National Cancer Institute Program Project Applications (P01 Clinical Trial Optional)

National Cancer Institute Program Project Applications (P01 Clinical Trial Optional) is sponsored by National Cancer Institute (NCI). This program funds large-scale, multi-component cancer research programs addressing a common scientific theme.

Expired PAR-23-059: National Cancer Institute Program Project Applications for the Years 2023, 2024, and 2025 (P01 Clinical Trial Optional) This notice has expired. For NIH, in limited situations, applications may be accepted on a case-by-case basis for a short period after expiration to accommodate NIH late or continuous submission policies . Contact the eRA Service Desk for any submission issues.

Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Cancer Institute ( NCI ) Funding Opportunity Title National Cancer Institute Program Project Applications for the Years 2023, 2024, and 2025 (P01 Clinical Trial Optional) P01 Research Program Projects For due dates on or after May 25, 2023, use PAR-23-059 (this FOA).

/ For AIDS due date on May 7, 2023, use PAR-20-077 (previous FOA). Notices of Special Interest associated with this funding opportunity February 12, 2026 - Notice of Extension of the Expiration Date for PAR-23-059 "National Cancer Institute Program Project Applications for the Years 2023, 2024, and 2025 (P01 Clinical Trial Optional)".

See Notice NOT-CA-26-010 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-22-189 - Implementation Details for the NIH Data Management and Sharing Policy NOT-OD-22-195 - New NIH "FORMS-H" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2023 NOT-OD-22-198 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023 NOT-OD-23-012 - Reminder: FORMS-H Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity See Section III.

3. Additional Information on Eligibility . Assistance Listing Number(s) Funding Opportunity Purpose Through this Funding Opportunity Announcement (FOA), the National Cancer Institute (NCI) invites applications for investigator-initiated Program Project (P01) applications.

The proposed Program may address any of the broad areas of cancer research, including (but not limited to) cancer biology, cancer prevention, cancer diagnosis, cancer treatment, and cancer control. Basic, translational, clinical, and/or population-based studies in all of these research areas are appropriate. Each application submitted in response to this FOA must consist of at least three research projects and an Administrative Core.

The projects must share a common central theme, focus, and/or overall objective. Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 30 days prior to the application due date The following table includes NIH standard due dates marked with an asterisk.

Dates in bold and italics reflect changes per NOT-CA-26-010 New Renewal / Resubmission / Revision (as allowed) Scientific Merit Review Advisory Council Review Earliest Start Date May 25, 2023 * May 25, 2023 * November 2023 January 2024 April 2024 September 25, 2023 * September 25, 2023 * March 2024 May 2024 July 2024 January 25, 2024 * January 25, 2024 * July 2024 October 2024 December 2024 May 25, 2024 * May 25, 2024 * November 2024 January 2025 April 2025 September 25, 2024 * September 25, 2024 * March 2025 May 2025 July 2025 January 25, 2025 * January 25, 2025 * July 2025 October 2025 December 2025 May 25, 2025 * May 25, 2025 * November 2025 January 2026 April 2026 September 25, 2025 * September 25, 2025 * March 2026 May 2026 July 2026 January 25, 2026 * January 25, 2026 * July 2026 October 2026 December 2026 May 25, 2026 * May 25, 2026 * November 2026 January 2027 April 2027 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. NOTE: For May 7, 2023 AIDS applications date and October 2023 Advisory Council, the applicants must apply using PAR-20-077 - National Cancer Institute Program Project Applications (P01 Clinical Trial Optional). New Date May 26, 2026 per issuance of NOT-CA-26-010 .

(Original Expiration Date: May 08, 2026) Required Application Instructions It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide , except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced.

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

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

Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV.

Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII.

Agency Contacts Section VIII. Other Information Part 2. Full Text of Announcement Section I.

Funding Opportunity Description Through this Funding Opportunity Announcement (FOA), the National Cancer Institute (NCI) invites grant applications for investigator-initiated Program Projects (P01) in any area of cancer research. P01 grants support integrated, multi-project research programs involving a number of independent investigators who share knowledge and common resources while working towards a unifying overall scientific goal.

The NCI provides support for Program Projects in the belief that a collaborative research effort can accelerate the acquisition of knowledge more effectively than a simple aggregate of research projects that have no interaction or thematic integration. Therefore, every P01 Program Project proposed should have a well-defined unifying research theme.

Each Program Project application must include at least three projects and an Administrative Core. The individual projects may represent several disciplines and/or address several discrete research aspects pertinent to one or more disciplines. However, all the projects must be relevant to the common unifying central theme or focus, and the overall objective of the entire Program.

Each individual project should reflect a self-standing scientifically meritorious research effort. 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 separately.

Specific Research Objectives Through this FOA, the NCI invites multidisciplinary coordinated research programs in any of the broad areas of cancer research, including (but not limited to) studies of cancer biology, cancer prevention, cancer diagnosis, cancer treatment, and cancer control. Basic, translational, clinical, and/or population-based studies in all of these research areas are appropriate.

The objective of the Program Project is to support an integrated, collaborative research Program with a well-defined, central research focus or objective. Minimum Number of Research Projects (required): Each P01 application must include at least three related research projects. The projects must share a common central theme, focus, and/or overall objective.

Administrative Core (required): This core will provide the organizational and administrative management of the Program, plans for monitoring of progress, and plans for effective coordination and communication within the Program. Shared Resource Core(s) (optional): Applicants may propose one or more Shared Resource Cores if needed for the proposed research.

Each Shared Resource Core must provide support and enhance the productivity, cost-effectiveness, and/or research outcome of at least two of the proposed research projects. New cores may be proposed and/or existing institutional cores may be augmented to support the proposed research.

NOTE: For May 7, 2023 AIDS applications date and October 2023 Advisory Council, the applicants must apply using PAR-20-077 - National Cancer Institute Program Project Applications (P01 Clinical Trial Optional) See Section VIII. Other Information for award authorities and regulations.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs. Section II. Award Information Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

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

Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards 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. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Section III.

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education 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 Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are allowed. Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award.

All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

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 SF424 (R&R) Application Guide. The NCI encourages P01 applicants to take advantage of the multiple PD/PI option.

The use of this option allows, for example, the designation of any (or all) of the leaders of the individual projects or cores as a PD/PI of the overall 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 (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 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 FOA.

See your administrative office for instructions if you plan to use an institutional system-to-system solution. 2. Content and Form of Application Submission It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide , except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.

gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. By the date listed in Part 1.

Overview Information , prospective applicants are asked to submit a letter of intent that includes the following information: Descriptive title of proposed activity Name(s), address(es), and telephone number(s) of the PD(s)/PI(s) Names of other key personnel Participating institution(s) Number and title of this funding opportunity The letter of intent should be sent to: National Cancer Institute (NCI) All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Component Type for Submission The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA. Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

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: Administrative Core: required; maximum of 1 Research Projects: minimum of 3 required Shared Resources Core(s): optional When preparing your application, use Component Type Overall . All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424(R&R) Cover (Overall) PHS 398 Cover Page Supplement (Overall) Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component. 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 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 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: Describe the overall goals and specific aims of the Program Project as a whole, and describe the expected impact of the overall Program on one or more broad fields of cancer research. Research Strategy: The Overall research strategy should include: A.

Program Background and Statement of Objectives : Present the background, rationale, and hypotheses of the central scientific theme, including overall significance, innovation, approaches, and preliminary studies, considering that specifics for each project will be discussed in depth in the individual projects. B.

Integration and Coordination of the Program Project: Explain how the proposed projects and shared resource cores (if proposed) will be integrated, coordinated and will work together to address the overall goals and aims of the Program more effectively than if the projects were done independently.

Clearly describe which components will be interacting with each other, and the advantages or value added that may be realized by conducting the research as a Program Project rather than through separate research efforts. Specific examples of inter-project collaborations should be given, if possible.

Explain how information, reagents, personnel, equipment, etc., will be shared between the proposed projects and shared resource cores to create synergy within the Program.

For renewal (Type 2) applications, summarize the major achievements of the overall Program Project in the current funding perio d including evidence of productive collaborations, and provide justification for adding new projects or cores, or for deleting components previously supported. Letters of Support: Attach letters of support relevant to the Program as a whole (e.g., letters of institutional support).

Letters of support relevant to specific Projects or Cores should be attached to the relevant Project or Core components. Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the SF424 (R&R) 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 the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

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

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

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

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

When preparing your application in ASSIST, use Component Type Admin Core. All instructions in the SF424 (R&R) 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. The Administrative core should not involve Human Subjects research.

Vertebrate Animals: Answer only the 'Are Vertebrate Animals Used?' question. The Administrative Core should not involve Vertebrate Animal research.

Project Narrative: Briefly describe how the Administrative Core will help the Program meet the public health goals of the NCI. 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.

More than one investigator can be designated as Core Lead. 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 the Administrative Core. Specific Aims: Describe the specific aims of the Administrative Core.

Research Strategy: The Administrative Core Research Strategy should include: A. Clearly described plans for organizational and administrative management, including scientific and fiscal management of the overall Program, and plans 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.

If internal or external advisory groups are proposed, describe the role of each group in planning and evaluation processes. List the membership if the group(s) has already been established, and if the group has not yet been established, describe areas of expertise and the roles and responsibilities of the group(s). B.

Clearly describe Program Leadership, including examples of prior experience leading large research endeavors. Describe the chain of responsibility for decision making, and a succession plan should the need arise.

For renewal applications , include a Progress Report that discusses the accomplishments of the Administrative Core during the current funding period, and the rationale for significant changes that may have occurred during the current funding period. Letters of Support: Attach letters of support relevant to the Administrative Core. Appendix: 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. Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the SF424 (R&R) Application Guide must be followed.

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed. When preparing your application, use Component Type Project.

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

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

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question. Project Narrative: Briefly describe how the project meets the public health goals of the NCI.

Project /Performance Site Location(s) (Research Project) List all performance sites that apply to the specific component. Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Research Project) In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of 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 (Research Project) 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 (Research Project) Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component. Specific Aims: Outline the hypothesis (or hypotheses) to be tested, the long-range objectives and goals, and the specific aims of the proposed Project.

Research Strategy: Describe the research strategy of the Project in the same detail and format as required for an investigator-initiated R01 grant application. This section should focus on the significance, specific strategies, innovation, leadership, and environment. This section should focus on the specific Project and not the potential synergy between this Project and the other projects and cores.

For renewal applications , include a Progress Report that discusses the progress in this Project during the current funding period, and the rationale for significant changes that may have occurred during the prior funding period. Letters of Support: Attach letters of support relevant to the specific project. Appendix: 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 (Research Project) 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.

Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the SF424 (R&R) Application Guide must be followed Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed. When preparing your application in ASSIST, 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 (Shared Resources Cores) 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 (Shared Resources Cores) Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Shared Resources Cores) 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: Briefly describe how the Shared Resource Core will help the Program meet the public health goals of the NCI.