Key Dates

Related Announcements

PA-20-260 - SBIR Omnibus/Parent Clinical Trial Not Allowed

PA-20-265 - STTR Omnibus/Parent Clinical Trial Not Allowed

Issued by

National Institute of Mental Health (NIMH)

National Eye Institute (NEI)

National Institute on Aging (NIA)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

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 Drug Abuse (NIDA)

National Institute of Neurological Disorders and Stroke (NINDS)

National Center for Complementary and Integrative Health (NCCIH)

Purpose

This Notice of Special Interest (NOSI) encourages the translation of the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative-supported technologies from academic and other non-small business research sectors to the marketplace. Small Business Concerns (SBCs) are encouraged to submit Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) grant applications that propose to further develop, optimize, validate and scale such technologies for commercial dissemination. Additionally, SBIR and STTR applications supporting the development and commercialization of novel technologies that fit within the mission of the BRAIN Initiative are encouraged.

Background

The BRAIN Initiative is aimed at revolutionizing our understanding of the human brain. By accelerating the development and application of innovative technologies, researchers will be able to produce a new dynamic picture of the brain that, for the first time, shows how individual cells and complex neural circuits interact in both time and space. It is expected that the application of these new tools and technologies will ultimately lead to new ways to identify, treat, cure, and even prevent brain disorders.

NIH is one of several federal agencies involved in the BRAIN Initiative. Planning for the NIH component of the BRAIN Initiative is guided by the long-term scientific plan, "BRAIN 2025: A Scientific Vision," which details seven high-priority research areas and calls for a sustained federal commitment of $4.5 billion over 12 years. This NOSI is based on the NIH's careful consideration of the recommendations of the BRAIN 2025 Report and input from the NIH BRAIN Multi-Council Working Group and the Advisory Committee to the NIH Director BRAIN Initiative Working Group 2.0.

NIH encourages BRAIN Initiative applications from investigators who are underrepresented in the biomedical, behavioral, or clinical research workforce (see NSF data) and the most recent report on Women, Minorities, and Persons with Disabilities in Science and Engineering. Such individuals include those from underrepresented racial and ethnic groups as well as individuals with disabilities.

NIH also encourages businesses to participate in the BRAIN Initiative. It is possible for companies to submit applications directly to BRAIN Initiative program announcements or to collaborate with academic researchers in joint submissions. Small businesses should consider applying to one of the BRAIN Initiative small business Funding Opportunity Announcements (FOAs).In addition to the national BRAIN Initiative, the NIH continues to have a substantial annual investment in neuroscience research and in technology development, including through the

SBIR and STTR programs. Potential applicants are strongly encouraged to contact Scientific/Program staff if they have any questions about the best FOA for their research.

Objectives

The BRAIN Initiative and other research sponsors have invested a significant amount of funds in the development of new technologies to study and understand the brain, from basic and clinical perspectives, through a variety of mechanisms. This investment has produced a large number of innovative neuroscience technologies. While these innovations are put to good use by their developers, non-commercial developers often lack the resources and product development training to make their technologies robust and easy to use by the broad neuroscience community. Moreover, ongoing support to maintain and update technologies in non-commercial settings is difficult to obtain. Consequently, the promise of these advanced technologies is often realized only by industry. The BRAIN Initiative 2.0: From Cells to Circuits, Towards Cures report highlights the need to further support the dissemination of innovative neuroscience technologies.

This NOSI is intended to alert SBCs and partnering institutions that there is a need to help move useful BRAIN Initiative-developed technologies and BRAIN Initiative-relevant technologies from non-commercial laboratories into the commercial marketplace. These translational projects can be submitted through the SBIR and STTR Programs.

Supported research and development will include further development, optimization, validation and scaling of technologies for commercial dissemination and will likely require close collaboration between the original developers of these technologies and SBCs. These partnerships may be accomplished in a number of ways, including the use of multiple program directors/principal investigators.

BRAIN Priority Areas were identified in the BRAIN 2025 Report; applications from SBCs that aim to commercialize technologies relating to these priority areas are encouraged:

1. Cell Type: identify and provide experimental access to the different brain cell types to determine their roles in health and disease.
2. Circuit Diagrams: generate circuit diagrams that vary in resolution from synapses to the whole brain.
3. Monitor Neural Activity: produce a dynamic picture of the functioning brain by developing and applying improved methods for large-scale monitoring of neural activity.
4. Interventional Tools: link brain activity to behavior with precise interventional tools that change neural circuit dynamics.
5. Theory & Data Analysis Tools: produce conceptual foundations for understanding the biological basis of mental processes through the development of new theoretical and data analysis tools.
6. Human Neuroscience: develop innovative technologies to understand the human brain; create and support integrated human brain research networks.
7. Integrated Approaches: integrate new technological and conceptual approaches produced in Goals #1-6 to discover how dynamic patterns of neural activity are transformed into cognition, emotion, perception, and action in health and disease.

Responsive Areas of Research

Examples of technologies responsive to this NOSI are listed below. This list is non-exhaustive and meant to provide a representation of appropriate applications from SBCs that support or enable the goals of the BRAIN Initiative.

• Improved Microscopy Imaging- ability to enhance single cell resolution while maintaining spatial and depth resolution, in vivo and ex vivo, automation of processes
• Improved Measures of Brain Activity - multielectrode, range of depths, correlation with imaging/behavior, ability to streamline analysis, record for long periods of time, collect during social interactions, decreasing size, improving signal-to-noise ratio (S/N), less injury
• Improved technologies for single cell transcriptomic/epigenomic analysis
• Novel technologies for measuring and quantifying human and non-human animal behavior
• Novel or improved preclinical and clinical imaging technologies with the potential to enhance our understanding of complex circuit function or neuropathology
• Clinical Electrophysiology - dry electrodes, easy application, clinical grade processing/analysis pipelines, combination image-related technology products, determination of minimal electrode ability to reflect brain activity vs. multi-electrodes and sufficiency for clinical studies/trials
• MRI (including fMRI) - technical approaches to standardization, improved temporal/spatial resolution (including pediatric resolution), correlation with EEG/other activity measures
• Software platforms and knowledge management systems for large datasets, such as molecular, imaging and electrophysiology to enable streamlined data processing and analysis

Applicants are strongly encouraged to consult Program Staff regarding the appropriateness of the planned application to the BRAIN Initiative’s mission, scientific areas of interests and programmatic priorities.

Awardees will be expected to participate in the NIH I-Corps Program or the Concept to Clinic: Commercializing Innovation (C3i) Program to help advance the commercial opportunity of the technology.

Application and Submission Information

This notice applies to due dates on or after April 5, 2021 and subsequent receipt dates through January 6, 2024.

Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissues of these announcement through the expiration date of this notice.

• PA-20-260 SBIR Omnibus/Parent Clinical Trial Not Allowed
• PA-20-265 STTR Omnibus/Parent Clinical Trial Not Allowed

All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:

• For funding consideration, applicants must include NOT-MH-21-125 (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.

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

Inquiries

Scientific/Research Contact(s)

Margaret C. Grabb, Ph.D.
National Institute of Mental Health (NIMH)
Phone: 301-443-3563
Email: mgrabb@mail.nih.gov

Martha C Flanders, Ph.D.
National Eye Institute (NEI)
Phone: 301-451-2020
E-mail: martha.flanders@nih.gov

Yuan Luo, Ph.D.
National Institute on Aging (NIA)
Phone: 301-496-9350
Email: yuan.luo@nih.gov

Qi-ying Liu, MD
National Institute On Alcohol Abuse And Alcoholism (NIAAA)
Phone: 301-443-2678
E-mail: liuqiy@mail.nih.gov

Ilana Grace Goldberg, Ph.D.
National Institute Of Biomedical Imaging And Bioengineering (NIBIB)
Phone: 301-402-3465
E-mail: ilana.goldberg@nih.gov

Clara Cheng, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Phone: 301-435-6992
E-mail: clara.cheng@nih.gov

Amy Poremba, Ph.D.
National Institute on Deafness And Other Communication Disorders (NIDCD)
Phone: 301-496-1804
E-mail: none

Leonardo Maria Angelone, Ph.D.
National Institute on Drug Abuse (NIDA)
Phone: 301-827-5946
E-mail: Leonardo.angelone@nih.gov

Taryn Aubrecht, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Phone: 301-496-1779
E-mail: taryn.aubrecht@nih.gov

Merav Sabri, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-496-2583
Email:merav.sabri@nih.gov

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Maggie Paolini
National Institute of Mental Health (NIMH)
Phone: 301-443-2746
Email: maggie.paolini@nih.gov

Karen Robinsonsmith
National Eye Institute (NEI)
Phone: 301-451-2020
E-mail: kyr@nei.nih.gov

Robin Laney
National Institute on Aging (NIA)
Phone: 301-496-1473
Email: laneyr@mail.nih.gov

Judy Fox
National Institute On Alcohol Abuse And Alcoholism (NIAAA)
Phone: 301-443-4704
E-mail: jfox@mail.nih.gov

James Huff
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4786
Email: james.huff@nih.gov

Bryan S. Clark, MBA
Eunice Kennedy Shriver National Institute Of Child Health & Human Development (NICHD)
Phone: 301-435-6975
E-mail: clarkb1@mail.nih.gov

Christopher Myers
National Institute On Deafness And Other Communication Disorders (NIDCD)
Phone: 301-435-0713
E-mail: none

Amy Connolly
National Institute On Drug Abuse (NIDA)
Phone: 301-827-4457
E-mail: amy.connolly@nih.gov

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

Shelley Carow
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-3788
Email: CarowS@mail.nih.gov