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Vol. 143, No. 46 — November 14, 2009

DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Notice is hereby given that, pursuant to section 127 of the Canadian Environmental Protection Act, 1999, Disposal at Sea Permit No. 4543-2-06524 authorizing the loading for disposal and the disposal of waste or other matter at sea is amended as follows.

3. Duration of Permit: Permit is valid from December 28, 2009, to March 31, 2010.

I. R. GEOFFREY MERCER
Environmental Protection Operations Directorate
Atlantic Region
On behalf of the Minister of the Environment

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DEPARTMENT OF HEALTH

FOOD AND DRUGS ACT

Interim Order Respecting the Immediate Distribution of the Vaccine for the Novel Influenza A H1N1 Virus

Whereas the Minister of Health believes that immediate action is required to deal with a significant risk, direct or indirect, to health, safety or the environment;

Therefore, the Minister of Health, pursuant to subsection 30.1(1) (see footnote a) of the Food and Drugs Act (see footnote b), hereby makes the annexed Interim Order Respecting the Immediate Distribution of the Vaccine for the Novel Influenza A H1N1 Virus.

Ottawa, October 23, 2009

LEONA AGLUKKAQ
Minister of Health

INTERIM ORDER RESPECTING THE IMMEDIATE DISTRIBUTION OF THE VACCINE FOR THE NOVEL INFLUENZA A H1N1 VIRUS

INTERPRETATION

1. The following definitions apply in this Interim Order.

“Act” means the Food and Drugs Act; (Loi)

“brand name” has the same meaning as in subsection C.01.001(1) of the Regulations; (marque nominative)

“Chief Public Health Officer” means the Chief Public Health Officer appointed under subsection 6(1) of the Public Health Agency of Canada Act; (administrateur en chef)

“common name” has the same meaning as in subsection C.01.001(1) of the Regulations; (nom usuel)

“lot number” has the same meaning as in section A.01.010 of the Regulations; (numéro de lot)

“manufacturer” includes an importer; (fabricant)

“proper name” has the same meaning as in subsection C.01.001(1) of the Regulations; (nom propre)

“Regulations” means the Food and Drug Regulations; (règlement)

“serious adverse reaction” has the meaning assigned by the definition “serious adverse drug reaction” in section C.05.001 of the Regulations; (réaction indésirable grave)

“vaccine” means an immunizing agent used to provide protection against the novel influenza A H1N1 virus in humans. (vaccin)

APPLICATION

2. (1) The quantity of the vaccine specified in the authorization for immediate distribution is, as of the date the authorization takes effect, exempt from section 12 of the Act.

(2) The exemption ceases to apply if the authorization for immediate distribution is cancelled.

3. (1) The Regulations do not apply, as of the date the authorization for immediate distribution takes effect, to the quantity of the vaccine specified in the authorization.

(2) The Regulations apply to the quantity of the vaccine if the authorization for immediate distribution is cancelled.

APPLICATION FOR AUTHORIZATION

4. The Chief Public Health Officer may submit to the Minister an application for authorization for immediate distribution, dated and signed, that includes the following:

(a) the name, address and telephone number of the manufacturer, together with the facsimile number and electronic mail address, if any, and the name and telephone number of a contact person designated by the manufacturer who can be reached to obtain information related to the vaccine;

(b) the addresses of the locations to which the vaccine is to be delivered by the manufacturer, and the name and title of the person at each location who will be responsible for receiving the vaccine;

(c) the brand name of the vaccine, if any, and any of its proper name, common name, chemical name or identifying name, and any code, number or mark;

(d) the use for which the vaccine is required;

(e) the total quantity of the vaccine that the Chief Public Health Officer wishes to obtain and the reason why that quantity is considered necessary, together with supporting information or documents;

(f) an attestation dated and signed by the Chief Public Health Officer certifying that the following conditions are met, together with sufficient supporting information or documents to enable the Minister to determine that those conditions are met:

(i) the public has been exposed to, or is at significant risk of being exposed to, the novel influenza A H1N1 virus,

(ii) exposure to that virus is likely to result in a disease that has the potential to be life-threatening or serious in humans,

(iii) immediate action is required to provide protection against that virus,

(iv) there is no vaccine available, or available in sufficient quantity, for sale in Canada that is for the use provided under paragraph (d), and

(v) the known and potential benefits associated with the use of a vaccine outweigh the known and potential risks associated with the novel influenza A H1N1 virus; and

(g) any information in the possession of the Chief Public Health Officer with respect to

(i) any use of the vaccine, and its safety or effectiveness, and

(ii) the regulatory status of the vaccine in other countries.

5. The Minister may require the Chief Public Health Officer to submit any supplementary information or documents that are necessary to enable the Minister to determine if the authorization for immediate distribution must be issued.

AUTHORIZATION

6. The Minister shall issue an authorization for immediate distribution if

(a) the application for authorization for immediate distribution complies with section 4 and, if applicable, section 5;

(b) the Minister has reasonable grounds to believe that the conditions specified in paragraph 4(f) are met; and

(c) the Minister has reasonable grounds to believe that the known and potential benefits associated with the use of the vaccine, as provided under paragraph 4(d), outweigh the known and potential risks associated with that use.

7. The authorization for immediate distribution shall include the following information:

(a) the brand name of the vaccine, if any, and any of its proper name, common name, chemical name or identifying name, and any code, number or mark;

(b) the use for which the distribution of the vaccine is authorized;

(c) the quantity of the vaccine that may be distributed;

(d) the name and address of the manufacturer that is authorized to sell the vaccine;

(e) the addresses of the locations to which the vaccine is to be delivered by the manufacturer, and the name and title of the person at each location who will be responsible for receiving the vaccine; and

(f) the date on which the authorization takes effect.

OBLIGATIONS OF THE CHIEF PUBLIC HEALTH OFFICER

8. The Chief Public Health Officer shall notify the Minister and the manufacturer, in the following manner and within the following times, of any serious adverse reaction to the vaccine that occurs in Canada, specifying the nature of the reaction, the circumstances, the lot numbers implicated and any corrective action taken

(a) in the case of a serious adverse reaction that is life-threatening or that results in a neurological disorder or death, by verbal notice given within 24 hours of the time the Chief Public Health Officer becomes aware of the reaction, followed by a written report given within 24 hours of the verbal notice; and

(b) in any other case, by a written report given within 15 days after the Chief Public Health Officer becomes aware of the reaction.

9. The Chief Public Health Officer shall, on request, submit a written report to the Minister respecting the use of the vaccine, including information respecting any serious adverse reactions.

10. The Chief Public Health Officer shall provide the Minister with any new information regarding the safety or effectiveness of the vaccine, for any use, as soon as possible.

11. The Chief Public Health Officer shall make available to persons identified in the authorization for immediate distribution as the persons responsible for receiving the vaccine, the following information:

(a) the brand name of the vaccine, if any, and any of its proper name, common name, chemical name or identifying name, and any code, number or mark;

(b) the use for which the distribution of the vaccine is authorized;

(c) the name and address of the manufacturer that is authorized to sell the vaccine;

(d) its composition, including a quantitative list of each medicinal ingredient designated by its brand name, if any, and any of its proper name, common name, chemical name or identifying name, and any code, number or mark;

(e) the concentration of the vaccine and of each medicinal ingredient;

(f) the dosage form;

(g) the recommended dosage;

(h) the recommended route of administration;

(i) any contra-indications or side effects; and

(j) the conditions of use recommended.

12. The Chief Public Health Officer shall account to the Minister, on request and by the date specified, for the total quantity of the vaccine that was distributed to the persons identified in the authorization for immediate distribution as the persons responsible for receiving the vaccine, including the outcome of each quantity of the vaccine and each location to which it was distributed.

OBLIGATIONS OF THE MANUFACTURER

13. The manufacturer named in an authorization for immediate distribution may sell to the Chief Public Health Officer the vaccine specified in the authorization in a quantity that does not exceed the quantity specified in the authorization.

14. The manufacturer shall only deliver the vaccine to the locations specified in the authorization for immediate distribution and shall only leave it in the care of the person identified in the authorization as the person responsible for receiving the vaccine.

15. The manufacturer shall, on request, submit to the Minister protocols of tests together with samples of any lot of the vaccine.

CANCELLATION OF AUTHORIZATION

16. The Minister may cancel an authorization for immediate distribution if the Minister has reasonable grounds to believe that

(a) information or documents contained in or referenced by the application for authorization for immediate distribution are incomplete, inaccurate, false or misleading;

(b) a condition specified in subparagraphs 4(f)(i) to (iii) is no longer met; or

(c) the manufacturer has contravened a provision of this Interim Order.

17. The Minister shall cancel an authorization for immediate distribution if

(a) the Minister has reasonable grounds to believe that the known and potential benefits associated with the use for which the distribution of the vaccine has been authorized do not outweigh the known and potential risks associated with that use; or

(b) the vaccine is subsequently authorized for sale in Canada, except under this Interim Order, for the use specified in the authorization for immediate distribution and that vaccine is available in sufficient quantity in Canada.

18. The Minister shall send the Chief Public Health Officer and the manufacturer a written notice of cancellation that sets out the reason for the cancellation and the effective date.

19. On receipt of a notice of cancellation, the Chief Public Health Officer shall forward a copy of the notice to the persons identified in the authorization for immediate distribution as the persons responsible for receiving the vaccine.

20. Despite subsection 3(2), a person to whom a quantity of the vaccine has been distributed may return it to the person from whom it was obtained, the Chief Public Health Officer or the manufacturer.

EXPLANATORY NOTE

(This note is not part of the Interim Order.)

Under the current Food and Drug Regulations (the Regulations), in order for a new drug to be sold in Canada, the manufacturer must submit information that demonstrates the drug is of high quality and is safe and effective under the prescribed conditions of use. If the information is sufficient, Health Canada will issue a Notice of Compliance, which will allow the manufacturer to sell that drug. The current regulatory framework is suitable for most drugs.

Because the development of the influenza A H1N1 vaccine could not begin until the pandemic strain was identified in the spring and it is anticipated that the vaccine will be needed almost immediately after it is manufactured, there is limited time for traditional clinical trials. The global outbreak of the influenza A H1N1 virus and its rapid spread have led to a situation in which the need for a vaccine must be weighed against the time required to collect and assess the safety and effectiveness data needed to authorize the sale of the vaccine under the Regulations.

This Interim Order provides a means by which Health Canada can allow the immediate distribution of a specific quantity of vaccine based on a public health need to access a vaccine that is not authorized for sale or is not available in sufficient quantity in Canada. This Interim Order is also required to enable access to a vaccine licensed by a regulatory authority in another country, should additional doses or an alternate form of the vaccine be required, such as an unadjuvanted vaccine.

Under the Interim Order, the Chief Public Health Officer (CPHO) — and not the manufacturer — submits an application requesting a specified quantity of the vaccine. The application requires the CPHO to sign an attestation certifying the urgent need for the vaccine in order to address the immediate risk to public health posed by the novel influenza A H1N1 pandemic, and that the known and potential benefits associated with a vaccine outweigh the known and potential risks associated with the novel influenza A H1N1 virus. The CPHO must provide any information in his possession with respect to any use of the vaccine and its safety or effectiveness, as well as the regulatory status of the vaccine in other countries.

The Minister will issue an authorization for immediate distribution of a specified quantity of the vaccine if the application complies with the requirements of the Interim Order and the Minister has reasonable grounds to believe that the conditions to which the CPHO has attested are met, and that the known and potential benefits associated with the use of the vaccine outweigh the known and potential risks associated with that use. As of the date the authorization takes effect, the sale of the specified quantity of vaccine is exempt from section 12 of the Food and Drugs Act (the Act), and the provisions of the Regulations. If the authorization is cancelled, section 12 of the Act and the Regulations will apply to the quantity of the vaccine.

Once authorization for immediate distribution is issued, the CPHO must provide to the persons identified in the authorization as responsible for receiving the vaccine information related to the recommended dosage, route of administration, any contra-indications or side effects, and the conditions of use recommended.

The CPHO must, on request, submit a written report to the Minister respecting the use of the vaccine, and provide the Minister and the manufacturer with information respecting any serious adverse reaction to the vaccine, specifying the nature of the reaction, the circumstances, the lot numbers implicated and any corrective action taken within the timeframes specified in the Interim Order.

The CPHO must account to the Minister, on request, for the total quantity of the vaccine distributed, and provide the Minister with any new information related to the safety and effectiveness of the vaccine, for any use, as soon as possible.

The manufacturer can only sell the specified quantity of the vaccine to the CPHO, and deliver the vaccine only to the locations specified in the authorization. In addition, the manufacturer is required to submit to the Minister, on request, protocols of tests together with samples of any lot of the vaccine.

The Minister may cancel an authorization if the need for the immediate distribution of the vaccine no longer exists, or if the manufacturer has contravened a provision of the Interim Order. The authorization will be cancelled if the Minister has reasonable grounds to believe that the known and potential benefits associated with the use of the vaccine do not outweigh the known and potential risks associated with that use, or if the vaccine is subsequently authorized for sale in Canada and is available in sufficient quantity.

Once an authorization is cancelled, the CPHO must notify the persons identified in the authorization as responsible for receiving the vaccine. Despite the application of the Regulations to the quantity of the vaccine once the authorization is cancelled, a person to whom the vaccine was distributed may return it to the person from whom it was obtained, the CPHO or the manufacturer.

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NOTICE OF VACANCY

FARM PRODUCTS COUNCIL OF CANADA

Chairperson (full-time position)

Salary range: $163,000–$191,800

Location: National Capital Region

The Farm Products Council of Canada (FPCC), which was previously known as the National Farm Products Council, plays a key role in the supply management system for poultry and eggs. Created in 1972, the Council oversees the operations of the four national marketing agencies that manage the supply of Canadian chicken, turkey, eggs and broiler-hatching eggs. These agencies establish and allocate production quota, promote products, raise funds through levies and licence marketers. The Council also supervises the operation of the Canadian Beef Cattle Research, Market Development and Promotion Agency. In addition to ensuring an efficient system that works in the balanced interests of stakeholders, FPCC assists national agencies, inquires into complaints and works with provincial counterparts.

The Chairperson of the FPCC is a full-time member and is its Chief Executive Officer. The Chairperson is responsible for the management and direction of all aspects of the Council’s activities and reports to Parliament through the Minister of Agriculture and Agri-Food.

The successful candidate must have a degree from a recognized university in economics, business or public administration, agriculture or an equivalent field of study or a combination of equivalent education, job-related training and/or experience. The ideal candidate should have significant management and leadership experience at the senior level in a private or public sector organization and should have significant experience dealing with different levels of government, preferably with senior officials. The position requires experience in maintaining effective relationships with and balancing the interests of multiple stakeholders with divergent views as well as experience in decision-making with respect to sensitive and complex issues. Knowledge and experience in the agri-food industry would be considered assets.

The selected candidate should have knowledge of the role and responsibilities of a Chairperson of a similar-sized organization, including fundamental accountabilities. Knowledge of the Farm Products Council of Canada’s mandate and activities, of the Farm Products Agencies Act and the Agricultural Products Marketing Act is necessary. The preferred candidate should be financially literate and have some knowledge of the operations of Government and its reporting mechanisms.

The successful candidate will adhere to high ethical standards and possess strong leadership and managerial skills to ensure the Council and staff conducts its work effectively and efficiently. He/she should also have the ability to provide corporate vision, leadership and strategic direction needed for the Farm Products Council of Canada to attain its mandate and objectives. The ability to lead and develop effective relationships with federal and provincial governments and industry partners is essential. The preferred candidate should be able to anticipate emerging issues, lead organizational change and develop strategies to enable national agencies to seize opportunities and resolve problems. Also required is the ability to foster debate and discussions among Council members, facilitate consensus and manage conflicts. The ideal candidate should possess the ability to develop effective working relationships with Council members, the Minister and his Office, the Deputy Minister and the Farm Products Council of Canada partners and stakeholders. Superior communication skills, both written and oral, and the ability to act as a spokesperson in dealing with the media, public institutions, governments and other organizations are required.

In order to achieve the Council’s objectives and carry out its mandate, the Chairperson must be a strategic leader with vision. He/she must also be a person of sound judgement and integrity and must have initiative, tact, diplomacy, and superior interpersonal skills.

Proficiency in both official languages would be an asset.

The successful candidate must be prepared to relocate to the National Capital Region or to a location within reasonable commuting distance. The candidate must also be prepared for intensive traveling to attend meetings mostly in Canada but also in foreign countries.

The Government is committed to ensuring that its appointments are representative of Canada’s regions and official languages, as well as of women, Aboriginal peoples, disabled persons and visible minorities.

The preferred candidate must comply with the Ethical Guidelines for Public Office Holders and the Guidelines for the Political Activities of Public Office Holders. The guidelines are available on the Governor in Council Appointments Web site, under “Reference Material,” at www.appointments-nominations.gc.ca.

The selected candidate will be subject to the Conflict of Interest Act. Public office holders appointed on a full-time basis must submit to the Office of the Conflict of Interest and Ethics Commissioner, within 60 days of appointment, a Confidential Report in which they disclose all of their assets, liabilities and outside activities. For more information, please visit the Office of the Conflict of Interest and Ethics Commissioner’s Web site at http://ciec-ccie.gc.ca.

The notice has been placed in the Canada Gazette to assist the Governor in Council in identifying qualified candidates for this position. It is not, however, the sole means of recruitment.

Further details about the Farm Products Council of Canada can be found on its Web site at www.fpcc-cpac.gc.ca.

Interested candidates should forward their curriculum vitae by November 30, 2009, to the Assistant Secretary to the Cabinet (Senior Personnel), Privy Council Office, 59 Sparks Street, 1st Floor, Ottawa, Ontario K1A 0A3, 613-957-5006 (fax), GICA-NGEC@bnet.pco-bcp.gc.ca (email).

Bilingual notices of vacancies will be produced in an alternative format (audio cassette, diskette, braille, large print, etc.) upon request. For further information, please contact Canadian Government Publishing, Public Works and Government Services Canada, Ottawa, Ontario K1A 0S5, 613-941-5995 or 1-800-635-7943.

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NOTICE OF VACANCIES

CANADIAN HUMAN RIGHTS TRIBUNAL

Vice-Chairperson (full-time) and Member (full-time)

Location: National Capital Region

Salary range: $163,000–$191,800 (Vice-Chairperson) and $133,200–$156,800 (Member)

The Canadian Human Rights Tribunal (the Tribunal) is a quasi-judicial body that hears complaints of discrimination referred by the Canadian Human Rights Commission and determines whether the activities complained about violate the Canadian Human Rights Act (CHRA). The purpose of the CHRA is to protect individuals from discrimination and to promote equal opportunity. The Tribunal also decides cases brought under the Employment Equity Act.

The Tribunal carries out its mandate through public hearings of complaints of discrimination in employment and in the provision of services based on the grounds enumerated in the CHRA, which are race, colour, national or ethnic origin, religion, age, sex, marital status, family status, disability, conviction for which a pardon has been granted and, since 1992, sexual orientation. The Tribunal’s jurisdiction covers matters that come within the legislative authority of the Parliament of Canada, including federal government departments, agencies and Crown corporations, as well as banks, airlines and other federally regulated employers and providers of goods, services, facilities and accommodation.

Vice-Chairperson (full-time)

The Vice-Chairperson plays a pre-eminent role within this administrative tribunal by ensuring a fair, timely and impartial adjudication process for human rights complaints, for the benefit of all Canadians. The Vice-Chairperson is also responsible for providing a fundamental contribution to the development of the Tribunal’s policies and procedures for human rights adjudications, under the direction of the Chairperson.

The qualified candidate must have a law degree from a recognized university and have been a member in good standing of the Bar of a province or the Chambre des notaires du Québec for at least 10 years. In addition, the qualified candidate must have experience, expertise and interest in, and sensitivity to, human rights issues.

The preferred candidate should have experience managing human and financial resources, in a private or public sector organization. Additionally, he/she will have proven decision making experience with respect to sensitive issues and demonstrated experience in the interpretation and application of legislation in a quasi-judicial context. Experience in the operation and conduct of a quasi-judicial tribunal, an agency or equivalent would be considered an asset.

The ideal candidate must have general knowledge of human rights law as well as knowledge of public law, including administrative and constitutional law, in addition to knowledge of the Canadian Human Rights Act, the Employment Equity Act and other related legislation. The successful candidate should possess understanding of the operations of an administrative tribunal, including the rules that govern its operations. Further, knowledge of the issues and challenges arising from the diversity of Canadian society, particularly the need for appropriate institutional responses, is required.

The preferred candidate must possess strong managerial abilities, with the requisite ability to provide intellectual and strategic leadership. The ability to interpret relevant statues, regulations and policies and analyze and evaluate complex and voluminous evidence in order to make sound and equitable decisions and recommendations is also required. He/she must possess the ability to represent the Tribunal at national and international conferences in order to further the understanding of the role and functions of the Tribunal as well as to use their superior communication skills, both orally and in writing, in dealing with stakeholders, media, public institutions, governments, the public and other organizations.

The chosen candidate must possess high ethical standards and integrity, superior interpersonal skills, impartiality, judgement and tact.

Member (full-time)

The Member is principally responsible for the adjudication of complaints filed under the Canadian Human Rights Act. In addition, the member contributes to the development of the Tribunal’s policies and procedures for human rights adjudications, under the direction of the Chairperson, and to the development of training programs for members, to ensure that the best possible adjudication services are provided to Canadians.

The qualified candidate must have a law degree from a recognized university and have been a member in good standing of the Bar of a province or the Chambre des notaires du Québec for at least 10 years. In addition, the qualified candidate must have experience, expertise and interest in, and sensitivity to, human rights issues.

The preferred candidate will have demonstrated experience in the interpretation and application of legislation in a quasi-judicial context as well as demonstrated decision making experience with respect to sensitive issues. Experience as a member or legal counsel of a quasi-judicial tribunal or experience appearing before a quasi-judicial tribunal would be an asset.

The ideal candidate must have general knowledge of human rights law, as well as knowledge of public law, including administrative and constitutional law, in addition to the Canadian Human Rights Act and the Employment Equity Act and other related legislation. He/she should also possess knowledge of the principles of natural justice and rules of practice followed by administrative tribunals in Canada and a solid understanding of the procedures and practices involved in conducting a quasi-judicial hearing.

The successful candidate will have the ability to interpret relevant statutes, regulations, and policies and analyze and evaluate complex and voluminous evidence in order to make sound and equitable decisions and recommendations. He/she should also have the ability to work independently and as a team member, be able to conduct proactive, fair and efficient quasi-judicial hearings and have the ability to communicate effectively both orally and in writing.

The chosen candidate must possess high ethical standards and integrity, superior interpersonal skills, impartiality, judgement and tact.

For both positions

Proficiency in both official languages is preferred. Proficiency in other languages is an asset.

The full-time member of the Tribunal shall reside in the National Capital Region, as described in the schedule to the National Capital Act, or within 40 kilometres of that Region. They must also be willing to travel for extended periods of time, to attend hearings and conferences in all parts of Canada.

The Government is committed to ensuring that its appointments are representative of Canada’s regions and official languages, as well as of women, Aboriginal peoples, disabled persons and visible minorities.

The preferred candidates must comply with the Ethical Guidelines for Public Office Holders and the Guidelines for the Political Activities of Public Office Holders. The guidelines are available on the Governor in Council Appointments Web site, under “Reference Material,” at www.appointments-nominations.gc.ca.

The selected candidate will be subject to the Conflict of Interest Act. Public office holders appointed on a full-time basis must submit to the Office of the Conflict of Interest and Ethics Commissioner, within 60 days of appointment, a Confidential Report in which they disclose all of their assets, liabilities and outside activities. For more information, please visit the Office of the Conflict of Interest and Ethics Commissioner’s Web site at http://ciec-ccie.gc.ca.

This notice has been placed in the Canada Gazette to assist the Governor in Council in identifying qualified candidates for this position. It is not, however, intended to be the sole means of recruitment.

Further details about the organization and its activities can be found on its Web site at www.chrt-tcdp.gc.ca.

Interested candidates should forward their curriculum vitae by November 23, 2009, to the Assistant Secretary to the Cabinet (Senior Personnel), Privy Council Office, 59 Sparks Street, 1st Floor, Ottawa, Ontario K1A 0A3, 613-957-5006 (fax), GICA-NGEC@bnet.pco-bcp.gc.ca (email).

Bilingual notices of vacancies will be produced in an alternate format (audio cassette, diskette, braille, large print, etc.) upon request. For further information, please contact Canadian Government Publishing, Public Works and Government Services Canada, Ottawa, Ontario K1A 0S5, 613-941-5995 or 1-800-635-7943.

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Footnote a
S.C. 2004, c. 15, s. 66

Footnote b
R.S., c. F-27