Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Funding Opportunity Title	Learning Disabilities Research Centers (P50)
Activity Code	P50 Specialized Center
Announcement Type	Reissue of RFA-HD-04-027
Related Notices	September 23, 2016 - This RFA has been reissued as RFA-HD-17-006.
Funding Opportunity Announcement (FOA) Number	RFA-HD-12-202
Companion FOA	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.865
FOA Purpose	The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) invites center program project applications for the Learning Disabilities Research Centers Program, hereafter termed Program . The Program will focus on generating new scientific knowledge to inform our understanding of learning disabilities and comorbid conditions. The request invites both foundational and translational, transdisciplinary research examining issues related to etiology, classification and definition of, and prevention and remediation of learning disabilities impacting listening, speaking, reading, writing and mathematics with an emphasis on comorbid conditions. The P50 mechanism allows for richly integrative, multi-method approaches to examining research topics focusing on learning disabilities that are not feasible through standard research mechanisms. Applicants should propose inter-disciplinary, coordinated programs of research that demonstrate cohesion and synergy across research subprojects and cores.

Posted Date	January 24, 2011
Letter of Intent Due Date	April 4, 2011
Application Due Date(s)	May 3, 2011
AIDS Application Due Date(s)	Not applicable
Scientific Merit Review	June/July 2011
Advisory Council Review	October 2011
Earliest Start Date(s)	December 1, 2011
Expiration Date	May 4, 2011
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, 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 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

The Child Development and Behavior (CDB) Branch of the Center for Research for Mothers and Children (CRMC), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), invites research grant applications to develop new knowledge about learning disabilities in language, reading and writing, and comorbid conditions. Specifically, we seek 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 component oral language abilities (phonology, morphology, vocabulary, pragmatics), reading (decoding and word recognition skills, reading fluency and automaticity, reading comprehension), and written expression abilities (e.g., composition, spelling, graphomotor skills) and relationships among these LDs and other disabilities. In addition, the interaction of these conditions with comorbid deficits in topics including but not limited to attention and/or mathematics are important to our full understanding of LD.

This FOA encourages both foundational and translational research on these topics. Of particular interest are investigations into approaches that serve as alternative classification approaches (including hybrid models) to models or approaches that make exclusive use of the IQ-achievement discrepancy criterion for identification. A major focus of the effort should include how these models or combinations of models distinguish LDs from low achievement and other disorders that affect learning, including those that encompass a range of cognitive abilities. Applications that identify basic behavioral/social, neurobiological and genetic, and environmental mechanisms that influence the expression of LDs are encouraged, as are those that would explicitly link basic and translational research protocols to increase internal and external validities of candidate classification and definition models. It is anticipated that centers proposed would use basic research to inform the development and testing of prevention measures and treatment decisions for those meeting identification criteria as well as those that could be categorized as at-risk, and to predict response to treatment.

This FOA requires investigators to examine, as part of a broader, richly integrated set of projects, factors related to at least two of the following topics: development of reading comprehension skills, writing skills, and/or executive functions skills (as these skills relate to literacy development in individuals at risk or identified with an LD impacting reading or writing). Although not all subprojects within a P50 application are expected to examine questions related to these three topical areas of interest, applications must include a focus on at least two of these topics across one or more subprojects. These investigations should be richly integrated with broader investigations into literacy development and intervention efforts for individuals at risk for or identified with LDs impacting reading and/or written expression.

Because the CDB Branch has developed an ongoing research program in learning disabilities in mathematics development and disorders, investigator-initiated applications with a primary research focus on Math LDs should be directed to that program (http://www.nichd.nih.gov/about/org/crmc/cdb/prog_mscld/index.cfm). However, centers are encouraged to include studies that examine comorbidities between mathematics deficits and/or attentional disorders (ADD/ADHD) with LDs in reading and/or written expression. Note also that this Program complements but does not replace funding opportunities available through NIH’s parent announcement for investigator initiated projects. This Program is intended to be a more focused effort on LDs impacting reading and writing as part of our broader support for literacy and related learning disabilities at the NICHD.

This FOA is expected to result in transdisciplinary, coordinated programs of research supported through the P50 center grant mechanism. The proposed research must include three or more related, highly-integrated, and high quality research projects that provide multidisciplinary, yet unified and interdisciplinary interaction, and include at least two resource cores. All centers are required to include a service core tasked with efficiently and effectively providing access to research resources to subprojects, and translating and disseminating results to broader research and practitioner communities as scientifically appropriate; applications should include as part of the service core’s responsibilities a cogent plan for professional mentorship for predoctoral, post-doctoral and/or early stage investigators that would be involved in one or more of the subprojects and how these efforts would be coordinated across projects and across sites. Additionally, an administrative core is required. This core will be responsible, at minimum, for overall management of the center and must include a plan for within-center data sharing and proposed procedure for developing a publication plan to be implemented across the center. Applicants should allocate responsibilities for oversight and management of external data sharing requests to either the service or the administrative core; this option of core assignment is provided to applicants to allow flexibility for the most coherent and cohesive integration of this activity into the core plans. Applicants may propose additional core(s) to meet the particular management and scientific needs of their specific proposed center.

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), NIH, has had a longstanding interest in the study of normal language and reading development, learning disabilities, and disorders that adversely affect the development of listening, speaking, reading, writing, and mathematics abilities. Since its inception in 1963, the NICHD has funded normative studies to delineate the basic biological and behavioral 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 has evolved over time to include corresponding interests in examining literacy (reading and writing) development as comprised of integrative processes including the relationship of both sets of skills to oral language development with diverse sets of learners.

In January 1987, a National Conference on Learning Disabilities, co-sponsored by the Interagency Committee on Learning Disabilities (of which the NICHD was designated as the lead agency) and the Foundation for Children with Learning Disabilities (FCLD, now National Center for Learning Disabilities [NCLD]), was held on the NIH campus. The proceedings of this conference were combined with other sources to provide a comprehensive document titled "Learning Disabilities: A Report to the U.S. Congress" (1987). A major recommendation of this report was a systematic research effort to develop a valid and reliable definition and classification system that could provide a theoretical, conceptual, and empirical framework for the identification of different types of learning disabilities and the distinctions and interrelationships of these types of LD with general academic underachievement, disorders of attention, mental retardation, genetic disorders, and emotional disturbance. Based on those recommendations, NICHD solicited applications for Learning Disabilities Research Centers (LDRCs) in 1988. Research conducted at the LDRCs, in concert with other reading disabilities research funded by the NICHD over the past decades, have yielded a number of discoveries and advances. These include delineating critical cognitive and linguistic factors involved in the normal acquisition of basic reading abilities and reading failure and their neurobiological and genetic correlates.

Translational projects including prevention and remediation studies that have addressed deficits in word level reading skills have produced converging evidence on the importance of phonological awareness, the development of the alphabetic principle, reading fluency, vocabulary, and reading comprehension strategies in learning to read, and studies have demonstrated the success of phonologically based interventions to improve reading ability in elementary school children. By integrating multi-modality neuroimaging protocols into both descriptive and treatment studies, NICHD-supported scientists have obtained evidence for specific neural systems related to the development of some componential reading skills and the malleability of these systems in response to successful intervention. Studies of the comorbidity between reading disabilities, mathematics deficits, and disorders of attention have also yielded important information, although much remains to be understood. Both behavioral and molecular genetic studies continue to inform our understanding of the influence of genetic factors on reading acquisition and reading disabilities, particularly through effects on the development of phonemic awareness and orthographic processing and our understanding of the relationship between reading disabilities and attention deficit hyperactivity disorder (ADHD).

The LDRCs continue to make significant strides in providing research findings to diverse audiences of researchers and practitioners in the field. In this solicitation, such dissemination is explicitly required within the service core for each center application. Additionally, the centers have proven to be fruitful grounds for mentorship of graduate students, post-doctoral researchers, and early career investigators on integrative research topics and approaches to LDs. Although mentoring was not previously codified, the current solicitation requests investigators to explicitly build in opportunities to allow for future growth of the next cadre of researchers through formalized mentorship plans.

The learning disabilities community continues to be challenged by persistent difficulties in the development and validation of classification system(s) and operational definitions of LDs. Recent changes in federal legislation have allowed for the implementation of alternative classification models in addition to an exclusionary model that uses an IQ-achievement discrepancy as a criterion for diagnosis. The use of an IQ-achievement discrepancy criterion for definition and identification is problematic for several reasons: (a) IQ is not a robust measure of one's potential to learn specific academic skills; (b) discrepancy scores are unreliable; (c) a focus on discrepancies hinders an emphasis on instruction and learning; (d) a reliance on discrepancies in the identification of LDs may prevent individuals from receiving the specialized instruction they need in a time sensitive manner, thus precluding early intervention; (e) individuals are both over- and under-identified as manifesting LDs when IQ-achievement discrepancy is employed as a criterion for identification; (f) IQ-achievement discrepancies have demonstrated low utility in distinguishing between LDs and other diagnostic and clinical entities; and (g) factors that would exclude individuals from a diagnosis of LDs may actually influence the expression of LDs (e.g., environmental disadvantage).

The development of a comprehensive classification and definition model for LDs continues to be constrained by insufficient examination of the basic neurobiological, genetic, instructional, and environmental factors that influence the expression and severity of LDs in reading fluency, reading comprehension, oral language (particularly vocabulary and listening comprehension), and written expression. Studies to improve classification and definition models of LDs must include these sub-categories of LDs in the process.

Both basic and translational studies of LDs in different domains of reading and written expression are encouraged. Multidisciplinary research designed to elucidate cognitive, linguistic, neurobiological, and genetic mechanisms in the development of word level reading and reading-related skills continue to be of interest to the NICHD LD Center initiative. However, if studies of word level processes are proposed, they should be integrated explicitly with multidisciplinary studies of individual differences in oral language development (e.g., vocabulary, syntax), reading fluency, reading comprehension, spelling and/or written expression to identify relationships among these literacy skills and in literacy-related domains. The role of oral language comprehension and its relation to both reading comprehension and written expression are of particular interest. Also of particular interest are studies of LDs that uniquely impact written expression or that impact both reading and writing with respect to the etiology, developmental course, and response to treatment characteristics of these types of LDs, as well as relationships with LDs impacting oral language and reading respectively. Projects examining the development of reading and writing in individuals with LDs should pay careful attention to broader aspects of oral language and possible influences of more general processing skills such as executive function skills. Also, projects examining the inter-relationship between the development of reading and writing skills are encouraged, especially as this relationship impacts reading comprehension for individuals identified or at risk for learning disabilities impacting literacy.

Applicants are expected to include significant numbers of individuals who have been historically under-represented in research studies or for whom we have a relative dearth of data regarding particular research question(s). Applicants should include plans to disaggregate data by subject population where possible and scientifically appropriate.

The research solicited by the FOA should focus on designing and conducting integrated multidisciplinary studies that 1) refine the classification and definition models for learning disabilities impacting reading and writing, 2) further extend basic and translational research on LDs with a particular interest in, but not limited to, research on writing, reading fluency, reading comprehension, the concomitant development of reading and writing, relationship of oral language and listening comprehension to the development of literacy skills, and relationship of these and related skills to executive function; 3) identify basic neurobiological, genetic, cognitive/behavioral, and environmental mechanisms that influence the expression of LDs at different developmental epochs across the lifespan; 4) further enumerate the relationships between LDs that impact reading and writing and other comorbid conditions (e.g., ADHD); and 5) continue these efforts with highly diverse participant samples including individuals from historically under-researched or understudied groups. 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 these domains. For this FOA, applicants can focus on learners across the developmental range from preliterate children to struggling adolescent and younger adult learners. There is a particular interest in understudied groups within this developmental range as well as under-researched topics across the developmental range. In the case of young adult learners, applicants may only pose research projects focused on adult basic and secondary education learners (or those individuals with equivalent literacy skills) and learners seeking remedial skill development in post-secondary settings or workplace literacy settings.

Research plans for the P50 program must include one or more projects with a primary focus on or that richly and significantly integrate a focus on at least two of the following three broad scientific topics, as these pertain to individuals at risk for or identified with LDs impacting reading and/or writing: 1) the development of writing skills and their relation to broader literacy and oral language skills; 2) the development of reading comprehension as it relates to broader literacy and oral language skills; and 3) the development of executive function skills as it relates to broader literacy and oral language skills in these individuals. We are particularly interested in applications with a focus on written composition. This would include, but is not limited to, investigations that help to chart the developmental acquisition of these skills in diverse learners. Such investigations may include attention to the relevant social and contextual environment within which learning is occurring and should relate these skills to development of broader literacy skills. Intervention projects with both proximal and distal (multi-year) longitudinal follow-up are encouraged and may include secondary foci on teacher professional development in support of the project’s intervention efforts; however, projects with a primary or sole focus on teacher professional development (PD) will be considered out of scientific scope for this FOA. NICHD also strongly encourages projects that would help refine our understanding of the construct of reading comprehension and how the relative import or weighting of component skills that form a full concept of reading comprehension might be stable or change developmentally as reading, writing, and oral language skills develop. Additionally, the role of executive function skills in facilitating or mediating skill development in learners with LDs impacting reading and writing is of interest. Examinations of comorbid conditions that include executive function dysfunction are of particular interest.

Critically, applicants should articulate scientific research questions that are most appropriate for the developmental period that is being examined and may pursue these questions with diverse learners across the developmental span into early adulthood. In early adulthood, we are primarily interested in adult basic and secondary education learners as well as those enrolled in post-secondary developmental programs in reading and writing; choice of other adult populations must be strongly justified. NICHD is particularly concerned about the match between the research questions posed and the methods used to investigate these questions. It is assumed that projects will take advantage of mixed methods as appropriate.

Listed below are possible suggestions of the types of research topics that could be within scope for this FOA. This list is not intended to be comprehensive and applicants should not feel confined by the examples listed below. Appropriate topics include but are not limited to those listed below. Applicants are encouraged to contact the listed program official regarding specific questions about scientific scope:

• Multi-disciplinary research examining the classification, definition, and identification of LDs that impact written expression, word recognition, reading fluency, and reading comprehension. This includes research on the viability of alternative models of identification such as Response to Intervention (RTI) frameworks. These topics could be addressed through primary data collection or secondary data analysis of longitudinal datasets such as state-wide educational or public health data systems.
• Investigations designed to better elucidate the concomitant development of writing, reading, pre-reading and writing skills, and oral language development in those at-risk for developing an LD and those identified to have an LD over the lifespan. Multi-disciplinary investigations integrating intervention, behavioral investigations, genetics and/or neurobiology are particularly encouraged.
• Investigations examining the theoretical and conceptual assumptions underlying RTI frameworks, particularly in relation to the frameworks use for classification of LD and/or instructional delivery and progress monitoring across tiers of instruction/intervention.
• Investigations to inform our understanding of reading and writing intervention treatment responders and non-responders in order to more effectively inform early identification and treatment protocols for non-responders or treatment resistors.
• Developmental and longitudinal examinations of interventions designed to prevent and/or remediate LDs in reading (e.g., word recognition skills, reading fluency, and reading comprehension) and written expression.
• Broader examination and measurement of the instructional context is strongly encouraged to document and inform our understanding of fidelity of implementation as well as to inform our understanding of the range of possible influences within and outside of a specific learning context that may impact student learning and inform current and future models of instruction. For instance, this could encompass intervention studies that include multi-year and multi-cohort longitudinal intervention designs addressing beginning learners, pre-adolescent, adolescent, or younger adult learners.
• Of particular interest are multi-year examinations that document both initial responses to intervention as well as longer term maintenance of reading, writing and oral language skills.
• Foundational research to inform the conceptualization of the construct of reading comprehension, examinations of the stability of potential instantiations of this construct over different developmental phases, and examinations of the development of reading comprehension skills across the lifespan. For instance, this may include work to conceptually constrain our understanding of what constitutes reading comprehension but also to enumerate its relation to other aspects of reading such as word decoding. This may include statistical modeling and psychometric approaches to constrain possible definitions of the construct of reading comprehension.
• Foundational and translational research to inform our understanding of motivation and engagement factors that may impact literacy development in learners across the lifespan and with attention to diverse groups of learners.
• Multi-modal (e.g., fMRI, DTI, MEG) investigations into neurobiological correlates of reading and writing, including the development of novel or enhanced computational approaches for integrating data across data sources.
• Continued work utilizing recent advances in behavior and molecular genetics to elucidate the genetic substrates of reading (e.g., word recognition, fluency and reading comprehension), written expression, and oral language development. Investigations elucidating the relationship between LDs and common comorbid conditions such as ADHD are encouraged. Of particular interest are investigations that include diverse samples of learners, with sufficient subsample sizes to disaggregate data for different populations and different potential LD subtypes as scientifically appropriate.
• Investigations into population-based estimates of the prevalence of reading disabilities impacting word recognition, fluency, and reading comprehension and LDs in written expression, which include attention to different subtypes of LD and corresponding comorbidities.

Funding Instrument	Grant
Application Types Allowed	New Renewal The OER Glossary and the PHS398 Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	NICHD intends to commit an estimated total of $7,000,000 for 4-5 awards. Future year amounts will depend on annual appropriations..
Award Budget	Application budgets are not limited, but need to reflect actual needs of the proposed project. Direct costs of up to $1,200,000 may be requested for the initial year.
Award Project Period	The scope of the proposed project should determine the project period. The maximum project period is 5 years.

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

Higher Education Institutions:

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

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 Organizations) are not eligible to apply. Foreign (non-U.S.) components of U.S. Organizations are allowed.

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

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

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

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

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

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 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.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

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

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

The letter of intent should be sent to:

Brett Miller, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B05, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: 301-496-9849
Email: [email protected]

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the appendix files must be sent to:

Sherry Dupere, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: 301-451-3415
Email: [email protected]

• All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed.
• Overview of the Center (for overall P50): 12 pages
• Research Project Descriptions:
• Research Project Cover Page: 1 page
• Research Project Summary: 1 page
• Specific Aims 1 page
• Research Strategy: 12 pages
  
  
• Core Descriptions:
• Core Unit CoverPage: 1 page
• Core Unit Summary: 1 page
• Core Unit structure, administration, and services: 6 pages

Budget Instructions for P50 Applications (Form Page 4)

This FOA uses non-formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).

Prepare a series of composite budget tables for the P50 grant as requested below, followed by a detailed budget for each Research Project component and each Core unit.

A. Composite Budget for P50 Center

• Use PHS-398 Form Page 4, "DETAILED BUDGET FOR INITIAL BUDGET PERIOD," to present the total budget for all requested support for the first year. For each category, such as "Personnel," "Equipment," etc., give the amount requested for each Research Project component and each Core unit, with subtotals.
• If consortium arrangements involving other institutions or organizations are anticipated, include total (direct and indirect) costs associated with such third-party participation in the Consortium/Contractual Costs category. Costs for purchased services should be itemized under the "Other Expenses" category.
• Use PHS-398 Form Page 5, "BUDGET FOR ENTIRE PROPOSED PROJECT PERIOD," to prepare a budget, by category, that provides totals for each year of requested support. Requests for any increases in succeeding years must be justified in the individual Research Project component and Core unit budgets.

B. Budgets for Individual Research Project Components and Core Components

• Detailed Budget for Initial Budget Period (use PHS-398 Form Page 4 for each)
• Budget for Entire Proposed Project (use PHS-398 Form Page 5 for each)
• Budget Justifications and Explanations: Describe the specific functions of all key personnel, consultants, collaborators, and support staff. For all years, explain and justify any unusual items such as major equipment or alterations and renovations. For additional years of support requested, justify any significant increases or decreases in any category over the first 12-month budget period. Identify such changes with asterisks against the appropriate amounts. If a recurring annual increase in personnel or other costs is anticipated, give the percentage; however, current NIH practice limits escalation to 3%. In addition, for COMPETING CONTINUATION applications, justify any significant increases in any category over the current level of support.
• Please Note: Consortium budgets (if applicable) should be presented as described in A, including budget for the entire proposed project period. Total direct and indirect costs of sub-awardee are to be shown under Consortium/Contractual costs on the individual component budget and a detailed sub-awardee budget is to be placed following the appropriate Research Project or Core budget.

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

Table of Contents

Identify each Research Project component and each Core unit by title. Assign each Research Project component a Roman numeral (I, II, III) and assign each Core unit a capital letter (A, B, C) that reflects the order in which they are presented.

For each Research Project component and Core unit, provide the name of the Principal Investigator and include biographical sketches for any personnel not identified previously.

Overview of the Center (12 pages)

A. History and Purpose of the Program

Discuss the overall P50 Center’s objectives and general plans for the proposed grant period, including research grant history with yearly funding level.

B. Administration, Organization, and Operation

Include information on the support and commitment of the parent institution for the program, the authority of the PD/PI, the use of advisory committees, and space assignment. Describe organizational framework and provide an organizational chart.

C. Research Program

Discuss the proposed research program, highlighting its central theme. List by title and investigator's name the component Research Projects and Core units. Describe the relationship between the projects and the Core units and their relationship to the central theme.

D. Description of Assurances and Collaborative Agreements

Provide an overview and rationale for any collaborative and cooperative endeavors or subcontracts. Letters of Assurance/Agreement for these arrangements are included below.

Research Project Descriptions (12 pages for each Research Strategy component)

Identify each project by a Roman numeral (I, II, III...) and a title.

A full description of each project is to be provided following the format and instructions for Form PHS-398 (http://grants.nih.gov/grants/funding/phs398/phs398.html).

Begin the presentation of each Research Project component on a separate page, and include the following:

A. Research Project Cover Page (1 page)

• Title of Project
• Research Project Director (Principal Investigator), title, affiliation
• Other investigators, titles, affiliations

B. Research Project Summary (1 page; use PHS-398 Form Page 2)

• Discuss the purpose and nature of the project and its relevance to the program's overall theme.

C. Content of Research Plan (Begin each section with a section header)

• Specific Aims (1 page)
• Research Strategy (12 pages; Significance, Innovation, and Approach): Start each section with the appropriate section heading Significance, Innovation, Approach. Cite published experimental details in the Research Strategy section and provide the full reference in the Bibliography and References Cited section.
• For new applications, include information on relevant Preliminary Studies within the page limits of the Research Strategy.
• Indicate the Research Project's use of Core unit services, including why needed and the advantages and cost effectiveness of Core unit usage for the project.
• Inclusion Enrollment Report (renewal applications only)
• Bibliography and References Cited, Progress Report Publication List
• Protection of Human Subjects
• Inclusion of Women and Minorities
• Targeted/planned Enrollment Table
• Inclusion of Children
• Vertebrate Animals
• Select Agent Research
• Investigators
• Consortium/contractual arrangements
• Letters of Support: Include pertinent letters of assurance and collaboration for the Research Project. For off-site projects, justification should be provided for the project's location, and plans for interaction and cooperation with the other components of the program should be addressed.
• Resource Sharing Plan

Core Unit Descriptions

Identify each proposed Core unit by a letter (A, B, C...) and a title (e.g., Administrative Core, Service Core, Other Cores). Provide a full description of each Core unit. Begin the presentation of each Core unit on a separate page. Include the following:

A. Core Unit Cover Page (1 page)

• Title of Core Unit
• Core Director (Principal Investigator), title, affiliation
• Other investigators, titles, affiliations

B. Core Project Summary (1 page; use PHS-398 Form Page 2)

• Include an Abstract that identifies and describes the purpose of the proposed Core unit. Summarize the Core unit's overall objectives; highlight the decision-making process for use of Core services and plans for cost-effectiveness and quality control.

C. Core unit Structure, Administration, and Services (6 pages for each core)

• Administrative Core
  • Objective
  • Organization
  • Staffing (Professional and Support)
  • Resources: include description of space and physical resources
  • Services provided to other Core units and Research Projects
  • Management plan for the overall center, within-center data sharing, and proposed publication plan to be implemented across the center
  • Protocols for extra-center data sharing
• Service Core
  • Objective
  • Organization
  • Staffing (Professional and Support)
  • Plans for translating and disseminating research based findings to the broader scientific and practitioner communities; include detailed information about the dissemination aims and implementation plans to achieve these aims.
  • Mentorship and inclusion plan for graduate students, post-doctoral fellows, and/or early stage investigators in the scientific plans proposed in the project; the plan should at minimum include information about project staff who would be involved in mentorship, the nature of this involvement, mentorship activities planned that are appropriate for the mentee’s career level, and how the mentees progress would be evaluated.
• Additional Core Unit(s)
  • Objective
  • Staffing (Professional and Support)
  • Resources: provide description of space and physical resources
  • Administration
  • Justification: describe services provided with their bearing on productivity and quality
  • Usage: Indicate past and/or current usage (e.g., assays performed, animals supplied, etc.) and list projects proposed for Core usage

Progress Report Publication List (for competing renewal applications only)

• List publications prepared during current grant period (or the past five-year period) which report results of research supported by the grant.

Letters of Assurance/Agreement

• Any arrangements for collaborative and cooperative endeavors or subcontracts should be highlighted. Include letters of agreement from consultants. For projects to be conducted off site, i.e., at an institution other than the applicant institution, a PHS-398 face page or other documentation, signed by the off-site institutional officials, must be submitted with the application.

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as provided in the PHS398 Application Guide.

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.

Part I. Overview Information contains information about Key Dates.

Information on the process of receipt and determining if your application is considered on-time is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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 received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

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

The proposed research must include three or more related, highly-integrated, and high quality research projects that provide multidisciplinary, yet unified and interdisciplinary interaction, and include at least two resource cores. All Centers are required to include an Administrative Core. This core will be responsible, at minimum, for overall management of the Center and must include a plan for within-center data sharing and proposed procedure for developing a publication plan to be implemented across the Center. Additionally, the Center must include a Service Core tasked with efficiently and effectively providing subprojects with access to research resources, and translating and disseminating results to broader research and practitioner communities as scientifically appropriate. Applications should include as part of the Service Core’s responsibilities a cogent plan for professional mentorship of predoctoral, post-doctoral and/or early stage investigators that would be involved in one or more of the subprojects and how these efforts would be coordinated across projects and across sites. Applicants should allocate responsibilities for oversight and management of external data sharing requests to either the Administrative Core or the Service Core. This option of core assignment is provided to allow applicants flexibility for the most coherent and cohesive integration of this activity into the core plans. Applicants may propose additional core(s) to meet the particular management and scientific needs of their specific proposed center.

Principal Investigators (PIs) of the Centers funded through this RFA will be required to attend the annual investigators' meeting to share common concerns, common research opportunities, and measurement and research design strategies, as well as methods and approaches to data collection and analysis. PIs will be encouraged to establish, where possible, common measurement protocols to maximize the systematic collection of converging data across Centers. The first meeting is expected to take place in June 2012 to identify common concerns and to discuss core instrumentation and replication strategies. Funds for travel to these meetings, which will be held in the Washington, D.C. area, should be included in the application budget request.

Because of their complexity and size, Research Center (P50) 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 should propose an External Advisory Board to provide objective outside counsel and periodic review of the Research Center's activities and progress. Applicants are not to contact or select Advisory Board members at this time. Details of the operation of the Board, including size, structure, function, and frequency of meetings should be specified, as well as the type and level of seniority of Board members to be recruited. Members of the Advisory Board are to be selected and confirmed, and notification sent to program staff at NICHD, within three months of the award date. Provisions for costs of the Advisory Board are to be included in the application budget request and justification.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115,

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

Given the multi-component structure of the specialized P50 center grants, special review criteria for the overall project will be considered as part of the overall scoring. These additional review criteria focus on the nature of the integration and synergy across research projects and cores. The overall score will also include the specific strengths of the individual projects and cores. Criteria for projects and cores are described in sections following criteria for the overall Center.

Reviewers will provide an overall impact/priority 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.

Significance

Does the Center address an important problem or a critical barrier to progress in the field? 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?

Investigator(s)

Are the PD/PIs, 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?

Innovation

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

Approach

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

If the Center involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Is the scientific environment amenable to mentoring of pre-doctoral, post-doctoral, and/or early career investigators within or across projects?

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/priority score, but will not give separate scores for these items.

Center as an Integrated Effort

• Do one or more of the subprojects focus significantly or exclusively on at least two of the following broad research topics for those individuals identified with or at risk for LDs: 1) development of writing skills and their relation to broader literacy and oral language skills; 2) the development of reading comprehension skills as they relate to broader literacy and oral language skills; and 3) the development of executive function skills in these individuals?
• Will there be coordination, interrelationships, cohesiveness, and synergy among the research projects and core components as they relate to the common theme of the center?
• Are the projects proposed multi-disciplinary in scope?
• What are the advantages of conducting the proposed research as a center program rather than through separate research efforts? Will the research efforts taken together 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?
• Are there mechanisms proposed for regular communication and coordination among investigators in the center?
• Are administrative structures in place for the day-to-day management of the center, including arrangements for internal quality control of ongoing research?

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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed Center involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

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

Biohazards

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

Resubmissions

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/priority score.

Applications from Foreign Organizations

Not applicable

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for each research project to exert a sustained, powerful influence on the research field(s) involved.

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the 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?

Investigator(s)

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

Innovation

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

Approach

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

If the Center involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

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

Reviewers will assign an impact/priority score for each core unit component, based on the assessment of each Core unit independently in terms of the specified review criteria for Cores. Separate criterion scores will not be assigned for Cores. The following review criteria will be used for the evaluation of the individual Core units.

• Are the qualifications, experience, and commitment of the core director and other core personnel appropriate?
• Will the quality of services provided enable center investigators to achieve their research goals?
• Is there cost effectiveness in the core; will there be quality control measures taken for core procedures?
• Is the proposed use of core services by the budgeted center projects appropriate?
• For the Administrative Core: Does the core director have experience in research administration? Is there a decision-making process within the proposed center for the evaluation of research productivity, for allocation of funds and for management of the resources? What is the overall strength of the plan for center evaluation, including the use of any internal and external advisory groups? What is the overall strength of the internal data sharing and publication plan?
• For the Service Core: Is there a well articulated plan for mentoring pre-doctoral, post-doctoral, and/or early career investigators? How effectively have the principal investigators integrated mentees into the individual projects and larger activities of the center? Is there a formal plan to monitor the progress of mentees toward formalized career goals? Does the applicant describe an effective plan for outreach/education activities? Do the activities proposed appear scientifically appropriate given the proposed audience(s) for the scientific outcomes from the center?

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.

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/priority score.
• Will receive a written critique.

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

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

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

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

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

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

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

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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

Not Applicable.

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

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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

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

Applicants are encouraged to contact the listed program official (Scientific/Research contact) regarding specific questions about scientific scope.

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]

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

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

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

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.