Revised Process for SBIR/STTR Life Cycle Certifications

Notice Number: NOT-OD-19-025

Key Dates
Release Date: October 29, 2018

Related Announcements
None

Issued by
National Institutes of Health (NIH)

Purpose

The purpose of this Guide Notice is to announce to the Small Business Innovation Research and Small Business Technology Transfer (SBIR/STTR) extramural community that NIH is updating its policy to collect all Life Cycle Certification forms consistent with the SBIR and STTR Policy Directives. Effective January 1, 2019, NIH will require the submission of all SBIR/STTR Life Cycle Certification forms in each Interim and Final Research Performance Progress Report (I-RPPR and F-RPPR) submitted for SBIR/STTR grant awards. This update is also relevant for CDC and FDA SBIR awardees.

Background

The SBIR and STTR Policy Directives require that small businesses certify at certain milestones that they are meeting the program's requirements during the life cycle of the funding agreement.¬† The Life Cycle Certification is intended to ensure ongoing compliance of the awardee with the assurances it provided in the Funding Agreement Certification prior to award. SBIR and STTR awardees indicate compliance with these certification requirements included in the terms and conditions of award by drawing or requesting funds from the Payment Management System (PMS). 

NIH, CDC, and FDA did not previously require recipients to submit the actual certifications but rather complete and maintain them within their official files in accordance with the records retention policy in Section 8.4.2 of the NIH Grants Policy Statement.

Requirement

Effective January 1, 2019, NIH, CDC, and FDA will require SBIR/STTR grant recipients to submit the Life Cycle Certifications within the I-RPPR and the F-RPPR under Section G.1: Special Notice of Award and Funding Opportunity Announcement Reporting Requirements (insert link and refer to submission timeline of 120 days).

1) SBIR and STTR Award Recipients will continue to complete and maintain a Life Cycle ¬†¬†Certification(s) at certain milestones during the project period.  Life Cycle certification(s) are required at the following times:

  • For SBIR and STTR Phase I Awardees: At the time of receiving final payment or disbursement from the Payment Management System.
  • For SBIR and STTR Phase II Awardees: prior to receiving more than 50% of the total award amount and prior to final payment or disbursement from the Payment Management System (PMS).

While these milestones remain unchanged, NIH, CDC, and FDA are now also requiring recipients to submit certification(s) maintained on file directly to their awarding agency when the F-RPPR and I-RPPRs are due. The F-RPPR and I-RPPR must be submitted via eRA Commons no later than 120 calendar days from the period of performance end date. 

2) Life Cycle Certification forms must be uploaded directly to NIH, CDC, and FDA in the Final Research Performance Progress Report under Section G.1: Special Notice of Award and Funding Opportunity Announcement Reporting Requirements. SBIR/STTR recipients should not select the “Nothing to Report” box in this section.

3) I-RPPR or F-RPPR will not be accepted by NIH, CDC, and FDA unless all completed Life Cycle Certification(s) are received.  Failure to provide all required completed certification(s) may cause NIH to take one or more actions that may include, but are not limited to, corrective actions, withholding of further awards, suspension or termination.

This policy does not impact the SBIR Funding Agreement Certification required by all SBIR/STTR applicants for new or renewal grants that is required prior to award of a new award or a competing renewal award.

Resources

Life Cycle Certification forms are available for SBIR and STTR applicants and awardees in fillable format at: https://grants.nih.gov/grants/forms/manage_a_small_business_award.htm. Applicants and awardees are encouraged to carefully review each form prior to apply for or accepting an award.

Inquiries

Please direct all inquiries to:

NIH SBIR/STTR Program Office
Telephone: 301-435-2688
Email: sbir@od.nih.gov
Website: http://sbir.nih.gov

For technical questions about this requirement, contact:

Division of Grants Compliance and Oversight
Office of Policy for Extramural Research Administration, OER
Telephone: 301-435-0938
Email: GrantsCompliance@mail.nih.gov