NIAID Investigator Initiated Program Project Applications

NIAID Investigator Initiated Program Project Applications is a grant from the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH) that funds integrated, multi-project research programs (P01) where independent investigators share common research goals and resources.

The program supports large-scale, coordinated research projects in infectious diseases, immunology, and allergy that would not be feasible through individual investigator awards. Eligible applicants include for-profit organizations, nonprofits, institutions of higher education, and state and local governments. Clinical trials are not allowed under this funding opportunity.

PAR-22-225: NIAID Investigator Initiated Program Project Applications (P01 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 ) of Participating Organizations National Institute of Allergy and Infectious Diseases ( NIAID ) Funding Opportunity Title NIAID Investigator Initiated Program Project Applications (P01 Clinical Trial Not Allowed) Research Program Projects September 2, 2025 - Notice of Additional Due Date for PAR-22-225 "NIAID Investigator Initiated Program Project Applications (P01 Clinical Trial Not Allowed)".

See Notice NOT-AI-25-041 . 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 04, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025.

See Notice NOT-OD-24-084 NOT-OD-23-012 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 Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity Additional Information on Eligibility .

Assistance Listing Number(s) Funding Opportunity Purpose This Funding Opportunity Announcement (FOA) invites submission of investigator-initiated Program Project (P01) applications.

The proposed programs should address scientific areas relevant to the NIAID mission including: biology and pathogenesis of infectious microbes, including HIV; host-microbe interactions; mechanisms regulating immune system development and function across the lifespan, and in response to infectious pathogens; immune dysfunction resulting in allergy, asthma, autoimmunity, immunodeficiency, or transplant rejection; and translational research to develop vaccines, therapeutics, and diagnostics to prevent and treat infectious and immune-mediated diseases.

Each P01 application submitted to this FOA must include at least two related, synergistic research projects that share a common central theme, focus, and/or overall objective; and an administrative core.

A P01 may include scientific cores, if needed for the Open Date (Earliest Submission Date) Letter of Intent Due Date(s) January 11, 2023; June 8, 2023; January 11, 2024; June 11, 2024; January 10, 2025; June 11, 2025, January 12, 2026 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. . AIDS Application Due Date(s) May 7, 2023; September 7, 2023; May 7, 2024; September 7, 2024; May 7, 2025; September 7, 2025, May 7, 2026 All applications are due by 5:00 PM local time of applicant organization.

All types of AIDS and AIDS-related 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.

Non-AIDS Applications: June 2023; October 2023; June 2024; October 2024; June 2025; October 2025, June 2026 AIDS Applications: June 2023; October 2023; June 2024; October 2024; June 2025; October 2025, June 2026 Non-AIDS Applications: October 2023; January 2024; October 2024; January 2025; October 2025; January 2026, October 2026 AIDS Applications: October 2023; January 2024; October 2024; January 2025; October 2025; January 2026, October 2026 Non-AIDS Applications: February 2024; March 2024; February 2025; March 2025; February 2026; March 2026, February 2027 AIDS Applications: February 2024; March 2024; February 2025; March 2025; February 2026; March 2026, February 2027 New Date May 8, 2026 per NOT-AI-25-041 (Prior Date September 8, 2025) 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. 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 the Announcement I. Funding Opportunity Description Section II.

Award Information Section III. Eligibility Information Section IV. Application and Submission Section V.

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

Other Information Full Text of Announcement Section I. Funding Opportunity The mission of the National Institute of Allergy and Infectious Diseases (NIAID) is to conduct and support basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases.

To accomplish its mission, NIAID conducts and supports a comprehensive portfolio of research on the biology and pathogenesis of microbes; host-microbe interactions; the mechanisms of normal immune system development and function across the lifespan, and/or in response to infectious pathogens; immune dysfunction resulting in allergy, asthma, autoimmunity, immunodeficiency, and transplant rejection; and translational research to develop vaccines, therapeutics, and diagnostics to prevent and treat infectious, immune-mediated, and allergic diseases that afflict people This Funding Opportunity Announcement (FOA) invites Program Project applications (P01) that address the mission of NIAID as outlined in the Background section above.

Investigators are encouraged to visit the NIAID website for additional information about the research mission and high-priority research The purpose of Program Project (P01) grants is to support integrated, multi-project research programs that have a well-defined, central research focus or objective. The P01 application must include a minimum of two individual research projects that contribute to the program objective.

Each individual research project should reflect a distinct, separate, scientifically meritorious research effort led by an independent investigator, the Project Leader.

In addition, the individual projects should be clearly interrelated and synergistic so that the research ideas, efforts, and outcomes of the program as a whole will offer a distinct advantage over pursuing the individual projects Clinical trials are NOT allowed and will not be reviewed or funded. However, projects and/or cores may include analyses of samples collected from independently funded clinical trials.

In addition to individual research projects, an administrative core is required.

The administrative core is responsible for the general organization and administrative management of the overall program, which includes ensuring lines of communication are effectively established and maintained, monitoring progress, and establishing the necessary infrastructure to support collaborative research and encourage optimal interactions and Applicants may propose one or more scientific cores if needed for the proposed research.

Each shared resource core must be utilized by two or more projects within the program. For renewals and resubmissions, new cores may be proposed and/or existing cores may be augmented or dropped to support the proposed research.

Applicants are encouraged to review NIAID s, Preparing Multiproject Research Applications tutorial for additional guidance on NIAID P01s, including the option to submit each research project simultaneously in Multi-project Applications This FOA supports multi-project applications.

In the context of a multi-project application, synergy entails enhancement of scientific knowledge, ideas, and outcomes obtained through the cooperative interactions of the individual projects and cores. The proposed merger of complementary skills, perspectives, and resources has the potential to produce outcomes greater than would otherwise be achieved.

The outcomes resulting from conducting the proposed research as a Program will exceed the outcomes from conducting separate research activities as a single project application. Synergy is defined as the sharing of data generated by the individual projects and cores that will inform the other project(s) such that the research is enhanced through this additional knowledge and/or the direction of science and research outcomes are changed.

Resources and tools that can help facilitate synergy include, but are not limited to sharing research data, samples, reagents, pathogens, human subject cohort(s), technologies, research approaches, data management/analytical tools, and model organisms. For more information, please see FAQ Link here: https://www. niaid.

nih. gov/grants-contracts/questions-answers-niaid-investigator-initiated-program-project-P01 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 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. Application budgets are not limited but 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. 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 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 Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of 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 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 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 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.

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.

Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants. gov registrations; 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.

Applicants must have an active 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.

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 Note that the multiple PDs/PIs option may only be used for the overall Program Leader. NIAID does not support multiple Project/Core Leaders for individual Projects and Cores within a multi-project application.

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 per 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 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 2. 3. 9.

4 Similar, Essentially Identical, or Identical Applications ). Section IV. Application and Submission Information 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 (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 Strategy/Program Plan Page Limits Core (use for Scientific Cores) Project (use for Research Projects) Additional page limits described in the SF424 Application Page Limits must be followed.

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.

The application should consist of the following components: Administrative Core: required; 1 Projects: required; minimum of 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 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 Senior/Key Person Profile (Overall) Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

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

The only budget information included in the Overall component is the Estimated Project Funding section of 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 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 applications, an Introduction to Application is required in goals of the research and summarize expected outcomes.

overall program section describes the significance and approach of the Program Project and should highlight the program's conceptual unity, innovation, and synergy. It should include a description of the major research objectives and (if proposed) will be coordinated and work together to address the overall goals and aims of the program more effectively than if the projects were conducted independently.

The synergistic nature of the proposed projects and shared scientific cores (if proposed) at the overall program level should be described, and include the placement/contribution of each project and core in the overall scheme.

The Program Project may include study design and methods that are not by themselves innovative but address innovative hypotheses or important questions and unmet needs, thus making the proposed study conceptually innovative.

A description of how the program as a whole will benefit from any unique cohorts and samples, collaborations, or resources should be included, as well as a summary of any special features in the environment and/or resources that make the overall program strong or unique.

If the applicant appoints an External Advisory Committee (EAC) (optional), the application must describe the expertise and responsibilities of the potential External Advisory Committee members. New applicants that include an optional EAC should not contact, recruit, or name potential members.

For a renewal application, applicants must provide the names of current and former members, but should not recruit or name new members in 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: All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

At the discretion of NIAID Scientific Staff, investigators funded under this FOA may be expected to share their data publicly through ImmPort or other public portals approved by NIAID. Therefore, the Data Sharing plan should include a summary of how the applicant will manage data submission and interactions with ImmPort or other public 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 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 All instructions in the SF424 (R&R) Application Guide must be followed.

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: Type of Applicant (optional) Descriptive Title of Applicant’s Project Proposed Project Start/Ending Dates PHS 398 Cover Page Supplement (Administrative Enter Human Embryonic Stem Cells in 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) 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 to Application: For Resubmission applications, an Introduction to Application is allowed for each component. Specific Aims: List in priority order, the broad, long-range objectives, tasks and goals of the proposed Administrative Core.

In addition, state the core’s relationship to the proposed Program’s goals and how it is related to the individual Research Projects and Cores in the application. institution and the Core Lead are responsible for the application and collaborative research activities. Explain the plans for organizational and administrative management of the overall program, and for coordination and communication within the program.

Explain the methods that will be used for monitoring progress in the projects and effective use of the shared resource cores. Explain the plans for internal quality control of on-going research, management of day-to-day program activities, management of contractual agreements (if applicable), and a plan for resolution of disputes.

Describe how the Core Lead’s administrative, management, and leadership capabilities adequately provide for: internal quality control of on-going research, management of day-to-day program activities, and management of contractual agreements.

Describe communication and cooperation among program leaders and/or program investigators, plans for resolution of disputes, development of scientific meetings and allocation of funds as applicable.

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

SF424 (R&R) Cover (Scientific 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 (Scientific Core) Enter Human Embryonic Stem Cells in each relevant component. Research & Related Other Project Information Human 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) (Scientific Core) List all performance sites that apply to the specific The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries. Research & Related Senior/Key Person Profile ASSIST will default to Project Lead . If you would like to use a different category, then replace Project Lead below with a different Category (e.g., Core Lead).

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 forms appropriate for the specific component will be included in the application package. 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) PHS 398 Research Plan (Scientific Core) to Application: For Resubmission applications, an Introduction to Application is allowed for each component. the Core’s relationship to the proposed Program’s goals and how it is related to the individual Research Projects and other Cores in the application. List in priority order, the tasks of the proposed Core.

Strategy: A scientific core is a resource for the entire program. The application should list the projects it will serve, services it will provide, and the applicable tasks. Each shared scientific core must be utilized by two or more projects within the program.

Research activities should only be conducted in the research projects; scientific cores perform services and tasks, not research activities. Describe the facilities, techniques, and skills the core will provide and the role of the Core Leader and each key participant.

Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) 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 PHS Human Subjects and Clinical Trials Information 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: PHS Human Subjects and Clinical Trials Information All instructions in the SF424 (R&R) Application Guide 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 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 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