NICHD Resource Program Grants in Bioinformatics (P41 Clinical Trial Not Allowed)

NICHD Resource Program Grants in Bioinformatics (P41 Clinical Trial Not Allowed) is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH). This program supports the continued operation, enhancement, and broad dissemination of major bioinformatics resources critical to the research community using animal models of embryonic development.

Expired PAR-20-126: NICHD Biomedical Informatic Resource Centers Grants (P41 Clinical Trial Not Allowed) 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 ) of Participating Organizations Eunice Kennedy Shriver National Institute of Child Health and Human Development ( NICHD ) Funding Opportunity Title Program Grants in Bioinformatics (P41 Clinical Trial Not Allowed Biotechnology Resource Grants September 24, 2024 - This PAR has been reissued as PAR-24-301 .

Reminder: FORMS-H Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022 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 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 Additional Information on Eligibility .

Catalog of Federal Domestic Assistance (CFDA) Number(s) Funding Opportunity Purpose The purpose of this Funding Opportunity Announcement (FOA) is to support the continued operation, enhancement, and dissemination of unique database bioinformatics resources that are of major importance to the research community using animal models of embryonic developmental processes.

These grants will support ongoing development, maintenance, and enhancement of the resource, user training and services, provision of community-generated data storage and archiving, wide dissemination of the tools and/or resources, and establishment of interoperability with other NIH bioinformatics resources.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 30 days prior to the application due date The first standard application due date for this FOA is May 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 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.

AIDS Application Due Date(s) The first standard AIDS application due date for this FOA 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. New Date September 26, 2027 per issuance of PAR-24-301 .

(Original Expiration Date: May 8, 2023) 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 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 . the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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

Funding Opportunity Description Section II. Award Information Section IV. Application and Submission Section V.

Application Review Section VI. Award Administration Section VII. Agency Contacts Section VIII.

Other Information Full Text of Announcement Section I. Funding Opportunity Description The purpose of this Funding Opportunity Announcement (FOA) is to support the continued operation, enhancement, and dissemination of unique database bioinformatics resources that are of major importance to the research community using animal models of embryonic developmental processes.

These grants will support ongoing development, maintenance, and enhancement of the resources, user training and services, provision of community-generated data storage and archiving, wide dissemination of the tools and/or resource, and establishment of interoperability with other NIH bioinformatics resources.

The emergence and rapid evolution of high-resolution sequencing and other omics technologies have generated unprecedented quantities of molecular-level data from the analyses of biological systems. This rapid progress has been particularly significant in the areas of genomics and proteomics.

This exponential increase of information has been augmented by increased computing power to digitally record, store, and analyze large amounts of molecular data.

However, for the ever-increasing quantities of information to be maximally useful to biomedical scientists requires the establishment and maintenance of database resources that enable the compilation, annotation, storage, and dissemination of available data in compliance with the FAIR Data principles (Findable, Accessible, Interoperable, and Reusable).

Additionally, corresponding tools in bioinformatics for data analysis and entry, as well as technical support and user training are required to efficiently utilize these database resources.

These Resource Program Grants in Bioinformatics are intended to support the continued availability, operation, improvement and maintenance of databases, digital information, or bioinformatics tools and/or resources, user training and services, and wide dissemination of these tools or resources.

To qualify for support, bioinformatics resources such as software and algorithms, or knowledge resources must be of demonstrable value toward advancing research utilizing animal model systems in the biomedical sciences, and must also be of particular importance to those seeking to understand the biological basis of human and animal development and the etiology of structural The resources must be sufficiently mature to have verifiable support and utility for users within the developmental biology research community; operate according to FAIR data principles and have a demonstrable national and international impact.

Examples of activities that Resource Program Grants in Bioinformatics are intended to support include but are not limited to: Efforts to curate and annotate unique collections of data, information or knowledge that support learning and research utilizing animal Information and knowledge processing, including information extraction, integration of data from heterogeneous sources, event detection, and feature recognition within these data sets; Tools for analyzing large datasets, including genomic and proteomic data, data regarding gene and protein expression in relation to cellular, anatomical, and/or developmental coordinates; Data sets and tools for analysis of gene regulatory networks, protein-protein interaction networks, epigenetic regulatory mechanism, systems biological approaches, and other tools for understanding normal and abnormal biological function and/or development; Other unique data sets or information tools of demonstrable utility for biomedical research using animal models of developmental processes; Systems for knowledge representation, including vocabularies, ontologies, simulations and virtual reality, retrieval tools and intelligent agents for scientific information related to developmental processes.

in Bioinformatics are not intended to support: Research and development intended as proof of concept, to ascertain feasibility, or to underwrite the initial development of a tool or Projects that utilize a tool or database being supported through these resource program grants. Such projects should seek funding through customary NIH research grant mechanisms.

Tools and resources that duplicate activities of the National Library of Medicine or existing resources supported by other Institutes of the National Institutes of Health. Applicants who wish to undertake biomedical informatics research, to develop and test novel information technologies, or to perform feasibility or proof-of-concept studies, should respond to other FOAs.

Applicants are strongly encouraged to consult with the Scientific/Research Contact listed below in Section VII to ensure that the proposed project reflects the objectives of this FOA and the programmatic interests of the 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 Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed Not Allowed: Only accepting applications that do not determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Requested direct costs cannot exceed $1,750,000 per year, are expected to range from $500,000 to no more than $1,750,000 per year and need to reflect the actual needs of the proposed project.

The scope of the proposed project should determine the project period. The maximum project period is 5 years. described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from 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 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 Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Nonprofits without 501(c)(3) IRS Status (Other than Institutions 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 Eligible Agencies of the Federal Government U.S. Territory or Possession 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 Non-domestic (non-U.S.) Entities (Foreign Institutions) are Non-domestic (non-U.S.) components of U.S. Organizations are not eligible 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 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 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. 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.

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. must have an active DUNS number and SAM registration in order to complete the 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 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 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 A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) 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 ). Section IV. Application and Submission Information 1.

Requesting an Application 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 2.

Content and Form of Application Submission It is critical that applicants follow the Multi-Project (M) Instructions (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 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 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: Developmental Biology and Structural Variation Branch Kennedy Shriver National Institute of Child Health and Human Development Strategy/Program Plan Page Limits Additional page limits described in the SF424 Application Page Limits must be followed.

Instructions for the Submission of Multi-Component The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component Revision applications must include an Overall component and the components that are affected by the revision. Therefore, the component requirements listed below may not apply to the revision application.

The application should consist of the following components: Overall: required, min:1 max:1 Administrative Core: required, min:1 max:1 Curation: optional, min:0 max:2 Technical Development: optional, min:0 max:2 Computation: optional, min:0 max:2 Dissemination: optional, min:0 max:2 When preparing your application, use Component Type 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 Information (Overall) Follow standard instructions.

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 Research & Related Senior/Key Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the 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 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) Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing (DMS) Plan will be attached in the Other Plan(s) attachment of the Overall Component in FORMS-H and subsequent application forms packages.

For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages. All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan.

All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. The Data Management and Sharing (DMS) Plan must be provided in the Overall component. Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

overall goals of the Resource Program. The Specific Aims should not be identical to the specific aims of the other components but should be overarching and at a higher level.

Research Strategy: Describe the major purpose of the overall Resource Program, its goals and objectives, background information and the overall importance of the resource to the conduct of biomedical research and specifically its importance to the developmental biology community.

Explain the strategy for achieving the goals defined for the Resource Program and how the Administrative Core and each specific component relate to that strategy. Explain the overall strategy for making the resource integrable and interoperable with other NIH resources such as the Alliance for Describe the roles of the Key personnel in the organizational structure of the Resource Program.

Explain how any additional assets will be leveraged by the Resource Program. Explain how the different aspects of the organization, including key personnel will interact and why they are essential to accomplishing the overall goals of the Resource Program. Letters of Support: Include any letters of support for the P41 resource overall.

Letters of support for the individual components should be included with those components of the application. Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification: applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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. Record: PHS Human Subjects and Clinical Trials Information All instructions in the SF424 (R&R) Application Guide must be followed. Not Applicable.

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. Not Applicable.

PHS Assignment Request Form (Overall) All instructions in the SF424 (R&R) Application Guide must be followed. Not Applicable. When preparing your application, use Component Type Admin All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Administrative Complete only the following fields: Title of Applicant’s Project Project Start/Ending Dates PHS 398 Cover Page Supplement (Administrative Enter Human Embryonic Stem Cells in & Related Other Project Information (Administrative Core) Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal 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 Project /Performance Site Location(s) (Administrative Core) List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for Senior/Key Person Profile (Administrative Core) Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.

single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component. than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

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

PHS 398 Research Plan (Administrative to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component. Specific Aims: Describe the specific aims of the Administrative Core. Research Strategy: Explain the strategy for achieving the specific aims of the Administrative core.

The Administrative Core will be responsible for the management and administration of the overall Resource Program. This section of the application should describe the organization of the Administrative Core, the processes that will be used to manage the Resource Program, and its importance to the Resource Program.

The Administrative Core will also provide the coordination and communications with the other components of the Resource Program and promote coordination and collaboration within the Resource Program and with other similar resources and relevant organizations, such as the Alliance for Genome Resources.

When multiple performance sites are planned, the Administrative Core should include leadership and communication plans adequate to manage the Letters of Support: Include any letters of support specific to this component.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. Only limited items are allowed in the Appendix.

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

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

on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Record: PHS Human Subjects and Clinical Trials Information All instructions in the SF424 (R&R) Application Guide must be followed 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 When preparing your application, use Component Type Curation.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted. SF424 (R&R) Cover (Curation) Complete only the following fields: Title of Applicant’s Project Project Start/Ending Dates PHS 398 Cover Page Supplement (Curation) Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Curation) Subjects : Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Animals : Answer only the Are Vertebrate Animals Used? question. 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) (Curation) List all performance sites that apply to the specific component.

Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries . Research & Related Senior/Key Person Profile (Curation) In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.

In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component. Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.

If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used. Budget forms appropriate for the specific component will be included in the application package. R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries.

All other SF424 (R&R) PHS 398 Research Plan (Curation) Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component. the specific aims of the Curation component.

Strategy: This component is intended to include efforts to improve the quality of the information included within the Program or to provide for or facilitate the addition of information to the Resource Program.

These efforts might include, but are not limited to, efforts to: annotate data, convert data from incompatible formats, enter data manually from existing literature or other sources, exclude or correct inaccurate data entries, or generate data in order to supplement or fill gaps in existing data.

Describe strategies to support FAIR data principles as well as use of community standards for data and metadata, data identifiers, provenance of data, adequate infrastructure and Describe the strategy of the Curation component(s) in the same detail and format as expected for an investigator-initiated R01 grant application.

In addition, include a description of the relationship of the Curation component to the other components of the Resource Program and how the Curation component contributes to the overall goals of the Resource Program.

of Support: Include any letters of support specific to this Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. 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. When preparing your application, use Component Type Tech All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Technical Development) Complete only the following fields: Title of Applicant’s Project PHS 398 Cover Page Supplement (Technical Development) Enter Human Embryonic Stem Cells in each relevant component. Research & Related Other Project Information (Technical Subjects : Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations?

questions. Animals : Answer only the Are Vertebrate Animals Used? 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) (Technical Development) List all performance sites that apply to the specific component.

Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries . Research & Related Senior/Key Person Profile (Technical In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.

In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component. Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.

If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used. Budget (Technical Development) Budget forms appropriate for the specific component will be included in the application package. R&R Budget form included in many of the component types allows for up