GOVERNMENT NOTICES

DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Order 2008-66-04-02 Amending the Non-domestic Substances List

DEPARTMENT OF HEALTH

FOOD AND DRUGS ACT

Notice of Intent — Food and Drug Regulations — Project No. 1652 — Schedule F

The purpose of this Notice of Intent (NOI) is to provide an opportunity for comment on the proposal to amend the current listing for l-asparaginase (also known as asparaginase) in Part I of Schedule F to the Food and Drug Regulations to maintain prescription status for injectable dosage forms while providing an exemption from prescription status for other dosage forms.

Schedule F is a list of medicinal ingredients, the sale of which is controlled under sections C.01.041 to C.01.049 of the Food and Drug Regulations. Part I of Schedule F lists ingredients that require a prescription for human use and for veterinary use. Part II of Schedule F lists ingredients that require a prescription for human use, but do not require a prescription for veterinary use if so labelled or if in a form unsuitable for human use.

Description

L-asparaginase is an enzyme that breaks down the amino acid asparagine in the body and is used as an injectable drug to treat some forms of cancer. L-asparaginase is not given orally to treat cancer because it is broken down in the stomach and therefore not absorbed by the body. Available information indicates that l-asparaginase is used therapeutically as an injectable drug but not in any other dosage forms. Therefore prescription status is required only for the injectable dosage form.

The enzyme, asparaginase, can also act on food to reduce the amount of the amino acid, asparagine. Adding asparaginase to food to reduce the amount of asparagine can reduce the risk of formation of the chemical acrylamide which occurs during processing. Any residual asparaginase in the food would be broken down in the stomach and consequently would not be absorbed by the body.

The Joint Food and Agriculture Organization and World Health Organization Expert Committee on Food Additives and Contaminants has determined that acrylamide in food may be a human health concern. Health Canada agrees with this assessment. This proposed amendment to the listing of l-asparaginase in Schedule F would remove prescription restrictions from asparaginase when used orally. This would then allow asparaginase to be proposed for use as a food additive under the Food and Drug Regulations for the reduction of acrylamide in prepared and packaged foods. Information on the proposal to use asparaginase in certain food products can be found in the consultation section of the Food and Nutrition part of the Health Canada Web site. Requests for information on the proposal can also be sent by email to the Food Directorate at sche-ann@hc-sc.gc.ca.

Alternatives

The alternative option would be to leave l-asparaginase in Schedule F for all strengths, dosages, dosage forms and conditions of use. As measured against the factors for listing drugs in Schedule F, it has been determined that maintaining the current listing in Schedule F for l-asparaginase is not appropriate.

As well, any alternatives to the degree of regulatory control recommended in this amendment would need to be established through additional scientific information and clinical experience.

Benefits and costs

• Public

The public would benefit from continued prescription status and oversight by a practitioner for injectable dosage forms of l-asparaginase, which are used in the treatment of cancer.

The public would benefit from exemption from prescription status for oral forms of l-asparaginase, as this would allow it to be proposed for use as a food additive under the Food and Drug Regulations to reduce the amount of acrylamide produced in the processing of some foods.

• Manufacturers

There would be no immediate impact on manufacturers, as there are currently no products on the market in Canada for the dosage forms proposed for exemption from Schedule F. The status of currently marketed prescription drugs containing l-asparaginase would not change. Food manufacturers would benefit from a proposal to allow asparaginase as a food additive under the Food and Drug Regulations to reduce the amount of acrylamide produced in the processing of some foods.

• Health insurance plans

There would be no change in costs to drug benefit plans for prescription drugs containing this medicinal ingredient, as their status would not change.

• Provincial health care services

There would be no change in costs to drug benefit plans for prescription drugs containing this medicinal ingredient, as their status would not change.

Compliance and enforcement

This amendment would not alter existing compliance mechanisms under the provisions of the Food and Drugs Act and the Food and Drug Regulations.

Consultation

The process for this consultation with stakeholders is described in the Memorandum of Understanding (MOU) to streamline regulatory amendments to Schedule F, which came into effect on February 22, 2005. The MOU is posted on the Health Canada Web site.

This NOI is being sent by email to stakeholders and is also being posted on the Health Canada Web site and the “Consulting with Canadians” Web site.

Any comments regarding this proposed amendment should be sent as follows within 75 days following the date of publication in the Canada Gazette, Part I. The policy analyst for this project, Karen Ash, may be contacted at the following address: Refer to Project No. 1652, Bureau of Policy, Science and International Programs, Therapeutic Products Directorate, Health Canada, Holland Cross, Tower B, 2nd Floor, 1600 Scott Street, Address Locator 3102C5, Ottawa, Ontario K1A 0K9, 613-948-4623 (telephone), 613-941-6458 (fax), regaff-affreg@hc-sc.gc.ca (email).

Final approval

In accordance with the MOU process, it is anticipated that this amendment will proceed directly from this consultation to consideration for final approval by the Governor in Council, approximately six to eight months from the date of publication of this NOI in the Canada Gazette, Part I. If the amendment is approved by the Governor in Council, publication in the Canada Gazette, Part II, would follow. The amendment would come into force on the date of registration.

MEENA BALLANTYNE
Assistant Deputy Minister

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RADIOCOMMUNICATION ACT

Notice No. DGTP-010-09 — Consultation on the spectrum allocations and spectrum utilization policies for the frequency range 1435-1525 MHz (L-Band)

This notice announces the publication of a consultation paper that initiates a review of the frequency range 1435-1525 MHz. Early in 2007, Industry Canada indicated its intention to review the future use of the spectrum assigned for digital audio broadcasting (DAB) in the band 1452-1492 MHz. Also, it is timely to review the spectrum adjacent to the DAB band in order to address the spectrum requirements for aeronautical mobile telemetry applications and provide more flexibility to the subscriber radio systems (SRS), which operates in rural areas.

The consultation paper discusses the spectrum allocations and utilization policies for the band 1435-1525 MHz, with a view to increasing regulatory flexibility and balancing the spectrum requirements of the SRS, broadcasting and utility telemetry, along with new applications, including fixed and mobile broadband wireless access and aeronautical mobile telemetry applications. Proposals include new allocations and changes to the Canadian Table of Frequency Allocations, spectrum utilization policies and transition policies.

To reduce transition issues, the Department is adopting a moratorium on new licensing in the band 1435-1525 MHz and will not issue new broadcasting certificates.

Submitting comments

Interested parties are invited to submit comments on the consultation paper. These comments are to be submitted by February 19, 2010. Soon after the close of the comment period, all comments received will be posted on Industry Canada’s Spectrum Management and Telecommunications Web site at www.ic.gc.ca/spectrum.

Respondents are requested to provide their comments in XHTML format to the following email address: wireless@ic. gc.ca. Other electronic formats such as WordPerfect, Microsoft Word or Adobe PDF will also be accepted, along with a note specifying the software, version number and operating system used.

Written submissions should be addressed to the Director General, Telecommunications Policy Branch, Industry Canada, 300 Slater Street, Ottawa, Ontario K1A 0C8.

All submissions should cite the Canada Gazette, Part I, the publication date, the title and the notice reference number (DGTP-010-09).

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 www.ic.gc.ca/spectrum.

Official versions of Canada Gazette notices can be viewed at www.gazette.gc.ca/rp-pr/p1/index-eng.html. Printed copies of the Canada Gazette can be ordered by telephoning the sales counter of Canadian Government Publishing at 613-941-5995 or 1-800-635-7943.

December 11, 2009

PAMELA MILLER
Director General
Telecommunications Policy Branch

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DEPARTMENT OF INDUSTRY

RADIOCOMMUNICATION ACT

Notice No. DGTP-012-09 — Spectrum utilization policy, technical and licensing decisions on a portion of the band 14.5-15.35 GHz for tactical common data link (TCDL) systems

The purpose of this notice is to announce the release of the above-mentioned spectrum document to accommodate TCDL systems in a portion of the band 14.5-15.35 GHz.

Discussion

The Government of Canada has identified the need for the exclusive Canada-wide use of the sub-band pair 14.660-14.820 GHz and 15.135-15.295 GHz. Currently, the band 14.5-15.35 GHz is allocated to the fixed service, on a primary basis, and to the mobile service, on a secondary basis, for the exclusive use of the Government of Canada. This band is presently shared by the fixed service and the Government of Canada under a coordination agreement for operation near Canadian Forces bases.

In December 2008, Industry Canada released the Consultation Paper on Using a Portion of the Band 14.5-15.35 GHz for Tactical Common Data Link (TCDL) Systems (DGTP-004-08). Also, in December 2008, a Spectrum Advisory Bulletin (SAB-001-08) was issued to announce a moratorium on licensing of fixed services in the bands 14.66-14.82 GHz and 15.135-15.295 GHz, while the Department assessed possible policy amendments to these bands.

In response to the consultation, seven comments were received. These comments generally supported the Department’s proposal to open a portion of the 14.5-15.35 GHz band for TCDL systems. Details of the spectrum policy, technical, licensing and transition provisions to allow TCDL systems in the 14.5-15.35 GHz band are specified in SP-14.5 GHz.

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 www.ic.gc.ca/spectrum.

Official versions of Canada Gazette notices can be viewed at www.gazette.gc.ca/rp-pr/p1/index-eng.html. Printed copies of the Canada Gazette can be ordered by telephoning the sales counter of Canadian Government Publishing at 613-941-5995 or 1-800-635-7943.

November 10, 2009

PAMELA MILLER
Director General
Telecommunications Policy Branch

MARC DUPUIS
Director General
Engineering, Planning and Standards Branch

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DEPARTMENT OF PUBLIC SAFETY AND EMERGENCY PREPAREDNESS

CRIMINAL CODE

Designation as fingerprint examiner

Pursuant to subsection 667(5) of the Criminal Code, I hereby designate the following person of the Royal Canadian Mounted Police as a fingerprint examiner:

Douglas Edward Standing

Ottawa, November 18, 2009

RICHARD WEX
Assistant Deputy Minister
Law Enforcement and Policing Branch

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BANK OF CANADA

Balance sheet as at November 30, 2009

(Millions of dollars) Unaudited

I declare that the foregoing return is correct according to the books of the Bank.

Ottawa, December 10, 2009

H. A. WOERMKE
Acting 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, December 10, 2009

M. CARNEY
Governor

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