Animal Studies to Support the Interpretation of Biomonitoring Data for the Flame Retardant TBOEP (Ethanol, 2-Butoxy-, Phosphate (3:1), CAS# 78-51-3).

HEALTH CANADA ADVANCE CONTRACT AWARD NOTICE TITLE:  Animal Studies to Support the Interpretation of Biomonitoring Data for the Flame Retardant TBOEP (Ethanol, 2-Butoxy-, Phosphate (3:1), CAS# 78-51-3). SOLICITATION NUMBER:  1000194748 1. The Purpose and Explanation of an ACAN An Advance Contract Award Notice (ACAN) allows Health Canada contracting authorities to post a notice on the Government Electronic Tendering System (GETS), for no less than fifteen (15) calendar days, indicating to the supplier community that a good, service or construction contract will be awarded to a pre-identified contractor. If no other supplier submits, on or before the closing date, a Statement of Capabilities that meets the requirements set out in the ACAN, the contracting authority may then proceed with the award. However, should a Statement of Capabilities be found to meet the requirements set out in the ACAN, then the contracting authority will proceed to a full tendering process. 2. Rights of Suppliers Suppliers who believe that they are fully qualified and available to provide the services or goods described in this ACAN may submit a Statement of Capabilities clearly demonstrating how they meet the advertised requirement. This Statement of Capabilities must be provided via e-mail only to the contact person identified in Section 12 of the Notice on or before the closing date and time of the Notice. If there is a reasonable level of evidence regarding capability, the requirements will be opened to electronic or traditional bidding processes. 3. Proposed Contractor Université de Montréal Bureau Recherche - Développement - Valorisation 3744 rue Jean-Brillant Bureau 6320 Montréal (Québec) H3T 1P1 4. Definition of Requirements or Expected Results Following a request from the Directed Needs Committee of the Chemicals Management Plan (CMP-DNC), a collaborative project between Health Canada researchers and regulatory scientists is developing approaches to prioritize risk assessment efforts for organophosphate flame retardants. To understand the potential health risks from human biomonitoring data, simple toxicokinetic models can be used to translate critical doses associated with potential toxicity into biomarker-equivalent measurements in blood or urine samples from biomonitoring surveys; these measurements are known as Biomonitoring Equivalents (BEs).  Evaluators in the Existing Substances Risk Assessment Bureau (ESRAB) and scientists in the Environmental Health Science and Research Bureau (EHSRB) identified organophosphate flame retardants as candidates to generate laboratory animal toxicokinetic (TK) data in order to develop the TK models and BEs required to interpret human biomonitoring data. Despite evidences on the toxic effects of tris (2-butoxyethyl) phosphate (TBEOP), this organophosphate flame retardant lacks suitable toxicokinetic information to translate dose exposure of potential toxicity in rodents into human biomarker-equivalent metrics. The service required from the Contractor in the fiscal years 2017-18 and 2018-19 will be to perform animal exposures to TBOEP, collect biological samples at different time points, and ship the samples back to Health Canada (HC). Then, based on TBOEP and metabolite levels in biological matrices measured at HC, the contractor will perform TK modeling and generate BE. 5. Minimum Requirements Any interested supplier must demonstrate by way of a Statement of Capabilities that it meets the following minimum requirements: 1) The expertise necessary to conduct literature reviews on organophosphate flame retardants toxicity and toxicokinetics, to design animal exposure protocols based on OECD guidelines and to develop toxicokinetic models and biomonitoring equivalents; 2) Animal housing facilities on the premises; 3) Competent staff and expertise to perform laboratory rat exposure protocols, monitor rat health and harvest various biological samples; 4) Relevant experience in the area of toxicokinetics modeling and biomonitoring equivalents (BEs). This experience must be at a level that clearly demonstrates an ability to lead in the development of study design, toxicokinetics models and biomonitoring equivalents; 5) Relevant experience in interacting and collaborating with Health Canada stakeholders for the integration of toxicokinetic models and biomonitoring equivalents within existing Canadian risk assessments and for providing guidance at a senior project level in similar projects; 6) Adherence to tight deadlines and budgets set for this toxicokinetics study (including pilot dose-range finding study) and for the development of toxicokinetics model and biomonitoring equivalent. The contractor will need to perform a literature review on the toxicology and toxicokinetics of TBOEP, design and get the approval for rat toxicokinetic studies based on OECD guidelines and perform the required pilot dose-range-finding study by February 1st, 2018. In the option year, the contractor will then have to perform the main studies and develop toxicokinetic models and biomonitoring equivalents for risk assessments by December 15th, 2018; 6. Reason for Non-competitive Award Section 6 of the Government Contracts Regulations contains four exceptions that permit the contracting authority to set aside the requirement to solicit bids. For the proposed procurement, the following exception applies: (d) Only One Person or Firm is capable of performing the contract. Université de Montréal is the only service provider that meets all of the minimum requirements and complies with the specified tight deadlines and budgets.  7. Applicable Trade Agreements and Justification for Limited Tendering or the Procurement Strategy for Aboriginal Business Not applicable. 8. Ownership of Intellectual Property Copyright shall vest with the Canada, as the deliverable is meant for public dissemination. 9. Period of the Proposed Contract The contract period shall be from the date of contract award until March 31, 2018, with one option period. 10. Estimated Value of the Proposed Contract The estimated value of the proposed contract is $6,000, including all applicable taxes, plus one option period worth an additional $60,000. Total potential value of the contract is $66,000. 11. Closing Date and Time The closing date and time for accepting Statements of Capabilities is the 11th of September 2017, 2 p.m. EDT. 12. Contact Person All inquiries with regard to this Notice must be addressed by e-mail to: Name:  Robert Merrick E-Mail: Robert.Merrick@hc-sc.gc.ca