Difference between revisions of "Regulatory Experimentation Expense Fund"

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[[FR: Fonds de dépenses d’expérimentation réglementaire]]
 
[[FR: Fonds de dépenses d’expérimentation réglementaire]]
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<br>
 
<big><big><big> Centre for Regulatory Innovation: Regulatory Experimentation Expense Fund</big></big></big>
 
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{| class="FCK__ShowTableBorders" style="border-right: 0px; border-top: 0px; border-left: 0px; border-bottom: 0px; background-color: #cfe2f3" width="100%" align="center"
 
 
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| style="border-right: white 1px solid; padding-right: 0px; padding-left: 0px; padding-bottom: 16px; padding-top: 10px; text-align: center; font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif !important;font-size: 11pt;line-height:1.1;font-weight:bold;" width="11%" |[[Centre for Regulatory Innovation|<span style="color: #Black">Home</span>]]
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| style="text-align: center; border: none; padding: 12px 5px; width: 10%;" | [[Centre for Regulatory Innovation|<span style="color: #1A2329; font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 12pt; font-weight: bold;" title="Centre for Regulatory Innovation">Home</span>]]
| style="border-right: white 1px solid; padding-right: 0px; padding-left: 0px; padding-bottom: 16px; padding-top: 16px; text-align: center; font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif !important;font-size: 11pt;line-height:1.1;font-weight:bold;" width="11%" |<span style="color:#Black">[[CRI Events|Events]]</span>
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| style="text-align: center; border: none; padding: 12px 5px; width: 17%;" | [[Regulatory Sandboxes|<span style="color: #1A2329; font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 12pt; font-weight: bold;" title="Regulatory Sandboxes">Regulatory Sandbox</span>]]
| style="border-right: white 1px solid; padding-right: 0px; padding-left: 0px; padding-bottom: 16px; padding-top: 16px; text-align: center; font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif !important;font-size: 11pt;line-height:1.1;font-weight:bold;" width="11%" |<span style="color: #Black">[[What is Regulatory Experimentation?]]</span>
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| style="text-align: center; border: none; padding: 12px 5px; width: 20%;" | [[What is Regulatory Experimentation?|<span style="color: #1A2329; font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 12pt; font-weight: bold;" title="What is Regulatory Experimentation?">Regulatory Experimentation</span>]]
| style="border-right: white 1px solid; padding-right: 0px; padding-left: 0px; padding-bottom: 16px; padding-top: 16px; text-align: center; font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif !important;font-size: 11pt;line-height:1.1;font-weight:bold;" width="11%" |<span style="color: #Black">[[Regulatory Experimentation Expense Fund]]</span>
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| style="text-align: center; border: none; padding: 12px 5px; width: 10%;" | [[Regulatory Experimentation Expense Fund|<span style="color: #1A2329; font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 12pt; font-weight: bold;" title="Regulatory Experimentation Expense Fund">REEF</span>]]
| style="border-right: white 1px solid; padding-right: 0px; padding-left: 0px; padding-bottom: 16px; padding-top: 16px; text-align: center; font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif !important;font-size: 11pt;line-height:1.1;font-weight:bold;" width="11%" |<span style="color: #Black">[[Regulators' Capacity Fund]]</span>
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| style="text-align: center; border: none; padding: 12px 5px; width: 10%;" | [[Regulators' Capacity Fund|<span style="color: #1A2329; font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 12pt; font-weight: bold;" title="Regulators' Capacity Fund">RCF</span>]]
! style="border-right: white 1px solid; padding-right: 0px; padding-left: 0px; padding-bottom: 16px; padding-top: 16px; text-align: center; font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif !important;font-size: 11pt;line-height:1.1;font-weight:bold;" width="11%" |<span style="color: #Black">[[Regulators’ Capacity Fund Projects|Completed CRI Supported Projects]]</span>
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| style="text-align: center; border: none; padding: 12px 5px; width: 13%;" | [[CRI Supported Projects|<span style="color: #1A2329; font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 12pt; font-weight: bold;" title="CRI Supported Projects">Projects</span>]]
| style="padding-right: 0px; padding-left: 0px; padding-bottom: 16px; padding-top: 16px; text-align: center; font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif !important;font-size: 11pt;line-height:1.1;font-weight:bold;" width="11%" |<span style="color: #Black">[[CRI Tools and Resources |Tools and Resources]]</span>
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| style="text-align: center; border: none; padding: 12px 5px; width: 10%;" |<span style="color: #1A2329; font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 12pt; font-weight: bold;" title="Regulatory Technology Forum">[https://gcxgce.sharepoint.com/teams/10002311/SitePages/Home.aspx RegTech Forum]</span>
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| style="text-align: center; border: none; padding: 12px 5px; width: 10%;" |[[CRI Tools and Resources|<span style="color: #1A2329; font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 12pt; font-weight: bold;" title="CRI Tools and Resources">Tools</span>]]
 
|}
 
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== '''Project Eligibility'''==
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<div style="background: #ffae42; color:white; font-family:Arial; padding:10px; margin-bottom:20px; border-radius:5px;">
The REEF is a fund to help regulators innovate or support innovation in the marketplace by experimenting with:
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[[Image:Deadline.png |30px|left|Deadline]] <span style="font-size: 12pt; font-weight:bold;">We extend our heartfelt gratitude for the overwhelming interest in REEF. As of October 17, 2024, we have concluded accepting Expressions of Interest (EOIs) and are no longer receiving submissions.</span>
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      <div style="padding-right: 20px;">
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        __TOC__
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      </div>
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    </td>
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    <td style="vertical-align: top;">
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      <div>
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== Project Eligibility ==
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The Regulatory Experimentation Expense Fund (REEF) supports federal regulators in innovating or facilitating innovation in the marketplace by experimenting with:
  
*Innovative approaches to any stage(s) of the regulatory lifecycle (issue definition and instrument choice, regulatory development, administration, compliance/enforcement, and review/evaluation)
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* Innovative approaches to any stage of the regulatory lifecycle
*Market innovations (e.g., products, business models, services.)
+
* Market innovations (e.g., new products, business models, and services)
All stages of regulatory experimentation are supported, including:
 
  
*determining whether an experiment would be the right approach (NEW)
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<div style="background-color: #E3F2FD; padding: 10px; border-left: 5px solid #1E88E5; margin: 5px 0;">
*developing a regulatory experiment (e.g., scope, evidence needs, experimental process, data collection methods) (NEW)
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'''All stages of [[What is Regulatory Experimentation?|regulatory experimentation]] are supported, including:'''
*conducting a regulatory experiment
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* Determining if an experiment is the right approach
 +
* Developing a regulatory experiment
 +
* Conducting a regulatory experiment
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</div>
  
=='''What can the REEF offer?'''==
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<div style="background-color: #FFF3E0; padding: 10px; border-left: 5px solid #FF6F00; margin: 5px 0;">
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'''New this year:''' Outcomes-based initiatives, like innovation challenges, are tools that can support your regulatory experimentation efforts. Consider [https://impact.canada.ca/en/challenges Impact Canada] as a partner in your expression of interest.
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</div>
  
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'''The REEF is open to all Government of Canada regulators.''' 
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</div>
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    </td>
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  </tr>
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</table>
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==What can the REEF offer?==
 
Regulators can receive:
 
Regulators can receive:
  
*financial support to offset expenses associated with experimenting. Up to $1,400,000 per fiscal year with multi-year funding is available.
+
===<small>Financial Support</small>===
*technical advice and guidance to help you navigate your specific situation.
+
*The total funding envelope is $1,400,000 per fiscal year. This amount represents the overall budget available to support multiple projects across potentially multiple fiscal years. Funding will be allocated to cover expenditures considered necessary to support the purposes of proposed regulatory experiments or pre-experiments. Individual project budgets will vary based on their scope and needs, within the constraints of this total funding envelope.
 +
**Funds transferred as operations and maintenance funds (O&M) on a cost recovery basis
 +
**The Treasury Board of Canada Secretariat reserves the right to make the final determination on eligible expenditures
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<div style="background-color: #E3F2FD; padding: 5px; border-radius: 5px; margin: 15px 0;">
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'''Important Update:''' Due to multiple ongoing multi-year projects, funding for the new round of REEF will be approximately $400K. This limited budget will be allocated to proposals that best align with Government of Canada priorities. Funds can support both project implementation and administration costs. Early consultation is recommended to ensure alignment with current funding availability and priorities.
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</div>
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<div style="background-color: #FFEBEE; padding: 5px; border-radius: 5px; margin: 15px 0;">
 +
'''Note:''' Funds cannot be used to award a financial prize for an [https://impact.canada.ca/en/challenges Impact Canada challenge prize]. Prize awards require grants and contributions from the applicant.
 +
</div>
 +
===<small>Technical Support</small>===
 +
*Expert advice and guidance to help navigate your specific regulatory context
 +
 
 +
==Eligibility Criteria==
 +
[[File:REEF criteria.png|right|frameless|379x379px|alt=]]
 +
To be eligible for the REEF, proposed regulatory projects must meet the following criteria:
 +
<div style="background-color: #E8F5E9; padding: 10px; border-left: 5px solid #4CAF50; margin: 5px 0;">
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'''Regulatory Experimentation:''' The project must be about [[What is Regulatory Experimentation?|regulatory experimentation]], either:
 +
 
 +
  a. Conducting a regulatory experiment, or
  
='''Interested in applying? Want to learn more?'''=
+
  b. Supporting pre-experimentation activities (developing an experiment or determining if experimentation is appropriate)
The first step is to contact the [mailto:cri-cir@tbs-sct.gc.ca?Subject=Regulatory%20Experimentation%20Expense%20Fund%20Enquiry&body=%20 <u>Centre for Regulatory Innovation</u>] to request an informal consultation to determine whether and how the REEF can best support your goals.
+
</div>
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<div style="background-color: #FFF9C4; padding: 10px; border-left: 5px solid #FBC02D; margin: 5px 0;">
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'''Problem or Opportunity:''' The project must address at least one of the following:
  
Several different types of projects have been eligible for the REEF – read more [[CRI Supported Projects|here]].
+
*  A defined industry need
 +
*  A technological challenge
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*  A market opportunity
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</div>
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<div style="background-color: #E1F5FE; padding: 10px; border-left: 5px solid #00ACC1; margin: 5px 0;">
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'''Innovation:''' The project must support innovation in regulatory approaches or in the marketplace.
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</div>
  
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<div style="background-color: #FFEBEE; padding: 5px; border-radius: 5px; margin: 15px 0;">
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'''Note:''' For an [https://impact.canada.ca/en/challenges Impact Canada challenge prize]:
 +
*  The proposed project does not need to be an experiment
 +
*  Eligibility criterion: Applicants must outline how their challenge will inform regulatory development.
 +
</div>
 +
[[File:Regulatory_innovation_tools.png|alt=|left|216x216px|thumb]]
  
='''The REEF Process'''=
+
=== <small>Webinar: Regulatory Innovation Tools (December 13, 2023)</small> ===
[[File:The_REEF_Process_Graphic_v2.png|alt=|799x799px]]
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For further insight into the eligibility criteria and examples of successful projects, please watch the webinar on [https://1drv.ms/v/s!AsrR00ThYnaKa3QDQ3B3xtblils?e=tcgaNX Regulatory Innovation Tools] from December 13, 2023. This webinar provides valuable information on how to meet the criteria and enhance your proposal.
{| class="mw-collapsible mw-collapsed" data-expandtext="Show Detailed Steps" data-collapsetext="Hide Detailed Steps"
 
|+
 
  
 +
Click to access presentation materials:[[:en:images/f/fd/CRI_Regulatory_Innovation_Tools_Webinar_(EN).pdf|Regulatory Innovation Tools Webinar Deck]]         
 +
<div style="clear: both;"></div>
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==The Process==
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[[File:REEF Process.png|center|frameless|1077x1077px]]
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{| class="wikitable mw-collapsible mw-collapsed" style="width: 100%;"
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! style="background-color: #C3D0C9; color: #333333; width: 5%;" |
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! style="background-color: #C3D0C9; color: #333333; width: 30%;" | Step
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! style="background-color: #C3D0C9; color: #333333; width: 65%;" | Description
 
|-
 
|-
|
+
| style="background-color: #C3D0C9;" |'''1.'''
== '''Step 2: Expression of Interest''' ==
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| style="background-color: #f2f2f2;" |'''Informal Consultation'''
  
 +
(ongoing)
 +
| style="background-color: #f2f2f2;" |
 +
Before submitting an EOI, consult with the CRI to confirm project eligibility. Email: [mailto:cri-cir@tbs-sct.gc.ca cri-cir@tbs-sct.gc.ca]
  
Departments submit a high-level 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 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>
+
'''Note:''' For challenge prize projects, please mention this in your email.
 +
|-
 +
| style="background-color: #C3D0C9;" |'''2.'''
 +
| style="background-color: #ffffff;" | '''Expression of Interest'''
  
<p class="highlighted inline mw-collapsible-content mw-collapsed">Any Government of Canada regulator may apply for funding. Priority will be given to experiments where regulators have identified collaboration with regulated entities or other businesses with the aim of bringing applications of new and emerging technologies into the Canadian marketplace or enhancing competitiveness.</p>
+
(a month)
 +
| style="background-color: #ffffff;" |
 +
* Submit an [https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fwiki.gccollab.ca%2Fimages%2Farchive%2Fc%2Fc2%2F20240913183841%2521Expression_of_Interest_%2528EOI%2529_Template.docx&wdOrigin=BROWSELINK Expression of Interest (EOI)] by October 16, 2024.
 +
* EOIs should be brief and take only a few hours to complete
 +
* Email submissions to: [mailto:cri-cir@tbs-sct.gc.ca cri-cir@tbs-sct.gc.ca]
 +
|-
 +
| style="background-color: #C3D0C9;" |'''3.'''
 +
| style="background-color: #ffffff;" | '''Expression of Interest Assessment'''
  
<p class="highlighted inline mw-collapsible-content mw-collapsed"></p>
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(a month)
 +
| style="background-color: #ffffff;" |<div style="background-color: #E3F2FD; padding: 5px; border-radius: 5px; margin: 15px 0;">
 +
After the submission deadline, there will be a review period where: The CRI team will provide feedback on submitted EOIs, applicants may be asked to update or clarify aspects of their EOI. This iterative process ensures all EOIs are as strong as possible before final assessment
 +
</div>
 +
When there are many high-quality Expressions of Interest (EOIs), the CRI will consult the SC to prioritize those that:
 +
* Foster innovation applicable across multiple sectors
 +
* Align with key government initiatives
 +
|-
 +
| style="background-color: #C3D0C9;" |'''4.'''
 +
| style="background-color: #f2f2f2;" | '''Proposal Submission'''
  
<p class="highlighted inline mw-collapsible-content mw-collapsed">The EOI provides a brief overview of the proposed experiment or pre-experimentation project and amount of funding requested. The EOI should not take more than a few hours to complete. If you have questions on how to complete the EOI, it is recommended that you reach out to the CRI. EOIs should be submitted by email to cri-cir@tbs-sct.gc.ca. The CRI will contact applicants as required if clarifications on the proposed experiment or pre-experimentation project are needed. Applicants with an eligible EOI will be invited to submit a proposal. </p>
+
(around four months)
 +
| style="background-color: #f2f2f2;" |
 +
* Successful EOI applicants 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]
 +
* Applicants must obtain support from Director General or above
 +
* CRI supports throughout the process
 +
* Use the [[:en:images/6/6b/CRI_Regulators'_Experimentation_Toolkit.pdf|Regulators' Experimentation Toolkit]]
 
|-
 
|-
|
+
| style="background-color: #C3D0C9;" |'''5.'''
== '''Step 3: Proposal Submission''' ==
+
| style="background-color: #ffffff;" | '''Funding Decision'''
|-
+
| style="background-color: #ffffff;" |
|Successful EOI applicants will be invited to complete the second stage of the application process which is the submission of a full 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 Regulators’ Experimentation Toolkit to assist in identifying, designing, and carrying out regulatory experiments and sandboxes.<p class="highlighted inline mw-collapsible-content"></p>
+
'''For proposal assessment, the Steering Committee (SC) will:'''
 +
 
 +
#'''Eligibility''': Ensure all proposals meet the basic requirements for consideration.
 +
#'''Assessment''': Eligible applications will be assessed and ranked based on:
 +
#* Public Benefits: Extent to which Canadians will benefit from the experiment's learnings
 +
#* Viability: Likelihood of delivering sought learnings, including risk assessment and mitigation
 +
#* Alignment with the Fund Objective: How well the proposal aligns with the overall goals of the funding initiative
 +
 
 +
'''Funding Decision'''
  
<p class="highlighted inline mw-collapsible-content mw-collapsed">
+
* Funding available from April 2025
Proposals will be assessed, and final funding decisions will be determined by an interdepartmental Steering Committee, made up of representatives from TBS, Privy Council Office, Innovation Science and Economic Development, Transport Canada, Environment and Climate Change Canada, Health Canada, and the Community of Federal Regulators.
+
* MOU completion required
</p>
+
* Regular reporting needed (financial forecast, progress, and final reports)
 +
* Scheduled invoices for expense recovery
 
|-
 
|-
|
+
| style="background-color: #C3D0C9;" |'''6.'''
== '''Step 4: Funding Decision''' ==
+
| style="background-color: #f2f2f2;" |'''Memorandum of Understanding'''
 +
| style="background-color: #f2f2f2;" |
 +
* CRI works with the applicant to develop and finalize an MOU
 +
* MOU outlines conditions of funding, reporting requirements, and committed funds
 +
* Allows CRI to transfer funds as Operations and Maintenance (O&M) funding on a cost-recovery basis
 
|-
 
|-
|Funding will be available from April 2023 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>
+
| style="background-color: #C3D0C9;" |'''7.'''
 +
| style="background-color: #ffffff;" | '''Reporting'''
 +
| style="background-color: #ffffff;" |'''1. Regular Reporting'''
  
<p class="highlighted inline mw-collapsible-content mw-collapsed">The department is responsible to forecast their expenses and include the spending schedule in the MOU. The department will be expected to submit scheduled invoices to TBS to recover the expenses incurred as well as submitting financial forecast to allow TBS to decommit the funds that the department no longer plans on recovering.</p><p class="highlighted inline mw-collapsible-content mw-collapsed"></p><p class="highlighted inline mw-collapsible-content mw-collapsed">For more information on each step of the process, please see 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.]</p>
+
Applicants must submit '''financial forecasts''' and '''progress reports''' to CRI as outlined in the MOU. This ensures transparency and tracks the project's status and use of funds.
|}
 
  
==Application Documents==
+
'''2. Invoices for Expense Recovery'''
  
*[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]
+
Submit invoices at scheduled intervals for expense recovery, in line with the terms of the MOU.
*[[Images/6/6b/CRI Regulators' Experimentation Toolkit.pdf|Regulators’ Experimentation Toolkit]]
 
  
*[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 <u>Expression of Interest (EOI) Template</u>]
+
'''3. Final Report'''
  
*<u>[https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fwiki.gccollab.ca%2Fimages%2Fa%2Fa6%2FProposal_Template.docx&wdOrigin=BROWSELINK Proposal Template]</u>
+
At the end of the project, provide a '''final report''' summarizing the key learnings and outcomes.
 
+
|-
= REEF Ongoing Projects=
+
| style="background-color: #C3D0C9;" |'''8.'''
{| class="wikitable mw-collapsible mw-collapsed"
+
| style="background-color: #f2f2f2;" | '''Lessons Learned and Knowledge Sharing'''
|+
+
| style="background-color: #f2f2f2;" |
! colspan="3" |[[CRI Supported Projects|Click here to see a list of the CRI’s '''completed''' '''projects''' and experimentation reports]]
+
* CRI organizes opportunities to share and discuss learnings with interested audiences
 +
* CRI prepares and publishes a report summarizing key lessons learned from regulatory experiments
 +
* Presentations may be given to raise awareness, with project lead verification for any project details
 +
|}
 +
== Application Documents ==
 +
{| class="wikitable" style="width: 100%;"
 +
! style="background-color: #C3D0C9; color: #333333;" | Document
 +
! style="background-color: #C3D0C9; color: #333333;" | Description
 +
|-
 +
| [[:en:images/6/6b/CRI_Regulators'_Experimentation_Toolkit.pdf|Regulators' Experimentation Toolkit]]
 +
| Toolkit for regulatory experiments and sandboxes
 +
|-
 +
| [https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fwiki.gccollab.ca%2Fimages%2Farchive%2Fc%2Fc2%2F20240913183841%2521Expression_of_Interest_%2528EOI%2529_Template.docx&wdOrigin=BROWSELINK Expression of Interest (EOI) Template]
 +
| Template for submitting your initial interest
 +
|-
 +
| [[Media:REEF Proposal Template.docx|Proposal Template]]
 +
| Template for full project proposal
 +
|}
 +
==Ongoing Projects==
 +
{| class="wikitable mw-collapsible mw-collapsed" style="width: 100%;"
 +
! style="background-color: #C3D0C9; color: #333333; width: 20%;" | Department/Agency
 +
! style="background-color: #C3D0C9; color: #333333; width: 25%;" | Project Title
 +
! style="background-color: #C3D0C9; color: #333333; width: 55%;" | Project Description
 
|-
 
|-
|'''Department/ Agency'''
+
| style="background-color: #ffffff;" | Transport Canada (TC)
|'''Project Title '''
+
| style="background-color: #ffffff;" | Light Sport Aircraft
|'''Project Description'''
+
| style="background-color: #ffffff;" |
 +
Transport Canada is conducting a regulatory experiment to assess the suitability of Light Sport Aircraft (LSA) for use in flight training. The project aims to evaluate LSA certified by the European Union Aviation Safety Agency in Canadian flight training environments. Working with selected flight schools, Transport Canada will gather data on aircraft performance, reliability, and training quality. The experiment seeks to inform potential updates to regulations, potentially allowing more modern and environmentally friendly aircraft options for pilot training while maintaining safety standards.
 
|-
 
|-
|Transport Canada (TC)
+
| style="background-color: #f2f2f2;" | Health Canada (HC)
| Light Sport Aircraft
+
| style="background-color: #f2f2f2;" | Advanced Therapeutic Products Framework for CAR-T Products
|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.
+
| style="background-color: #f2f2f2;" |
 +
Health Canada is developing a regulatory sandbox for Chimeric Antigen Receptor T-cell (CAR-T) therapy products manufactured at the point of care. This experiment aims to test a co-creation process for developing tailored regulatory requirements under Health Canada's Advanced Therapeutic Products pathway. The project will involve collaboration with various stakeholders to design market access authorization requirements for these innovative cancer treatments. The goal is to create an adaptive regulatory framework that maintains safety standards while facilitating faster access to new therapies.
 
|-
 
|-
|Innovation Science and Economic Development (ISED) –  Standards Council of Canada (SCC)
+
| style="background-color: #ffffff;" | Canada Energy Regulator (CER)
|Piloting an Accreditation Program for the Assessment  of Artificial Intelligence Management Systems (AIMS)
+
| style="background-color: #ffffff;" | Assessing Compliance of Potential New Requirements to Prevent and Address Impacts to Indigenous Rights and Interests: A Regulatory Experiment
|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.
+
| style="background-color: #ffffff;" |
 
+
The Canada Energy Regulator (CER) is conducting a regulatory experiment to develop and test new requirements for preventing and addressing impacts to Indigenous rights and interests related to energy infrastructure projects. The experiment aims to enhance Indigenous involvement in compliance verification and oversight processes. Using a co-creation approach with Indigenous communities and other stakeholders, the CER will develop tailored regulatory requirements and test a joint compliance verification process. The project seeks to strengthen measures to protect Indigenous rights while informing updates to CER's regulatory framework.
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)
+
|Agriculture and Agri-Food Canada (AAFC) and Canadian Food Inspection Agency (CFIA)
| Aviation E-Licensing Pilot
+
|Facilitating Industry Collaboration to Streamline Regulatory Pathways for Novel Fertilizers
|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.
+
|Canadian Food Inspection Agency (CFIA) in collaboration with Agriculture and Agri-Food Canada (AAFC), aims to streamline regulatory pathways for novel fertilizers in Canada. The project will test an industry-developed prioritization matrix to identify key ingredients for potential exemption from registration, potentially reducing the backlog of premarket applications. It will evaluate the effectiveness of allocating CFIA resources towards expanding the List of Materials (LOM) and explore industry collaboration in prioritizing materials and developing application packages. By comparing the costs and efficiency of adding materials to the LOM versus reviewing individual registration applications, the project seeks to inform strategies for reducing regulatory burdens while maintaining safety standards. This approach could lead to faster market access for novel fertilizers, supporting agricultural productivity and environmental sustainability in Canada.
 
|-
 
|-
|Health Canada (HC)
+
! colspan="3" style="background-color: #C3D0C9;" |[[CRI Supported Projects|View list of completed projects and experimentation reports]]
| Machine Learning Enabled Medical Device (MLMD)  Sandbox Development
 
|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.
 
 
|}
 
|}
__NOTOC__
+
'''Questions?'''
 +
 
 +
If you have any questions, please contact the CRI at: [mailto:&#x20;cri-cir@tbs-sct.gc.ca cri-cir@tbs-sct.gc.ca].
 +
 
 
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Latest revision as of 14:05, 30 October 2024

Home Regulatory Sandbox Regulatory Experimentation REEF RCF Projects RegTech Forum Tools
Deadline
We extend our heartfelt gratitude for the overwhelming interest in REEF. As of October 17, 2024, we have concluded accepting Expressions of Interest (EOIs) and are no longer receiving submissions.

Project Eligibility

The Regulatory Experimentation Expense Fund (REEF) supports federal regulators in innovating or facilitating innovation in the marketplace by experimenting with:

  • Innovative approaches to any stage of the regulatory lifecycle
  • Market innovations (e.g., new products, business models, and services)

All stages of regulatory experimentation are supported, including:

  • Determining if an experiment is the right approach
  • Developing a regulatory experiment
  • Conducting a regulatory experiment

New this year: Outcomes-based initiatives, like innovation challenges, are tools that can support your regulatory experimentation efforts. Consider Impact Canada as a partner in your expression of interest.

The REEF is open to all Government of Canada regulators.

What can the REEF offer?

Regulators can receive:

Financial Support

  • The total funding envelope is $1,400,000 per fiscal year. This amount represents the overall budget available to support multiple projects across potentially multiple fiscal years. Funding will be allocated to cover expenditures considered necessary to support the purposes of proposed regulatory experiments or pre-experiments. Individual project budgets will vary based on their scope and needs, within the constraints of this total funding envelope.
    • Funds transferred as operations and maintenance funds (O&M) on a cost recovery basis
    • The Treasury Board of Canada Secretariat reserves the right to make the final determination on eligible expenditures

Important Update: Due to multiple ongoing multi-year projects, funding for the new round of REEF will be approximately $400K. This limited budget will be allocated to proposals that best align with Government of Canada priorities. Funds can support both project implementation and administration costs. Early consultation is recommended to ensure alignment with current funding availability and priorities.

Note: Funds cannot be used to award a financial prize for an Impact Canada challenge prize. Prize awards require grants and contributions from the applicant.

Technical Support

  • Expert advice and guidance to help navigate your specific regulatory context

Eligibility Criteria

To be eligible for the REEF, proposed regulatory projects must meet the following criteria:

Regulatory Experimentation: The project must be about regulatory experimentation, either:

  a. Conducting a regulatory experiment, or

  b. Supporting pre-experimentation activities (developing an experiment or determining if experimentation is appropriate)

Problem or Opportunity: The project must address at least one of the following:

  •   A defined industry need
  •   A technological challenge
  •   A market opportunity

Innovation: The project must support innovation in regulatory approaches or in the marketplace.

Note: For an Impact Canada challenge prize:

  •   The proposed project does not need to be an experiment
  •   Eligibility criterion: Applicants must outline how their challenge will inform regulatory development.

Webinar: Regulatory Innovation Tools (December 13, 2023)

For further insight into the eligibility criteria and examples of successful projects, please watch the webinar on Regulatory Innovation Tools from December 13, 2023. This webinar provides valuable information on how to meet the criteria and enhance your proposal.

Click to access presentation materials:Regulatory Innovation Tools Webinar Deck

The Process

REEF Process.png
Step Description
1. Informal Consultation

(ongoing)

Before submitting an EOI, consult with the CRI to confirm project eligibility. Email: cri-cir@tbs-sct.gc.ca

Note: For challenge prize projects, please mention this in your email.

2. Expression of Interest

(a month)

3. Expression of Interest Assessment

(a month)

After the submission deadline, there will be a review period where: The CRI team will provide feedback on submitted EOIs, applicants may be asked to update or clarify aspects of their EOI. This iterative process ensures all EOIs are as strong as possible before final assessment

When there are many high-quality Expressions of Interest (EOIs), the CRI will consult the SC to prioritize those that:

  • Foster innovation applicable across multiple sectors
  • Align with key government initiatives
4. Proposal Submission

(around four months)

5. Funding Decision

For proposal assessment, the Steering Committee (SC) will:

  1. Eligibility: Ensure all proposals meet the basic requirements for consideration.
  2. Assessment: Eligible applications will be assessed and ranked based on:
    • Public Benefits: Extent to which Canadians will benefit from the experiment's learnings
    • Viability: Likelihood of delivering sought learnings, including risk assessment and mitigation
    • Alignment with the Fund Objective: How well the proposal aligns with the overall goals of the funding initiative

Funding Decision

  • Funding available from April 2025
  • MOU completion required
  • Regular reporting needed (financial forecast, progress, and final reports)
  • Scheduled invoices for expense recovery
6. Memorandum of Understanding
  • CRI works with the applicant to develop and finalize an MOU
  • MOU outlines conditions of funding, reporting requirements, and committed funds
  • Allows CRI to transfer funds as Operations and Maintenance (O&M) funding on a cost-recovery basis
7. Reporting 1. Regular Reporting

Applicants must submit financial forecasts and progress reports to CRI as outlined in the MOU. This ensures transparency and tracks the project's status and use of funds.

2. Invoices for Expense Recovery

Submit invoices at scheduled intervals for expense recovery, in line with the terms of the MOU.

3. Final Report

At the end of the project, provide a final report summarizing the key learnings and outcomes.

8. Lessons Learned and Knowledge Sharing
  • CRI organizes opportunities to share and discuss learnings with interested audiences
  • CRI prepares and publishes a report summarizing key lessons learned from regulatory experiments
  • Presentations may be given to raise awareness, with project lead verification for any project details

Application Documents

Document Description
Regulators' Experimentation Toolkit Toolkit for regulatory experiments and sandboxes
Expression of Interest (EOI) Template Template for submitting your initial interest
Proposal Template Template for full project proposal

Ongoing Projects

Department/Agency Project Title Project Description
Transport Canada (TC) Light Sport Aircraft

Transport Canada is conducting a regulatory experiment to assess the suitability of Light Sport Aircraft (LSA) for use in flight training. The project aims to evaluate LSA certified by the European Union Aviation Safety Agency in Canadian flight training environments. Working with selected flight schools, Transport Canada will gather data on aircraft performance, reliability, and training quality. The experiment seeks to inform potential updates to regulations, potentially allowing more modern and environmentally friendly aircraft options for pilot training while maintaining safety standards.

Health Canada (HC) Advanced Therapeutic Products Framework for CAR-T Products

Health Canada is developing a regulatory sandbox for Chimeric Antigen Receptor T-cell (CAR-T) therapy products manufactured at the point of care. This experiment aims to test a co-creation process for developing tailored regulatory requirements under Health Canada's Advanced Therapeutic Products pathway. The project will involve collaboration with various stakeholders to design market access authorization requirements for these innovative cancer treatments. The goal is to create an adaptive regulatory framework that maintains safety standards while facilitating faster access to new therapies.

Canada Energy Regulator (CER) Assessing Compliance of Potential New Requirements to Prevent and Address Impacts to Indigenous Rights and Interests: A Regulatory Experiment

The Canada Energy Regulator (CER) is conducting a regulatory experiment to develop and test new requirements for preventing and addressing impacts to Indigenous rights and interests related to energy infrastructure projects. The experiment aims to enhance Indigenous involvement in compliance verification and oversight processes. Using a co-creation approach with Indigenous communities and other stakeholders, the CER will develop tailored regulatory requirements and test a joint compliance verification process. The project seeks to strengthen measures to protect Indigenous rights while informing updates to CER's regulatory framework.

Agriculture and Agri-Food Canada (AAFC) and Canadian Food Inspection Agency (CFIA) Facilitating Industry Collaboration to Streamline Regulatory Pathways for Novel Fertilizers Canadian Food Inspection Agency (CFIA) in collaboration with Agriculture and Agri-Food Canada (AAFC), aims to streamline regulatory pathways for novel fertilizers in Canada. The project will test an industry-developed prioritization matrix to identify key ingredients for potential exemption from registration, potentially reducing the backlog of premarket applications. It will evaluate the effectiveness of allocating CFIA resources towards expanding the List of Materials (LOM) and explore industry collaboration in prioritizing materials and developing application packages. By comparing the costs and efficiency of adding materials to the LOM versus reviewing individual registration applications, the project seeks to inform strategies for reducing regulatory burdens while maintaining safety standards. This approach could lead to faster market access for novel fertilizers, supporting agricultural productivity and environmental sustainability in Canada.
View list of completed projects and experimentation reports

Questions?

If you have any questions, please contact the CRI at: cri-cir@tbs-sct.gc.ca.