Learning Disabilities Innovation Hubs

Learning Disabilities Innovation Hubs is sponsored by National Institutes of Health (NIH), Department of Health and Human Services (DHHS). This program seeks applications to address nascent or understudied research topics and highly innovative and high-risk research topics and approaches related to learning disabilities impacting reading, writing, and mathematics, with a special focus on under-studied and under-rep…

Expired RFA-HD-22-005: Learning Disabilities Innovation Hubs (P20 Clinical Trial Optional) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information 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 Innovation Hubs (P20 Clinical Trial Optional) P20 - Research Program Projects and Centers - Exploratory Grants October 28, 2021 - Reminder: FORMS-G Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2022 - New Grant Application Instructions Now Available.

See Notice NOT-OD-22-018 . September 13, 2021 - Updates to the Non-Discrimination Legal Requirements for NIH Recipients. See Notice August 5, 2021 - New NIH "FORMS-G" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2022.

August 5, 2021 - Update: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements. See Notice NOT-OD-21-170 April 20, 2021 - Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel. See Notice NOT-OD-21-109 Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity See Section III.

3. Additional Information on Eligibility . Catalog of Federal Domestic Assistance (CFDA) Number(s) Funding Opportunity Purpose This funding opportunity announcement (FOA) invites exploratory grant applications, hereafter referred to as the Learning Disabilities Innovation Hubs or LD Hubs, addressing the etiology, manifestation, prevention and remediation of reading, writing and/or mathematics specific learning disorders (SLDs).

An LD Hub includes a single research project and a Leadership Core that support the goals and aims of the LD Hub.

This FOA seeks to serve as a catalyst to understand and address 1) the needs of diverse, under-represented populations in SLD research, 2) the role technology plays in improving or limiting the learning experiences of children with SLD, including the impact of remote learning on service delivery, family stress, and peer socialization, 3) investigate more complex behavioral phenotypes of learners in SLD research, 4) speed the maturation of nascent/novel, high-impact, high-risk SLD studies that advance research on SLDs and demonstrate potential to directly benefit the SLD community, policy or practice, and 5) provide project embedded, career enhancing research and professional development opportunities to support the next generation of SLD scientists.

This initiative provides opportunities to support planning and building of a body of research and corresponding intellectual infrastructure to enable P20 grantees to compete for large research and program project opportunities in the future.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 30 days prior to application receipt date Renewal / Resubmission / Revision (as allowed) All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. No late applications will be accepted for this Funding Opportunity Announcement.

Required Application Instructions It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide , except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced.

Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 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 Part 2. Full Text of Announcement Section I.

Funding Opportunity Description This Funding Opportunity Announcement (FOA) invites exploratory grant applications (referred to as LD Hubs) to address understudied research topics and highly innovative and high risk research topics and approaches related to specific learning disorders impacting reading, writing, and mathematics.

This program has a specific focus and requirement that projects address research topics of particular relevance and need for under-studied and under-represented populations. In line with these goals, applications in response to this FOA must address high public health impact research topics where there is limited data or where progress is limited and novel solutions are needed to improve public health outcomes.

Additionally, an equal focus and requirement involves enhancing data collection reflective of the diversity of learners in the U.S. Given the exploratory nature of this funding mechanism, NICHD expressly and strongly encourages research applications that involve high-risk, high reward science.

As such, it is understood that a high tolerance for risk with the potential promise of innovative solutions to meaningful public health problems is expected and responsive to this FOA. Given that this announcement encourages a high tolerance for risk, topics related to the most difficult research questions in the field are directly relevant and encouraged.

LD Hubs should provide opportunities for feasibility and exploratory research endeavors that utilize, or are informed by, transdisciplinary research perspectives with the explicit goal of competitively transitioning to larger research or program projects in the future.

The FOA integrates research topics that cut across various research portfolios within the Child Development and Behavior Branch (CDBB) of NICHD, specifically the Language, Bilingualism, and Biliteracy Program; Early Learning and School Readiness Program; Math & Science Cognition, Reasoning, & Learning - Development & Disorders Program; and Reading, Writing, and Related Learning Disabilities Program and provides formal opportunities to advance trans-disciplinary and crosscutting scientific topics and provide opportunities for project-embedded, career enhancing opportunities to support the next generation of scientists.

Pursuing lines of research inquiry directly responsive to this FOA may involve managing and mitigating various scientific risks. NICHD recognizes that lines of inquiry responsive to this FOA will likely, but not required to be, high or higher risk and expects projects proposed to emphasize innovative approaches to manage risk and address the project aims to benefit the scientific understanding of LD and individuals with LDs.

To advance the field, the LD Hubs are envisioned to serve as a conceptual hub to facilitate the development of the scientific research base and equally important corresponding resources to push the next generation of LD science and diverse cadre of scientists capable of conducting research forward.

This FOA recognizes that for many scientific topics there is a limited extant research base directly relevant to the research topic; there may be difficulties in identification, recruitment and retention of particular populations of interest; and methodological challenges have limited pursuit of many research questions of express relevance to this FOA.

To help address these challenges, this FOA encourages projects to leverage the existing evidence base of more rigorously specified and studied LDs and comorbidities. This will allow the field to better understand and address the needs of understudied populations of learners including those with complex behavioral phenotypes.

An express intent of this FOA is to provide opportunities for project-embedded research, professional development, and learning opportunities of a new cadre of early career investigators and build a research base on understudied topics and populations with SLDs in the areas of mathematics, reading and writing. The intent of the LD Hubs is to provide an opportunity to launch new directions and inquiries in SLD research.

LD Hubs are expected to build a research base sufficiently compelling to gain future funding support and advance the understanding of complex learning challenges. As such, the LD Hubs are conceptualized as a time-limited research support opportunity and may only be renewed for one additional 4 year period for a total of up to 8 years of support.

At the end of that time, investigators and projects should be sufficiently developed and prepared to transition to opportunities available through Centers programs such as the LDRC program or warrant independent support as an NIH investigator-initiated research project. Examples of LD Hub Research Topics Listed below are possible suggestions of the types of research topics for this FOA.

This list is not intended to be comprehensive; applicants should not feel confined to the examples listed below. Regardless of the topic, applicants must develop a creative, evidence-informed approach to inclusivity and diversity in the construction of project, construction of aims and approach to sample selection and recruitment. Responsive topics include, but are not limited to, those listed below.

Identify and model epigenetic indicators of response-to-intervention in math and reading Develop computational modeling approaches to test hypotheses of the relative emphasis of instructional elements, modeled over time, in order to guide the development of novel approaches to instruction in math, reading and writing Develop computational modeling approaches to connect behavioral and neurobiological data, with the goal of developing enhanced accounts of mechanisms involved in the development of specific learning disorders Develop novel approaches to enhance and speed acquisition and development of reading, math or writing for children and adolescents for learners with substantial learning challenges Identify novel approaches to improving literacy outcomes for transient (e.g., homeless) and other high-risk populations (e.g., incarcerated youth) Conduct longitudinal investigations of early precursors beyond approximate number acuity of math learning and learning disabilities in children 0-4 years of age.

Identify and elucidate the nature of risk factors for learning disabilities sensitive to differences across developmental period and population Examine the manifestation and possible intervention approaches for learners with mathematics, writing, or comorbid reading disabilities using systems science approaches.

Develop new intervention and service delivery models for addressing the English and/or math literacy needs of low-literate or developmental, young adult learners that are based on current mechanistic evidence for intervention efficacy in specific subgroup populations (e.g., younger English Language Learners, younger persons with IDD).

Develop and assess new intervention and service delivery models to comprehensively address the oral language, preliteracy, and early math learning of children birth to age eight for underserved, at-risk populations.

Investigate the prevalence of and potential etiologic role of comorbid anxiety disorders in LD (e.g., math anxiety in math learning disability) and/or develop and assess targeted interventions for persons with comorbid anxiety disorder(s) and LD Identify normative early life exposure to and spontaneous production of comparative (e.g., more than, shorter than, equally) and numeracy-related language and its relationship to early numeracy skills (e.g., Approximate Number acuity, acquisition of the principle of cardinality, object counting skills, etc.); identify the role of early exposure to numeracy-relevant language to the later development and/or refinement of numeracy and math skill.

Non-Responsive Applications: For all submissions, applications will be deemed non-responsive to this RFA if the application: Focuses on population(s) that do not substantially include individuals at risk for SLDs, diagnosed with one or more SLDS, and/or face significant and persistent learning challenges in reading, writing or mathematics Involves a primary research focus on co-occurring reading disabilities and ADHD Proposes a renewal that would extend a project beyond 8 years of support Primarily focusing on technology development or of examining the impact of a specific technology tool regardless of the population served Proposes research utilizing technology-based learning tools targeting primary and direct usage by children 3 and younger rather than targeting caregivers See Section VIII.

Other Information for award authorities and regulations. Section II. Award Information Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA. Optional: Accepting applications that either propose or do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards NICHD intends to commit $1,600,000 in FY 2022 to fund up to 3 awards. Application budgets are limited to $390,000 in direct costs per year, but need to reflect the actual needs of the proposed project.

The maximum project period is 4 years. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA. Section III.

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education: Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations (Other than Small Businesses) 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 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 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) 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 to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.

gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application. Grants.

gov Applicants must have an active 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.

Eligible Individuals (Program Director/Principal Investigator) 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. 3. Additional Information on Eligibility 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 ). Funding is limited to a total of eight years for this initiative.

Hence, funding for only one renewal is permitted for a specific grant. Section IV. Application and Submission Information 1.

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

2. Content and Form of Application Submission It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide , except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants. gov downloadable forms currently used with most NIH opportunities.

Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review. 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: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Component Type for Submission Instructions for the Submission of Multi-Component Applications The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application. When preparing your application, use Component Type Overall . All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424(R&R) Cover (Overall) PHS 398 Cover Page Supplement (Overall) Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component. Project/Performance Site Locations (Overall) A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research & Related Other Project Information (Overall) Follow standard instructions. 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. PHS 398 Research Plan (Overall) Specific Aims: Include Specific Aims for the LD Hub project overall. Describe the short- and long-term objectives and goals of the proposed LD Hub.

Include the objectives for the Research Project and the Leadership Core.

The Research Strategy section of the Overall Component serves to introduce the proposed LD Hub and its objectives, identify the focus or theme of research addressed in the proposed LD Hub, describe the project-embedded research, professional development, and learning opportunities for early career scholars to support their trajectories towards independent SLD research, the goals and planned activities for the Leadership Core and importantly, the synergy between the research and leadership core activities.

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

Given the strong focus historically on reading and ADHD in the Learning Disabilities Research Centers' program and via the R01 funding mechanism, applications with a primary focus on co-occurring reading disabilities and ADHD will be deemed non-responsive to this RFA: 1) Expanding representation/inclusion: Applicants must have a primary focus on a population of learners that have been historically under-represented in SLD research.

These learners must be at risk for SLDs, diagnosed with one or more SLDs and co-occurring condition(s) or face significant and sustained learning challenges resistant to intervention. The goal is to inform the nature and development of learning challenges for these children/young adults and to build a research base that informs service development and/or delivery for all learners.

For applicants claiming this focus, the application must include a justification of the selected population(s) proposed and how these population(s) constitute an under-represented population at risk for SLDs, diagnosed with one or more SLDs and co-occurring condition(s) or face significant and sustained learning challenges in mathematics, reading and/or writing.

Additionally, applicants need to explicitly describe and utilize innovative recruitment and/or methodological approaches to ensure adequate participant recruitment from groups historically under-represented in SLD research and rigor and reproducibility of the proposed research.

2) Pushing innovation: Applicants must propose innovative (potentially high risk), under-studied research topics involving either individuals at risk for SLDs, diagnosed with one or more SLDS, and/or face significant and persistent learning challenges in reading, writing or mathematics.

These projects may be wholly focused on at-risk or understudied populations; however, all projects must over-sample individuals from groups that have been historically under-represented in SLD research. Preference will be given to projects focused on individuals with complex behavioral phenotypes (e.g., multiple SLDs or SLD and co-occurring condition(s)).

Applications claiming this focus must provide evidence that the topic is understudied and provide justification for how the research topic and/or approach constitute an innovation. As these applications are expected to be higher risk, applicants should ensure an appropriate risk mitigation plan is included as part of the requirements outlined in the FOA for the Leadership Core.

3) Technology and learning: Applicants must propose projects examining the use of technology by learners directly or instructor/caregiver led, including remote learning, for individuals at risk for SLDs, diagnosed with one or more SLDs and co-occurring condition(s) or face significant and sustained learning challenges.

Individuals pursuing this topic should be particularly sensitive to differences in IT infrastructure across schools, libraries, homes, etc. and to the extent possible utilize this variability as a natural experiment to inform and innovate learning solutions flexible enough to address individuals with diverse learning needs. This topic’s primary focus must be on generating generalizable results focused on mechanisms of learning.

Projects primarily focused on examining the efficacy of a specific IT learning solution are not within scope of this initiative. Applicants utilizing this topic may only propose research on technology-based learning for ages 4 and up if the project directly targets the child/young adult; alternatively, projects examining caregiver/instructor usage of technology-based learning tools does not have an age restriction.

All applications should provide an overview of the major themes of the overall project, its goals and objectives, background information and the overall importance of the research to the theme of this project, which must align to one (or more) of the FOA foci listed above. Explain the strategy for achieving the goals defined for the overall grant and how the single Research Project and single Leadership Core relate to that strategy.

Explain how the different aspects of the organization, including key personnel, will coordinate and communicate, why they are essential to accomplishing the overall goal of the research, how the combined resources create a synergistic, overall programmatic effort of integrated research and describe how the project-embedded, research experiences, professional development and learning activities support the next generation of LD scholars.

Include any necessary tables, graphs, figures, diagrams and charts in this section.

Additionally, provide the following information as part of the research strategy: All applicants must discuss the philosophy, objectives, and potential impact of the proposed Research Project and Leadership Core on specific learning disorders research and describe how they would build on resources and expertise of the applicant institution (and collaborative institutions), if applicable.

Provide background on recent advances, limitations, and overall impact on research in domains of relevance to the application and more broadly to the field of learning disabilities research. Letters of Support: Please include only letters that reflect support for overall activities of the entire LD Hub.

Resource Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide. NICHD Plans for Sharing Human and Non-Human Data and/or Biospecimens NICHD expects that data, biospecimens, and results of NICHD-funded research will be shared with the wider scientific community to the extent feasible and in a timely manner.

NIH Data Sharing Policy expects the timely release and sharing of data to be no later than the acceptance for publication of the main findings from the final dataset. All NICHD applications, regardless of the amount of direct costs requested for any one year, must include a Sharing Plan that addresses sharing of data as well as biospecimens, if applicable.

Ideally, this plan would include submitting data or biospecimens to an appropriate repository. These plans will also be considered by program staff as award decisions are being made as appropriate and consistent with achieving the goals of the program.

Specifically, for human data, the NICHD encourages the use of the Data and Specimen Hub (DASH), a centralized resource for researchers to store and access de-identified data from studies funded by NICHD. They can also submit information about the location and availability of biospecimens to DASH, if applicable.

Submission of data to the NICHD DASH is one way that grantees may meet the requirements of the NIH Data Sharing Policy and make study data available for secondary analyses. Information about DASH may be obtained at https://dash. nichd.

nih. gov/ . If use of DASH is not feasible, NICHD expects awardees to share data and/or biospecimens through other equivalent broad-sharing data and/or biospecimen repositories.

For projects generating large-scale human genetic data, applicants should provide a Provisional or Institutional Certification specifying whether the individual-level data can be shared through an NIH approved repository, such as dbGaP, in line with the NIH Genomic Data Sharing Policy ( https://grants. nih. gov/grants/guide/notice-files/NOT-OD-14-124.

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

PHS Human Subjects and Clinical Trials Information (Overall) When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions: If you answered Yes to the question Are Human Subjects Involved?

on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components.

To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components. Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the SF424 (R&R) Application Guide must be followed.

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

When preparing your application, use Component Type Research Project. All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Research Project) Complete only the following fields: Type of Applicant (optional) Descriptive Title of Applicant’s Project Proposed Project Start/Ending Dates PHS 398 Cover Page Supplement (Research Project) Enter Human Embryonic Stem Cells in each relevant component. Research & Related Other Project Information (Research Project) Human Subjects: Answer only the Are Human Subjects Involved?

and 'Is the Project Exempt from Federal regulations? questions. Vertebrate Animals: Answer only the Are Vertebrate Animals Used?

question. Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required.

However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components. Project /Performance Site Location(s) (Research Project) List all performance sites that apply to the specific component. Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Research Project) In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of