August 3, 2022
PAR-21-315 - UG3/ UH3 Blueprint MedTech Translator (UG3/UH3 - Clinical Trial Optional)
PAR-21-282 - U44 Blueprint Medtech: Small Business Translator (U44 - Clinical Trial Optional)
National Institute of Neurological Disorders and Stroke (NINDS)
National Eye Institute (NEI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Center for Complementary and Integrative Health (NCCIH)
National Cancer Institute (NCI)
More than 25 million Americans suffer from daily chronic pain, a highly debilitating medical condition that is complex and difficult to manage. In recent decades, there has been an overreliance on the prescription of opioids for chronic pain despite their poor ability to improve function and high addiction liability. This contributed to a significant and alarming epidemic of opioid overdose deaths and addictions. Innovative scientific solutions to develop alternative pain treatment options are thus critically needed.
This Notice of Special Interest (NOSI) encourages the translation of the novel neurotechnologies, funded through the Helping to End Addiction Long-Term (HEAL) Initiative and overseen by the NIH Blueprint MedTech program. Academic institutions and Small Business Concerns (SBCs) are encouraged to submit grant applications that propose non-clinical validation for subsequent clinical feasibility studies of medical devices for the diagnosis and treatment of pain and opioid use disorder (OUD). Applications supporting the development and translation of groundbreaking neurotechnologies that fit within the mission of the HEAL Initiative are encouraged.
Background
The NIH HEAL Initiative:
This NOSI is part of the NIH’s Helping to End Addiction Long-term (HEAL) Initiative to speed scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative bolsters research across NIH to (1) improve treatment for opioid misuse and addiction and (2) enhance pain management. More information about the HEAL Initiative is available at: https://heal.nih.gov/.
The NIH Blueprint MedTech incubator program aims to accelerate access to groundbreaking, safe, and effective medical devices. Blueprint MedTech offers an opportunity to address these gaps by providing support to sufficiently develop and de-risk technologies to the point where additional investments are warranted from industry partners, investors, and government.
The Blueprint MedTech Program aims to accelerate the development of cutting-edge medical devices to diagnose and/or treat nervous system disorders. The program's mission is to catalyze the translation of novel neurotechnologies from early-stage development to first-in-human clinical studies. The program provides: (a) non-dilutive funds to support medical device development activities led by investigators and (b) additional resources and support services.
Applicants should strive to incorporate diversity in their team development plan. Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust. In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. NIH encourages institutions to diversify their student and faculty populations to enhance the participation of individuals from groups that are underrepresented in the biomedical, clinical, behavioral, and social sciences. Please refer to Notice of NIH's Interest in Diversity (NOT-OD-20-031) for more details.
The NIH HEAL Initiative will require a high level of coordination and sharing between investigators. It is expected that NIH HEAL Initiative recipients will cooperate and coordinate their activities after awards are made by participating in Program Director/Principal Investigator (PD/PI) meetings, including an annual HEAL Investigators Meeting, as well as other activities.
Objectives
This NOSI alerts applicants that there is a need to help transition HEAL Initiative-relevant technologies from early device development to first-in-human studies.
For applications coming into the BP MedTech UG3/UH3 and U44 funding opportunities, HEAL will support projects developing novel invasive or non-invasive devices for the diagnosis and/or treatment of pain and/or OUD. Proposed medical devices and their indications will likely follow De Novo or Premarket Approval (PMA) regulatory pathways. Medical devices with indications that may fit within an existing 510(k) pathway may also be accepted, as long as the application can demonstrate a clear clinical and technological innovation beyond the state of the art of existing FDA-cleared predicates.
Applicants are strongly encouraged to consult the Scientific/Research Contact listed at the bottom of this NOSI regarding the appropriateness of the planned application to the HEAL Initiative's mission, scientific areas of interest, and programmatic priorities.
Resources are available for applicants looking to maximize the impact of their HEAL-supported projects through broad data sharing. Information on HEAL Data Stewardship can be found at https://www.healdatafair.org/
Awardees are expected to participate in the Blueprint MedTech Program, which provides consultants, industry experts, and resources to support the device's technological, regulatory, clinical, and commercial advancement.
Application and Submission Information
This notice applies to due dates on or after October 18, 2022 and subsequent receipt dates through June 20, 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. Applicants must select the IC and associated FOA to use for submission of an application in response to the NOSI. The selection must align with the IC requirements listed in order to be considered responsive to that FOA. Non-responsive applications will be withdrawn from consideration for this initiative.
- PAR-21-315 - Blueprint MedTech Translator (UG3/UH3 - Clinical Trial Optional)
- PAR-21-282 - Blueprint MedTech: Small Business Translator (U44 - Clinical Trial Optional)
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-NS-23-002 (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.
Although NCI and NIAMS are not listed as a Participating Organizations in all the FOAs listed above, applications for this initiative will be accepted.
Applications nonresponsive to terms of this NOSI will be withdrawn from consideration for this initiative.
Scientific/Research Contact(s)
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1779
Email: NINDS-Devices@nih.gov
and Human Services (HHS)
