Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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

In the United States, injuries are the leading cause of death among persons age 1-44 years. Deaths caused by injuries, intentional or unintentional, account for more years of potential life lost under the age of 18 years than do deaths attributable to sudden infant death syndrome, cancer, and infectious diseases combined.

Leading causes of injury-related death vary by age. For infants less than one year of age, suffocation is the leading cause of injury-related death. For children ages 1-4 years, drowning is the leading cause. After age 5, the greatest number of injury related deaths are from vehicle traffic crashes. The nature of the injuries that account for most of the disability and death among injured children include cerebral, abdominal and thoracic injuries. Notably, every year in the United States, almost 12,000 children sustain traumatic brain injury and nearly 3,000 children per year die from these injuries.

It is estimated that 1 in 4 children sustain an unintentional injury that requires medical care each year. Falls are the leading cause of non-fatal injuries for all children ages 0 to 19. Every day, approximately 8,000 children are treated in U.S. emergency rooms for fall-related injuries. More than 2.6 million children 0-19 years old are treated in the emergency department each year for sports and recreation-related injuries. Increasingly, attention is being paid to firearm-related injury as a serious public health concern accounting for a significant number of fatal and nonfatal injuries.

Risk factors for injuries include being male, age (fatal injury rates are highest in infants and after the age of 16 years), and rural setting. Rates of injury also vary by region of the country. Death rates for unintentional injuries are especially high in nonmetropolitan counties of the South and West. Death rates for motor vehicle traffic-related injuries in the most rural counties are over twice as high as the rates in central counties of large metro areas. Additionally there are disparities by race. Fatal injury rates are highest in black males and in American Indian/Alaska Native males.

Although the principles of resuscitation of injured children are similar to those for adults, appreciation of the differences in cardiorespiratory variables, airway anatomy, response to blood loss, thermoregulation and the required specialized equipment is essential for successful initial resuscitation of children. Thus studies that recognize and elucidate these age related differences are highly desirable.

In treating injured children, physical child abuse must be considered as a potential cause of injury. Approximately 10 percent of pediatric emergency department visits are due to various forms of physical child abuse. However the diagnosis of intentional injury is frequently missed due to challenges in distinguishing between intentional and unintentional injuries, both of which may present with bruising, fractures, and other non-specific signs. Additional research is needed to develop and refine tools and technologies to improve diagnostic accuracy of abuse related injuries.

Finally, the long term sequelae of injury are substantial. Survivors may suffer from long-term physical, cognitive, psychological, and emotional impairments Additional research is needed to fully understand the long term impact of childhood injury. The immediate emotional well-being of the injured child should also be taken into account. Treatments and interventions focused on psychological trauma and family functioning are critical. Management of the psychological problems cannot always be appropriately addressed in the emergency department. Children are not mature enough to understand their injuries and to cope with such stressors as separation from their parents and painful procedures. As a consequence they may suffer long-term psychological problems long after the physical injuries have healed.

Trauma and injury in the pediatric population can have great economic and emotional impact on both the child's family and society. In addition to regaining lost skills, developing children are expected to acquire new skills, making the burden of injury even greater. Children with severe injury can require an extended amount of chronic care throughout their lifetime.

Much remains to be studied in this area of pediatric trauma, emergency care and injury prevention. There is a need for researchers, clinicians and providers to collaborate, share resources, and generate new knowledge on these compelling issues.

A priority of the Pediatric Trauma and Critical Illness Branch is to advance the science related to the prevention and treatment of childhood injuries. Accordingly, the purpose of this initiative is to fund the development of research resources, as well as studies targeting critical gaps in research on pediatric trauma and injury prevention.

Increasingly, the complexity and pace of biomedical science require input and expertise from a group of investigators working together as an investigative team. This FOA will foster collaborations to devise breakthrough ideas, concepts and approaches to therapies in pediatric trauma and injury research. In addition, the FOA is being used to create a Consortium of collaborative research teams to address the aforementioned and other relevant priorities. The sites funded through this initiative comprise the NICHD Consortium.

This FOA provides resources to identify and address problems where multiple expertise is needed to focus on a single complex research problem or to enhance research infrastructure. Through this mechanism, support is provided for multidisciplinary research teams each to focus on innovative approaches to answering a single critically important research question or problem. Collectively, the team should bring together the necessary expertise to pursue a specific scientific question or generate new knowledge regarding a specific problem, design an intervention, or develop a research resource which is expected to result in a greater contribution to program goals than would occur if each team member worked independently. Where feasible, teams should involve researchers or clinicians with expertise to address important questions related to disparities in injury rates such as clinicians or researchers from rural or nonmetropolitan areas. Teams should also use this as an opportunity to mentor early career scholars interested in pursuing an independent research career in pediatric trauma and injury prevention.

Applications to this FOA should have the following characteristics:

• The formation of an interdisciplinary team that will develop a synergistic approach to investigate a single critically important research question or to generate a research resource for the scientific community. The question or problem addressed should represent a major gap in our knowledge and thus have the potential to be paradigm-shifting for the field.

This FOA is not intended to support:

• Traditional investigator-initiated and highly focused studies (best supported by the R01 or P01 activity codes).
• Core (or related) services to supplement the budgets of existing R01-type efforts.
• Groups of investigators at the same institution who would normally interact and collaborate in the absence of a collaborative initiative.

A required element of this initiative is an annual consortium meeting through which investigators can share ideas, best practices and lessons learned as well as discuss a national research agenda on pediatric trauma and injury. This consortium meeting will allow program staff the opportunity to foster greater collaboration among consortium members and will help leverage existing resources and platforms to further the work of the consortium.

An important goal of the PTCIB is to build research capacity in the pediatric trauma, emergency care and injury prevention fields. Therefore we expect research teams to provide opportunities for mentoring and career development to early career researchers, and underrepresented minorities poised to make contributions to this field of inquiry.

Examples of high priority topics for research and research resources include, but are not limited to the following:

1) Risk and Prevention

• Basic, clinical or epidemiological projects elucidating the behavioral, social, and environmental risk and protective factors for unintentional and intentional pediatric injury including injuries sustained from falls, recreational activities, motor vehicle crashes, firearms, violence, child abuse, and other mechanisms of injury.
• Projects illuminating the pathogenesis and prevention of sequelae of traumatic brain injury, (including abusive head trauma, and other cerebral injuries) in infants and children
• Translational and interventional studies focused on primary and secondary prevention of unintentional and/or intentional injuries

2) Treatment, Management and Rehabilitation

• Innovative research projects that examine the translation of appropriate adult trauma, treatment and therapies to pediatric care.
• Research resources and innovative approaches to improve screening, evaluation, and diagnosis of brain injury in children, including the use of biomarkers, imaging, and biomechanics.
• Studies examining effective neuroprotective treatments in pediatric acute brain injury.
• Paradigm shifting projects focused on pediatric injury management from prevention through pre-hospital care, emergency and acute hospital care, to rehabilitation and long-term follow-up.
• 3) Outcomes
• Novel projects designed to improve short and long-term health outcomes for pediatric trauma patients as well as such complementary issues as family functioning and systems engagement (school, health, child protection, legal etc).
• Development and validation of new methods of measuring morbidity, quality of life, and functional status.

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

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) 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 SF424 (R&R) Application Guide.

The PD(s)/PI(s) should be an established research scientist(s) who has the experience, ability, and time commitment to provide scientific leadership and to ensure quality control, effective administration and integration of the R24.

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 scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows. The NIH will accept submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

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, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

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

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

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Valerie Maholmes, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Chief, Pediatric Trauma and Critical Illness Branch
Telephone: 301-496-1514
Email: [email protected]

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

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

Other Attachments: An attachment called "Team Science Justification and Organization" should be uploaded in Other Attachments. Although no specific page limitation applies to this section of the application, be succinct. Do not use this section to circumvent the page limits of the Research Strategy. The following points should be addressed in this attachment and are an important part of the application:

1) A description of the collaborative team aspect of the work proposed including the requirements and roles to be played by each member of the team.

The PD(s)/PI(s) of the application may be located at one institution while other members of the collaborative team may be located at the same, affiliated, or other institutions. It is anticipated that members of the team may not already be interacting on this, or other, projects. Lines of communication and exchange of data should be clearly established. If some of the participating investigators are at the same institution, a rationale must be provided explaining how this grant will enhance integration and collaboration amongst those participants, beyond what would normally be expected of a group of investigators with shared interests at the same institution. Since the overall goal of the FOA is to bring together investigators from varied disciplines to attack a complex problem in a coherent fashion, the justification for drawing investigators from varied disciplines should be well defined. The role(s) for each member of the team and how this will provide the requisite synergies for answering the complex problem should be clearly articulated. These activities should significantly enhance the investigators' existing capabilities and introduce new approaches to the research aims of the objective of the collaborative team.

2) A clear plan of operation should be provided for the administrative structure and proposed interactions among the investigators.

The coordinated use of shared resources that could increase the efficiency of the entire team, as well as facilitate the use of new technologies and the pursuit of new lines of investigation should be defined. The plan for development and use of resources should help to promote the interdisciplinary and collaborative research around which the team has formed. The final administrative structure will be left largely to the discretion of the applicant institution (subject to review by NIH peer review mechanisms). However, NIH's experience has demonstrated that the effective development of a collaborative, interdisciplinary team such as this requires close interaction between the PD/PI (or multi-PDs/PIs), collaborating investigators, and appropriate institutional administrative personnel, and the staff of the awarding agency. It is expected that the PD/PI would provide a plan for the organization of collaborating investigators and institutions, including the need for electronic communication and/or travel. Depending on how the R24 is structured, the PD/PI might need to develop policies and procedures for the operations of project resources. The allocation of resources to the development of new technologies in comparison to provision of services with existing technologies should be addressed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

Key Personnel salaries derived from the grant will depend on the effort provided and institutional salary as well as existing NIH policies. It is recommended that the contact PD/PI devote at least three person months of his/her efforts to the project.

The application should include salaries for individual PD/PIs only to the extent that they provide an essential function of the collaborative team. No overlap of time or effort between the R24 and separately-funded projects is permitted.

It is anticipated that the research environment available to each team member will be sufficient to support the proposed work. However, requests for essential equipment must include a clear justification in terms of need and service to collaborative team investigators. General purpose equipment needs should be included only after surveying the availability of such items within the institution.

Research patient care costs (both in-patient and out-patient expenses) will be considered in the context of other existing institutional clinical resources. Attempts should be made by the applicant institution to utilize existing clinical facilities, such as CTSAs. The award is not intended to be a facility for health care delivery; thus, only those patient costs directly related to research activities may be charged to the grant.

Domestic and foreign travel of project personnel directly related to the collaborative team activities of the application is allowable. Travel of collaborative team members for attendance at annual meetings is allowable.

Collaborative teams must budget for travel to the NIH for an Annual Consortium Meeting.

Consultants and any associated costs (consultant fees, per diem, travel) may be included when their services are required within the application.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Research Strategy: In addition to describing the significance of the problem being addressed and the relevance to the mission of the NICHD, the applicant should specifically address why the problem is best suited for a collaborative team science approach. Provide an explanation of how the project proposed will fill a gap in the current knowledge in the field, or contribute a significant resource or technology that is currently lacking.

Letters of Support: Any resources or expertise outside of the team of investigators, including institutional support through core facilities or resources should be evidenced by appropriate letters of support from the relevant individual.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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.

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants are responsible for viewing their application before the due date 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 SF424 (R&R) Application Guide. Paper applications will not be accepted.

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

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

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. 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 our Post Submission Application Materials policy.

Important Update: See NOT-OD-16-006 for updated review language for applications for due dates on or after January 25, 2016.

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

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project 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. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the application address a significant research topic that fills a gap in the current knowledge?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Is the proposed research topic best addressed by an interdisciplinary approach as presented by this particular team? Does the team that has been assembled have the appropriate mix of expertise necessary to achieve the objectives of the work proposed?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?Has a plan been developed to facilitate the interaction of PD/PIs and key personnel at different institutions? Will data and resources be easily shared among consortium members in order to address the proposed questions in an integrated, interdisciplinary way? Does the administrative organization reflect a coordination of ongoing research and establish and maintain internal communication and cooperation among investigators.

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

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

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. Each application can be renewed only one time

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 score.

Applications from Foreign Organizations

Not Applicable

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).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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

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

As part of the scientific peer review, all applications:

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

Applications will be assigned on the basis of established PHS referral guidelines 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. 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’s business official.

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

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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.

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: https://grants.nih.gov/support/index.html
Email: [email protected]

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
| Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-945-7573
Email: [email protected]

Valerie Maholmes, PhD CAS
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-1514
Email: [email protected]

Ruth Brenner, MD MPH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-594-8668
Email: [email protected]

Sherry Dupere, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-451-3415
Email: [email protected]

Bryan S. Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: (301)435-6975
Email: [email protected]

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

Awards are made under the authorization of 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.