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	Child Health Research Career Development Award (CHRCDA) Program (K12)
Activity Code	K12 Physician Scientist Award (Program) [PSA]
Announcement Type	Reissue of RFA-HD-10-007
Related Notices	April 6, 2016 - See Notice NOT-HD-16-009. February 12, 2015 - This PA has been reissued as RFA-HD-16-018. March 23, 2012 - This RFA has been reissued as RFA-HD-13-011.
Funding Opportunity Announcement (FOA) Number	RFA-HD-12-189
Companion FOA	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.865
FOA Purpose	This funding opportunity announcement (FOA) issued by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health, solicits applications for institutional research career development (K12) programs from applicant organizations that propose to support a national program of mentored institutional career development programs for fellows and new investigators who have recently completed postgraduate clinical training in Pediatrics, and are committed to launching an independent research career. The program provides supervised research training to assist the transition into productive, physician scientists in areas related to pediatrics and its subspecialties.

Posted Date	April 4, 2011
Open Date (Earliest Submission Date)	April 26, 2011
Letter of Intent Due Date	April 26, 2011
Application Due Date(s)	June 21, 2011 , by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	June/July 2011
Advisory Council Review	October 2011
Earliest Start Date(s)	December 2011
Expiration Date	June 22, 2011
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide especially the Supplemental Instructions to the SF424 (R&R) for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application, except where 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

Purpose

This funding opportunity announcement (FOA) issued by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health, intends to provide new clinical investigators with state of the art training in an academic research setting to stimulate pediatric research over a variety of disciplines. The program provides supervised researchcareer development opportunities to assist junior faculty in their transition into productive, physician scientists in pediatrics and its subspecialties.

The goal of the Child Health Research Career Development Award Program is to promote the performance of research and transfer of findings that will benefit the health of children. This will be accomplished by supporting research career development of new faculty-level pediatricians, to be known as CHRCDA Scholars. These K12 Program grant awards will ultimately result in a well-qualified cadre of pediatrician-scientists who will help strengthen the research capacity and meet the need for highly skilled physician scientists who can respond to the increasing demands of pediatric research.

Background

The CHRCDA program was initiated by NICHD in 1990 in response to the need for greater numbers of physician-scientists in pediatric research. The CHRCDA Program supports research career development of pediatricians who have recently completed postgraduate clinical training and who are commencing basic or translational research relevant to the field of pediatrics. This funding opportunity is intended to address the need for a strong research foundation and to provide a transition to independence. Senior investigators with established research programs covering a broad range of basic and applied biomedical science related to pediatrics, together with collaborating departments, form the intellectual and technical base for mentoring CHRCDA scholars. Although mentors from collaborating departments may provide the needed expertise and resources, the emphasis should be on research that is relevant to pediatrics. There is an expectation that the K12 Programs established in response to this announcement will provide the ideal environment for development of independent researchers able to sustain viable careers and mentor those that follow them.

Types of Research and Experimental Approaches

The research scope encompasses all areas of pediatrics and its related subspecialties. Projects should be mostly basic science and must be within the biomedical purview of the NIH. Scholars with minimal past basic science research experience may devote the initial months of their program to didactics such as courses in proteomics, genomics, molecular biology techniques, newest options for DNA sequencing, and tools to analyze and manage the data.

The NIH encourages all proposed programs to foster the participation of individuals from racial and ethnic groups underrepresented in biomedical and behavioral research, individuals from disadvantaged backgrounds, individuals with disabilities, and women.

Organization

Principal Investigator (PD/PI) -- The PD/PI must be a Chairperson of a Department of Pediatrics of an eligible institution. He/she should possess the scientific background, leadership, and administrative capabilities required to coordinate and supervise an interdisciplinary research and development program of this scope. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

Training Director (TD) -- The TD (in prior FOAs, referred to as the Program Director) must be an experienced investigator with responsibility for the day-to-day operations of the Program. The experience and qualifications of the TD should complement those of the PD/PI, and the division of responsibility between the two individuals should be described clearly in the application. If appropriate, the PD/PI may serve a dual role as both the PD/PI and the TD.

K12 Scholars -- Candidates for appointment to the K12 program are new faculty who have recently completed postgraduate clinical training in Pediatrics, and are committed to launching an independent research career. The program provides supervised research training to assist these faculty as they transition into productive, physician scientists in areas related to pediatrics and its subspecialties.

Funding Instrument	Grant
Application Types Allowed	New Renewal Resubmission The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The NICHD intends to award up to $2,400,000 in total costs [Direct plus Facilities and Administrative (F & A) costs] in FY 2011 to fund up to six new and/or renewal (formally known as competing continuation application) grants in response to this funding announcement.
Award Budget	Applicants may request direct cost budgets of up to $400,000 per year. Future year amounts will depend on annual appropriations.
Award Project Period	The scope of the proposed project should determine the project period. The maximum period is 5 years.

Personnel Costs	Salary and fringe benefits may be requested for the Training Director (TD) for up to 1.2 person months of effort. If the PD/PI serves a dual role (i.e., functions as both the PD/PI and the TD), up to 1.2 person months may be requested. Partial salary for a dedicated recruiting officer may be requested (maximum 2.4 person months effort). If the TD also functions as the recruiting officer, effort cannot exceed 2.4 person months for the combined roles. Salary for a part-time Program Assistant with responsibilities directly associated with the institutional career development program can be requested, if applicable and justified. Salaries must be commensurate with institutional policy for similar positions. Items that may NOT be supported with K12 funds include: Salaries and fringe benefits for the PD/PI or program mentors, unless the PD/PI also serves as TD (see above); Salaries for support of ancillary personnel, i.e. secretarial and administrative assistance, etc.; Direct support of the laboratories, salaries, fringe benefits, travel, and research projects of the established investigators serving as mentors beyond those expenses directly attributable to the scholar's project; 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 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. All expenses must be itemized in the proposed budget. Each Scholar's total award may be up to $100,000 per year. Each Scholar may be provided salary support up to $75,000 per year, which includes any fringe benefits charged according to grantee institutional policy. Salaries must be consistent with the institution's salary scale for equivalent positions. The total salary requested must be based on a full-time, 12-month staff appointment and requires Scholars to devote a minimum of 9 person months (equivalent to 75 percent) of full-time professional effort toward health-related research and career development activities, with the remaining effort being devoted to activities related to the development of a successful research career. For information regarding NIH policy on determining full-time professional effort for career awards, see: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-056.html. 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. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the program. Each Scholar may be provided up to $25,000 annually for research and career development costs. Allowable costs under this category may include: 1) research expenses such as supplies, equipment and technical personnel, including expenses generated in the laboratories of the established investigators who serve as mentors; 2) travel to receive training or attend scientific meetings where the scholar will be presenting CHRCDA-funded work (not to exceed $3500 annually); 3) tuition, fees, or books; and 4) computer services. These research and development costs must be itemized for each individual candidate and related to the Scholar's research activities. They cannot be pooled and used for other programs unrelated or indirectly related to the research activities of individual Scholars.
Other Program Related Expenses	Consultant costs, equipment, supplies, travel for key persons, and other program-related expenses may be included in the proposed budget. These expenses must be justified as specifically required by the proposed program and must not duplicate items generally available at the applicant institution. Allowable costs include: Travel to an annual CHRCDA Program meeting for the PD/PI, the TD, and for the current CHRCDA Scholars. Travel may also be requested for one additional training or scientific meeting per year for current Scholars. Minimal costs can be allocated for advertising and recruitment in order to attract the best candidates nationally. Some laboratory costs may be provided to scholars to offset expenses of the scholar's research project related to K12 training. These costs may include partial salary support for technical assistants. Administrative support services that are directly associated with and necessary for the CHRCDA program, and are not covered by institutional overhead charges, may be requested. Allowable costs include supplies, duplicating equipment, telephone, or maintenance contracts for equipment. Items that may NOT be supported with K12 funds include: Travel of the PD/PI, TD, or program mentors to scientific meetings other than the yearly CHRCDA retreat; Patient care costs such as inpatient bed days or outpatient visits, except for clinical laboratory analyses essential for the Scholars research; Alterations and renovations.
Indirect Costs	Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees 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

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

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

All Program Directors/Principal Investigators (PD/PIs) 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.

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 one or more high quality research programs in the area(s) proposed under this FOA and must have the requisite faculty and facilities on site to conduct the proposed institutional program. The applicant institution must have an adequate pool of highly trained established investigators in research related to pediatrics and its subspecialties and the basic science research facilities sufficient to meet the purposes of the CHRCDA 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. 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.

Applicant organizations must complete the following registrations as described in the SF 424 (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.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• Grants.gov
• eRA Commons

All Program Directors/Principal Investigators (PD/PIs) 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 four (4) 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/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 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 CHRCDA Principal Investigator (PD/PI) must be the Chair of the Department of Pediatrics. The Training Director (TD) must possess the educational and scientific expertise, leadership, and administrative capabilities required to coordinate and supervise a multidisciplinary research and career development program of this scope. As the PD/PI and TD are essential to the administration of the program, any changes in these positions should be immediately reported to the NIH Program Officer.

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.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.

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 mentee’s participation in this award. The mentors should hold 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. 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 have track records in mentoring and training, and must interact closely with the Scholar in order to develop a career development plan. Assigned mentors will provide guidance for the development of each Scholar appointed to the program. Mentors are not required to be members of the Department of Pediatrics. Although mentors from collaborating departments may provide needed expertise and resources, the emphasis of the CHRCDA Scholars' scientific projects should be on research relevant to pediatrics, and its subspecialties.

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.

By the time of award, each scholar must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status).

An institution receiving a CHRCDA Program award must recruit and select Scholars who have the potential to develop into independent investigators. At the time of appointment to the K-12 Program, candidates for CHRCDA Scholars must:

• Be a pediatrician holding the M.D. degree;
• Have completed postgraduate residency training in pediatrics;
• Be no more than 4 years after attaining board eligibility in their subspecialty;
• Identify an approved mentor or mentors with extensive research experience;
• Not be or have been a 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 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.

The Scholar position is a faculty appointment, not a fellowship or extension of a fellowship position. Completion of subspecialty training is not required. Scholars may be appointed to the K12 program in the final research year of subspecialty fellowship training, if the fellowship provides basic science training similar to this K-12 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 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 remain eligible for other individual mentored career development awards (e.g., K01, 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. Scholars should contact NICHD staff if there are questions regarding eligibility.

K12 Scholars are strongly encouraged to apply for independent research grant support (e.g., R01, R21, R03) during the award. K12 Scholars in the last two years of career award support may reduce effort on the career award to a minimum of 50% and hold concurrent support from their career award and a competing NIH research grant if they are recognized as a Principal Investigator or Subproject Director (see: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html. Independent NIH research grant support must conform to all NIH policies and guidelines as described in the NIH Guide for Grants and Contracts (NOT-OD-08-065).

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 IntentAlthough 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 research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

The letter of intent should be sent to:

Karen Winer, M.D.
Endocrinology, Nutrition, Growth Branch
Center for Research for Mothers and Children
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 4B11, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 for courier/non-USPS service
Telephone: 301-435-6877
Fax: (301) 480-9791
Email: [email protected]

The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for application submission. Follow the instructions in the SF 424 (R&R) Application Guide to determine which components are required.

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

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 modifications:

Substitute all references to trainees in the SF 424 (R&R) Application Guide with scholars and all references to training in the SF 424 (R&R) Application Guide with career development .

Project Summary /Abstract

Provide an abstract of the entire application, including the long-term goals and objectives of the program, key elements of the career development plan, and brief descriptions of planned research projects. Include the rationale and design of the program, the planned duration and projected number of scholars, including their levels (i.e., predoctoral, postdoctoral, faculty).

Advisory Committee (Uploaded via the Other Attachments section)

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 Advisory Committee members should not be named in the application, particularly if they include individuals from outside the institution.

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 with the following modifications:

• The R&R Budget Component must be used instead of the Training Budget Component.
• Include all personnel other than the PD/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 additional instructions described below:

• Substitute all references to trainees in the SF 424 (R&R) Application Guide with scholars and all references to training in the SF 424 (R&R) Application Guide with career development

PROGRAM PLAN (Item 3)

Program Administration (Component of Program Plan)

Describe the acknowledged strengths, leadership and administrative skills, and scientific expertise of the PD/PI. Include active research and the planned strategy to be used to oversee and monitor the program. For applications with multiple PDs/PI(s), 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. For the Training Director (TD), if different from the PD/PI, 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 (Component of Program Plan)

Describe the complementary expertise and experiences of the proposed mentors for the scholars. Include active research and other scholarly activities in which the mentors are engaged, as well as track records of mentoring and training.

Proposed Training (Component of Program Plan)

Provide an overview of the proposed program: Describe the immediate and long-term objectives of the program, including training or career development 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 proposal from the others, how the programs will synergize, if applicable, and make it clear that the faculty, 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 scholars in establishing independent productive scientific careers.

Program Evaluation (Component of Program Plan)

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

Trainee Candidates (Component of Program Plan)

Describe in general terms the pool of potential candidates including information about the types of prior clinical and research training and career level required for the program. Do not name prospective Scholars. Describe the criteria to be used for candidate evaluation in the selection of Scholars. Describe plans to recruit candidates, including those from economically, socially, or culturally disadvantaged backgrounds, individuals with disabilities or from racial or ethnic groups that are currently underrepresented in biomedical, behavioral, or clinical sciences and explain how these plans will be implemented. Provide brief summaries of training plans that the program will employ. The application should contain a description of how the career development plan will be tailored to the needs of the prospective candidates, taking into account their past experiences and competences, and should distinguish the plan from fellowship training. PDs/PIs should submit a plan for recruiting trainees from both outside and inside the sponsoring institution. The appointment of Trainees should be documented by a Statement of Appointment Form (Form 2271) and submitted to the funding IC.

Institutional Environment and Commitment to the Program (Component of Program Plan)

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 PDs/PIs, other faculty and mentors, and the required protected time for scholars (9 person months, equivalent to 75%) selected for the program. Describe the research infrastructure and facilities that are available and accessible to this Program. This includes the existence of funded laboratories and research space and activities that will meet and sustain the needs of the Program. Provide information establishing the commitment of the Principal Investigator/Program Director (PD/PI), the Training Director (TD), and the faculty mentors to providing training experiences that lead to independence in biomedical research..

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 in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via 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 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 SF 424 (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/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(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 Central Contractor Registration (CCR). 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 the NICHD, 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/priority 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?
• 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?
• Is the career development plan likely to contribute significantly to the scientific development of the scholars?
• Are adequate research facilities and relevant resources being made available for the planned program?
• For institutions with other K12 programs, what is the effectiveness of the plan to keep the career development activities of the proposed program distinct from that offered by the other K12 Programs?
• Did the other K12 program(s) have sufficient high-quality Scholars and are those Scholars engaged in research at the present time as judged by their current position and evidence of independent support?
• Is adequate information provided to understand what distinguishes the proposed CHRCDA Program from these other training-related or career development efforts?
• Are there enough high-quality Scholar candidates and faculty mentors to support an additional program?
• What is the probable effect of the CHRCDA on enhancing the capacity of the grantee institution to develop well-qualified new pediatric investigators, thereby advancing pediatric research at the grantee institution, in the local medical environment, and in the nation?
• Will the Program provide individualized career development training for Scholars?
• If there are NIH-supported Centers or other large research projects at the applicant institution, are there plans to take advantage of the resources provided for the benefit of the proposed CHRCDA Program?
• Does the institution provide assurances that it intends the Program to be an integral part of its research endeavor?
• Is there a commitment to 75% protected time for all CHRCDA Scholars?
• Is there evidence of institutional commitment to the Program and its goals, such as recruitment efforts, salaries, or equipment?
• Is there adequate availability of research-oriented faculty positions at the grantee institution for new investigators previously trained by the CHRCDA?

Program Director(s)/Principal Investigator(s) (PDs/PIs)

• Do the PD/PI and Training Director (TD) 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?
• Are the mentors established investigators supported by NIH or other competitively awarded grants and acknowledged experts in basic science methodology?
• Are the mentors' research interests relevant to the overall mission of the CHRCDA?
• Are the aggregate interests of established investigators broadly based and not too narrowly defined by a specific disease category or organ system?
• Is the number of proposed established investigators who will serve as mentors adequate?

Candidates/Scholars

• What is the quality of plans to identify, recruit, and select candidates, with a commitment to research relevant to the mission of the FOA, and the potential to develop as independent researchers?
• 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?
• How useful is the research plan as a vehicle for ensuring research training for all scholars as described in the career development plan?
• What is the likelihood that the career development plan will contribute significantly to the scientific development of the scholars?
• Does the program include a plan to recruit, identify, and select scholars with a commitment to research relevant to the objectives of the FOA?
• Does the plan for selection of the scholars include all of the eligibility criteria stated in the FOA?
• Does the application demonstrate an adequate pool of prospective junior investigators, trained locally or recruited from elsewhere, who could benefit from receiving career development support from the CHRCDA Program at this site?
• Is there evidence of a scientifically sound and equitable system for evaluating candidates for scholar positions and providing internal quality control of ongoing research?

Training Record

• Does the program have a rigorous evaluation plan to assess the quality and effectiveness of the training?
• Is there evidence of a successful past training record of the PD/PI, TD, and mentors, including the success of former scholars in seeking independent support and establishing productive scientific careers?

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/priority 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

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

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?
• Has the K12 program successfully recruited scholars who show great promise for achieving academic success?
• 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?
• Has the career development program successfully achieved its stated objectives during the prior project period?
• Has the program been innovative in the past and does it continue to demonstrate innovation?
• Does the past performance demonstrate superior mentoring capabilities as evidenced by current and past career development programs?
• What are the quality and effectiveness of the institution's career development program in training and producing independent pediatrician scientists?

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/priority 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.

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. Review assignments 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/priority score.
• Will receive a written critique.

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 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, CCR 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.

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. Accordingly, scholars are hereby notified that they 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.

Not Applicable.

The Non-Competing Continuation Grant Progress Report (PHS 2590) and financial statements (Financial Status Report) as described in the NIH Grants Policy Statement are required annually. Continuation support will not be provided until the required forms are submitted and acceptedThe 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 to the K12 program. 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.
• Participant Termination Notice: Within 30 days of the end of the total support period for each participant, the institution must submit a Termination Notice (PHS Form 416-7) via xTrain for each participant appointed for eight weeks or more.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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]

Karen Winer, M.D.
Endocrinology, Nutrition, Growth Branch
Center for Research for Mothers and Children
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 4B11, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 for courier/non-USPS service
Telephone: 301-435-6877
Fax: (301) 480-9791
Email: [email protected]

Sherry Dupere, Ph.D.
Director, Division of Scientific Review
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 for courier/non-USPS service
Telephone: 301-496-1485
Email: [email protected]

Bryan S. Clark, M.B.A.
Chief, Grants Management Branch
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard
Bethesda, MD 20892-7510
Rockville, MD 20852 for courier/non-USPS service
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.