Notice Clarifying SBIR Direct-to-Phase II Eligibility Criteria

Notice Number: NOT-OD-16-052

Key Dates
Release Date:   January 12, 2016

Related Announcements
PAR-14-088    

Issued by
National Cancer Institute (NCI)
National Eye Institute (NEI)
National Heart, Lung, and Blood Institute (NHLBI)
National Human Genome Research Institute (NHGRI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute on Dental and Craniofacial Research (NIDCR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute on Drug Abuse (NIDA)
National Institute of General Medical Sciences (NIGMS)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute on Minority Health and Health Disparities (NIMHD)
National Center for Advancing Translational Sciences (NCATS)
Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs (ORIP)

Purpose

The purpose of this Notice is to clarify the types of applications which can be submitted to the National Institutes of Health Small Business Innovation Research (NIH SBIR) Direct-to-Phase II pilot funding opportunity announcement PAR-14-088. The NIH Direct-to-Phase II program will accept Phase II submissions regardless of the funding source for the Phase I-like proof of principle work on which the proposed Phase II research is based.

NIH strongly encourages small businesses to contact the appropriate Institute or Center early in their application planning process to ensure their technology is of priority to the Institute/Center.

Information regarding the funding opportunity submission information is changed as follows: 

Part 2. Section I. Funding Opportunity Description

The following text is deleted: 

The goal of this FOA is to enable a small business that has accomplished the objectives of a Phase I SBIR grant through non-SBIR funds to initiate the Phase II SBIR stage of development, without needing to perform more early stage, Phase-I-SBIR-type research.

This FOA will also not accept ‘regular’ Phase II submissions from SBCs that have received a Phase I SBIR or STTR award from NIH or any other agency that participates in the SBIR/STTR programs for projects for which applicants now seek follow-on research and development funding. 

The following text is added: 

The NIH Direct-to-Phase II program will accept Phase II submissions regardless of the funding source for the Phase I-like proof of principle work on which the proposed Phase II research is based, with the following exception: 

Small business concerns (SBCs) eligible to submit Phase II applications for projects that were supported with a Phase I SBIR or STTR award from NIH or any other agency are expected to submit the regular Phase II application through SBIR/STTR solicitations as "Renewal" applications based on the awarded Phase I SBIR or STTR project. Only one Phase II application may be awarded for a specific project supported by a Phase I award. NIH policies regarding overlapping applications still apply (NOT-OD-14-082). A Phase II awardee may receive one additional, sequential Phase II award (called the NIH Phase IIB) to continue the work of an initial Phase II award.  

All other aspects of these FOAs remain unchanged.

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

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