Part 1. Overview Information

Key Dates

It is critical that applicants follow the Multi-Project (M) 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 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose 

This Funding Opportunity Announcement (FOA) invites specialized center applications (referred to as Learning Disabilities Research Centers [LDRCs]) to develop new knowledge about learning difficulties and specific learning disorders (SLDs) in language, reading, writing, mathematics, and comorbid conditions. The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) seeks to support research to address the definition, classification, etiology, diagnosis, epidemiology, early identification, prevention and preventive approaches, and remediation of children, adolescents, or young adults identified with or at risk for SLDs. This FOA focuses on SLDs impacting component oral language abilities (e.g., morphology, phonology, pragmatics, vocabulary), reading (e.g., decoding and word recognition skills, reading fluency and automaticity, reading comprehension), written expression abilities (e.g., composition, handwriting and graphomotor skills, spelling), mathematics (e.g., subitizing, symbolic and non-symbolic quantity or number comprehension and processing, number sense, math fact learning and retrieval, mathematical word problems, mathematics procedural learning, higher-order mathematics competencies), and relationships among these SLDs and other disabilities and co-occurring or comorbid conditions. This FOA encourages both foundational and translational research on these topics and emphasizes the promise of utilizing transdisciplinary, team-based scientific approaches combined with data collection from convergent methodologies to inform the science of SLDs, its practice, and beyond. This FOA integrates and complements research topics that span various research portfolios within the Child Development and Behavior Branch (CDBB) and Intellectual and Developmental Disabilities Branch at the NICHD. 

The LDRCs represent NICHD’s single largest investment in research examining learning difficulties and SLDs that affect the development of listening, speaking, reading, writing, and mathematics abilities. This FOA is a reissuance of the Learning Disabilities Research Centers initiative (RFA-HD-17-006) and intends to extend the impact of NICHD’s investments in SLDs to a broader range of learners, particularly those from diverse backgrounds, including but not limited to, individuals from historically under-represented groups such as individuals from under-represented racial and ethnic groups, persons with disabilities, individuals from disadvantaged backgrounds, and individuals from resource-limited communities. The focus of NICHD’s investment in this area of research continues to evolve over time to be responsive to needs of the scientific field, practitioners, communities, and policymakers and to known/anticipated needs generated by the COVID-19 pandemic. Consistent with this evolution, this announcement expands the focus to a) further emphasize addressing the developmental needs of linguistically and culturally diverse populations (e.g., those for whom English is either not the first and/or dominant language, who learn multiple languages simultaneously, or who speak a dialect of English that deviates from mainstream American English dialiect) to ensure that research benefits all in society; b) more fully engage (i.e., bidirectionally) with communities to best match research activities and outcomes to the needs of community members; c) further emphasize identification of early risk factors and implications for early, intensive intervention for children with high cumulative risk, in combination with the need for invigorated skill development for pre-adolescent and older learners with demonstrated minimal intervention response; and d) enhance understanding of when and how to utilize assistive technology with individuals that struggle and those with SLDs, and how to balance assistive technology use with direct instruction in skill development to optimally benefit the learner. 

Consistent with its historic emphases, the LDRCs continue their focus on the development and validation of robust classification system(s) and operational definitions of SLD. This focus necessitates an enhanced understanding of pre-existing and emergent risk factors and their developmental ontogeny as they vary across individuals, families, and populations in combination with an improved understanding of learners’ response(s) over time to intervention content. This FOA reflects NICHD’s continued and increasing emphasis on understanding risk for SLDs and seats SLD science within a framework of multi-level prevention models (i.e., primary, secondary and tertiary prevention). This multi-level framework intends to support efforts to elucidate possible geneses, manifestations over time, improved intervention efficacy, and enhance our understanding of the developmental time course and effects (direct and indirect) of learning difficulties and disabilities across the life course.  

More broadly, the LDRC initiative aligns with CDBB efforts to improve early, prospective model predictions of risk for learning difficulties/SLDs to inform intensive service delivery allocation. LDRCs also provide a unique platform to examine SLDs from multiple perspectives; for example, complementing behavioral sciences' approaches to SLD research with genetic/epigenetic and/or neurobiological data sources to synergistically examine the underlying nature of learning difficulties and SLDs and co-occurring conditions, their manifestations, and screening and treatment implications and approaches. When used in a developmentally sensitive and team-based context, this interdisciplinary perspective holds the promise of pushing the boundaries of current science and practice to the benefit of those with SLDs.  

The multi-project nature of the LDRCs further allows applicants to balance thematic investigations into more mature areas of science along with exploratory topics. In line with the potential opportunities enabled by the LDRC structure, applicants are required to include a focus on one or more exploratory research topics (i.e., higher risk) that align with the overall theme of the Center. The goal of the exploratory topic(s) is to extend the reach, impact, and reciprocal influence of work in the broader research ecosphere. New to this announcement, projects are also required to initiate and evaluate approaches to bidirectional engagement with respective communities that they serve, with the goal of informing current and future research and engagement efforts. Additionally, this FOA expands the research-embedded, career enhancing opportunities for early career scholars, particularly those from under-represented groups (URGs), to include community members. The goal and intent is to develop research-informed community liaisons that would be positioned to further the LDRCs’ mission of addressing the needs of communities and to be well-positioned to facilitate constructive, bidirectional communication and inform culturally-sensitive investment in communities.  These community scholars may be engaged actively in the research and/or the community engagement components of the LDRCs in line with professional interests of the individuals and the needs of the community. Finally, the LDRCs will serve as models of data sharing within the research communities exemplifying best practices for open science. 

Research Scope and Foci 

This FOA encourages research studies ranging the spectrum of basic through translational science focused on SLDs and learning difficulties in the domains of component oral language abilities, reading, written expression abilities, mathematics, and relationships among these SLDs and other disabilities and co-occurring or comorbid conditions. LDRC applications must include at least four focused research projects and three or more cores minimally including Administrative, Engagement and Data Management Cores. The LDRC applications should utilize state-of-the-science experimental, methodological, and statistical and other modeling approaches to enhance our understanding of SLDs and difficulties and co-occurring conditions. The P50 mechanism enables applicants to build a rich research environment and infrastructure to innovate conceptually and methodologically, and as such, at least one research project must include a focus on an emerging and high-risk topic. This project should align thematically with the center and provide a framework to a) push the boundaries of SLDs research at its intersection with other fields, b) embrace the complexities of studying SLDs in the real world inclusive of the context of multiple comorbid or co-occurring conditions, c) increase the applicability of findings from SLDs to other populations with learning difficulties more generally, d) build theoretical and conceptual bridges between research, practice and/or policy communities, and e) constitute a risk level such that the projects are too premature or high-risk for an R01 or similar research funding mechanism. The second required project must focus on examining engagement approaches with communities of interest to the themes of the Center. This project is expected to be modest in size to accommodate the nascent nature of this requirement relative to other scientific endeavors. The communities served across Centers are expected to be diverse in terms of factors such as (but not limited to) geographic distribution; poverty levels; and racial, ethnic, linguistic variability and disabilities distribution. Applicants are expected to make a cogent argument for the specific needs of the selected community and relevance to the themes of the Center. This project is intended as an initial effort by the LDRCs to have meaningful, bidirectional engagement with their respective communities and to study the potential efficacy of the approaches taken. The expectation is that LDRC applicants will utilize the science around community engagement to 1) propose approaches to build bidirectional communication; 2) propose formal methods for gathering formative and summative input to evaluate their success; and, critically, 3) inform agile improvements in engagement strategies. In line with the risk level for both the emerging/high-risk and the community-engagement projects, neither requires pilot data as part of the application submission.  

This FOA requires well-integrated, synergistic, transdisciplinary research studies that address one or more of the following broad themes:  

1) refine classification and definition models of SLDs for component oral language abilities, reading, written expression abilities, and/or mathematics and, critically, develop developmentally sensitive models that prospectively predict risk of substantial learning difficulties and SLDs;  

2) further extend basic and translational research on SLDs impacting component oral language abilities, reading, writing, and/or mathematics and co-occurring conditions and enhance understanding of the nature of the relationship between SLDs and co-occurring conditions;  

3) enhance understanding of risk factors for the development of learning difficulties or SLDs and predictors of responsiveness to intervention preceding formal intervention and during intervention efforts;  

4) further identify basic neurobiological, genetic/epigenetic, cognitive/behavioral, and environmental mechanisms that influence the expression of SLDs at different developmental epochs across the lifespan;  

5) enhance the research knowledge base on early preventive efforts (i.e., prevention based models) including enhanced primary prevention services (e.g., early, primary intervention and screening) and later secondary and tertiary intervention efforts for those individuals minimally responsive to early intervention;  

6) emphasize research efforts which include a substantial emphasis on diverse participants samples. Applicants will need to make a case for why their population constitutes a diverse sample. For the purposes of the FOA, diverse participant samples include but are not limited to a) individuals from historically under-researched or understudied groups at high risk for or with demonstrated learning difficulties or SLDs, b) multilingual and English language learning populations, c) Native American, Native Hawaiian and Pacific Islanders’ communities in the U.S., U.S. territories and sovereign tribal nations, d) individuals experiencing housing insecurity and those involved in the social services or justice systems and e) more broadly, individuals living in poverty.  

Note: applicants must integratively address theme 6 when planning and executing the LDRC’s broader theme(s). Applications responsive to the FOA must clearly describe and delineate samples proposed and include measurement batteries that allow examination of intersectionality across samples. Critically, applications should provide a cogent argument for the specific research emphases proposed, the populations to be served, and how the communities of relevance to the application will be engaged. Applicants are encouraged to propose the most scientifically appropriate research designs and methods to integrate studies across relevant domains. For this FOA, applicants can focus on learners across the developmental range from birth to struggling adolescent and young adult learners. In the case of young adult learners, applicants may only pose research projects focused on individuals with performance levels consistent with adult basic and secondary education learners, learners seeking remedial skill development in post-secondary settings or workplace settings, or individuals developing foundational literacy or numeracy skills in transition programs. 

Examples of LDRC Research Topics 

Listed below are possible suggestions of responsive research topics for this FOA. This list is not intended to be comprehensive, and applicants should not feel confined to the examples listed below.  

• Develop sustainable models for community engagement focused on communities with learners experiencing significant learning difficulties and SLDs. 

• Conduct neurodevelopmental studies of learners at high risk for SLDs focused on individuals from URGs.  

• Model and develop comprehensive risk assessments of anticipated minimal response before formal instruction in mathematics, reading and/or writing. Develop complementary modeling approaches to identify early behavioral, epigenetic or neurobiological indicators of instructional response that presage minimal intervention response for children and youth exposed to formal instructional and receiving active intervention. 

• Develop and refine classification systems that provide categorical and/or probabilistic judgments about disability status utilizing simulated and human performance data. 

• Develop and refine causal, probabilistic, and biologically plausible models of reading, writing and mathematics development. 

• Enhance understanding of causes versus consequences of reading and mathematics development on functional and structural brain development. 

• Develop and refine early screening efforts to identify children at high risk for learning difficulties (including multilingual and English language learning individuals) who may be streamlined to early, intensive intervention services regardless of disability status. 

• Develop and evaluate enhanced, intensive, multi-year intervention efforts for children at high risk of learning challenges or those with demonstrated minimal response in reading, writing or mathematics. 

• Examine potential cohort effects for existing longitudinal samples to better understand the long-term, developmental effects of COVID-19 pandemic on individuals at different developmental epochs. 

• Examine potential efficacy and efficacy of assessment and intervention approaches delivered remotely and/or through hybrid methods (mix of in-person and remote) with approaches sensitive to the limitations of low-resource settings. 

• Examine the potential positive and negative implications of assistive technology for learners with significant learning difficulties or disabilities with sensitivity to how learner characteristics may impact what technology to use, when and how to incorporate it in the learning environment, the potential of the technology in lower resource environments and how to balance assistive technology usage with continued core instruction in reading, writing or mathematics. 

• Develop computational and statistical modeling approaches to elucidate mechanistic accounts of the neurobiological underpinnings of learning disabilities impacting reading and mathematics learning and achievement. 

• Identify and model epigenetic indicators of response-to-intervention in math and reading. 

• Investigate the role of oral language development and skills to enhance the pace of vocabulary acquisition in reading. 

• Investigate the development of executive function skills and the relationship to concomitant development of reading, writing and math skills. 

• Examine potential impact of multi-level, contextual factors influencing skill acquisition and development, e.g., student level, instructor and classroom, school, and neighborhood factors.

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

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

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)

Local 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)

Federal Governments

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

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.

• System for Award Management (SAM) – 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.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. 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 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 diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. 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 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, 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.

Letter of Intent

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

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

• Descriptive title of proposed 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: [email protected]

Page Limitations

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

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

Overall Component

When preparing your application, use Component Type ‘Overall’.

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

SF424(R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

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

Research & Related Other Project Information (Overall)

Follow standard instructions.

Other Attachments:  The application must include the following attachment.

Plan for Enhancing Diverse Perspectives (PEDP) (2-page maximum): All applications must include a summary of strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity. The PEDP should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the application and can incorporate elements with relevance to any review criteria (significance, investigator(s), innovation, approach, and environment) as appropriate. Where possible, applicant(s) should align their description with these required elements within the research strategy section. The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured. The PEDP should include a timeline and milestones for relevant components that will be considered as part of the review. Examples of items that advance inclusivity in research and may be part of the PEDP can include, but are not limited to:

• Discussion of engagement with different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).

• Description of any planned partnerships that may enhance geographic and regional diversity.

• Plan to enhance recruiting of women and individuals from groups historically under-represented in the biomedical, behavioral, and clinical research workforce.

• Proposed monitoring activities to identify and measure PEDP progress benchmarks.

• Plan to utilize the project infrastructure (i.e., research and structure) to support career-enhancing research opportunities for diverse junior, early- and mid-career researchers.

• Description of any training and/or mentoring opportunities available to encourage participation of students, postdoctoral researchers and co-investigators from diverse backgrounds.

• Plan to develop transdisciplinary collaboration(s) that require unique expertise and/or solicit diverse perspectives to address research question(s).

• Publication plan that enumerates planned manuscripts and proposed lead authorship.

• Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as research participants including those from under-represented backgrounds.

If this attachment is not included, the application will be considered incomplete and will not be reviewed.

For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see https://braininitiative.nih.gov/about/plan-enhancing-diverse-perspectives-pedp.

Project/Performance Site Locations (Overall)

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.

Research and Related Senior/Key Person Profile (Overall)

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.

Budget (Overall)

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.

PHS 398 Research Plan (Overall)

Specific Aims: Include Specific Aims for the LDRC overall. Describe the broad, short- and long-term objectives and goals of the proposed LDRC.

Research Strategy: The Research Strategy section of the Overall Component serves to introduce the proposed LDRC, to state its objectives, to identify the thematic focus of research proposed in the application, the goals and planned activities for the Administrative, Engagement, Data Management, and other core(s) if relevant, and, importantly, the synergy between the research and core activities. 

More generally, applications should provide an overview of the major themes of the LDRC, its goals and objectives, background information, and the overall importance of the research to the theme of the Center. Explain how the different aspects of the organization, including key personnel, will coordinate and communicate, why they are essential to accomplishing the overall goal(s) of the LDRC, how the combined resources create a synergistic, programmatic effort of integrated research, and describe how the engagement efforts with the project-embedded, early career enhancement efforts support the development of the next generation of SLD scholars and how corresponding efforts build a generation of community members interested and prepared to be research-engaged with skills to advance the interests of their communities and engage in bidirectional communication with the research community. 

Discuss the philosophy, objectives, and potential impact of the proposed Research Projects, Administrative Core, Data Management Core, Engagement Core, and other Core(s), as relevant, to SLD research and describe how the LDRC 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 SLD research. 

Additionally, applicants must explicitly highlight how they address required topics for research projects (listed below and also in the research project research strategy section) thematically in the context of the overall application. The emphasis here is on providing a cohesive and coherent framework regarding how these requirements are addressed within the theme of the overall Center, which should address topic(s) of high public health relevance related to SLDs impacting oral language, mathematics, reading, and/or writing.  

Applicants must synergistically address the following topics, indicated by numbered bullets below, including any sub-bullets, in the Center application. Given the emphasis on synergy across projects within a Center, applicants may address more than one numbered bullet or sub-bullet in a single project and are encouraged to address these requirements in a manner that aligns most effectively with the Center's proposed focus and structure. The emphasis is to allow for the most comprehensive, coherent, and cogent integration of topics within the overall theme of the Center application. Additionally, NICHD recognizes that these numbered bullets and sub-bullets are not always mutually exclusive; therefore, applicants may address one or more numbered bullets or sub-bullets collectively if the proposed work appropriately addresses multiple requirements. 

Importantly, please note that applications not addressing all of the aspects below will be deemed incomplete and will not proceed to review. The required topics of the FOA are numbered immediately below for reference:  

1) Applicants must examine more than one SLD in the context of a Center and include a focus on understudied and underserved populations. Specifically, applicants must: 

1a) Examine learning difficulties or SLDs in at least two domains (i.e., oral language, math, reading, and writing). 

1b) Include a focus on populations that have been under-represented and under-served in SLD research and practice. 

2) One of the research projects must focus on a high-risk research topic of high public health relevance related to SLDs that would be unlikely to be feasible as an R01-scale project. The topic must align thematically with the LDRC and should provide a potential framework to push the boundaries of SLD research's intersection with other fields. Applicants are encouraged to utilize state-of-the-science approaches in research design and modeling of data. 

3) Applicants must include a project focused on studying the potential efficacy or efficacy of engagement with communities of interest for their thematic LDRC application. This project should focus on examining approach(es) to bidirectional engagement with a specific community or communities and evaluating the potential efficacy or efficacy of these approaches through formative and summative methods. This requirement anticipates mixed methods approaches to richly capture perspectives and efficacy of engagement. 

4) Applicants must include research projects that provide converging evidence by utilizing multiple methodologies (e.g., behavioral, genetic/epigenetic, and neurobiological approaches). Applicants are not required to utilize multiple methodological approaches within each project. Rather, applicants should utilize the most scientifically appropriate methodology and analytic approach in relation to the aims and design of the research project. 

5) Career-enhancing efforts for early career scholars must include a focus on experience and career guidance with bidirectional engagement with community partners and, new to this FOA, include efforts to recruit and provide rich developmental opportunities for community members (i.e., individuals in the community) to enable enhanced bidirectional engagement in the future. 

Note: A Plan for Enhancing Diverse Perspectives (PEDP) is required under Other Project Information; the 2-page maximum PEDP does not count against the 12-page limit for the Research Strategy (Overall) section. 

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

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.

Do not include a Data/resource sharing plan for this component; any resources and activities under this component should be included only under the Data Management Core.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form (Overall)

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

Do not include a Data/resource sharing plan for this component; the plan should be included only under the Data Management Core

Administrative Core

When preparing your application, use Component Type ‘Admin Core’.

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

SF424 (R&R) Cover (Administrative 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 (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

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) (Administrative 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 (Administrative Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Admin 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 (Administrative Core)

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.

PEDP implementation costs:

• Applicants may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement section 7:https://grants.nih.gov/grants/policy/nihgps/html5/section_7/7.1_general.htm)

Annual Learning Disabilities Research Center investigators' meeting

• Applicants should plan for costs related to attendance at the anticipated annual in-person meeting for the consortium of awardees of this FOA

PHS 398 Research Plan (Administrative Core)

Specific Aims: Include Specific Aims for the Administrative Core.

Research Strategy: Specifically, as part of the Administrative Core, the applicant must:

• Provide overall management and administration plans for the LDRC.
• Describe the experience, accomplishments, and expertise of the Core Lead and other key core personnel that illustrate group synergies. Information in the biographical sketches may be referenced and should not be repeated.
• Provide concrete steps 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.
• Provide SMART (specific, actionable, measurable, realistic, and timely) benchmarks that will be used to evaluate the success of the Administrative Core.
• Provide a risk mitigation plan that encompasses plans to prospectively and retrospectively identify and mitigate emergent risks to the scientific project inclusive of the career enhancement activities.

Advisory Boards: Because of their complexity, inclusion of one or more high risk projects and a new project examining the potential efficacy or efficacy of community engagement approach(es), all LDRC grants require guidance and interaction with members of the scientific community and broader 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 LDRC’s activities and progress (i.e., prospective and retrospective input). Applicants should emphasize creative prospective utilization of advisory board members to provide opportunity for ongoing project enhancement and timely input. This includes objective input to the PD/PI on the review. Applicants must not 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 LDRC as a historic reference. All applicants should describe the operation of the Board, including size, structure, function, and frequency of meetings, as well as the type and level of experience of Board members to be recruited. Note, Advisory Boards must include at least one non-scientific community member and one rotating ECR member (not involved in the center). The ECR member will have a time-limited appointment of no more than 2-years. Renewal applications should not specify whether existing members will be recruited in the future, but instead focus on the expertise needed for the renewal application. Only after an award is made should members of the Advisory Board 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 Administrative Core.

Resource Sharing Plan:

Do not include a Data/resource sharing plan for this component; any resources and activities under this component should be included only under the Data Management Core.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Administrative Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

Engagement Core

When preparing your application, use Component Type ‘Engage Core’

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

SF424 (R&R) Cover (Engagement 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 (Engagement Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Engagement Core)

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) (Engagement 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 (Engagement Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Engagement 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 (Engagement Core)

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.

PHS 398 Research Plan (Engagement Core)

Specific Aims: Include Specific Aims for the LDRC Engagement Core.

Research Strategy: The Engagement Core will oversee required plans for 1) bidirectional engagement with communities of interest across the entire Center; 2) translation and dissemination of research findings with the broader scientific, practitioner, and policy communities as appropriate to the science posed, targeting communities beyond those emphasized in plans to address item 1 in this list; and 3) structured project-embedded, career enhancing research opportunities for early career researchers and community members.

Applicants should describe plans to provide career enriching opportunities for early career researchers through meaningful integration in the proposed research projects and cores and describe planned oversight provided by the Engagement Core. The intent is to provide structured project-embedded, career enhancement for early career investigators to springboard their career into relevant LD topics and to provide opportunities for established investigators to engage scientifically on LD research topics. Applicants must also plan a corresponding focus on knowledge sharing with emphasis on skill development for LDRC-engaged, community members. The goal for these community members collaborating with Centers should be to build a research knowledge base in the community and to enhance opportunities for long-term bidirectional communication to inform research engagement.

All Center applicants must include:

• Structured plans for bidirectional engagement with communities emphasized in the LDRC inclusive of SMART metrics.
• Clear enumeration of the proposed community or communties of interest.
• Plans for translating and disseminating research-based findings to the broader scientific, practitioner, and policy communities as appropriate to the science of the Center, beyond those emphasized in the first bullet above. Include detailed information about the dissemination aim(s) and implementation plans to achieve these aim(s).
• Formal procedure to develop an overall publication plan. Publication plan must be submitted within 90 days of award for all funded applications.
• Formal procedure to develop an individualized development plans for early career investigators within 90 days of onboarding and engaging with the LDRC.
• Formal plans to utilize technology to facilitate engagement among LDRC investigators (regardless of career level), community/communities of interest and planned dissemination activities.

Applicants must also designate a core staff member to facilitate cross-LDRC collaborative activities among early career investigators. These activities will be designated post-award; applicants, after time of award, will be required to propose activities that would synergize career-enhancing opportunities across LDRC and Learning Disabilities Innovation Hub funded projects that will form the foundation of the LDRC Early Career Scholars. This person should plan for thrice yearly, virtual discussions to coordinate interests, opportunities and ongoing synergistic, cross-LDRC activities. Responsibility for these discussion will rotate by year among NIH program staff and individual centers.

Letters of Support: Please provide any letters of support directly relevant to the Engagement Core.

Resource Sharing Plan:

Do not include a Data/resource sharing plan for this component; any resources and activities under this component should be included only under the Data Management Core.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Engagement Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

Data Management Core

When preparing your application, use Component Type ‘Data Core.’

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

SF424 (R&R) Cover (Data Management 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 (Data Management Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Data Management Core)

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) (Data Management 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 (Data Management Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Data Management 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 (Data Management Core)

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.

PHS 398 Research Plan (Data Management Core)

Specific Aims: Include Specific Aims for the Data Management Core.

Research Strategy: The Data Management Core will be responsible for data management leadership and coordination critical to LDRCs. Strong data management and statistical leadership and expertise, and robust, flexible data management systems that support the research projects outlined in the proposal are essential. The Data Management Core will play a central role in harmonizing statistical and data management activities across studies, both to allow cross-study data analyses and to maximize the efficiency with which studies can be developed and implemented. The Data Management Core provides the LDRC in-depth understanding of statistical theory, and broad practical experience in design and analysis relevant to the research projects proposed. The Data Management Core provides leadership, services, and systems for data collection and management required for complete, high-quality data, and meeting data sharing requirements; and leadership and services for analysis, interpretation and publication of results, including innovative, state-of-the-science statistical methods.

The Data Management Core provides scientific and analytic resource availability and supervision. The Data Management Core is responsible for the integrity of study design and statistical analysis for all research projects. The Data Management Core is responsible for ensuring LDRC compliance with the upcoming NIH Policy for Data Management and Sharing (Policy). The Data Management Core has a central role in standardizing and harmonizing data management and statistical activities within the LDRC. The Data Management Core will provide comprehensive data management and data analyses for Center studies in compliance with regulatory standards. The Data Management Core will provide leadership and services for biostatistics, study design, analysis, interpretation and publication of results, including supporting integration with state-of-the-art data management and data sharing platforms.

All Center applicants must include formal plans to facilitate, oversee, and advise on the overall methodology and analyses to be used to accomplish the specific aims of the LDRC, as well as required plans for coordinating intra- and extra-LDRC resource and data sharing activities. These plans are required to comply with the upcoming NIH Policy for Data Management and Sharing (Policy).

All Center applicants must provide the following information:

• Provide a general overview of the Data Management Core and describe the general features and operations of the Data Management Core.
• Staffing: Structure of the core, roles of Data Management Core leader and core staff, and lines of authority within the core. Discuss how the proposed structure and the individual strengths of the key personnel will facilitate the objectives of the Data Management Core.
• In detail, describe data management, statistical analysis, and data sharing systems.
• Description of how Data Management Core resources and services will contribute to the objectives of the Research Projects. This section of the application should present a clear picture of the facilities, techniques, and skills that the core will provide.
• Describe how the sharing of expertise, resources, and procedures will be encouraged, including the harmonization of common data elements/latent constructs and data entry interfaces.
• Provide plans for statistical and data management mentoring opportunities and involvement of early-stage investigators, individuals from under-represented groups in science, and investigators from resource-limited institutions/settings.

Letters of Support: Please provide any letters of support directly relevant to the specific Data Management Core.

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, are required to address a Data Sharing Plan. Resource and Data Sharing Plans for all components should be addressed here under the Data Management Core component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Data Management Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

Cores

When preparing your application, use Component Type ‘Cores.’

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

SF424 (R&R) Cover (Cores)

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 (Cores)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Cores)

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) (Cores)

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 (Cores)

• 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 (Cores)

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.

PHS 398 Research Plan (Cores)

Specific Aims: Include specific aims for the core.

Research Strategy: Provide a cogent description of:

• The objective of the Core resource
• Proposed staffing including brief description of scientific, technical, and support staff functions
• Proposed services provided including a description of current and projected services to Research Projects as well as the process for prioritizing requests for use of Core facilities by the various research project.
• Overall management plan for the Core
• Description of cost effectiveness, plans for quality control and formative evaluation plans utilizing a continuous improvement model
• Plans for long-term sustainability

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

Resource Sharing Plan:

Do not include a Data/resource sharing plan for this component;  the plan should be included only under the Data Management Core.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Cores)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

Research Project

When preparing your application, use Component Type ‘Research Project.’

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

SF424 (R&R) Cover (Research Project)

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 (Research Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Project)

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) (Research Project)

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 (Research Project)

• 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 (Research Project)

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.

PHS 398 Research Plan (Research Project)

Specific Aims: Include Specific Aims for each LDRC research project. The research project should have its own set of aims relevant to the science proposed in that 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. For each research project, clearly describe the objectives and explain its relevance to the overall Center’s theme. Specify the significance of the work proposed to our understanding of learning difficulties and SLDs in domains relevant to the scope of the research. Specify any existing preliminary evidence or pilot data in support of the aims of the project. Note for high-risk projects or aims (if explicitly indicated as high-risk) and the project examining engagement approaches with communities of interest to the themes of the Center, no pilot or preliminary evidence is required. Additionally, renewal applications must provide a Progress Report as part of the Research Strategy section.

All applicants must:

• Provide a cogent argument for the choices of research theme(s), aims, study populations and inclusion criteria, and methods.
• Clearly describe the developmental characteristics of their proposed sample(s) and how study of SLD(s) in this population will contribute to our larger understanding of SLDs.
• Describe the method(s) planned for recruitment and retention of participants, identification of risk for individuals with learning difficulties or, for those individuals too young to be identified or to where there are concerns about the quality of identification (e.g., struggling young adult learners), broader behavioral description of the participants, and definition of learning difficulties/disabilities planned.
• Describe the developmental epoch under study. When addressing SLD research in early adulthood, NICHD will only permit research conducted on individuals with performance levels consistent with adult basic and secondary education learners, learners seeking remedial skill development in post-secondary settings or workplace literacy settings, or individuals developing foundational literacy or numeracy skills in transition programs.
• Indicate which of the topic(s) listed in the Overall component Research Strategy instructions (i.e., numbered bullets and sub-bullets) are being addressed within the research project, if any.
   

Specific Enhancement Activities -- This FOA additionally targets career enhancement of the next generation of SLD research scholars through project-embedded involvement of early career researchers (ECRs; defined as graduate and medical students, post-doctoral scholars, medical residents, and early career investigators) in the planning and execution of the research endeavor (see the Engagement Core for specific requirements). These activities must include community-engaged activities for ECRs as part of their career enhancement to support the next generation of engaged SLD scholars. Per the theme of the Center as defined by the applicant, the community or communities delineated should be the focus of these engagement activities. Communities of interest are defined broadly in the scope of the RFA allowing applicants flexibility in identifying and aligning community-engaged experiences for ECRs. Applicants are strongly encouraged to include community members as mentors for this component of the ECR development. Additionally, in line with this FOA’s focus on knowledge sharing, activities are expected to include a corresponding emphasis on skill development for LDRC-engaged, community members. The goal for these community members collaborating with Centers should be to build a research knowledge base in the community and to enhance opportunities for long-term bidirectional communication to inform research engagement. In conceptualizing the research projects, applicants are encouraged to think creatively about the structure and nature of the research activities given the multi-project and core nature of the LDRCs to support these career enhancing efforts. The goal is to facilitate activities occurring within the context of the Engagement Core by building in structural opportunities that could efficiently and effectively be utilized to strengthen career enhancing opportunities for scholars. Applicants should briefly describe (i.e., 2-3 paragraphs) how career enhancing opportunities have been structurally integrated in the research project and how opportunities may change over the temporal course of the research project.
 

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

Resource Sharing Plan:

Do not include a Data/resource sharing plan for this component; the plan should be included only under the Data Management Core.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information (Research Project)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

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

4. Submission Dates and Times

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.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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 How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. 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 form. 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 unique entity identifier provided on the application is the same identifier 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 and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

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

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this specific announcement, please note the following: 

The overall LDRC will be evaluated as an integrated and synergistic research effort focused on SLDs impacting mathematics, reading and writing. The relationship and contributions of the thematic Research Projects and Cores 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 LDRC overall. Reviewers do not need to weigh all components of the application equally and may weigh the research projects and overall review more heavily in their final review of impact of the application.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

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? Is the prior research that serves as the key support for the proposed project rigorous? 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?

Specific to this FOA:

Will there be coordination, cohesiveness, and synergy between the Research Projects and Cores as they relate to the common theme of the LDRC?

What is the likelihood the LDRC will enhance collaborative efforts and bring transdisciplinary perspectives together to advance LD science?

How strong are the applicant's effort to synergistically build integrated efforts for bi-directional community engagement and career-enhancing activities for early career scholars across projects and cores (as relevant)?

To what extent do the efforts described in the Plan for Enhancing Diverse Perspectives further the significance of the project?

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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?

To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives strengthen and enhance the expertise required for the project?

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

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?

To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives meaningfully contribute to innovation?

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed 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?

Specific to this FOA:

Are plans included for engagement and integration of early career scholars to receive research embedded, career-enhancing experiences?

Does the team include established and emerging investigators from complementary research fields that could make a substantial contribution to the LDRC?

Are the timeline and milestones associated with the Plan for Enhancing Diverse Perspectives well-developed and feasible?

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 individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

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?

To what extent will features of the environment described in the Plan for Enhancing Diverse Perspectives (e.g., collaborative arrangements, geographic diversity, institutional support) contribute to the success of the project?

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

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.

Center as an Integrated Effort

What are the advantages of conducting the proposed research as a center program rather than through separate and independent research efforts?

Will the research efforts, when taken together, likely have more impact on the field than each separate project conducted in isolation?

Will the research proposed in individual projects be enhanced by the center? Will the cores facilitate the research of the projects?

Study Timeline

Specific to applications involving clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the 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 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 Individuals Across the Lifespan

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 individuals of all ages (including children and older adults) 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).

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.

Review Criteria for Research Projects

Reviewers will assign an impact score based on the likelihood of success for each specific Research Project. NICHD recognizes that applications will include Research Project(s) that are exploratory, discovery-based and/or higher risk in nature. In evaluating higher risk components or exploratory projects without or with limited preliminary data, the reviewers will weigh the potential to achieve significant advances against the risks. The reviewers will evaluate the likelihood that interpretable results will be obtained from exploratory or high-risk studies.

Scored Review Criteria - Research Projects

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 research 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 the prior research that serves as the key support for the proposed project rigorous? 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?

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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?

Does the team include established and emerging investigators from complementary research fields that could make a substantial contribution to the LDRC?

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

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?

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed 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?

Are plans included for engagement and integration of early career scholars to receive research embedded, career-enhancing experiences? Is the proposed sample, inclusive of the developmental characteristics and how study of SLD(s) in this population will contribute to our larger understanding of SLDs, well described and justified by applicant? Are the sample recruitment and retention plans for cogent?

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 individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

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?

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

Additional Review Criteria – Research Project

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.

Study Timeline

Specific to applications involving clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Protections for Human Subjects

For research that involves human subjects but does not involve one of thecategories 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 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 Individuals Across the Lifespan

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 individuals of all ages (including children and older adults) 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.

Additional Review Considerations – Research Project

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).

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.

Review Criteria for Cores

Reviewers will assign an impact score based on the assessment of each Core Component in terms of the following review criteria. Separate criterion scores will not be assigned for Cores.

Administrative Core

Reviewers will evaluate the following:

• Core Director’s and key core personnel(s) experience in research administration;
• Group synergy of the Core Lead(s) and other Core personnel
• Appropriateness of administrative structures and day-to-day management of the program;
• Decision-making process within the proposed center for the evaluation of research productivity, allocation of funds, and management of resources;
• Process for prioritizing use of Core facilities by the various research projects;
• Mechanisms proposed for regular communication and coordination among investigators in the program;
• Plan for program evaluation including use of SMART metrics and an External Advisory Board
• Adequacy of risk mitigation plans

Engagement Core

Reviewers will evaluate the following:

• Comprehensive and innovative nature of plans for bidirectional engagement with communities emphasized in the LDRC application
• Quality of the SMART metrics proposed to evaluation the bidirectional engagement and through these efforts enhance the potential to impact future directions of science, practice, communities themselves and/or policy (as appropriate to the proposed science of the Center)
• Clear enumeration of the proposed community or communties of interest
• Plans for coordinating intra- and extra-LDRC resource and data sharing activities
• Quality and richness of the plans for project-embedded, career enhancing research opportunities for early career researchers and development of individualized development plans for each early career researcher
• Plans to utilize technology to facilitate engagement among LDRC and planned dissemination activities

Data Management and Sharing Core

Reviewers will evaluate the following:

• Clarity, comprehensiveness and quality of the planned data management, statistical analysis and data sharing plans
• Appropriateness of the staffing plans including expertise, clarity of lines of authority and decision making and strengths of the personnel in relation to the needs of the center as a whole
• Clarity of the resources and services that will be available to projects and whether these are sufficient for the needs of the center writ large
• Clarity of the data sharing plans and how the core staff will work with research projects to facilitate efficient, cost effective and timely data sharing
• Quality of the plans for involvement and career development opportunities for early stage investigators particularly those from under-represented groups
• SMART metrics proposed to evaluate the quality of services and usage of core resources
• Does the application propose an effective data management and sharing plan?

All Other Cores

Reviewers will evaluate the following:

• Qualifications, experience, group synergy and commitment of the Core Lead(s) and other Core personnel;
• Quality of the services provided;
• Cost effectiveness and quality control of the Core;
• Utility of the Core to the individual research projects and overall LDRC
• SMART metrics proposed to evaluate the quality of services and usage of core resources

2. Review and Selection Process

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 will receive a written critique.

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.

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

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 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 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.
• Relevance of the proposed project to program priorities including the PEDP.

3. Anticipated Announcement and Award Dates

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

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in theNIH 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 recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. 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.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

Prior Approval of Pilot Projects

Recipient-selected projects are not permitted under this RFA. Prior approval is therefore not applicable.

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: Generaland Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federalwide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

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.

Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.htmlandhttps://www.lep.gov.

• For information on an institution's specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

Not Applicable

When multiple years are involved, recipients 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 RPPR, 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. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients 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 the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM)about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75and 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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, application errors and warnings, documenting system problems that threaten submission by the due date, and 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)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Brett Miller, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-9849
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]

Mario Martinez
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-402-4078
Email: [email protected]

Section VIII. Other Information

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

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 and 2 CFR Part 200.