Expositions in vitro de cellules lymphoblastoïdes humaines (TK6) traitées par plusieurs agents chimiques génotoxiques et non génotoxiques

HEALTH CANADA ADVANCE CONTRACT AWARD NOTICE

TITLE: In Vitro Exposures of Human Lymphoblastoid (TK6) Cells Treated with Diverse Genotoxic and Non-Genotoxic Chemicals

SOLICITATION NUMBER: 1000162248

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

Georgetown University 3970 Reservoir Road, NW Research Building E504 Washington, DC 20057

4. Definition of Requirements or Expected Results

Health Canada is seeking to award a contract to Georgetown University (GU) to perform exposures in human cells treated with diverse genotoxic and non-genotoxic chemicals to further develop and refine a genotoxicity biomarker. The scientific data will be used to assist Health Canada in the development of non-animal based lab methods for the practical application of genomics tools for hazard identification and human health risk assessment of environmental chemicals. Dr. Carole Yauk, a research scientist at Health Canada, was recently awarded a five-year Genomics Research and Development Initiative (GRDI) grant through a competitive, externally reviewed process. Drs. Albert Fornace Jr. and Heng-Hong Li of Georgetown University (GU), who originally developed in their research laboratory the genotoxicity biomarker to be used in this contract, also co-authored with Dr. Yauk, the proposal that won the five-year GRDI grant. In order to further develop and refine the 65-gene biomarker, GU will repeat the human cellular exposures using the original training set of twenty-eight chemicals. This will allow Health Canada to conduct further gene expression analysis to broaden the precision, applicability and utility of the biomarker for public use and formal validation for use in human health risk assessment.

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’s principal investigator must have a PhD in biomedical sciences (toxicology, biochemistry, molecular biology, etc.) and at least ten years of direct experience managing in vitro genetic toxicology experiments.

b. The project team must have significant expertise in mechanistic-based toxicology research in the area of mutagenesis, toxicogenomics and genotoxicity assessment.

c. The supplier must have at least ten years of experience conducting chemical exposures in human TK6 cells.

d. The supplier must have demonstrated proficiency conducting cytotoxicity assays to measure cell viability (e.g., MTT or MTS assay) in human TK6 cells.

e. The supplier must be extremely knowledgeable with respect to the TGx-28.65 genotoxicity classifier, a 65-gene signature derived from 28 genotoxic and non-genotoxic chemicals in human TK6 cells in culture

f. The supplier must be able to reproduce the work necessary to further develop and refine the TGx-28.65 classifier and have the twenty-eight test chemicals available for cellular exposures.

g. The project team must include a minimum of 2 members, including a project manager/mechanistic-based toxicologist, specializing in mutagenesis and toxicogenomics, and a laboratory technician.

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.

In light of the fact that the work of the proposed contract will build on the genotoxicity biomarker developed by Drs. Albert Fornace Jr. and Heng-Hong Li of Georgetown University (GU), and the fact that Drs Fornace and Li helped to draft the proposal that won the funding for this latest work, it is believed that Georgetown University has unique technical expertise and advantage that makes it highly unlikely any other supplier could do the work, especially for the funding available.

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) and the Agreement on Internal Trade (AIT). 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)

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

Health Canada will retain ownership of the copyright on the deliverables of this contract by virtue of Section 6.4.1 of the Treasury Board Secretariat Policy on Title to Intellectual Property Arising Under Crown Procurement Contracts, which states that the Crown may retain ownership of intellectual property when the main purpose of the contract is to generate knowledge and information for public dissemination.

9. Period of the proposed contract

The contract period shall be from the award of the contract until May 31, 2015. Health Canada reserves the right to exercise four option periods.

10. Estimated value of the proposed contract

The initial contract is worth $50,000.00 CAD. However, the contract will include three option years at a maximum of $35,000.00 CAD for the first option year; $30,000.00 CAD for the second year; and $15,000.00 CAD for the third year, for a maximum total potential contract value of $130,000.00 CAD.

11. Closing date and time

The closing date and time for accepting Statements of Capabilities is 2 p.m. EDT on the 24th 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: Robert.Merrick@hc-sc.gc.ca