Notice of Special Interest: SBIR Technology Transfer (R43/R44 Clinical Trial Not Allowed)
Notice Number:
NOT-NS-22-017

Key Dates

Release Date:

November 12, 2021

First Available Due Date:
January 05, 2022
Expiration Date:
January 07, 2025

Related Announcements

PA-21-259 - Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R4/R44] Clinical Trial Not Allowed)

Issued by

National Institute of Neurological Disorders and Stroke (NINDS)

National Eye Institute (NEI)

National Institute on Aging (NIA)

National Institute of Dental and Craniofacial Research (NIDCR)

National Cancer Institute (NCI)

Purpose

The SBIR Technology Transfer (SBIR-TT) Notice of Special Interest (NOSI) 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: https://www.ott.nih.gov or the web sites of the technology transfer offices of the participating Institutes.

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 SBIR-TT 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 technology transfer office of the participating institute 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 institute's technology transfer office.  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 NIH Technology Transfer Office: https://www.ott.nih.gov/ or the web sites of the technology transfer offices of the participating Institutes.

Participating NIH Institutes 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 inter-institute intramural neuroscience research see https://neuroscience.nih.gov/. For information on the NINDS Division of Intramural Research see https://neuroscience.nih.gov/ninds.

For information about NIH intramural Neuroscience technologies which are available, please see the NINDS Technology Transfer Office https://tto.ninds.nih.gov/.

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.

For a complete listing of NEI intramural technologies which are available for licensing, please visit NIH Office of Technology Transfer: https://www.ott.nih.gov/ and search NEI licensing opportunities: Results for search "National Eye Institute" (nih.gov).

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 Institute of Dental and Craniofacial Research (NIDCR)

Any project that fits within the NIDCR mission and relies on the use of an NIH intramural technology is appropriate for this award. The NIDCR supports research related to improvement of dental, oral, and craniofacial health via basic, translational, and clinical research.

Please see the NIDCR Office of Technology Transfer and Development for more details on NIDCR licensing opportunities: https://www.nidcr.nih.gov/research/conducted-at-nidcr/technology-transfer. 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 NIDCR Division of Intramural Research performs high quality and innovative research in a variety of basic, translational, and clinical areas, including autoimmunity in the oral cavity, xerostomia, oral Graft vs. Host Disease, and disorders of bone and mineral metabolism. For more information about the research and investigators in the NIDCR Division of Intramural Research, please see: https://www.nidcr.nih.gov/research/conducted-at-nidcr.

An NIDCR 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 NIDCR intramural investigator or the NIDCR intramural program.

National Institute on Aging (NIA)

NIA’s Small Business R & D Programs are dedicated to funding commercializable products (e.g., compounds, devices, and other technologies) that focus on aging and/or aging-specific conditions and health-related concerns.In addition, NIA has been charged with the task of leading the federal government’s R & D effort on Alzheimer’s disease (AD) and encourages R & D focusing on the prevention, diagnosis, and treatment of AD and AD-related dementias.

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. Such areas include: immunotherapy, 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 NCI technologies available for licensing, please see: https://techtransfer.cancer.gov.

The SBIR-TT program enables an SBC grantee to license and commercialize an available NCI invention in any portfolio area. Another feature of the SBIR-TT Program is that the SBC awardee may work closely with the NCI inventor(s), who can 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. Awardees of a Phase I NCI SBIR-TT Program should immediately submit a completed Non-Exclusive Patent License Agreement for Internal Research Use form, which can be downloaded from http://www.ott.nih.gov/forms-model-agreements. The NCI also offers a term-limited, exclusive Start-Up Evaluation Option License to start-up companies developing certain early-stage vaccine, therapeutic, device, and diagnostic technologies. See Start-Up Program 2.0: An Evaluation Option License Program (https://techtransfer.cancer.gov/partnering-with-nih/licensingagreements/exclusive-licenses/start-exclusive-licenses) for details.

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 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 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 NCI Technology Transfer Center website to view NCI intramural technologies: https://techtransfer.cancer.gov/availabletechnologies. NCI is particularly interested in the development and commercialization of its inventions in the areas of cancer vaccines, antibodies and antibody conjugates, and nucleic acid 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). NCI highly recommends applicants to the SBIR-TT discuss their proposed project with the NCI Technology Transfer Center (TTC), the NCI SBIR Scientific/Research Contact, and the NCI researcher; this can be done under a Confidential Disclosure Agreement available through the NCI TTC.

Further information on the NCI SBIR-TT program and more detailed information on specific inventions may be obtained by sending an email to the NCI TTC contact email ncitechtransfer@mail.nih.gov and/or the NCI SBIR Scientific/Research Contact.

Description of circumstances for which administrative supplements are available. This notice applies to due dates on or after January 5, 2022 and subsequent receipt dates through January 7, 2025.

Application and Submission Information

Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.

  • PA-21-259 - Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R4/R44] Clinical Trial Not Allowed)

All instructions in the SF424 (R&R) Application Guide and PA-21-259 must be followed, with the following additions:

  • Standard dates apply, by 5:00 PM local time of applicant organization.
  • For funding consideration, applicants must include “NOT-NS-22-017” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.
  • Applicants are strongly encouraged to notify the program contact at the Institute supporting the parent award that a request has been submitted in response to this FOA in order to facilitate efficient processing of the request.

Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.

Inquiries

Please direct all inquiries to the contacts in Section VII of the listed funding opportunity announcements with the following additions/substitutions:

Scientific/Research Contact(s)

Emily Caporello, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1779
Email: Emily.caporello@nih.gov

Kory Hallett, PhD
National Cancer Institute (NCI)
Telephone: 240-276-5882
Email: kory.hallett@nih.gov

Saroj Regmi, Ph.D.
National Institute on Aging (NIA)
Phone: 301-480-8964
Email: saroj.regmi@nih.gov

Paek Lee
National Eye Institute (NEI)
Phone: (301)435-864
E-mail: paek.lee@nih.gov

Orlando Lopez, PhD
National Institute Of Dental & Craniofacial Research (NIDCR)
Phone: (301) 402-4243
E-mail: orlando.lopez@nih.gov

Financial/Grants Management Contact(s)

Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: ChiefGrantsManagementOfficer@ninds.nih.gov

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: wolfreyc@mail.nih.gov

Karen Robinson Smith
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: kyr@nei.nih.gov

Diana Rutberg, MBA
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4798
Email: rutbergd@mail.nih.gov