The Stephen I. Katz Early Stage Investigator Research Project Grant supports an innovative project that represents a change in research direction for an early stage investigator (ESI) and for which no preliminary data exist. Applications submitted to this Notice of Funding Opportunity Announcement (NOFO) must not include preliminary data. Applications must include a separate attachment describing the change in research direction. The proposed project must be related to the programmatic interests of one or more of the participating NIH Institutes and Centers (ICs) based on their scientific missions. This Funding Opportunity is for basic science experimental studies involving humans, referred to in NOT-OD-18-212 as prospective basic science studies involving human participants. These studies fall within the NIH definition of a clinical trial and also meet the definition of basic research. Types of studies that should submit under this NOFO include studies that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application towards processes or products in mind. Studies that are NOT conducted with specific applications toward processes or products in mind and which also do not meet the clinical trial definition should submit under the appropriate Clinical Trial Not Allowed NOFO .Application budgets are not limited but need to reflect the actual needs of the proposed project. The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.