NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

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) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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) invites exploratory grant applications (referred to as LD Hubs) to address nascent or understudied research topics and highly innovative and high risk research topics and approaches related to learning disabilities impacting reading, writing, and mathematics, with a special focus on the study of under-studied and under-represented populations. This FOA is expressly designed to address high public health impact topics where there is limited data or where progress is limited and novel solutions are needed to improve outcomes and to enhance data collection reflective of the diversity of learners in the U.S. NICHD expressly encourages research applications that necessitate a high tolerance for risk with the potential promise of innovative solutions to meaningful public health problems. Given that this announcement encourages a high tolerance for risk, topics related to some of the most difficult research questions in the field are directly relevant and encouraged. LD Hubs are intended to provide opportunities for feasibility and exploratory research endeavors that utilize, or are informed by, transdisciplinary research perspectives with the explicit goal of competitively transitioning to larger research or program projects in the future. The FOA integrates research topics that cut across various research portfolios within the Child Development and Behavior Branch (CDBB) of NICHD, specifically the Language, Bilingualism, and Biliteracy Program; Early Learning and School Readiness Program; Math & Science Cognition, Reasoning, & Learning - Development & Disorders Program; and Reading, Writing, and Related Learning Disabilities Program and provides formal opportunities to advance trans-disciplinary and crosscutting scientific topics and provide opportunities for project-embedded, career enhancing opportunities to support the next generation of scientists.

NICHD has had a long-standing interest in learning disabilities (LDs). This funding opportunity announcement is a renewal of the Learning Disabilities Innovation Hub FOA (originally an R24 activity code, RFA-HD-12-203) and is intended to continue NICHD’s emphases on nascent and understudied research topics addressing the needs of individuals with LDs that impact mathematics, reading and writing with an explicit focus on understudied populations that struggle to acquire and master relevant skills and individuals with more complex behavioral phenotypes (e.g., multiple co-occurring conditions). In line with NICHD’s historic interest in these areas, the focus of this FOA is on developmental LDs although applications will be considered for projects with well-characterized pediatric patient populations where the underlying etiology of the learning difficulty may be difficult to ascertain and may not currently have a diagnosis of learning disability (e.g., individuals with history of traumatic brain injury). This initiative represents NICHD s efforts to seed nascent, LD research topics of high public health import and to provide critical data on acquisition and mastery of numeracy and mathematics, reading and writing, and translational efforts designed to directly intervene and improve individuals performance in these domains. As an exploratory grant, the research activities supported in this initiative are intended to directly complement the Learning Disabilities Research Centers (LDRCs) Program and the broader investment in learning disabilities at the NICHD and NIH. The LDRCs have historically been focused on learning disabilities impacting reading and more recently on writing development; the topics within the LDRCs generally represent more mature domains of inquiry and necessitate substantial preliminary data at time of application. This announcement intends to complement the scientific scope of the LDRCs with expanded attention to understudied scientific questions and populations where a minimal scientific base exists and there is a need to tolerate a high-degree of scientific risk. The LD Hub program aligns with cross-programmatic efforts within the NICHD to examine topics related to learning disabilities and provide an opportunity for scientific maturation of investigators and topics such that they can transition to a LDRC, other NIH program or research project funding opportunities. This initiative is part of a larger systemic effort within the CDBB and more broadly at the NICHD to enhance trans-disciplinary interaction, team development with project-embedded career enhancing opportunities to advance team-based scientific approaches with the goal of improving outcomes for children, youth and adults with disabilities.

Pursuing lines of research inquiry directly responsive to this FOA may involve managing and mitigating various scientific risks. NICHD recognizes that lines of inquiry responsive to this FOA may be inherently high or higher risk and expects projects proposed to emphasize innovative approaches to manage risk and address the project aims to benefit the scientific understanding of LD and individuals with LDs.

This FOA is specifically designed to tackle the most challenging research topics in the LD research fields with the goal of systemically addressing the needs of all learners at-risk for or diagnosed with LDs impacting reading, writing and mathematics. The LD Hubs are envisioned to serve as a conceptual hub to facilitate the development of the scientific research base and corresponding resources to push the next generation of LD science and scientists forward. This FOA recognizes that for many scientific topics there is a limited extant research base directly relevant to the research topic; there may be difficulties in identification, recruitment and retention of particular populations of interest; and methodological challenges have limited pursuit of many research questions of express relevance to this FOA. To help address these challenges, this FOA encourages projects to leverage the existing evidence base of more rigorously specified and studied LDs and comorbidities. This will allow the field to better understand and address the needs of understudied populations of learners including those with complex behavioral phenotypes.

An express intent of this FOA is to provide opportunities for project-embedded career enhancement of a new cadre of investigators and build a research base on understudied topics and populations with learning disabilities in the areas of mathematics, reading and writing. The research activities occurring within the LD Hub provide unique opportunities for investigators to leverage the developing research resources to springboard their future research endeavors and careers into emergent scientific domains. LD Hubs are expected to build a research base sufficiently compelling to gain future funding support and advance the understanding of complex learning disabilities. As such, the LD Hubs are conceptualized as a time-limited research support opportunity and may only be renewed for one additional 4 year period for a total of up to 8 years of support. At the end of that time, investigators and projects should be sufficiently developed and prepared to transition to opportunities available through Centers programs such as the LDRC program or warrant independent support as an NIH investigator-initiated research project.

This announcement encourages foundational and translational (e.g., intervention-based) research approaches to learning disabilities that impact the acquisition and mastery of mathematics, reading, and writing. The constitution of an LD Hub must include a single focused research project and a single Administration Core that supports the broader goals and aims of the LD Hub. The research investigations developed and conducted within the scope of the LD Hub are intended to (1) inform the understanding of underlying etiology, manifestation, prevention and/or remediation of the focal LD(s) and related comorbidities, (2) provide project-embedded career enhancement opportunities for the next generation of LD investigators and (3) serve to develop a body of research and cadre of investigators that is sufficiently compelling and mature to compete for a LDRC or other NIH investigator-initiated funding opportunities. Proposed research projects must include a behavioral sciences component as the scientific core of their project; applicants are encouraged, but not required, to integrate this approach with other approaches (e.g., neurobiological and/or genetic) as appropriate to answer the research question(s) proposed. Specifically, NICHD is interested in behavioral and biobehavioral research topics that are significantly understudied as they relate to LDs and/or research topics that involve significantly understudied populations at high risk for, or diagnosed with, LDs in mathematics, reading, and/or writing.

This FOA seeks to support developmentally sensitive, LD Hub projects that address 1 (or more) of 3 target areas - all applications must address at least one of the 3 target areas. These topic areas are not mutually exclusive, and applicants may choose to address more than one of the target areas listed; regardless of their choice to address one or more topics, applicants will need to select the most central focus from the three options below and explicitly indicate this focus in the application:

1) Primary focus on historically under-studied and under-represented populations who are at risk for, or diagnosed with, one or more learning disabilities impacting reading, writing, or mathematics.

2) Nascent, understudied, and highly innovative and/or high risk research topics, involving LDs impacting mathematics, reading and/or writing, which may or may not be wholly focused on at-risk or understudied populations with LDs.

3) Historically challenging, yet established, research topics involving populations at risk for or diagnosed with one or more of these LDs where progress has been limited despite high public health need.

Examples of LD Hub Research Topics

Listed below are possible suggestions of the types of research topics for this FOA. This list is not intended to be comprehensive; applicants should not feel confined to the examples listed below. Responsive topics include, but are not limited to, those listed below.

• Identify and model epigenetic indicators of response-to-intervention in math and reading
• Develop computational modeling approaches to test hypotheses of the relative emphasis of instructional elements, modeled over time, in order to guide the development of novel approaches to instruction in math, reading and writing
• Develop computational modeling approaches to connect behavioral and neurobiological data, with the goal of developing enhanced accounts of mechanisms involved in the development of learning disabilities
• Develop novel approaches to enhance and speed acquisition and development of reading, math or writing for children and adolescents with overall lower cognitive functioning
• Develop novel approaches to reliably screen for, identify and classify reading disabilities in multi-lingual children and English language learning populations
• Identify novel approaches to improving literacy outcomes for transient (e.g., homeless) and other high-risk populations (e.g., incarcerated youth)
• Apply computational modeling approaches to examine the neurobiological underpinnings of learning disabilities impacting mathematics learning and achievement
• Develop novel approaches to significantly accelerate the pace of vocabulary acquisition in developing readers at risk for and/or with reading disabilities
• Identify shared and/or unique paths to/etiologies underlying comorbid reading and writing disabilities.
• Conduct longitudinal investigations of the prevalence, manifestation, and developmental trajectory of writing disabilities in children and adolescents.
• Conduct longitudinal investigations of early precursors beyond approximate number acuity of math learning and learning disabilities in children 0-4 years of age.
• Apply novel, previously not utilized, or significantly underutilized statistical or modeling approaches to inform the underlying etiology or manifestation of math learning disabilities at any age from birth into early adulthood.
• Investigate genetic x environmental etiologies of math learning disabilities in underserved, at-risk groups that are traditionally under-represented in genetics research.
• Identify and elucidate the nature of risk factors for learning disabilities sensitive to differences across developmental period and population
• Examine the manifestation and possible intervention approaches for learners with mathematics, writing, or comorbid reading disabilities using systems science approaches.
• Develop new intervention and service delivery models for addressing the English and/or math literacy needs of low-literate or developmental, adult learners that are based on current mechanistic evidence for intervention efficacy in specific subgroup populations (e.g., younger English Language Learners, younger persons with IDD).
• Develop and assess new intervention and service delivery models to comprehensively address the oral language, preliteracy, and early math learning of children birth to age eight for underserved, at-risk populations.
• Utilize epigenetic approaches to examine writing and mathematics disabilities.
• Examine and explicate the impact of non-cognitive (e.g., motor; sleep) interventions on mathematics, writing, or comorbid reading disabilities and achievement.
• Investigate the prevalence of and potential etiologic role of comorbid anxiety disorders in LD (e.g., math anxiety in math learning disability) and/or develop and assess targeted interventions for persons with comorbid anxiety disorder(s) and LD
• Investigate the role of early primary language mismatch to formal math learning language in the development of math learning disabilities and/or math learning difficulties in multi-lingual populations
• Identify normative early life exposure to and spontaneous production of comparative (e.g., more than, shorter than, equally) and numeracy-related language and its relationship to early numeracy skills (e.g., Approximate Number acuity, acquisition of the principle of cardinality, object counting skills, etc.); identify the role of early exposure to numeracy-relevant language to the later development and/or refinement of numeracy and math skill.

In addition to the focus on nascent, understudied, or high innovation and higher risk topics, this FOA targets the career enhancement of the next generation of LD research scholars through project-embedded involvement of early career researchers (defined as graduate and medical students, post-doctoral scholars, medical residents and early career investigators) in the planning and execution of the research endeavor. Such efforts should be designed to help springboard their careers into these nascent LD topics. Applicants are also encouraged, but not required, to incorporate project-embedded, career enhancement opportunities for established investigators (EI) who have not traditionally investigated topics related to developmental learning disabilities but have complementary expertise that could enhance team-based, transdisciplinary approaches to studying learning disabilities. The inclusion of EIs provides opportunities for established investigators to transition to focal LD research topics and to benefit the other project team by bringing in diverse perspectives not represented by other investigators on the project. These activities are intended to leverage the rich, resource base provided by an LD Hub - i.e., research resources of the exploratory project and unique intellectual capital of mid- and senior-level investigators.

See Section VIII. Other Information for award authorities and regulations.

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.

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).

Applicants can access 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.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

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 and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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:

Brett Miller, PhD
Telephone: 301-496-9849
Fax: 301-480-0230
Email: brett.miller@nih.gov

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	12
Research Project	12
Administration Core	6

Additional page limits 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 a multi-component application.

The application should consist of the following components:

• Overall: required
• Research Project: required, one maximum
• Administration Core: required, one maximum

When preparing your application in ASSIST, use Component Type Overall .

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

Complete entire form.

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Follow standard instructions.

Facilities and Other Resources: Describe the organizational resources available to the LD Hub. Identify the facilities to be used, including, but not limited to, dedicated space, computer facilities and resources, laboratories, and other facilities. If appropriate, indicate their capacities, pertinent capabilities, relative proximity and extent of availability to the project and all key investigators. Provide any information describing the other resources available to the project (e.g., secure data room, centralized participant recruitment services) and the extent to which they would be available to the overall LD Hub. Describe only those resources that are directly applicable to achieving the overall LD Hub aims.

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

Specific Aims: Include Specific Aims for the LD Hub project overall. Describe the broad, short- and long-term objectives and goals of the proposed LD Hub. Include the objectives for the Research Project and the Administration Core.

Research Strategy: The Research Strategy section of the Overall Component serves to introduce the proposed LD Hub, to state the LD Hub's objectives, to identify the focus or theme of research addressed in the proposed LD Hub, the goals and planned activities for the Administration Core and importantly, the synergy between the research and core activities.

To be responsive to this FOA, applicants must explicitly indicate to which and how their application responds to one of the three foci listed below. Note, these foci are not mutually exclusive; applicants are guided to select the single most central focus from the three foci below:

1) Primary focus on historically under-studied and under-represented populations who are at risk for, or diagnosed with, one or more learning disabilities impacting reading, writing, or mathematics. Applications claiming this focus must justify why the population(s) proposed constitutes an under-studied and under-represented population at risk for one or more learning disabilities and identify innovative recruitment and/or methodological approaches to be developed and/or used in order to allow for scientifically sound study of this population(s).

2) Nascent, understudied, and highly innovative and/or high risk research topics, involving LDs impacting mathematics, reading or writing, which may or may not be wholly focused on at-risk or understudied populations with LDs. Applications claiming this focus must provide evidence that the topic is understudied and provide justification for how the research topic and/or approach constitute an innovation. As these applications are expected to be higher risk, applicants should ensure an appropriate risk mitigation plan is included as part of the requirements outlined in the FOA for the Administration Core. Given the strong focus historically on reading in the LDRCs program, applicants responding to the present FOA would need to provide a very strong justification for why a focus on reading disabilities in isolation or in conjunction with ADHD alone could qualify as a nascent or understudied topic.

3) Historically challenging, yet established, research topics involving populations at risk for or diagnosed with one or more of these LDs where progress has been limited despite high public health need. Applicants selecting this focus need to provide clear justification for why the research topic has been difficult, clearly argue for the novelty of their approach, and how the approach constitutes a highly innovative path to overcome research impediments, hasten scientific progress and improve public health outcomes.

More generally, all applications should provide an overview of the major themes of the overall project, its goals and objectives, background information and the overall importance of the research to the theme of this project, which must align to one (or more) of the FOA foci listed above. Explain the strategy for achieving the goals defined for the overall grant and how the single Research Project and single Administration Core relate to that strategy. Explain how the different aspects of the organization, including key personnel, will coordinate and communicate, why they are essential to accomplishing the overall goal of the research, how the combined resources create a synergistic, overall programmatic effort of integrated research and describe how the project-embedded enhancement efforts support the next generation of LD scholars. Include any necessary tables, graphs, figures, diagrams and charts in this section. Additionally, provide the following information as part of the research strategy:

Discuss the philosophy, objectives, and potential impact of the proposed Research Project and Administration Core on learning disabilities research and describe how they would build on resources and expertise of the applicant institution (and collaborative institutions), if applicable. Provide background on recent advances, limitations, and overall impact on research in domains of relevance to the application and more broadly to the field of learning disabilities research.

Letters of Support: Please include only letters that reflect support for overall activities of the entire LD Hub.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans 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 preparing your application in ASSIST, use Component Type Research Project.

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

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Specific Aims: Include Specific Aims for the LD Hub research project.

Research Strategy: Following the instructions in the SF424 (R&R) Application Guide, start each section with the appropriate section heading Significance, Innovation, Approach. Cite published experimental details and provide the full reference in the Bibliography and References Cited section. Clearly describe the project's objectives and explain its relevance to the overall program's theme. Specify the significance of the work proposed to our understanding of learning difficulties and disabilities in domains relevant to the scope of the research. For applications, no pilot or preliminary data is required. Note that renewal applications must provide a Progress Report as part of the research strategy section.

All applicants are strongly encouraged to provide a cogent argument for the choices of aims/topics, study populations and methods. Applicants should clearly describe the developmental characteristics of their proposed sample(s) and how study of LD(s) in this population will contribute to our larger understanding of LDs. Additionally, please describe the methods planned for recruitment and retention of participants, LD or LD risk identification, broader behavioral description of the participants, and definition of learning difficulties/disabilities planned. Applicants must describe the developmental epoch under study. Note, no preference will be given for a particular developmental epoch from birth through early adulthood. When addressing LD research in early adulthood, NICHD is especially interested in struggling learners that are seeking remedial skill development in mathematics, reading, and/or writing in post-secondary or workplace programs but otherwise achieve performance levels commensurate with adult basic and adult secondary education. Rationale for the study of LD(s) in other adult populations must be articulated and strongly justified.

Applicants should provide a description of planned project-embedded research activities for early career investigators in the LD Hub research activities and more generally, involvement of individuals who are members of groups that are currently underrepresented in scientific domains relevant to LD research.

Letters of Support: Please provide any letters of support directly relevant to the research project.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans 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.

When preparing your application in ASSIST, use Component Type Administrative Core .

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

SF424 (R&R) Cover (Administration Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Administration Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administration Core)

Facilities and Other Resources: Describe institutional investment(s) planned to facilitate the success of the LD Hub’s developing scholars (e.g., graduate or medical student, post-doctoral fellow, Early Stage Investigators). List types and amount of committed funding the LD Hub receives from the applicant institution. Examples include but are not limited to dedicated equipment, dedicated space, salary support for investigators or core staff, and financial support for new space or equipment. Include salaries only if the support is provided for an LD Hub-related function such as directing the LD Hub, managing a core, or similar activities. Institutional support for LD Hub personnel and research faculty should be reflected in the budget request. This information may be presented in tabular form.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Administration Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administration Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Administration Core)

Budget forms appropriate for the specific component will be included in the application package.

Program Director(s)/Principal Investigator(s) (PD(s)/PIs) of the LD Hubs funded through this FOA will be required to attend the annual investigators' meeting, which will be held in the Washington, D.C. area. Applicants should plan and budget for this expense in the Administration Core budget request. Applicants are strongly encouraged, but not required, to plan and budget for other key LDR Hub staff to attend the yearly PD(s)/PI(s) meeting in addition to the PD(s)/PI(s).

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Administration Core)

Specific Aims: Include Specific Aims for the LD Hub Administration Core.

Research Strategy: In the description of the Administration Core, applicants must clearly describe the 1) overall administration plans for the center, 2) scientific risk mitigation strategy that will be utilized to minimize foreseeable risk and to identify and resolve challenges as they arise, 3) the meaningful integration of early career researchers, defined as pre-doctoral or medical students, post-doctoral individuals, and investigators who have recently finished their pre-doctoral, medical, or post-doctoral training and are pursuing research careers (e.g., assistant professor level faculty). These individuals should be involved in the planning and execution of a research project as appropriate to their level of training and experience and recruitment schedule.

Applicants should describe plans to provide career enriching opportunities for early career researchers through meaningful integration in the proposed research project and describe any oversight provided by the Administrative Core. The intent is to provide project-embedded, career enhancement for early career investigators to springboard their career into these nascent LD topics and to provide opportunities for established investigators to transition to focal LD research topics. Applicants are also encouraged, but not required, to incorporate project-embedded, career enhancing opportunities for established investigators (EI) who have not traditionally investigated topics related to developmental learning disabilities but have complementary expertise that would enhance team-based approaches to studying learning disabilities.

Specifically, as part of the Administration Core, the applicant must provide:

• Overall management plan for the LD Hub
• Describe the team experience, accomplishments, and expertise of the Core Lead and other key core personnel that illustrate group synergies not apparent from individual experiences, accomplishments, and expertise. Information in the biographical sketches may be referenced and should not need to be repeated.
• Explain the steps taken to ensure that the core is cost-efficient. If there are cost-sharing arrangements (note that cost-sharing is not a requirement of this FOA), describe them.
• Explicit benchmarks that will be used to evaluate the success of the Administration Core.
• Risk mitigation plan that should encompass identifying and monitoring known risks and identifying and mitigating emergent risks to the scientific project inclusive of the career enhancement activities.
• Formal procedure to develop a publication plan. Publication plan will be requested at the beginning of an award for all funded applications.
• The NIH continues to encourage institutions to increase the participation of individuals currently underrepresented in the biomedical, behavioral, clinical and social sciences such as: individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. Applicants should discuss efforts to promote diversity within the NIH-funded scientific workforce and describe how they will identify and address barriers that may impede the participation of underrepresented racial and ethnic minorities, and persons with disabilities in the proposed program.
• Protocols for extra-center data sharing as appropriate and consistent with achieving the goals of the program.

As part of this core, applicants may, but are not required to, propose a portion of the funds from the LD Hub to be used to support ancillary pilot projects that will include LD Hub early-career investigators as a means to achieve articulated LD research career milestones, as well as support the broader goals of the LD Hub. For applicants requesting the flexibility to utilize Core budget funds for pilot projects, the Core description must describe a formal process by which pilot study applications will be solicited, reviewed, and selected. Projects are expected to solicit pilot study applications from both LD Hub and non-LD Hub early career investigators within their own research organization/larger university system and those of partnering institutions. LD Hub applicants should be aware that additional funds will not be available to accommodate secondary indirect costs for pilot projects at research institutions outside of the applicant organization.

The goal of the pilot project effort is to provide opportunities for a new cohort of investigators to leverage the larger LD Hub activities such that they can develop their own identifiable line of research and facilitate broader career transitioning goals. Given this goal, only early-career investigators are eligible to apply for a pilot research project and only projects that are within scope of the LD Hub’s funded aims will be considered for support. Up to $35,000 in total costs (i.e., inclusive of direct and indirect costs) per year may be requested for any one pilot project, with a total costs limit of $35,000 per year per LD Hub for all pilot projects. This limit applies for the full duration of the LD Hub. The Advisory Board (see below for full details) will be tasked with reviewing and recommending pilot concepts for consideration and are advisory to the PD/PI. Pilot applications recommended for support should include all necessary administrative assurances (e.g., Institutional Research Board approvals; certification of investigator(s) completion of required Ethical Conduct of Research education) and be submitted to the NICHD program official.

For projects proposing pilot projects, applicants must also provide:

• Plans to solicit and review applications for pilot/seed projects from early career investigators currently involved in the center and from the broader scientific community. This should include information on at least the following items: (1) priorities for allocating funds; (2) procedures for reviewing applications; (3) requirements, if any, for leveraging funds or preparing research applications to continue or expand the research project; (4) size of awards; (5) length of award periods; (6) number of awards permitted to an individual researcher; and (7) planned efforts to recruit and encourage applications from individuals from under-represented groups in the LD Hub's target area of science.
• Safeguards that will be put in place to assure the integrity of the pilot project and compliance with all human subjects' requirements (if relevant).
• Explicit plans for monitoring pilot projects throughout the pilot investigation.
• Plans for evaluating the success of the pilot program.

Advisory Boards: Because of their complexity and higher risk nature of relevant science, all LD Hubs grants require guidance and interaction with senior members of the scientific community not directly involved in the conduct of the proposed research activities and operations. Applicants must develop plans for an External Advisory Board to provide objective outside counsel and periodic review of the LD Hub’s activities and progress including objective input to the PD/PI on the review and recommendations for support of proposed pilot projects (if applicable). Applicants are not to contact or select Advisory Board members at time of application. In the case of renewal applications only, please list the existing advisory board members for the current, funded LD Hub as a historic reference. All applicants should describe the operation of the Board, including size, structure, function, and frequency of meetings should be specified, as well as the type and level of seniority of Board members to be recruited. Renewal applications should not specify whether existing members will be recruited in the future, but instead focus on the scientific expertise needed for the renewal application. Members of the Advisory Board are to be selected and confirmed, and notification sent to program staff at NICHD, within three months after the award date. Provisions for costs of the Advisory Board are to be included in the application budget request and justification.

Letters of Support: Please provide any letters of support directly relevant to the Administration core only.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans 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.
• All applicants should include plans for dissemination of research based findings to the broader scientific and practitioner (as appropriate) communities; including detailed information about implementation plans to achieve these aims.

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.

Planned Enrollment Report (Administration Core)

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

PHS 398 Cumulative Inclusion Enrollment Report (Administration Core)

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

Not Applicable

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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

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.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the Eunice Kennedy Shriver National Institute of Child Health and Human Development's (NICHD) Referral Office by email at duperes@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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

For this specific announcement, please note the following:

The overall LD Hub Project will be evaluated as an integrated research effort focused on one or more research areas. The relationship and contributions of the Research Project and Administration Core to the central theme will be discussed and evaluated. Reviewers will assign an impact score based on assessment of the scientific and technical merit of the LD Hub overall. Reviewers do not need to weigh all components of the application equally and may weigh the research project and overall review more heavily in their final review of impact of the application.

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

Does the LD Hub address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the LD Hub 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? Will there be coordination, cohesiveness, and synergy between the Research Project and Core as they relate to the common theme of the LD Hub? What is the likelihood that the research project will address either (1) a nascent or significantly understudied research topic or a higher risk, high innovation approach to examining learning difficulties or learning disabilities impacting mathematics, reading, or writing, (2) significantly underserved populations that are at high risk for or diagnosed with learning disabilities in these areas, or (3) historically challenging, yet established, research topics involving populations at risk for or diagnosed with one or more of these LDs where progress has been limited despite a high public health need? What is the likelihood the LD Hub will enhance collaborative efforts and bring transdisciplinary perspectives together to advancement of LD science?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the LD Hub? 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? What is the likelihood for meaningful and long-term collaboration among the LD Hub investigators? Does the team include established or emerging investigators from complementary research fields that could make a substantial contribution to the LD Hub?

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?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the LD Hub? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the LD Hub 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?

Is the LD Hub's overall strategy to foster scientific interactions and the development of more mature line of LD research appropriate and likely to succeed? Will it provide the foundation necessary to establish a well-integrated research team that is capable of generating new and innovative research grant applications?

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?

As applicable for the LD Hub 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.

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.

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.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

Not Applicable

For Renewals, the committee will consider the progress made in the last funding period.

Not Applicable

As applicable for the LD Hub 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.

Not Applicable

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).

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) Genomic Data Sharing Plan .

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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

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? Is there a strong scientific premise for the project? 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?

Investigator(s)

Are the Project Lead(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-Lead, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

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? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

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?

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 criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. 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

Not Applicable

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

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) Genomic Data Sharing Plan .

Authentication of Key Biological and/or Chemical Resources

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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.

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 Core that by its nature is not innovative may be essential to advance a field.

Significance

Does the Core address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the Core? If the aims of the Core 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?

Investigator(s)

Are the Core Lead(s), collaborators, and other researchers well suited to the Core? 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 Core is collaborative or multi-Lead, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

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 Core? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the Core is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the Core 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?

Are the Core plans adequate to assure meaningful integration of early career researchers in research activities? Are there adequate plans describing the process, review and administration of pilot projects if proposed? Will this plan enhance inclusion of individuals who are under-represented in science or investigators? Are there effective administrative structures for day-to-day management of the LD Hub, including arrangements for internal quality control of ongoing research? Are there adequate benchmarks to evaluate the success of the core and its impact on participants or groups that utilize its services?

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 Core proposed? Will the Core benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

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 criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. 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

Not Applicable

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

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) Genomic Data Sharing Plan .

Authentication of Key Biological and/or Chemical Resources

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

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

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

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

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

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

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

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

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

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually 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)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

Brett Miller, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-9849
Email: brett.miller@nih.gov

Sherry Dupere, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-451-3415
Email: duperes@mail.nih.gov

Bryan Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: clarkb1@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 Part 75.