Canada Gazette, Part I, Volume 149, Number 26: GOVERNMENT NOTICES
June 27, 2015
DEPARTMENT OF THE ENVIRONMENT
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Significant New Activity Notice No. 15310
Rescinding Significant New Activity Notice
(Section 85 of the Canadian Environmental Protection Act, 1999)
Whereas the Minister of the Environment published on January 24, 2009, Significant New Activity Notice No. 15310 pertaining to the substance silane homopolymer, hydrolysis products with magnesium hydroxide;
And whereas the Minister of the Environment and the Minister of Health no longer suspect that a significant new activity in relation to the substance may result in the substance becoming toxic within the meaning of section 64 of the Canadian Environmental Protection Act, 1999,
Therefore, the Minister of the Environment hereby indicates, pursuant to subsection 85(2) of the Canadian Environmental Protection Act, 1999, that subsection 81(4) of the Act no longer applies to the substance and rescinds Significant New Activity Notice No. 15310.
LEONA AGLUKKAQ
Minister of the Environment
EXPLANATORY NOTE
(This explanatory note is not part of the Significant New Activity Notice.)
Description
This explanatory note relates to Significant New Activity (SNAc) Notice No. 15310 adopted in relation to the substance silane homopolymer, hydrolysis products with magnesium hydroxide, pursuant to section 85 of the Canadian Environmental Protection Act, 1999 (CEPA 1999). In view of the current SNAc policy (https://www.ec.gc.ca/ese-ees/default.asp?lang= En&n=5CA18D66-1), and pursuant to subsection 85(2) of CEPA 1999, where the Minister of the Environment, by notice published in the Canada Gazette, may vary or rescind a notice, SNAc Notice No. 15310 is rescinded. This action is being taken as part of the review of current SNAc notices adopted under CEPA 1999 (http://www.chemicalsubstanceschimiques.gc.ca/plan/approach-approche/snac-nac/index-eng.php#a2).
Rescission of the Significant New Activity Notice
The Significant New Activity Notice was designed to collect information on the nanoscale forms of the notified substance. A review of this Notice found that it is no longer needed. The Government of Canada is considering using other means of collecting information on nanoscale forms of this type of substance.
Notifiers who intend to manufacture or import a new nanoscale substance should consult New Substances Program Advisory Note 2014-02 — Assessment of nanomaterials under the New Substances Notification Regulations (Chemicals and Polymers). (see footnote 1) This note provides additional clarity regarding nanoscale substances that are notifiable under the Regulations.
[26-1-o]
DEPARTMENT OF THE ENVIRONMENT
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Significant New Activity Notice No. 15345
Rescinding Significant New Activity Notice
(Section 85 of the Canadian Environmental Protection Act, 1999)
Whereas the Minister of the Environment published on January 24, 2009, Significant New Activity Notice No. 15345 pertaining to the substance tin titanium zinc oxide, Chemical Abstracts Service Registry No. 923954-49-8;
And whereas the Minister of the Environment and the Minister of Health no longer suspect that a significant new activity in relation to the substance may result in the substance becoming toxic within the meaning of section 64 of the Canadian Environmental Protection Act, 1999,
Therefore, the Minister of the Environment hereby indicates, pursuant to subsection 85(2) of the Canadian Environmental Protection Act, 1999, that subsection 81(4) of the Act no longer applies to the substance and rescinds Significant New Activity Notice No. 15345.
LEONA AGLUKKAQ
Minister of the Environment
EXPLANATORY NOTE
(This explanatory note is not part of the Significant New Activity Notice.)
Description
This explanatory note relates to Significant New Activity (SNAc) Notice No. 15345 adopted in relation to the substance tin titanium zinc oxide, Chemical Abstracts Service Registry No. 923954-49-8, pursuant to section 85 of the Canadian Environmental Protection Act, 1999 (CEPA 1999). In view of the current SNAc policy (https://www.ec.gc.ca/ese-ees/default.asp?lang=En&n=5CA18D66-1), and pursuant to subsection 85(2) of CEPA 1999, where the Minister of the Environment, by notice published in the Canada Gazette, may vary or rescind a notice, SNAc Notice No. 15345 is rescinded. This action is being taken as part of the review of current SNAc notices adopted under CEPA 1999 (http://www.chemicalsubstanceschimiques.gc.ca/plan/approach-approche/snac-nac/index-eng.php#a2).
Rescission of the Significant New Activity Notice
The Significant New Activity Notice was designed to collect information on the nanoscale forms of the notified substance. A review of this Notice found that it is no longer needed. The Government of Canada is considering using other means of collecting information on nanoscale forms of this type of substance.
Notifiers who intend to manufacture or import a new nanoscale substance should consult New Substances Program Advisory Note 2014-02 — Assessment of nanomaterials under the New Substances Notification Regulations (Chemicals and Polymers). (see footnote 2) This note provides additional clarity regarding nanoscale substances that are notifiable under the Regulations.
[26-1-o]
DEPARTMENT OF THE ENVIRONMENT
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Significant New Activity Notice No. 15367
Rescinding Significant New Activity Notice
(Section 85 of the Canadian Environmental Protection Act, 1999)
Whereas the Minister of the Environment published on December 27, 2008, Significant New Activity Notice No. 15367 pertaining to the substance ferrate(1-), bis[3,5-bis(1,1-dimethylethyl)-2-(hydroxy-.kappa.O)benzoato(2-)-.kappa.O]-, hydrogen (1:1), Chemical Abstracts Service Registry No. 102561-69-3;
And whereas the Minister of the Environment and the Minister of Health no longer suspect that a significant new activity in relation to the substance may result in the substance becoming toxic within the meaning of section 64 of the Canadian Environmental Protection Act, 1999,
Therefore, the Minister of the Environment hereby indicates, pursuant to subsection 85(2) of the Canadian Environmental Protection Act, 1999, that subsection 81(4) of the Act no longer applies to the substance and rescinds Significant New Activity Notice No. 15367.
LEONA AGLUKKAQ
Minister of the Environment
EXPLANATORY NOTE
(This explanatory note is not part of the Significant New Activity Notice.)
Description
This explanatory note relates to Significant New Activity (SNAc) Notice No. 15367 adopted in relation to the substance ferrate(1-), bis[3,5-bis(1,1-dimethylethyl)-2-(hydroxy-.kappa.O)benzoato(2-)-.kappa.O]-, hydrogen (1:1), Chemical Abstracts Service Registry No. 102561-69-3, pursuant to section 85 of the Canadian Environmental Protection Act, 1999 (CEPA 1999). In view of the current SNAc policy (https://www.ec.gc.ca/ese-ees/default.asp?lang=En&n=5CA18D66-1), and pursuant to subsection 85(2) of CEPA 1999, where the Minister of the Environment, by notice published in the Canada Gazette, may vary or rescind a notice, SNAc Notice No. 15367 is rescinded. This action is being taken as part of the review of current SNAc notices adopted under CEPA 1999 (http://www.chemicalsubstanceschimiques.gc.ca/plan/approach-approche/snac-nac/index-eng.php#a2).
Rescission of the Significant New Activity Notice
The Significant New Activity Notice was designed to collect information on the nanoscale forms of the notified substance. A review of this Notice found that it is no longer needed. The Government of Canada is considering using other means of collecting information on nanoscale forms of this type of substance.
Notifiers who intend to manufacture or import a new nanoscale substance should consult New Substances Program Advisory Note 2014-02 — Assessment of nanomaterials under the New Substances Notification Regulations (Chemicals and Polymers). (see footnote 3) This note provides additional clarity regarding nanoscale substances that are notifiable under the Regulations.
[26-1-o]
DEPARTMENT OF THE ENVIRONMENT
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Significant New Activity Notice No. 15847
Rescinding Significant New Activity Notice
(Section 85 of the Canadian Environmental Protection Act, 1999)
Whereas the Minister of the Environment published on March 27, 2010, Significant New Activity Notice No. 15847 pertaining to the substance silica gel, fluorinated, Chemical Abstracts Service Registry No. 72319-09-6;
And whereas the Minister of the Environment and the Minister of Health no longer suspect that a significant new activity in relation to the substance may result in the substance becoming toxic within the meaning of section 64 of the Canadian Environmental Protection Act, 1999,
Therefore, the Minister of the Environment hereby indicates, pursuant to subsection 85(2) of the Canadian Environmental Protection Act, 1999, that subsection 81(4) of the Act no longer applies to the substance and rescinds Significant New Activity Notice No. 15847.
LEONA AGLUKKAQ
Minister of the Environment
EXPLANATORY NOTE
(This explanatory note is not part of the Significant New Activity Notice.)
Description
This explanatory note relates to Significant New Activity (SNAc) Notice No. 15847 adopted in relation to the substance silica gel, fluorinated, Chemical Abstracts Service Registry No. 72319-09-6, pursuant to section 85 of the Canadian Environmental Protection Act, 1999 (CEPA 1999). In view of the current SNAc policy (https://www.ec.gc.ca/ese-ees/default.asp?lang=En&n=5CA18D66-1), and pursuant to subsection 85(2) of CEPA 1999, where the Minister of the Environment, by notice published in the Canada Gazette, may vary or rescind a notice, SNAc Notice No. 15847 is rescinded. This action is taken as part of the review of current SNAc notices adopted under CEPA 1999 (http://www.chemicalsubstanceschimiques.gc.ca/plan/approach-approche/snac-nac/index-eng.php#a2).
Rescission of the Significant New Activity Notice
The Significant New Activity Notice was designed to collect information on the nanoscale forms of the notified substance. A review of this Notice found that it is no longer needed. The Government of Canada is considering using other means of collecting information on nanoscale forms of this type of substance.
Notifiers who intend to manufacture or import a new nanoscale substance should consult New Substances Program Advisory Note 2014-02 — Assessment of nanomaterials under the New Substances Notification Regulations (Chemicals and Polymers). (see footnote 4) This note provides additional clarity regarding nanoscale substances that are notifiable under the Regulations.
[26-1-o]
DEPARTMENT OF THE ENVIRONMENT
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Significant New Activity Notice No. 16509
Rescinding Significant New Activity Notice
(Section 85 of the Canadian Environmental Protection Act, 1999)
Whereas the Minister of the Environment published on November 5, 2011, Significant New Activity Notice No. 16509 pertaining to the substance calcium magnesium hydroxide (CaMg(OH)4), Chemical Abstracts Service Registry No. 39445-23-3;
And whereas the Minister of the Environment and the Minister of Health no longer suspect that a significant new activity in relation to the substance may result in the substance becoming toxic within the meaning of section 64 of the Canadian Environmental Protection Act, 1999,
Therefore, the Minister of the Environment hereby indicates, pursuant to subsection 85(2) of the Canadian Environmental Protection Act, 1999, that subsection 81(4) of the Act no longer applies to the substance and rescinds Significant New Activity Notice No. 16509.
LEONA AGLUKKAQ
Minister of the Environment
EXPLANATORY NOTE
(This explanatory note is not part of the Significant New Activity Notice.)
Description
This explanatory note relates to Significant New Activity (SNAc) Notice No. 16509 adopted in relation to the substance calcium magnesium hydroxide (CaMg(OH)4), Chemical Abstracts Service Registry No. 39445-23-3, pursuant to section 85 of the Canadian Environmental Protection Act, 1999 (CEPA 1999). In view of the current SNAc policy (https://www.ec.gc.ca/ese-ees/default.asp?lang=En&n=5CA18D66-1), and pursuant to subsection 85(2) of CEPA 1999, where the Minister of the Environment, by notice published in the Canada Gazette, may vary or rescind a notice, SNAc Notice No. 16509 is rescinded. This action is being taken as part of the review of current SNAc notices adopted under CEPA 1999 (http://www.chemicalsubstanceschimiques.gc.ca/plan/approach-approche/snac-nac/index-eng.php#a2).
Rescission of the Significant New Activity Notice
The Significant New Activity Notice was designed to collect information on the nanoscale forms of the notified substance. A review of this Notice found that it is no longer needed. The Government of Canada is considering using other means of collecting information on nanoscale forms of this type of substance.
Notifiers who intend to manufacture or import a new nanoscale substance should consult New Substances Program Advisory Note 2014-02 — Assessment of nanomaterials under the New Substances Notification Regulations (Chemicals and Polymers). (see footnote 5) This note provides additional clarity regarding nanoscale substances that are notifiable under the Regulations.
[26-1-o]
DEPARTMENT OF THE ENVIRONMENT
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Significant New Activity Notice No. 16568
Rescinding Significant New Activity Notice
(Section 85 of the Canadian Environmental Protection Act, 1999)
Whereas the Minister of the Environment published on February 18, 2012, Significant New Activity Notice No. 16568 pertaining to the substance quino[2,3-b]acridine-7,14-dione, dichloro-5,12-dihydro-, dihydro, dioxo (heteropolycyclic)methyl derivs.;
And whereas the Minister of the Environment and the Minister of Health no longer suspect that a significant new activity in relation to the substance may result in the substance becoming toxic within the meaning of section 64 of the Canadian Environmental Protection Act, 1999,
Therefore, the Minister of the Environment hereby indicates, pursuant to subsection 85(2) of the Canadian Environmental Protection Act, 1999, that subsection 81(4) of the Act no longer applies to the substance and rescinds Significant New Activity Notice No. 16568.
LEONA AGLUKKAQ
Minister of the Environment
EXPLANATORY NOTE
(This explanatory note is not part of the Significant New Activity Notice.)
Description
This explanatory note relates to Significant New Activity (SNAc) Notice No. 16568 adopted in relation to the substance quino[2,3-b]acridine-7,14-dione, dichloro-5,12-dihydro-, dihydro, dioxo (heteropolycyclic)methyl derivs., pursuant to section 85 of the Canadian Environmental Protection Act, 1999 (CEPA 1999). In view of the current SNAc policy (https://www.ec.gc.ca/ese-ees/default.asp?lang=En&n=5CA18D66-1), and pursuant to subsection 85(2) of CEPA 1999, where the Minister of the Environment, by notice published in the Canada Gazette, may vary or rescind a notice, SNAc Notice No. 16568 is rescinded. This action is being taken as part of the review of current SNAc notices adopted under CEPA 1999 (http://www.chemicalsubstanceschimiques.gc.ca/plan/approach-approche/snac-nac/index-eng.php#a2).
Rescission of the Significant New Activity Notice
The Significant New Activity Notice was designed to collect information on the nanoscale forms of the notified substance. A review of this Notice found that it is no longer needed. The Government of Canada is considering using other means of collecting information on nanoscale forms of this type of substance.
Notifiers who intend to manufacture or import a new nanoscale substance should consult New Substances Program Advisory Note 2014-02 — Assessment of nanomaterials under the New Substances Notification Regulations (Chemicals and Polymers). (see footnote 6) This note provides additional clarity regarding nanoscale substances that are notifiable under the Regulations.
[26-1-o]
DEPARTMENT OF THE ENVIRONMENT
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Significant New Activity Notice No. 16877
Rescinding Significant New Activity Notice
(Section 85 of the Canadian Environmental Protection Act, 1999)
Whereas the Minister of the Environment published on August 25, 2012, Significant New Activity Notice No. 16877 pertaining to the substance rutile, tin zinc, sodium-doped, Chemical Abstracts Service Registry No. 389623-07-8;
And whereas the Minister of the Environment and the Minister of Health no longer suspect that a significant new activity in relation to the substance may result in the substance becoming toxic within the meaning of section 64 of the Canadian Environmental Protection Act, 1999,
Therefore, the Minister of the Environment hereby indicates, pursuant to subsection 85(2) of the Canadian Environmental Protection Act, 1999, that subsection 81(4) of the Act no longer applies to the substance and rescinds Significant New Activity Notice No. 16877.
LEONA AGLUKKAQ
Minister of the Environment
EXPLANATORY NOTE
(This explanatory note is not part of the Significant New Activity Notice.)
Description
This explanatory note relates to Significant New Activity (SNAc) Notice No. 16877 adopted in relation to the substance rutile, tin zinc, sodium-doped, Chemical Abstracts Service Registry No. 389623-07-8, pursuant to section 85 of the Canadian Environmental Protection Act, 1999 (CEPA 1999). In view of the current SNAc policy (https://www.ec.gc.ca/ese-ees/default.asp?lang=En&n=5CA18D66-1), and pursuant to subsection 85(2) of CEPA 1999, where the Minister of the Environment, by notice published in the Canada Gazette, may vary or rescind a notice, SNAc Notice No. 16877 is rescinded. This action is being taken as part of the review of current SNAc notices adopted under CEPA 1999 (http://www.chemicalsubstanceschimiques.gc.ca/plan/approach-approche/snac-nac/index-eng.php#a2).
Rescission of the Significant New Activity Notice
The Significant New Activity Notice was designed to collect information on the nanoscale forms of the notified substance. A review of this Notice found that it is no longer needed. The Government of Canada is considering using other means of collecting information on nanoscale forms of this type of substance.
Notifiers who intend to manufacture or import a new nanoscale substance should consult New Substances Program Advisory Note 2014-02 — Assessment of nanomaterials under the New Substances Notification Regulations (Chemicals and Polymers). (see footnote 7) This note provides additional clarity regarding nanoscale substances that are notifiable under the Regulations.
[26-1-o]
DEPARTMENT OF THE ENVIRONMENT
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Significant New Activity Notice No. 16878
Rescinding Significant New Activity Notice
(Section 85 of the Canadian Environmental Protection Act, 1999)
Whereas the Minister of the Environment published on August 25, 2012, Significant New Activity Notice No. 16878 pertaining to the rutile, tin zinc, calcium-doped, Chemical Abstracts Service Registry No. 389623-01-2;
And whereas the Minister of the Environment and the Minister of Health no longer suspect that a significant new activity in relation to the substance may result in the substance becoming toxic within the meaning of section 64 of the Canadian Environmental Protection Act, 1999,
Therefore, the Minister of the Environment hereby indicates, pursuant to subsection 85(2) of the Canadian Environmental Protection Act, 1999, that subsection 81(4) of the Act no longer applies to the substance and rescinds Significant New Activity Notice No. 16878.
LEONA AGLUKKAQ
Minister of the Environment
EXPLANATORY NOTE
(This explanatory note is not part of the Significant New Activity Notice.)
Description
This explanatory note relates to Significant New Activity (SNAc) Notice No. 16878 adopted in relation to the substance rutile, tin zinc, calcium-doped, Chemical Abstracts Service Registry No. 389623-01-2, pursuant to section 85 of the Canadian Environmental Protection Act, 1999 (CEPA 1999). In view of the current SNAc policy (https://www.ec.gc.ca/ese-ees/default.asp?lang=En&n=5CA18D66-1), and pursuant to subsection 85(2) of CEPA 1999, where the Minister of the Environment, by notice published in the Canada Gazette, may vary or rescind a notice, SNAc Notice No. 16878 is rescinded. This action is being taken as part of the review of current SNAc notices adopted under CEPA 1999 (http://www.chemicalsubstanceschimiques.gc.ca/plan/approach-approche/snac-nac/index-eng.php#a2).
Rescission of the Significant New Activity Notice
The Significant New Activity Notice was designed to collect information on the nanoscale forms of the notified substance. A review of this Notice found that it is no longer needed. The Government of Canada is considering using other means of collecting information on nanoscale forms of this type of substance.
Notifiers who intend to manufacture or import a new nanoscale substance should consult New Substances Program Advisory Note 2014-02 — Assessment of nanomaterials under the New Substances Notification Regulations (Chemicals and Polymers). (see footnote 8) This note provides additional clarity regarding nanoscale substances that are notifiable under the Regulations.
[26-1-o]
DEPARTMENT OF THE ENVIRONMENT
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Significant New Activity Notice No. 16879
Rescinding Significant New Activity Notice
(Section 85 of the Canadian Environmental Protection Act, 1999)
Whereas the Minister of the Environment published on August 25, 2012, Significant New Activity Notice No. 16879 pertaining to the substance rutile, tin zinc, potassium-doped, Chemical Abstracts Service Registry No. 207691-99-4;
And whereas the Minister of the Environment and the Minister of Health no longer suspect that a significant new activity in relation to the substance may result in the substance becoming toxic within the meaning of section 64 of the Canadian Environmental Protection Act, 1999,
Therefore, the Minister of the Environment hereby indicates, pursuant to subsection 85(2) of the Canadian Environmental Protection Act, 1999, that subsection 81(4) of the Act no longer applies to the substance and rescinds Significant New Activity Notice No. 16879.
LEONA AGLUKKAQ
Minister of the Environment
EXPLANATORY NOTE
(This explanatory note is not part of the Significant New Activity Notice.)
Description
This explanatory note relates to Significant New Activity (SNAc) Notice No. 16879 adopted in relation to the substance rutile, tin zinc, potassium-doped, Chemical Abstracts Service Registry No. 207691-99-4, pursuant to section 85 of the Canadian Environmental Protection Act, 1999 (CEPA 1999). In view of the current SNAc policy (https://www.ec.gc.ca/ese-ees/default.asp?lang=En&n=5CA18D66-1), and pursuant to subsection 85(2) of CEPA 1999, where the Minister of the Environment, by notice published in the Canada Gazette, may vary or rescind a notice, SNAc Notice No. 16879 is rescinded. This action is being taken as part of the review of current SNAc notices adopted under CEPA 1999 (http://www.chemicalsubstanceschimiques.gc.ca/plan/approach-approche/snac-nac/index-eng.php#a2).
Rescission of the Significant New Activity Notice
The Significant New Activity Notice was designed to collect information on the nanoscale forms of the notified substance. A review of this Notice found that it is no longer needed. The Government of Canada is considering using other means of collecting information on nanoscale forms of this type of substance.
Notifiers who intend to manufacture or import a new nanoscale substance should consult New Substances Program Advisory Note 2014-02 — Assessment of nanomaterials under the New Substances Notification Regulations (Chemicals and Polymers). (see footnote 9) This note provides additional clarity regarding nanoscale substances that are notifiable under the Regulations.
[26-1-o]
DEPARTMENT OF HEALTH
CONTROLLED DRUGS AND SUBSTANCES ACT
Pre-consultation notice — Proposed Tamper-Resistant Properties of Drugs Regulations
Background
The Government of Canada posted a notice to interested parties regarding tamper resistance under the Controlled Drugs and Substances Act (CDSA) in the Canada Gazette, Part I, on June 28, 2014, that described a proposal to develop tamper-resistant properties regulations. As part of the notice, controlled-release oxycodone tablets were proposed as the first category of substances that would be subject to the regulations. Tamper resistance is a part of the Government of Canada's comprehensive strategy to address prescription drug abuse. Key elements of the Government's approach include
- launching public awareness activities to equip parents with the information they need to talk with their teenagers about prescription drug abuse and educating Canadians on the safe use, storage and disposal of prescription medications;
- enhancing access to prevention programs and treatment capacity for prescription drug abuse within First Nations communities across Canada;
- increasing the number of annual pharmacy inspections carried out by Health Canada to help reduce the diversion of prescription drugs;
- introducing labelling changes for controlled-release opioid pain medicines to enhance their safe and appropriate use;
- investing in projects to develop new guidelines and other training tools for physicians and other regulated health care professionals who prescribe and dispense drugs;
- supporting a coordinated pan-Canadian approach for the monitoring and surveillance of prescription drugs; and
- providing new funding for research on clinical and community-based interventions for preventing and treating prescription drug abuse.
What we heard
Almost 100 submissions were received, with the majority from health care professionals and individuals.
Many stakeholders commented that requiring tamper resistance is one part of a comprehensive approach to addressing prescription drug abuse that should also include, for example, education and changes in prescribing and dispensing practices.
The majority of the comments received agreed that if new technologies were available to help mitigate the harms of prescription drug abuse, products at high risk for abuse should be required to incorporate the technology into their formulation. However, stakeholders also recognized that tamper-resistant technology is new and emerging and that it may therefore be challenging to project its long-term impact.
Some patients, health care professionals, and organizations expressed concern that this proposal could affect the availability and affordability of existing medications. Several stakeholders also highlighted concern that the adoption of tamper-resistant drugs could encourage people who abuse them to shift to other, non-tamper-resistant products, or illicit substances like heroin. Some of these comments indicated that ultimately the regulation should be applied to other opioids, and possibly to other drugs at high risk of abuse, such as amphetamine-like substances.
The pharmaceutical industry raised a number of points about the complexity of the pharmaceutical supply chain. Some manufacturers estimated that it would take several years to transition to new formulations and receive marketing approvals. There were questions about the coordination of any requirements under these regulations and the Food and Drug Regulations, as well as concerns about alignment with other international regulators.
Proposed regulatory approach
The draft Tamper-Resistant Properties of Drugs Regulations propose that controlled-release solid oral dosage forms of oxycodone products, where oxycodone is the only medicinal ingredient, be required to have tamper-resistant properties.
Within Health Canada, there will be one process for assessing a product's tamper-resistant properties. Authorizations of tamper-resistant properties for the proposed Regulations would link to the existing drug submission and scientific review process under the Food and Drugs Act. A product will be considered tamper-resistant if its product monograph includes a statement that the product has a tamper-resistant property. The scientific evidence that will be included in the sponsor's submission to support the statements and the acceptable statements of tamper-resistant properties in the product monograph are described in Health Canada's guidance document, published in draft form for public consultation, at http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/consult_draft_guid_opioid_ebauche_ld-eng.php.
The Regulations propose a three-year coming-into-force period to provide sufficient time for product reformulation and the necessary supply chain adjustments. The Regulations would apply to parties authorized as licensed dealers (e.g. manufacturers, distributors, wholesalers) under the CDSA. Other parties regulated under the CDSA, including pharmacists, hospitals and practitioners, could deplete existing stock, or return it to distributors.
Sponsors of products sold in Canada with approved tamper-resistant statements would be required to gather data on the abuse and abuse potential of these products. This information could be requested by the Minister, which would establish a mechanism to monitor the impact on abuse of the tamper-resistant formulation over time.
In the event that the continued sale of a tamper-resistant product presents a risk to public health, safety or security, the Minister would have the authority to suspend the authorization for the sale and distribution of that product in Canada.
An opportunity for further input
The purpose of this pre-consultation notice is to provide an additional opportunity to gather feedback on the draft Regulations, as well as to provide an additional opportunity for interested parties to describe specific impacts of such regulations, both in terms of the benefits that are expected to be realized as well as the impact on product development and the pharmaceutical supply chain.
The publication of this notice begins a 45-day comment period, ending August 4, 2015. Copies of the draft Regulations and a stakeholder questionnaire can be requested by email at tamper. resistance@hc-sc.gc.ca, or by mail at 150 Tunney's Pasture Driveway, Main Statistics Canada Building, Address Locator: 0302A, Ottawa, Ontario K1A 0K9.
Responses can be sent by email or by post to the addresses listed above.
We thank all stakeholders for the valuable information already provided to the Department and their continued input into this proposal.
JACQUELINE GONÇALVES
Director General
Controlled Substances and Tobacco Directorate
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DEPARTMENT OF INDUSTRY
RADIOCOMMUNICATION ACT
Notice No. SMSE-010-15 — Release of ICES-008, Issue 1
Notice is hereby given by Industry Canada that the following document will come into force upon its publication on the Department's Web site:
- Interference-Causing Equipment Standard ICES-008, Issue 1, Cable Distribution Networks, replaces BPR-8, Issue 2, Application Procedures and Rules for Broadcasting Receiving Undertakings (Cable Television), published in January 2009.
General information
The review of ICES-008 has been coordinated with industry through the Radio Advisory Board of Canada.
The Radio Equipment Technical Standards Lists will be amended accordingly.
Industry Canada has removed the requirement for cable distribution undertakings to hold broadcasting certificates and is replacing the existing technical requirements with respect to interference through the issuance of ICES-008. Therefore, cable system operators must continue to meet the applicable technical requirements in accordance with ICES-008. The goal remains the same, i.e. to mitigate potential interference to radiocommunications.
Submitting comments
Interested parties are requested to provide their comments within 90 days of the date of publication of this notice in electronic format (Microsoft Word or Adobe PDF) to the Manager, Regulatory Standards (res.nmr@ic.gc.ca). Comments received will be taken into consideration in the preparation of the next issue of ICES-008.
Obtaining copies
Copies of this notice and of documents referred to herein are available electronically on Industry Canada's Spectrum Management and Telecommunications Web site at http://www.ic.gc.ca/spectrum.
Official versions of Canada Gazette notices can be viewed at http://www.gazette.gc.ca/rp-pr/p1/index-eng.html.
June 18, 2015
DANIEL DUGUAY
Director General
Engineering, Planning and Standards Branch
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OFFICE OF THE DIRECTOR OF PUBLIC PROSECUTIONS
DIRECTOR OF PUBLIC PROSECUTIONS ACT
Directive
Whereas terrorist activities pose a threat to the safety and security of Canadians and Canadian society;
Whereas the Anti-Terrorism Act, 2015 strengthening the legal regime to combat terrorism has come into force;
Whereas federal jurisdiction in respect of terrorism proceedings under the Criminal Code is concurrent with that of the provinces;
Whereas the mandate of the Director of Public Prosecutions includes providing advice to investigative agencies during investigations where requested and initiating and conducting prosecutions within federal jurisdiction;
Whereas the Attorney General's consent is required under the Criminal Code to apply for a terrorism peace bond or recognizance with conditions and to initiate a terrorism prosecution;
Whereas the Director of Public Prosecutions and the Deputy Directors of Public Prosecutions have the power to consent on my behalf under the Criminal Code;
Whereas it is generally in the public interest to proceed with the prosecution of a terrorism case where there is a reasonable prospect of conviction on the evidence;
Whereas I have consulted with the Director of Public Prosecutions under subsection 10(2) of the Director of Public Prosecutions Act;
1. I hereby direct the Director of Public Prosecutions as follows:
- (a) The Director shall ensure that terrorism cases are identified and assigned at the earliest opportunity.
- (b) The Director shall ensure that the Public Prosecution Service of Canada engages in ongoing communications with investigative agencies regarding their operational priorities in respect of terrorism investigations.
- (c) The Director shall ensure that the Public Prosecution Service of Canada provides investigative agencies conducting terrorism investigations with timely legal advice and, where appropriate, timely consent for applications for recognizances with conditions and terrorism peace bonds and for the initiation of prosecutions.
- (d) The Director shall ensure that provincial prosecution services are notified of terrorism cases within their respective territory and shall coordinate the efforts of the Public Prosecution Service of Canada with those of the provincial prosecution services as appropriate.
Ottawa, June 18, 2015
THE HONOURABLE PETER MACKAY
Attorney General of Canada
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BANK OF CANADA
Statement of financial position as at May 31, 2015
| ASSETS | Amount | Total |
|---|---|---|
| Cash and foreign deposits | 5.6 | |
| Loans and receivables | ||
| Securities purchased under resale agreements | — | |
| Advances to members of the Canadian Payments Association | — | |
| Advances to governments | — | |
| Other receivables | 4.4 | |
| 4.4 | ||
| Investments | ||
| Treasury bills of Canada | 20,304.5 | |
| Government of Canada bonds | 74,634.4 | |
| Other investments | 372.8 | |
| 95,311.7 | ||
| Property and equipment | 332.4 | |
| Intangible assets | 40.3 | |
| Other assets | 188.6 | |
| Total assets | 95,883.0 | |
| LIABILITIES AND EQUITY | Amount | Total |
|---|---|---|
| Bank notes in circulation | 69,698.9 | |
| Deposits | ||
| Government of Canada | 23,627.0 | |
| Members of the Canadian Payments Association | 149.8 | |
| Other deposits | 1,348.6 | |
| 25,125.4 | ||
| Other liabilities | ||
| Securities sold under repurchase agreements | — | |
| Other liabilities | 589.2 | |
| 589.2 | ||
| 95,413.5 | ||
| Equity | ||
| Share capital | 5.0 | |
| Statutory and special reserves | 125.0 | |
| Available-for-sale reserve | 339.5 | |
| 469.5 | ||
| Total Liabilities and Equity | 95,883.0 | |
I declare that the foregoing return is correct according to the books of the Bank.
Ottawa, June 15, 2015
CARMEN VIERULA
Chief Financial Officer and Chief Accountant
I declare that the foregoing return is to the best of my knowledge and belief correct, and shows truly and clearly the financial position of the Bank, as required by section 29 of the Bank of Canada Act.
Ottawa, June 15, 2015
STEPHEN S. POLOZ
Governor
[26-1-o]