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 National Institute of Child Health and Human Development (NICHD), NIH. Supports the continued operation, maintenance, and dissemination of unique database bioinformatics resources important to the research community using animal models of embryonic developmental processes.

PAR-24-301: NICHD Resource Program Grants in Bioinformatics (P41 Clinical Trial Not Allowed) This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. 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 NICHD Resource Program Grants in Bioinformatics (P41 Clinical Trial Not Allowed) P41 Biotechnology Resource Grants March 31, 2025 - This funding opportunity was updated to align with agency priorities.

Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 .

August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198 . August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy.

See Notice NOT-OD-22-189 . Funding Opportunity Number (FON) Companion Notice of Funding Opportunity See Section III. 3.

Additional Information on Eligibility . Assistance Listing Number(s) Notice of Funding Opportunity Purpose The purpose of this Notice of Funding Opportunity (NOFO) is to support the continued operation, maintenance, and dissemination of unique knowledge, data, and/or bioinformatics resources that are of major importance to the research community using animal models of embryonic developmental processes.

These grants will support ongoing development and enhancement of the resources, user training and services, provision of community generated data storage and curation, wide dissemination of the tools and/or resources, and expansion of interoperability with other NIH bioinformatics resources. Open Date (Earliest Submission Date) The following table includes NIH standard due dates marked with an asterisk.

Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed All applications are due by 5:00 PM local time of applicant organization. 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.

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

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

There are several options available to submit your application through Grants. gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

Use the NIH ASSIST system to prepare, submit and track your application online. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants. gov and eRA Commons to track your application.

Check with your institutional officials regarding availability. Part 1. Overview Information Part 2.

Full Text of Announcement Section I. Notice of 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. Notice of Funding Opportunity Description The purpose of this Notice of Funding Opportunity (NOFO) is to support the continued operation, maintenance, and dissemination of unique knowledge, data, and/or bioinformatics resources that are of major importance to the research community using animal models of embryonic developmental processes.

These grants will support ongoing development and enhancement of the resources, user training and services, provision of community generated data storage and curation, wide dissemination of the tools and/or resources, and expansion 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, it is necessary to establish and maintain resources that enable the compilation, annotation, storage, and dissemination of available data integrated with existing and/or contextualizing information in compliance with the FAIR Data principles (Findable, Accessible, Interoperable, and Reusable).

Additionally, corresponding tools in bioinformatics for data input, curation, and analysis, as well as technical support and user training are required to efficiently utilize these knowledge and/or data resources.

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

To qualify for support, knowledge or bioinformatics resources, such as software and algorithms, 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 congenital anomalies.

The resources must be sufficiently mature to have verifiable support from 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 model systems Information and knowledge processing, including information extraction, integration of data from heterogeneous open access sources, event detection, and feature recognition within these datasets Tools for analyzing large datasets, including genomic and proteomic data, data regarding gene and protein expression, and elements that regulate that expression in relation to cellular, anatomical, and/or developmental coordinates Datasets and tools for analysis of gene regulatory networks, protein-protein interaction networks, epigenetic regulatory mechanisms, systems biological approaches, and other tools for understanding normal and abnormal biological function and/or development Other unique datasets or information tools of demonstrable utility for biomedical research using animal models of developmental processes Systems for knowledge representation, including simulations and virtual reality, retrieval tools and intelligent agents for scientific information related to developmental processes Utilization of appropriate data standards for the model organism community being served, such as controlled vocabularies and ontologies Resource Program Grants 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 resource 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 NOFOs.

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 NOFO and the programmatic interests of the NICHD. See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information Grant: A financial assistance 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 How to Apply - Application Guide provides details on these application types.

Only those application types listed here are allowed for this NOFO. Not Allowed: Only accepting applications that do not propose clinical trials. Need help 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. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III.

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education 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) 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 Organization) 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 How to Apply- 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.

3. 9. 2 Electronically Submitted Applications for additional information.

System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually . The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM. gov registration process.

The same UEI must be used for all registrations, as well as on the grant application. eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants. gov registration; all registrations must be in place by time of submission.

eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application. Grants. gov – Applicants must have an active SAM registration in order to complete the Grants.

gov registration. Program Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.

If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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.

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 How to Apply - Application Guide . This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1. 2- Definitions of Terms.

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 per NIH Grants Policy Statement Section 2.

3. 7. 4 Submission of Resubmission Application .

This means that the NIH will not accept: A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application. A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2. 3. 9.

4 Similar, Essentially Identical, or Identical Applications ). Section IV. Application and Submission Information 1.

Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this NOFO. See the administrative office for instructions if planning 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 How to Apply - Application Guide , except where instructed in this notice of funding opportunity to do otherwise and where instructions in the How to Apply - Application Guide are directly related to the Grants. gov downloadable forms currently used with most NIH opportunities.

Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review. All page limitations described in the How to Apply- 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 How to Apply- Application Guide and should be used for preparing a multi-component application. Revision applications must include an Overall component and the components that are affected by the revision. When preparing the application, use Component Type ‘Overall’.

All instructions in the How to Apply - 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. Research & Related Other Project Information (Overall) Follow standard instructions.

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 and Related Senior/Key Person Profile (Overall) Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this NOFO) for the entire application. A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover. A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall) Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component. Specific Aims: State the 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. The importance to the developmental biology community should be detailed and may include usage statistics or other metrics that provide evidence of community utility.

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 of Genome Resources . Describe the roles of the Key personnel in the organizational structure of the Resource Program.

Explain how any additional local resources or existing 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. Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide .

It is expected that portals, tools, workflows, and/or pipelines created or used with support from this NOFO will be well-documented and shared with the wider scientific community, in a timely manner that would enable other researchers to replicate and build on for future research efforts, aligned with the open-source regime used to distribute software, where possible.

In the Resource Sharing Plan, applicants should describe the anticipated timeline, formats, and methods of sharing software created under this NOFO (e.g. public GitHub links). Plans to share open-source software, including source code, use cases, and system design documentation should be specified where appropriate.

If commercial or proprietary resources will be used, provide a justification for this approach including a description of how requirements for data transparency and interoperability will be maintained.

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions: 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. Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in How to Apply- Application Guide ; any instructions provided here are in addition to the How to Apply - 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 How to Apply - 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 How to Apply - 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 How to Apply- Application Guide must be followed. PHS Assignment Request Form (Overall) All instructions in the How to Apply- Application Guide must be followed.

When preparing your application, use Component Type ‘Administrative Core’. All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Administrative Core) 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 (Administrative Core) Enter Human Embryonic Stem Cells in each relevant component. Research & Related Other Project Information (Administrative Core) Human Subjects: Answer only the ‘Are Human Subjects Involved?

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

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

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

Research & Related Senior/Key Person Profile (Administrative Core) In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field. In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.

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

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

PHS 398 Research Plan (Administrative Core) Introduction 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 of Genome Resources. The Administrative Core will assemble any advisory group(s) necessary and manage activities and communication for the group.

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

Follow all instructions for the How to Apply- Application Guide ; any instructions provided here are in addition to those in the How to Apply- 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 How to Apply- Application Guide, with the following additional instructions: If you answered “Yes” to the question “Are Human Subjects Involved?

” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record. Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the How to Apply- 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 How to Apply- Application Guide must be followed. When preparing your application, use Component Type ‘Curation'.

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted. SF424 (R&R) Cover (Curation) 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 (Curation) Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Curation) 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) (Curation) 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 (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. 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 (Curation) Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component. Specific Aims: Describe the specific aims of the Curation component.

Research 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, harmonize data to relevant data standards, convert data from incompatible formats, enter data manually from existing literature or other sources, apply quality control procedures, such as excluding or correcting 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 storage. 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. Letters of Support: Include any letters of support specific to this component. Only limited items are allowed in the Appendix.

Follow all instructions for the How to Apply- Application Guide ; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions. When preparing your application, use Component Type ‘Technical Development’. All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Technical Development) 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 (Technical Development) Enter Human Embryonic Stem Cells in each relevant component. Research & Related Other Project Information (Technical Development) 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) (Technical Development) 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 (Technical Development) 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