NIH Application Development

Consult the funding opportunity announcement (FOA) for due date information. FOAs 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 FOA refer to NIH’s table for application due dates: Standard Due Dates. AIDS and AIDS-related applications have specific cycle due dates.

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 subcontracts/consortium investigators (senior/key persons) on externally led NIH projects. Both lead investigators and subrecipient 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)

Targeting due dates on or after January 25, 2022, the 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 are entered on NIH biographical sketches, and enable access to the NIH submission platform ASSIST.

Post-award, annual 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 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 Research Services.

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

Notify Research Services 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), applicants use the 'Forms Version H Series of ‘Research Instructions for NIH and Other PHS Agencies, SF424 (R&R) Application Packages’ instructions to complete the application.

The Forms H Application Instructions Series applies to applications submitted on/after January 25th, 2023.

Research Services 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 G Research Instructions.

• Western Research R21 Checklist
• Western Research R01 Checklist

As a non-domestic (non-U.S.) foreign entity, Western full applications and subcontract/consortium 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 $5000 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 external 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 are required in both competing applications and progress reports. Links to instructions, blank format pages, and sample biosketches have been included below. Try SciENcv, a tool supporting multiple research agencies, to help you develop your biosketch and automatically format it according to NIH requirements.

Resources

• Forms-H: biographical sketch instructions
• Non-fellowship biosketch template
• SAMPLE: Non-fellowship biosketch (pdf)
• FAQ – biographical sketch
• SciENcv: Is there a tool that can help me prepare my Biosketch in the NIH Format?

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

This requires an exchange of documents between the participating organizations’ Research Offices.

The applicant (lead) organization will request an administrative point of contact at the subrecipient’s central sponsored research office to facilitate the delivery of institutionally approved subrecipient documents, including an ‘intent to enter a consortium agreement’, two to four weeks prior to the NIH due date. Contact Research Services for assistance.

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 PD/PI 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.

When sending or receiving 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, contact Research Services and Research Contracts & Agreements if you are a Western subaward investigator on a successful NIH application. Research Contracts will work with the recipient (lead) entity to finalize a Consortium Agreement between institutions.

As always, please contact Research Services for assistance with subrecipient requests.