A ‘Direct-to-Phase II’ SBIR award is a Phase II award issued to a small business that did not receive a Phase I award for that research/research & development. Recent legislation has re-instated this SBIR Direct Phase II provision through Fiscal Year 2022 and NIH is re-implementing the SBIR Direct-to-Phase II program. The prior program had specific SBIR Direct-to-Phase II funding opportunity announcements (FOAs). These will not be needed now.
Effective October 1, 2018, NIH will implement the new final regulations of the Bayh-Dole Act. The new regulations will apply to all NIH new (including renewals) and continuation awards beginning on or after October 1, 2018. The Bayh-Dole Act permits funding to retain ownership of the inventions made under federally funded research grants or contract programs, while also giving the government a license to practice the Subject Invention. See NOT-OD-18-233.