RFA-AI-16-009

The SBIR/STTR Programs have been reauthorized by the United States Congress with the SBIR/STTR Reauthorization Act of 2011 (P.L. 112-81).  One change that was made to the SBIR program in this reauthorization was the authority for certain participating federal agencies to ‘issue a Phase II award to a small business concern that did not receive a Phase I award for that research/research & development.  This is a so-called ‘Direct-to-Phase II’ SBIR award.  This authority would permit SBCs to submit Direct-to-Phase-II SBIR applications, if the small business had performed the Phase I stage-type of research through other funding sources.  The legislative rationale for permitting the Direct-to-Phase II  award is to allow a SBC that has already built a technology prototype  and tested its feasibility (i.e. completed Phase-I-type R&D) to move directly into a Phase-II-type R&D that tests the functional viability of the prototype according to scientific methods and potential for commercial development. The Direct-to-Phase-II SBIR mechanism eliminates the need for the SBCs to propose additional small feasibility studies, if the technology is ready for the Phase II stage of development.  The Direct-to-Phase II authority is not available to the STTR program.

The National Institutes of Allergy and Infectious Diseases (NIAID) Division of Intramural Research (DIR) is a component of NIAID, whose mission is to conduct and support basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. DIR scientists study all aspects of infectious diseases, including the causative agent, vectors, and pathogenesis in human and animal hosts. Clinical research also is integral to the DIR mission, enabling key laboratory discoveries to be rapidly translated into methods to prevent, diagnose, or treat disease.

The NIAID Technology Transfer and Intellectual Property Office (TTIPO) furthers this mission by fostering collaborations of NIAID scientists with partners in industry, academia, nonprofits, and other government agencies and facilitates the exchange of research materials and information.

The goal of this FOA is to move commercially-viable inventions for the development of novel treatment and prevention strategies from the NIAID intramural research laboratories into the marketplace. This FOA solicits Small Business Innovation Research (SBIR) grant applications from Small Business Concerns (SBCs) for projects that further develop and commercialize such inventions. Any project that fits within the NIAID mission described above that relies on the use of a NIAID intramural invention included in the list of NIAID intramural investigator inventions is eligible for this award.

This FOA applies to vaccine and treatment inventions originating from the NIAID intramural laboratories for which the US Government has various levels of patent protection for their use in treatment and prevention.  The inventions include:

• HIV anti-gp120 env vaccine as a therapeutic or HIV prevention vaccine,
• HPV virus-like particles as a vaccine delivery system and adjuvant,
• Malaria p47 protein for use as a vaccine or as product therapeutic antibodies,
• Methicillin-resistant Staphylococcus aureus (MRSA) phenol soluble proteins (PSM) for use as a vaccine immunogen,
• Norovirus (Norwalk) antibodies for treatment and prevention of virus disease,
• Strongyliodes (S. stercoralis) immunoreactive antigen (SsIR) for use as therapeutic or preventive vaccine,
• Use of the 10E8 broadly neutralizing antibody for HIV treatment and prevention,
• Methods to induce anti-HIV CD8 activity:
  • Methods for use of chimeric antigen receptor (CAR),
  • Methods for CD8 reactivation using PBMCs from AIDS-infected individuals,  
• Use of octameric anthrax protective antigen protein (PA) for treatment of cancers and infectious diseases.

For more details on these inventions, please see a list of eligible inventions.

Applications proposing human clinical trials will be considered non-responsive and will not be reviewed.

Applications that do not relate to the inventions listed above will be considered not responsive and will not be reviewed.  Applicants are strongly encouraged to contact the Scientific/Research Contact(s) prior to submitting any application.

For this FOA, it is expected that the treatment or prevention vaccine or drug product will have passed the proof of principle stage and demonstrated feasibility to support the Phase II application.  During the SBIR award period, an NIAID intramural investigator/inventor or laboratory may provide assistance in a collaborative manner by providing reagents and/or discussions. If collaboration with an intramural scientist/inventor is not applicable, the SBC should explain this in the SBIR application.

If selected for SBIR funding the SBC will be granted a royalty-free, non-exclusive, internal research-use license to the United States Government’s intellectual property for the eligible inventions from the NIAID intramural programs, with the intent that the SBC will develop the technology into a commercial product to benefit the public, consistent with NIAID's mission. The license will be for the term of award and within the field of use of the SBIR award.

For more information please check The Small Business Innovation Research -Technology Transfer (SBIR-TT) FAQs page.      

See Section VIII. Other Information for award authorities and regulations.