Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

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

Funding Opportunity Title

Rehabilitation Research Career Development Programs (K12)

Activity Code

K12 Physician Scientist Award (Program) (PSA)

Announcement Type

Reissue of RFA-HD-06-010

Related Notices
Funding Opportunity Announcement (FOA) Number

RFA-HD-12-208

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) invites applications to coordinate the mentoring and career development of rehabilitation researchers in one of the following three domains: physical/occupational therapy and allied health professionals, clinicians involved in neurological rehabilitation, or bioengineers. Unlike some other NIH K12 programs this FOA requests applications for a national network rather than a program exclusively located at the applicant institution. The applicant will be responsible for identifying qualified candidates (scholars) and supporting them in appropriate research environments throughout the country. The NICHD anticipates making three awards for K12 programs, one in each of three academic disciplines indicated above.

Key Dates
Posted Date

July 15, 2011

Open Date (Earliest Submission Date)

October 14, 2011

Letter of Intent Due Date

October 14, 2011

Application Due Date(s)

November 14, 2011, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

February/March 2012

Advisory Council Review

May 2012

Earliest Start Date(s)

July 1, 2012

Expiration Date

November 15, 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.

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

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, invites applications to coordinate the mentoring and career development of rehabilitation researchers in one of the following three domains: therapy and allied health professionals, clinicians involved in neurological rehabilitation, or bioengineers. Unlike some other NIH K12 programs, this FOA requests applications for a national network rather than a program exclusively located at the applicant institution. The applicant will be responsible for identifying qualified candidates (scholars) and supporting them in appropriate research environments throughout the country. The NICHD anticipates making three awards for K12 programs, one in each of the three academic disciplines indicated above.

Goals

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

The proposed institutional career development programs are intended to promote networking among clinical and academic departments as well as professional organizations in order to attract and nurture a new cadre of rehabilitation researchers. Scholars supported under these programs will be encouraged to seek independent and stable research support through grants from the NIH and other federal agencies and research foundations.

The proposed 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.

Background

Despite the increasing population of individuals coping with chronic disabilities at various levels, the field of medical rehabilitation has not responded sufficiently to the need for research to validate approaches, optimize treatments, and incorporate new technologies and opportunities. Unprecedented opportunities exist to explore the biomedical, behavioral, and social bases for rehabilitative strategies and their application to appropriate populations. One of the earliest priorities of the NICHD’s National Center for Medical Rehabilitation Research (NCMRR) has been the training of research scientists in the field of rehabilitation. There now exists critical masses of successful investigators in therapy and allied health, neurological rehabilitation (e.g., neurology, neuropsychology, neurosurgery, and physical medicine and rehabilitation), bioengineering, and related fields, who could recruit and train promising young rehabilitation researchers through national mentoring programs.

Through the career development programs described here, the NCMRR/NICHD is seeking to attract and support a broad cohort of basic and clinical investigators for research on improving the lives of people with chronic physical disabilities. Rehabilitation research goals include the development of strategies to minimize tissue pathophysiology and secondary complications, to facilitate tissue plasticity and regeneration, to support behavioral and psychosocial adaptation, and to promote and integrate assistive technologies.

Bioengineering research must continue to improve the access and use of orthotics, prosthetics, robotics, and other assistive devices for people with disabilities. Other opportunities include the integration of therapeutic exercise, functional stimulation, pharmacological approaches, and brain imaging technologies.

Research is also needed to develop better treatments for clinical conditions such as chronic pain, weakness and paralysis, spasticity and tremors, problems with balance, coordination, and gait, and sensory and autonomic dysfunction. Behavioral and psychosocial studies are needed to promote cognitive rehabilitation and psychosocial support, understand the role of environmental factors, increase participation, and improve quality of life.

Special research is also needed for understanding rehabilitative issues specific to pediatric populations. Children are more dependent on family and environmental factors and react differently to trauma, pharmacological compounds, and physical interventions. While the developing brain has a greater degree of vulnerability, it has higher potential for plasticity and recovery.

The NCMRR/NICHD encourages the development of improved diagnostic and prognostic measures; better ways to assess function, impairment, disability, and patient goals; and broader measures of participation and quality of life. Molecular genetic approaches may have a role in understanding rehabilitative processes, improving prognostic measures, and targeting therapeutic strategies. The NCMRR/NICHD also supports the development of clinical trials, comparative effectiveness research, and studies of health-service utilization.

The Institutional Career Program shall be responsible for:

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Renewal

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NICHD intends to fund up to three awards for total costs of up to $1,500,000 in FY 2012, and total costs of up to $3,000,000 per year for FY 2013-2016.

Award Budget

Applicants may request up to $600,000 total costs in the initial year and up to $1.2 million total costs annually for years two through five. 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.

Other Award Budget Information
Personnel Costs

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

Up to 1.2 person months effort may be provided to support a Deputy Director with expertise and experience complementary to that of the PD/PI. Support can be provided for a recruitment officer, up to 1.2 calendar months effort, to enhance participation of women, individuals from underrepresented racial and ethnic backgrounds, individuals with disabilities, and individuals from disadvantaged backgrounds. A part-time administrative/clerical assistant may also be supported, up to 6 person months effort, to specifically assist the PD/PI and/or Deputy Director in the coordination and administration of the K12 program.

Limited program-related administrative and clerical salary costs associated distinctly with the program that are not normally provided by the applicant organization may be direct charges to the grant only when they are in accordance with applicable cost principles. For institutions covered by OMB Circular A-21, this type of training program may qualify as a major project where administrative salaries are allowable as a direct cost. When specifically identified and justified, these expenses must be itemized in Sections A and B, as appropriate, of the R&R Budget.

Items that may NOT be supported with K12 funds include:

  • Salaries and fringe benefits for the program mentors;
  • Direct support of the laboratories, salaries, fringe benefits, travel, and research projects of the 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

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

The NICHD will provide total support for each Scholar position of up to $125,000 in direct costs per year. This amount includes salary, fringe, and research and career development expenses as itemized below.

Salary and Fringe Benefits: Scholars are eligible for annual salary support of up to $100,000 per year, in addition to fringe benefits, consistent with the institution's salary scale. Scholars must spend at least 9 person months (equivalent to 75 percent) of full-time professional effort conducting research and research career development activities.

The total salary requested for each scholar must be based on a full-time, 12-month staff appointment. It must be consistent with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. 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.

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 support. Allowable research expenses may include (1) travel for training or to scientific meetings; (2) research supplies and equipment; and (3) technical support and statistical or computer services.

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.

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.

Section III. Eligibility Information

1. Eligible Applicants
Eligible Organizations

Higher Education Institutions:

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

Nonprofits Other Than Institutions of Higher Education

Governments

Other

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.

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 administer the proposed institutional program. In many cases, it is anticipated that the proposed program will complement other ongoing career development programs occurring at the applicant institution and that a substantial number of program faculty will have active research projects in which participating scholars may gain relevant experiences consistent with their research interests and goals. 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.

Required Registrations

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.

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.

Eligible Individuals (Program Director/Principal Investigator)

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.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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.

Mentors

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. 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 often extend beyond those of the applicant organization; the specific expertise of those mentors will depend on the needs of scholar pool. Therefore, the K12 applicant need not provide a list potential mentors at their institution and beyond, but rather a strategy for linking candidates to appropriate mentors and ensuring that those mentors commit to candidate support. Moreover, providing an advanced listing of prospective mentors and collaborators at other institutions may also compromise the review process by creating unnecessary institutional conflicts for the recruitment of peer reviewers.

Scholar Participants

Candidates must have received, as of the beginning date of the K12 appointment, a Ph.D., M.D., D.D.S., or comparable doctoral degree from an accredited domestic or foreign institution. Eligible doctoral degrees include, but are not limited to, the following: D.M.D., D.C., D.O., D.V.M., O.D., D.P.M., Sc.D., Eng.D., Dr. P.H., D.N.Sc., D.P.T., Pharm.D., N.D. (Doctor of Naturopathy), D.S.W., Psy.D, as well as a doctoral degree in nursing research.

Scholars to be supported by the respective national career development networks must be at an appropriate career level and are expected to devote a minimum of 9 person-months (75% of full-time professional effort) during their appointment on the K12 award. By the time of appointment, 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).

Candidates must make a 4-5 year commitment to the career-development program, spanning both Phase I and Phase II. Upon entering the program, candidates should develop, in conjunction with their primary mentor, a long-range research and career development plan.

During Phase I, scholars may be supported by the K12 program for up to three years, provided they are making appropriate progress as judged by the Advisory Committee in conjunction with the PD/PI. Toward the end of the second year, candidates are expected to apply for independent and stable research support outside the K12 grant as they transition to independent-researcher status. Support may include research grants from the NIH, other federal agencies, research foundations, or possibly advanced mentored development through individual K awards (the NICHD stipulates that an individual may have no more than six years of aggregate K support across all mentored career-development mechanisms).

During Phase II (generally another 2-3 years), scholars should be supported by independent grants or departmental funds; they can no longer be supported by the K12 grant. Nonetheless, they will be encouraged to remain associated with the program for career-development opportunities and participation in annual K12 meetings. It is expected that the scholars departments will provide at least 50% - and preferably 75% - protected time for research activities during the Phase II period. The total combined duration of Phase I and Phase II interaction should not exceed five years.

As part of its recruitment efforts, the K12 program should make every effort to broadly advertise career development opportunities and to provide information on prospective mentors. In general, candidates should be no more than three years beyond their postdoctoral (therapists and engineers) or fellowship (clinicians) training when they enter this program. An individual who has previously served as PD/PI on an NIH research grant (e.g., R01, R21, R03), subproject of program project (P01) or contract (N01) may not be considered for further mentoring through this program.

Section IV. Application and Submission Information

1. Requesting an Application Package

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.

2. Content and Form of Application Submission

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

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

Letter of Intent

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

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

Descriptive title of proposed 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:

Ralph Nitkin, Ph.D.
National Center for Medical Rehabilitation Research
Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 2A03, MSC 7510
Bethesda, MD 20992-7510
Rockville, MD 20852 (for courier/expres service or non-USPS delivery)
Telephone: 301-401-4206
Email: nitkinR@mail.nih.gov

Required and Optional Components

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.

Page Limitations

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

SF424 (R&R) Other Project Information Component

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 modification:

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 program plan, and projected number of scholars.

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 Scholar 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.

Research and Related (R&R) Budget Component

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

PHS 398 Research Training Program Plan

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:

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. When a program administrator and/or deputy director position is planned, a description of the scientific expertise, leadership, and administrative capabilities essential to coordinate a program for developing investigators must be included in the application.

Program Faculty (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.

Scholar 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 candidates. Describe the criteria to be used for evaluation in the selection of candidates. 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.

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.

Recruitment and Retention Plan to Enhance Diversity

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

Plan for Instruction in the Responsible Conduct of Research

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

Appendix

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

3. Submission Dates and Times

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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.

6. Other Submission Requirements and Information

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. Applications that are incomplete and/or nonresponsive will not be reviewed.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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.

Overall Impact

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).

Scored Review Criteria

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?

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

Do the PD/PI, Deputy Director, and Research Administrator (if applicable), have the experience to develop, direct and administer the proposed program? Does the leadership team bring complementary and integrated expertise to the program? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure program objectives? Are the research qualifications, scientific stature, previous leadership and mentoring experience, and track record(s) appropriate for the proposed career development program? Are the PD(s)/PI(s) currently engaged in research relevant to the scientific area of the proposed program?

Mentors

Is there a plan to connect scholars with mentors who have appropriate expertise and experience, as well as track records of past mentoring and training? Are the plans to evaluate the quality and extent of the mentors roles in providing guidance and scientific advice to the scholars acceptable?

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?

Training Record

Does the program have a rigorous evaluation plan to assess the quality and effectiveness of the training? Are there adequate plans to evaluate overall goals of developing a national career-development network and a cadre of rehabilitation researchers in the indicated domain?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/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

Not Applicable

Renewals

:For Renewals, the committee will consider the progress made in the last funding period, including on the Recruitment and Retention Plan to Enhance Diversity, and Training in the Responsible Conduct of Research. Does the application describe the program’s accomplishments over the past funding period(s)? Are changes proposed that would improve or strengthen the career development experience? Is there evidence of a successful past training record of the PD/PI and mentors, including the success of former scholars in seeking independent support and establishing productive scientific careers?

Revisions

Not Applicable

Additional Review Considerations

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

2. Review and Selection Process

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:

. 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:

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

2. Administrative and National Policy Requirements

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

Evaluation

In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program. 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.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

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.

Other Reporting Requirements

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.

Section VII. Agency Contacts

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

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov

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: commons@od.nih.gov

Scientific/Research Contact(s)

Ralph Nitkin, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-402-4206
Email: nnitkinr@mail.nih.gov

Peer Review Contact(s)

Sherry L. Dupere, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-451-1485
Email: duperes@mail.nih.gov

Financial/Grants Management Contact(s)

Bryan Clark, M.B.A
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: clarkb1@mail.nih.gov

Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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