The HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R41/R42 Clinical Trial Not Allowed) is a funding opportunity provided by the National Institutes of Health (NIH) under its Small Business Technology Transfer (STTR) program. The initiative aims to combat the national opioid public health crisis by supporting small businesses in developing innovative therapies and technologies focused on improved pain management, particularly non-addictive alternatives. This opportunity does not permit clinical trials but encourages preclinical research and technological innovations to address chronic pain through better measurement and management techniques.

The focus of this funding opportunity is on technologies and therapies that can enhance pain management and measurement without the risk of addiction. It prioritizes new tools for understanding pain biology, non-addictive treatments, devices for measuring pain objectively, and strategies for acute and chronic pain management. Applications that propose to develop treatments targeting opioid mechanisms or clinical trials investigating new pain management methods will not be considered. However, the FOA encourages innovative approaches such as screening tools, non-addictive analgesics, and models that improve pain therapy development.

NIH is interested in a broad range of pain conditions and diseases. Participating Institutes and Centers, such as the National Institute of Neurological Disorders and Stroke (NINDS), the National Institute on Aging (NIA), and others, each have specific interests in areas like neurological pain, arthritis, musculoskeletal pain, and minority health. This provides applicants with opportunities to align their projects with the specific missions of these NIH components, thus increasing the relevance of their submissions.

Eligible applicants for this funding must be U.S.-based small business concerns that meet the STTR requirements. At least 40% of the work must be conducted by the small business itself, and at least 30% by a partnering nonprofit research institution. Key collaborators, including the project directors or principal investigators, should have a formal commitment to the small business. The program is designed for both Phase I and Phase II applicants, with Phase I typically focused on feasibility studies and Phase II on more comprehensive development efforts.

The maximum award budget for Phase I projects is $275,766, and for Phase II projects, it can go up to $1,838,436, though exceptions for higher funding levels can be made in special cases. Award periods may extend up to two years for Phase I and up to three years for Phase II. Applicants are strongly encouraged to consult NIH program officials for advice on budget proposals exceeding these amounts.

The application process involves multiple steps, including completing registrations with various government systems such as the System for Award Management (SAM) and the Small Business Administration’s (SBA) company registry. Applicants must also submit a comprehensive proposal including technical and commercial details, which will be reviewed based on factors such as significance, innovation, the environment for success, and commercialization potential. Special attention is given to the project's likelihood to address the critical opioid and pain management challenges in ways that are scalable and non-addictive.

Applications must be submitted through one of the NIH’s approved submission systems, with deadlines occurring several times per year until the expiration date of April 5, 2025.