Metals, Micronutrients, and Gallbladder Cancer, Urine Creatinine Testing

Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E226, Bethesda, MD 20892, UNITED STATES. Non-USPS mail such as Fedex, UPS and other private carriers please use Rockville, MD 20850. The National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), would like to issue a contract to evaluate the association of metals and micronutrients with 1) gallbladder cancer (GBC) compared to gallstones and 2) gallstones compared to population-based controls. This is a combined synopsis/solicitation for commercial items, prepared in accordance with format in FAR 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation and a separate written solicitation will not be issued. This solicitation: No. N02CP72607-24 includes all applicable provisions and clauses in effect through FAR FAC 2005-95 (January 2017) simplified procedures for commercial items. The North American Industry Classification System code is 541380 and the business size standard is $15.0 million. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price contract. I. Description of Requirement The Division of Cancer Epidemiology and Genetics (DCEG) is a research program of the National Cancer Institute (NCI), one of the National Institutes of Health (NIH). The Division is the world's most comprehensive cancer epidemiology research group. Its renowned epidemiologists, geneticists, and biostatisticians conduct population and multidisciplinary research to discover the genetic and environmental determinants of cancer and new approaches to cancer prevention. The Division's research informs public health policy in the United States and around the world. DCEG carries out its research program with a cadre of in-house researchers and trainees. Our investigators conduct research on most cancer organ sites among diverse populations in the United States and around the world. They utilize a full range of research approaches to study risk factors ranging from workplace exposures to lifestyle choices. A number of metals, such as arsenic, cadmium, and chromium, have been associated with increased risk of many cancers. Micronutrients, which are elements required for normal growth and functioning in trace amounts and include both metals, like calcium, and non-metals, like selenium, have been associated with decreased cancer risk, however various studies yield contradictory results. The role of micronutrients seems to depend on the tissue type and concentration and timing of exposure. Exposure to metals and micronutrients is a combination of nutrition, environmental exposure, and occupational exposure. Different biological samples also provide distinct but complementary information regarding an individual's exposure to metals and nutritional status. For example, measurement of cadmium using serum is indicative of short-term exposure whereas measurement of cadmium in urine is indicative of long-term cadmium exposure. The half-life of cadmium in kidney is 7-10 years, whereas the half-life of cadmium in serum is approximately 30 days. Lead analysis is another example. Primarily lead is analyzed in whole blood, where the pharmacologic mechanism of action is binding to red blood cells. Lead is rarely found in serum, but since the primary route of excretion is through the kidney, urinary measurements of lead can serve as an exposure measure. Many metals (e.g., lead, vanadium, chromium, cobalt, molybdenum, arsenic, manganese, calcium) are primarily excreted in urine. Thus, urine can serve as a valid measurement of body burden and exposure toxicity when biological specimens such as whole blood are not readily available. Few studies have evaluated the role of metals in gallbladder carcinogenesis. A small case-control study of 30 gallbladder cancer (GBC) cases and 30 gallstones controls from northern India found that trace micronutrients (selenium and zinc) were lower in serum, bile, and gallbladder tissue from GBC cases compared to gallstone controls, while cadmium, chromium, copper, lead, manganese, and nickel were significantly higher in one or more of these sample types among GBC cases. Another small study in India involving 96 patients with biliary disease, including 38 with gallbladder cancer and 58 with gallstones, found that the levels of cadmium, chromium, and lead in bile were significantly higher in patients with gallbladder cancer than in those with gallstones. A study comparing heavy metals and trace elements among GBC cases and gallstone patients in India (8 GBC, 5 gallstone) and Japan (5 GBC, 4 gallstone) found that in general, levels of metals (chromium, lead, arsenic, zinc) were significantly higher in India than in Japan, both in GBC and gallstone patients. In both countries, heavy metal levels tended to be higher among GBC cases than gallstone patients. However, Northern Chile has the highest levels of heavy metal (e.g., arsenic, cadmium, chromium) contamination in Chile, particularly with regard to copper and arsenic, and yet this region has the lowest risk of GBC nationwide. To clarify the role of metals and the possible interaction of heavy metals and micronutrients in biliary tract cancers, it is necessary to conduct larger studies in populations with wide variation in exposure. In addition, most studies have evaluated metals independently, not jointly, but co-exposure to metals and micronutrients can have synergistic or antagonistic effects on human health. Dr. Lauren Amable of the National Institute on Minority Health and Disparities (NIMHD) recently developed a "metallome" panel to allow simultaneous evaluation of metals and essential elements involved in human health using Inductively Coupled Plasma-Mass Spectrometry (ICP-MS). ICP-MS measures the presence of elements at the atomic level. Thus, elements are separated based on atomic mass. This metallome panel has the capability to measure metal measurements to the part per trillion (ppt) level in small sample sizes. We propose to apply this panel to serum and urine samples from the Shanghai Biliary Tract Cancer Case-Control Study. NCI RESPONSIBILITIES: NCI will transfer the specimens to the contractor within the same month that the purchase order is awarded. Remaining samples should be returned to the NCI, the NCI technical point of contact will be responsible for coordination. Shipment fees will be covered by NCI. The NCI technical point of contact/COR will be in direct contact with the contractor as to the progress of the testing. Monthly follow-up will occur. Final results are expected to be delivered a month prior to the end of the period of performance. If any issues arise they will be addressed in a timely manner during the monthly follow-up. DELIVERABLES Encrypted data file showing urine creatinine assay results from 659 samples. PERIOD OF PERFORMANCE One year from date of award QUESTIONS ARE DUE: July 18, 2017 The purchase order will be awarded to the Lowest Price Technically Acceptable (LPTA). The award will be made on the basis of the lowest evaluated price of quotations meeting or exceeding the acceptability standards for the requirements/technical specifications stated above. The technical evaluation will be a determination based on information furnished by the vendor. The Government is not responsible for locating or securing any information which is not identified in the quote. The Government reserves the right to make an award without discussions. PROVISIONS AND CLAUSES: The following FAR provisions and clauses apply to this acquisition: 52.212-1 Instruction to Offerors Commercial Items (October 2016) FAR 52.212-3, Offeror Representations and Certifications - Commercial Items (October 2016) - with Addenda [Representation By Corporations Regarding an Unpaid Delinquent tax Liability or a Felony Conviction Under Any Federal Law and FAR 52.204-6, Unique Entity Identifier (October 2016)] FAR 52.212-4, Contract Terms and Conditions - Commercial Items (May 2015) - With Addenda FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (November 2016) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items: FAR 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (OCT 2014) FAR 52.219-28, Post Award Small Business Program Representation (Jul 2013) FAR 52.222-3, Convict Labor (June 2003) FAR 52.222-21, Prohibition of Segregated Facilities (Apr 2015) FAR 52.222-26, Equal Opportunity (Sept 2016) FAR 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011) FAR 52.225-13, Restrictions on Certain Foreign Purchases (June 2008) FAR 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Jul 2013) Full text copies of the representations and certifications for other cited provisions and clauses may be obtained on line at the NCI website at http://ncioa.cancer.gov/oa-internet/reference.jsp or from Kimesha Leake, Contracting Specialist at contact@example.gov OFFERORS: Offers must be submitted with a completed 52.212-3 Offeror Representations and Certifications-Commercial Items-with DUNS Number Addendum, signed by an authorized representative of the offeror OR provide a copy of the valid SAM registration through www.sam.gov. Quotations must be received in the NCI-OA contracting office by 5:00 p.m. EST on July 21, 2017. Please refer to solicitation number N02CP72607-24 on all correspondence. Faxed quotations will NOT be accepted. Quotations may be submitted via email to Kimesha Leake, Contract Specialist at contact@example.gov All questions shall be in writing and may be addressed to the aforementioned individual noted above. In order to receive an award, contractors must be registered and have valid certification in the System for Award Management through sam.gov.