EXPIRED
National Institutes of Health (NIH)
Postdoctoral Research in Pediatric Clinical Pharmacology (T32 Clinical Trial Not Allowed)
T32 Institutional National Research Service Award (NRSA)
Reissue RFA-HD-16-015
RFA-HD-21-014
None
93.865
This funding opportunity announcement (FOA) invites grant applications from institutions/organizations that propose to develop clinician-scientists and others 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.
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.
March 13, 2020
April 27, 2020
April 27, 2020
May 27, 2020
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
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.
Not applicable
November 2020
January 2021
April 2021
New date July 1, 2020 per NOT-HD-20-016 (Original Expiration Date: May 28, 2020).
Not Applicable
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:
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.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
New
Renewal
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
Not Allowed: Only accepting applications that do not propose clinical trials
Note: Appointed Trainees are permitted to obtain research experience in a clinical trial led by a mentor or co-mentor.
Need help determining whether you are doing a clinical trial?
NICHD intends to commit $600,000 in FY 2021 to fund 3-4 awards.
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.
The scope of the proposed project should determine the project period. The maximum project period is 5 years.
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.
Stipend levels, as well as funding amounts for tuition and fees and the institutional
allowance are announced annually in the NIH Guide for Grants and Contracts, and are also posted on the Ruth L. Kirschstein National Research Service
Award (NRSA) webpage.
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.
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 announced annually in the NIH Guide for Grants and Contracts, and are also posted on the Ruth L. Kirschstein National Research Service Award (NRSA) webpage.
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 from this FOA.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
Governments
Other
The sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program.
The applicant institution must have a strong and high-quality research program in the area(s) proposed under this FOA and must have the requisite faculty, 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.
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:
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:
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: pawlykac@mail.nih.gov
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:
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
Specific to this RFA:
Training Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))
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?
Are there well-defined and justified selection and re-appointment criteria as well as retention strategies?
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.
Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.
Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.
Not applicable
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?
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.
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:
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:
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.
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: GrantsInfo@nih.gov (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: support@grants.gov
Aaron C. Pawlyk, Ph.D.
Eunice
Kennedy Shriver National Institute of Child Health and Human
Development (NICHD)
Telephone: (301) 451-7299
Email: pawlykac@mail.nih.gov
Sherry Dupere, PhD
Eunice
Kennedy Shriver National Institute of Child Health and Human
Development (NICHD)
Telephone: 301-451-3415
Email: duperes@mail.nih.gov
Robin Kurtz
Eunice
Kennedy Shriver National Institute of Child Health and Human
Development (NICHD)
Telephone: 301-435-6978
Email: rkurtz@nih.gov
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.