Support for Strategic Planning and Activities for NCI's Center for Strategic Scientific Initiatives (CSSI) Office of the Director

General Information: This is not a Request for Proposal (RFP). The National Cancer Institute (NCI), National Institutes of Health (NIH) intends to negotiate with the CCS Associates (CCSA) on a sole source basis for a five year (inclusive of options) period. Purpose: The purpose of this project is to provide support activities for the Director and Deputy Director of the Center for Strategic Scientific Initiatives (CSSI). This contract shall provide a wide and changing spectrum of expertise that can be applied to support activities in such areas as drug and device development, biomarker development and validation for use in drug development, U.S. regulatory requirements for investigational new drugs and investigational new devices, standard operating procedures for clinical laboratory research, clinical considerations in imaging probe development, clinical trial design in the development of biomarkers and imaging modalities as biomarkers that can be used in drug development, treatment, and monitoring of therapeutic responses. The principal function of this project is to provide scientific and project planning support for activities which require expertise in oncology, drug development, advanced technologies applied to drug and device development, biomarker science, imaging technologies, regulatory affairs, research project management, clinical trial management, business plan development, scientific writing, meeting implementation, and general business documentation. The NCI=s requirement can only be met by the CCS Associates, which possesses the following unique capabilities and expertise: 1) Deep and specialized knowledge and experience that crosses a wide spectrum of disciplines that includes drugs (basic, translational, clinical, and regulatory science); diagnostic tests; imaging; biomarkers; relational databases; statistics; informatics; protocol design and monitoring; regulatory science; intellectual property issues; and policies and regulations required to establish and effectively carry out public-private partnerships. 2) CCSA has acquired nonreproducible, specific and valuable knowledge and expertise from their past teamed effort that spans all areas of the proposed research efforts; and 3) CCSA's extensive experience and knowledge gained in the support of the research and planning efforts of CSSI initiatives such as the NCI Alliance for Nanotechnology in Cancer Program, The Cancer Genome Atlas, the Physical Sciences-Oncology Centers Program, and the Clinical Proteomics Technologies in Cancer Program. CCSA is the only firm that can fulfill this requirement within the required timeframe, with the necessary experience and expertise, and without substantial duplication of costs/effort, or substantial delay in performance. Authority: 41 U.S.C. 253(c) (1), as set forth in FAR 6.302-1(a)(2)(ii). This notice of intent is not a request for competitive proposals. No solicitation document exists. If there are any responsible contractors who have proven experience and meet the capabilities cited to perform the requirement, they may submit tailored capability statements that document experience, capabilities and qualifications which will be considered by the NCI. All information furnished must be in writing and must contain sufficient detail to allow the NCI to determine if it can meet the above unique specification described within this synopsis and the attached draft Statement of Work. Your tailored capability statement must address your demonstrated experience as a cross-disciplinary team composed of scientific personnel having scientific and business expertise and experience in all areas of the workscope including; drug and diagnostic test development, imaging, devices, relational databases, statistics, informatics, protocol design and monitoring, regulatory science, insurance coverage for clinical research, intellectual property issues, and policies and regulations required to establish and effectively carry out multi-party, public-private partnerships that has successfully supported research within executive-level projects at CSSI, NCI, NIH, and the pharmaceutical and biotechnology industries, can be submitted electronically (via e-mail) to Robin M. Irving at irvingr@mail.nih.gov and Kimberly Goetz at goetzk@mail.nih.gov in Adobe Portable Document Format (PDF) or by mail at the below addresses. If submitting the capability statement via e-mail, the subject line must specify N02-CO-07035-04. Facsimile responses will not be accepted. All information received within fifteen (15) calendar days after date of publication of this synopsis will be considered by the Government. Capability statements received after the due date and time will not be considered. 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 normally be considered solely for the purpose of determining whether to conduct a competitive procurement. No collect calls will be accepted. Please reference solicitation number N02-CO-07035-04 on all correspondence. If no responses are received, NCI will proceed with a sole source award. 1. Points of Contact: Robin M. Irving, Contracting Officer irvingr@mail.nih.gov Phone: 301-228-4220 (No collect calls will be accepted.) Contracting Office Address: If hand-delivered or delivery service Robin M. Irving, Contracting Officer Treatment and Support Branch Office of Acquisitions, NCI National Cancer Institute Building 244, Room 100 Frederick, MD 21702-1201 If using U.S. Postal Service: delete Building 244, Room 100 replace with P.O. Box B, 244 Miller Drive, Room 100 NOTE: Ft. Detrick is a secured military base. All visitors to the base must go through a security screening process before gaining access to the base. It is your responsibility to ensure that sufficient time is allotted to enter Fort Detrick, locate and deliver your capability statement prior to the date and time specified for receipt. It is recommended that you contact Kimberly Goetz on 301-228-4225 or Robin Irving on 301-228-4220 to schedule a specific date/time in order to deliver your capability statement.