HEALTH CANADA ADVANCE CONTRACT AWARD NOTICE
TITLE: Quantitative Approaches for Improved Regulatory Evaluation of Genotoxic Substances
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
Rijksinstituut voor Volksgezondheid en Milieu
(National Institute for Public Health & the Environment)
P.O. Box 1, 3720 BA Bilthoven
The Netherlands
4. Definition of Requirements or Expected Results
Assessment of the ability to damage genetic material is an essential part of chemical screening required under the Canadian Environmental Protection Act. Traditional assessments have been qualitative (i.e., yes/no) rather than quantitative; however, there is increasing recognition that dose-response data for genotoxic substances can be used to determine a “point-of-departure” (PoD) that could be the basis for human health risk assessment and regulatory decision-making. Consequently, Health Canada is seeking a contractor to: (1) employ recently established quantitative methods to analyze genetic toxicity dose-response data, and derive Point-of-Departure (PoD) metrics for a wide range of endpoint-agent combinations; and (2) scrutinize, analyze, and interpret the derived genetic toxicity PoD metrics in a Human Health Risk Assessment context. The contracted work is divided into four main activities. The first activity involves the collection of detailed dose-response data across a wide range of in vitro and in vivo genetic toxicity endpoints for as many chemical agents as possible. The second activity involves detailed dose-response modelling and statistical analysis of the collected data. This activity requires the use of PROAST software to determine Benchmark Dose (BMD) values; and moreover, to fit dose-response models to combined datasets relating to different chemicals. The latter, which is uniquely implemented in PROAST, is required to improve the precision of the BMDs estimates, which may be poor in separated analyses, particularly for chemicals with relatively weak dose-response data. In addition, the PROAST software, and modifications thereof, are required to rigorously examine the influence of covariates such as gender, species, strain, route of exposure, and target tissue on BMD values. The third activity will involve empirical comparisons of PoDs across a variety of in vitro and in vivo endpoints, including induction of cancer, to determine the utility of popular in vitro tools for the prediction of in vivo effects; and moreover, popular in vivo tools for prediction of carcinogenic potency. The analyses should employ methods previously described by Hernández et al. (2011and 2012). This will also necessitate the use of PROAST, and moreover, modifications thereof that will improve the software’s ability to carry out the analyses required to complete the aforementioned tasks. The fourth activity requires the establishment of a quantitative framework for the use of genetic toxicity PoD metrics in human health risk assessment and regulatory decision-making. This work would, for example, involve the use of genetic toxicity PoD metrics for the determination of regulatory exposure limits (e.g., RfD or Reference Dose, TDI or Tolerable Daily Intake, etc.) that could subsequently be employed as the basis for MOE (Margin of Exposure) determination. Such calculations would ultimately permit genetic toxicity studies to be used as a basis for risk assessment and/or risk management. The contractor will be required to participate in knowledge transfer and exchange (KTE) activities to disseminate all findings and recommendations to local, regional and international communities of risk assessment professionals.
5. Minimum requirements
Any interested supplier must demonstrate by way of a Statement of Capabilities that it meets the following minimum requirements:
a. The supplier must have detailed familiarity with the computational methods and algorithms employed for dose-response modeling and point-of-departure determination;
b. More specifically, the supplier must be capable of using the dose-response modeling software known as PROAST, to undertake, for example, fitting multi-parameter models to combined datasets and determining Benchmark Dose (BMD) confidence intervals for equipotent doses related to each chemical in a combined dataset;
c. The supplier must be capable of adjusting and debugging the PROAST code and associated algorithms to ensure successful analyses of collected data;
d. The supplier must have unrestricted access to the coding functions of the PROAST library; the copyright thereof being owned by the State of the Netherlands;
e. The supplier must be capable of using the results of the dose-response modeling to correlate the equipotent doses obtained from different study types (e.g., genetic toxicity versus carcinogenicity), and rigorously examine the influence of covariates such as gender, species, strain, route of exposure, and target tissue on the equipotent doses; and
f. The supplier must have detailed familiarity with the principles of quantitative human health risk assessment and their applications for regulatory evaluations of new and existing chemicals.
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.
The State of the Netherlands owns the copyright on the dose-response modeling software known as PROAST.
7. Applicable trade agreements and justification for limited tendering or the Procurement Strategy for Aboriginal Business
This requirement is subject to the various trade agreements, including the North American Free Trade Agreement (NAFTA); the Agreement on Internal Trade (AIT); and the World Trade Organization - Agreement on Government Procurement (WTO-GPA). However, this requirement also meets the conditions for limiting the tendering procedures in accordance with:
I. AIT, Article 506.12 (b).
II. NAFTA, Article 1016.2 (b)
III. WTO-AGP, Article XV
which allow for contracts to be directed to a particular firm when the products or services can be supplied only by a particular supplier and no reasonable alternative or substitute exists.
This requirement is not subject to the Procurement Strategy for Aboriginal Business.
8. Ownership of Intellectual Property
In compliance with the Treasury Board Secretariat Policy on Title to Intellectual Property Arising Under Crown Procurement Contracts, the Contractor will own any new intellectual property. However, the Contractor shall grant to Canada a broad license to use the deliverables rendered under this contract.
9. Period of the proposed contract
The contract period shall be from the award of the contract until March 31, 2015. Health Canada reserves the right to exercise two subsequent single option years.
10. Estimated value of the proposed contract
The total estimated value of the proposed contract should not exceed €180,000.00 (one hundred and eighty thousand Euro) over three fiscal years (€60,000.00 FY 2014-2015, €60,000.00 for option 1 FY 2015-2016, and €60,000.00 for option 2 FY 2016-2017). This amount includes travel and living expenses (if applicable) and all applicable taxes.
11. Closing date and time
The closing date and time for accepting Statements of Capabilities is 2 p.m. EDT on the 4th of July 2014.
12. Contact Person
All inquiries with regard to this Notice must be addressed by e-mail to:
Robert Merrick
Senior Contracting Officer
Materiel and Assets Management Division
Health Canada
E-mail: R••••••••@•••••.••.ca
