NINDS Program Project Grant (P01 Clinical Trial Optional) - PAR-24-169

NINDS Program Project Grant (P01 Clinical Trial Optional) - PAR-24-169 is sponsored by National Institute of Neurological Disorders and Stroke (NINDS). This Notice of Funding Opportunity (NOFO) issued by the National Institute of Neurological Disorders and Stroke (NINDS) supports program project grant applications proposing innovative, interactive research to address significant scientific questions relevant to the NINDS missio…

Participating Organization(s) National Institutes of Health (NIH) Components of Participating Organizations National Institute of Neurological Disorders and Stroke (NINDS) Funding Opportunity Title NINDS Program Project Grant (P01 Clinical Trial Optional) P01 Research Program Projects * **August 31, 2022**- Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023.

See NoticeNOT-OD-22-198. * **August 5, 2022**- Implementation Details for the NIH Data Management and Sharing Policy. See NoticeNOT-OD-22-189.

Funding Opportunity Number (FON) Companion Notice of Funding Opportunity Assistance Listing Number(s) Notice of Funding Opportunity Purpose This notice of funding opportunity announcement (NOFO) is issued by the National Institute of Neurological Disorders and Stroke to enable submission of program project grant applications that propose conducting innovative, interactive research to answer significant scientific questions that are important for the mission of NINDS, via a synergistic collaboration between outstanding scientists who might not otherwise collaborate.

The program project grant is designed to support research in which the funding of several interdependent highly meritorious projects as a group offers significant scientific advantages over support of these same projects as individual research grants. 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.

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.

** The National Institute of Neurological Disorders and Stroke's program project grants (PPG) support investigator-initiated research programs, consisting of three or more highly interdependent projects, in which a team of investigators works in a clearly defined area of mutual scientific interest.

In a program project, there should be a unifying, well-defined goal or targeted area of research to which each project relates and contributes, thereby producing a synergistic and collaborative research environment that allows each research project to share the creative strengths of the others.

Programs should present a compelling case in support of interrelated projects and collaborating investigators will yield results beyond those achievable if each project were pursued separately and without formal interaction among the participating investigators.

The applicants should consider why the program project is required to achieve the proposed research goals, how reaching these goals may transform the field, and why the goals of the component projects cannot be achieved without significant contributions from the other components. Overall, the applicants should demonstrate a clear and compelling case that the component projects require one another and the shared core facilities.

In keeping with its tradition of strong support of investigator-initiated research, the NINDS expects the PPG director to define the integrating theme and to develop the approaches that would be used to accomplish the objectives of the proposed research program.

The theme of a program project could be, for example, basic research on regeneration and plasticity in the nervous system or basic and clinical research on a specific disease process; the unifying concept could be a hypothesis concerning the fundamental mechanisms that result in the clinical manifestations of the specific disease process.

Clinical trials of new interventions in patients are NOT appropriate for inclusion in a program project grant. Investigators who wish to conduct such trials should consult with the NINDS Office of Clinical Research (http://www. ninds.

nih. gov/research/clinical_research/index. htm.)

Additionally, investigators are strongly encouraged to contact NINDS Scientific/Research staff if they want to propose a PPG in a subject area that is already represented by existing multi-component Center or grant programs (e.g., P50 or U54 activity codes). Every component to be included in a PPG should be carefully considered. All projects that are included should be of the highest scientific and technical merit.

All cores should provide resources that are essential to success of the goals and synergistic nature of the PPG. The PPG director must be an established leader in scientific research with demonstrated capabilities in program direction. Regular meetings of participating investigators who share and evaluate results and new ideas are essential to the consolidation of the research projects into a cohesive program.

In summary, the following distinguishing features must be well documented in the program project application: There should be a clearly defined overarching goal or targeted area of research to which each component relates and makes essential contributions.

It is expected that support of this set of interrelated projects and collaborating investigators will yield results that would not be achievable if each project were pursued separately and without formal interaction and/or collaboration among the participating investigators.

The PPG director should possess recognized scientific and administrative excellence, must make a substantial commitment of time and effort to the program, and must exercise leadership in the maintenance of its quality. The anticipated duties and responsibilities of the PPG Director should be clearly defined and an appropriate level of effort proposed; A PPG must contain a minimum of three component research projects.

Each project should have significant and substantial scientific merit on its own as well as being an essential contributor to the central theme of the PPG. It should be evident that the synergistic and/or collaborative nature of the projects will help transform the field.

Program projects are expected to involve the participation of investigators in several disciplines (e.g., basic, translational, or clinical research) or investigators with special expertise in several areas of one discipline. All investigators should contribute to, and share in, the responsibilities of fulfilling the objectives of the PPG.

It is strongly recommended that potential applicants consult NINDS Scientific/Research staff about their anticipated budget very early in the planning stage and a minimum of 8 weeks before submission of an application is anticipated. This PAR encourages applications supporting diverse teams with members from broadly diverse backgrounds, including individuals from underrepresented groups (https://grants. nih.

gov/grants/guide/notice-files/NOT-OD-20-031. html). NINDS will only support applications to this NOFO that propose human mechanistic trials/studies that meet NIH's definition of a clinical trial.

A mechanistic study is designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention.

**Applications Not Responsive to this NOFO** The following types of clinical trials are not responsive to this NOFO and applications proposing such activities will be deemed non-responsive and will not be reviewed: * Clinical Trials designed to answer specific questions about safety, tolerability, efficacy and/or effectiveness of pharmacologic, behavioral, biologic, surgical, or device (invasive or non-invasive) interventions (e.g., phase I, phase II, phase III, or pivotal clinical trials).

Such designs should be submitted to an NINDS clinical trial-specific funding announcement (listed on the NINDS website at https://www. ninds. nih.

gov/Current-Research/Research-Funded-NINDS/Clinical-Research). Applicants are strongly advised to consult with NINDS Scientific/Research staff prior to submitting an application with human subjects to determine the appropriate funding opportunity. Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

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 Only 1 renewal is allowed. Optional: Accepting applications that either propose or do not propose clinical trial(s).

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. NINDS will rarely, if ever, accept an application requesting more than 1 million dollars in direct costs per year.

It is strongly recommended that potential applicants contact NINDS while they are still in the process of developing conceptual plans for a PPG and at least 8 weeks before submitting. After applicants have obtained agreement from the NINDS to accept the application, the PD/PI should include a cover letter with the application that identifies the NINDS staff member who agreed to accept assignment of the application.

The maximum project period for these awards is 5 years. As perNOT-NS-08-010, there is a 10 year limit on the total project period for all NINDS P01 grants including renewal. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Higher Education Institutions * Public/State Controlled Institutions of Higher Education * Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education: * Hispanic-serving Institutions * Historically Black Colleges and Universities (HBCUs) * Tribally Controlled Colleges and Universities (TCCUs) * Alaska Native and Native Hawaiian Serving Institutions * Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) Nonprofits Other Than Institutions of Higher Education * Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) * Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) * For-Profit Organizations (Other than Small Businesses) * City or Township Governments * Special District Governments * Indian/Native American Tribal Governments (Federally Recognized) * Indian/Native American Tribal Governments (Other than Federally Recognized) * 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. **Applicant organizations** 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 referenceNIH Grants Policy Statement Section 2. 3.

9. 2 Electronically Submitted Applicationsfor 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.

Individuals from diverse backgrounds, including individuals from underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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. 3. Additional Information on Eligibility 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. Instructions for the Submission of Multi-Component Applications The following section supplements the instructions found in How to Apply- Application Guideand 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. Therefore, the component requirements listed abovemay not apply to the revision application. 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:**Describe the specific aims for the Program Project as a whole.

**Research Strategy:**Describe the major themes of the overall Program Project, its goals and objectives, background information and the overall importance of the research to the theme of this program. Explain the strategy for achieving the goals defined for the overall program and how each Research Project and Core relate to that strategy.

Explain how the different aspects of the organization, including key personnel, will collaborate, coordinate and communicate, why they are essential to accomplishing the overall goal of the research, and how the combined resources create an overall program that is more than the sum of its parts. Include all necessary tables, graphs, figures, diagrams and charts in this section. In addition, provide the following information.

* History, Purpose, and Objectives of the Program * Discuss the overall P01 program's objectives and general plans for the proposed grant period, including research grant history with yearly funding level. * Every component citing and/or proposing preclinical research should ensure it meets the scientific rigor guidelines published by NINDS (seehttp://grants. nih.

gov/grants/guide/notice-files/NOT-NS-11-023. htmlandhttp://www. ninds.

nih. gov/funding/transparency_in_reporting_guidance. pdf).

Characteristics of any preliminary research results provided in support of a proposed project, whether conducted by the applicant or others, should be described in the application so that peer review may evaluate the strength of the supporting evidence. If preclinical data (e.g., animal studies) do not meet the rigor guidelines, the applicant should discuss the limitations of those data.

* Administration, Organization, and Operation * Include information on the support and commitment of the parent institution for the program, the authority of the PD/PI, the use of any proposed advisory committees, and space assignment. Describe organizational framework and provide an organizational chart. Describe how the composition of the leadership team is suited for performing the roles of the program .

If an internal advisory committee is being proposed, members should be named and their letters of agreement included. In new applications, the expertise to be represented on any external advisory committee should be described, but potential members of the committee should NOT be named and letters from such individuals should NOT be included. * Discuss the proposed research program, highlighting its central theme.

Describe the relationship between the projects and the Core units and their relationship to the central theme. Describe the composition of the investigator team and how their expertise is complementary and synergistic to meet the goals of the projects.

Applicants are encouraged to compose teams of scientists from broadly diverse backgrounds such as, for example, scientists from underrepresented groups (see NIH's Notice of Interest in Diversity). Please note that the race, ethnicity, or sex of PD/PIs, key personnel, or other research team members will not be considered during application review or when making funding decisions.

* Description of Assurances and Collaborative Agreements * Provide an overview and rationale for any collaborative and cooperative endeavors or subcontracts. **Letters of Support:** Attach letters of support relevant to the Program Project as a whole (e.g., letters of institutional support). Letters of support relevant to specific projects or cores should be attached in the relevant Project or Core research plans.

**Resource Sharing Plan**: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide. * 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.

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.

#### **Administrative Core** 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.

**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 for the Administrative Core. **Research Strategy:**Provide the following information: * Objectives of the Administrative Core * Staffing: Description of administrative, scientific, technical, and support staff. * Resources: Description of how Administrative Core resources will contribute to the objectives of the Research Projects.

* Services provided: Description of the services provided to other Cores and Research Projects. * Administration: Description of the strategies and processes that will be used to manage the P01 and achieve the overall goals. The Administrative Core will provide oversight for the Cores and Research Projects, and will promote coordination and collaboration within the program and with investigators and organizations outside the program.

The Research Strategy should describe the planning and coordination of research activities, the integration of cross-disciplinary research, allocation of funds, management of resources and quality control, the maintenance of ongoing communication, plans for conflict resolution, and plans for evaluation of the Program Project by internal or external advisory committees. Indicate who will be responsible for each of these activities.

Include tables or organizational charts, if appropriate. For new applications, include information on past activities or accomplishments relevant to the Administrative Core as a whole, without repeating information on individual biosketches. For renewal/revision applications, provide a Progress Report.

**Letters of Support:**Include Letters of Support specific to the Administrative Core **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 modification: * Do not include a Resource Sharing Plan for this Component.

Any resources to be developed under this component should be included with the Resource Sharing Plan for the Overall Component. 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. #### **Research Core(s)** 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 (Research Core(s))** Complete only the following fields: * Type of Applicant (optional) * Descriptive Title of Applicant’s Project * Proposed Project Start/Ending Dates **PHS Human Subjects and Clinical Trials Information (Research Core(s))** When involving NIH-defined human subjects research, clinical research, and/or 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. All instructions in the SF424 (R&R) Application Guide must be followed.

**PHS 398 Cover Page Supplement (Research Core(s))** Enter Human Embryonic Stem Cells in each relevant component. **Research & Related Other Project Information (Research Core(s))** **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. **Project /Performance Site Location(s) (Research Core(s))** 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 Core(s))** * 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 (Research Core(s))** 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 Core(s))** **Introduction to Application:** For Resubmission and Revision applications, an Introduction to Application is allowed for each component. **Specific Aims:**Describe the specific aims for the Research Core. **Research Strategy:**Provide the following information: * Objectives of the Research Core.

* Staffing: Brief description of scientific, technical, and support staff. * Resources: Description of how Research Core resources will contribute to the objectives of the Research Projects. A Research Core has to serve at least 2 or more Research Projects.

* Services provided: Description of current and projected services to other Core and Research Components, as well as the process for prioritizing requests for use of Core facilities by the various Research Projects. If a Core already exists, include a description of past services provided, new technologies developed, changes in protocols or Core administration, and other significant developments.

* Management: Description of overall management of the Core, decision-making process for use of Core services, and plans for cost-effectiveness and quality control. * Utilization of Core: Provide a summary of past and/or projected usage of Core services (e.g., assays performed, animals supplied, etc.). Include estimates of the percentage use of each Core unit by the affiliated Research Project component.

**Letters of Support:**Include Letters of Support specific to the Research Core. **Resource Sharing Plan:** Individuals are required to comply with the instructions for the Resource Sharing Plans. **Appendix:** .

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide. #### **Research Projects** When preparing your application in ASSIST, 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 Projects)** 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 Projects)** Enter Human Embryonic Stem Cells in each relevant component.

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

**Vertebrate Animals:** Answer only the