The National Institute of Allergy and Infectious Diseases (NIAID) intends to negotiate with McKesson BioServices, for a modification to its Contract N01-AI-05413. The contract currently provides regulatory support services for the operations of the Office of Regulatory Affairs, Division of Microbiology and Infectious Diseases. The Contractor is responsible for data and document collection and compilation for regulatory filing for Investigational New Drug Applications (IND) with the US Food and Drug Administration; technical review and report preparation; clinical site monitoring activities; final container packaging; labels, storage, distribution and tracking of investigational products; implementing and maintaining computer information systems; providing administrative coordination and general logistical support for regulatory activities and other services as required. The planned negotiated modification will provide for a level of increased effort over a period of five (5) years (within the contract's current period) to expand the DMID's capability to conduct Phase I, II and III evaluations of candidate vaccines and treatments for the Congressionally mandated development of medical counter measures against biological agents and toxins that may be involved in bio-defense emergencies. This will require expansion of all aspects of the infrastructure that McKesson and their subcontractors already have in place to meet this requirement for rapid response in the development and testing of these products. Authority: 41 USC 253(c)(1), as set forth in FAR 6.302-1(b)(1), Unique capabilities. If there are responsible sources who feel that they are able to perform the requirement, they must respond by the closing date noted above. See Government-Wide Numbered Note 22. No collect calls will be accepted.

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