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	NICHD Continuing Education Training Programs (T15)
Activity Code	T15 Continuing Education Training Grants
Announcement Type	New
Related Notices	June 12, 2012 - See Notice NOT-HD-12-017. Effective immediately, applications for T15 awards will no longer be accepted. September 22, 2011 - See Notice NOT-HD-11-025. This Notice revises the budgetary instructions for this Funding Opportunity Announcement. August 24, 2011 - See Notice NOT-HD-11-021. Clarification of Parameters and Scope.
Funding Opportunity Announcement (FOA) Number	PAR-11-233
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 Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) invites applications for grants to develop and conduct short-term continuing education programs to improve the knowledge and skills of a broad-based community of biomedical and behavioral researchers conducting research on reproductive, developmental, behavioral, social, and rehabilitative processes that determine the health and well-being of newborns, infants, children, adults, families, and populations, and to disseminate course materials and instructional experience to the scientific community. The program should include both didactic and hands-on experiences. Programs focusing on uses of model organisms are also encouraged.

Posted Date	June 16, 2011
Open Date (Earliest Submission Date)	August 25, 2011
Letter of Intent Due Date	30 days before application receipt date.
Application Due Date(s)	Standard dates apply, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Standard dates apply, by 5:00 PM local time of applicant organization.
Scientific Merit Review	Standard dates apply
Advisory Council Review	Standard dates apply
Earliest Start Date(s)	Standard dates apply
Expiration Date	(Now Expired June 13, 2012 per NOT-HD-12-017), Original Date September 8, 2014
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

This funding opportunity announcement (FOA) issued by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), encourages applications to develop, implement and evaluate innovative and interactive short-term training courses for scientists interested in learning state-of-the-art procedures used for conducting research on topics relevant to NICHD's mission. These topics include reproductive, developmental, behavioral, social, and rehabilitative processes that relate to the health and well-being of newborns, infants, children, adults, families, and populations.

The Continuing Education Training Grant (T15) is designed to assist institutions to establish, expand, or improve programs of continuing professional education, especially for programs dealing with new developments in the science or technology of the profession. The mechanism is intended for the support of short, advanced-level courses, to emphasize new techniques and enhance skills of scientists. Depending on the goals of the proposed training programs, the duration of the short courses can vary from one week or less to a maximum of 12 weeks. Recurring courses are welcome.

The NICHD invites T15 applications in any research area relevant to the mission of the Institute as represented by its program areas. The research interests of NICHD are described in more detail at: http://www.nichd.nih.gov/research/org/supported_by.cfm

Developmental Biology and Perinatal Medicine

Complex biological processes, which determine health and well-being later in life, begin even before conception. Fetal and early childhood development set the stage for physical, cognitive, and behavioral outcomes. A major NICHD priority is to advance fundamental and clinical knowledge about maternal health and problems of child development. This research includes (but is not limited to):

• Basic research on the biochemistry, molecular biology, genetics, and cellular mechanisms of early embryonic development and regenerative processes;
• Biomedical, biobehavioral, clinical, and translational research to prevent or ameliorate intellectual and developmental disabilities, including (but not limited to) such conditions as intellectual disability, Fragile X, autism spectrum disorders (ASDs), and Down syndrome;
• Basic, clinical, and translational research on maternal health, pregnancy, fetal well-being, labor and delivery, newborn screening, and the developing child.

Maternal and Child Health

A major priority of the NICHD is to conduct research to improve maternal and child health in the United States and worldwide. This research includes (but is not limited to):

• Basic, translational, and clinical research on serious threats to health and quality-of-life, including gestational diabetes, obesity and overweight, mechanisms of cognition and learning, growth retardation, HIV/AIDS, and other congenital infections and diseases;
• Applied research on the psychological, psychobiological, language, behavioral, and educational development of children;
• Advanced clinical research to understand the effects and effectiveness of pharmaceuticals on maternal and child health.

Contraception, Reproduction, and Population Research

Understanding reproductive health and biology for both men and women is crucial to improving health and quality-of-life around the world. Improved knowledge about human population dynamics is also essential to successful and sustainable communities. This research includes (but is not limited to):

• Basic and clinical research in reproductive health to improve diagnosis and treatment of reproductive health conditions, such as uterine fibroids, endometriosis, infertility, and pelvic floor and pain disorders, among others;
• Efforts to develop safe, effective, inexpensive, reversible, and acceptable contraceptive methods;
• Studies to improve understanding of the causes and consequences of population size and distribution changes, including fertility, migration and immigration, population diversity, and family functioning.

Medical Rehabilitation Research

Medical rehabilitation research is essential to developing scientific and technical knowledge needed to enhance health, productivity, independence, and quality-of-life for people with disabilities. This research includes (but is not limited to):

• Studies to elucidate the scientific underpinnings of clinical rehabilitation and to understand the mechanisms of recovery and adaptation;
• Applying technological advances in engineering and bioengineering to improve the human environment interface and to restore or enhance an individual’s functional capabilities through assistive technologies, such as prosthetics, wheelchairs, and biomechanical devices;
• Basic and clinical research to understand the underlying mechanisms of Traumatic Brain Injury (TBI) and stroke, and to assess medical rehabilitation therapies and interventions for people with these conditions;
• Research on pediatric critical care and rehabilitation to ultimately improve outcomes for children who are survivors of trauma, congenital anomalies, neonatal asphyxia, infections, septic shock, and other less common, but still devastating childhood injuries and illnesses. .

Funding Instrument	Grant
Application Types Allowed	New Renewal Resubmission Revision 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 number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.
Award Budget	Direct costs for an application are limited to a maximum of $125,000 per year. Course duration can vary from a minimum of three weeks to a maximum of twelve weeks. Because of the nature and scope of the proposed program will vary from application to application, the size of each award may also vary.
Award Project Period	The scope of the proposed project should determine the total project period. The maximum period is 5 years.

Personnel Costs	Individuals designing, directing, and implementing the 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. 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.
Participant Costs	Trainee participant support for travel and per diem while attending the continuing education program are appropriate when necessary. However, it is expected that the program will be partially funded through registration fees paid for by the Trainee participants and their home Institutions.
Other Program Related Expenses	Consultant costs, purchase of laboratory supplies required for experiments, animal acquisition and care costs, travel and per diem for faculty, and other costs such as printing, telephone, audio-visuals, postage, recruitment materials, and computer software are allowed. Off-site rental space and rental of laboratory equipment will be considered if shown to be necessary for the implementation and execution of the continuing education program. Matching funds from the applicant institution or other organizations for such rental costs are strongly encouraged. These expenses must be justified as specifically required by the proposed program and must not duplicate items generally available at the applicant institution. Equipment costs and renovation costs are not allowable.
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.

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

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

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

The PD/PI should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required.

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

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

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

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

Trainee Participants may range from graduate students through senior biomedical researchers. The program should foster the participation of individuals from racial and ethnic groups underrepresented in biomedical and behavioral research, individuals from disadvantaged backgrounds, individuals with disabilities, and women.

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:

Dennis A. Twombly, PhD
Deputy Director, Office of Extramural Policy
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 2C01, MSC 7510
Bethesda, MD 20892
Rockville, MD 20852-7510 (for express mail and courier service)
Telephone: 301-451-3371
Fax: (301) 480-2400
Email: dtwombly@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:

Project Summary /Abstract

Provide an abstract of the entire application, including the long-term goals and objectives of the program, key elements of the education/training plan, and brief descriptions of the course topics, technologies, and target trainee participants. Include the rationale and design of the program, the planned duration and projected number of trainee participants, including their levels (i.e., predoctoral, postdoctoral, faculty).

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.
• Section E. Participant Trainee Support Costs: Include all allowable categories of funds requested to support trainee participants in the program.

Section K. Budget Justification: In addition to following the standard R & R instructions, provide a narrative justification for each proposed personnel position, including role and proposed level of effort. Include information regarding efforts to obtain funding for this educational training program from other sources. Provide details of available program support from sources such as other grants, registration fees, trainee participant contributions, institutional matching funds, travel awards, etc.

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.

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.

Short Course Program Plan (Component of Program Plan)

Describe the objectives and logistical arrangements for the continuing education program. Describe the curricula for the program including the objectives for each didactic and hands-on laboratory course in terms of scientific skills and knowledge. Describe the format and list the agenda and speakers, including the principal topics to be covered, problems to be addressed, and developments or contributions the course might stimulate. Describe plans for announcing the program, application and selection procedures, and criteria for selection of trainee participants that range from students through senior biomedical researchers. Describe any educational materials to be developed and those that are currently available. Describe any plans for continuing exchange of information after trainee participants return to their home institutions. Provide a detailed justification for the educational program, including the scientific need, timeliness, and usefulness of the program to the scientific community. Describe the composition and role of any organizing committee or advisory committee.

Applications requesting multiple years of support must provide the following additional information for each future year requested, in as much detail as possible: course topic(s); tentative dates, locations, and trainee participants; and contingency plans for future meetings dependent upon, for example, the outcome of the first year’s education program or new developments in the field.

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. 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 trainee candidates including information about the types of prior clinical and research training and career level required for the program. Do not name prospective Trainee Participants. Describe the criteria to be used for trainee candidate evaluation in the selection of Trainee Participants. Describe plans to recruit trainee 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.

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.

Recruitment and Retention Plan to Enhance Diversity

A critical part of the application for support of T15 short courses is documentation of appropriate representation of women, racial/ethnic minorities, persons with disabilities, and other individuals who have been traditionally underrepresented in science. A broad cross section of individuals must be included in all aspects of planning, organization, and implementation of NIH-sponsored and/or supported conferences/meetings. Appropriate representation means representation based on the availability of these scientists from these groups known to be working in a particular field of biomedical or behavioral research. If appropriate representation is not apparent, no award will be issued until program staff members are assured of concerted recruitment efforts.

Plan for Instruction in the Responsible Conduct of Research

Plans for instruction in the responsible conduct of research (RCR) may not be applicable for any particular T15 short course. However, some courses are dedicated to RCR-related topics, while others may feature specialty RCR courses as a part of the overall curriculum. If any course component includes RCR topics, these features of the program should be described and related to the overall objectives of the program.

Progress Report

For renewal applications, provide a description of previously supported educational activities and any changes in administration, course design, or targeted trainee participant groups. Describe prior course activities and any available outcome measures.

Human Subjects

Not applicable for T15 short courses.

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, NIH. Applications that are incomplete 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.

For this particular announcement, note the following: The goal of this short course training program is to develop skills and knowledge among investigators for successful application in research studies, and to disseminate course materials and instructional experience to the larger scientific community. The below review criteria will be related to those objectives.

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.

Training Program and Environment

Does the educational program address an important problem or a critical barrier to progress in the field? If the aims of the program are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? Are the objectives, design, direction, and quality of the proposed educational research training program appropriate? Does the proposed program provide suitable training for the levels of trainee Participants being proposed and the area of science to be supported by the program? Does the program provide training in inter- or multi-disciplinary research and/or provide training in state of the art or novel methodologies and techniques? Are the necessary institutional facilities (for example, laboratory space, equipment and reagents) adequate for the training program? Are the course content and syllabus appropriate? Is there an adequate balance between didactic and hands-on training? Is the time allotted sufficient to cover the planned material? Is the level of individual attention for trainee participants sufficient? Is a significant level of institutional commitment to the program evident? Is the dissemination plan for the course content and materials to the broader scientific community adequate? Will the course content and materials be useful to the broader community? Is there a course evaluation plan that is adequate and sufficiently detailed to rate trainee participants satisfaction with the course and determine the success of the course?

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

Does the Training PD/PI have the scientific background, expertise, and experience to provide strong leadership, direction, management, and administration to the proposed research training program? Does the PD/PI plan to commit sufficient time to the program to ensure its success? Is sufficient administrative and research training support provided for the program?

For applications designating multiple PD/PIs: Is a strong justification provided that the multiple PD/PI leadership approach will benefit the training program and the trainee Participants? Is a strong and compelling leadership approach evident, including the designated roles and responsibilities, governance, and organizational structure consistent with and justified by the aims of the training program and with the complementary expertise of each of the PD/PIs?

Preceptors/Mentors

Are sufficient numbers of experienced preceptors/mentors with appropriate expertise available to support the number and level of trainee participants proposed in the application? Do the preceptors/mentors have strong records as researchers and experience with the topics and technologies to be covered in the course? What is the track record of the preceptors in directing continuing education training programs or the potential of those preceptors who lack a track record? Are the commitment and availability of the faculty well-suited for the program? Is there sufficient interaction planned between faculty and trainee participants? What is the track record of the preceptors in directing such training that crosses departmental boundaries?

Trainee Candidates/Participants

Are the quality and size of the applicant pool and plans for the selection of individuals appointed to the training program appropriate? Are the recruiting/advertising procedures for the course and selection criteria for trainee participants adequate and well-defined? Are the plans to recruit women, minorities and individuals with disabilities adequate? Are there plans for awarding scholarships, and if so, are the criteria appropriate and well-defined?

Training Record

How successful is the program in terms of training individuals at different career stages? How many individuals have participated in the program, and what disciplines have been represented? Is there evidence that the program has had an impact on the approaches and technologies former trainee participants have used in their own research? Are there any other indicators of the success of the program?

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

Protections for Human Subjects

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

Inclusion of Women, Minorities, and Children

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

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

Renewals

For Renewals, the committee will consider the progress made in the last funding period. Does the application describe the program’s accomplishments over the past funding period(s)? Are changes proposed that would improve or strengthen the training experience?

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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 training program, level of trainee experience, and the particular circumstances of the trainees, the reviewers will address the following questions. Does the plan satisfactorily address the format of instruction, e.g. lectures, coursework and/or real-time discussion groups? Do plans include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety? Do the plans adequately describe how faculty will participate in the instruction? Does the plan meet the minimum requirements for RCR, i.e., eight contact hours of instruction every four years?

Plans and past record will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

Select Agent Research

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

Budget and Period of Support

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

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

As part of the scientific peer review, all applications:

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 . Following initial peer review, recommended applications will receive a second level of review by the National Advisory Child Health and Human Development (NACHHD) Council. l 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.

Awards made primarily for educational purposes are exempted from the PHS invention requirements and thus invention reporting is not required, as described in the NIH Grants Policy Statement.

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, trainee Participants 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.

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.

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.

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

Dennis A. Twombly, Ph.D.
Deputy Director, Office of Extramural Policy
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-301-451-3371
Email: dtwombly@mail.nih.gov

Sherry L. Dupere, Ph.D.
Director, Division of Scientific Review
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-451-3415
Email: duperes@mail.nih.gov

Robin KurtzSenior Grants Management Specialist
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6978
Email: rkurtz@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 63A and 45 CFR Parts 74 and 92.