PA-27-061-Full-Announcement.html

Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Office of The Director, National Institutes of Health (OD)

National Heart, Lung, and Blood Institute (NHLBI)

National Human Genome Research Institute (NHGRI)

National Institute on Aging (NIA)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute of Allergy and Infectious Diseases (NIAID)

National Institute on Drug Abuse (NIDA)

National Institute of Environmental Health Sciences (NIEHS)

National Institute on Minority Health and Health Disparities (NIMHD)

National Library of Medicine (NLM)

National Cancer Institute (NCI)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Research on Women's Health (ORWH)

Note: Not all NIH Institutes, Centers, and Offices (ICOs) participate in Announcements. Refer to NIH Institute, Center, and Office Grants & Funding Profiles for ICO-specific missions, interest areas, priorities, and funding considerations. ICOs that do not participate in this announcement will not consider applications for funding.

Funding Opportunity Title

NIH Research Program Projects (Parent P01 Clinical Trial Optional)

Activity Code

P01 Research Program Projects

Announcement Type

New

Related Notices

Funding Opportunity Number (FON)

PA-27-061

Companion Notice of Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)

93.393, 93.307, 93.879, 93.394, 93.395, 93.399, 93.396, 93.172, 93.233, 93.837, 93.838, 93.839, 93.840, 93.866, 93.273, 93.855, 93.279, 93.313, 93.113

Notice of Funding Opportunity Purpose

Through this Notice of Funding Opportunity (NOFO), the participating NIH Institutes, Centers, and Offices (ICOs) invite applications for the investigator-initiated Program Project (P01). A P01 supports a broadly based, multidisciplinary research program with a specific major scientific objective or theme. The proposed Program Projects are focused on the programmatic interests of one or more of the participating ICOs based on their scientific missions. A program project utilizes research projects with a common central scientific theme, an administrative core, and optional shared resource core(s) to accomplish ICOs' programmatic objectives.

Funding Opportunity Goal(s)

NIH's mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability.

The goals of the agency are:

In realizing these goals, the NIH provides leadership and direction to programs designed to improve the health of the Nation by conducting and supporting research:

Key Dates

Posted Date

October 14, 2026

Open Date (Earliest Submission Date)

October 20, 2026

The following table includes NIH standard due dates marked with an asterisk.

November 20, 2026

November 20, 2026

Not Applicable

July 2027

January 25, 2027 *

January 25, 2027 *

Not Applicable

December 2027

May 25, 2027 *

May 25, 2027 *

Not Applicable

April 2028

September 25, 2027 *

September 25, 2027 *

Not Applicable

July 2028

January 25, 2028 *

January 25, 2028 *

Not Applicable

December 2028

May 25, 2028 *

May 25, 2028 *

Not Applicable

April 2029

September 25, 2028 *

September 25, 2028 *

Not Applicable

July 2029

January 25, 2029 *

January 25, 2029 *

Not Applicable

December 2029

May 25, 2029 *

May 25, 2029 *

Not Applicable

April 2030

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.

Expiration Date

May 26, 2029

Due Dates for E.O. 12372

Not Applicable

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.

Table of Contents

Part 1. Overview Information Key Dates Part 2. Full Text of Announcement Section I. Notice of Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Specific Research Objectives Through this NOFO, NIH invites applications proposing multidisciplinary, coordinated research programs that represent the investigators' specific interests and competencies and that fall within the mission of the participating NIH Institutes Centers, and Offices (ICOs). The goal of the Program Project is to support an integrated, collaborative research program composed of interrelated projects that address a well-defined central research focus or objective. Individual research projects should be scientifically meritorious and contribute synergistically to the overall Program, providing added value through scientific integration and collaboration. Refer to NIH Institute, Center, and Office Grants & Funding Profiles for ICO-specific missions, interest areas, priorities, and funding considerations.

Synergy in Multi-project Applications This NOFO supports multi-project applications. In the context of a multi-project application, synergy entails cooperative interaction of multiple projects, teams, or resources to produce a combined effect greater than the sum of their separate parts for enhancement of scientific knowledge, ideas, and outcomes. 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. 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.

Applications Not Responsive to this NOFO The following types of studies are not responsive to this NOFO:

Applications that propose a clinical trial and only align with the mission of an IC that does not support clinical trials under this NOFO, including; National Heart, Lung, and Blood Institute (NHLBI)

Applications proposing such studies will be considered non-responsive and will not be reviewed or considered for funding.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

Funding Instrument

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

New

Renewal

Resubmission

Revision

The OER Glossary and the How to Apply - Application Guide provides details on these application types. Only those application types listed here are allowed for this NOFO.

Clinical Trial?

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.

Award Budget

Application budgets are not limited but need to reflect the actual needs of the proposed project.

Applicants are strongly encouraged to contact program officials prior to submitting any application and early in the application planning process. Refer to Large Complex Projects Funding Considerations and Contacts for ICO-specific funding information.

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is 5 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Local Governments

Federal Governments

Eligible Agencies of the Federal Government

U.S. Territory or Possession

Other

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

Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Organizations)

Foreign Organizations/International Collaborations

Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. See NIH Grants Policy Statement 16.8 Collaborative International Research Awards.

Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.

For foreign components, as defined in the NIH Grants Policy Statement, only unfunded international collaborations or foreign components, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors are allowed.

Required Registrations

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 reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

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

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. Obtaining an eRA Commons account can take up to 2 weeks.

All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply - Application Guide.

2. Cost Sharing This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2- Definitions of Terms.

3. Additional Information on Eligibility Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.

A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this NOFO. See the administrative office for instructions if planning to use an institutional system-to-system solution.

2. Content and Form of Application Submission It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed in this notice of funding opportunity to do otherwise (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts) 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.

Page Limitations All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.

Required

Required

Optional

Required

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in How to Apply- Application Guide and should be used for preparing a multi-component application.

Revision applications must include an Overall component and the components that are affected by the revision. Therefore, the component requirements listed below may not apply to the revision application.

The application should consist of the following components:

Overall Component 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) Complete entire form.

PHS 398 Cover Page Supplement (Overall) Follow standard instructions.

Research & Related Other Project Information (Overall) Follow standard instructions.

Project/Performance Site Locations (Overall) Enter primary site only.

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.

Budget (Overall) The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A PD/PI (whether designated as contact or not) must commit a minimum of 1.8 person-months per year to the award. For applications with multiple PDs/PIs, each PD/PI must commit 1.8 person months per year. The multiple PDs/PIs option is only for the Overall Program Leader(s). The NOFO does not support multiple Project/Core Leaders for individual Projects and Cores. If applicants (multi-PD/PI approach) lead multiple project components, the minimum level of effort is additive. This commitment for PD(s)/PI(s) cannot be reduced in later years of the award. Note that this is a minimum level of effort that should be increased as appropriate to meet the needs of the work.

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.

Research Strategy:

The overall Research Strategy section describes the significance and innovation of the Program Project, along with its approach, and should highlight the program's conceptual unity and synergy. It should include a description of the major research objectives and strategic plan, detailing how the proposed projects and shared scientific cores (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. Include the placement/contribution of each project and core(s) 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 Program involves clinical research, concisely describe overall plans for ensuring feasibility of recruiting sufficient participants from the proposed population(s) to achieve the stated objectives.

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.

Other Plan(s):

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:

A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format. Where the DMS Plan Format Page requires a "Yes or No" response, no additional narrative is allowed. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in How to Apply- Application Guide; any instructions provided here are in addition to the How to Apply - Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall) When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the How to Apply - Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.

PHS Assignment Request Form (Overall) All instructions in the How to Apply- Application Guide must be followed.

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

SF424 (R&R) Cover (Administrative Core) Complete only the following fields:

PHS 398 Cover Page Supplement (Administrative Core) Follow standard instructions.

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)

Budget (Administrative Core) Budget forms appropriate for the specific component will be included in the application package.

A Core Lead must commit a minimum of 1.2 person-months per year to the Administrative Core. This commitment cannot be reduced in later years of the award. Note that this is a minimum level of effort that should be increased as appropriate to meet the needs of the work.

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) Specific Aims: List in priority order, the broad, long-range objectives 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 component Research Projects and Core(s) in the application.

Research Strategy: The 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 ongoing research, management of day-to-day program activities, 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 ongoing research, management of day-to-day program activities, and management of contractual agreements. Describe communication and cooperation among program leaders and/or project investigators, plans for resolution of disputes, development of scientific meetings and allocation of funds as applicable.

Depending on the nature of the Program, the Core may include the use of (a) an external advisory council (EAC) that is charged to provide appropriate and objective advice and evaluation, as needed, to the PD/PI; and/or (b) an internal advisory council (IAC), to advise on decision-making, and priority setting process to support the activities of the Program. If applicable, describe the expertise and responsibilities of the potential External Advisory Committee members.

For new applications, do not contact, recruit, or name potential external advisory council members in the application, only describe the expertise and responsibilities needed for the potential external advisory council members.

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.

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Do not include a Data Management and Sharing (DMS) Plan within this Component. If a DMS Plan is required for this NOFO, it must be included within the Overall Component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Administrative Core) When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the How to Apply- Application Guide must be followed.

Delayed Onset Study Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.

Shared Resource Core(s) When preparing your application, use Component Type 'Core' All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Shared Resource Core(s)) Complete only the following fields:

PHS 398 Cover Page Supplement (Shared Resource Core(s)) Follow standard instructions.

Research & Related Other Project Information (Shared Resource 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. 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) (Shared Resource 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 (Shared Resource Core(s))

Budget (Shared Resource Core(s)) Budget forms appropriate for the specific component will be included in the application package.

A Shared Resource Core Lead must commit a minimum of 0.6 person months per year to the Core. This commitment cannot be reduced in later years of the award. Note that this is a minimum level of effort that should be increased as appropriate to meet the needs of the work. Applicants should justify minimum effort, based on the proposed activities of the Core 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 (Shared Resource Core(s)) Specific Aims: List in priority order, the broad, long-range objectives, and goals of the proposed Shared Resource Core(s). In addition, state the Shared Resource Core's relationship to the proposed Program goals and how it relates to the individual Research Projects and other Share Resource Core(s), if applicable, in the application. If proposed, the Shared Resource Core(s) must support at least two Research Projects.

Research Strategy: Describe the function of the Shared Resource Core (s) as a resource to the Program Project. Describe the facilities, techniques, and skills the Shared Resource Core will provide and the role of the Core Leader and each key participant. Explain why the inclusion of this Shared Resource Core is essential to one or more of the individual research Projects and to the entire Program. Provide justification for the essential nature of this Shared Resource Core for the Program. Address issues such as quality control, procedures for selecting projects that use the core, cost-effectiveness, and increased efficiency. Hypothesis-driven aims are not required for Scientific Cores. Research activities should only be conducted in the research projects.

Shared Resource Cores should not simply duplicate resources already available at the institution. If the Shared Resource Core augments an existing shared resource, describe how this Shared Resource Core augments or complements the existing resource.

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.

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Do not include a Data Management and Sharing (DMS) Plan within this Component. If a DMS Plan is required for this NOFO, it must be included within the Overall Component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Shared Resources Core(s)) When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the How to Apply- Application Guide must be followed.

Delayed Onset Study Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.

Research Projects When preparing your application, use Component Type 'Project' All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Research Projects) Complete only the following fields:

PHS 398 Cover Page Supplement (Research Projects) Follow standard instructions.

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 '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) (Research Projects) 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 Projects)

Budget (Research Projects) Budget forms appropriate for the specific component will be included in the application package.

A Project Lead must commit a minimum of 1.8 person-months per year to the project. This commitment cannot be reduced in later years of the award. Note that this is a minimum level of effort that should be increased as appropriate to meet the needs of the work.

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 Projects) Specific Aims: List the broad long-range objectives and goals of the proposed research project. Concisely and realistically describe the hypothesis or hypotheses to be tested. In addition, state the individual project's relationship to the Program's goals and how it is synergistic to other projects and relevant cores.

Research Strategy: The Research Strategy should be organized into sections on Significance, Innovation, and Approach. The Significance section should include discussion of how this project relates to overall program goals. State the significance of the research, indicating the project's relevance to the primary theme of the application. Describe how the proposed study is innovative, which may include innovative hypotheses (sis) and/or a study design and methods that are not by themselves innovative but address important questions or unmet needs. Explain the rationale for selecting the methods to accomplish the specific aims.

Each research project must interact with other research projects of the Program and also, interact with the Administrative Core and Shared Resource Core(s) (if proposed). Individual research projects should describe the interactions with other Research Projects and Core(s) of the Program and explain the expected impact of those interactions on the overall goals of the Program. However, the Research Strategy section should focus on the specific Project and not the potential synergy between this Project and the other projects and cores. Synergy should be discussed in the Overall Component.

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.

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Do not include a Data Management and Sharing (DMS) Plan within this Component. If a DMS Plan is required for this NOFO, it must be included within the Overall Component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Research Projects) When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the How to Apply- Application Guide must be followed.

Delayed Onset Study Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.

Foreign Organizations Foreign (non-U.S.) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the How to Apply - Application Guide.

3. Unique Entity Identifier and System for Award Management (SAM) See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times Part I. contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH's electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in How to Apply- Application Guide.

5. Intergovernmental Review (E.O. 12372) This initiative is not subject to intergovernmental review.

6. Funding Restrictions All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.

For information on how applications will be automatically assembled for review and funding consideration after submission, refer to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply - Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization's profile in the eRA Commons and for the System for Award Management. Additional information may be found in How to Apply - Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Mandatory Disclosure

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the…