With the new SBIR/STTR re-authorization of 2026, a number of requirements have either been added or strengthened to make sure U.S. taxpayer money is developing technology America can keep, including protection from IP theft by foreign malign actors, and that all work is being done in the U.S.   You can see a details on on the Foreign Disclosure and CyberSecurity questionniare page and also on the Accounting System questionnaire page.

Potential awardees who get a JIT (Just in Time) request for documentation are in the final stage of evaluation prior to funding.  The turn around time for JIT documents can be as short as 10 business days of this email receipt and response documents must be uploaded using the NIH eRA Commons Just-In-Time feature accessible at: https://public.era.nih.gov/commonsplus/home.era.*

Potential awardees who get a JIT (Just in Time) request for documentation are in the final stage of evaluation prior to funding.

 SBIR STTR Foreign Disclosure Form: For SBIR and STTR competing applications, applicants must submit the Required Disclosure of Foreign Affiliations or Relationships to Foreign Countries form. This form must be submitted in the “SBIR STTR Foreign Disclosure Form” section of the Just in Time (JIT) Screen in eRA Commons.

Here is a compiled list of forms, documents and certifications that you may be required to submit to NIH if you get a JIT email!  And remember, 10 business days!

SBIR Funding Agreement Certification: SBIR applicants must provide the SBIR Funding Agreement Certification. This certification should be submitted in the “Other Upload” section of the Just in Time (JIT) Screen in eRA Commons.

STTR Funding Agreement Certification: STTR applicants must provide the STTR Funding Agreement Certification. This certification should be submitted in the “Other Upload” section of the Just in Time (JIT) Screen in eRA Commons.

Venture Capital Operating Companies (VCOC) Certification: If the applicant is majority-owned by multiple VCOC, the VCOC Certification form is required. This certification should be submitted in the “Other Upload” section of the Just in Time (JIT) Screen in eRA Commons.

Financial Statements:  Please provide a copy of your most recent financial statements (balance sheet and income statement).  (VentureWrench Note – If you don’t have an actual accounting system, this can be a challenge!)

Evaluation of Financial Management Systems – Please complete the attached “Evaluation of Financial Management Systems” Questionnaire.

Shareholders:  Please provide a list of shareholders with percentage of their holdings, including institutional investors and venture capital investment companies.  (VentureWrench Note, do you have a Cap Table?)

Audit Report:  Please provide the date your last audit report was submitted, and/or the date your next audit report will be submitted.  For more information regarding non-federal audit requirements for commercial organizations, please visit: http://oamp.od.nih.gov/dfas/faq/for-profit-audits. (VentureWrench Note – If you don’t have an actual accounting system, this can be a challenge, however, supplemental documentation seems to imply that an audit is only required with over $750k in government awards – but make sure you know the details for your institute!)

Your FCOI Policy (Appliable to competing Phase II and fast-track awards):  The NIH funded recipients are required to submit their publicly accessible FCOI policy to NIH via the eRA Commons Institution Profile (IPF) Module (IPF Module).  Details of the requirement are described in the NIH Guide Notice NOT-0D-21-002.  NIH has made resources, including a “FCOI Policy Development Checklist,”  available on its Office of Extramural Research (OER), Financial Conflict of Interest Web site.

  • Current and Pending (Other) Support: Current and Pending (Other) support information is used to assess the capacity or any Conflicts of commitment that may impact the ability of the individual to carry out the research effort as proposed. The information also helps assess any potential scientific and budgetary overlap/ duplication with the project being proposed. Provide Current and Pending (Other) Support information for all individuals designated in an application as senior/key personnel. The Current and Pending (Other) Support Common Form must be completed using Science Experts Network Curriculum Vitae (SciENcv). Instructions for the Current and Pending (Other) Support Common Form are available on the NIH Forms Directory. See our FAQs for Additional resources. 

IMPORTANT REMINDERS:

    • Malign Foreign Talent Recruitment Program (MFTRP) Certifications:
      • Institutional Certification(s): Completed when the AOR/SO signs the face page of the application (i.e., SF424 R&R cover form), signs and submits the Research Performance Progress Report (RPPR) or submits materials via the Just-In-Time (JIT) Module or Prior Approval (PA) Module.
      • Individual Certification at Time of Application: Completed when the individual certifies and downloads their Biographical Sketch Common Form from SciENcv and attaches it on the R&R Senior/Key Person Profile (Expanded) Form.
      • Individual Annual Certification at time of RPPR: Completed when the individual provides a certification statement that is uploaded in Section G.1, Special Notice of Award and Funding Opportunity Announcement Reporting Requirements as a flattened PDF file. Alternatively, a certified Biographical Sketch Common Form or Current and Pending (Other) Support Common Form from SciENcv attached in Section D.1 Participants of the RPPR also meets this requirement.
    • Research Security Training (RST) Certifications:
      • Institutional Certification(s): Completed when the AOR/SO signs the face page of the application (i.e., SF424 R&R cover form), signs and submits the Research Performance Progress Report (RPPR) or submits materials via the Just-In-Time (JIT) Module or Prior Approval (PA) Module.
      • Individual Certification at Time of Application: Completed when the individual certifies and downloads their Biographical Sketch Common Form from SciENcv and attaches it on the R&R Senior/Key Person Profile (Expanded) Form.

Applicants and recipients must maintain supporting documentation to reasonably authenticate that the appropriate individual signed the form.  Recipients must make the documentation available upon request in accordance with 45 CFR Part 75.364.

  • Certifications:
    • IRB Approval: If the proposed project involves human subjects research, a certification to NIH that all non-exempt research involving human subjects has been reviewed and approved by an appropriate IRB must be submitted. Pending or expired approvals are not acceptable. See NIHGPS Section 4.1.15.2 Certification of IRB Approval for additional information. Note that NIH-funded sites in the United States cannot accept or rely on a non-U.S. IRB.
    • Name of the Single IRB (sIRB) of Record: Provide the name of the sIRB of record when required to use an sIRB. Note that NIH expects the NIH-funded domestic sites in a multi-site study to rely on a U.S. sIRB. This certification should be submitted in the “Other Files” section of the Just in Time (JIT) Screen in eRA Commons.
    • Human Subjects Education: If the proposed project involves human subjects research, certification that any investigator and key personnel involved in human subjects research has completed an education program in the protection of human subjects must be submitted.  See NIHGPS Section 4.1.15.5 Education in the Protection of Human Research Participants for additional information. This certification should be submitted in the “Human Subjects Education” section of the Just in Time (JIT) Screen in eRA Commons.
    • Tri-yearly Milestone Recruitment:  This NIMH policy monitors the recruitment of participants in NIMH-sponsored clinical research studies proposing to enroll 150 or more subjects per study, and all clinical trials, regardless of size.  Please refer to the automated Recruitment Milestone Reporting (RMR) system provided at:   http://www.nimh.nih.gov/rmr.  Contact your Program Officer if you have questions regarding this policy.
    • Human Embryonic Stem Cells (hESCs): If the proposed project involves hESCs and the applicant did not identify a hESC line from the NIH Human Embryonic Stem Cell Registry in the application, the line(s) should be included in the Just-in-Time submission. See NIHGPS Section 4.1.13 Human Stem Cell Research for additional information.
    • Institutional Certification for Human Genomic Data Sharing: If the proposed project involves a genomic data sharing plan for the generation of human genomic data, investigators must submit an Institutional Certification, or, in some cases, a Provisional Institutional Certification. Institutional certification forms and directions for completing them are available on the Institutional Certifications | Data Sharing website. This certification should be submitted in the “Genome Data Sharing Certification” section of the Just in Time (JIT) Screen in eRA Commons.

Timely submission of the requested information will enable NIH staff to expedite an award should an application be identified for funding.

All the information must be submitted electronically using the Just-In-Time (JIT) feature of the eRA Commons found in the Commons Status section. Unless otherwise specified, the NIH Format Attachment instructions should be followed. Please note materials can be submitted as they become available, and the system does not limit the number of JIT submissions. Additional submissions will be appended to the composite JIT report, with the latest version at the top of the report. Note that when submitting additional JIT information, it is only necessary to provide the new or updated information and to not resend what has already been previously submitted.

This is in reference to any requested updates or clarifications based on the merit review and is NOT submitted to JIT, but instead directly to the PO.  “Response to any scientific concerns raised in your application’s Summary Statement will need to be addressed in writing and handled directly with your Program Officer with a copy to the GMS identified below. Depending on the nature of your application and its review, you may receive an additional request for scientific information.”

As a note, the National Institute of Health (NIH) suggests four (lengthy) documents that provide information about the administration of NIH SBIR/STTR grants, including:

*If this applies to you, instructions may be found at:  https://era.nih.gov/erahelp/commons/default.htm#cshid=1033.

If you want advice and support as you build out your team, check out our StartupTherapy™ Resources and Help page!
Designer Investor Resources – Fundamentals of Raising Startup Capital is another summary page of great resources to help you if you are raising capital from investors.

Don’t forget, if you need more help, check out our online course, Develop a Winning SBIR Strategy, and don’t forget your free guide below!  It is truly unique in the industry, make sure to grab your copy!

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