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	Male Reproductive Health Research (MRHR) Career Development Program [K12]
Activity Code	K12 Physician Scientist Award (Program) [PSA]
Announcement Type	Reissue of RFA-HD-05-040.
Related Notices	None
Funding Opportunity Announcement (FOA) Number	RFA-HD-12-187
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	The purpose of this FOA is to announce the re-competition of the Male Reproductive Health Research (MRHR) Career Development Program. The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) provides funding for a limited number of programs in male reproductive health. These centers support the research career development of urologists, reproductive endocrinologists and other clinicians who have recently completed sub-specialty training and who are commencing basic, translational and/or clinical research relevant to men's reproductive health. The goal of this initiative is to increase the clinical research capacity among practitioners in the area of male reproductive biology and promote the translation of basic science advances to clinical practice. The MRHR program will accomplish this through a mentored program, bridging clinical training with research independence. The intent is to stimulate clinical research in male reproductive health and bring a more holistic approach to fertility regulation in clinical practice in which the male is an equal partner.

Posted Date	June 14, 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 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.

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Purpose

This FOA encourages applications from organizations that propose creative and innovative institutional research career development programs in male reproductive health research. These programs will support the research career development of urologists, reproductive endocrinologists and other clinicians who have recently completed sub-specialty training and who are commencing basic, translational and/or clinical research relevant to male reproductive health. The goal of this initiative is to increase the clinical research capacity among practitioners in the area of male reproductive biology and promote the translation of basic science advances to clinical practice. The programs will accomplish this through a mentored program, bridging clinical training with research independence. The intent is to stimulate clinical research in male reproductive health and bring a more holistic approach to fertility regulation in clinical practice in which the male is an equal partner.

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.

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.

Background

There is a clinical void in male reproductive health care that is currently filled by a diffuse collection of practitioners, including urologists, internists, general practitioners and endocrinologists; however, there is a dearth of practitioners in this field who are able to translate the rapid advances in male gamete biology and genetics into effective treatments for male infertility and contraception. Although male contraception and infertility have been included in the scope of many programs sponsored by the NICHD Reproductive Sciences Branch, translational and clinical research in the male has been slow to build on this progress. For example, of the 15 Specialized Cooperative Centers in Reproductive Research, only four focus on the male. Thus, the currently available mechanisms have failed to recruit clinicians with a strong research base into the area of male infertility and contraception.

These areas, however, remain critical components of the NICHD Strategic Plan in Reproductive Health. Establishing a base of clinical investigators in male reproductive health will speed the design of effective treatments for male infertility and male fertility regulation, promote the analysis of the long-term effects of new synthetic hormone treatments designed for contraceptive use, and facilitate the discovery of genetic factors of male infertility by providing the necessary patient population and epidemiology. The basic and clinical investigations on the male reproductive system need to converge to take advantage of the current efforts to discover novel molecular targets of male fertility regulation and the recent advances in 'omics' technology such as metabolomics and epigenomics. This will translate into novel therapeutic agents and diagnostics for male fertility and reproductive health.

In order to facilitate this convergence, the Male Reproductive Health Research Career Development awards provide institutions with an opportunity to support the early careers of junior clinical investigators in male reproductive health. Established investigators at a research institution would combine to establish a career development program -- agreeing to serve as mentors to recruited Scholars who are newly trained in a medical specialty relevant to male reproductive health. The mentors make available their expertise, guidance and laboratory facilities to be utilized by the junior investigators for research projects that will enhance their basic science knowledge and skills. The research projects can be either basic or clinical in nature, as long as there is a described career development plan that would delineate how the project would enhance the Scholar's ability to conduct individual, peer-reviewed research at the end of the project period. Further details of the program are described below under "Special Requirements."

Research Scope

Applications responsive to this FOA may propose a program encompassing several aspects of male reproductive health. The following list of topics provides examples and should not be considered exhaustive:

• Identifying the biologic and molecular bases of idiopathic male infertility.
  
  
• Improving diagnostic methods for male infertility, particularly rapid screening methods that can be widely applied in a clinical setting. This would include the identification of biomarkers to assess sperm quality.
  
  
• Evaluating potential male contraceptive agents. These agents can be hormonal, immunological, mechanical, or based on novel targets identified through the Male Contraceptive Initiative [Novel Approaches to Male Fertility Regulation].
  
  
• Analyzing the long-term health effects of synthetic hormonal therapies designed for contraceptive use, as well as the reproductive health effects of therapeutic hormone replacement in men.
  
  
• Analyzing the reproductive health effects of toxic environmental factors.
  
  
• Evaluating the efficacy and reproductive health effects of nutritional supplements and herbal treatments.
  
  
• Analyzing the effect of paternal age on male fertility potential and subsequent offspring.
  
  
• Evaluating the long-term effect on male fertility and reproductive health of sexually transmitted diseases, prostatitis, and other infections of the genitourinary tract.
  
  
• Identifying and/or evaluating the efficacy of novel treatments for male sexual dysfunction, including erectile dysfunction and premature ejaculation.

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	The NICHD intends to commit $700,000 in Total Costs [Direct plus Facilities and Administrative (F & A) costs] to fund up to two new and/or renewal applications in response to this FOA in FY 2012.
Award Budget	Applicants may request direct cost budgets of up to $324,000 per year. Application budgets need to reflect actual needs of proposed project. Future year amounts will depend on annual appropriations.
Award Project Period	The scope of the proposed project should determine the project period. The maximum period is 5 years.

Personnel Costs	Salary and fringe benefits for a Research Director, if any, up to 0.6 person-months (5 percent) effort, may be requested. This person will be responsible for designing, directing, and implementing the career development program for Scholars. Salary and fringe for the PD/PI is not allowed, unless the PD/PI also serves as the Research Director. 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 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 MRHR 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. Scholars in certain surgical subspecialties may request between 6 and 9 person-months of full-time effort with sufficient justification and approval of NICHD. 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 to training or scientific meetings; (2) tuition, fees, and books; (3) research supplies and equipment; and (4) technical support and statistical or computer services. These research and development costs must be documented specifically for each individual candidate and must be related to the scholar’s research activities.
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. Travel to the annual MRHR retreat for thePD/PI, the Research Director, and each Scholar must be requested. Items that may NOT be supported with K12 funds include: Travel of the PD/PI, Research Director, or program mentors to scientific meetings other than the yearly MRHR retreat; Patient care costs such as inpatient bed days or outpatient visits, except for clinical laboratory analyses essential for the Scholars research; Alterations and renovations.
Indirect Costs	Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees and expenditures for equipment), rather than on the basis of a negotiated rate agreement.

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

Higher Education Institutions:

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

Governments

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

Other

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

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

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

All registrations must be completed by the application due date.

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

The applicant institution must have a strong and high quality research program(s) in the area(s) proposed under this FOA and must have the requisite faculty and facilities on site to conduct the proposed institutional program. In many cases, it is anticipated that the proposed program will complement other ongoing career development programs occurring at the applicant institution and that a substantial number of program faculty will have active research projects in which participating scholars may gain relevant experiences consistent with their research interests and goals. Institutions with existing programs must explain what distinguishes this program from the others, how their programs will synergize with one another, if applicable, and make it clear that the pool of faculty, potential scholars, and resources are robust enough to support additional programs.

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

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

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

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project 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.

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

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

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.

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.

Each MRHR Scholar appointed under the K12 award must have a mentor who is recognized as an independent investigator, who is actively involved in basic, translational, and/or clinical research relevant to this initiative, and who has a successful record of providing research training of a type expected in this Program. An assigned mentor will provide guidance for the development of each MRHR Scholar assigned to the program. The mentor must be committed to continue this involvement throughout the MRHR Scholar's total period of development under the award. Mentors not included in this application must be approved by NICHD Program Staff before being assigned a Scholar.

Scholars to be supported by the institutional career development program must be at the career level for which the planned program is intended. The Scholar position is a junior faculty appointment, not a fellowship. At the time of the award, the scholar candidates must: 1) be a physician holding the M.D. or M.D./Ph.D. degree; 2) have completed post-graduate residency training normally expected for a faculty appointment in their field (including clinical or postdoctoral fellowship training, or residency if they have chosen not to subspecialize); 3) identify an approved mentor with extensive research experience; 4) not be or have been a PD/PI on an R01, R29, R42, R44 or individual mentored or non-mentored career development award (e.g., K01, K02, K08, K22, K23, K24, K25, K99), or the PD/PI of a subproject of a P01, P50, P60, U01, U10, or U54 award. Individuals who have received support through an NRSA grant (F32, T32), an NIH Small Grant (i.e., R03), or an Exploratory/Developmental Grant (i.e., R21s) may be eligible providing they meet the other eligibility requirements.

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).

Completion of subspecialty training is not required of candidates in general practice in their specialty; however, those who chose to subspecialize must have completed their fellowship. To accommodate the needs of those interested in participation in this program who may have had a career hiatus because of family responsibilities, uniformed service, etc., there is no limit on time elapsed since completion of training. However, Scholars cannot have more than six years of research training experience beyond their last doctoral degree. Programs are encouraged to recruit members of underrepresented minorities, women and candidates with disabilities.

Support is in the form of a minimum of two consecutive 12-month appointments, renewable in annual increments for up to five years total, and is contingent upon satisfactory progress as reported to the Advisory Committee and to the NICHD in the Non-Competing Continuation Progress Report for the Program. At least 9 person months of the MRHR Scholars' full-time effort must be devoted to the research program and career development activities of the award. However, Scholars in certain surgical subspecialties may request between 6 and 9 person months of full-time effort with sufficient justification and approval of the awarding component.

During the period of this award, Scholars may not accept or hold any other PHS award that duplicates the provisions of this career award. However, Scholars may remain eligible for other individual mentored career development awards (e.g., K01, K08, K22, K23, K25, K99) at the conclusion of the K12 appointment if additional training is needed to establish research independence. Combined support through the K12 and other mentored career development award programs must not exceed six years. Scholars should contact NICHD staff if there are questions regarding eligibility.

• K12 Scholars are strongly encouraged to apply for independent research grant support (e.g., R01, R21, R03) during the award. K12 Scholars in the last two years of career award support may reduce effort on the career award to a minimum of 6 person months (50 percent) and hold concurrent support from their career award and a competing NIH research grant if they are recognized as a PD/PI or Subproject Director (see: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html. Independent NIH research grant support must conform to all NIH policies and guidelines as described in the NIH Guide for Grants and Contracts (NOT-OD-08-065).

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

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

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

Letter of 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:

Stuart B. Moss, PhD
Reproductive Sciences Branch (RSB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 8B01H
Bethesda, MD 20892-7510
Rockville, MD 20852 for courier/non-USPS service
Telephone: 301-435-6979
Fax: 301-480-2389
Email: mossstua@mail.nih.gov

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

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

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

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

Project Summary /Abstract

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

Advisory Committee (Uploaded via the Other Attachments section)

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

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

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

• The R&R Budget Component must be used instead of the Training Budget Component.
• Include all personnel other than the PD/PI(s) in the Other Personnel section, including clerical and administrative staff. Also include proposed salary costs for planned scholars.
• Do not complete the section on Participant/Trainee Support Costs.

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

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

Program 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 Research 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.

Trainee Candidates (Component of Program Plan)

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

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

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

Appendix

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

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

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

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

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

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide.  Paper applications will not be accepted.

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

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

Important reminders:

All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by NICHD, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

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

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

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the program to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

Career Development Program and Environment

Does the proposed program clearly outline a plan to recruit and develop well-qualified junior investigators for successful careers as biomedical or clinical researchers? Is there evidence of an adequate pool of potential scholars who could benefit from receiving career development support? Are the content and duration of any proposed didactic, training-related, and research-related activities of the program appropriate? Are appropriate timelines indicated for career progression and transition to independence? Does the institutional environment (e.g., research facilities and other relevant resources) in which the program will be conducted contribute to the probability of success? Does the proposed career development program benefit from unique features of the scientific environment, subject populations, or employ useful collaborative arrangements? Is the institutional commitment to the proposed program appropriate? If multiple sites are participating, is this adequately justified in terms of the career development and research experiences provided? Is there sufficient assurance that the required effort of the PD/PI, mentors and scholars will be devoted directly to the research training, career development, and related activities? When applicable, is there adequate documentation describing the responsibilities of the advisory committee with regard to the provision of input, guidance and oversight of the program?

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

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

Mentors

Do the mentors have expertise and experience, as well as track records of past mentoring and training? Are the quality and extent of the mentors roles in providing guidance and scientific advice to the scholars acceptable? Are the mentors currently engaged in relevant research?

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? 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?

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

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

Recruitment & Retention Plan to Enhance Diversity

Peer reviewers will separately evaluate the recruitment and retention plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented groups. The review panel’s evaluation will be included in an administrative note in the summary statement.

Training in the Responsible Conduct of Research

Taking into account the specific characteristics of the career development program, level of scholar experience, and the particular circumstances of the scholars, the reviewers will address the following questions. Does the plan satisfactorily address the format of instruction, e.g. lectures, coursework and/or real-time discussion groups? Do plans include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety? Do the plans adequately describe how faculty will participate in the instruction? Does the plan meet the minimum requirements for RCR, i.e., eight contact hours of instruction every four years? Plans and past record will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

Select Agent Research

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

Budget and Period of Support

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

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

As part of the scientific peer review, all applications:

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

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

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

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

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

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

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

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

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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

In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program. Accordingly, scholars are hereby notified that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

Not Applicable

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

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

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

• The institution must submit a completed Statement of Appointment (PHS Form 2271) for each scholar appointed for eight weeks or more to the K12 program. Grantees must submit the PHS 2271 data electronically using the xTrain system. More information on xTrain is available at xTrain (eRA Commons). An appointment or reappointment may begin any time during the budget period, but not before the budget period start date of the grant year.
  
  
• A notarized statement verifying possession of permanent residency documentation must be submitted with the Statement of Appointment (Form PHS 2271). Individuals with a Conditional Permanent Resident status must first meet full (non-conditional) Permanent Residency requirements before receiving support.
  
  
• Participant Termination Notice: Within 30 days of the end of the total support period for each participant, the institution must submit a Termination Notice (PHS Form 416-7) via xTrain for each participant appointed for eight weeks or more.

A final Progress Report 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.

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

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

Stuart B. Moss, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6979
Email: mossstua@mail.nih.gov

Sherry Dupere, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-1485
Email: duperes@mail.nih.gov

Mr. Ted Williams
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6996
Email: williate@mail.nih.gov

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

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