The National Cancer Institute intends to negotiate a sole source modification(s) with M.D. Anderson Cancer Center HHSN261200622002C, the University of California at Davis -HHSN261200622009C, the University of Chicago - HHSN261200622001C, Montefiore Medical Center - HHSN261200622004C, the Mayo Clinic - HHSN261200622005C, H. Lee Moffitt Cancer Center - HHSN261200622008C, the Memorial Sloan-Kettering Cancer Center HHSN261200622006C, the Ohio State University - HHSN261200622007C and
Princess Margaret Hospital - HHSN261200622003C. The Government is currently conducting the Early Therapeutics Development with Phase II Emphasis which has created a flexible platform so that early clinical trials consortia are prepared to rapidly evaluate the biologic effects of NCI-sponsored anticancer agents on their molecular targets and to determine clinically-relevant correlates. This scalable mechanism, which permits the formation of flexible consortia in response to scientific opportunities, has provided the majority of the essential clinical trials infrastructure and laboratory support to the Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis (DCTD), NCI for complex Phase II trials in its partnerships with academia and industry.

The proposed sole source modification to the current contract(s) will allow for a 3-6 month extension of the current contract(s) until the competitive acquisition for the follow on contract(s) which are planned to be awarded by February 28, 2011, and to also allow for a completion period in the event the incumbent(s) are not successful in the competitive acquisition process. Statutory authority to justify this procurement is 41 U.S.C. 253(c)(1) as set forth in FAR 6.302-1(a)(2), Only One Responsible Source. This extension will support the uninterrupted continuation of clinical trials involving the treatment of cancer patients. The current contractors are uniquely qualified by virtue of their ongoing performance because they have the appropriate administrative and technical infrastructure in place for clinical trials, both currently ongoing and in review (e.g. Institutional Review Board (IRB) and patient consents, etc.), and have established the necessary relationships with the subjects participating in ongoing clinical trials. If this effort were to be awarded to any other contractor it would result in the disruption of treatment of subjects participating in ongoing clinical trials, which would be unethical. In addition, it would take approximately 3-6 months for other contractors to establish infrastructure (clinical setting, IRB and FDA approvals, and the recruitment of subjects) and be able to perform at the same level as the current contractor. This would result in unacceptable delays to the government and result in a duplication of costs which competition of this requirement unfeasible.

The proposed contract action is for supplies or services for which the Government intends to solicit and negotiate with only one source under the authority of FAR 6.302-1. Interested persons may identify their interests and capability to respond to the requirement or submit proposals. This notice of intent is not a request for competitive proposals. However, all proposals received within 15 days after the date of publication of this synopsis will be considered by the Government. A determination by the Government not to compete this proposed modification, 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.

 

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