Consult the Notice of Funding Opportunity (NOFO) for due date information. NOFOs supporting unsolicited project submissions note “standard dates apply”.

There are three (3) standard deadline cycles per year. Each cycle informs:

• the application due date;
• Scientific merit review;
• Advisory council round; and
• Earliest project start dates.

From submission to project start date the process may take approximately nine months.

Using the activity code specified in the title of the NOFO refer to NIH’s table for application due dates: Standard Due Dates.

AIDS and AIDS-related applications had specific cycle due dates, however, beginning with applications for Advisory Council Review in Jan. 2027 (i.e. application due dates on or after May 25, 2026), NIH will no longer accept applications submitted on dedicated AIDS application due dates (NOT-OD-26-029).

Note that solicited (request for application) grant opportunities will typically have a single deadline, specified in the announcement.

Researchers at Western can hold NIH funding as project directors/principal investigators (PD/PI) and co-investigators on Western led projects, and as International Research Project directors/principal investigators (PD/PI) on U.S. led NIH PF5 projects. All Senior/Key investigators require an eRA Commons account/registration and are subject to NIH policy and compliance.

• NIH presentation slides: Ready, Set, Submit

Investigator Registrations (Senior/Key Investigators and Trainees)

NIH, along with the Agency for Healthcare Research and Quality (AHRQ), the Food and Drug Administration (FDA), and the Office of Research and Development (ORD)/Department of Veterans Affairs (VA) require senior/key personnel* on research grant applications to have an eRA Commons ID.

Accounts result in eRA Commons credentials, which enable access to the NIH submission platform ASSIST and the Commons Forms platform SciENcv.

Post-award, Research Performance Progress Reports (RPPRs) require eRA Commons IDs for investigators, undergraduate, graduate student and/or postdoctoral scholars who contribute at least one person month to an NIH-funded project.

Only one eRA Commons account is required over a career. The account can be affiliated to multiple or new organizations, as the researcher changes/adds organization affiliations.

Contact the Office of Research Services:

• To initiate a first-time eRA Commons account;
• To affiliate an existing eRA Commons account to Western University; or
• If uncertain if there is an existing account affiliated to any organization.

Institution Registrations

Western University maintains the following Organization Registrations:

• Dun & Bradstreet (DUNS)/ Unique Entity Identifier (UEI);
• eRA Commons;
• System for Award Management (SAM);
• Grants.gov; and
• Commercial and Government Entity (CAGE).

For identifiers/numbers related to these registrations – as well as Western’s U.S. federal employer identification number (EIN), animal assurance number, and federal-wide assurance (FWA) number – please contact the Office of Research Services (researchoffice@uwo.ca). 

NIH applications are created and submitted using the ASSIST platform. The application consists of standardized online Forms and Attachments. The Office of Research Services (ORS) has real-time access to Western led applications and manages the final submission.

Notify ORS when a new application has been started in ASSIST. A grants officer will ensure the forms version is current.

Application Instructions

Unless otherwise specified in the funding announcement (FOA), for Due Dates ON/AFTER Jan. 25, 2025 applicants use the Forms Version I Series of ‘Research Instructions for NIH and Other PHS Agencies, SF424 (R&R) Application Packages’ instructions to complete the application.

Western Research maintains up-to-date application checklists for R01 (NIH Research Project Grant Program), and R21 (NIH Exploratory/Developmental Research Grant Award) activity codes. These checklists reference NIH’s Forms I Research Instructions.

• Western Research R21 Checklist (under development for Forms I)
• Western Research R01 Checklist (under development for Forms I)

As a non-domestic (non-U.S.) foreign entity, Western submissions require a research and related (R&R) budget form, as opposed to a modular budget. The R&R template contains a detailed budget request for each performance period (year) of the potential grant. The budget template contents are supported by a separate budget justification attachment.

Research Services offers guidance on how to complete the R&R budget form, including direction on:

• Effort/person month calculations;
• Investigator salary requests and NIH salary caps;
• Indirect/overhead costs; and
• Cost eligibility.

Indirect Costs (Facilities and Administration - F&A Costs)

Indirect costs are an eligible expense. Foreign entities, such as Western University, apply a standard 8% of modified total direct costs (MTDC), with the following exclusions:

• Exclusive of tuition and related fees;
• Direct expenditures for equipment (over $10,000 USD); and
• Subawards in excess of $25,000.

NIH policy provides for the exclusion of consortium/contractual F&A costs when determining if an applicant is in compliance with a direct cost limitation. This is a welcome policy when U.S. organizations with high F&A rates participate on Western applications.

Resources

• NIH details budget terms on their Develop Your Budget webpage
• NIH Presentation: Budget Building Blocks for Investigators (Oct. 2021)
• NIH Presentation: Partnering with International Research Organizations & the Process (Oct. 2021)
• Western University Human Resources – Researcher Toolbox
• Western University Research Finance – US Federal Award Requirements

A foreign justification attachment is required for Western led full applications. The attachment has no page limit and is uploaded to Field 12. ‘Other Attachments’ of the R. 200 – R&R Other Project Information Form. NIH asks Applicants to 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 (U.S.) setting.

The Foreign Justification must:

• Articulate how the application presents special opportunities for furthering research programs through the use of unusual talents, resources, populations, or environmental conditions not available in the U.S. or that augment existing U.S. resources.
• State how the project has specific relevance to the mission and objectives of the awarding IC and has the potential for significantly advancing the health sciences in the U.S.

Resources

• NIH Presentation: Partnering with International Research Organizations & the Process (Oct. 2021)
• NIH Application Submission Tips for International Applicants (2016)
• Information For Foreign Grants

Biosketches for Senior/Key Personnel are required in both competing applications and progress reports. Use of the Commons Forms for Biographical Sketch and the NIH Biographical Sketch Supplement is required for application due dates on or after January 25, 2026 (with some leniency granted under NOT-OD-26-033 until May 2026).

The Common Forms Biographical Sketch and Biographical Sketch Supplement must be prepared using SciENcv. This platform can be accessed with eRA Commons login credentials.

The Common Forms Biographical Sketch will require investigators to have an ORDID iD that has been previously linked to the investigator's eRA Commons Account.

Resources

• Instructions for Biographical Sketch Common Form (PDF)
• Common Forms for Biographical Sketch and Current and Pending (Other) Support Frequently Asked Questions (FAQs)
• Additional Tips about SciENcv in NOT-OD-26-018.

Have you been asked to participate on another organization’s NIH application/project, or will a Western University led NIH application include funded co-investigators at another institution?

Connect early with Western's ORS for guidance on eligible collaborative funding mechanisms and related administration.

Western University as a Collaborative International Research Project: Following the May 1, 2025 NIH Policy Notice NOT-OD-25-104: 'Updated NIH Policy on Foreign Subawards, foreign organizations' non-U.S. entities (i.e. Western University) can no longer participate on NIH applications as subaward/consortium organizations.  

Western University can participate as an International Research Project on Collaborative International Research Projects (PF5). PF5 projects must be submitted by an U.S. primary applicant organization and contain one or more international subprojects. The application is reviewed as a whole. If identified for funding consideration the International Project Components will be disaggregated, with each organization responding separately to Just-in-Time requests. If the project is selected for funding, each entity receives a separate Notice of Award/grant number.

The application will require early coordination between the partcipating organizations' Research Offices.

Western University led application with US-based subaward: NIH defines consortium contracts as formalized agreements whereby a research project is carried out by the recipient (lead) and one or more other organizations that are separate legal entities. Under the agreement, the recipient (lead) must perform a substantive role in the conduct of the planned research and not merely serve as a conduit of funds to another party or parties. These agreements typically involve a specific level of effort from the consortium organization's Investigator and a categorical breakdown of costs, such as personnel, supplies, and other allowable expenses, including F&A costs. The relationship between the recipient and the collaborating organizations is considered a subaward relationship.

NIH no longer funds applications with non U.S. subawards. UWO led NIH applications can only include subawards to U.S. entities.

When sending a subrecipient/consortium invitation, the communication should outline the following relevant information:

• NIH program announcement (i.e. PA-20-196);
• NIH application due date;
• Lead entity’s due date for subrecipient/consortium documents;
• Project title; and
• Period of performance (start date – end date).

The following subrecipient documents will be requested:

• Budget (R&R Budget Form);
• Budget justification;
• NIH-formatted biographical sketches for all key personnel from the site;
• Facilities and resources page for inclusion in proposal;
• Equipment page for inclusion in proposal;
• Letter(s) of support (from investigator on letterhead);
• Letter/statement-of-intent from the subrecipient institution to enter into a subaward agreement – signed by Western Research;
• Subrecipient commitment form (required for compliance with client risk assessment regulations) – signed by Western Research;
• Subrecipient statement of work, (specific to the work the entity will be performing on the project, i.e., will be used as statement of work to issue the Subaward)

Post-award, Research Contracts & Agreements will work with the US-based subrecipient entity to finalize a Consortium Agreement between institutions.

As always, please contact researchoffice@uwo.ca for assistance with subrecipient requests.