Investigating the Effects of Dissolution Rates of Metal-based Nanoparticles on Cellular Responses

Advance Contract Award Notice (ACAN)

Title: Investigating the Effects of Dissolution Rates of Metal-based Nanoparticles on Cellular Responses

Solicitation Number: 1000224899

1. The Purpose and Explanation of an ACAN

An Advance Contract Award Notice (ACAN) allows Health Canada to post a notice for no less than fifteen (15) calendar days, indicating to the supplier community that a goods, services 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 minimum requirements identified in the ACAN, the Contracting Authority may then proceed to award a contract to the pre-identified contractor.

2. Rights of Suppliers

Suppliers who consider themselves fully qualified and available to provide the services or goods described in this ACAN may submit a Statement of Capabilities 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 the Bidder can clearly demonstrate they possess the required capabilities, the requirement will be opened to electronic or traditional bidding processes.

3. Name and address of the pre-identified supplier

Dalhousie University

Jong Sung Kim, Director

Health and Environments Research Centre (HERC)

Life Sciences Research Institute (LSRI)

1348 Summer Street N-228

Halifax, NS B3H 4R2 Canada

4. Definition of Requirements or Expected Results

Many chemical substances currently in commerce in Canada (i.e., those listed on the DSL) also exist at the nanoscale (i.e., have a particle diameter between 1 and 100 nm); however, their nanoscale forms have not yet been evaluated for their potential risks to human health or the environment. As such, HC and Environment and Climate Change Canada (ECCC) are addressing nanoscale forms of substances on the DSL as a part of the third phase of the Chemicals Management Plan (2016-2021). Given the large number of nanomaterials that exist, each of which may also exist in several forms (e.g., shapes, sizes, agglomeration states etc.), HC and ECCC are faced with challenges in appropriately concluding on the risk posed by these substances. It is unclear, however, how best to fill existing data gaps for nanoforms given the uncertainty regarding effects of a nanomaterial’s physical-chemical properties on its toxicity. Even nanomaterials that are described by a single CAS RN (e.g., ZnO, CAS RN 1314-13-2) may exist in several forms (i.e., sizes, shape, surface modifications, charge etc.), each of which may differ in toxicity and thus potential human health risk. In order to better inform strategies for their eventual risk assessment, HC is investigating the relationship between the physico-chemical properties, such as dissolution rate, of different nanoforms of metal-based nanomaterials and the outcomes of in vitro toxicological tests.

Health Canada is interested in generating specific toxicity data over a range of sensitive endpoints for a broad set of nanomaterial metal-oxide particles representative of the diversity within their CASRN. The requirement of the testing would be to establish the relationships between physico-chemical properties of nanomaterials and their toxicity. For the currently proposed contract, the relationship between dissolution rates and cellular responses or toxicological outcomes of selected nanoforms of ZnO will be investigated. The contractor will conduct dissolution assays and in vitro toxicity testing on a set of seven commercially available nanoforms of ZnO, spanning a broad range of characteristics under one Chemical Abstract Service Registry Numbers (CASRN) or chemical grouping. These nanoforms comprise different size ranges, different primary particle shapes, and different particle coatings. The contractor will determine dissolution rates of these nanoforms in biologically relevant media at the air-liquid interface system and will conduct cytotoxicity testing (Alamar Blue Assay and LDH assay) as well as mechanistic assays for markers of oxidative stress and inflammation on these nanoforms to assess the effects of dissolution rates on cellular responses of the test metal-based nanomaterial.

The information from the test data obtained through this contract will be used directly in nanomaterial risk assessments and will also allow evaluators at HC to determine whether this particular property of nanomaterials is the driver of their potential toxicity and will allow for refinement of tools and approaches that HC evaluators will be using for assessment of risk of nanomaterials on the DSL.

The contractor will be required to receive and appropriately store samples of commercially available ZnO nanoforms. All equipment and approaches applied to the dissolution rate determination and toxicity testing of samples must be validated for its application to nanomaterials. Dissolution rates of ZnO nanoforms will be determined in biological media as well as in cell and exposed media. Sample physico-chemical properties will need to be characterized to a degree required for appropriate dosing of cell cultures. Toxicological profiling will be undertaken using the dynamic in vitro exposure system which consists of an air-liquid interface chamber containing epithelial cells, A549 for assessing pulmonary toxicity potential of inhaled nanoparticles. For toxicity profiling, the contractor must perform two (2) cytotoxicity assays to determine cellular viability and at least two (2) mechanistic assays assessing the effects of nanoparticle dissolution rates on cellular responses. Complete analysis of the data will be presented in the form of technical reports.

5. Minimum Requirements

Any interested supplier must demonstrate by way of a Statement of Capabilities that it meets the following minimum requirements:

a) The proposed team must include a principal investigator and a minimum of one (1) technician. The principle investigator or the proposed team must have at least five (5) years cumulative experience to conduct the required work.

b) The proposed team must have a minimum of five (5) years cumulative experience conducting toxicity testing specific to metal-oxide nanoparticles, including zinc oxide nanoparticles.

c) The proposed team must have a minimum of five (5) years cumulative experience conducting toxicity testing related to investigating mechanism(s) underlying toxicity in response to airborne nanoparticles.

d) The proposed team must have capacity and a minimum of five (5) years experience to conduct dissolution assays and toxicity testing evaluating the pulmonary toxicity potential of inhaled nanoparticles using a dynamic in vitro exposure system such as an air-liquid interface system that mimics a realistic animal and human exposure to inhaled nanoparticles.

e) The proposed team must have a proven track record with more than five (5) years of published toxicity study outcomes in peer-reviewed literature concerning nanotoxicology and/or inhalational nanotoxicology.

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.

7. Ownership of Intellectual Property

Ownership of any Foreground Intellectual Property arising out of the proposed contract will vest in the Contractor.

8. Cost estimate of the proposed contract
The estimated value of the contract, including option(s), is $80,000.00 (GST/HST included).

9. Period of the Proposed Contract

The contract period shall be from date of contract award until March 31, 2021, with an option to extend the contract up to three (3) one-month periods.

1. Suppliers' right to submit a statement of capabilities

Suppliers who consider themselves fully qualified and available to provide the goods, services or construction services described in the ACAN may submit a statement of capabilities in writing to the contact person identified in this notice on or before the closing date of this notice. The statement of capabilities must clearly demonstrate how the supplier meets the advertised requirements.

1. Closing date for a submission of a statement of capabilities
   The closing date and time for accepting statements of capabilities is December 16, 2020 at 2:00 p.m. EST.
2. Inquiries and submission of statements of capabilities

   Inquiries and statements of capabilities are to be directed to:

   Darlene Fisher, Senior Procurement & Contracting Officer

   Telephone: 343-543-4197
   E-mail: Darlene.Fisher2@canada.ca