A -- Data Coordinating Center for the Immune Tolerance Network (ITN)
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The National Institute of Allergy and Infectious Diseases (NIAID), specifically the Division of Allergy, Immunology and Transplantation (DAIT), plans to negotiate a multi-year contract with Pharmaceutical Product Development (PPD) to continue providing essential statistical, data management, and safety monitoring support for the Immune Tolerance Network (ITN). This action is being taken under sole-source authority due to PPD's unique capabilities and the impracticality of competition, which would cause duplication of costs and unacceptable delays in the project's completion. PPD has been supporting the ITN under a subcontract with EMMES Corporation, and interruption of this support would critically impede clinical data collection, analysis, scientific development, and publication efforts related to immune tolerance research. The contract aims to ensure continuity in managing and analyzing critical clinical data for immune tolerance studies, with DAIT asserting that no other source can meet these requirements without significant risk of delay or increased cost. While the contract is intended for PPD on a sole-source basis, other interested parties may submit statements of capability by the specified deadline, provided they can demonstrate an ability to assume the work promptly without causing unnecessary delay or duplicative expenses. This procurement will follow the authority outlined in federal regulations under 41 U.S.C. 253(c)(1) and FAR 6.302-1(b)(1)(i), emphasizing the agency's reliance on PPD's unique expertise to support these specialized clinical research activities.
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