Pelvic Floor Disorders

The Food and Drug Administration is seeking sources to provide consulting services collaborate for a research program entitled, - Evaluation of Safety and Effectiveness of Mesh Implantation in Surgical Interventions for the Treatment of Pelvic Floor Disorders. ' This is a REQUEST FOR QUOTATION (RFQ). This study is designed to assess: 1) the rates and types of surgical procedures and common adverse events experienced by women as a result of mesh implantation for the treatment of SUI and POP; 2) differences in safety and effectiveness of synthetic meshes in comparison to that of biologic meshes for the treatment of SUI and POP; 3) differences in safety and effectiveness of meshes implanted through abdominal approaches in comparison with those implanted through a transvaginal approach; and. The completion of these objectives will provide information regarding the safe and effective use of synthetic mesh devices for the treatment of SUI and POP. These findings will contribute to the science base in FDA on women's health by providing informative guidance for both pre-market regulation and post-market surveillance of surgical mesh devices by the United States Food and Drug Administration, Center for Devices and Radiological Health (FDA/CDRH). This proposal will be approved through the FDA IRB approval process prior to initiation of the study. All confidential data files are maintained at Kaiser Permanente. The contractor, will coordinate development of analytical data sets that can be used by FDA. He will oversee data collection at the Los Angeles Medical Center and serve as the primary point person for communication with CDRH/OSB/DPS/EB. The specific activities will include: 1. Serve as the point person for communication between the CDRH Epidemiologist and Los Angeles County Medical Center Kaiser Permanente 2. Ensure access to necessary data and develop de-identified datasets for analysis at CDRH 3. Develop questionnaires and collect data on additional questions necessary to meet the goals of the study 4. Obtain and maintain IRB approved status at Los Angeles County Medical Center Kaiser Permanente 5. Participate in manuscript and presentation preparation and dissemination 6. Other duties as necessary to attain the goals of the study. Work will be conducted for a 12-month period from July1, 2008-June 30, 2009. REQUEST FOR QUOTE (RFQ) any firm that believes it is capable of providing the required service as stated herein may submit a proposal to document its ability to provide the required services, which will be considered if received by the fifteenth (15th) calendar day following the appearance of this announcement. A determination to compete this procurement based on a response to this notice is solely within the discretion of the Government. All responses or questions regarding this posting must be in writing and can be sent via email to joseph.pishioneri@fda.gov. No phone calls will be accepted. An award will be made in fifteen (15) calendar days from the date of this notice. This sole source procurement will be awarded as a simplified acquisition for commercial items in accordance with FAR Subpart 13.5.