Inactive

The U.S. Food and Drug Administration’s (FDA) Center for Tabacco aims to provide a proactive regulatory assessment of human research studies in order to preclude the development of non-compliance situ... The U.S. Food and Drug Administration’s (FDA) Center for Tabacco aims to provide a proactive regulatory assessment of human research studies in order to preclude the development of non-compliance situations, with emphasis on improving the quality of research practices while ensuring the protection of human subjects. Under the FDA Quality Assurance Program, each Center has been tasked with developing programs in human research quality assurance and quality improvement. The CTP Office of Compliance and Enforcement (OCE) is responsible for the management of the CTP QA/QI HSP Program. This is a combined synopsis/solicitation prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subparts 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested, and a separate written solicitation will not be issued. This solicitation is a Request for Proposal (RFP) using FAR Parts 13 procedures. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2020-07. The North American Industry Classification System (NAICS) code for the proposed acquisition is 541690 - Other Scientific and Technical Consulting Services. This is a total Women-Owned Small Business set-aside, in accordance with FAR 19.15.