Key Dates

Related Announcements

• August 3, 2022 - Notice of Special Interest (NOSI): HEAL Initiative: Clinical Translation of Diagnostic and Therapeutic Devices via Blueprint MedTech. See Notice NOT-NS-23-002.
• August 20, 2021 - Blueprint MedTech Translator (UG3/UH3 - Clinical Trial Optional). See NOFO PAR-21-315.
• August 20, 2021 - Blueprint Medtech: Small Business Translator (U44 - Clinical Trial Optional). See NOFO PAR-21-282.

Issued by

National Institute of Neurological Disorders and Stroke (NINDS)

National Institute on Aging (NIA)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute of Dental and Craniofacial Research (NIDCR)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

National Institute on Drug Abuse (NIDA)

National Institute of Mental Health (NIMH)

National Center for Complementary and Integrative Health (NCCIH)

National Cancer Institute (NCI)

Purpose

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 development and translation of 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 development and validation activities 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 Program

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.

Promoting Diversity

Applicants are encouraged to incorporate individuals from diverse backgrounds into their project teams, including those from underrepresented groups in the biomedical research workforce. 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. Please refer to Notice of NIH's Interest in Diversity  NOT-OD-20-031 for more details. Please note that consistent with NIH practice and applicable law, funded programs may not use the race, ethnicity, or sex of prospective program participants or faculty as an eligibility or selection criteria. The race, ethnicity, or sex of candidates will not be considered by NIH in the application review process or when making funding decisions.

Engaging People with Lived Experience and Other Collaborators:

People with lived experience (e.g., patients, patient advocates, caregivers, families, community leaders) have important insights that can improve meaningful outcomes, uptake of research findings, and health equity across the continuum of research from basic through implementation studies. The perspectives of other relevant collaborators (e.g., health service providers, payors, public health agencies, community-based organizations, biotech, pharma) can further improve research impact. The NIH HEAL initiative strongly encourages applicants to specify their plan for meaningful engagement of people with lived experience and other collaborators in the research process. Meaningful engagement will vary with the focus of the research but should at minimum ensure that researchers are connecting with relevant collaborators and incorporating their perspectives throughout the conception, implementation, and dissemination of the research. Meaningful engagement should address what the researchers will learn and how the people with lived experience and/or collaborators will benefit from the partnership.  To promote health equity, as is relevant for the research proposed, it is recommended that at least two people with lived experience from populations who experience health disparities should be meaningfully engaged in these efforts: https://www.nimhd.nih.gov/resources/understanding-health-disparities/minority-health-and-health-disparities-definitions.html  

See this resource for more information in engaging people with lived experience: https://aspe.hhs.gov/lived-experience .  

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 Blueprint MedTech Incubator (blueprintneurotech.org) or Translator (UG3/UH3 and U44) program, 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. 

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.

Note: Investigators at the development stage who do not require access to the Blueprint MedTech Resources to advance their technology and its commercialization potential are encouraged to consider an application to RFA-EB-22-002: HEAL Initiative: Translational Development of Diagnostic and Therapeutic Devices (R18 Clinical Trial Not Allowed).

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.

HEAL Initiative Data-Sharing Resources

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 here: https://www.healdatafair.org/ 

Publications resulting from NIH HEAL Initiative funded studies can be made immediately publicly available upon publication.

• For manuscripts published in journals that are not immediately open access, authors may arrange with journals in advance to pay for immediate open access.
• Costs to ensure manuscripts are immediately publicly available upon publication can be included in budget requests.

 Budgeting guidance for data sharing can be found in NOT-OD-21-015 and the NIH Scientific Data Sharing site.

HEAL Initiative Common Data Elements (CDEs)

The HEAL Clinical Pain Common Data Element (CDE) Initiative provides an unprecedented opportunity for the pain research community to access quality and meaningful data across pain conditions, diverse populations, and multiple interventions. The HEAL CDE initiative aims to facilitate cross-study comparisons, improve interpretability of findings for patient-reported outcomes, and improve the ability to compare results across trials to quantify the impact of interventions. For studies with a focus on pain and involving human subjects, this initiative will support projects that use the HEAL Clinical Pain Core CDEs, which include measures within ten pain domains and are specific to either adult or pediatric populations and acute or chronic pain conditions. The domains include pain intensity, pain interference, physical functioning/quality of life, sleep, pain catastrophizing, depression, anxiety, treatment satisfaction, quality of life, and a substance use screener (HEAL CDE Program). For studies that use additional pain screening tools, this initiative will support studies that select from a comprehensive set coded through HEAL or that submit their tools for coding to comply with HEAL pain data harmonization. This initiative will support studies where outcome measures specific to clinical pain are validated measures appropriate for the pain condition.

HEAL Initiative Scientific Meeting Attendance

The NIH HEAL Initiative will require a high level of coordination and sharing between investigators. It is expected that NIH HEAL Initiative awardees will cooperate and coordinate their activities after awards are made by participating in Program Director/Principal Investigator (PD/PI) meetings, including an annual HEAL Initiative Scientific Meeting, as well as other activities.

Application and Submission Information

This notice applies to due dates on or after September 16, 2024 through February 29, 2028. 

Applicants interested in applying to the MedTech Incubator programs should apply directly at blueprintneurotech.org and note HEAL Initiative relevance as part of the submission form. Applicants to the Translator Program should submit applications using one of the following notices of funding opportunity (NOFOs) or any reissues of these announcements. Applicants must select the IC and associated NOFO 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 NOFO. 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-24-075” (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.

All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

Although NIAMS, NIDDK, and NCI is not listed as a Participating Organization in all the NOFOs listed above, applications for this initiative will be accepted.

Applications nonresponsive to terms of this NOSI will be withdrawn from consideration for this initiative.

Inquiries

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

Scientific/Research Contact(s)

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