities Act of 1990, as amended.  See NSF data at, http://www.nsf.gov/statistics/wmpd/2013/pdf/tab7-5_updated_2014_10.pdf.

C. Individuals from disadvantaged backgrounds, defined as:

1. Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size, published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at http://aspe.hhs.gov/poverty/index.shtml.

2. Individuals who come from an educational environment such as that found in certain rural or inner-city environments that has demonstrably and directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career.

The disadvantaged background category (C1 and C2) is applicable only to programs focused on high school and undergraduate candidates.  Note: this group is generally NOT part of the recruitment plan for predoctoral trainees on institutional training grants (e.g., T32).

New applications must include a description of plans to enhance recruitment, including the strategies that will be used to enhance the recruitment of trainees from underrepresented backgrounds and may wish to include data in support of past accomplishments. Renewal applications must include a detailed account of experiences in recruiting individuals from underrepresented groups during the previous funding period. Information should be included on both successful and unsuccessful recruitment strategies.

History and Achievements. Describe efforts to recruit trainees from Diversity groups A and B, as well as group C (when applicable), into the existing training program. For competing continuation/renewal applications, also describe past efforts to recruit underrepresented minority students and individuals with disabilities into training grant funded positions. If required by the FOA, refer to the data presented in Tables 6 and 7, as applicable. 

Use these data to document the success of the program in recruiting trainees who are under-represented and provide information on their support.

Proposed plans. Describe steps to be taken during the proposed award period regarding the identification, recruitment of graduate students from Diversity groups A and B, as well as group C (when applicable). Consider the success and/or failures of recruitment strategies used in the past. In particular, describe the specific efforts to be undertaken by the training program and how these might relate to the recruitment efforts of the medical school, graduate school, and/or the university at large. In most cases, institutional efforts alone will not satisfy the requirement to recruit individuals from underrepresented groups.

Applications without a Recruitment Plan to Enhance Diversity  will be considered incomplete and will not be reviewed.

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. 

All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). The plan must address the five, required instructional components outlined in the NIH policy: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the program faculty in the instruction; 4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and 5) Frequency of Instruction –instruction must occur during each career stage and at least once every four years. See also NOT-OD-10-019. The plan should be appropriate and reasonable for the nature and duration of the proposed program. Renewal (Type 2) applications must, in addition, describe any changes in formal instruction over the past project period and plans to address any weaknesses in the current instruction plan. All participating faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period must be named in the application.

Applications lacking a Plan for Instruction in the Responsible Conduct of Research will not be reviewed.

Appendix

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

3. Submission Dates and Times

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

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

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

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The National Research Service Award (NRSA) policies apply to this program. An NRSA appointment may not be held concurrently with another Federally sponsored fellowship, traineeship, or similar Federal award that provides a stipend or otherwise duplicates provisions of the NRSA.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement. Note, however, that pre-award costs are not allowable charges for stipends or tuition/fees on institutional training grants because these costs may not be charged to the grant until a trainee has actually been appointed and the appropriate paperwork submitted to the NIH awarding component.   

6. Other Submission Requirements and Information

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

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

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

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

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

See more tips for avoiding common errors.

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

Post Submission Materials

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

Section V. Application Review Information
1. Criteria

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

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood that the proposed 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.

Training Program and Environment

  • Are the research facilities and research environment conducive to preparing trainees for successful careers as biomedical research scientists?
  • Are the objectives, design and direction of the proposed research training program likely to ensure effective training?
  • Do the courses, where relevant, and research experiences provide opportunities for trainees to acquire state-of-the-art scientific knowledge, methods, and tools that are relevant to the goals of the training program?
  • Does the program provide appropriate inter- or multidisciplinary research training opportunities?
  • Is the proposed training program likely to ensure trainees will be well prepared for research-intensive and research-related careers?
  • Is the level of institutional commitment to the training program, including administrative and research training support, sufficient to ensure the success of the program?
  • Is it clear how the proposed training program is distinguished from other externally funded training programs at the institution? Are laboratory facilities using "omics" technology; are drug and biomarker measurements using microsamples available?
  • Does the Division of Pediatric Pharmacology have a documented history of doing drug studies in collaboration with pediatric subspecialists?
  • Have any of the drug studies resulted or contributed to FDA labeling of drugs in the pediatric population?
  • Is there documented evidence that there is a sufficient number of eligible research patients in the pediatric age groups: newborn, infants, preadolescents, and adolescents? Does the clinical pharmacology division support or have access to a pharmacometric laboratory staffed with a pediatric pharmacometrician?

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

  • Does the PD/PI have the scientific background, expertise, and administrative and training experience to provide strong leadership, direction, management, and administration of the proposed research training program?
  • Does the PD/PI plan to commit sufficient effort to ensure the program’s success?
  • For applications designating multiple PDs/PIs:
  • Is a strong justification provided that the multiple PD/PI leadership approach will benefit the training program and the trainees?
  • 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 training program and the complementary expertise of the PDs/PIs?

Preceptors/Mentors

  • Are sufficient numbers of experienced preceptors/mentors with appropriate expertise and funding available to support the number and level of trainees (including short-term trainees, if applicable) proposed in the application?
  • Do the preceptors/mentors have strong records as researchers, including recent publications and successful competition for research support in areas directly related to the proposed research training program?
  • Do the preceptors/mentors have strong records as researchers, including recent publications and successful competition for research support in areas directly related to the proposed research training program?

Trainees

  • Is a recruitment plan proposed with strategies likely to attract well-qualified candidates for the training program?
  • Is there a competitive applicant pool of sufficient size and quality to ensure a successful training program?

Are there well-defined and justified selection and re-appointment criteria as well as retention strategies?

Training Record

  • How successful are the trainees (or, for new applications, other past students/postdoctorates in similar training) in completing the program?
  • Has the training program ensured that trainees are productive (or, for new applications, other past students/postdoctorates in similar training) in terms of research accomplishments, publication of research conducted during the training period, and subsequent training appointments and fellowship or career development awards?
  • How successful are the trainees (or, for new applications, other past students/postdoctorates in similar training) in achieving productive scientific careers as evidenced by successful competition for research science positions in industry, academia, government or other research venues; grants; receipt of honors, awards, or patents; high-impact publications; promotion to scientific leadership positions; and/or other such measures of success?
  • To what extent do trainees’ subsequent positions in industrial, academic, government, non-profit, or other sectors benefit from their NRSA-supported research training and directly benefit the broader biomedical research enterprise?
  • Does the program propose a rigorous evaluation plan to assess the quality and effectiveness of the training?  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)? Is the program achieving its training objectives? Has the program evaluated the quality and effectiveness of the training experience (and when applicable, short-term training experience), and is there evidence that the evaluation outcomes and feedback from trainees have been acted upon? Are changes proposed that are likely to improve or strengthen the research training experience during the next project period (may not be applicable to short-term training)? Does the program continue to evolve and reflect changes in the research area in which the training occurs?

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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 the 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

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.

Institutional NRSA training grants must be administered in accordance with the current NRSA section of the NIH Grants Policy Statement - Institutional Research Training Grants.

The taxability of stipends is described in the NIH Grants Policy Statement. Policies regarding the Ruth L. Kirschstein-NRSA payback obligation are explained in the NIH Grants Policy Statement.

As specified in the NIH Revitalization Act of 1993, Kirschstein-NRSA recipients incur a service payback obligation for the first 12 months of postdoctoral support. Policies regarding the Ruth L. Kirschstein-NRSA payback obligation are explained in the NIH Grants Policy Statement; and more details are in the Frequently Asked Questions. Officials at the grantee institution have the responsibility of explaining the terms of the payback requirements to all prospective trainees before appointment to the training grant. Additionally, all trainees recruited into the training program should be provided with information related to the career options that might be available when they complete the program. The suitability of such career options as methods to satisfy the NRSA service payback obligation should be discussed.

Leave Policies

Note: The leave durations stated below apply to full-time trainees. Short-term trainee leave must be proportionally adjusted based on the duration of appointment.

In general, trainees may receive stipends during the normal periods of vacation and holidays observed by individuals in comparable training positions at the sponsoring institution. For the purpose of these awards, however, the period between the spring and fall semesters is considered to be an active time of research and research training and is not considered to be a vacation or holiday. Trainees may receive stipends for up to 15 calendar days of sick leave per year. Under exceptional circumstances, this period may be extended by the NIH awarding IC in response to a written request from an AOR. Sick leave may be used for the medical conditions related to pregnancy and childbirth. Trainees may receive stipends for up to 60 calendar days (equivalent to 8 work weeks) of parental leave per year for the adoption or the birth of a child when individuals in comparable training positions at the grantee organization have access to this level of paid leave for this purpose. Either parent is eligible for parental leave. The use of parental leave must be approved by the PD/PI (see also: NOT-OD-08-064).

A period of terminal leave is not permitted, and payment may not be made from traineeship funds for leave not taken. Trainees requiring periods of time away from their research training experience longer than specified here, i.e., more than 15 calendar days of sick leave or more than 60 calendar days of parental leave, must seek approval from the NIH awarding component for an unpaid leave of absence. Approval for a leave of absence must be requested in advance by an AOR on behalf of the trainee. Trainees supported by academic institutions should refer to the NIH Institutional NRSA training grant guidelines in the NIH Grants Policy Statement for further guidance regarding vacations and requested leave. 

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. 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.
  • Additionally, a completed Payback Agreement Form (PHS Form 6031) must be submitted for each postdoctoral trainee in his or her first 12 months of support.
  • 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. Trainees with service payback requirements must notify the NIH of any change in address and submit Annual Payback Activities Certification Forms (PHS Form 6031-1) until the payback service obligation is satisfied.

A final Progress Report, the expenditure data portion of the Federal Financial Report, and Termination Notices for all Trainees, are required for closeout of an award as described in the NIH Grants Policy Statement.

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)

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

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

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

Scientific/Research Contact(s)

George P. Giacoia, M.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-5589
Email: giacoiag@exchange.nih.gov

Peer Review Contact(s)

Sherry Dupere, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-451-3415
Email: duperes@mail.nih.gov

Financial/Grants Management Contact(s)

Bryan S. Clark, M.B.A.
Eunice Kennedy Shriver  National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: clark1@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.

NIH Office of Extramural Research Logo
Department of Health and Human Services (HHS) - Home Page
Department of Health
and Human Services (HHS)
USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.