SOURCES SOUGHT - MEDICAL REVIEWER This is a SOURCES SOUGHT NOTICE to determine the availability and capability of potential small businesses (including HUBZone firms; certified 8(a), Small Disadvantaged, veteran and service-disabled veteran-owned small businesses, and women-owned small businesses) that can provide services of a Medical Reviewer as follows : 1.Project Management - Development and maintenance of an overall work plan and timeline, management of overall project activities to meet this timeline, and reporting on project status on a monthly basis. Monthly status reports, to include number of hours worked. 2.Literature Review – Collect all relevant data and information on the drug class or product identified and evaluate the data as it relates to clinical safety and efficacy of the products. 3.Strategy Development – Identify incentives and innovative regulatory strategies that could be employed to encourage firms to submit applications and obtain approval for specific medically necessary drugs. 4.Identification of obstacle(s) to obtaining approval – Perform research necessary to identify the obstacle(s) to obtaining approval specifically for medically necessary drugs. 5.Development of documents to support strategy – Develop the specific documents, including but not limited to guidelines, federal register notices and draft regulations that implements the strategy to streamline the application process and identify for firms the requirements for obtaining approval of specific medically necessary drugs. 6.Prepare protocols for clinical trials – Evaluate data and prepare protocols for clinical trials. If necessary develop specific protocols for clinical trials on medically necessary drugs. 7.Generally Recognized as Safe and Effective (GRAS/E) review – Evaluate products to determine if they are GRSA/E as outlined in 21 U.S.C. 321(P) (1). Firms responding to this SOURCES SOUGHT announcement should indicated whether they are small business (please include the name of the Small Business Specialist and telephone number, if applicable). This information will be used to determine the appropriateness and type of small business set-aside. The applicable North American Industry Classification System (NAICS) Code is 541990 and the size standard is $6.5 million dollars. A fixed price contract with one, twelve (12) month option period is contemplated. Qualification statements are due no later than 10 business days after publication of this notice (or August 8, 2008) and should reference Sources Sought No. 1046609.

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