Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

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

Funding Opportunity Title
Pediatric Clinical Pharmacology Research Career Development Award (K12 Clinical Trial Not Allowed)
Activity Code

K12 Physician Scientist Award Program (PSA)

Announcement Type
New
Related Notices

NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022

Funding Opportunity Announcement (FOA) Number
RFA-HD-23-023
Companion Funding Opportunity
None
Number of Applications

See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)
93.865
Funding Opportunity Purpose

This funding opportunity announcement (FOA) encourages applications for institutional research career development (K12) programs that support mentored research and career development experiences for scholars pursuing clinical, translational, and/or basic research in pediatric therapeutics. This program constitutes a national network of mentors and scholars, in contrast to K12 programs that are based solely at a single applicant institution. The primary purpose of this FOA is to ensure that a pipeline of diverse and highly trained workforce is available in pediatric pharmacology-related clinical and biomedical fields that currently have a limited number of researchers. This FOA will support essential research career development opportunities and ensure “protected” time to pursue impactful research experiences for new faculty-level clinical pharmacologists, fostering the transition to productive highly skilled clinical pharmacologist investigators.

This initiative proposes to expand and strengthen the community of clinical pharmacologist investigators engaged in pediatric clinical pharmacology research.

Key Dates

Posted Date
September 09, 2022
Open Date (Earliest Submission Date)
November 06, 2022
Letter of Intent Due Date(s)

Not Applicable

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
December 06, 2022 Not Applicable December 06, 2022 March 2023 May 2023 July 2023

All applications are due by 5:00 PM local time of applicant organization.

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.

Expiration Date
December 07, 2022
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

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

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

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose and Background Information

The overall goal of the NIH Research Career Development programs is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation’s biomedical, behavioral, and clinical research needs. More information about Career programs may be found at the NIH Extramural Training Mechanisms website.

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

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

This Funding Opportunity Announcement (FOA) does not allow appointed Scholars 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 and so gaining experience in clinical trials under the guidance of a mentor or co-mentor is encouraged.

The overall goal of the Pediatric Clinical Pharmacology Research Career Development program is to help ensure that a diverse pool of highly trained clinical pharmacologists is available to address the Nation's biomedical, behavioral, and clinical research and leadership needs. More information about Career programs may be found at the NIH Extramural Training Mechanisms website.

Because this FOA focuses on fostering a diverse workforce, institutions with demonstrated commitment to diversity and inclusion are encouraged to apply. NIH programs recognize the important role that institutions with historical commitment to diverse individuals have played in supporting scientific research and providing health care in underserved communities. These institutions are uniquely positioned to engage minority populations in research and in the translation of research advances into culturally competent, measurable and sustained improvements in health outcomes. The proposed institutional research career development program may complement other, ongoing research training and career development programs at the applicant institution, but the proposed career development experiences must be distinct from those career development programs currently receiving Federal support.

Purpose and Background Information

The goal of the Pediatric Clinical Pharmacology Research Career Development Program is to promote rigorous career development experiences and inspire innovative research in support of pediatric drug development, with specific focuses in the following groups: neonates, infants, developing children, adolescents, and the transition to adulthood. This will be accomplished by supporting research career development of new faculty-level clinical pharmacologists. These K12 Program grant awards will generate well-qualified researchers who will help meet the need for highly skilled clinical pharmacologist investigators who can take advantage of new technologies and respond to the increasing demands of pediatric clinical pharmacology research. The Pediatric Clinical Pharmacology Research Career Development Program will constitute a national network of mentors and scholars, in contrast to K12 programs that are based solely at a single applicant institution. These K12 programs will augment the existing NICHD Pediatric Clinical and Developmental Pharmacology Training Network (PCDPTN), a collaborative network which allows interdisciplinary training of clinical, translational, and basic investigators who research pediatric therapeutics.

The PCDPTN was formed in response to the Best Pharmaceuticals for Children (BPCA) Act legislative mandate, requiring pediatric clinical pharmacologists to be included in existent NIH career development programs. This collaborative network—which allows interdisciplinary collaboration of clinical, translational, and basic investigators who research pediatric therapeutics-is demonstrated resource for training and mentorship opportunities. To ensure a diverse pool of highly trained independent clinical pharmacologists, intensive, expanding, supervised career development experiences are necessary. The K12 programs will run in parallel with the existing T32 Pediatric Clinical Pharmacology Postdoctoral Training program leveraging resources offered by existing programs (i.e., Maternal and Pediatrics Precision in Therapeutics (MPRINT) Hub, Pediatric Trials Network (PTN), Maternal Fetal Medicine Units (MFMU) Network, Neonatal Research Network (NRN)) and other NICHD/NIH programs. The pediatric clinical pharmacology training and career development programs, together, intend to address NICHD’s aspirational goals of established the next generation of scientists to harness the techniques necessary for future investigation.

Program Objective

The primary objective of the Pediatric Clinical Pharmacology Research Career Development program is to support pediatric research-intensive institutions in the development of creative, innovative, independent researchers, who will have the skills necessary to conduct rigorous and reproducible research, and to transition successfully into independent academic careers in the biomedical research workforce. Each program should provide high-quality research training, mentored research experiences, including training in appropriate methods, technologies, relevant quantitative/computational approaches, rigorous experimental design, and interpretation of data, and professional development skills such as interdisciplinary collaboration, communication, management, leadership, and teamwork. These programs will serve as a bridge between formal research training and the receipt of independent research grants.

Applications for this award should propose a research plan which has both intrinsic and extrinsic research importance and will also serve as a suitable vehicle for learning the methodology, theories, and conceptualizations necessary for a well-trained independent researcher. The Program Director/Principal Investigator will select the scholars and develop mentored research experiences, promote technical and professional skills development, and support a program of coursework, appropriate for the selected trainees. The entire program should be designed to:

  • increase, enhance and diversify the pool of investigators (doctoral biomedical professionals, including, but not limited to, MD, DO, PharmD, PhD, DC, ND, DDS, DMD, DVM, ScD, DNS, or equivalent biomedical professional doctoral degrees) trained in clinical and translational pediatric clinical pharmacology research, and to promote their career development as clinical pharmacology researchers.
  • provide opportunity for early career awardees to conduct their research independently at institutions without strong clinical pharmacology programs while getting formal mentorship, magnifying exposure to rigorous clinical research programs and support (with possible collaboration) from leading clinical pharmacologists, thus ensuring competitiveness for major grant support.
  • provide continued development of research leaders in the field of clinical pharmacology, building a strong foundation in research design, methods, and analytic techniques appropriate for a more comprehensive clinical pharmacology research area.

NICHD K12 programs must establish individualized career development plans to accommodate scholars with different levels of prior research training/experience. For example, a prospective candidate with limited clinical research experience may find it appropriate to engage in a structured, phased developmental program, including a designated period of didactic training followed by a period of supervised research experience. Additionally, the assignment of multiple mentors to each Scholar may be necessary, for example a clinical pharmacologist conducting patient-oriented research and a basic science researcher.

Scholar appointments to NICHD K12 programs are from 2-3 years in length and are expected to compete for independent NIH funding at its completion. At the conclusion of the program, scholars will be able to work effectively with colleagues from a variety of backgrounds and scientific disciplines to contribute to inclusive and supportive scientific research environments. Scholars will possess the knowledge, professional skills, and experiences required to identify and transition into independent research careers that sustain biomedical research in areas that are relevant to the NIH mission.

The completion of a strong, well-planned, thorough career development plan, in addition to development of an impactful research project, is a critical aspect of this K12. The major outcome measures of this FOA are related to the career development of program graduates: high-quality publications (number, citations, journal impact), employment (research position, sector), successful NIH grant competition (number, time to award) and persistence in research (time).

Program Considerations

Under this FOA, all K12 scholars are expected to participate in cross-institutional interactions, encouraged to attend Principles of Pediatric Clinical Pharmacology Course lectures developed by NICHD (https://www.nichd.nih.gov/research/supported/bpca/lectures), participate in monthly journal clubs, and attend Summer Yaffe Memorial Lectures in Pediatric Clinical Pharmacology and other didactic webinars.

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

Pre-Submission Consultation

Applicants are strongly encouraged to consult with NIH scientific/research staff when planning an application. Early contact provides an opportunity for NIH scientific/research staff to provide guidance on program scope and appropriateness of the proposed research and career development for potential funding in response to this FOA. Applicants should contact NIH scientific/research staff as early as possible before the due date.

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

Section II. Award Information

Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed
New

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.

Clinical Trial?

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.

Funds Available and Anticipated Number of Awards

The NICHD intends to commit $600,000 in FY2023 to fund up to 2 awards.

Award Budget

Application budgets are limited to $275,000 in direct costs per year.

Award Project Period

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

Other Award Budget Information

Personnel Costs

Individuals designing, directing, and implementing the career development program may request salary and fringe benefits appropriate for the person months devoted to the program. Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap. If mentoring interactions and other activities with scholars are considered a regular part of an individual's academic duties, then mentoring and other interactions with scholars are non-reimbursable from grant funds.

Salary support for individuals involved in program administration and management must be substantially justified. Salary support for ancillary personnel (e.g. administrative assistance or secretarial support) on CDAs is not allowable.

Scholar Costs

Scholars are those individuals who benefit from the proposed activities and experiences involved in the career development program. Scholar costs must be justified as specifically required for the proposed career development program and based on institutional policies for salaries paid to individuals in similar positions, regardless of the source of funds. These expenses must be itemized in the proposed budget.

The program will support Scholars for periods of approximately 2-3 years consisting of consecutive 12-month appointments.

NICHD will contribute up to $100,000 per year toward each Scholar's salary and fringe benefits. In addition, NICHD will contribute up to $25,000 per year to the research development costs of each Scholar. The total salary requested must be based on a full-time, 12-month staff appointment and requires Scholars to devote a minimum of 9 person months (equivalent to 75 percent) of full-time professional effort toward health-related research and career development activities, with the remaining effort being devoted to activities related to the development of a successful career as a clinical pharmcologist. Allowable research and career development costs may include: 1) research expenses such as supplies, equipment and technical personnel, including expenses generated in the laboratories of the established investigators who serve as mentors; 2) travel to receive training or attend scientific meetings where the scholar will be presenting K12-funded work (not to exceed $1000 annually); 3) tuition, fees, or books; and 4) computer services. These research and development costs must be related to the Scholar's research activities.

The scholar's institution may supplement the NIH salary contribution up to a level that is consistent with the institution's salary scale from non-federal sources, however, supplementation may not be from federal funds unless specifically authorized.

Other Program Related Expenses

Consultant costs, equipment, supplies, travel for key persons, and other program-related expenses may be included in the proposed budget. These expenses must be justified as specifically required by the proposed program and must not duplicate items generally available at the applicant institution.

Items that may NOT be supported with K12 funds include:

  • Travel of the PD(s)/PI(s), or program mentors to scientific meetings other than the annual K12 Scholar's meeting;
  • Patient care costs such as inpatient bed days or outpatient visits, except for clinical laboratory analyses essential for the Scholars research;
  • Alterations and renovations. 
Indirect Costs

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

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

Governments

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

Other

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

Federal Governments

  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

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 career development programs occurring at the applicant institution and that a substantial number of program faculty will have active research projects in which participating scholars may gain relevant experiences consistent with their research interests and goals.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

 

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Required Registrations

Applicant Organizations

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

  • 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.
  • Unique Entity Identifier (UEI) – A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
  • eRA Commons – Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; 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 SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research training program as the Training Program Director/Principal Investigator (Training PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

The PD/PI should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI will be 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/PI will be expected to monitor and assess the program and submit all documents and reports as required. The PD/PI has 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.

The participation of multiple PDs/PIs is encouraged, particularly when each brings a unique perspective and skill set that will enhance training.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Only one application per institution (normally identified by having a unique UEI number or NIH IPF number) is allowed.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission. 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 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Only one application per institution (normally identified by having a unique UEI number or NIH IPF number) is allowed.

Preceptors/Mentors

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

Scholars

Scholars to be supported by the institutional career development program must be at the career level for which the planned program is intended. Scholars are expected to devote a minimum of 9 person-months (75% of full-time professional effort) during the appointment on the K12 award.

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

During the time of appointment, Scholars may not accept or receive support under any other PHS award that duplicates the provisions of this career award. However, Scholars may remain eligible for support under other individual mentored career development awards (e.g., K01, K08, K23, K25, K99) at the conclusion of the K12 appointment. Scholars may not receive support under concurrent K awards. Combined support through the K12 and other mentored career development award programs from NICHD must not exceed six years. The PD/PI should contact NICHD staff if there are questions regarding eligibility.

Section IV. Application and Submission Information

1. Requesting an Application Package

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.

2. Content and Form of Application Submission

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.

Overview Information, prospective applicants are asked to submit a letter of intent, 30 days prior to the application due date, 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:

Lesly Samedy Bates, PharmD, PhD, MS
Program Officer, Obstetric and Pediatric Pharmacology and Therapeutics Branch (OPPTB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-827-3241
Email: lesly-anne.samedy-bates@nih.gov

Page Limitations

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424 (R&R) Other Project Information

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

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

Project Summary/Abstract. Provide an abstract of the entire application. Include the objectives, rationale and design of the career development program, as well as key activities in the training plan. Indicate the plannedduration of appointments, the projected number of scholars including their levels (i.e., predoctoral , postdoctoral , short-term faculty ), and intended trainee/scholar 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”.

The appointment of an Advisory committee is strongly encouraged. The Advisory Committee will be a group of scientists from the sponsoring department and other departments or institutions, as appropriate, with research interests relevant to the K12 Program. The two major functions of the committee are to: 1) evaluate applications from potential Scholar candidates, and 2) evaluate the overall conduct of the Program. Specifically, the committee makes recommendations concerning Scholar appointments, evaluates ongoing research activities annually (including the interaction and integrated nature of the Scholars' research experience), and makes recommendations regarding their continuation.

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

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

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

PHS 398 Cover Page Supplement

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

PHS 398 Training Subaward Budget Attachment(s)

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

Research and Related (R&R) Budget

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

  • Include all personnel other than the Training PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff. Also include proposed salary costs for planned scholars.
  • Do not complete the section on Participant/Trainee Support Costs.

PHS 398 Research Training Program Plan

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

  • Training Program
  • Faculty, Scholars , 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.

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.

For this FOA, applicants should use the following Data Tables only (Data for Scholars should be entered into the Postdoctoral sections of the Data Tables.

Table 2 (Renewal applications only)

Table 3 (Renewal applications only)

Table 4 (Renewal applications only)

Table 5B (Renewal applications only)

Table 7 (Renewal applications only)

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

Program Administration

Applications should describe how the Training Program Director(s)/Principal Investigator(s) (PDs/PIs) will promote the success of the scholars and training program. Applications should describe acknowledged strengths, leadership and administrative skills, training experience, scientific expertise, and active research of the PD/PI. Multiple PDs/PIs are encouraged, particularly when each brings a unique perspective and skill set that will enhance training, as described in the Eligible Individuals section.

Institutions with existing programs must explain what distinguishes this program from the others, how their programs will synergize with one another, if applicable, and make it clear that the pool of faculty, potential scholars, and resources are robust enough to support additional programs. Institutions should also describe plans for synergy and/or collaboration with existing PCDPTN. When a program administrator position is planned, a description of the scientific expertise, leadership, and administrative capabilities essential to coordinate a program for developing investigators must be included in the application.

Program Faculty

Career-development programs developed under this FOA shall be members of a national and/or regional network rather than programs based solely at the applicant institution. Scholars shall be matched to the most appropriate mentors and institutions, which will often extend beyond those of the applicant organization; the specific expertise of those mentors will depend on the needs of scholar pool. Applicants must describe a plan for identifying appropriate mentors, linking candidates to those mentors, and ensuring that mentors will commit to candidate support.

In addition to the information specified in the Application Guide, the application must include information about the program faculty who will be available to serve as preceptors/mentors and provide guidance and expertise appropriate to the level of scholars proposed in the application. Applications should include the following:

  • How the program faculty are trained to ensure the use of training and mentoring practices that promote the development of scholars from all backgrounds.

  • How the program has recruited a diverse team of program faculty, including faculty at a range of career stages and from a variety of scientific backgrounds.

  • How the program faculty will provide supportive mentoring.

  • In programs where scholars will have multiple mentors, how the faculty will effectively coordinate training and mentorship responsibilities.

  • How mentors at remote sites will be integrated into the national network of the proposed K12 program in terms of providing guidance and scientific advice to the scholars and supporting their transition to independent status.

Scholars

Applications should describe plans for scheduling scholar appointments. Support for Scholars should be provided through a minimum of two consecutive 12-month appointments, renewable in annual increments, for up to five years total. The ideal amount of time is 2-3 years. Support of Scholars is renewable at the discretion of the PD/PI, contingent upon presentation of evidence of satisfactory progress as determined by the Advisory Committee. The pool of potential Scholars and criteria for selecting Scholars and assessing progress must be described in the grant application. Institutions are encouraged to develop novel mechanisms for recruiting qualified pediatricians.

Applications should not name prospective scholars, but rather:

  • Describe in general terms the pool of potential candidates including information about the types of prior clinical and research training and career level required for the program.

  • Describe the criteria to be used for candidate evaluation in the selection of Scholars.

All scholars will be required to:

  • attend an annual PCDPTN meeting sponsored by the Obstetric and Pediatric Pharmacology and Therapeutics Branch (OPPTB), and are encouraged to present their career development award-supported research to their peers,
  • serve as a speaker for at least (1) lecture seminar in the Principles of Pediatric Clinical Pharmacology Course
  • serve as a mentor to a post-doctoral fellow in the PCDPTN or NICHD-related network (e.g. MPRINT, PTN, etc.), facilitating contact (virtually/in-person) once every quarter at a minimum.

Training Program Evaluation

In addition to the information specified in the Application Guide, describe:

  • How the proposed evaluation will assess the extent to which scholars find the training program to be inclusive and supportive of scholar development.

  • The program’s procedures for responding to program evaluation findings.

  • How the program plans to track scholar outcomes and make the data available to potential applicants and current scholars.

Institutional Environment and Commitment to Training

Appropriate institutional commitment to the program also includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program. This commitment may include features such as PD/PI salary, stipend or tuition support for individuals involved in the proposed training program, or other commitments essential to a successful career development program. The sponsoring institution must assure support for the proposed program including assurance that sufficient time will be allowed for the PDs/PIs and other Program Faculty to contribute to the proposed program, and that there will be protected time for scholars (9 person months, equivalent to 75%) selected for the program.

Recruitment Plan to Enhance Diversity

The applicant must provide a Recruitment Plan to Enhance Diversity. Include outreach strategies and activities designed to recruit prospective scholars from diverse backgrounds, e.g. those from groups described in the Notice of NIH's Interest in Diversity. Describe the specific efforts to be undertaken by the training program and how these might coordinate with scholar recruitment efforts of the medical school(s), graduate school(s), and/or the institution(s). Program faculty are expected to be actively involved in recruitment efforts.

​​​​​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.

Program Faculty.

If any mentors will supervise a Scholar proposing to either lead a clinical trial, or gain research experience in a clinical trial, provide documentation of his/her expertise, experience, and ability to provide guidance in the organization, management and implementation of the proposed clinical trial, ancillary, or feasibility study and help him/her to meet the study timelines.

Trainee Candidates.

If the event that a clinical trial may be proposed, discuss the potential of prospective Scholars to organize, manage, and implement the proposed clinical trial, feasibility or ancillary study.

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.

PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional modifications:

Study Record: PHS Human Subjects and Clinical Trials Information

DO NOT USE. Attempts to submit a full, detailed study record will result in a validation error.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must complete a Delayed Onset Study.

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The National Research Service Award (NRSA) policies apply to this program.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit 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 form. 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 unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. 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 NICHD , NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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.

For this particular announcement, note the following:
Reviewers should evaluate the candidate’s potential for developing an independent research program that will make important contributions to the field, taking into consideration the years of research experience and the likely value of the proposed research career development as a vehicle for developing a successful, independent research program.

Overall Impact

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

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of the merit of the training program and give a separate score for each. When applicable, the reviewers will consider relevant questions in the context of proposed short-term training. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

Career Development Program and Environment

  • Does the proposed program clearly outline a plan to recruit and develop well-qualified junior investigators for successful careers as biomedical or clinical researchers?
  • Is there evidence of an adequate pool of potential scholars who could benefit from receiving career development support?
  • Are the content and duration of any proposed didactic, training-related, and research-related activities of the program appropriate? Do the program activities foster the development of skill and expertise in transparent, rigorous, and reproducible research methodologies, including relevant areas of data science?
  • Are appropriate timelines indicated for career progression and transition to independence?
  • Does the institutional environment (e.g., research facilities and other relevant resources) in which the program will be conducted contribute to the probability of success?
  • Does the proposed career development program benefit from unique features of the scientific environment, subject populations, or employ useful collaborative arrangements?
  • Is the institutional commitment to the proposed program appropriate?
  • If multiple sites are participating, is this adequately justified in terms of the career development and research experiences provided?
  • Is there sufficient assurance that the required effort of the PD/PI, mentors and scholars will be devoted directly to the research training, career development, and related activities?
  • When applicable, is there adequate documentation describing the responsibilities of the advisory committee with regard to the provision of input, guidance and oversight of the program?
  • For institutions with other K12 programs, is there justification for an additional program and will there be synergistic relationships among the programs?
  • Are there sound plans for ensuring that each scholar is progressing with respect to career development and a timely transition to independence?
  • Are the research-intensive and teaching-intensive institution(s) appropriate and likely to provide supportive, safe, and inclusive career development environments?
  • Is there sufficient assurance that the required effort on the part of the scholars will be devoted directly to the research, career development, and related activities?

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

  • Do the PD/PI and Research Administrator (if applicable) have the experience to develop, direct and administer the proposed program?
  • Does the leadership team bring complementary and integrated expertise to the program? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure program objectives?
  • Are the research qualifications, scientific stature, previous leadership and mentoring experience, and track record(s) appropriate for the proposed career development program?
  • Are the PD(s)/PI(s) currently engaged in research relevant to the scientific area of the proposed program?
  • For applications designating multiple PDs/PIs:
    • Is a strong justification provided that the multiple PD/PI leadership approach will benefit the career development program and the scholars?
    • Is a strong and compelling leadership approach evident, including the designated roles and responsibilities, governance, and organizational structure consistent with and justified by the aims of the career development program and the complementary expertise of the PDs/PIs?
  • Have the PD(s)/PI(s) received training on how to effectively mentor scholars from diverse backgrounds, including those from underrepresented groups, and promote inclusive, safe, and supportive career development environments?
  • If a multi-PD/PI leadership team is proposed does each person bring complementary and integrated expertise to the program? Is a strong leadership plan evident, including the designated roles and responsibilities, governance, and organizational structure?

Mentors

  • Do the mentors have appropriate expertise and experience, as well as track records of past mentoring and training?
  • Are the quality and extent of the mentors’ roles in providing guidance and scientific advice to the scholars acceptable? Are the mentors currently engaged in relevant research?
  • 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?

This Funding Opportunity Announcement (FOA) does not allow appointed Scholars 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.

  • Does the applicant describe how the program has recruited a diverse team of participating faculty designated for the mentored research component, including faculty at a range of career stages and from a variety of scientific backgrounds ? If not, are there plans to recruit prospective faculty who may enhance the diversity?
  • Do the participating faculty demonstrate a commitment to effective mentoring and promoting inclusive and supportive scientific and career development environments? For example, have they received training on how to effectively mentor individuals from all backgrounds, including individuals from groups underrepresented in the biomedical sciences (NIH's Interest in Diversity)?
  • Will mentors at remote sites be effectively integrated into the national network of the proposed K12 program in terms of providing guidance and scientific advice to the scholars and supporting their transition to independent status?

Scholars

  • Is a recruitment plan proposed with strategies likely to attract high quality scholars?
  • Are there well-defined and well justified recruitment and selection strategies?
  • Is there evidence of a sufficiently large, competitive scholar pool to warrant the proposed size of the career development program?
  • Are the content, phasing, and proposed duration of the career development plan appropriate for achieving scientific independence of the scholars?
  • What is the likelihood that the career development plan will contribute significantly to the scientific development of the scholars?
  • Does the plan for selection of the scholars include all of the eligibility criteria stated in the FOA?
  • Is the recruitment plan proposed likely to recruit a diverse pool of potential candidates with a commitment and potential to pursue academic research careers?
  • Are there plans to ensure that scholars will participate in cross-institutional interactions, NICHD-related network opportunities and PCDPTN-related engagements (including but not limited to, required annual meeting attendance, post-doctoral mentorship, seminar/ speaking activities)?

Training Record

  • Is there evidence of a successful past training record of the PD/PI and mentors, including the success of former scholars in seeking independent support and establishing productive scientific careers? Does the program have a rigorous evaluation plan to assess the quality and effectiveness of the training?
Additional Review Criteria
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Program Evaluation

  • Is there a well thought out evaluation or assessment process to determine whether the overall program is effective in meeting its mission and short, intermediate and long-term objectives? Does the plan include comparator groups as well as appropriate metrics and methods for determining the success?

  • Is there a mechanism for determining whether the career development environments are inclusive, safe, and supportive of the scholars’ development?

  • Is there evidence that the program has been and/or will be responsive to internal and external critiques and evaluations?

  • Are effective mechanisms in place for obtaining feedback from current and former scholars?

  • Does the program have a feasible plan to track scholar outcomes and make the aggregated data available to potential applicants and current scholars?

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 Individuals Across the Lifespan

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.

Career Development in Methods for Enhancing Reproducibility

Does the plan for Instruction in Methods for Enhancing Reproducibility describe how the program will provide career development in scientific reasoning, rigorous research design, relevant experimental methods, consideration of relevant biological variables such as sex, authentication of key biological and/or chemical resources, quantitative approaches, and data analysis and interpretation, appropriate to field of study and the level and prior preparation of the scholars?

Resubmissions

Not applicable

Not applicable

Revisions

Not applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Recruitment Plan to Enhance Diversity

Peer reviewers will separately evaluate the recruitment plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment of prospective 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 career development program, the level of scholar experience, and the particular circumstances of the scholars, the reviewers will evaluate the adequacy of the proposed RCR career development 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 career development faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period named in the application? 4) Duration of Instruction - Does the plan meet the minimum requirements for RCR, i.e., at least eight contact hours of instruction? 5) Frequency of Instruction – Does the plan meet the minimum requirements for RCR, i.e., at least once during each career stage (undergraduate, post-baccalaureate, predoctoral, postdoctoral, and faculty levels) and at a frequency of no less than once every four years?

For renewal applications, does the progress report document acceptable RCR instruction in the five components described above? Does the plan describe how participation in RCR instruction is being monitored? Are appropriate changes in the plan for RCR instruction proposed in response to feedback and in response to evolving issues related to responsible conduct of research?

Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

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

As part of the scientific peer review, all applications will receive a written critique.

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.

Appeals for initial peer review will not be accepted for applications submitted in 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 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

Demonstrated willingness of the applicants to work as part of an overall training and career development network.

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient’s business official.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

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.

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.

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 and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants." This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

3. Reporting

When multiple years are involved, recipients 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 recipient institution to submit required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

Other Reporting Requirements

The institution must submit a completed Statement of Appointment (PHS Form 2271) for each scholar appointed or reappointed to the training grant for 8 weeks or more. Recipients 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.

  • 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 scholar appointed for eight weeks or more. Scholars 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, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award as described in the NIH Grants Policy Statement. Evaluation results should be included as part of the final RPPR.

4. Evaluation

In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten on-time submission, 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 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

Scientific/Research Contact(s)

Lesly Samedy Bates, PharmD, PhD, MS
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-827-3241  
Email: lesly-anne.samedy-bates@nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Maggie Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
Email: margaret.young@nih.gov

Section VIII. Other Information

Section VIII. Other Information header text

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.

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