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The purpose of this Funding Opportunity Announcement (FOA) is to support research that advances compounds towards FDA approval by leveraging NIDA funds with the strengths and resources of outside organizations, such as for-profit and not-for-profit entities, including academic institutions, pharmaceutical and biotechnology companies, private and public foundations, and small businesses. Applications from single entities that possess considerable resources for medications development will also be considered, provided the entity demonstrates a significant resource commitment to the proposed project. A resource commitment from a single entity could, for example, consist of salary support for key personnel or production and formulation of clinical trial material. It is anticipated that in comparison with traditional grant-funded research, strategic alliances will increase the pace at which medications to treat Substance Use Disorders (SUDs) move through the drug development process. Both the project period and budget of the grant are consistent with the objective of accelerating the pace of medications development compared to traditional research project grant funding. Project aims can range from the development of a new molecular entity to the expansion of an existing medication's clinical indication(s). Each project should have a defined entry and exit point in the medications development pathway, with the objective of advancement in the FDA approval process. It is hoped that support for these collaborations will accelerate the rate of medications development for SUDs.

This Funding Opportunity Announcement (FOA) solicits behavioral, social, and implementation science research designed to (a) identify gaps in the HIV pre-exposure prophylaxis (PrEP) care continuum and associated determinants; (b) develop and test interventions to strengthen PrEP delivery, use, and outcomes; and (c) reduce racial/ethnic and age-related disparities in PrEP uptake and use This FOA uses the R01 grant mechanism while corresponding FOA PA-18-271 uses the R21 mechanism. High risk/high payoff projects that lack preliminary data are appropriate for the R21 mechanism, while applicants with preliminary data who propose longitudinal analyses and/or large scale projects may consider the R01 mechanism.