DHHS/FDA/OFACS/IT CONTRACTS BRANCH, HFA-511, 5600 FISHERS LANE, PARK BLDG, RM 3-20, ROCKVILLE, MD 20857

D -- MISCELLANEOUS SOL FDA B39125-97 DUE 121396 POC Debbie Hammond, Contract Specialist (301)443-5970, Contracting Officer, Dennis H. Hunt (301)443-1555, FAX # (301) 594-3702 This solicitation is a notice of intent to issue this solicitation on a sole source basis to RHO, Chapel Hill, NC only. This procurement is for services to be performed on FDA's COMPUTER ASSISTED REVIEW OF SAFETY (CARS) electronic data base according to the following Scope of Work: 1) Obtain a pharmaceutical company or CRO database (PharmCo database) containing complete data from multiple studies of a real compound that has been developed for submission in an NDA, and preferable submitted in an NDA. Data should represent all domains of data that would eventually constitute an NDA submission, 2) Develop complete documentation of the PharmCo database, 3) Map the PharmCo database to the CARS database to the maximum practical extent, 4) Identify any CARS design characteristics that make the mapping expensive, difficult, or impossible, 5) Prepare a brief report documenting any CARS design characteristics that cause difficulties, 6) Obtain two additional independent assessments of the report. These assessments should address the feasibility and efficiency of mapping live pharmaceutical data into the proposed data model, 7) Present the report, with the assessments, to FDA staff and consultants and participate in discussions of potential modifications to the CARS database design. See Note(s): 26. (0331)

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