DESCRIPTION OF NOTICE: The National Cancer Institute (NCI) anticipates issuing an award on a non-competitive basis for pyruvic-1-13C acid pursuant to the authority in FAR 13.106-1(b)(1) using simplified acquisition procedures. Clinical-grade pyruvic-1-13C acid from Sigma Aldrich ISOTEC, Inc. has been tested, validated and utilized in all previous studies utilizing hyperpolarized pyruvate imaging in humans using the GE SPINlab dynamic nuclear polarization system. This includes ongoing studies with Sigma Aldrich ISOTEC-sourced clinical-grade pyruvic-1-13C acid at University of California at San Francisco, University of Texas Southwestern Medical Center, and other medical centers in the United States. Moreover, GE Healthcare and UCSF researchers have specifically tested and validated the sterile filling and sealing processes of the SPINlab clinical fluid path using Sigma Aldrich ISOTEC-sourced clinical-grade pyruvic-1-13C acid, and the IND covering studies with pyruvic-1-13C acid. The NCI's final drug product is investigational and produced under an IND. A change in product suppliers for the active ingredient (13C pyruvic acid) is considered a major change and requires a full amendment process, and revalidation of the entire process using the new product before the FDA will allow use of the new product. Thus, no other supplier is feasible for this procurement. This acquisition will be exempt from the requirements of FAR Part 6. This notice is not a request for a competitive quotation; however, if any interested part - especially any small business - believes it can meet this requirement, it may submit a capability statement for the Government to consider . A determination by the Government not to compete this proposed requirement 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 respond to any subsequent solicitation and must be registered and have valid certifications through SAM.gov. PROJECT BACKGROUND: The NCI requires pyruvic-1-13C acid for use in ongoing clinical studies. Most major diseases, including cancer, are often linked to metabolic alterations. However, being able to see the changes as they occur and to see if a treatment is working in ‘real-time’ is challenging. Here, the emerging methodology of Hyperpolarized Carbon-13 Metabolic Imaging has created new opportunities to non-invasively study biochemical changes in disease processes by improving the sensitivity of Magnetic Resonance Imaging by more than 20,000-fold as reported in the J.H. Ardenkjaer-Larsen et al., Proceedings of the National Academy of Sciences, 2003. SPINlab™, a powerful new imaging technology, uses hyperpolarized 13C (carbon-13) to monitor metabolic processes in real time. This approach helps researchers to study the real-time metabolism of disease to reveal visual information related to the flow, perfusion, metabolism, enzyme activity, and organ and cell viability in human patients. Clinical-grade pyruvic-1-13C acid from Sigma Aldrich ISOTEC, Inc. has been tested, validated and utilized in all previous studies utilizing hyperpolarized pyruvate imaging in humans using the GE SPINlab dynamic nuclear polarization system. This includes ongoing studies with Sigma Aldrich ISOTEC-sourced clinical-grade pyruvic-1-13C acid at University of California at San Francisco, University of Texas Southwestern Medical Center, and other medical centers in the United States. Moreover, GE Healthcare and UCSF researchers have specifically tested and validated the sterile filling and sealing processes of the SPINlab clinical fluid path using Sigma Aldrich ISOTEC-sourced clinical-grade pyruvic-1-13C acid, and the IND covering studies with pyruvic-1-13C acid with which we are cross-filing with the FDA was originally generated using data obtained from the Sigma Isotec product. The Molecular Imaging Branch in NCI possesses a SPINlab clinical polarizer instrument that is intended for hyperpolarization of clinical doses of 13C imaging agents such as pyruvic-1-13C acid. Researchers in the Molecular Imaging Branch, Urologic Oncology Branch , Radiation Biology Branch, Neuro-Oncology Branch, are collaborating to perform clinical trials utilizing hyperpolarized pyruvic-1-13C acid to visualize metabolism in urologic (e.g. kidney, prostate) as well as brain malignancies. These clinical doses of pyruvic-1-13C acid are necessary for the conduct of these studies. Additional information can be found in the attached Statement of Need. REQUESTED INFORMATION: Responses must be furnished in writing and must contain material in sufficient detail to allow the Government to determine if the party can provide the supplies outlined in this requirement. Responses must be received in the contracting office by the deadline stated in this notice. All responses and/or questions must be submitted via e-mail to Renee Jones-Chuang, Contract Specialist, at
[email protected]. Responses should include both the STATEMENT OF CAPABILITY and the BUSINESS SIZE AND SOCIOECONOMIC STATUS information as explained below. (1) Statement of capabilitity - Submit a brief description (10 pages or fewer) that includes product specifications. Include past experience with supplying this product to Government agencies or for a private medical facility. Please indicate your business address and unique entity identifier (UEI). (2) Business Size and Socio-Economic Status: (a) Indicate whether your organization is a small business or other-than-small business. (b) If small, indicate if your firm qualifies as a small, emerging business; or a small disadvantaged business. (c) If disadvantaged, specify under which disadvantaged group and if your firm is certified under Section 8(a) of the Small Business Act. (d) Indicate if your firm is a certified HUB-Zone firm. (e) Indicate if your firm is a woman-owned or operated business. (f) Indicate if your firm is a certified Service-Disabled Veteran Owned Small Business (SDVOSB) or a Veteran Owned Small Business (VOSB). (g) Include the DUNS number of your firm. (h) State whether your firm is registered in the System for Award Management (SAM).