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

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

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 agency-approved support levels.

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, and must be clearly distinct from related programs currently receiving Federal support.

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 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 MD 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 trainees from racial or ethnic groups underrepresented in the biomedical, behavioral and clinical sciences, individuals with disabilities, and individuals from disadvantaged backgrounds. See the Training (T) Instructions in the SF424 (R&R) Application Guide for further background and instructions.

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 are expected to 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 MD, DDS, or other clinical, health-professional training except when those studies are part of a formal combined research degree program, such as the MD/PhD. 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.

Goal

The goal of this initiative is to develop clinician-scientists and others who will be leaders in the field of pediatric clinical pharmacology research. This will be accomplished by providing training and experience in the methods and conduct of basic and clinical drug research in the different phases of pediatric drug development and fostering interaction with pediatric subspecialists to address deep knowledge gaps in pediatric therapeutics.

This RFA aligns with the NICHD’s Strategic Plan 2020, which promotes the goal of advancing safe and effective therapeutics for children and supports Scientific Stewardship through training an inclusive scientific workforce, and with the Best Pharmaceuticals for Children Act (BPCA) requirement that pediatric clinical pharmacologists be included in existent NIH career development programs.

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. The explosion in biomedical knowledge and the growing number of disease targets dictate the need to reevaluate traditional approaches to pediatric pharmacology and incorporate 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. This situation must be remedied 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 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. In addition, knowledge deficits in developmental pharmacology, developmental pharmacogenetics/pharmacogenomics, and pharmacologic biomarker development and validation in pediatrics will be part of the core curriculum.

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. If the PD/PI does not have subspecialty training in pediatrics, the Sr. Key Persons must include a qualified individual to serve as a pediatric liaison to facilitate interactions between the Clinical Pharmacology Division and other pediatric subspecialty 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.

2) Research Experience: The trainees 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 trainees 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 trainees 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. T32 programs funded through this FOA will constitute a "virtual" network of institutions linked by a website created by NICHD for the use of faculty and trainees. 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 cross-institutional interactions and are also required to attend an annual NICHD-sponsored 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 (https://www.nichd.nih.gov/research/supported/bpca/lectures), and participate in monthly journal clubs and Summer Yaffe Memorial Lectures in Pediatric Clinical Pharmacology and other didactic webinars.

This Funding Opportunity Announcement (FOA) does not allow appointed Trainees to lead an independent clinical trial but does allow them to obtain research experience in a clinical trial led by a mentor or co-mentor. NIH strongly supports training towards a career in clinically relevant research;

therefore gaining experience in clinical trials under the guidance of a mentor or co-mentor is encouraged.

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

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

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

Governments

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

Other

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

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

The applicant institution must have a strong and high-quality research program in the area(s) proposed under this FOA and must have the requisite faculty, staff, potential trainees and facilities on site to conduct the proposed institutional program. In many cases, it is anticipated that the proposed program will complement other ongoing training programs occurring at the applicant institution and that a substantial number of program faculty will have active research projects in which participating trainees may gain relevant experiences consistent with their research interests and goals.

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.

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) 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 to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. 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.

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 Program Directors/Principal Investigators (PD(s)/PI(s)) of the training program

For single PD/PI or multi-PD/PI applications, at least one of the PD(s)/PI(s)

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 PD(s)/PI(s) 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 PD(s)/PI(s) will be expected to monitor and assess the program and submit all documents and reports as required. The PD(s)/PI(s) have responsibility for the day to day administration of the program and is responsible for appointing members of the Advisory Committee (when applicable), using their recommendations to determine the appropriate allotment of funds.

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

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).

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

The 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 awarding unit, or when trainees are appointed to approved, short-term training positions.

Postdoctoral 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., DO, DVM., OD, DPM, ScD, EngD, DrPH, DNSc, DPT, PharmD, DSW, PsyD, 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 a year or more to engage in full-time research training before completing their formal training programs, are also eligible.

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

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

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:

Aaron C. Pawlyk, Ph.D.

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

Telephone: (301) 451-7299

Email: [email protected]

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.

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

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

Follow all instructions provided in the SF424 (R&R) Application, 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., l, postdoctoral, ), and intended trainee outcomes.

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 .

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. Clearly indicate how the proposed training program differs from others at the institution. 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.

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

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

For single PD/PI or multi-PD/PI applications, at least one of the PD(s)/PI(s) 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. If none of the PD(s)/PI(s) has subspecialty training in pediatrics, the Sr/Key Persons must include a qualified individual to serve as a pediatric liaison to facilitate interactions between the Clinical Pharmacology Division and other pediatric subspecialties divisions within Pediatric Departments.

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

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

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

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

Training Program

Faculty, Trainees, and Training Record

Other Training Program Sections

Appendix- Note that the Appendix should only be used in circumstances covered in the NIH policy on appendix materials or if the FOA specifically instructs applicants to do so.

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

Particular attention must be given to the required Training Data Tables. Applicants should summarize, in the body of the application, key data from the tables that highlight the characteristics of the applicant pool, faculty mentors, the educational and career outcomes of participants, and other factors that contribute to the overall environment of the program.

Training Program

Program Plan

Proposed 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 steps 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.

Plan for Instruction in the Responsible Conduct of Research

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

Appendix

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to theSF424 (R&R) Application Guide instructions.

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

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

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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

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

This initiative is not subject to intergovernmental review.

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. Any additional costs associated with the decision to allow research elective credit for short-term research training are not allowable charges on an institutional training grant.

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 How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

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

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

See more tips for avoiding common errors.

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

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

Only the review criteria described below will be considered in the review process.

Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

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

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?

Specific to this RFA:

• 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 Pharmacology (or equivalent) 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?
• 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 of training individuals at the level of trainees (including short-term trainees, if applicable) proposed in the program? Are appropriate plans in place to ensure that preceptors lacking sufficient research training experience are likely to provide strong and successful mentoring?

If the program will support clinical trial research experience for the Trainees, do the mentor(s) who will supervise the Trainee(s) have the expertise, experience, resources, and ability to provide appropriate guidance and help the Trainee(s) to meet the timelines?

Trainees

• Is a recruitment plan proposed with strategies likely to attract well-qualified trainees 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?

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

Not Applicable

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.

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

As part of the scientific peer review, all applications:

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

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

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

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

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date

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

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.

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

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

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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

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.

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.

Not Applicable

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.

• The institution must submit a completed Statement of Appointment (PHS Form 2271) for each trainee appointed or reappointed to the training grant for 8 weeks or more. Grantees must submit the PHS 2271 data electronically using the xTrain system. More information on xTrain is available at xTrain (eRA Commons). An appointment or reappointment may begin any time during the budget period, but not before the budget period start date of the grant year.
• 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 RPPR, 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.

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

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.

The overall evaluation of the program will be based on metrics that will include, but are not limited to, the following:

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

eRA Commons Help Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)

Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Aaron C. Pawlyk, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: (301) 451-7299
Email: [email protected]

Sherry Dupere, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-451-3415
Email: [email protected]

Robin Kurtz
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6978
Email: [email protected]

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.

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.