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

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

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

This Funding Opportunity Announcement (FOA) invites specialized center applications (referred to as Learning Disabilities Research Centers [LDRCs]) to develop new knowledge about learning difficulties and disabilities 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 adults identified with or at risk for learning disabilities (LDs). In particular, this FOA is interested in LDs impacting component oral language abilities (e.g., phonology, morphology, vocabulary, pragmatics), reading (e.g., decoding and word recognition skills, reading fluency and automaticity, reading comprehension), written expression abilities (e.g., composition, spelling, graphomotor skills), 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 LDs 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 learning disabilities science, practice and beyond. This FOA integrates and complements research topics that span various research portfolios within the Child Development and Behavior Branch and Intellectual and Developmental Disabilities Branch at the NICHD.

The LDRCs represent NICHD’s single largest investment in research examining learning difficulties and disabilities and reflect our longstanding interest in addressing learning difficulties and disabilities that adversely affect the development of listening, speaking, reading, writing, and mathematics abilities. This FOA is a reissuance of the Learning Disabilities Research Centers FOA (RFA-HD-12-202) and intends to extend the impact of NICHD’s investments in learning disabilities to an even broader range of learners. Since its inception, the NICHD has funded normative studies to delineate the basic mechanisms that underlie individual differences in oral language and normal reading development, as well as specific deficits in attention, perception, language, cognition, and academic skills, particularly reading. This focus continues to evolve over time as corresponding areas of science and practice mature with the ultimate goal of informing current and future needs of researchers, practitioners and policymakers. Consistent with this evolution, this announcement a) expands to address mathematics learning disabilities in addition to learning disabilities impacting reading and writing; b) emphasizes 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 response; c) enhances the focus on linguistically and culturally diverse populations; and d) expands the population foci to formally include individuals with overall lower cognitive functioning who may not receive a formal LD diagnosis but face challenges in the acquisition of reading, mathematics or writing.

Consistent with its historic emphases, the LDRCs continue their focus on the development and validation of classification system(s) and operational definitions of LD. Such a push 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, dosage and intensity. This announcement reflects a broader transition that more heavily emphasizes risk for LD (broadly speaking) and contextualizes LD science within a framework of multi-level prevention models (i.e., primary, secondary and tertiary prevention). This multi-level framework could 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. Critically, this framework focuses intervention efforts across the skill performance spectrum with explicit goals of 1) reducing the incidence of learning difficulties and disabilities through effective primary and secondary prevention efforts; 2) improving outcomes for those minimally responsive to current state-of-the-science intervention efforts (i.e., tertiary prevention) and enhancing the science of intensive intervention services across the lifecourse; and 3) providing effective screening and progress monitoring to facilitate intensive, early intervention services for those at greatest risk for learning difficulties or disabilities. The emphases align with broader efforts to improve early, prospective model predictions of risk for learning difficulties to inform intensive service delivery allocation.

The LDRCs provide a unique opportunity for the research community to tackle research topics central to learning disabilities research, practice and policy communities by utilizing complementary methodological approaches. Specifically, the LDRCs complement behavioral sciences' approaches to LD research with genetic/epigenetic and/or neurobiological data sources to synergistically examine the underlying nature of learning difficulties and disabilities and co-occurring conditions, their manifestations, and screening and treatment implications and approaches. Utilizing this approach in a developmentally sensitive and team-based context holds the promise of further pushing the edge of the state-of-the-science and practice with the intent to continue to inform practice and policies impacting children, youth and adults with LD. Additionally, new to this initiative, investigations will include a focus on exploratory topics (i.e., higher risk) that align with the overall theme of the center with the goal of extending the reach, impact and reciprocal influence of work in the broader research ecosphere to LD research topics. The P50 framework provides applicant unique opportunities to mitigate risk and enhance the viability of high-risk topics by embedding these research activities in a broader LD research center enterprise.

The P50 mechanism provides a strong platform to support transdisciplinary, coordinated programs of research and research-embedded, career enhancing opportunities. This opportunity expands the historical LDRC foci through the introduction of the cross-LDRC Early Career Scholars and Pilot program providing opportunities for developing scholars to harness and leverage the broader resources within and across Centers and to gain critical early experience and publication(s) that can be leverage for independent research awards.

Finally, in order to enhance meaningful connections with other researchers in the scientific community, practitioners and to inform policy, the LDRCs will include efforts to disseminate to external audience as appropriate. The intent is to develop meaningful relationships that allow for dissemination of research findings and their implications and allow for feedback mechanisms from the external community members (inclusive of but not limited to researchers) back to LDRC sites to facilitate greater impact of the LDRC investment. Importantly, dissemination of research findings and engagement with external stakeholders should be appropriate for the science to be conducted and aligned to the interests and needs of specific audience(s).

Both basic and translational studies of LDs and difficulties in domains of component oral language abilities, reading, written expression abilities, mathematics and relationships among these LDs and other disabilities and co-occurring or comorbid conditions are encouraged. The constitution of an LDRC must include at least three focused research projects and two or more cores minimally including Administrative and Engagement Cores. The LDRC applications should utilize state-of-the-science experimental, methodological, and statistical and other modeling approaches to enhance our understanding of learning disabilities and difficulties and co-occurring conditions. The LDRCs provide a research environment and infrastructure to innovate conceptually and methodologically, and as such, applications include a focus on emerging and high risk topics and approaches. These topics should align thematically with the center and provide a framework to a) push the boundaries of LDs research at its intersection with other fields, b) embrace the complexities of studying LDs in the context of multiple comorbid or co-occurring conditions, c) increase the applicability of findings from LD to other populations with learning difficulties more generally, and d) build theoretical and conceptual bridges between research, practice and policy communities.

This FOA invites integrated transdisciplinary studies that 1) refine classification and definition models of learning disabilities for component oral language abilities, reading, written expression abilities and mathematics and develop developmentally-sensitive models that prospectively predict risk of substantial learning difficulties and disabilities; 2) further extend basic and translational research on LDs impacting reading, writing and mathematics and co-occurring conditions and enhance understanding of the nature of the relationship between learning disabilities and co-occurring conditions; 3) enhance understanding of risk factors for the development of learning difficulties or disabilities 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 LDs at different developmental epochs across the lifespan; 5) enhance the research knowledge base on early preventive efforts 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; and 6) extend research efforts to highly diverse participant samples including but not limited to a) individuals from historically under-researched or understudied groups at high risk for or with demonstrated learning difficulties or disabilities, b) multi-lingual and English language learning populations, and c) individuals with overall lower cognitive functioning that show (or are likely to demonstrate) significant difficulties in acquiring literacy and mathematics. Researchers are encouraged to cogently and coherently tackle a subset of these target areas and recognize that these foci are not mutually exclusive; indeed, they are inextricably linked. 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 younger adult learners. As articulated in the sixth focus immediately above, there is a particular interest in understudied groups across the developmental range. 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 literacy 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.

• Modeling and developing comprehensive risk assessments of anticipated minimal response before formal instruction in mathematics, reading and/or writing. Complementary modeling approaches to identify early behavioral, epigenetic or neurobiological indicators of instructional response that presages minimal intervention response for children and youth exposed to formal instructional and receiving active intervention.
• 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.
• Development and refinement of 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 refine classification systems that provide categorical and/or probabilistic judgments about disability status utilizing simulated and human performance data.
• Enhanced, intensive early intervention efforts for children at high risk of learning challenges in reading, writing or mathematics.
• Develop enhanced intensive intervention efforts for children with demonstrated minimal response inclusive of multi-year, intensive clinical trials with longitudinal follow-up.
• Examine the potential benefit 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 and how to balance assistive technology usage with continued core instruction in reading, writing or mathematics.
• Develop novel approaches to reliably screen for, identify and classify reading disabilities in multi-lingual children and English language learning populations.
• Develop novel approaches to enhance and speed acquisition and development of reading, math or writing for children and adolescents with overall lower cognitive functioning.
• 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 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.

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

Higher Education Institutions

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

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

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

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

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

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

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

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

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

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

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

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

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

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

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

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

A button to access the online ASSIST system 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.

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

It is critical that applicants follow the instructions in the Multi-Project Instructions for the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

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

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

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

The letter of intent should be sent to:

Brett Miller, PhD
Telephone: 301-496-9849
Fax: 301-480-0230
Email: [email protected]

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	12
Research Project	12
Administrative Core	6
Engagement Core	6
Core(s)	6

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

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

The application should consist of the following components:

• Overall: required
• Research Projects: required, minimum of three and maximum of six
• Administrative Core: required, one maximum
• Engagement Core: required, one maximum
• Core(s): optional; maximum of four

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

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

Complete entire form.

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

Follow standard instructions.

Enter primary site only.

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

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

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

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

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

Specific Aims: Include Specific Aims for the 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 the LDRC's objectives, to identify the thematic focus of research proposed in the application, the goals and planned activities for the Administrative and Engagement Cores 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 as a whole, 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 of the research, how the combined resources create a synergistic, overall programmatic effort of integrated research and describe how the project-embedded enhancement efforts support the development of the next generation of LD scholars. Include any necessary tables, graphs, figures, diagrams and charts in this section. Additionally, provide the following information as part of the research strategy:

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

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 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 learning disabilities impacting mathematics, reading, and/or writing. Note applicants may address more than one topic in a single project and are explicitly encouraged to do so and must address all topics (including sub-bullets). The required topics of the FOA are bulleted immediately below for reference:

Applicants must synergistically address the following numbered bullets, 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 numbered bullets and sub-bullets are not always mutually exclusive (e.g., sub-bullet 1b and 1c); 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:

1) Applicants must examine more than one learning disability in the context of a Center and include a focus on understudied and underserved populations and individuals with more complex behavioral phenotypes. Specifically, applicants must:

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

1b) Include a focus on populations with complex phenotypes defined as individuals with at least one learning difficulty or disability and one or more co-occurring conditions or individuals with overall low cognitive functioning. No preference will be given to high versus low prevalence co-occurring conditions.

1c) Include a focus on historically understudied and underserved populations. These populations are defined broadly (inclusive by design) and may include groups that differ in social, cultural and linguistic backgrounds; vary in cognitive capacities; be homeless, transient or incarcerated. No preference will be given for a particular population.

2) One of the research projects must focus on a high risk research topic of high public health relevance related to learning disabilities. The topic must align thematically with the LDRC and should provide a potential framework to push the boundaries of LD 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 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 for every project. Rather, applicants should utilize the most scientifically appropriate methodology and analytic approach in relation to the aims and design of the research project.

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, with the following modification:

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

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

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

When preparing your application in ASSIST, use Component Type Research Project.

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

All of the required topics described in the Overview section guidance (i.e., numbered bullets and sub-bullets) apply to the research project. Note applicants may propose one or more research projects that do not address a required topic listed in the Overall Component Research Strategy instructions, and NICHD explicitly encourages this approach if it leads to a more coherent and synergistic Center application as long as applications have addressed all of the required numbered bullets and sub-bullets.

Complete only the following fields:

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

Enter Human Embryonic Stem Cells in each relevant component.

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

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

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

List all performance sites that apply to the specific component.

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

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

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

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

Specific Aims: Include Specific Aims for the 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 program's theme. Specify the significance of the work proposed to our understanding of learning difficulties and disabilities in domains relevant to the scope of the research. Specify any existing preliminary evidence or pilot data in support of the aims of the project. Note for high risk project(s) or aims (if explicitly indicated as high risk), no pilot or preliminary evidence is required. Additionally, renewal applications must provide a Progress Report as part of the research strategy section.

All applicants are strongly encouraged to provide a cogent argument for the choices of aims/topics, study populations and methods. Applicants should clearly describe the developmental characteristics of their proposed sample(s) and how study of LD(s) in this population will contribute to our larger understanding of LDs. Additionally, please describe the methods planned for recruitment and retention of participants, LD or LD risk identification, broader behavioral description of the participants, and definition of learning difficulties/disabilities planned. Applicants must describe the developmental epoch under study. When addressing LD 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 LD research scholars through project-embedded involvement of early career researchers (defined as graduate and medical students, post-doctoral scholars, medical residents and early career investigators) in the planning and execution of the research endeavor (see the Engagement Core for specific requirements). Applicants are also encouraged, but not required, to incorporate project-embedded, career enhancement opportunities for established investigators (EI) who have not traditionally investigated topics related to developmental learning disabilities but have complementary expertise that could enhance team-based, transdisciplinary approaches to studying learning disabilities. 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 being 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., 1-2 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: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

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

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

PHS Inclusion Enrollment Report (Research Projects)

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

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

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

SF424 (R&R) Cover (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.

Facilities and Other Resources: List types and amount of committed resources/funds the LDRC receives from the applicant institution, participating sites or other complementary sources. Examples include but are not limited to dedicated equipment, dedicated space, salary support for investigators or core staff, substantive support for dissemination activities and financial support for new space or equipment. Include salaries only if the support is provided for an LD LDRC-related function such as directing the LDRC, managing core, or similar activities. Institutional support for LDRC personnel and research faculty should be reflected in the budget request. This information may be presented in tabular form.

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 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.

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

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

PHS 398 Research Plan (Administrative Core)

Specific Aims: Include Specific Aims for the LDRC 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 team experience, accomplishments, and expertise of the Core Lead and other key core personnel that illustrate group synergies not apparent from individual experiences, accomplishments, and expertise. Information in the biographical sketches may be referenced and should not be repeated.
• Explain the steps taken to ensure that the core is cost-efficient. If there are cost-sharing arrangements (note that cost-sharing is not a requirement of this FOA), describe them.
• Explicit benchmarks that will be used to evaluate the success of the Administrative Core.
• Risk mitigation plan that encompasses identifying and monitoring known risks and identifying and mitigating emergent risks to the scientific project inclusive of the career enhancement activities.
• The NIH continues to encourage institutions to increase the participation of individuals currently underrepresented in the biomedical, behavioral, clinical and social sciences such as: individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. Applicants should discuss efforts to promote diversity within the NIH-funded scientific workforce and describe how they will identify and address barriers that may impede the participation of underrepresented racial and ethnic minorities, and persons with disabilities in the proposed program.

Advisory Boards: Because of their complexity and the inclusion of one or more high risk projects, all LDRC grants require guidance and interaction with senior members of the scientific community not directly involved in the conduct of the proposed research activities and operations. Applicants must develop plans for an External Advisory Board to provide objective outside counsel and periodic review of the 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 and recommendations for support of proposed pilot projects (if applicable; see Engagement Core for discussion). 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 seniority of Board members to be recruited. Renewal applications should not specify whether existing members will be recruited in the future, but instead focus on the scientific expertise needed for the renewal application. 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 specific Administrative 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:

A Data Sharing Plan is not required for this component.

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

PHS Inclusion Enrollment Report (Administrative Core)

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

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

Facilities and Other Resources: Describe institutional investment(s) planned to facilitate the success of the LDRC’s developing scholars (e.g., graduate or medical student, post-doctoral fellow, Early Career Investigators).

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 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.

Optional Pilot Projects (budget info)

Up to $50,000 in total costs (i.e., inclusive of direct and indirect costs) per year may be requested for any one pilot project, with a total costs limit of $50,000 per year for all pilot projects. This limit applies for the full duration of the LDRC.

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) translation and dissemination of research findings with the broader scientific, practitioner and policy communities as appropriate to the science posed; 2) coordinating intra- and extra-LDRC resource and data sharing activities; 3) project-embedded, career enhancing research opportunities for early career researchers; and 4) plans for soliciting, reviewing and decision making for pilot projects (if proposed).

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 any oversight provided by the Engagement Core. The intent is to provide 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 are also encouraged, but not required, to incorporate project-embedded opportunities for established investigators (EI) who have not traditionally investigated topics related to developmental learning disabilities but have complementary expertise that would enhance team-based approaches to studying learning disabilities.

All Center applicants must include:

• Plans for translating and disseminating research based findings to the broader scientific, practitioner and policy communities as appropriate to the science of the Center; include detailed information about the dissemination aims and implementation plans to achieve these aims.
• Formal plans to facilitate intra-LDRC and extra-LDRC data sharing
• Formal procedure to develop a publication plan. Publication plan will be requested at the beginning of an award for all funded applications.
• Formal plans to utilize technology to facilitate engagement among LDRC investigators (regardless of career level) and planned dissemination activities

Applicants must also designate a core staff member to facilitate cross-site collaborative activities among early career investigators. These activities will be designated post-award and applicants may, but are not required to, propose activities that would synergize career-enhancing opportunities across LDRC and LD Hub funded projects that will form the foundation of the LDRC Early Career Scholars and Pilot program.

Pilot projects

As part of this core, applicants may, but are not required to, propose a portion of the funds from the LDRC to be used to support ancillary pilot projects to LDRC early career researchers as a means to achieve articulated LD research career milestones, as well as support the broader goals of the LDRC. For applicants requesting the flexibility to utilize Core budget funds for pilot projects, the Core description must describe a formal process by which pilot study applications will be solicited, reviewed, and selected. Centers are encouraged to solicit pilot study applications from both the applicant s LDRC site(s) and from domestic, extra-LDRC institutions; note, applicants from foreign institutions are not eligible. LDRC applicants should be aware that additional funds will not be available to accommodate secondary indirect costs for pilot projects at research institutions outside of the applicant organization.

The goal of the pilot project effort is to provide opportunities for a new cohort of investigators to leverage the broader LDRC activities such that they can develop their own identifiable line of research and facilitate broader career transitioning goals. Given this goal, only early-career researchers are eligible to apply for a pilot research project and only projects that are within scope of the LDRC’s overall or project specific funded aims will be considered for support. Up to $50,000 in total costs (i.e., inclusive of direct and indirect costs) per year may be requested for any one pilot project, with a total costs limit of $50,000 per year for all pilot projects. This limit applies for the full duration of the LDRC. Independent review of pilot proposal applications must directly involve Advisory Board members and can optionally be supplemented by other researchers, with needed expertise, who are not actively involved in the Center. Meritorious pilot applications proposed for support should include all necessary administrative assurances (e.g., Institutional Research Board approvals; certification of investigator(s) completion of required Ethical Conduct of Research education) and be submitted to the NICHD program official before any pilot research activities can commence.

For Centers proposing pilot projects, applicants are additionally required to provide:

• Plans to solicit and review applications for pilot projects from early career researchers currently involved in the center and from the broader scientific community. This should include information on at least the following items: (1) priorities for allocating funds; (2) procedures for reviewing and selecting applications; (3) requirements, if any, for leveraging funds or preparing research applications to continue or expand the research project; (4) size of awards; (5) length of award periods; (6) number of awards permitted to an individual researcher; (7) plans to engage pilot investigators in Engagement Core activities; and 8) planned efforts to recruit and encourage applications from individuals from under-represented groups in the LDRC's target area of science.
• Safeguards that will be put in place to assure the integrity of the pilot project and compliance with all human subjects' requirements (if relevant).
• Plans for monitoring the progress of pilot projects throughout the pilot investigation and for the pilot program itself over the course of the grant cycle.

Letters of Support: Please provide any letters of support directly relevant to the specific Engagement 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, should address a Data Sharing Plan.

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

PHS Inclusion Enrollment Report (Engagement Core)

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

When preparing your application in ASSIST, use Component Type Core(s).

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

SF424 (R&R) Cover (Core(s))

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 (Core(s))

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Core(s))

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) (Core(s))

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 (Core(s))

• 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 (Core(s))

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 (Core(s))

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 projects.
• Overall management plan for the Core
• Cost effectiveness and plans for quality control
• Plans for long-term sustainability

Letters of Support: Please provide any letters of support directly relevant to the specific Core(s).

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:

A Data Sharing Plan is not required for this component.

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

PHS Inclusion Enrollment Report (Core(s))

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

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

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

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

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

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

This initiative is not subject to intergovernmental review.

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

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

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

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

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

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

For this specific announcement, please note the following:

The overall LDRC will be evaluated as an integrated and synergistic research effort focused on LDs 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.

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

Does the Center address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the Center are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Will there be coordination, cohesiveness, and synergy between the Research 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?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Center? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Does the team include established and emerging investigators from complementary research fields that could make a substantial contribution to the LDRC?

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

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

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

Is the LDRC's overall strategy to foster scientific interactions and conduct thematic, integrated and synergistic transdisciplinary-based science likely to succeed? Does the LDRC provide converging evidence by utilizing multiple methodologies (e.g., behavioral, genetic/epigenetic, and neurobiological approaches) to investigate LD research topics?

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

As applicable for the Center 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?

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

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

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

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

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

Not Applicable

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

Not Applicable

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

Not Applicable

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

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

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

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

Reviewers will 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.

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 research project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the research project are achieved, how will theoretical models and scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s)

Are the Project Lead, collaborators, and other researchers well suited to the research project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the research project is collaborative or more formally has multiple Project Leads, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Does the application propose to address LDs in under-studied or under-served populations with innovative new approaches or methodologies that will enable their meaningful scientific study?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the research 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 science conducted within the scope of the research project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

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

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the research project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

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

Revisions

Not Applicable

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

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

Authentication of Key Biological and/or Chemical Resources

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

Budget and Period of Support

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

Reviewers will 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 the use of an External Advisory Board
• Adequacy of risk mitigation plans

Engagement Core

Reviewers will evaluate the following:

• Comprehensive and innovative nature of plans to translate and disseminate research findings and through these efforts enhance the potential to impact future directions of science, practice and/or policy (as appropriate to the proposed science of the Center)
• Plans for coordinating intra- and extra-LDRC resource and data sharing activities
• Plans for project-embedded, career enhancing research opportunities for early career researchers
• Plans for soliciting, reviewing and decision making for pilot projects (if proposed)
• Plans for monitoring and evaluating pilot projects (if proposed)
• Plans to utilize technology to facilitate engagement among LDRC and planned dissemination activities

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

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

As part of the scientific peer review, all applications:

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

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

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

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

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

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

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

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

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

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

Awardee-selected projects that involve {clinical trials or studies involving greater than minimal risk to human subjects} require prior approval by NIH prior to initiation.

• The awardee institution will provide NIH with written study protocols that address risks and protections for human subjects in accordance with NIH s Instructions for Preparing the Human Subjects Section of the Research Plan.
• The awardee institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

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

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

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 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement. Progress reports should briefly describe status of pilot projects, including data and safety monitoring, and should notify NIH of serious adverse events and unanticipated problems.

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

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

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, 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 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: https://grants.nih.gov/support/ (preferred method of contact)

Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)

Telephone: 301-945-7573

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]

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

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.