Part 1. Overview Information

Key Dates

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.

It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

The National Institutes of Health (NIH) seeks to advance its mission by maintaining strong, productive, and secure international research collaborations in support of the NIH mission. The NIH Collaborative International Research Project (PF5) is specifically designed to support funded international collaborations between a domestic (U.S.-based) prime organization and foreign organizations. As described in NOT-OD-25-104, this funding opportunity is structured to support collaborative projects such as those that had previously been awarded as domestic awards with one or more consortia/subawards to foreign organizations.

Each PF5 application should support research project(s) in a scientific area that represents the investigators' specific interests and competencies and that fall within the mission of participating NIH ICOs.

As further described in Section IV. Application and Submission Information, each PF5 application must include at a minimum the following components: Overall, Research Project, and International Project.

The Overall component should provide a broad overview of the proposed PF5 including the goals of the program, why an international collaboration is critical for addressing these goals, and how the project will be coordinated across international sites.

The Research Project component(s), led by the domestic applicant organization, should provide sufficient details of the significance, innovation, and approach of the project to allow an assessment of the scientific and technical merit.

The International Project component(s) should describe the scope of work, unique attributes, and contributions of the foreign organization(s). It is expected that the scope of the International Project supports the aims identified in the Overall and Research Project components. Should the PF5 project be selected for funding consideration, the International Project(s) will be disaggregated from the PF5 and assigned their own grant number (i.e., RF2 Linked International Research Project); therefore, it is critical that each International Project has a clearly described scope of work and demonstrated ability to manage the administrative aspects of an award. See Section V.2. Review and Selection Process for more information on the disaggregation process. 

In addition to the required components described above, the PF5 applicant has the option of including Core(s) and/or Institutional Career Development and Training components. These optional components are intended for international collaborations that will pursue complex activities such as NIH program projects (e.g., P01s), centers (e.g., P50), and institutional training programs (e.g., K12). Before utilizing these more complex structures, applicants are strongly encouraged to discuss their plans with their intended IC Program Officers. 

New applications must not include elements of resubmission or renewal including but not limited to progress reports or mention of a prior application or award history of the project.

This funding opportunity is specifically designed to support funded international collaborations between a domestic prime organization and foreign organizations. This NOFO should not be used for foreign consultants, purchasing unique equipment or supplies from foreign vendors, foreign collaborations that do not involve NIH funding, or any other foreign component that would not result in a foreign subaward. 

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

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

Higher Education Institutions - Includes all types

• 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

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

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

Foreign Organizations/International Collaborations

Non-domestic (non-U.S.) Entities (Foreign Organization) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

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

One or more International Project is required.

This funding opportunity is specifically designed to support funded international collaborations between a domestic prime organization and foreign organizations. This NOFO should not be used for projects in which the only international elements are foreign consultants, purchasing unique equipment or supplies from foreign vendors, foreign collaborations that do not involve NIH funding or any other foreign component that would not result in a foreign subaward.  

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.
  • 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.

International Project Organizations

Should the project be selected for funding, the International Project(s) will also be intended to fill the role as a recipient organization for the disaggregated award(s), and therefore must have all the necessary registrations completed, as listed above, at just-in-time. The foreign organization(s) are strongly encouraged to begin the registration process as soon as possible. Failure to complete registrations in a timely manner may delay funding if the project is selected for funding.

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.

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.

Project Leader (International Project)

Should an application be selected for funding, any foreign components with funding submitted under the International Project component type will be disaggregated from the main award and issued as a separate award. The Project Leader(s) of the International Project component type will be named the Program Director/Principal Investigator of the subsequent International Project award. Therefore, any individual named as a Project Leader of an International Project should also have the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) of the component and is invited to work with their organization to develop the application component. As with the foreign organization registrations listed above, prior to award, the project lead of the International Project must have a PD/PI Commons role affiliated with the foreign organization.

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.

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: required
• Research Projects: required; minimum 1 Research Project component must be added for the domestic applicant organization. Research Project components must be led by a domestic organization.
• International Projects: required; minimum 1 International component must be added. Add one International Project component for each foreign organization.
• Core: optional
• Institutional Career Development and Training (ICDT): optional

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)

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, with the additional instructions as noted.

Activities outside of the United States or Partnerships with international collaborators:

In Field 6, check "yes", and identify the countries of all foreign components, both monetary and non-monetary, participating in any component of the application.

In Field 12, Other Attachments, upload a pdf document file named "ForeignJustification_Overall" without quotations. Identify each foreign component, and specify whether it is monetary (i.e., an International Project), or non-monetary. For each component, describe special resources or characteristics of the research project (e.g., human subjects, animals, disease, equipment, and techniques), including the reasons why the facilities or other aspects of the proposed project are more appropriate than a domestic setting.

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.

If Project Leader(s) of International Project(s) are also considered to be multi-PD/PI(s) of the entire application, they may be listed in the Overall section, but their Biosketches should be uploaded to the applicable International Project component. 

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.

PHS Additional Indirect Costs Form (Overall)

The applicant organization (i.e., the domestic institution) should use the Additional Indirect Costs Form to detail its first $50,000 indirect (Facilities and Administrative [F&A]) costs on each subaward domestic organization that leads a component, in accordance with their Negotiated Indirect Cost Rate Agreement. The applicant organization cannot claim the first $50,000 indirect costs on an international organization that leads an International Project, as NIH will disaggregate that component to manage as an independent award. Each individual foreign award will receive 8% indirect costs, to support the cost of compliance.

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: All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: The Specific Aims of the Overall component should encompass the international collaborative project as a whole, including activities anticipated for both domestic and international performance sites.  

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

Within the Significance section, the relevance of the overall project to both domestic (U.S.) and global audiences should be identified. The applicant may choose to reference the Foreign Justification provided in the Research & Related Other Project Information form to highlight the unique resources, expertise, populations, and environments available through the international collaborations, and how they uniquely position the team to address the specific research questions posed.

Within the Approach section, the rationale and implementation of an international collaborative approach should be explained. Applicants are encouraged to address how this implementation aligns with NIH's Plan for Promoting Gold Standard Science, such as promoting the tenets of reproducibility (e.g., incorporating best practices for harmonizing data collection across all international sites) and collaboration (e.g., incorporating team science best practices). This section must include a clearly labeled dispute resolution plan.

Given the broad range of scientific areas covered by this Parent PF5 NOFO, it is anticipated that the size and scope of the international collaboration may vary considerably between applications. While the Research Strategy of the Overall section should provide sufficient details for reviewers to understand the purpose and general approach taken by the research team, the applicant may refer to the Research Strategy of the Research Project component(s) for technical details of specific experimental approaches proposed. For straightforward collaborative arrangements, it is anticipated that applicants may not need all 12 pages to describe their Overall Research Strategy.

Letters of Support: In each International Project component, a letter of support must be provided from an AOR of the foreign organization. Do not submit duplicate letters in the Overall component that have been provided in other sections.

Multiple PD/PI Leadership Plan: All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: Only include a Multiple PD/PI Leadership Plan if multiple individuals are intended to serve in a PD/PI role for the overall PF5 project. Although Project Leaders of International Projects will serve the role of the disaggregated RF2 award PD/PI, should the project be selected for funding, it is not a requirement that all International Project Leaders are also named as PD/PI(s) of the PF5 overall.

Consortium/Contractual Arrangements: Subawards to foreign (non-U.S.) organizations are not allowed. An International Project component must be used in lieu of a foreign subaward.

Other Plan(s): 

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

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.
  • The DMS Plan must be provided in the Overall component to address the data management and sharing needs of the project overall, as well as the roles and responsibilities for the applicant organization and all components. During the Just-in-Time process, DMS Plans for the disaggregated foreign awards may be requested. 

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.

Research Project

When preparing your application, use Component Type ‘Project.’

This NOFO requires at least 1 domestic Research Project component, led by the domestic applicant organization, but includes the flexibility for more than one Research Project components to accommodate complex, interdisciplinary research areas. It is highly recommended that any applicant considering more than 1 Research Project component confer with Program staff at the intended IC to ensure alignment with the IC's scientific priorities and available resources. 

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

SF424 (R&R) Cover (Research Project)

Complete only the following fields:

• Applicant Information
• 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.

Activities outside of the United States or Partnerships with international collaborators: Answer 'Yes' to Field 6 only if the Research Project includes foreign involvement distinct from what is included in the International Project(s) components, such as foreign consultants or foreign travel by U.S. members of the research team for the purpose of gathering data.

If Field 6 is 'Yes', a Foreign Justification must be uploaded in Field 12, Other Attachments, and the file name must include "ForeignJustification" without quotations (e.g., ForeignJustification_ResProj1.pdf). The Foreign Justification for the Research Project should only address the activities specific to the Research Project, and not duplicate the Foreign Justification provided in the International Project component(s). 

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 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.

The component budget must not include any subawards/consortium/contractual costs identified for foreign (non-U.S.) organizations. An International Project component must be included in lieu of a foreign subaward. However, this line may be used for consortium/contractual costs to domestic (U.S.-based) organizations.

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:  All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: List the broad, long-range objectives and goals of the proposed Research Project. Concisely and realistically describe the hypothesis or hypotheses to be tested. If multiple Research Projects are included, state the individual Research Project's relevance to the overall PF5 Project's aims and intended interactions with other Research Projects.

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

It is anticipated that the scope of the Research Project will include both domestic and international efforts. The Research Strategy should provide a comprehensive description of the Research Project's Significance, Innovation, and Approach, regardless of the location where the research is conducted. Where relevant, the applicant should identify the site(s) performing the proposed activities and clearly articulate how these activities come together to rigorously address the proposed hypotheses.

Other Plan(s):

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

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. 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 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 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 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.

International Project

When preparing your application, use Component Type ‘International Proj’ for each foreign organization that requests monetary support. Each International Project must correspond with a single foreign organization. 

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

SF424 (R&R) Cover (International Project)

Complete only the following fields:

• Applicant Information: For the International Project, this must be the foreign organization information, not the information for the Overall applicant.
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Foreign organizations leading International Projects are strongly encouraged to complete SAM.gov registration prior to applying. If SAM.gov registration is still pending at the time of application and a UEI is not available, under 'Applicant Information' the organization may list a temporary placeholder UEI that consists of a counting number and enough leading zeros to reach 12 digits. Note that at the time of submission, if multiple International Projects are led by foreign organizations missing UEIs, each organization should use a different placeholder UEI (e.g., 000000000001, 000000000002) to indicate unique organizations.

PHS 398 Cover Page Supplement (International Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (International 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.

Activities outside of the United States or Partnerships with international collaborators:

In Field 6, check "yes", and identify the country for this International Project only.

In Field 12, Other Attachments, upload a pdf document file named "ForeignJustification_[site]" without quotations, where "[site]" is a short descriptive name of the foreign organization or country. Describe the special resources or characteristics of the research project (e.g., human subjects, animals, disease, equipment, and techniques), including the reasons why the facilities or other aspects of the proposed project are more appropriate than a domestic setting. 

Project Narrative: Include a Project Narrative for the International Project. Follow the instructions in the Application Guide, focusing on the relevance of the research conducted within the International Project to public health.

Facilities & Other Resources: Applicants must include a Facilities & Other Resources section in the International Project component which highlights the scientific environment in which the work will be done. The section can include a description of logistical support available to address budgetary, regulatory, and other compliance concerns.  

Project /Performance Site Location(s) (International Project)

List all performance sites that apply to the specific international 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 (International Project)

ASSIST will default to “Project Lead” for the first individual listed. If you would like to use a different category, then replace “Project Lead” below with a different Category (e.g., Core Lead). 

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field. If selected for funding, the Project Lead will become the (Contact) PD/PI on the disaggregated award. 
• 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 affiliated with non-U.S. organization is listed in multiple components, the Biographical Sketch should be included in International Project component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (International Project)

Budget forms appropriate for the specific component will be included in the application package.

The foreign organization must enter a UEI on the budget form. If the foreign organization does not have a valid UEI at the time of the application submission, the same placeholder UEI that is listed on the 'SF 424 R&R-International Project' form should be listed on the corresponding budget form.

The International Project budget must not include any subawards/consortium/contractual costs identified for other foreign (non-U.S.) organizations. Subaward budgets to domestic (U.S.-based) organizations are allowed. 

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 (International Project)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims:  All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: List the long-range objectives and goals of the proposed International Project.

Given the broad range of scientific areas covered by this Parent PF5 NOFO, it is anticipated that the size and scope of International Projects may vary considerably between projects and even within a single PF5 application. The Specific Aims of an International Project may be contained within a subset of a Research Project's Specific Aims or be independent of the Research Project(s) but within the scope of the Overall Aims. The applicant should justify how the aims of each International Project support the Overall PF5 goal and integrate with the other components. 

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

The Significance section should address the significance of the contribution of the foreign organization to the overall collaborative team effort for this project.  

The Approach section should address the research approach taken by the foreign organization to address the scope of work described in the component's Specific Aims. The applicant should clearly articulate how the experimental and technical approaches undertaken by the foreign organization integrate with the overall goals of the PF5 project. 

Letters of Support: For each International Project component, a letter of support must be provided from an AOR of the foreign organization. The AOR must clearly indicate in the letter of support that they understand that, should the application be selected for funding, the foreign organization will fill the role as a recipient organization for the disaggregated award, and therefore will have all the necessary registrations completed, as listed above, prior to award.

Other Plan(s):

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

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. A Data Management and Sharing (DMS) Plan must be provided in the Overall Component. A DMS Plan for the International Project component that addresses data that is generated, managed, and shared from the International Project organization may be requested during the Just-in-Time process.

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 (International 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 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.

Core(s) (Optional)

When preparing your application, use Component Type ‘Core.’

The Core component is intended for activities and resources that are needed to support multiple coordinated research projects falling under the PF5, and thus should only be applicable to complex international collaborations similar to domestic program project grants or centers (e.g., P01, P50, U54). By organizing aims and activities through a Core component, the applicant should be able to identify opportunities to improve efficiencies, reduce costs, or identify synergies that would not be available through support of individual Research Project components. Examples of Cores include, but are not limited to: Administrative Core, Research Subjects Core, and Informatics and Data Management Core.

For the PF5 application, while a Core may support activities from all international collaborative partners, the Core itself must be based at a domestic organization and only request funds for domestic sites. Foreign organizations serving functions similar to cores should use the International Project component type instead.

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

SF424 (R&R) Cover (Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (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) (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 (Core)

ASSIST will default to “Project Lead”. If you would like to use a different category, then replace “Project Lead” below with a different Category (e.g., Core Lead).

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘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 affiliated with a domestic organization is listed in multiple components, the Biographical Sketch can be included in any one component.
• If a Senior/Key person affiliated with a non-U.S. organization is listed in multiple components, the Biographical Sketch should be included in International Project component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.   

Budget (Core)

The component budget must not include any subawards/consortium/contractual costs identified for foreign (non-U.S.) organizations. An International Project component must be included in lieu of a foreign subaward. However, this line may be used for consortium/contractual costs to domestic (U.S.-based) organizations.

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 (Core)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

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

Specific Aims: List the broad objectives and goals of the proposed Core. Identify the Core's relationship to the Overall Project goals and individual Research Projects.    

Research Strategy: Within the Significance section, the Core should clearly articulate which Research Projects and International Projects will be able to leverage the Core resources, expertise, and services.  The Core should make a clear case for its necessity as part of the Overall application, highlighting efficiencies, cost-savings, and synergies produced.

Within the Approach section, the Core should explain how it will be accessed by the other components of the PF5. If the international collaborators are intended to leverage the services, explain how the Core will facilitate international collaboration. If existing resources at the applicant institution or partner institutions have similar functions, articulate how this Core will provide distinct services and coordinate with existing resources as necessary to prevent unnecessary duplication.

Other Plan(s):

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

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. 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 the 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 (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.

Institutional Career Development and Training (ICDT) (Optional)

When preparing your application, use Component Type ‘Inst Career Dev.’

The ICDT component should only be used for applicants who are proposing biomedical research career and professional development training activities that support cohorts of scholars or trainees in connection with the research activities described in the Overall, Research Project, and International Project components. Similar programs for domestic-only applications include the K12, R25, or T15 activity codes, as well as career development cores on complex centers (e.g., CTSAs). The PF5 mechanism must NOT be used for National Research Service Award (NRSA) institutional training programs.

For the PF5 application, the ICDT component should support domestic activities, which may include domestic scholars (funded through their domestic institutions) engaging in research training activities with international partners, or domestic training activities (e.g., summer short courses) hosted at domestic institutions for international partners to attend. Career development and training activities intended to be supported through the collaborating foreign institutions should be supported through the International Project component type.  

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions, as noted. The ICDT component is both a multi-project mechanism and an institutional training mechanism. For form pages specific to institutional training (i.e., PHS 398 Training Program Plan Form), applicants are encouraged to refer to the Institutional Training (T) and Multi-project (M) special instructions in the Application Guide.

SF424 (R&R) Cover (ICDT)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (ICDT)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (ICDT)

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.

Application guide states that Project Narrative is required.  However it is only required for the Overall component.  If you would like the applicant to provide a project narrative for this component, update the above instructions accordingly. Specific names provided for Other Attachments must be no more than 50 characters including spaces.

Project /Performance Site Location(s) (ICDT)

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 (ICDT)

ASSIST will default to “Project Lead”. If you would like to use a different category, then replace “Project Lead” below with a different Category (e.g., Core Lead).

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘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 affiliated with a domestic institution is listed in multiple components, the Biographical Sketch can be included in any one component.
• If a Senior/Key person affiliated with a non-U.S. organization is listed in multiple components, the Biographical Sketch should be included in International Project component.
• Individuals who will only be serving in a mentor/preceptor role for this component should use the Participating Faculty Biosketches section on the PHS398 Research Training Program Plan form in lieu of being listed on the Research & Related Senior/Key Person Profile.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.   

Budget (ICDT)

Budget forms appropriate for the specific component will be included in the application package.

The ICDT component uses the SF424 R&R detailed budget form, rather than the PHS 398 Training Budget form.

The component budget must not include any subawards/consortium/contractual costs identified for other foreign (non-U.S.) organizations. An International Project component must be included in lieu of a foreign subaward. However, this line may be used for consortium/contractual costs to domestic (U.S.-based) organizations.

Costs requested must be well-justified and appropriate to the career stage of trainees. Applicants are encouraged to review current funding levels for NIH National Research Service Award Programs, or similar mechanisms, to identify reasonable estimates for training expenses. Budget justifications should clearly indicate if costs are determined on a per-trainee basis, and the expected number of trainees/scholars per budget period.

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 Training Program Plan (ICDT)

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

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Program Plan: The Proposed Training section should clearly identify why international collaboration is critical for the training program. The training should clearly align with the biomedical and health related research questions and challenges raised in the Overall section and any Research Project components.

Within the Program Administration section, the applicant should clearly describe how the leadership team of the ICDT component will coordinate with the Overall PF5 PD/PI and any other component leadership, including International Project Leader(s).

Within the Institutional Environment and Commitment to Training section, the applicant should address all the training performance sites supporting the described activities. The described institutional letter should reflect the commitment from any participating domestic institutions. For any foreign organizations participating in the program, they should provide an institutional Letter of Support within the International Project component for their institution.     

Plan for Instruction in the Responsible Conduct of Research: In addition to the instructions provided in the Application Guide, applicants should highlight any specific subject matter topics that are specifically relevant to the international collaboration proposed. For example, if the participating sites operate under different applicable laws and regulatory frameworks for the conduct of research, the applicant should address how this will be conveyed to the trainees.

Plan for Instruction in Methods for Enhancing Reproducibility: Applicants should follow the instructions provided in the Application Guide.

Participating Faculty Biosketches: Applicants should follow the instructions provided in the Application Guide.

Letters of Support: Applicants should follow the instructions for providing the Institutional Letter of Support for the participating domestic institutions. Any collaborating foreign institutions should provide the requisite information for their Letter of Support within the respective International Project section.

Data Tables: Applicants should be sure to use the International Programs version of the Training Tables. The applicant should describe their method for identifying the relevant cohort of international trainees in the Background Section of the Program Plan, such that reviewers will be able to assess the information provided in the Data Tables 1, 2, 5, and 8.

Other Plan(s):

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

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. 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 the 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 (ICDT)

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 

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, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address:

1) the protection of human subjects from research risks, and
2) inclusion (or exclusion) of individuals on the basis of sex, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, sex, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

Additional Review Criteria - Overall

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Study Timeline

Specific to applications involving clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Human Subjects Policies

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for inclusion. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research. 

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the American Veterinary Medicine Association (AVMA) Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions (as applicable), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

For Renewals (as applicable), the committee will consider the progress made in the last funding period.

Revisions

For Revisions (as applicable), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations - Overall

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

International Collaborations

Reviewers will assess whether the overall project and collaborative structure present special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Scored Review Criteria - Research Projects

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous?  If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?   

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?   

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?   

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?  Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address:

1) the protection of human subjects from research risks, and 

2) inclusion (or exclusion) of individuals on the basis of sex, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?     

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?   

Additional Review Criteria - Research Projects

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Human Subjects Policies

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for inclusion. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research.  Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application.  For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations - Research Projects

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Overall Impact - International Projects

Each International Project will be evaluated as “Recommended” or “Not Recommended” based on whether the component is essential for the proposed research and has the capability to achieve its proposed Aims.

Reviewers should evaluate the extent to which the International Project presents special opportunities for furthering NIH research programs through the use of unusual talent, resources, populations, or environmental conditions that are not readily available in the United States, or that augment existing U.S. resources.

Furthermore, reviewers should identify whether the International Project has the potential for significantly enhancing the health sciences in the United States.

Additionally, the reviewers should evaluate if the resources available at the lead international organization site are sufficient to accomplish the proposed scope of work, are adequately requested through the budget, or are otherwise described (e.g., through Letters of Support) in the International Project.

Overall Impact - Cores

Each Core will be evaluated as "Recommended" or "Not Recommended" based on whether the component is essential for the proposed research and has the capability to achieve its proposed Aims.

Overall Impact - ICDT

Reviewers will provide an overall impact score to reflect their assessment of the likelihood that the proposed training program will prepare individuals for successful, productive scientific research careers and thereby exert a sustained influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria - ICDT

Reviewers will consider each of the review criteria below in the determination of the merit of the training program and give a separate score for each. When applicable, the reviewers will consider relevant questions in the context of proposed short-term training. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

Institutional Career Development and Training Program and Environment

• Does the application provide a compelling rationale for the proposed career development program and propose appropriate training goals and objectives relevant to the rationale?
• Are the content and duration of any proposed didactic, career development, and research-related activities of the program appropriate to achieve the program’s goals and objectives? Do the program activities foster the development of scholar skill and expertise in transparent, rigorous, reproducible, and relevant research methodologies and tools applicable to the goals of the career development program?
• Are appropriate timelines indicated for scholar career progression and transition to independence? What is the likelihood that the career development plan will contribute significantly to the scientific development of the scholars?
• Is there an effective mechanism to monitor mentoring and to promote the development, retention and success of all scholars throughout their training?
• Does the environment have adequate and appropriate facilities to support the proposed career development program?
• Is the level of institutional commitment to the career development program, including administrative and research training support, sufficient to promote the success of the program?
• Is there sufficient assurance that the effort of the PD/PI, mentors and scholars will be devoted directly to the research, career development, and related activities?
• When applicable, is there adequate documentation describing the responsibilities of the advisory committee with regard to the provision of appropriate and helpful input and guidance to the program?
• If clinical trials may be proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed? Does the application adequately address the capability and ability to conduct the trial feasibility or ancillary study at the proposed site(s) or centers? If applicable, are there plans to add or drop enrollment centers, as needed, appropriate? If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial? If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

Career Development and Training Program Director(s)

• Does the ICDT Program Director(s) have the experience to develop, direct and administer the proposed program?
• Does the leadership team bring complementary and integrated expertise to the program? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure program objectives?
• Are the research qualifications, scientific stature, previous leadership and mentoring experience, and track record(s) appropriate for the proposed career development program?
• Are the ICDT Program Director(s) currently engaged in research relevant to the scientific area of the proposed program?
• If multiple Program Director(s) are proposed, is a strong justification provided that the multiple Director leadership approach will benefit the career development program and the scholars?
• Is a strong and compelling leadership approach evident, including the designated roles and responsibilities, governance, and organizational structure consistent with and justified by the aims of the career development program and the complementary expertise of the leadership team?
• If Clinical Trials are proposed, do the ICDT Program Director(s) have the expertise, experience, and ability to oversee the organization, management and implementation of the proposed clinical trial?
• Is there a clear explanation for how the ICDT Program Director(s) will coordinate with the Overall PF5 PD/PI(s) and Leaders of other proposed components including the International Project Leader(s)?

Mentors

• Do the mentors have appropriate expertise and experience, as well as track records of past mentoring and training?
• Are the quality and extent of the mentors’ roles in providing guidance and scientific advice to the scholars acceptable? Are the mentors currently engaged in relevant research?
• Is there a strong plan to ensure mentors receive appropriate training in the use of evidence-informed mentoring practices that promote the development of all scholars/trainees?
• If the program will support clinical trial research experience for the scholars/trainees, do the mentor(s) who will supervise the scholars/trainees have the expertise, experience, resources, and ability to provide appropriate guidance and help the scholars/trainees to meet the timelines?

International Scholars/Trainees

• Is there evidence of an adequate pool of potential scholars who could benefit from receiving training or career development support? As applicable, does the proposed program clearly outline a plan to recruit and develop junior investigators for successful careers as biomedical or clinical researchers?
• Is a recruitment plan proposed with strategies likely to identify candidates with the potential to strongly benefit from, and with proper support, succeed in the career development program?
• Are there well-defined and justified selection and re-appointment criteria?
• If the program will support clinical trial research experiences, do prospective Trainees/Scholars have the potential to organize, manage, and implement the proposed clinical trial, feasibility or ancillary study?
• Are there plans to provide instruction in data management and statistics, including those relevant to clinical trials, to the prospective trainees or scholars?

Training Record

• How successful are the trainees/scholars (or, for new applications, recent graduates in similar training) in completing the program?
• Does the application provide evidence that trainees/scholars (or, for new applications, other recent graduates in similar training) conducted rigorous research that advanced scientific knowledge and/or technologies with increasing self-direction (such as peer-reviewed publications and other accomplishments appropriate to the field)?
• How successful are the trainees/scholars (or, for new applications, recent graduates in similar training) in transitioning to appropriate careers in the biomedical research workforce that utilize their training and directly benefit the broader biomedical research enterprise?
• Does the program have a rigorous evaluation plan to assess the effectiveness of the career development program and the extent to which it is meeting its overall goals and objectives? Are effective mechanisms in place for obtaining feedback from current and former scholars, and appropriate plans to respond to feedback?

Additional Review Criteria - ICDT

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Inclusion Policies for Human Subjects

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Vertebrate Animals

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Biohazards

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Instruction in the Responsible Conduct of Research

All applications for support under this NOFO must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the specific characteristics of the training program, the level of trainee/scholar experience, and the particular circumstances of the trainees/scholars, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - Does the plan satisfactorily address the format of instruction, e.g., lectures, coursework and/or real-time discussion groups, including face-to-face interaction?  (A plan involving only on-line instruction is not acceptable.); 2) Subject Matter – Does the plan include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics? 3) Faculty Participation - Does the plan adequately describe how faculty will participate in the instruction?  For renewal applications, are all training faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period named in the application?  4) Duration of Instruction - Does the plan meet the minimum requirements for RCR, i.e., at least eight contact hours of instruction? 5) Frequency of Instruction – Does the plan meet the minimum requirements for RCR, i.e., at least once during each career stage (undergraduate, post-baccalaureate, predoctoral, postdoctoral, and faculty levels) and at a frequency of no less than once every four years?

For renewal applications, does the progress report document acceptable RCR instruction in the five components described above? Does the plan describe how participation in RCR instruction is being monitored? Are appropriate changes in the plan for RCR instruction proposed in response to feedback and in response to evolving issues related to responsible conduct of research?

Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee.

Instruction in Methods for Enhancing Reproducibility

Does the plan for Instruction in Methods for Enhancing Reproducibility describe how the program will provide training in scientific reasoning, rigorous research design, relevant experimental methods, consideration of relevant biological variables such as sex, authentication of key biological and/or chemical resources, quantitative approaches, and data analysis and interpretation, appropriate to field of study and the level and prior preparation of the trainees/scholars? 

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

 For Renewals, the committee will consider the progress made in the last funding period, including the Training in RCR. Has the program been successful in attracting individuals from a variety of backgrounds? Does the application describe the program’s accomplishments over the past funding period(s)? Is the program achieving its training objectives? Has the program evaluated the quality and effectiveness of the training experience (and when applicable, short-term training experience), and is there evidence that the evaluation outcomes and feedback from trainees have been acted upon? Are changes proposed that are likely to improve or strengthen the research training experience during the next project period (may not be applicable to short-term training)? Does the program continue to evolve and reflect changes in the research area in which the training occurs?

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific aspect of the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including (1) the Select Agent(s) to be used in the proposed research, (2) the registration status of all entities where Select Agent(s) will be used, (3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and (4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by CSR, in accordance with NIH peer review policies and practices, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Appeals of initial peer review will not be accepted for applications submitted in response to this NOFO.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Relevance of the International Project(s) to the mission and objectives of the ICO and the potential for significantly advancing the health sciences in the United States.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov.  NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

Disaggregation of Applications

This funding opportunity utilizes the PF5 mechanism for collaborative projects with funding for a foreign component. To better support federal oversight of activities, should an application be considered for funding, each International Project will be pulled out and assigned a unique grant number. The Project Leader of the International Project will be assigned the role of PD/PI for the linked International Project grant, and the lead foreign organization identified in the International Project will be assigned as the recipient for the linked International Project.

When considering a collaborative international project for award, NIH will consider the merits of the Overall project as well as the contributions of each linked component (domestic and international). NIH may request "just-in-time" information from both the applicant and the international project recipient(s) independently; furthermore, NIH may elect to fund all, some, or none of the disaggregated components of the application. 

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access their Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

Prior Approval of Pilot Projects

Recipient-selected projects that involve clinical trials or studies involving greater than minimal risk to human subjects require prior approval by NIH prior to initiation.

• The recipient institution will comply with the NIH Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval.
• The recipient institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

Dispute Resolution

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients of the domestic PF5 award and the disaggregated International Project(s) may be brought to Dispute Resolution. Prior to award, NIH will administratively review the dispute resolution plan provided within the Overall component. The implementation of a dispute resolution plan does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16. 

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

By applying for or accepting federal funds from HHS, recipients certify compliance with all federal antidiscrimination laws and these requirements and that complying with those laws is a material condition of receiving federal funding streams. Recipients are responsible for ensuring subrecipients, contractors, and partners also comply.

Applicants and recipients are strongly encouraged to refer to the NIH Director’s Statement of Priorities, entitled “Advancing NIH’s Mission Through a Unified Strategy.” 

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. Pursuant to 2 CFR 200.340, by accepting an NIH award, the recipient agrees that continued funding for the award is contingent upon the availability of appropriated funds, recipient satisfactory performance, compliance with the Terms and Conditions of the award, and may also otherwise be terminated, to the extent authorized by law, if the agency determines that the award no longer effectuates the program goals or agency priorities, in line with 2 CFR 200.340(a)(4).

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

1. ongoing and consistent access to HHS owned or operated information or operational technology systems; and
2. receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Recipients shall develop plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data. Please refer to NIH Post-Award Monitoring and Reporting for additional information. 

Not Applicable

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described. 

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

For disaggregated applications, each component assigned a unique grant number and Notice of Award will be expected to provide independent RPPR and financial statement reports. The annual RPPR for the disaggregated International Project(s) must include a letter of attestation from the domestic PF5 recipient Authorized Organization Representative (AOR) certifying that the progress of the International Project has been satisfactory to continue to receive funding. 

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk - Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues.

Grants.gov Support Center - Questions regarding Grants.gov registration and services (e.g., Workspace, subscriptions).

Participating NIH Institutes and Centers are listed in "Components of Participating Organizations" in Part 1. Overview. Scientific/Research Contact information is listed on PF5 Table of ICO Contacts website.

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Participating NIH Institutes and Centers are listed in "Components of Participating Organizations" in Part 1. Overview. Financial/Grants Management Contact information is listed on the PF5 Table of ICO Contacts website.

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.