The National Institutes of Health, National Institute on Drug Abuse (NIDA), is accepting applications under RFA-DA-27-015, Establishing a Center for the Advancement of Substance Use Disorder (SUD) Pharmacotherapeutics through Training and Preclinical Support (U54 Clinical Trial Not Allowed).
The program will establish a national Center that educates and mentors academic researchers in formal product development for new SUD pharmacotherapeutics and advances the strongest concepts through early preclinical feasibility studies. The Center is expected to recruit program participants, build a mentor and expert network, deliver drug-development training, help investigators define target product profiles and clinical needs, and operate a competitive seed-funding process for selected early-stage studies.
Deadline: Applications are due September 30, 2026 at 5:00 PM local time of the applicant organization. The NOFO opened August 30, 2026, does not accept late applications, and expires October 1, 2026. The earliest anticipated start is July 2027.
Funding: NIDA intends to commit $3 million in FY 2027 to fund one award. Application budgets are not formally capped but must reflect the actual needs of the proposed project. The maximum project period is five years. Cost sharing is not required.
Eligibility: Broad organizational eligibility includes public and private institutions of higher education, nonprofits, small businesses and other for-profit organizations, state and local governments, Tribal governments and organizations, eligible federal agencies, U.S. territories, independent school districts, housing authorities, faith-based and community-based organizations, regional organizations, and eligible foreign organizations. The NOFO permits foreign organizations and foreign components but states that applications involving foreign subawards or subcontracts are noncompliant under current NIH policy unless submitted through the designated international-collaboration mechanism. Required NIH registrations must be active before submission.
Center architecture: Applications use NIH Multi-Project instructions and include an Overall component plus required Administrative, Outreach and Networking, Drug Development Training and Education, and Preclinical Study Support Cores. Center leadership must demonstrate operational, business, scientific, biomedical product-development, mentoring, program-management, and subaward-management expertise. The Center must establish training in formal SUD drug development, recruit academic investigators, develop a network of drug-development, regulatory, intellectual-property and investment experts, and issue and manage subawards for selected preclinical studies. Clinical trials are not allowed.
Atlas fit: This is a high-value addiction medicine, pharmacotherapy development, translational research, biomedical entrepreneurship, research training, and preclinical-product-development opportunity. Although for-profit organizations are structurally eligible and no match is required, a credible direct Dr. Miltie prime pursuit would require a proven SUD pharmacotherapeutics and biomedical product-development program, experienced drug-development and regulatory leadership, academic-research recruitment and mentoring capacity, preclinical technical expertise, compliant subaward administration, and the institutional infrastructure to operate a national U54 cooperative center. Preferred posture: Partner-Led / SUD Pharmacotherapeutics Product-Development Center. Route organization-specific applicant evaluation to established academic medical centers, addiction-research institutions, drug-development centers, translational-science organizations, and other consortium-capable entities.