The National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), plans to procure on a sole source basis services to conduct an analysis of four steroid hormones using serum from women who subsequently developed HCC and serum from women that did not develop HCC from Laval University, 2705, Boulevard Laurier, Room T3-48, Quebec, QC, V1V 4G2, Canada. 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 541380 and the business size standard is $14.0 Million. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract. The period of performance is twelve (12) months from date of award. It has been determined there are no opportunities to acquire green products or services for this procurement. The NCI Division of Cancer Epidemiology and Genetics is conducting a retrospective cohort study of primary liver cancer, among members of the Liver Cancer Pooling Project of the NCI Cohort Consortium. In order to understand better the etiology of primary liver cancer in the U.S., all U.S. based cohort in the NCI Cohort Consortium were invited to participate in the LCPP. All cohorts were invited to contribute questionnaire data from the entire cohort and prediagnostic serum samples from individuals who developed liver cancer and matched controls. Additionally, a nested case-control study of primary liver cancer is being conducted in tandem, utilizing the resources of the Multiphasic Health Cohort study (MHC) from Kaiser Permanente of Northern California. This study consists of Kaiser Permanente plan members who voluntarily enrolled into Multiphasic Health Checkups between 1965 and 1970. Similar to the LCPP, the MHC contributed questionnaire data and prediagnostic serum samples from individuals who developed liver cancer and matched controls. One of the hypotheses that the LCPP and MHC wish to examine was whether women who developed liver cancer had different steroid hormone levels than women who did not develop liver cancer. Serum samples from 555 women were provided from the LCPP and MHC. Contractor Requirements: The Contractor shall: 1. Conduct gas chromatography-mass spectrometry (GC-MS) assays to quantify the following hormones in 555 samples: a. Testosterone (T) b. Estradiol (E2) 2. Additionally in 528 samples with sufficient quantity of serum (200 uL), liquid chromatography-tandem mass spectrometry (LC-MSMS) assays shall be used to quantify the following hormones: a. Dehydroepiandrosterone Sulfate (DHEAS) b. Estrone Sulfate (E1S) 3. Provide an interim report on the preliminary results 2 weeks after initiating the analysis of serum samples. This report shall include information of the coefficient of variations (CVs) of each analyte measured thus far, and quality on the results ascertained to date, including the values of those serum samples ascertained to date. 4. Provide the hormone and protein quantitation data on all 555 samples, plus additional QC samples run by the contractor in each batch, in an accessible format (such as .xlsx, .dta, or .csv) no later than 12 months from the date of the award. 5. All biological materials provided by the U.S. Government, all residual specimens, and all data generated shall be the property of the U.S. Government. Government Responsibilities: The Government will: 1. Ship 555 serum samples with a separate identification number to the Contractor. All samples will be shipped at the same time on dry ice from Frederick, Maryland, USA on the first day of period of performance. 2. Provide the Contractor with information as to which samples should be analyzed in which batch and in which order. This will be in order to blind the Contractor as to the unaffected/unaffected status of the samples to ensure integrity of analysis for subsequent publication review. 3. The Government COR will examine the interim report. 4. Upon receipt of the second and final deliverable from the Contractor, the Government COR will examine the received data. Reporting and/or Deliverables: Two weeks after initiating the analysis of serum samples the Contractor shall provide the government with an interim report of results in the form of an email. This report shall include information on the results to date including the CVs and quality of quantitation. The second and last deliverable is a dataset which contains the identification number of each participant (or QC sample) and the quantified levels, including units, of all hormones and proteins stated in C1. This data shall be delivered by email to the COR in an accessible format such as xlsx, .dta, or .csv. Stored serum samples from the cohort are available for the study. As very little serum is available for these analyses, DCEG proposes to contract with Laval University, the only capable vendor known to determine levels of estradiol in an exceedingly small amount of serum (220 - L) based on previous studies conducted by NCI. The use of other laboratory that requires much larger amount of serum will result on incomplete testing based on available quantity. Therefore, Laval University is the only vendor that can meet the DCEG's needs and be cost effective for the Government 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 AM EST, on August 20, 2014. All responses and questions must be in writing and faxed to
+1 (555) 000-0000 or emailed to Reyes Rodriguez, Contracting Specialist via electronic mail at
contact@example.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. No collect calls will be accepted. In order to receive an award, contractors must be registered and have valid certification in the Central Contractor Registration (CCR) and the Online Representations and Certifications Applications (ORCA) through sam.gov. Reference: N02CP42612-57 on all correspondence.
