EARLY PHASE CLINICAL TRIAL UNITS (EPCTU)

Introduction This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. Background Research conducted and supported by the National Institute of Allergy and Infectious Diseases (NIAID) strives to understand, treat, and ultimately prevent the myriad infectious, immunologic, and allergic diseases that threaten millions of human lives. NIAID's Division of Microbiology and Infectious Diseases (DMID) supports extramural research to control and prevent diseases caused by virtually all infectious agents. An essential element of NIAID's extramural research efforts is evaluating new and improved therapeutic and vaccine candidates or finding additional uses for already approved therapies for selected infectious diseases via clinical trials and clinical studies. These clinical studies are crucial from a public health perspective because they help guide policy decisions regarding product use and/or facilitate development and evaluation of therapeutic candidates critical to advancing product development and, therefore, aid in public health preparedness. The purpose of the pending solicitation is to solicit proposals for the requirement of implementing Phase 0 to Phase II clinical trials, including proof-of-concept studies in healthy and diseased human populations, in an expeditious and efficient manner, aided by bioanalysis when necessary. In the event of urgent public health need, Phase III studies may be conducted using surge capacity. The candidate products to be evaluated under the Early Phase Clinical Trial Units (EPCTU) IDIQ contracts could include new or tested investigational products, such as small molecules; monoclonal antibodies; immunoglobulins; convalescent plasma; passive transfer studies; vaccines; adjuvants; and novel immunomodulatory products against infectious diseases, arising within DMID's preclinical and early product development programs, as well as those arising from other research partners outside of DMID. NIAID anticipates awarding Indefinite Delivery/Indefinite Quantity (IDIQ) type contracts to multiple contractors that meet the overall qualifications for individual Task Areas and will be based on best value to the US government. All projects carried out under the IDIQ contract(s) must be conducted in a manner consistent with all applicable U.S. federal regulations or international regulatory authorities, and the DHHS, NIH, NIAID, and DMID policies and guidelines for the conduct and oversight of research involving human subjects.