Evaluation and Testing Services (ETS) for Vaccines and Other Biologics for Infectious Diseases   3

The purpose of the anticipated solicitation is to establish a NIAID resource entitled "EVALUATION AND TESTING SERVICES (ETS) FOR VACCINES AND OTHER BIOLOGICS FOR INFECTIOUS DISEASES" that provides a suite of preclinical, nonclinical, and clinical testing services for vaccines and other biologic products. While the overall suite of testing services is comprehensive, the intent is to provide individual services on a case-by-case basis for a diverse collection of vaccine and biological product candidates, rather than carry a single product candidate through an entire preclinical development pathway. These services are intended to help a wide variety of investigators in a broad 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/III trials), fulfill regulatory requirements, and complete studies needed to apply for an IND and enter Phase I/II/III trials. These testing capabilities may also support vaccines or other biological products that are intended to interrupt or block pathogen transmission (such as vector-borne diseases) or for use in animals that constitute a disease reservoir for, or other disease threat from, a pathogen that has public health significance. Support for efforts associated with zoonotic diseases may be considered on a case-by-case basis dependent on adequate justification for Public Health considerations. The Offeror shall be responsible for ALL work performed and shall be responsible for project planning, initiation, implementation, management and communication; evaluation, selection, and management of subcontractors; and for all deliverables specified in this contract and each awarded Task Order.