Toxicological and toxicokinetic studies of xenobiotics.

Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E224, Rockville, MD 20850, UNITED STATES. 1. Description The National Cancer Institute (NCI), Center for Cancer Research (CCR), National Institute of Environmental Health Sciences (NIEHS), Basic Laboratory Research (BLR) has a requirement to procure services to evaluate Toxicological and toxicokinetic studies of xenobiotics. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 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 includes all applicable provisions and clauses in effect through FAR FAC 2005-89 (August 2016) Simplified Procedures for Commercial items. The Government contemplates only one award of a Firm-Fixed Price contract. The Associated North America Industry Classification Code (NAICS) 325414 and the Business Size Standard is 1,250. It has been determined there are no opportunities to acquire green products or services for this procurement. Only one award will be made as a result of this solicitation. This will be 100% small business set-aside. 2. Background The National Institute of Environmental Health Sciences (NIEHS), located in Research Triangle Park, North Carolina, is one of 27 research institutes and centers that comprise the National Institutes of Health (NIH), U.S. Department of Health and Human Services (DHHS). The mission of the NIEHS is to discover how the environment affects people in order to promote healthier lives. The purpose of this acquisition is to procure services to evaluate 1,2-dibromo-4-(1,2-dibromoethyl) cyclohexane Tetrabromoethylcyclohexane (TBECH) is an emerging flame retardant composed principally of alpha and beta stereoisomers (?-TBECH and ?-TBECH, respectively). TBECH is a flame retardant used as an additive FR used in expandable polystyrene beads for house insulation, extruded polystyrene, for adhesives in fabric, electrical cable coatings, high impact plastic in appliances and some construction materials. The US production volumes were 4.5 to 230 tons/year from 1986 to 2002. TBECH isomers have a high predicted bioconcentration potential, low biodegradation rates and long range atmospheric transport potential. TBECH activate the human androgen receptor, indicating that it is a potential endocrine disruptor. Isomers of TBECH are expected to be principally metabolized to ?- and ?-monohydroxy-TBECH (OH-TBECH), dihydroxy-TBECH ((OH)2-TBECH). In addition, many of the metabolites NCI seek to identify and quantify are not available as authentic standards, necessitating the detection of radiolabeled chemical. The NIEHS project includes, but is not limited to, the study of the toxic responses of model organisms (whole animals, tissues, and/or tissue preparations) to exposures to common and known xenobiotics or agents foreign to the body. The project explores the biological disposition (the absorption, distribution, metabolism, and excretion rates, routes, and mechanisms) of these agents. Blood, tissues, and excreta are analyzed using sophisticated analytical techniques to determine total mass balance (recovery of compound applied) and metabolite products formed by the biological system to inform the risk assessments for these often common chemicals. The use of [14C]-radiolabeled ?-TBECH and ?-TBECH for evaluation and description of individual chemical disposition profile for each isomer in mammalian models will greatly improve the quality and accuracy of available datasets for these molecules. Contractor Tasks shall be as follows: 1. SCOPE: Contractor shall perform custom synthesis of 1,2-dibromo-4-(1,2-dibromoethyl) cyclohexane (TBECH), an emerging flame retardant composed principally of alpha and beta stereoisomers (?-TBECH and ?-TBECH, respectively). The contractor shall provide 5 mCi of each isomer, labeled at the 2-ethyl position, in separate vials. All syntheses shall be performed in accordance with the manufacturer's standard commercial practices. All chemicals shall be authenticated according to the manufacturer's standard commercial practices. 2. PERSONNEL QUALIFICATIONS: Personnel shall have 5+ years of laboratory training and experience in the custom synthesis of [14C]-radiolabeled chemicals as covered by this order. All primary personnel shall have at least one backup support person with at least the same level of expertise on the custom synthesis of [14C]-radiolabeled chemicals covered by this contract. 3. PLACE OF PERFORMANCE: Synthesis of the radiolabeled chemicals will be performed at the Contractors site in accordance with the manufacturer's standard commercial practices. 4. PERIOD OF PERFORMANCE: The period of performance shall be 4-6 weeks to deliver from date of award. 5. PAYMENT: Payment shall be made after delivery of the custom synthesized radiolabeled chemicals, lab approval and submission of invoice to the address shown in Block 21 of the purchase order. 6. CONTRACT TYPE: Firm Fixed Price QUESTIONS ARE DUE: September 12, 2016 at 11:00 AM, EST. PROVISIONS AND CLAUSES: The following provisions and clauses will be incorporated by reference: 52.212-1 Instruction to Offerors Commercial Items (October 2015) 52.212-2, Evaluation Commercial Items (October 2014): The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: The 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 requirements stated above. Offerors shall demonstrate knowledge and/or experience of each of the tasks listed 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 proposal. The Government reserves the right to make an award without discussions. Offerors price proposal will be evaluated for reasonableness. For price to be considered to be reasonable, it must represent a price to the Government that a prudent person would pay when consideration is given to the price in the market. Normally, price reasonableness is established through adequate price competition, but may also be determined through price analysis techniques as described in FAR 15. 52.212-3 Offerors Representations and Certifications Commercial Items (April 2016) WITH DUNS NUMBER ADDENDUM (52.204-6) (July 2013) 52.212-4 Contract Terms and Conditions Commercial Items (May 2015), applies to this acquisition. (May 2015) 52.212-5 Contract terms and Conditions Required to Implement Statutes or Executive Orders---Commercial Items (June 2016). The following additional FAR clauses cited in this clause are applicable: (b) 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: 52.204-10 Reporting Executive Compensation and First Tier Subcontract Awards (Oct 2015) (Pub.L. 109-282) (31 U.S.C. 6101 note). 52.209-6, Protecting the Government' Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment October 2015) (31 U.S.C. 6101 note). 52.219-4 Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Oct 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a). 52.219-6 Notice of Total Small Business Set-Aside (NOV 2011) (15 U.S.C. 644) 52.219-28 Post Award Small Business Program Representation (JUL 2013) (15 U.S.C. 632(a) (2)). 52.222-3, Convict Labor (JUNE 2003) (E.O. 11755). 52.222-21 Prohibition of Segregated Facilities (Apr 2015) 52.222-26 Equal Opportunity (Apr 2015) (E.O. 11246). 52.222-36 Affirmative Action for Workers with Disabilities (Jul 2014) (29 U.S.C. 793). 52.223-18 Encouraging Contractor Policies to Ban Text Messaging while Driving (AUG 2011) (E.O. 13513). 52.225-13 Restrictions on Certain Foreign Purchase (JUN 2008) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury). 52.232-33 Payment by Electronic Funds Transfer System for awards Management (JUL 2013) (31 U.S.C. 3332). Full text copies of the representations and certifications for other cited provisions and clauses many be obtained online at the NCI website at http://ncioa.cancer.gov/oa-internet/reference.jsp or from Kathy Elliott, Contract Specialist at Elliottk@mail.nih.gov. Quotations must be received in the NCI-OA Contracting Office by 11:00 a.m. EST, on September 13, 2016. Please refer to the solicitation number: N02RC62702-61 on all correspondence. No collect calls will be accepted. Electronic mail quotations will be accepted. All questions shall be in writing and may be addressed to the aforementioned individual noted above. In order to receive an award, contractor must be registered and have valid certification in the Central Contractor Registration (CCR) and the Online Representation and Certifications Applications (ORCA) through www.sam.gov.