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SBIR Technology Transfer (R43/R44)

Description:

The SBIR Technology Transfer (SBIR-TT) Funding Opportunity Announcement (FOA) is intended to help move commercially-viable technologies from the NIH Intramural Program to the marketplace. Small Business Concerns (SBCs) are encouraged to submit applications that further develop available technologies from the NIH Intramural Program and bring them to the commercial market. While universities can spin off companies, use incubator resources, and obtain funding from venture capital, the NIH intramural programs have no similar mechanism to develop technologies. If selected for SBIR funding, the SBC will be granted a royalty-free, non-exclusive patent license agreement for internal research use for the term of and within the field of use of the SBIR award to technologies held by NIH with the intent that the SBC will develop the invention into a commercial product to benefit the public. For a complete listing of NIH intramural technologies which are available, please see NIH Office of Technology Transfer at: http://www.ott.nih.gov/.

The NIH Intramural Research Program leverages the unique NIH research environment to perform interdisciplinary research from the bench to bedside. Investigators conduct basic, translational, and clinical research at NIH campuses across the country. As part of the project, an NIH intramural investigator may provide assistance in a collaborative manner by providing technology, reagents and/or discussions during the SBIR award period. No SBIR funds are allowed to go to the NIH intramural investigator or to the NIH intramural program.

Small business concerns should submit an SBIR application through Grants.gov using the SF424(R&R) application package. SBCs are encouraged to submit a license application to the NIH Office of Technology Transfer (OTT) before submitting an SBIR application. The SBIR application will be reviewed by the NIH Center for Scientific Review (CSR), while license applications will be reviewed by the NIH Office of Technology Transfer. Under the NIH SBIR-TT program, the SBIR grant review process will be conducted in parallel with, but distinct from, the review of any application for a license. A list of relevant technical, invention, and licensing-related answers can be found online at the NINDS Technology Transfer Office: http://tto.ninds.nih.gov/.

Participating NIH Institutes and Centers encourage applications within the topic areas listed below.

NIH Institute and Center Interests and Guidance:

National Institute of Neurological Disorders and Stroke (NINDS)

This FOA encourages applications focusing on collaborations with intramural investigators on those projects that address neurological mechanisms or disorders falling within the scope of the NINDS mission, such as stroke, Parkinson's Disease, Multiple Sclerosis, and MRI imaging related to neurological disorders. Any project that fits within the NINDS mission that relies on the use of an NIH intramural technology is eligible for this award. For more information on NINDS research from intramural labs see: http://neuroscience.nih.gov/ and http://intra.ninds.nih.gov/.

Please see the NINDS Technology Transfer Office for more details on NINDS licensing opportunities: http://tto.ninds.nih.gov/Licensing.asp.

NINDS will not accept applications that include clinical trials. A clinical trial is a prospective biomedical or behavioral research study of human subjects designed to answer specific questions about safety, tolerability, efficacy and/or effectiveness of pharmacologic, behavioral, biologic, surgical, or device (invasive or non-invasive) interventions. This policy does not apply to (1) exploratory IND studies as defined by the FDA (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm078933.pdf) or (2) early feasibility studies of devices as defined by the FDA (http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm279103.pdf). NINDS accepts and supports SBIR and STTR clinical trial applications through specific opportunities, which can be found on the NINDS SBIR webpage: http://www.ninds.nih.gov/funding/small-business/small_business_funding_opportunities.htm.

National Eye Institute (NEI)

Any project that fits within the NEI mission and relies on the use of an NIH intramural technology is appropriate for this award.  The NEI supports research with respect to eye diseases, visual disorders, mechanisms of normal visual function, preservation of sight, and the special health problems and requirements of individuals with impaired vision.

Please see the NEI Office of Technology Transfer and Development for more details on NEI licensing opportunities: http://www.nei.nih.gov/resources/technologytransfer.asp.  For a complete listing of NIH intramural technologies which are available, please see NIH Office of Technology Transfer at: http://www.ott.nih.gov/opportunities.

The NEI Division of Intramural Research performs high quality and innovative research in a variety of basic, translational, and clinical areas, including imaging, diagnostics, regenerative medicine, genetics/genomics, developmental biology, cellular and gene therapy, and cell and molecular biology related to vision disorders and diseases. For more information about the research and investigators in the NEI Division of Intramural Research, please see: http://www.nei.nih.gov/intramural/

An NEI intramural investigator may provide assistance in a collaborative manner by providing technology, reagents and/or discussions during the SBIR award period; however, no SBIR funds are allowed to go to the NEI intramural investigator or the NEI intramural program.  

National Center for Advancing Translational Sciences (NCATS)

The mission of the National Center for Advancing Translational Sciences (NCATS) is to catalyze a generation of innovative methods and technologies that will enhance the development, testing, and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions. Any project that fits within the NCATS mission and relies on the use of an NIH intramural technology is eligible for this award.

Please refer to the NCATS Strategic Alliances and licensing page https://ncats.nih.gov/alliances for more detail on available technologies for development and licensing.  For a complete listing of NIH intramural technologies which are available, please refer to the NIH Office of Technology Transfer at: http://www.ott.nih.gov/opportunities

The NCATS Division of Pre-clinical Innovation houses the NCATS intramural program which focuses on NCATS pre-clinical programs and resources focus on key obstacles and inefficiencies in the translational process, overcoming bottlenecks that slow the development of new treatments for patients.  For more information about the research and investigators in the NCATS Division of Pre-Clinical Innovation, please see: http://www.ncats.nih.gov/preclinical

When there is mutual scientific interest between the applicant and an NCATS intramural investigator, assistance by the NCATS intramural investigator may be provided in a collaborative manner by providing technology, reagents and/or discussions during the SBIR award period; however, no SBIR funds are allowed to go to the NCATS intramural investigator or the NCATS intramural program.

National Institute on Drug Abuse (NIDA)

The mission of the National Institute on Drug Abuse (NIDA) is to lead the Nation in bringing the power of science to bear on drug abuse and addiction. NIDA’s Intramural Research Program (IRP) conducts state-of-the-art research on basic mechanisms that underlie drug abuse and addiction, and develops new methods for the treatment of drug abuse and addiction. Research is supported at the molecular, genetic, cellular, animal, and clinical levels and is conceptually integrated, highly innovative, and focused on major problems in the field. For more information about the research and investigators in the NIDA Intramural Research Program (IRP), please see: http://irp.drugabuse.gov/

Through hard work and dedication, the IRP has created a number of promising technologies and resources that can be commercialized and help those fighting substance abuse or those working towards developing the next generation of drugs, diagnostics and devices. The full list is presented below. Any project that relies on the use of an NIH intramural technology is appropriate for this award.

The NIDA Office of Translational Initiatives and Program Innovations (OTIPI), which coordinates the SBIR/STTR program at NIDA, will provide assistance in the establishing the collaborative efforts by enabling an access to IRP investigators, their technology, reagents and/or discussions during the SBIR award period. For contact information please see: https://sbir.nih.gov/nida/contact-us

National Cancer Institute (NCI)

The NCI Intramural Research Program is one of the largest cancer research programs in the world. The NCI Center for Cancer Research (CCR), Division of Cancer Treatment and Diagnosis (DCTD), and the Division of Epidemiology and Genetics (DCEG)  perform high quality and innovative research in a variety of basic, translational, and clinical areas, including imaging, diagnostics, cancer therapeutics, genetics/genomics, developmental biology, cellular and gene therapy, and cell and molecular biology related to cancer and the infectious diseases of HIV and AIDS. For more information about the research and investigators in the NCI, please see: http://irp.nih.gov.  The SBIR-TT program enables a SBC grantee to commercialize an NCI invention in one of these areas.

An SBIR-TT SBC awardee may work closely with the NCI inventor(s), who will provide assistance during the award period. The NCI SBIR-TT Program asks SBCs to examine the NCI intellectual property portfolio, as well as specific interest areas of NCI-developed technology, for commercial viability. In addition, Phase I applicants to the NCI SBIR-TT Program should include in their application the completed Non-Exclusive Patent License Agreement for Internal Research Use form, downloadable from http://www.ott.nih.gov/forms-model-agreements.

The company or companies selected for the SBIR-TT grants, with access to NCI technology and personnel knowledgeable about the invention, will be expected to innovate and develop a commercial product based on the NCI invention. If selected for SBIR Phase I funding, the SBC will be granted a royalty-free Non-Exclusive Patent License Agreement for Internal Research Use. If selected for Phase II funding, the SBC will be required to apply for and negotiate either a non-exclusive or an exclusive Commercial Use license, within the field of use of the SBIR award, to technologies held by NIH. It is expected that the SBC will develop the invention into a commercial product to benefit the public, such that the conditions of 37 CFR 404.7 are met. For a searchable listing of NCI inventions, please refer to the NIH Office of Technology Transfer website to view NCI intramural technologies: http://www.ott.nih.gov/ic/nci.  NCI is particularly interested in the development and commercialization of its inventions in the areas of imaging, cancer vaccines, antibodies and antibody conjugates, and RNAi therapeutics.

An NCI intramural investigator  may provide assistance in a collaborative manner to the funded SBC by providing technology, research materials, reagents and/or discussions during the SBIR award period. No SBIR funds are allowed to go to the NCI intramural investigator or the NCI intramural program. SBIR funds may go toward specific projects through service agreements to the Frederick National Laboratory for Cancer Research in Frederick, MD, which operates under contract of NCI as a Federally Funded Research and Development Centers (FFRDC).

 

Further information on the NCI SBIR-TT program may be obtained by sending an email to ncitechtransfer@mail.nih.gov.

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