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 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.

The purpose of this FOA is to provide new healthcare professionals with state of the art environmental health training that blends academic research and practice-based applications in real-world settings. The program will provide supervised research career development opportunities to assist junior faculty. The goal of the Pediatric and Reproductive Environmental Health Scholars (PREHS) program is to create of a strong network of healthcare professionals who possess the skills and knowledge to address the complexities of pediatric and reproductive environmental health.

Background and Objectives

The NIEHS, the Agency for Toxic Substances and Disease Registry at the Centers for Disease Control and Prevention (ATSDR/CDC) and the Environmental Protection Agency (EPA) have a long history of working together on children’s environmental health. Through regular program interactions and discussions, the Pediatric and Reproductive Environmental Health Scholars (PREHS) program was identified as a new, collaborative opportunity to bring together shared interests in children's environmental health and the advancement of the Pediatric Environmental Health Specialty Unit (PEHSU) program, which is a jointly supported program between CDC/ATSDR and the EPA. The agencies see the PREHS as a program for scholars to acquire advanced content in pediatric and reproductive environmental health, and gain an understanding of the many interactions biological, psychological, social and cultural that occur between children, pregnant women, and new mothers and their environment. With this newly acquired knowledge, scholars will be better equipped to assess and manage pediatric health conditions related to exposures in the child's environment.

The PREHS program will bring together environmental health science research expertise at academic institutions with clinical and translational expertise at Pediatric Environmental Health Specialty Units (PEHSUs) to provide pediatric healthcare providers, obstetricians/gynecologists, nurses, and other interested healthcare professionals (PREHS Scholars) with research experiences that bridge clinical practice in environmental health, community-level engagement, and teaching. These K12 grant awards will generate well-qualified pediatric and reproductive environmental health leaders.

Applications for this award must propose a comprehensive career development and research plan that: (1) has environmental health research relevant to pediatrics and reproductive health and is within the mission of the NIEHS, (2) serves as a mechanism for gaining research competencies in environmental medicine related to pediatrics and reproductive health to advance scholars' medical knowledge, patient care, interpersonal and communication skills, professionalism, and systems-based practice, and (3) provides scholars with the necessary environmental public health and clinical expertise to advance their careers as academic researchers and physician scientists, such as improving scientific and grant writing skills, developing effective advocacy skills, and fostering expertise in risk assessment and risk communication.

Programs should include both didactic components and supervised research experiences designed to accommodate research candidates with varying levels of experience and at various stages of their career. For example, a scholar with limited experience in environmental health 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. While scholars will likely have limited research experiences, they are expected to be prepared to apply for independent research funding by the completion of the program.

Program Considerations

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

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.

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

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

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

Governments

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

Other

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

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

The applicant institution must have a strong and high-quality research program in the area(s) proposed under this FOA and must have the requisite faculty, staff, potential scholars 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..

Applicant institutions must possess sufficient clinical specialties and subspecialties, as well as research facilities to meet the purposes of the PREHS Program, namely, to bridge clinical training with a career in environmental health research relevant to pediatrics and reproductive health. The applicant institution must have a pool of highly trained established investigators in environmental health research related to pediatric and reproductive health. The applicant institution must possess an active PEHSU, or have a demonstrated collaborative working relationship with one, that aligns to the goals of the PREHS and provides scholars with appropriate opportunity to learn about real-world environmental health concerns, to gain awareness of community-engaged practices, and to apply their skills and knowledge in real-world settings. These institutions should also have the commitment and capability to provide career development guidance to promising candidates who aspire to become independent investigators.

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

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

Applicant Organizations

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

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research career development program as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple 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 administrative, clinical, and scientific leadership to the development and implementation of the proposed program. Ideally, the PD/PI will have demonstrated experience leading training or career development programs. The PD/PI will be responsible for the selection and appointment of scholars to the approved research career development 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 PREHS Advisory Committee, using their recommendations to determine the appropriate allotment of funds.

The PD/PI must demonstrate that they have support from, and a line of communication with, the Chair of their respective Department (such as Pediatrics, Environmental Health, Nursing, Occupational Medicine).

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

Applicant organizations may submit more than one application, provided that each application is programmatically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

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

Each Scholar appointed under the PREHS K12 award must be assigned one or two mentors based on the scholar’s research experience and need for intensive supervision and support. The mentors should be recognized as independent investigators who are actively involved in fundamental or translational research relevant to children's or reproductive environmental health, and who have a successful record of providing research training to pediatricians or other individuals with a clinical background. The mentors should hold senior faculty positions, be supported by NIH or other competitively awarded grants, and be acknowledged experts in the application of new advances in basic science or translational research. Mentors are not required to be members of the participating departments (such as Pediatrics, Environmental Health, Nursing, Occupational Medicine). Although mentors from collaborating departments may provide needed expertise and resources, the emphasis of the Scholars' scientific projects should be on environmental health science research and clinical practice relevant to pediatric and reproductive environmental health impacts. The established investigators, as mentors, will make available their expertise, guidance, and laboratory facilities to be utilized by Scholars for research projects that will enhance their knowledge and skills. Mentors must interact closely with the Scholar to develop a tailored career development plan. Mentors must be committed to continue their involvement throughout the Scholar's total period of development under the award. One of the two mentors must be an active member of the PEHSU. If only one mentor is proposed, it should be someone with the expertise to bridge clinical practice with environmental health research. If community-engaged research approaches are proposed as part of the PREHS program, then it is encouraged to have a mentor from a community-based organization with a demonstrated history of working with the applicant institution and/or the PEHSU.

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.

An institution receiving a PREHS Program award must recruit and select Scholars who have the potential to develop into independent investigators. At the time of appointment to the K12 Program, candidates for PREHS Scholars must:

(1) Hold a clinical doctoral degree (e.g., MD, DDS, DMD, DO, DC, OD, ND, DVM, PharmD, or PhD in clinical disciplines) with a primary specialty focused on children and reproductive health (e.g., pediatrics, family medicine, women's health/obstetrics;

(2) Have completed postgraduate residency training in pediatrics, family medicine, women's health/obstetrics, or equivalent if from a different healthcare profession;

(3) Be no more than 4 years after attaining board eligibility in their subspecialty;

(4) Identify an approved mentor or mentors with extensive research experience;

(5) Not be or have been a PD/PI on an R01, R29, U01/U10, subproject of a Program Project (P01), Center (P50, P60, U54) grant, or individual mentored or non-mentored career development award (e.g., K01, K02, K08, K22, K23, K24, K25, K99). Individuals who are or were PD/PIs on NIH Small Grants (i.e., R03s) or Exploratory/Developmental Grants (i.e., R21s) may be eligible providing they meet the other eligibility requirements. Individuals who received Pediatric Scientist Development Program (PSDP) K12 funds are eligible for this program, subject to the 6-year limitation on mentored K support described below.

The PREHS program is designed to support 3 scholar positions per year at each of the awarded sites. Appointments may be 2-3 years in duration, consisting of consecutive 12-month terms. Scholars are generally expected to hold junior faculty appointments. However, scholars may be appointed to the K12 program in the final research year of subspecialty fellowship training if the fellowship is designed to provide an in-depth research experience like this K12 program.

Some individuals who are interested in the K12 program may have had a career hiatus because of family responsibilities, uniformed service, or other circumstances. For such individuals, the hiatus will not count against the 4-year limit specified above. New Scholar appointments may be made at any time during the year.

During the period of this award, Scholars may not accept or hold any other PHS award that duplicates the provisions of this career award. However, Scholars may compete for individual mentored career development awards (e.g., K01, K08, K23, K25, K99) provided they meet the eligibility requirements of those programs. Scholars may not hold concurrent K awards.

Combined support through the K12 and other NIEHS mentored career development award programs must not exceed six years. Scholars should contact NIEHS staff if there are questions regarding eligibility.

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

Letter of Intent

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

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

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

The letter of intent should be sent to:

Varsha Shukla, Ph.D.
Scientific Review Branch
National Institute of Environmental Health Sciences
Telephone: 984-287-3288
Email: [email protected]

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

Instructions for Application Submission

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

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

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

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

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 research career development program, as well as key activities in the training plan. Indicate the planned duration of appointments, the projected number of scholars including their levels (i.e., , postdoctoral, faculty), and intended scholar outcomes.

Other Attachments. A plan must be provided for the appointment of an Advisory Committee. The PREHS Advisory Committee is a group of scientists and clinicians from the sponsoring department and other departments or institutions, as appropriate, with research interests relevant to the PREHS Program. The Advisory Committee should include at least one representative from the collaborating PEHSU. The two major functions of the committee are to evaluate: 1) applications from potential Scholar candidates, and 2) 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 committee may use institutional or outside consultants, including community partners, if needed.

In the plan provided, describe the composition, roles, responsibilities, and desired expertise of committee members, frequency of committee meetings, and other relevant information. 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. Please name your file Advisory_Committee.pdf .

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

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

Applicants may designate a Scholars Director (SD) who will have responsibility for the day-to-day administration of the program. The Scholars Director may be one of the PD(s)/PI(s). The Scholars Director should be an established pediatric or reproductive environmental health physician scientist with the expertise, leadership, and administrative capabilities required to coordinate and supervise a multidisciplinary research and career development program of this scope. Working with the PD/PI, the Scholars Director will be expected to monitor and assess the PREHS and submit all documents and reports as required.

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

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

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

• Include all personnel other than the 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 Support Costs.

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:

Data Tables: Particular attention must be given to the required Training Data Tables. For this FOA, Table 1, Table 2, Table 3, and Table 4 must be completed. All other data tables listed in the SF424 (R&R) Application Guide do not apply.(Data for Scholars should be entered into the Postdoctoral sections of the Data Tables).

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.

Training Program

Program Plan

Program Administration.

Describe the acknowledged strengths, leadership and administrative skills, training experience, scientific expertise, clinical experience, and active research of the PD/PI and Scholars Director. Relate these strengths to the proposed management of the career development program. Describe the respective roles of those in leadership positions and the planned strategy and administrative structure to be used to oversee and monitor the program. If there are multiple PDs/PIs, then the plan for Program Administration is expected to synergize with the Multiple PD/PI Leadership Plan section of the application. If an administrative coordinator position is planned, a description of the administrative capabilities essential to coordinate a program for developing investigators must be included in the application.

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.

Applicants are encouraged to use the Partnerships for Environmental Public Health Evaluation Metrics Manual as a resource for developing an evaluation plan. https://www.niehs.nih.gov/research/supported/translational/peph/metrics/index.cfm

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

Institutional Environment and Commitment to the Program.

Applicants must describe the institutional environment and commitment to the K12 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% effort) selected for the program.

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 (e.g. MPH degree) for individuals involved in the proposed career development program, or other commitments essential to a successful career development 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.

Program Faculty.

The application must include information about the program faculty who will be available to serve as mentors and provide guidance and expertise appropriate to the level of scholars proposed in the application. Describe the complementary expertise and experiences of the proposed Program Faculty, including active research, clinical teaching, and other scholarly activities in which the faculty are engaged, connection to PEHSU, as well as experience mentoring and training individuals at the proposed career stage(s). For any proposed Program Faculty lacking research training experience, describe a plan to ensure successful scholar guidance by these individuals. If a community mentor is proposed, describe the expertise, knowledge, and skills they will provide to advance the participating scholar in the PREHS program. Describe the criteria used to appoint and remove faculty as Program Faculty and to evaluate their participation.

Scholars.

The application 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 three 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 PREHS Scholars must be described in the grant application. Institutions are encouraged to develop novel mechanisms for recruiting qualified pediatric and reproductive clinicians and/or other healthcare professional with appropriate advanced degree and a focus on pediatric and/or reproductive health.

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, 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.

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.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement. 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 NIEHS, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NIEHS Referral Office by email at [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

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.

Career Development Program and Environment

• Does the proposed program clearly outline a plan to recruit and develop diverse, well-qualified junior clinical investigators for successful careers as biomedical or clinical researchers, as well as leaders in pediatric and reproductive environmental health?
• Is there evidence of an adequate pool of potential scholars who could benefit from receiving career development support?
• Is there evidence of an adequate pool of environmental health researchers at the proposed PREHS program?
• Are the content and duration of any proposed didactic, training-related, and research-related activities of the program appropriate to meet the goals of the PREHS program?
• Are the plans for working with a PEHSU appropriate to ensure the scholars receive the relevant skills and training?
• What is the potential of the PREHS program to develop well-qualified healthcare professionals as leaders in pediatric and reproductive environmental health?
• If there are other NIEHS-supported Centers or other large research projects at the applicant institution, are there plans to leverage the resources for the benefit of the PREHS program?
• 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 research career development and related activities?

Is there adequate documentation describing the appropriate composition and responsibilities of the advisory committee regarding the provision of input, guidance and oversight of the program?

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

• Do the PD(s)/PI(s) and Scholars Director (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 and clinical qualifications, scientific stature, previous leadership and mentoring experience, and track record(s) of the leadership team appropriate for the proposed career development program?
• Are the PD(s)/PI(s) currently engaged in research and clinical practice relevant to the scientific area of the proposed program?
• Are the PD(s)/PI(s) and Scholars Director currently funded and engaged in research and clinical practice related to pediatric or reproductive environmental health?

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?

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 research and clinical practice relevant to the PREHS program?
• Does the program include mentors from a broad range of basic and applied biomedical science related to pediatric or reproductive environmental health, from collaborating departments, to form the intellectual and technical base for the mentoring of scholars?

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?

Training Record

• Is there evidence of a successful past training record of the PD(s)/PI(s), Scholars Director, 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 career development program?

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 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.

Training in Methods for Enhancing Reproducibility

Does the plan for Instruction in Methods for Enhancing Reproducibility describe how scholars will receive training 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

Renewals

Not Applicable

Revisions

Not Applicable

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

Recruitment Plan to Enhance Diversity

Peer reviewers will separately evaluate the recruitment plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment of 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? 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?

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

Select Agent Research

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

Budget and Period of Support

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

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

As part of the scientific peer review, all applications:

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

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

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

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

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

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

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

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

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

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

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

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. 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 http://www.hhs.gov/ocr/civilrights/understanding/section1557/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.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides 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/fact-sheet-guidance/index.html and https://www.lep.gov. 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 https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
• Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/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.

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.

Not Applicable

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually. Continuation support will not be provided until the required forms are submitted and accepted.

Failure by the grantee institution to submit required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award.

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

• The institution must submit a completed Statement of Appointment (PHS Form 2271) for each trainee appointed or reappointed to the training grant for 8 weeks or more. Grantees must submit the PHS 2271 data electronically using the xTrain system. More information on xTrain is available at xTrain (eRA Commons). An appointment or reappointment may begin any time during the budget period, but not before the budget period start date of the grant year.
• A notarized statement verifying possession of permanent residency documentation must be submitted with the Statement of Appointment (PHS Form 2271). Individuals with a Conditional Permanent Resident status must first meet full (non-conditional) Permanent Residency requirements before receiving support.
• Termination Notice: Within 30 days of the end of the total support period, the institution must submit a Termination Notice (PHS Form 416-7) via xTrain for each 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.

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:

• Subsequent participation in research or employment in a field related to pediatric and reproductive environmental health
• Authorship of scientific publications in pediatric and reproductive environmental health
• Subsequent recognition as a leader in pediatric and reproductive environmental health
• Subsequent independent research grant support from NIH or another source

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

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

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

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

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

Liam O'Fallon, MA
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984.287.3298
Email: [email protected]

Varsha Shukla, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984.287.3288
Email: [email protected]

Jenny L. Greer
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984.287.3332
Email: [email protected]

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

Awards are made under the authorization of 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.