GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Clean Fuel Regulations — 5
5 The following information with respect to the compliance credits that the primary supplier will use to satisfy the reduction requirement and the volumetric requirements set out in subsections 6 (1) and 7 (1) of these Regulations in respect of their pool of gasoline or diesel in accordance with sections 11 and 12 of these Regulations: (a) the number of compliance credits referred to in paragraph 4(c) that they will use to reduce the reduction requirement; (b) the number of each of the specific types of compliance credits that are referred to in subsection 106 (3) of these Regulations that they will use to reduce the reduction requirement and satisfy the volumetric requirements set out in subsections 6 (1) and 7 (1) of these Regulations; (c) the number of each of the specific types of compliance credits referred to in subsection 106 (3) of these Regulations that were created with respect to a gasoline replacement and, for each such compliance credit, the volume of the fuel that is associated with it as well as the carbon intensity and any alphanumeric identifier to it; (d) the number of each of the specific types of compliance credits referred to in subsection 106 (3) of these Regulations that were created with respect to a diesel replacement and, for each such compliance credit, the volume of the fuel that is associated with it as well as the carbon intensity and any alphanumeric identifier to it; and (e) the total number of compliance credits from each of the primary supplier’s accounts that they will use to reduce the reduction requirement.
Clean Fuel Regulations — 6
6 If the primary supplier has, in accordance with subsection 16 (1) of these Regulations, deferred satisfaction of their reduction requirements in respect of a pool of gasoline or diesel for one of the five compliance periods that immediately precede the compliance period to which the report relates, the following information: (a) the number of compliance credits that they must use in accordance with subsection 18 (1) of these Regulations in order to satisfy the deferred portion of their reduction requirements in accordance with subsection 16 (3) of these Regulations; and (b) the number of each of the specific types of compliance credits that are referred to in subsection 106 (3) of these Regulations that they must use in accordance with subsection 18 (1) of these Regulations; and (c) the number of compliance credits referred to in paragraph 4(c) that they must use in order to reduce the deferred portion of the reduction requirements.
Clean Fuel Regulations — 7
7 Unless the information is otherwise provided by the primary supplier in a report they submit under section 120 or 122 of these Regulations, the quantity and carbon intensity of each liquid or gaseous low-carbon-intensity fuel that was produced in Canada or imported into Canada and was used to create compliance credits, if (a) during the compliance period, the primary supplier exported the fuel or sold the fuel for export; or (b) the primary supplier acquired the fuel in accordance with a transfer request referred to in section 108 of these Regulations and, during the compliance period, the fuel was exported or sold for export by a person who is not a primary supplier nor a registered creator.
Clean Fuel Regulations — 8
8 With respect to each low-carbon-intensity fuel referred to in section 7, the number of compliance credits that should be cancelled and the specific accounts in which they are located.
Clean Fuel Regulations — 2
2 If the primary supplier has not satisfied the reduction requirement for a compliance period in respect of gasoline or diesel on the July 31 that follows the expiry of the compliance period, the following information: (a) the value of the reduction requirement that has not been satisfied in respect of gasoline or diesel, expressed in tonnes of CO 2 e; and (b) the value of the volumetric requirement that is determined under, in the case of gasoline, subsection 6 (1) of these Regulations or, in the case of diesel, subsection 7 (1) of these Regulations and that has not been satisfied, expressed in cubic metres.
Clean Fuel Regulations — 3
3 With respect to each of the specific types of compliance credits that are referred to in subsection 106 (3) of these Regulations, the number of those compliance credits that were transferred to the primary supplier through the credit clearance mechanism in accordance with section 112 of these Regulations.
Clean Fuel Regulations — 4
4 The number of compliance credits referred to in section 3 that were created with respect to a gasoline replacement or diesel replacement and, for each compliance credit, the volume of the fuel that is associated with it as well as the carbon intensity and any alphanumeric identifier to it.
Clean Fuel Regulations — 5
5 If the primary supplier made a contribution to a registered emission-reduction funding program in accordance with paragraph 118 (1)(b) of these Regulations, (a) the name of the registered emission-reduction funding program; (b) the amount of the contribution; (c) the number of compliance credits created by making the contribution; and (d) the receipt referred to in subsection 118 (2) of these Regulations.
Clean Fuel Regulations — 6
6 If the primary supplier will defer satisfaction of the reduction requirement with respect to gasoline or diesel, for the compliance period in accordance with subsection 16 (1) of these Regulations, the value of the reduction requirement that has been deferred and the types of fuel to which the deferral applies.
Clean Fuel Regulations — 7
7 If the primary supplier has, in accordance with subsection 16 (1) of these Regulations, deferred satisfaction of their reduction requirements in respect of gasoline or diesel for one of the five compliance periods that immediately precede the compliance period to which the report relates, the following information: (a) the number of compliance credits that they must use in accordance with subsection 18 (1) of these Regulations in order to satisfy the deferred portion of the reduction requirements for each previous compliance period in accordance with subsection 16 (3) of these Regulations; (b) the number of each of the specific types of compliance credits that are referred to in subsection 106 (3) of these Regulations that they must use in accordance with subsection 18 (1) of these Regulations; and (c) the number of compliance credits referred to in paragraph 5(c) that they must use in order to reduce the deferred portion of the reduction requirements.
Clean Fuel Regulations — 2
2 Any other information that is, in the opinion of the verification body, relevant to the verification.
Clean Fuel Regulations — 1
1 A list of other systems of tradeable units in which the participant participates and other third-party audit programs with which they comply.
Clean Fuel Regulations — 2
2 A description of the operations to be verified, including a description of (a) the activities and processes of the operations; (b) the geographical boundaries within which the operations occur; and (c) the technologies, facilities and infrastructure that are used to perform the operations.
Clean Fuel Regulations — 3
3 A simplified block diagram of the operations to be verified, including (a) the feedstock and the fuel, thermal energy or electricity sources that are used in the operations; (b) the intermediate products and final products that the operations produce; (c) the mechanical equipment that is used to perform the operations; (d) the process control instrumentation, including sensors and measurement devices, that are used to monitor the operations; (e) the sampling locations that are used to monitor the operations; and (f) a designation for each element of the block diagram.
Clean Fuel Regulations — 4
4 A description of each source of the data to which the application or report relates that includes, if applicable to the source, (a) its accuracy; (b) its sampling characteristics; and (c) the frequency with which data is collected.
Clean Fuel Regulations — 5
5 A description of the data management system that is used to manage the data to which the application or report relates, including (a) the policies and procedures that ensure data quality, including those that relate to (i) data collection and measurement, (ii) the emission-reduction quantification methods that were used, (iii) reporting, (iv) maintenance, inspection and repair of continuous monitoring systems, flow meters, laboratory equipment and other instrumentation used to collect the data, including procedures for deferring their maintenance and inspection, (v) contingency plans in the event of a failure of a measurement device or a component of a continuous monitoring system, (vi) the keeping of records, including the logbook of measurement device and laboratory equipment repair, calibration and replacement, (vii) the training of key personnel responsible for the data management; (viii) the frequency of sampling, (ix) the laboratory procedures and methods of analysis, and (x) the quality control program that is used by the laboratories; (b) the roles and responsibilities of personnel with respect to the data management system; (c) its design, including the information technology infrastructure and applications used to manage the data; (d) its data management controls, including their location, purpose, frequency and type; (e) the procedures with respect to missing data; (f) the procedures with respect to non-representative data such as data generated during plant shutdowns or emergencies; (g) the subcontractors or the software that are used to manage the data; (h) the security methods that are used to ensure data integrity; and (i) data back-up procedures.
Clean Fuel Regulations — 6
6 The following information with respect to each measurement device that is used to measure data to which the application or report relates: (a) its description; (b) its make, model and serial number; (c) its location, installation method and approximate date of installation; (d) its measurement characteristics, including the units of measure, accuracy and lower detection limits; (e) its maintenance, including the calibration method and calibration frequency; (f) any postponements in calibration and any supporting documents; and (g) the frequency with which it provides measurements.
Clean Fuel Regulations — 7
7 Information with respect to the calculations and use of data to which the application or report relates, including (a) the equations used to (i) calculate flows in mass, volume or energy units of measurement, (ii) convert units, (iii) estimate non-measured parameters, (iv) aggregate data, and (v) estimate, interpolate or extrapolate data; (b) any software used to transform the data; and (c) any statistical methods or techniques applied to transform the data.
Clean Fuel Regulations — 8
8 If the verification is in respect of an application made under section 80 of these Regulations or a report submitted under section 123 of these Regulations, the following information: (a) an explanation of the processes and methods followed to collect the data used in the application or report, including any supporting documents; (b) a description of the steps taken, and calculations made, to aggregate the data; (c) the methodology used to assign volumes, in respect of a fuel, source of electricity or feedstock, for each carbon intensity value; and (d) the methodology used to monitor and calculate the weighted average of the transportion distance, in respect of a fuel, source of electricity or feedstock, for each transport mode, including any supporting documents.
Clean Fuel Regulations — 9
9 An explanation of the process and methodology that was used to calculate the maximum quantity of a low-carbon-intensity fuel in accordance with subsection 45 (1), including any supporting documents and data.
Clean Fuel Regulations — 10
10 If the verification is in respect of a credit-creation report submitted under section 120 of these Regulations, a credit-adjustment report submitted under section 122 of these Regulations or a compliance report submitted under section 127 of these Regulations, a reference to the documents that relate to the quantity of any fuel or energy source that was produced and the sale, purchase or transport of any fuel or energy source.
Order Bringing Individual Agreements with First Nations into Effect — Order Bringing Individual Agreements with First Nations into Effect
Whereas an individual agreement has been entered into with each of the bands referred to in the annexed Order;
Order Bringing Individual Agreements with First Nations into Effect — a
Therefore, Her Excellency the Governor General in Council, on the recommendation of the Minister of Crown-Indigenous Relations makes the annexed Order Bringing Individual Agreements with First Nations into Effect under subsection 5(1) of the First Nations Jurisdiction over Education in British Columbia Act a . a S.C. 2006, c. 10
Order Bringing Individual Agreements with First Nations into Effect — 1
Individual agreements 1 For the purposes of the First Nations Jurisdiction over Education in British Columbia Act , the following individual agreements are in effect: (a) the Canada-First Nation Education Jurisdiction Agreement between Canada and ?aq’am Community, entered into on May 26, 2022; (b) the Canada-First Nation Education Jurisdiction Agreement between Canada and Cowichan Tribes, entered into on May 26, 2022; (c) the Canada-First Nation Education Jurisdiction Agreement between Canada and Lil’wat Nation, entered into on May 25, 2022; and (d) the Canada-First Nation Education Jurisdiction Agreement between Canada and Seabird Island Band, entered into on May 25, 2022.
Order Bringing Individual Agreements with First Nations into Effect — 3
Registration 3 This Order comes into force on July 1, 2022, but if it is registered after that day, it comes into force on the day on which it is registered.
Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations — (a)
Her Excellency the Governor General in Council, on the recommendation of the Minister of Health with respect to the provisions of the annexed Regulations other than sections 53 and 54, and on the recommendation of the Minister of Health and the Minister of Industry with respect to those sections 53 and 54, makes the annexed Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations pursuant to (a) section 30 a of the Food and Drugs Act b ; and a S.C. 2021, c. 7, s. 9 b R.S., c. F-27 (b) subsection 134(1) c of the Patent Act d . c S.C. 2018, c. 27, s. 199 d R.S., c. P-4
Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations — (a)
(a) section 30 a of the Food and Drugs Act b ; and a S.C. 2021, c. 7, s. 9 b R.S., c. F-27
Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations — (b)
(b) subsection 134(1) c of the Patent Act d . c S.C. 2018, c. 27, s. 199 d R.S., c. P-4
Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations — 1
Definitions 1 The following definitions apply in these Regulations. Act means the Food and Drugs Act . ( Loi ) COVID-19 means the coronavirus disease 2019. ( COVID-19 ) COVID-19 drug means a drug for human use that is manufactured, sold or represented for use in relation to COVID-19. ( drogue utilisée en lien avec la COVID-19 ) COVID-19 drug authorization means an authorization to do any of the following activities: (a) import or sell a COVID-19 drug that is to be tested in a clinical trial; (b) conduct a clinical trial in respect of such a drug. ( autorisation relative à une drogue utilisée en lien avec la COVID-19 ) COVID-19 medical device means a medical device that is manufactured, sold or represented for use in relation to COVID-19. ( instrument médical utilisé en lien avec la COVID-19 ) COVID-19 medical device authorization means an authorization to do any of the following activities: (a) import or sell a COVID-19 medical device that is to be tested in a clinical trial; (b) conduct a clinical trial in respect of such a device. ( autorisation relative à un instrument médical utilisé en lien avec la COVID-19 ) incident means any incident that involves a COVID-19 medical device tested in a clinical trial and that (a) is related to a failure of the device or a deterioration in its quality or effectiveness or any inadequacy in its labelling or its directions for use; or (b) has led to the death or a serious deterioration in the state of health of a clinical trial subject, user or other person or could do so were it to recur. ( incident ) qualified investigator means a person who is a member in good standing of a professional association of persons entitled under the laws of a province to provide health care under their licence in that province and who (a) conducts a clinical trial; or (b) in the case of a clinical trial conducted by a team, is the responsible leader of that team. ( chercheur compétent ) research ethics board means a body that is not affiliated with an applicant for a COVID-19 medical device authorization or a COVID-19 drug authorization, or a holder of such an authorization, and whose principal mandate is to approve the initiation of, and conduct periodic reviews of, biomedical research involving human subjects in order to ensure the protection of their rights, safety and well-being. ( comité d’éthique de la recherche )
Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations — Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations
Act means the Food and Drugs Act . ( Loi )
Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations — Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations
COVID-19 means the coronavirus disease 2019. ( COVID-19 )
Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations — Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations
COVID-19 drug means a drug for human use that is manufactured, sold or represented for use in relation to COVID-19. ( drogue utilisée en lien avec la COVID-19 )
Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations — (a)
COVID-19 drug authorization means an authorization to do any of the following activities: (a) import or sell a COVID-19 drug that is to be tested in a clinical trial; (b) conduct a clinical trial in respect of such a drug. ( autorisation relative à une drogue utilisée en lien avec la COVID-19 )
Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations — Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations
COVID-19 medical device means a medical device that is manufactured, sold or represented for use in relation to COVID-19. ( instrument médical utilisé en lien avec la COVID-19 )
Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations — (a)
COVID-19 medical device authorization means an authorization to do any of the following activities: (a) import or sell a COVID-19 medical device that is to be tested in a clinical trial; (b) conduct a clinical trial in respect of such a device. ( autorisation relative à un instrument médical utilisé en lien avec la COVID-19 )
Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations — (a)
incident means any incident that involves a COVID-19 medical device tested in a clinical trial and that (a) is related to a failure of the device or a deterioration in its quality or effectiveness or any inadequacy in its labelling or its directions for use; or (b) has led to the death or a serious deterioration in the state of health of a clinical trial subject, user or other person or could do so were it to recur. ( incident )
Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations — (a)
qualified investigator means a person who is a member in good standing of a professional association of persons entitled under the laws of a province to provide health care under their licence in that province and who (a) conducts a clinical trial; or (b) in the case of a clinical trial conducted by a team, is the responsible leader of that team. ( chercheur compétent )
Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations — Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations
research ethics board means a body that is not affiliated with an applicant for a COVID-19 medical device authorization or a COVID-19 drug authorization, or a holder of such an authorization, and whose principal mandate is to approve the initiation of, and conduct periodic reviews of, biomedical research involving human subjects in order to ensure the protection of their rights, safety and well-being. ( comité d’éthique de la recherche )
Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations — 2
Words and expressions 2 (1) Unless the context requires otherwise, words and expressions used in these Regulations have the same meaning as in the Medical Devices Regulations and the Food and Drug Regulations , as applicable. Definition of clinical trial (2) However, clinical trial has the same meaning as in section 2 of the Act, except as otherwise provided.
Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations — 3
Application 3 (1) These Regulations apply to the importation and sale of a COVID-19 medical device, other than a Class I device, that is to be tested in a clinical trial, to the importation and sale of a COVID-19 drug, other than a drug that is described in Schedule C to the Act, that is to be tested in a clinical trial and to the conduct of a clinical trial in respect of such a device or drug. Non-application — COVID-19 medical device (2) The Medical Devices Regulations , other than sections 6 and 7 and Schedule 1, do not apply to the importation or sale of a COVID-19 medical device that is to be tested in a clinical trial or to the conduct of a clinical trial in respect of such a device if a COVID-19 medical device authorization has been issued for that device and the authorization has not been revoked in whole. Non-application — COVID-19 drug (3) The following regulations do not apply to the importation or sale of a COVID-19 drug that is to be tested in a clinical trial or to the conduct of a clinical trial in respect of such a drug if a COVID-19 drug authorization has been issued for that drug and the authorization has not been revoked in whole: (a) the Food and Drug Regulations , other than sections A.01.022 to A.01.024, A.01.026, A.01.041, A.01.042, A.01.050, A.01.067, A.01.068, C.01.015, C.01.036, C.01.037 to C.01.040, C.01.040.2, C.01.051, C.01.064 to C.01.067, C.01.070, C.01.131, C.01.133 to C.01.136 and C.01.435 and Divisions 2 and 4 of Part C; and (b) the Blood Regulations .
Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations — 5
Issuance 5 The Minister must issue a COVID-19 medical device authorization if the following requirements are met: (a) the applicant has submitted to the Minister an application that meets the requirements set out in section 4 ; (b) the applicant has submitted to the Minister any additional information or material requested under subsection 10 (1) in the time, form and manner specified under subsection 10 (2); and (c) the Minister determines that (i) the use of the device that is to be tested in the clinical trial will not unduly affect the health or safety of clinical trial subjects, users or other persons, (ii) the clinical trial is not contrary to the best interests of clinical trial subjects, and (iii) the objectives of the clinical trial are achievable.
Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations — 6
Research ethics board approval 6 A holder of a COVID-19 medical device authorization must not import or sell a COVID-19 medical device for which the authorization has been issued or conduct a clinical trial in respect of such a device unless the holder has obtained, for each clinical trial site, the approval of a research ethics board in respect of the protocol and informed consent form referred to in paragraph 4 (2)(p).