The National Institutes of Health (NIH), National Cancer Institute (NCI), intends to procure on a sole-source basis with Dr. Anthony B. Miller, 392 Lakeshore Road, Oakville, Ontario L6J18, Canada to provide services regarding the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial and the National Lung Screening Trail. This acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR 13.106-(b)(1). The North American Industry Classification System Code is 541990 and the business size standard is $6.5M. Period of performance: Base Year shall be twelve (12) months from date of award with one twelve (12) month option period. The Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial is a large scale, randomized study to determine whether certain screening tests will reduce the number of deaths from these cancers. The NCI ongoing trial involves nearly 155,000 men and women ages 55 through 74 at 10 study centers across the United States. Secondary objectives of the trial include assessment of: a.) Screening process measures for each intervention, including sensitivity, specificity, and positive predictive value; b) Incidence, stage, and survival experience of cancer cases; c) The mortality predictive value of biologic and/or prognostic characteristics of tumor tissue as intermediate endpoints. The Contractor shall provide epidemiological services to the NCI Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial. The Contractor shall provide scientific expertise for the protocol projects noted herein. All data is collected by the PLCO screening centers and is owned and will be supplied to the Contractor by the Government when required. Guidance and recommendations shall be provided quarterly, two of the reports shall be submitted in conjunction with the two PLCO/NLST Steering Committee meetings and two reports shall be submitted three (3) months after each steering committee meeting. The contractor shall use his expertise and knowledge of the current literature and epidemiological concepts as the community develops such recommendations. The Contractor shall: - provide guidance relating to the epidemiological and PLCO-related studies that are supported by the Early Detection Research Group (EDRG), DCP, NCI. - provide recommendations on epidemiological aspects of data analysis and modeling in the PLCO trial. - provide recommendations on epidemiological aspects of health-related quality of life (HRQL) and cost-effectiveness (CE) studies in the PLCO trial - provide recommendations for the pathology review in the PLCO trial. - provide planning for combined data analysis of the PLCO trial prostate arm and the International Prostate Screening Trials Evaluation Group (IPSTEG). - serve as Chair of the Endpoint Verification Committee (EVT). The committee reviews death certificates of NLST participants who are chosen by the committee chair. Dr. Miller has an in-depth knowledge of the Trial protocols, operations, and requirements of this complex screening trial. Dr. Miller developed the PLCO Death Data Review Protocol and the Pathology Protocol for PLCO while a visiting scientist at NCI. Dr. Miller also developed the National Lung Screening Trial (NLST) Endpoint Verification Protocol. This protocol is currently being used to determine the cause of death of NLST participants. Dr Miller analyzed the Quality of Life and Cost Effectiveness needs of the PLCO trial and the development of pilot projects to establish availability of data and suitability of analysis approaches. Continuity in this effort with Dr. Miller is essential to assure no interruption in the ongoing work. Dr. Miller participates in annual working meetings of International Prostate Screening Trials Evaluation Group (IPSTEG) held in the U.S. and abroad as a representative of the PLCO and is accepted among the international trialists as a qualified expert of international reputation. This is not a solicitation for competitive quotations. However, if any interested party believes it can meet the above requirement, they may submit a statement of capabilities. All information furnished shall be in writing and must contain sufficient detail to allow the NCI to determine if it can meet the above unique specifications described herein. An original and one copy of the capability statement must be received in the NCI contracting office by 1:00 PM EST on February 5, 2008. All questions must be in writing and can be faxed (301) 402-4513 or emailed to Melissa Marino, Contract Specialist at [email protected]. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. In order to receive an award, contractors must have valid registration and certification in the Central Contractor Registration (CCR) www.ccr.gov and the Online Representations and Certifications Applications (ORCA), http://orca.bpn.gov. No collect calls will be accepted. Please reference NCI-80025-MM on all correspondence.

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