Urinary amino polycyclic aromatic hydrocarbon, OH-phenanthrene, and cotinine, and blood nitro-PAHs-Hgb content assays

National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Metabolic Epidemiology Branch (MEB), plans to procure on a sole source basis services to quantify amino-PAHs (1-aminonaphthalene, 2-aminonaphthalene,1-aminopyrene and 3-aminobenzanthrone), OH-PHEs (1-, 2-, 3-, 4-, 9-hydroxyphenanthrene, and total OH-PHE), creatinine and cotinine in urine samples, and nitro-PAH-Hgb adducts in red blood cell samples. from Duke University, 2200 W Main St Ste 710; Durham, NC, 27708-4677. The response close date of this notice for this requirement is in accordance with FAR 5.203(a)(1). This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1(b)(1), and is exempt from the requirements of FAR Part 6. The North American Industry Classification System code is 621511 and the business size standard is $32.5M. 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 will be twelve (12) months from date of award. It has been determined there are no opportunities to acquire green products or services for this procurement. Diesel engines are used in automobiles, generators, light-duty and heavy-duty vehicles as well as railroad locomotives. When diesel fuel burns in an engine, the resulting exhaust is made up of soot and gases representing thousands of different chemical substances. 90% of the soot consists of <1um diameter particles that can be inhaled and deposited in the lungs. Diesel exhaust contains 20-100 times more particles than gasoline exhaust. These particles carry absorbed cancer causing substances such as nitro polycyclic aromatic hydrocarbons (nitro-PAH)'s. Residents of the neighboring counties of Xuanwei and Fuyuan have the highest lung cancer mortality rates in China, regardless of gender or smoking status (lung cancer mortality among non-smoking women in this population is among the highest in the world). Several lines of research have established that exposure to the household air pollution (HAP) produced by the domestic combustion of locally sourced "smoky" (bituminous) coal is responsible for the lung cancer epidemic in the area. While the carcinogenic constituents of smoky coal and its associated HAP are not yet entirely known, exposure to high levels of polycyclic aromatic hydrocarbons (PAHs) have been implicated in playing at least a part of the overall cancer risk in the area. After entering human bodies, nitro-PAHs can be metabolized into amino-PAHs that are excreted in human urine. Therefore, urinary amino-PAHs may serve as biomarkers of diesel exhaust or coal combustion exposure. Hydroxylated phenanthrene (OH-PHEs), human metabolites of phenanthrene (the 5 isomers: 1-, 2-, 3-, 4- and 9-hydroxyphenanthrene), are among the most widely used urinary biomarkers for measuring PAHs exposure. In addition, both populations are exposed to tobacco via active or passive smoking and it is critical to measure a biomarker of exposure , cotinine, so that it can be taken into account in the statistical analysis as a potential confounder. Hgb adducts are usually stable over the lifetime of erythrocytes (120 days) and are eliminated together with the erythrocytes. The adduct levels represent therefore a steady state situation resulting from exposure over the last 3-4 months. Therefore, to detect nitro-PAH-Hgb contents in red blood cell is critical to evaluate the long-term exposure to diesel exhaust or coal combustion. The NCI is conducting a diesel biomarker study and an exposure assessment study (MQ515928) in Xuanwei and Fuyuan and will analyze urinary OH-PHEs, urinary cotinine, amnio-PAHs, and blood nitro-PAHs-Hgb adduct levels in these studies to assess the association between PAHs exposure and cancer risk. The NCI will ship 1 ml urine for each of 225 samples (for OH-PHEs), 2.2 ml for each of 125 urine samples (for nitro-PAHs metabolites), 0.3 ml for urinary cotinine for 300 samples, and 1 ml red blood cell samples for each of 125 blood samples (for hemoglobin adducts of nitro-PAHs) in one batch to contractor within 2 weeks of the contract start. Samples will be coded and will not have any personal identifiers attached. The NCI principal investigators will review the final report from this project. The contractor shall apply HPLC-fluorescence technique to analyze urinary amino-PAH metabolites, nitro-PAHs-Hgb adducts in blood samples from 125 samples (including QC samples), analyze 300 urine samples for cotinine, and apply a new developed gas chromatography-mass spectrometry (GC-MS) method to quantify OH-PHEs (1-, 2-, 3-, 4-, 9-hydroxyphenanthrene, and total OH-PHE), cotinine, and creatinine concentration for 225 urine samples. This analysis will benefit the U.S. government and the public by providing new information about the etiology of environmentally caused lung cancer, which is an important public health concern particularly among non-smoking populations. Isomers of hydroxyphenanthrene (OH-PHEs), amino-PAHs, nitro-PAH-Hgb adducts are sufficient PAH biomarkers to predict environmental PAHs and nitro-PAH exposure and urinary cotinine can predict tobacco exposure. Duke University has developed sensitive assays to measure the OH-PHEs (1-, 2-, 3-, 4-, 9-hydroxyphenanthrene) and cotinine in human urines. These assays use unique quality assurance procedure by GC-MS technique that is sensitive enough to detect these OH-PHEs and cotinine in the general population. In addition, the proposed laboratory has developed a unique assay for nitro-PAH-Hgb adducts. Further, Duke University has previously performed amino polycyclic aromatic hydrocarbon content assays in a NCI study. As such, it is critical that samples from this same study are analyzed by the same lab using the same equipment, QC and data processing procedures to ensure scientific comparability of the results. This notice is not a request for competitive quotation. However, if any interested party, especially small businesses, believes it can meet the above requirement, it may submit a capability statement, proposal, or quotation, which shall be considered by the agency. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow the NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 4:00PM EDT, on September 15, 2016. All responses and questions must be in writing and faxed (240) 276-5401 or emailed to Seena Ninan, Contracting Officer via electronic mail at ninans@mail.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. No collect calls will be accepted. In order to receive an award, Contractors must be registered and have valid, current Entity Record, including current Representations and Certifications, in the System for Award Management (SAM) through SAM.gov. Reference: N02CP66000-63 on all correspondence.