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D -- SUBMISSION MANAGEMENT AND REVIEW TRACKING SYSTEM DEVELOPMENT SOL 223-94-5529 DUE 082396 POC Leonard Grant, Contract Specialist, (301) 443-1555, Dennis Hunt, Contracting Officer, (301) 443-1555, FAX (301) 827-0966 The FDA has launched a major management information systems initiative which has the purpose of reducing the time required required to bring new regulated products to market through process improvement and the use of information systems technologies in the preparation, submission, and review of applications from industry. The purpose of this contract is to obtain technical support for the development of application software and the conduct of analysis and technical studies to support the SUBMISSION MANAGEMENT AND REVIEW TRACKING (SMART) Program being develop by the FDA. The FDA intends to extend the contract to include additional work that needs to be performed in order to complete this system. A sole source award is planned to the incumbent Systems Research and Applications Corporation (SRA). SRA is uniquely qualified to continue the development of the SMART initiatives. Any other contractor would have to ascend a learning curve that would result in unacceptable delays in fulfilling the FDA's requirements; also it would result in substantial duplication of costs to the Government that are not expected to be recovered through competition. Some tasks under the SMART contract are in their final stages; therefore, the incumbent is needed to complete deliverables and training and establish maintenance methodology. See Numbered Note 22. (0194)

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