MANUFACTURING AND CHARACTERIZATION SERVICES FOR VACCINES AND OTHER BIOLOGICS FOR INFECTIOUS DISEASES

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 supported by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), strives to understand, treat, and ultimately prevent the myriad infectious, immunologic, and allergic diseases that threaten millions of human lives. The NIAID Division of Microbiology and Infectious Diseases (DMID) supports extramural research for the investigation, control and prevention of diseases caused by all infectious agents other than HIV. Support for basic and applied research to develop and evaluate therapeutics, vaccines, and diagnostics is provided through a variety of research grants and contracts. NIAID also supports an array of research resources and services to assist investigators, including programs that provide or make available genomic data and technologies; organisms and state-of-the-art reagents; biocontainment facilities; and preclinical and clinical translational research services (http://www3.niaid.nih.gov/research/resources/dmid). The development and introduction of new vaccines and biologics against potential agents of bioterrorism, drug-resistant pathogens, emerging and re-emerging infectious diseases, as well as infectious diseases prevalent in resource-limited countries remain a high public health priority. To assist in filling these public health gaps, the NIAID requires a product development-oriented program to provide preclinical development support for multiple vaccine and biologic candidates that emerge from academia, the private sector, or other sources. These services are intended to help a wide variety of investigators in a number of scientific areas obtain critical data needed to acquire additional funding, gain prospective partnerships (either for further development or to support Phase I/II trials), fulfill regulatory requirements, and support Phase I/II clinical studies. While the overall suite of services provided is comprehensive, the intent is to provide individual services on a case-by-case basis for a diverse collection of product candidates, rather than carry a single product candidate through an entire preclinical development pathway. NIAID anticipates awarding a single IDIQ contract that provides a guaranteed minimum award to the organization or consortium that best meets the overall qualifications needed to fulfill the technical requirements of this solicitation. Sample Task Orders are provided in the RFP solely to evaluate offeror responses and capabilities. Task Orders for specific tasks will be issued after award of the Parent Contract.