NIH Collaborative International Research Project (Parent PF5 Clinical Trial Optional)

NIH Collaborative International Research Project (Parent PF5 Clinical Trial Optional) is sponsored by National Center for Complementary and Integrative Health (NCCIH). Supports collaborative international research projects in complementary and integrative health, including clinical trials.

PA-26-002: NIH Collaborative International Research Project (Parent PF5 Clinical Trial Optional) Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations Office of The Director, National Institutes of Health ( OD ) National Eye Institute ( NEI ) National Heart, Lung, and Blood Institute ( NHLBI ) National Human Genome Research Institute ( NHGRI ) National Institute on Alcohol Abuse and Alcoholism ( NIAAA ) National Institute of Allergy and Infectious Diseases ( NIAID ) National Institute of Arthritis and Musculoskeletal and Skin Diseases ( NIAMS ) National Institute of Biomedical Imaging and Bioengineering ( NIBIB ) Eunice Kennedy Shriver National Institute of Child Health and Human Development ( NICHD ) National Institute on Deafness and Other Communication Disorders ( NIDCD ) National Institute of Dental and Craniofacial Research ( NIDCR ) National Institute of Diabetes and Digestive and Kidney Diseases ( NIDDK ) National Institute on Drug Abuse ( NIDA ) National Institute of Environmental Health Sciences ( NIEHS ) National Institute of General Medical Sciences ( NIGMS ) National Institute of Mental Health ( NIMH ) National Institute of Neurological Disorders and National Institute of Nursing Research ( NINR ) National Institute on Minority Health and Health Disparities ( NIMHD ) National Library of Medicine ( NLM ) National Center for Complementary and Integrative Health ( NCCIH ) National Center for Advancing Translational Sciences ( NCATS ) Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs ( ORIP ) Office of Strategic Coordination ( Common Fund ) National Cancer Institute ( NCI ) All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers.

The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Research on Women's Health ( ORWH ) INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE ( INCLUDE Project ) Office of Data Science Strategy ( ODSS ) Funding Opportunity Title NIH Collaborative International Research Project (Parent PF5 Clinical Trial Optional) PF5 Collaborative International Research Project Check for any recent Notices of NIH Policy Changes that may impact application requirements.

September 12, 2025 - New Application Structure for NIH-Funded International Collaborations. See Notice NOT-OD-25-155 . May 1, 2025 - Implementation of Updated NIH Policy on Foreign Subawards.

See Notice NOT-OD-25-104 . Funding Opportunity Number (FON) Companion Notice of Funding Opportunity See Section III. 3.

Additional Information on Eligibility . Assistance Listing Number(s) 93. 310, 93.

286, 93. 361, 93. 172, 93.

866, 93. 394, 93. 350, 93.

395, 93. 396, 93. 397, 93.

393, 93. 398, 93. 399, 93.

867, 93. 233, 93. 837, 93.

838, 93. 865, 93. 839, 93.

840, 93. 279, 93. 121, 93.

879, 93. 313, 93. 173, 93.

372, 93. 213, 93. 242, 93.

847, 93. 113, 93. 846, 93.

351, 93. 859, 93. 307, 93.

273, 93. 855, 93. 853 Notice of Funding Opportunity Purpose 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 (Parent Announcement) supports international research collaborations. This opportunity specifically implements an award structure of prime domestic awards with independent foreign awards that are linked to the prime. This structure provides NIH with oversight capacity for international collaborations, and allows NIH to track international funding, as identified in NOT-OD-25-104 .

This funding opportunity is specifically designed for NIH 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.

All collaborative international research project applications must include at least 1 international subproject. The proposed project must be related to the programmatic interests of one or more of the participating NIH Institutes, Centers and Offices (ICOs) based on their scientific missions.

The application will be evaluated as a whole, and the international subproject(s) will be evaluated on whether the project presents 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 United States resources, and whether the proposed project has specific relevance to the mission and objectives of the ICO and has the potential for significantly advancing the health sciences in the United States.

Funding Opportunity Goal(s) NIH’s mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability.

to foster fundamental creative discoveries, innovative research strategies, and their applications as a basis for ultimately protecting and improving health; to develop, maintain, and renew scientific human and physical resources that will ensure the Nation's capability to prevent disease; to expand the knowledge base in medical and associated sciences in order to enhance the Nation's economic well-being and ensure a continued high return on the public investment in research; and to exemplify and promote the highest level of scientific integrity, public accountability, and social responsibility in the conduct of science.

In realizing these goals, the NIH provides leadership and direction to programs designed to improve the health of the Nation by conducting and supporting research: in the causes, diagnosis, prevention, and cure of human diseases; in the processes of human growth and development; in the biological effects of environmental contaminants; in the understanding of mental, addictive and physical disorders; and in directing programs for the collection, dissemination, and exchange of information in medicine and health, including the development and support of medical libraries and the training of medical librarians and other health information specialists.

See the NIH Mission Statement and the NIH Director’s Statement of Priorities , entitled “Advancing NIH’s Mission Through a Unified Strategy. ” Open Date (Earliest Submission Date) The following table includes NIH standard due dates marked with an asterisk. Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. Required Application Instructions It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts ).

Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide , follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review. There are several options available to submit your application through Grants. gov to NIH and Department of Health and Human Services partners.

You must use one of these submission options to access the application forms for this opportunity. Use the NIH ASSIST system to prepare, submit and track your application online. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.

gov and eRA Commons to track your application. Check with your institutional officials regarding availability. Part 1.

Overview Information Part 2. Full Text of Announcement Section I. Notice of Funding Opportunity Description Section II.

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

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

Other Information Part 2. Full Text of Announcement Section I. Notice of Funding Opportunity Description 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 Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Application Types Allowed Renewal and Revisions applications are only allowed for PF5 awards. Resubmission applications are only allowed for PF5 applications.

The OER Glossary and the How to Apply - Application Guide provides details on these application types. Only those application types listed here are allowed for this NOFO. Optional: Accepting applications that either propose or do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Application budgets are not limited but need to reflect the actual needs of the proposed project.

The scope of the proposed project should determine the project period. Generally, the maximum project period is 5 years for non-clinical trial(s) and up to 7 years for clinical trial(s). 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 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 (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) Eligible Agencies of the Federal Government U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations 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 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.

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

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

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. 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 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.

All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed. Component Type for Submission Institutional Career Development and Training (ICDT) 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: 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.

Institutional Career Development and Training (ICDT): optional When preparing the application, use Component Type ‘Overall’. All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions, as noted.

SF424(R&R) Cover (Overall) PHS 398 Cover Page Supplement (Overall) Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component. Research & Related Other Project Information (Overall) Follow standard instructions, 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) 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.

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. 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. 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.

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.

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: 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