National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Pediatric Scientist Development Program (K12)
K12 Physician Scientist Award (Program) (PSA)
Reissue of RFA-HD-12-209
- March 22, 2021 - This RFA has been reissued as RFA-HD-22-006.
RFA-HD-17-023
None
93.865
This FOA invites applications for the pediatric scientist development program (PSDP). This program constitutes a national network of mentors and scholars, in contrast to K12 programs that are based solely at a single applicant institution. The program will be responsible for identifying pediatricians who have completed their clinical training and who have promising research potential, and for matching them with established mentors with strong records of research productivity. The program will develop guidelines for mentoring and career development in order to promote the successful transition of the candidates into independent research careers in academic settings.
October 21, 2016
November 28, 2016
November 28, 2016
December 28, 2016, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Not applicable
March 2017
May 2017
July 2017
December 29, 2016
Not Applicable
It is critical that applicants follow the instructions in the Training Instructions for the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission
Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
The overall goal of the NIH Research Career Development
programs is to help ensure that a diverse pool of highly trained scientists is
available in appropriate scientific disciplines to address the Nation s
biomedical, behavioral, and clinical research needs. More information about Career programs may be found at the NIH Extramural Training Mechanisms website.
This FOA invites applications from organizations that propose a creative and
innovative research career development program (K12) for pediatric scientists. The
PSDP constitutes a national network of mentors and scholars, in contrast to K12
programs that are based solely at a single applicant institution. The program
will be responsible for identifying pediatricians who have completed their
clinical training and have promising research potential and matching them with
established mentors with a strong record of research productivity. The program
will develop guidelines for mentoring and career development in order to
promote the successful transition of the candidates into independent research
careers in academic settings.
The PSDP program targets clinical fellows and junior faculty in pediatrics, who will be referred to as "Scholars" in the remainder of the FOA. The Scholars supported by the NICHD will train in laboratories located at premier research institutions across the country. After having been nominated for the PSDP by his/her Department Chair, each Scholar will be chosen for entry into the first year of the program by a Selection Committee comprised of chairs of pediatric departments.
Career development activities of the PSDP can be in basic biomedical or clinical sciences, in the population sciences, in health services research, or in any other discipline relevant to the NICHD mission. Institutional K12 programs are designed to allow the Career Development Program Director (PD/PI) to develop a plan for providing an intensive research experience and complementary career development activities for each participating scholar.
Within the framework of the NICHD's longstanding commitment to excellence and the projected need for well-trained pediatric scientists across the country, attention must be given to recruiting applicants from racial or ethnic groups under-represented in the biomedical, behavioral and clinical sciences, and individuals with disabilities.
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.
See Section VIII. Other Information for award authorities and regulations.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
New
Renewal
The OER
Glossary and the SF424 (R&R) Application Guide provide details on
these application types.
NICHD intends to fund one award, corresponding to a total of $1.5 million, for fiscal year 2017. Future year amounts will depend on annual appropriations.
Applicants may request direct cost budgets of up to $1.40M per year.
The scope of the proposed project should determine the project period. The maximum period is 5 years.
Individuals designing, directing, and implementing the career development program may request salary and fringe benefits appropriate for the person months devoted to the program. Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap. If mentoring interactions and other activities with scholars are considered a regular part of an individual's academic duties, then mentoring and other interactions with scholars are non-reimbursable from grant funds.
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 45 CFR 75.413(c), 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.
Allowable Costs:
- Up to $25,000 may be requested for all faculty who are involved in designing, directing, and administering the K12 program. This may include the PD(s)/PI(s), Training Director, and/or Recruiting Officer, as appropriate to the proposed program. The Cost limit applies to all faculty salaries combined.
- Up to $100,000 per year may be requested for administrative, clerical, or other staff with responsibilities directly associated with the institutional career development program. The cost limit applies to all staff salaries combined.
Items that may NOT be supported with K12 funds include:
- Salaries and fringe benefits for the 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.
Scholars are those individuals who directly benefit from the proposed activities and experiences involved in the career development program. Requested salary and fringe benefit amounts must be in accordance with institutional policies applied consistently to individuals in like circumstances and must be supported by acceptable accounting principles. If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure. Salary amounts requested on career development awards must be based on the investigator's institutional base salary (IBS) prorated for their commitment on the project. While requested salary and fringe benefit information is provided in the initial application, confirmation of these costs may be required prior to the issuance of an award.
The PSDP program will provide support for Scholars for periods of up to three years consisting of consecutive 12-month appointments. The number of PSDP Scholars supported by funds from the NICHD shall be no more than 10.
NICHD will provide total support for each Scholar position of up to $125,000 in direct costs per year. This amount includes salary, fringe benefits, and research and career development expenses as itemized below.
Salary and Fringe Benefits:
Scholars may receive up to $100,000 per year for salary and fringe benefits, consistent with the institution's salary scale. Scholars must devote a minimum of 9 person-months (equivalent to 75 percent) of full-time professional effort toward health-related research and career development activities, with the remaining effort being devoted to activities related to the development of a successful career as a physician-scientist.
The institution may supplement the NIH salary contribution up to a level that is consistent with the institution's salary scale from non-federal sources; however, supplementation may not be from federal funds unless specifically authorized 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.
Research and Career Development Support:
Within each scholar's $125,000 direct cost award, up to $25,000 per year may be allocated for research and career development costs. Allowable research expenses 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 attend the annual PSDP scholar's meeting which may be held at an appropriate professional meeting or at a site chosen by the grantee; 3) travel to receive training or attend scientific meetings; 4) tuition, fees, or books; 5) technical support for data analysis and statistical or computer services. These research and development costs must be 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.
Items that may NOT be supported with each Scholar's Research and Career Development Support category include:
- Direct support of the laboratories, travel, and research projects of the investigators serving as mentors beyond those expenses directly attributable to the scholar's project.
Consultant costs, equipment, supplies, non-Scholar travel for Senior/Key persons, meeting costs, and other program-related expenses may be included in the proposed budget. These Other Program-Related Expenses must be justified as specifically required by the proposed program and must not duplicate items generally available at the applicant institution.
Other Program-Related Expenses are limited to $25,000 per year. This allowance may be used for the PD(s)/PI(s), other faculty, or advisory committee members to attend the annual Scholars meeting or other organizational/administrative meetings associated with the K12 program.
Items that may NOT be supported with K12 funds include:
- Travel of the PD(s)/PI(s), Training Director, or program mentors to scientific meetings other than the annual K12 Scholar's meeting;
- Patient care costs such as inpatient bed days or outpatient visits, except for clinical laboratory analyses essential for the Scholars research;
- Alterations and renovations.
Indirect Costs (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 applicant institution must have a strong and high-quality research program in the area(s) proposed under this FOA and must have connections to the requisite faculty, staff, potential trainees and facilities to conduct the proposed national career-development 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.
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
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
- Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
- System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
- NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
- eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
- Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with
the skills, knowledge, and resources necessary to carry out the proposed research training program as the
Training Program Director/Principal Investigator (Training PD/PI) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person
Profile (Expanded) Component of the SF 424 (R&R) Application Guide.
The PD/PI should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI will be responsible for the selection and appointment of scholars to the approved research training program, and for the overall direction, management, administration, and evaluation of the program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required. The PD/PI has responsibility for the day to day administration of the program and is responsible for appointing members of the Advisory Committee, using their recommendations to determine the appropriate allotment of funds.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is programmatically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
- A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
- A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
- An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).
Program faculty should have strong records as researchers, including recent publications and successful competition for research support in the area of the proposed research training program. Program faculty should also have a record of research training, including successful, former trainees who have established productive careers relevant to the NIH mission. Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as mentors.
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 PSDP.
Scholars to be supported by the institutional career
development program must be at the career level for which the planned program
is intended. Scholars must have an M.D. degree and must have completed a
residency in one of the pediatric specialties. PSDP Scholars may also have a
Ph.D. or other doctoral degree in addition to an M.D.
Scholars must be citizens or
noncitizen nationals of the United States or have been lawfully admitted for
permanent residence at the time of appointment. Additional details on
citizenship requirements are available in the NIH
Grants Policy Statement.
During the time of appointment, Scholars may not accept or 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. Combined support through the K12 and other mentored career development award programs from NICHD must not exceed six years. The PD/PI should contact NICHD staff if there are questions regarding eligibility.
Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
It is critical that applicants follow the instructions in
the Training Instructions for the SF424
(R&R) Application Guide including Supplemental
Grant Application Instructions 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:
Gilman Grave, M.D.
Eunice
Kennedy Shriver National Institute of Child Health and Human
Development (NICHD)
Telephone: 301-496-5593
Email: [email protected]
All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed.
Instructions for Application Submission
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
Follow all instructions provided in the SF424 (R&R) Application Guide.
Follow all instructions provided in the SF424 (R&R) Application.
Follow all instructions provided in the SF424 (R&R) Application, with the following additional modifications:
Substitute the term scholars for all references to trainees in the SF424 (R&R) Application Guide, and substitute the term career development for all references to training in the SF424 (R&R) Application Guide.
Project Summary/Abstract. Provide an abstract of the entire application. Include the objectives, rationale and design of the research career development program, as well as key activities in the career development plan. Indicate the planned duration of appointments, the projected number of scholars including their levels (i.e., postdoctoral fellows, faculty), and intended scholar outcomes.
Other Attachments. Provide a plan for the appointment of an Advisory Committee to monitor progress of the career development program. The composition, roles, responsibilities, and desired expertise of committee members, frequency of committee meetings, and other relevant information should be included. Describe how the Advisory Committee will evaluate the overall effectiveness of the program. Proposed Advisory Committee members should be named in the application if they have been invited to participate at the time the application is submitted. Renewal applications with Advisory Committees should include the names of all committee members during the past project period. Please name your file Advisory_Committee.pdf .
The 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.
Follow all instructions provided in the SF424 (R&R) Application.
Follow all instructions provided in the SF424 (R&R) Application Guide.
Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:
- Include all personnel other than the 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.
The PHS 398 Research Training Program Plan Form is comprised of the following sections:
- Training Program
- Faculty, Trainees, and Training Record
- Other Training Program Sections
- Appendix
Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:
Data Tables: Particular attention must be given to the required Training Data Tables. For this FOA, applicants should use the following Data Tables only (Data for Scholars should be entered into the Postdoctoral sections of the Data Tables):
Table 2 (Renewal applications only)
Table 3 (Renewal applications only)
Table 4 (Renewal applications only)
Table 5B (Renewal applications only)
Table 7 (Renewal applications only)
Table 8C, Part I only (Renewal applications only)
Substitute the term scholars for all references to trainees in the SF424 (R&R) Application Guide, and substitute the term career development for all references to training in the SF424 (R&R) Application Guide.
Training Program
Program Plan
a. Program Administration:
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. 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.
For renewal applications, highlight how the training program has evolved in response to changes in relevant scientific and technical knowledge, educational practices, and to evaluation of the training program
b. Program Faculty
Career-development programs developed under this FOA shall be national networks rather than programs based solely at the applicant institution. Scholars shall be matched to the most appropriate mentors and institutions, which will usually extend beyond those of the applicant organization; the specific expertise of those mentors will depend on the needs of scholar pool. Applicants must describe a plan for identifying appropriate mentors, linking candidates with those mentors, and ensuring that mentors will commit to candidate support. The K12 applicant need not provide a list of potential mentors. Providing an advanced listing of prospective mentors and collaborators at other institutions may compromise the review process by creating unnecessary institutional conflicts for the recruitment of peer reviewers. Applicants should describe how mentors at remote sites will be integrated into the national network of the proposed K12 program in terms of providing guidance and scientific advice to the scholars and supporting their transition to independent status.
e. Scholar Candidates
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 individuals with disabilities or from racial or ethnic groups that are currently underrepresented in biomedical, behavioral, or clinical sciences and explain how the plans will be implemented. 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 competencies.
Plan for Instruction in the Responsible Conduct of Research
Individuals are required to comply with the instructions for Plan for Instruction in the Responsible Conduct of Research as provided in the SF424 (R&R) Application Guide.
Appendix
Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
All instructions in the SF424 (R&R) Application Guide must be followed.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to
submit applications before the due date to ensure they have time to make any application
corrections that might be necessary for successful submission. When a
submission date falls on a weekend or Federal
holiday, the application deadline is automatically extended to the next
business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants
across all Federal agencies). Applicants must then complete the submission
process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants
administration. NIH and Grants.gov systems check the application against many
of the application instructions upon submission. Errors must be corrected and a
changed/corrected application must be submitted to Grants.gov on or before the
application due date and time. If a Changed/Corrected application is submitted
after the deadline, the application will be considered late. Applications that
miss the due date and time are subjected to the NIH Policy on Late Application
Submission.
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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in
the Credential field of the Senior/Key Person Profile Component of the
SF424(R&R) Application Package. Failure to register in the Commons
and to include a valid PD/PI Commons ID in the credential field will prevent
the successful submission of an electronic application to NIH.
The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the System for Award Management (SAM). Additional information
may be found in the SF424 (R&R) Application Guide.
See more
tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.
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 that the proposed training program will prepare individuals for successful, productive scientific research careers and thereby exert a sustained influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of the merit of the training program, and give a separate score for each. When applicable, the reviewers will consider relevant questions in the context of proposed short-term training. An application does not need to be strong in all categories to be judged likely to have major scientific impact.
Career Development Program and Environment
- Does the proposed program clearly outline a plan to recruit and develop 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?
Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))
- Do the PD/PI and Research Administrator (if applicable) have the experience to develop, direct and administer the proposed program?
- Does the leadership team bring complementary and integrated expertise to the program? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure program objectives?
- Are the research qualifications, scientific stature, previous leadership and mentoring experience, and track record(s) appropriate for the proposed career development program?
- Are the PD(s)/PI(s) currently engaged in research relevant to the scientific area of the proposed program?
- For applications designating multiple PDs/PIs:
- Is a strong justification provided that the multiple PD/PI leadership approach will benefit the career development program and the scholars?
- Is a strong and compelling leadership approach evident, including the designated roles and responsibilities, governance, and organizational structure consistent with and justified by the aims of the career development program and the complementary expertise of the PDs/PIs?
- For this national K12 program, is there an effective plan for identifying highly-qualified mentors and linking them to potential candidates?
- Will the plan for identifying mentors provide opportunities for pediatrics scholars to receive high quality research training in disciplines relevant to the NICHD mission, including basic biomedical or clinical sciences, population sciences, or health services research?
- Is there an effective plan for ensuring that mentors will be sufficiently committed to candidate support?
- Will mentors at remote sites be effectively integrated into the national network of the proposed K12 program in terms of providing guidance and scientific advice to the scholars and supporting their transition to independent status?
- Is a recruitment plan proposed with strategies likely to attract high quality scholars?
- Are there well-defined and well justified recruitment and selection strategies?
- Is there evidence of a sufficiently large, competitive scholar pool to warrant the proposed size of the career development program?
- Are the content, phasing, and proposed duration of the career development plan appropriate for achieving scientific independence of the scholars?
- What is the likelihood that the career development plan will contribute significantly to the scientific development of the scholars?
- Does the plan for selection of the scholars include all of the eligibility criteria stated in the FOA?
- Is 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.
Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.
Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.
Not Applicable
For Renewals, the committee will consider the progress made in the last funding period, including on the Recruitment Plan to Enhance Diversity, and Training in the Responsible Conduct of Research. Does the application describe the program’s accomplishments over the past funding period(s)? 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 research careers?
Not Applicable
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Recruitment Plan to Enhance Diversity
Peer reviewers will separately evaluate the recruitment plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment of individuals from underrepresented groups. The plan will be rated as ACCEPTABLE or UNACCEPTABLE, and the consensus of the review committee will be included in an administrative note in the summary statement.
Training in the Responsible Conduct of Research
All applications for support under this FOA must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the specific characteristics of the career development program, the level of scholar experience, and the particular circumstances of the scholars, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - Does the plan satisfactorily address the format of instruction, e.g. lectures, coursework and/or real-time discussion groups, including face-to-face interaction? (A plan involving only on-line instruction is not acceptable.); 2) Subject Matter Does the plan include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics? 3) Faculty Participation - Does the plan adequately describe how faculty will participate in the instruction? For renewal applications, are all training faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period named in the application? 4) Duration of Instruction - Does the plan meet the minimum requirements for RCR, i.e., at least eight contact hours of instruction? 5) Frequency of Instruction Does the plan meet the minimum requirements for RCR, i.e., at least once during each career stage (undergraduate, post-baccalaureate, predoctoral, postdoctoral, and faculty levels) and at a frequency of no less than once every four years?
For renewal applications, does the progress report document acceptable RCR instruction in the five components described above? Does the plan describe how participation in RCR instruction is being monitored? Are appropriate changes in the plan for RCR instruction proposed in response to feedback and in response to evolving issues related to responsible conduct of research?
Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee.
Reviewers will assess the information provided in this section of the application, including (1) the Select Agent(s) to be used in the proposed research, (2) the registration status of all entities where Select Agent(s) will be used, (3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and (4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by NICHD, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
- 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. Refer to Part 1 for dates for peer review, advisory council
review, and earliest start date
Information regarding the disposition of applications is available in the NIH
Grants Policy Statement.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH
Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and
conditions found on the Award
Conditions and Information for NIH Grants website. This includes any
recent legislation and policy applicable to awards that is highlighted on this
website.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.
For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
Awards made primarily for educational purposes are exempted from the PHS invention requirements and thus invention reporting is not required, as described in the NIH Grants Policy Statement.
Not Applicable
When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually. Continuation support will not be provided until the required forms are submitted and accepted.
Failure by the grantee institution to submit required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
- The institution must submit a completed Statement of Appointment (PHS Form 2271) for each scholar appointed for 8 weeks or more. Grantees must submit the PHS 2271 data electronically using the xTrain system. More information on xTrain is available at xTrain (eRA Commons). An appointment or reappointment may begin any time during the budget period, but not before the budget period start date of the grant year.
- A notarized statement verifying possession of permanent residency documentation must be submitted with the Statement of Appointment (PHS Form 2271). Individuals with a Conditional Permanent Resident status must first meet full (non-conditional) Permanent Residency requirements before receiving support.
- Termination Notice: Within 30 days of the end of the total support period, the institution must submit a Termination Notice (PHS Form 416-7) via xTrain for each scholar appointed for eight weeks or more.
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 accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.
In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
eRA Commons Help Desk (Questions regarding eRA Commons
registration, submitting and tracking an application, documenting system
problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Grants.gov
Customer Support (Questions
regarding Grants.gov registration and submission, downloading forms and
application packages)
Contact Center Telephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573
Gilman Grave, M.D.
Eunice
Kennedy Shriver National Institute of Child Health and Human
Development (NICHD)
Telephone: 301-496-5593
Email: [email protected]
Sherry Dupere, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-1485
Email: [email protected]
Bryan S. 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 Section 487 of the Public Health Service Act as amended (42 USC 288) and under Federal Regulations 42 CFR 66.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.
and Human Services (HHS)
