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 Critical Care and Trauma Scientist Development Program (K12)
Activity Code	K12 Physician Scientist Award (PSA)
Announcement Type	Reissue of RFA-HD-08-022
Related Notices	July 27, 2018 - This RFA has been reissued as RFA-HD-19-008. August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications.
Funding Opportunity Announcement (FOA) Number	RFA-HD-14-019
Companion Funding Opportunity	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.865
Funding Opportunity Purpose	The purpose of this Funding Opportunity Announcement (FOA) is to invite applications to support a national program of mentored advanced career development and training in research for junior faculty in pediatric critical care medicine and pediatric trauma surgery at research-intensive institutions.

Posted Date	May 16, 2013
Open Date (Earliest Submission Date)	October 13, 2013
Letter of Intent Due Date(s)	October 13, 2013
Application Due Date(s)	November 13, 2013, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	January/February 2014
Advisory Council Review	May 2014
Earliest Start Date	July 2014
Expiration Date	November 14, 2014
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

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

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 needs. More information about Career programs may be found at the NIH Extramural Training Mechanisms website.

The purpose of this funding opportunity announcement (FOA) is to invite applications for the program administration and direction of the Pediatric Critical Care and Trauma Scientist Development Program (PCCTSDP), a national program of research career development for physician-scientists specializing in pediatric critical care and trauma.

The goals of the PCCTSDP are to expand the cadre of investigators trained to advance research in pediatric critical care and to support educational institutions in their ability to stimulate novel research and innovative investigation into the scientific basis of pediatric critical care and trauma practice and the consequences of critical illness and injury for families and children. The program will fund, up to a maximum of 5 years, the administration and infrastructure of one K12 Career Development Program.

Within the framework of the Pediatric Critical Care and Trauma Scientist Development Program's longstanding commitment to excellence and projected need for investigators in particular areas of research, attention must be given to recruiting trainees from racial or ethnic groups underrepresented in the biomedical, behavioral and clinical sciences, individuals with disabilities, and individuals from disadvantaged backgrounds. A formal program to facilitate this recruitment should be part of the proposed program.

Several convergent developments in critical care medicine, as well as in larger medical, scientific, and national communities, were fundamental to the initial NICHD decision to develop and maintain special support of pediatric critical care and trauma career development and research at the junior faculty level. While clinical expertise in these rapidly evolving specialties is in short supply, the demand for intensivists and trauma surgeons to supervise the care of critically ill and injured children is growing. As the clinical, educational, and administrative agendas increase in complexity in critical care, time for fully trained pediatric intensivists and trauma surgeons to devote to research is decreasing.

The introduction of a number of principles of management and innovative methodologies without the rigorous controlled observation necessary for their objective evaluation, presents a number of concerns. A major problem has been the balance between assuring prompt implementation of new technologies, procedures, treatments, and drugs, and evaluation of their safety, efficacy, and cost/risk/benefit ratios. In a critically ill or injured child, for example, an innovative idea may be tried, which, if the patient's condition improves, may rapidly start a new trend and become the standard of care, expected and demanded by families of such children and the professionals caring for them. As a result, incorporation into the arsenal of critical care and trauma therapies may be based on limited experience, and efficacy and/or safety incompletely evaluated. The use of the scientific method may be compromised by the pressured operational clinical milieu that surrounds pediatric critical care and trauma care practice.

In addition, careful descriptive studies of the pathophysiology of the consequences of critical illness and injury in children as related to intermediate and long-term outcomes remain minimal; more is urgently needed. Research into the mechanisms of tissue injury and organ failure in children would be of great benefit for children with complex illnesses, injuries and disability. Very little is understood about how the developmental trajectory might affect or be affected by trauma, sepsis and organ failure. The effect on families, siblings, communities and schools of the increasing population of disabled survivors of childhood critical illness and injury also remains understudied.

The first NICHD Pediatric Critical Care Scientist Development Program (PCCSDP) competition was held in 2003, and resulted in the successful establishment of a national K12 career development program. The original FOA called for creation and direction of a K12 Career Development Program of national scope, providing mentored support for junior faculty in departments of pediatric critical care medicine in the USA. This program was to prepare a cohort of researchers in pediatric critical care medicine, with the goal of generating scientists who would be able to obtain independent support to conduct research in this urgently needed area. The PCCSDP has succeeded in developing an operational administrative and scientific consortium for the counseling, selection, and education of national pediatric intensivist junior faculty K12 applicants utilizing a National Advisory Committee of accomplished pediatric scientists. The NICHD provides only consultative and supportive advice to the PD/PI, ensuring that NIH priorities and policies are followed. While previous competitions of this FOA did not specifically include trauma surgical junior faculty as targeted for research career development support, the current FOA seeks to establish a program of support for both pediatric critical care medicine and trauma surgery.

It is expected that the scholars supported by this program will emphasize basic, clinical and translational research focused on intermediate and longer-term outcomes for children and families, especially related to reduction in morbidity and disability. Recent discoveries across a broad range of basic and clinical science research areas have greatly expanded the options for the critically ill and injured child. Advances in understanding the molecular biology underlying organ system failure offer the possibility of manipulating otherwise poorly controlled processes, including inflammation, cell and organ injury, dysfunction and death, regeneration of tissues, and functional organ system capacity.

Modalities of mechanical ventilation, non-invasive ventilation, circulatory support, and extracorporeal life support have extended therapeutic options to patients previously beyond the reach of state-of-the-art therapy. The use of less invasive techniques in neurosurgery, general, and vascular surgery, as well as implementation of newer techniques of respiratory and circulatory support have been central to the radical changes in mortality achieved with cutting-edge pediatric critical care medicine and surgery. As a result, children in higher risk groups who are victims of critical illness and injury, and those who might benefit from advanced life support and surgical interventions once not feasible, are benefiting from increased critical care options in increasing numbers.

Children with complex illnesses, combinations of medical, surgical, and traumatic processes, are surviving to discharge from multidisciplinary pediatric critical care units more frequently than before. As mortality from critical illness and injury declines, survival of patients with disabling residuals of the critical pathology increases, and chronic medical condition become more common in childhood. In children, it is well known that such conditions make the risk of subsequent critical illness and injury greater than their age-peers.

Relatively few studies are available that might quantitate the risk and the impact of the increasing numbers of medically fragile children on families, schools, pediatric practices, and health care costs. Measuring the efficacy of critical care practice by mortality, while essential in the early years of the specialty, is presently not practical. Basic and translational critical care and trauma researchers can no longer afford to seek cell or tissue survival as an outcome independent of functional capacity and the implications for morbidity and disability. Clinical researchers cannot effectively plan to use mortality as an outcome measure because contemporary pediatric critical care medical and surgical practice has ensured that mortality rates are uniformly low. Certain diagnostic groups (i.e. critical illness and organ failure in pediatric malignancy and head trauma) continue to have mortality rates that are substantial, although overall mortality has plummeted as pediatric critical care practice has evolved over the last two decades.

Support of pediatric critical care and trauma research must depend on basic and clinical science designed by intensivists and surgeons in order to form the foundation of pediatric critical care and trauma practice. There are few human laboratories in which tissue and organ function, pharmacologic kinetics, immune dysfunction, cell signaling and changes over time in humans can be studied, especially in the young. Contemporary tertiary pediatric critical care units (PICUs) and trauma centers present unique scientific opportunities for the evolution of the science needed. The subspecialty has evolved rapidly in the clinical arena as described above, and the clinical services and leadership provided are in great demand. Trained researchers in these fields are in critically short supply.

About one half (45-55 percent) of emergency admissions to PICUs occur in children with known special needs. When one considers, in addition, the admission of children for postoperative critical care following elective surgical procedures, the percentage of children in PICUs with special needs is much higher. In addition, a large percentage of the cohort of previously healthy children admitted to pediatric critical care units will have special health care needs upon discharge. Thus, focus on family effects, restoration of organ system function, and stress adaptation in basic, clinical and translational research is urgently needed.

Applicants responding to this FOA should consider plans for the following:

• Developing guidelines for training, didactic interactions, career development, and the responsible conduct of research.
• Developing and promoting a network of established faculty with a record of research support and productivity, who could serve as potential mentors and secondary resources for scholars.
• Assuring that first consideration be given to candidates whose research interests will lead to expanded knowledge that ultimately will improve outcomes and quality of life for children with potential and present disability.
• Negotiating and coordinating with participating institutions and departments to ensure that scholars get appropriate research support, non-clinical time commitments, and opportunities for advancement.
• Recruiting, selecting, and placing those individuals who would most benefit from participation in this program and are most likely to develop independent careers in research.
• Providing special opportunities for research presentations and professional advancement, and career counseling and networking.
• Enhancing the involvement of individuals from underrepresented minority groups or those returning to research careers after family obligations and, whenever possible, enabling persons with disabilities as scholars, mentors, and other resource positions.
• Providing a periodic evaluation of the PCCTSDP as a whole.

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.

Funding Instrument	Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Application Types Allowed	New Renewal The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The NICHD intends to commit up to $778,000 in total costs for one award in FY 2014.
Award Budget	Application budgets are limited to $720,037 in direct costs, but must reflect the actual needs of the proposed project.
Award Project Period	The scope of the proposed project should determine the project period. The maximum project period is five years.

Personnel Costs	Individuals designing, directing, and implementing the career development program may request salary and fringe benefits appropriate for effort 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 and fringe benefits may be requested for the following personnel if applicable and justified: PD/PI for up to 1.2 person-months of effort Up to 1.2 person-months effort for an administrative assistant with responsibilities directly associated with the K12 program Up to 1.2 person-months effort for a recruiting officer, to enhance participation in the program by women, members of minority groups that are underrepresented in biomedical research, and individuals with disabilities. Limited program-related administrative and clerical salary costs associated distinctly with the program that are not normally provided by the applicant organization may be direct charges to the grant only when they are in accordance with applicable cost principles. For institutions covered by OMB Circular A-21, this type of training program may qualify as a major project where administrative salaries are allowable as a direct cost. When specifically identified and justified, these expenses must be itemized in Sections A and B, as appropriate, of the R&R Budget. Items that may NOT be supported with K12 grant funds include: Salaries and fringe benefits for program mentors; Salary and support for central institutional administrative personnel (e.g. budget officers, grant assistants, and building maintenance personnel), which are usually paid from institutional overhead charges; Salary and support for administrative activities such as institutional public relations or health and educational services.
Participant (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 and justified in the proposed budget. Candidates receive two to three years of intense career development training in a basic or clinical science discipline with an established investigator serving as mentor. The program is designed to support an average of six Scholars per year. Funds for prospective Scholars should be itemized on the R & R Budget, with indication of the number of positions requested. Individual Scholars are eligible for up to $75,000 per year in salary, plus fringe benefits, consistent with the institution's salary scale. The institution may supplement the NIH salary contribution up to a level that is consistent with the institution's salary scale; however, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. 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 (75% full-time professional effort) of full-time professional effort to conducting career development and health-related research, with the remaining effort being devoted to activities related to the development of a successful research career. For information regarding NIH policy on determining full-time professional effort for career awards, see http://grants1.nih.gov/grants/guide/notice-files/not-od-04-056.html. For each Scholar, up to $10,000 in additional funds may be budgeted each year to help defray the costs of materials, supplies, technical assistance, and miscellaneous expenses generated by the Scholar's research in the departments and laboratories of the established investigators who serve as mentors. In specific cases, grant funds may also be used for tuition, fees, and books related to career development. Up to $3,500 per Scholar in travel funds may be budgeted to attend annual PCCTSDP functions and other professional meetings. Total awards to individual Scholars need not be equal across these different budget categories.
Other Program Related Expenses	Allowable costs include: Funds for expenses specific to the administration of this program and not typically covered by institutional overhead charges, including supplies, equipment, consultant costs, telephone, or maintenance contracts for equipment. These expenses must be justified as specifically required by the proposed program and must not duplicate items generally available at the applicant institution. Travel expenses for the PD/PI to attend the annual PCCTSDP meetings. Travel expenses for members of the Advisory Committee to attend the annual PCCTSDP meetings and any other meetings required for the management or evaluation of the K12 program. Limited travel funds for featured speakers and former Scholars to attend annual PCCTSDP meetings for the purpose of providing career development guidance to those currently in the program. Items that may NOT be supported with K12 funds include: Direct support of the mentor's laboratories beyond those expenses directly attributable to the scholar's project; Travel of the PD/PI, mentors, other investigators to scientific meetings beyond those associated with the administration of the PCCTSDP; Patient care costs such as inpatient bed days or outpatient visits, except for clinical laboratory analyses essential for the scholar's 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 in response to 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 sponsoring institution is the organization where the applicant PD/PI of the national K12 program is located.

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 and facilities on site to administer the proposed program. As this is a national program, administered at the PD/PI’s institution on behalf of the development of research training for Scholars from across the United States, it is particularly important that the institution where the PD/PI is based be research-intensive.

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

Applicant organizations must complete the following registrations as described in the SF424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• System for Award Management (SAM) must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the Sam.gov Manage Entity function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
• Grants.gov
• eRA Commons

All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) 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 PD(s)/PI(s), visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (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 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 PCCTSDP and is responsible for appointing members of the National Advisory Committee (see below), using their recommendations to determine the appropriate allotment of funds for research and career development. The PD/PI must be a physician and senior faculty member who is knowledgeable about pediatric critical care research, has a record of success in laboratory and/or clinical investigation, and demonstrated skill in mentoring and career development. The PD/PI, in consultation with the National Advisory Committee, shall define the application process, review candidates, make appointments to qualified individuals, and monitor progress.

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

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

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as mentors. Mentors should have research expertise and experience relevant to the proposed program. Mentors must be committed to continue their involvement throughout the total period of the award.

Mentors shall be tenured faculty (or their equivalent) who have an established record of research productivity and grant support in areas of basic and translational research relevant to pediatric critical care and/or trauma research. Generally, they will be researchers and clinicians from pediatric critical care and allied fields, whose particular expertise is needed to support certain career research goals. Linkages to other departments should be encouraged, as they enhance the power of this career development program and pediatric critical care and trauma care research, in general. Mentors may be added to the roster of the program as appropriate, with NICHD approval

Mentors and their institutions are expected to make a strong commitment to the career development of PCCTDSP Scholars as they seek to establish themselves as independent investigators.

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.

Details on citizenship requirements are available in the NIH Grants Policy Statement.

Postdoctoral scholars must have received, as of the beginning date of their support, an MD or DO degree, or its equivalent from an accredited domestic or foreign institution, and be fully qualified in postgraduate training for pediatric critical illness and trauma practice. PCCTSDP candidates should be physicians who have completed clinical training and are no more than five years beyond fellowship training when they enter the program. Scholars must hold junior faculty positions at institutions with academic and research intensive programs in pediatric critical illness and trauma.

An individual who has previously served as PD/PI of an NIH research grant (R01, R03, R21, P01), mentored career development award (K series), subproject of program project (P01) or contract (N01) may not be considered for career development training in this program.

During the period of their appointment, scholars may not accept or hold any other PHS award that duplicates the provisions of this career award. However, scholars may remain eligible for other individual mentored career development awards (e.g., K08, K22, K23, K25, K99) at the conclusion of the K12 appointment if additional training is needed to establish research independence. Combined support through the K12 and other mentored career development award programs must not exceed six years.

As part of its recruitment efforts, the PCCTSDP should make every effort to broadly advertise career development opportunities and provide information on prospective mentors. The program is required to seek out qualified women, individuals from underrepresented minorities, and persons with physical disabilities.

Prospective scholars should be encouraged to contact potential mentors prior to formally applying to the PCCTSDP. Although remaining at the institution of their fellowship is a possibility for scholars under this award, academic diversity through research career development and clinical practice at a different institution should be strongly encouraged.

Scholars selected for the program receive two to three years of intense career development training in a basic or clinical science discipline with an established mentor. Wherever and however possible, the program should support career development in those areas of research that would have the greatest potential for a positive effect on the emerging field of pediatric critical care and/or trauma medicine, and benefit the growing population of children surviving critical illness and injury. In conjunction with the mentor, the candidate develops a research and career development plan, which will be reviewed annually by the PD/PI and Advisory Committee. At least 9 person-months (75 percent of the scholar's professional effort) must be devoted to basic, translational, or clinical research activities supported by the PCCTSDP. In the beginning of the second year, scholars should start seeking outside grant support as they transition to independent researcher positions in their sponsoring pediatric critical care medicine or trauma surgery departments and institutions. It is expected that the departments associated with this PCCTSDP will make a strong commitment to supporting individuals as they develop their independent research careers.

Scholars may engage in brief research activities at another institution if the experience is directly related to the purpose of the award. Periods of leave from the program for greater than two months, whether for professional or personal reasons, require prior written approval from NIH.

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

It is critical that applicants follow the 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.

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

Letter of Intent

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

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

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

The letter of intent should be sent to:

Valerie Maholmes, PhD, CAS
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-1514
Email: [email protected]

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

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow the instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

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

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

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

Substitute all references to trainees in the SF424 (R&R) Application Guide with scholars and all references to training in the SF424 (R&R) Application Guide with career development .

Other Attachments

Project Summary /Abstract. Provide an abstract of the entire application, including the long-term goals and objectives of the program. Include the rationale and design of the program, the planned duration of the program and the projected number of scholars, including their levels (i.e., predoctoral, postdoctoral, junior faculty).

Advisory Committee. A plan must be provided for the appointment of an Advisory Committee to monitor progress. Composition, responsibilities, frequency of meetings, and other relevant information should be included. Describe the composition of the Advisory Committee, identifying the role and the desired expertise of members. A plan for Advisory Committee approval and selection of participants should be included. Describe how the Advisory Committee will function in providing oversight of the development, implementation, and evaluation of recruitment strategies, the recruitment and retention of candidates, and the evaluation of the overall effectiveness of the program. Note that proposed Advisory Committee members should not be named in the application, particularly if they include individuals from outside the institution. However, renewal applications with Advisory Committees should include names of existing external advisors. Please name your file Advisory_Committee.pdf

The National Advisory Committee (NAC), chaired by the PD/PI, is a select group of scientists who have interests and expertise in pediatric critical care and trauma research. The members of the NAC may also be potential PCCTSDP mentors.

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 Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA).

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

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

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

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

• The R&R Budget Component must be used instead of the Training Budget Component.
• 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.

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

Substitute all references to trainees in the SF424 (R&R) Application Guide with scholars and all references to training in the SF424 (R&R) Application Guide with career development .

Program Plan

Program Administration. Describe the strengths, leadership and administrative skills, and scientific expertise of the Training PD/PI. Include the planned strategy and administrative structure to be used to oversee and monitor the program. For applications with multiple PDs/PIs, address the Leadership Plan and how the combined knowledge, skills and experience of the individual PDs/PIs will enhance the likelihood of success of the program. 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. Describe in general terms the complementary expertise and experiences of the proposed mentors. Provide an overview of their active research and other scholarly activities, as well as track records of mentoring and training.

Proposed Training. Provide an overview of the proposed program: Describe the immediate and long-term objectives of the program, including activities that will be used to ensure that the objectives of the program are met. Include information about planned courses, curricula, seminars, workshops, or tutorials that will be incorporated into the training program and mentored research experiences and activities. Institutions with existing training or career development programs must explain what distinguishes this program from the others, how the programs will synergize, if applicable, and justify that the faculty, pool of potential trainees, and resources are robust enough to support additional programs. The description should include planned strategies to be used to ensure that the objectives are met. The PD/PI should also describe past research career development activities/experiences including those of mentors, documenting the success of former trainees in establishing independent productive scientific careers.

Program Evaluation. Describe an evaluation plan to review and determine the effectiveness of the program. This should include plans to obtain feedback from current and former trainees to help identify weaknesses and to provide suggestions for program improvements, as well as plans for assessing trainees career development and progression, including metrics such as degree completion (if applicable), publications, and subsequent positions. Specified evaluation metrics should be tied to the goals of the program. Evaluation results should be included in future renewal applications and in the Final Progress Report.

Trainee Candidates. Describe in general terms the pool of potential candidates including information about the types of prior clinical and research training and the expected career level required for the program. Do not name prospective trainees. Describe plans to recruit candidates and explain how these plans will be implemented (see also section on Recruitment and Retention Plan to Enhance Diversity). Describe the evaluation criteria to be used in the selection of trainees. Provide brief summaries of training plans that the program will employ. The application should contain a description of how training plans will be tailored to the needs of the prospective candidates, taking into account their past experiences and competences.

Institutional Environment and Commitment to the Program. The application must include a statement from the applicant institution describing the commitment to the planned program. The institution must assure that essential time will be allowed for the PD(s)/PI(s), other faculty and mentors, and the required protected time for scholars (9 person months, equivalent to 75% effort) selected for the program.

Recruitment and Retention Plan to Enhance Diversity

Individuals are required to comply with the instructions for Recruitment and Retention Plan to Enhance Diversity as provided in Chapter 8 of the SF424 (R&R) Application Guide.

Plan for Instruction in the Responsible Conduct of Research

Individuals are required to comply with the instructions for Plan for Instruction in the Responsible Conduct of Research as provided in Chapter 8 of the SF424 (R&R) Application Guide.

Appendix

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

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

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

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

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

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.

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

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 by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

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

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the program to exert a sustained, powerful 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 scientific merit, and give a separate score for each. 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? 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? Will the proposed PCCTSDP contribute to the development of well-qualified pediatric critical care medicine and/or trauma medicine investigators, advancement of pediatric critical care and trauma research, and the application of current and emerging research developments to significant clinical problems?

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?

Mentors

Do the mentors have 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? Does the program include a broadly based and productive network of established investigators who are involved in research areas relevant to pediatric critical care and trauma medicine?

Candidates/Scholars

Is a recruitment plan proposed with strategies likely to attract high quality scholar candidates? 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 career development program? Is there an appropriate plan for the content, the phasing, and the proposed duration of the career development plan for achieving scientific independence for the prospective candidates? 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?

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?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Inclusion of Women, Minorities, and Children

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Vertebrate Animals

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Biohazards

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Resubmissions

Not Applicable

Renewals

For Renewals, the committee will consider the progress made in the last funding period, including on the Recruitment and Retention Plan to Enhance Diversity, and Training in the Responsible Conduct of Research. Does the application describe the program’s accomplishments over the past funding period(s)? Are changes proposed that would improve or strengthen the career development experience? 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?

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 & Retention Plan to Enhance Diversity

Peer reviewers will separately evaluate the recruitment and retention plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented groups. The review panel’s evaluation will be included in an administrative note in the summary statement. Plans and past record will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

Training in the Responsible Conduct of Research

Taking into account the specific characteristics of the career development program, level of scholar experience, and the particular circumstances of the scholars, the reviewers will address the following questions. Does the plan satisfactorily address the format of instruction, e.g., lectures, coursework and/or real-time discussion groups? Do plans include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety? Do the plans adequately describe how faculty will participate in the instruction? Does the plan meet the minimum requirements for RCR, i.e., eight contact hours of instruction 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 the NICHD, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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

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

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

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

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

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

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 the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants 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.

Not Applicable

The Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) and financial statements as described in the NIH Grants Policy Statement are required annually. Continuation support will not be provided until the required forms are submitted and accepted. Chapter 8 of the SF424 (R&R) Application Guide, Additional Instructions for Preparing a Progress Report for an Institutional Research Training Grant, Including Ruth L. Kirschstein National Research Service Awards, must be followed.

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 scholar appointed for eight 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 (Form PHS 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. Trainees with service payback requirements must notify the NIH of any change in address and submit Annual Payback Activities Certification Forms (PHS 6031-1) until the payback service obligation is satisfied.

A final progress report, 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 Progress Report.

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.

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

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]

Valerie Maholmes, PhD, CAS
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-1514
Email: [email protected]

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

Bryan Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
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 Parts 74 and 92.