Mitochondria, Telomeres, and Lifestyle in Li-Fraumeni Syndrome Outcomes

The National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Clinical Genetics Branch (CGB) plans to procure, on a sole source basis, services for the creation of EBV lymphocytes, and myoblasts; storage of both, and shipment to NCI when ready; and assistance with data analysis; in order to improve risk stratification of patients with LFS and advance the understanding of the consequences of germline TP53 mutations, from Funda'ao Ant'nio Prudente (DBA Hospital A C Camargo), Rua Professor Ant'nio Prudente 211, Sao Paulo, SP, BRAZIL, 01509 - 010. This acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1(b)(1). The North American Industry Classification System code is 541990 and the business size standard is $14.0 million. The period of performance is twelve (12) months from the date of award. It has been determined there are no opportunities to acquire green products or services for this procurement. PROJECT OBJECTIVES: Under the previous contract, DNA extraction of 100 samples, sample processing, and shipment of DNA samples to NCI for telomere measurement was completed. The objectives of this requirement include: the creation of EBV lymphocytes, and myoblasts; storage of both, and shipment to NCI when ready; as well as assist in analyses of data in order to improve risk stratification of patients with LFS and advance the understanding of the consequences of germline TP53 mutations. UNIQUE QUALIFICATIONS OF THE CONTRACTOR: Studies of LFS in Southern Brazil have identified a unique cohort of patients with a founder mutation (TP53*R337H) in approximately 0.3% of newborns. This mutation was originally associated with adrenocortical cancer but subsequent studies have shown that carriers of this mutation are at risk of the complete spectrum of LFS-related cancers. Notably, there is a subset of cancer-free TP53*R337H mutation-carriers who have a "youthful" appearance, suggesting a yet-to-be identified genetic modifier with an impact on aging. This mutation is only found in Brazil; the requested services can only be achieved through the collaborative efforts of the Hospital A. C. Camargo - Fundao Antonio Prudente and the NCI. The LFS patient population at Hospital A. C. Camargo - Fundao Antonio Prudente is unique and not readily available elsewhere. CONTRACTOR REQUIREMENTS: The Contractor shall: 1.Create EBV lymphocytes, myoblasts from 100 samples previously collected and stored in Brazil until ready to ship to NCI 2.Assist with data analyses, under the direction of NCI GOVERNMENT RESPONSIBILITES: The NCI shall: 1.Perform mitochondrial DNA copy number measurement 2.Analyze the primary mitochondrial DNA copy number data in TP53 mutation carriers compared with controls in both the Brazil and NCI cohorts REPORTING REQUIREMENTS AND DELIVERABLES: No later than 12 months after the period of performance start date, the Contractor shall deliver the following to NCI/DCEG/CGB: 1.EBV lymphocytes, myoblasts from 100 individuals with LFS and their family members. 2.Provide de-identified data on the 100 individuals who contributed specimens, as specified by NCI. INSPECTION AND ACCEPTANCE CRITERIA: NCI will have one month in which to review and accept the specimens and final data. If no comments or request for revisions are provided within one month, the deliverables shall be considered acceptable. This notice is not a request for competitive quotation. However, if any interested party, especially small business believes it can meet the above requirement, it may submit a proposal or quote for the Government to consider. The response and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 11:00 AM EST, on March 11, 2016. All responses and questions must be via email to Megan Kisamore, Contract Specialist at megan.kisamore@nih.gov. 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 be registered and have valid certification through SAM.GOV and have Representations and Certifications filled out. Reference: N02CO62536-8 on all correspondence.