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Line 19: − <div style="background: #ffae42; color:white; font-family:Arial;padding:10px; text-align:center"><span style="font-size: 10pt">'''We express our gratitude for the overwhelming interest in the REEF, and as of January 16, 2024, we are no longer accepting Expressions of Interest for the Regulatory Experimentation Expense Fund.'''</span>+ − </div> − − Line 34:
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Line 99: − |- bgcolor="#C8D0C1" − |Innovation Science and Economic Development (ISED) – Standards Council of Canada (SCC) − |Piloting an Accreditation Program for the Assessment of Artificial Intelligence Management Systems (AIMS) − | The purpose of this experiment is to pilot a prototype accreditation program to understand whether the main SCC Requirements and Guidance document that works in conjunction with ISO/IEC 17021-1:2015 Conformity assessment is clear and appropriate and obtain feedback from the certification bodies and Artificial Intelligence (AI) companies about the program. This information is necessary to improve and refine the prototype. − − The SCC is also looking to gather information on whether the AIMS could have an impact on the level of risk of AI products to inform potential use of AIMS for regulators. − |- − |Transport Canada (TC) − |Aviation E-Licensing Pilot − | This is a follow up to previous experiment to test a new QR code prototype with pilots of an air operator within Canada for effectiveness. The sandbox experiment will test if the digital solution lowers the cost of compliance and improve compliance with respect to air operators’ obligation to track employee compliance with licensing requirements. − + − +
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==='''Project Eligibility'''===
=='''Project Eligibility'''==
The Regulatory Experimentation Expense Fund (REEF) is a fund to help regulators innovate or support innovation in the marketplace by experimenting with:
The Regulatory Experimentation Expense Fund (REEF) is a fund to help regulators innovate or support innovation in the marketplace by experimenting with:
*conducting a regulatory experiment</p>
*conducting a regulatory experiment</p>
=='''What can the REEF offer?'''==
==='''What can the REEF offer?'''===
Regulators can receive:
Regulators can receive:
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='''The REEF Process'''=
==='''The REEF Process'''===
[[File:The_REEF_Process_Graphic_v2.png|alt=|799x799px]]
[[File:The_REEF_Process_Graphic_v2.png|alt=|799x799px]]
{| class="mw-collapsible mw-collapsed" data-expandtext="Show Detailed Steps" data-collapsetext="Hide Detailed Steps"
{| class="mw-collapsible mw-collapsed" data-expandtext="Show Detailed Steps" data-collapsetext="Hide Detailed Steps"
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=='''Step 2: Expression of Interest'''==
===='''Step 2: Expression of Interest'''====
Departments submit a high-level [https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fwiki.gccollab.ca%2Fimages%2F1%2F17%2FExpression_of_Interest_%2528EOI%2529_Template_.docx&wdOrigin=BROWSELINK Expression of Interest (EOI)] that is used by the CRI to determine the eligibility of the project. To be eligible for funding, proposed experiments must clearly demonstrate how their funding request meets the criteria as outlined in the [https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fwiki.gccollab.ca%2Fimages%2Fd%2Fdd%2FREEF_Guide_-_2022.docx&wdOrigin=BROWSELINK REEF Guide]. It is highly recommended that applicants informally confirm the eligibility of their project by scheduling an informal consultation with the CRI before completing an EOI. EOI submissions are due '''January 16, 2024.'''<p class="highlighted mw-collapsible-content"></p>
Departments submit a high-level [https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fwiki.gccollab.ca%2Fimages%2F1%2F17%2FExpression_of_Interest_%2528EOI%2529_Template_.docx&wdOrigin=BROWSELINK Expression of Interest (EOI)] that is used by the CRI to determine the eligibility of the project. To be eligible for funding, proposed experiments must clearly demonstrate how their funding request meets the criteria as outlined in the [https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fwiki.gccollab.ca%2Fimages%2Fd%2Fdd%2FREEF_Guide_-_2022.docx&wdOrigin=BROWSELINK REEF Guide]. It is highly recommended that applicants informally confirm the eligibility of their project by scheduling an informal consultation with the CRI before completing an EOI. EOI submissions are due '''January 16, 2024.'''<p class="highlighted mw-collapsible-content"></p>
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=='''Step 3: Proposal Submission'''==
===='''Step 3: Proposal Submission'''====
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|Successful EOI applicants will be invited to complete a full [https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fwiki.gccollab.ca%2Fimages%2Fa%2Fa6%2FProposal_Template.docx&wdOrigin=BROWSELINK proposal]. Before developing a proposal, applicants should obtain the support of their Director General or above. The CRI supports applicants throughout the proposal development process. Regulators should refer to the [[:en:images/6/6b/CRI_Regulators'_Experimentation_Toolkit.pdf|Regulators’ Experimentation Toolkit]] to assist in identifying, designing, and carrying out regulatory experiments and sandboxes.<p class="highlighted inline mw-collapsible-content"></p>
|Successful EOI applicants will be invited to complete a full [https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fwiki.gccollab.ca%2Fimages%2Fa%2Fa6%2FProposal_Template.docx&wdOrigin=BROWSELINK proposal]. Before developing a proposal, applicants should obtain the support of their Director General or above. The CRI supports applicants throughout the proposal development process. Regulators should refer to the [[:en:images/6/6b/CRI_Regulators'_Experimentation_Toolkit.pdf|Regulators’ Experimentation Toolkit]] to assist in identifying, designing, and carrying out regulatory experiments and sandboxes.<p class="highlighted inline mw-collapsible-content"></p>
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=='''Step 4: Funding Decision'''==
===='''Step 4: Funding Decision'''====
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|Funding will be available from April 2024 upon completion of a MOU with the successful applicant and TBS, and is made available on a cost recovery basis.<p class="highlighted inline mw-collapsible-content"></p>
|Funding will be available from April 2024 upon completion of a MOU with the successful applicant and TBS, and is made available on a cost recovery basis.<p class="highlighted inline mw-collapsible-content"></p>
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==Application Documents==
===Application Documents===
*[https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fwiki.gccollab.ca%2Fimages%2Fd%2Fdd%2FREEF_Guide_-_2022.docx&wdOrigin=BROWSELINK REEF Guide]
*[https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fwiki.gccollab.ca%2Fimages%2Fd%2Fdd%2FREEF_Guide_-_2022.docx&wdOrigin=BROWSELINK REEF Guide]
*[https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fwiki.gccollab.ca%2Fimages%2Fc%2Fc2%2FExpression_of_Interest_%2528EOI%2529_Template.docx&wdOrigin=BROWSELINK Expression of Interest (EOI) Template]
*[https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fwiki.gccollab.ca%2Fimages%2Fc%2Fc2%2FExpression_of_Interest_%2528EOI%2529_Template.docx&wdOrigin=BROWSELINK Expression of Interest (EOI) Template]
*[[Media:REEF_Proposal_Template.docx|Proposal Template]]
*[[Media:REEF Proposal Template.docx|Proposal Template]]
<h1 id="ongoingprojects">REEF Ongoing Projects</h1>
<h3 id="ongoingprojects">REEF Ongoing Projects</h3>
{| class="wikitable mw-collapsible mw-collapsed"
{| class="wikitable mw-collapsible mw-collapsed"
|Light Sport Aircraft
|Light Sport Aircraft
|This experiment as proposed by TC involves setting up a sandbox to determine if Light Sport Aircraft, with appropriate conditions, are as reliable as other aircraft currently being used for the purpose of flight training and if the quality of training is as good, or better, than other aircraft currently used for pilot training. The experiment will also inform Transport Canada on potential additional conditions/measures that should be included in future exemptions or regulatory amendments.
|This experiment as proposed by TC involves setting up a sandbox to determine if Light Sport Aircraft, with appropriate conditions, are as reliable as other aircraft currently being used for the purpose of flight training and if the quality of training is as good, or better, than other aircraft currently used for pilot training. The experiment will also inform Transport Canada on potential additional conditions/measures that should be included in future exemptions or regulatory amendments.
|- bgcolor="#C8D0C1"
|- bgcolor="#C8D0C1"
|Health Canada (HC)
|Health Canada (HC)
|Machine Learning Enabled Medical Device (MLMD) Sandbox Development
|Advanced Therapeutic Products Framework for CAR-T Products Manufactured at the Point of Care
|Health Canada is developing a sandbox to test new regulatory approach for MLMDs. Currently, MLMD can be marketed in Canada if the device algorithm behaviour is locked to remain the same overtime as what was presented in the product’s market authorization application. Any change to the algorithm behaviour requires the submission of an amendment to the licence. Health Canada wants to test a new regulatory approach that would use a different method of risk management than requiring a licence amendment so that the device can change its behaviour over time as it learns from new data it acquires over time. The current project scope is limited to accessing the legislative authorities to establish the sandbox and developing the sandbox application scheme.
|The objective of the project is to test the use of a co-creation process to develop tailored requirements for a regulatory sandbox for HC’s Advanced Therapeutic Products pathway, for CAR-T products manufactured at point of care.
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! colspan="3" |[[CRI Supported Projects|Click here to see a list of the CRI’s '''completed''' '''projects''' and experimentation reports]]
! colspan="3" |[[CRI Supported Projects|Click here to see a list of the CRI’s '''completed''' '''projects''' and experimentation reports]]
