Vol. 133, No. 31 — July 31, 1999

Regulations Amending the Patented Medicines (Notice of Compliance) Regulations

Statutory Authority

Patent Act

Sponsoring Department

Department of Industry

REGULATORY IMPACT ANALYSIS STATEMENT

Description

The Patented Medicines (Notice of Compliance) Regulations were enacted to ensure that a second entry manufacturer who applies for a notice of compliance (NOC) for a competing version of a patented drug will not obtain a NOC until the relevant patent expires, or until disputes respecting patent infringement or invalidity are resolved by the courts.

Currently, when a second entry manufacturer seeks marketing approval (an "NOC") from Health Canada and compares its drug with or makes reference to a patentee's drug already approved by Health Canada, the Patented Medicines (Notice of Compliance) Regulations require that the second entry manufacturer address the relevant patents listed against that drug on the patent register maintained by the Minister of Health. In these circumstances, the second entry manufacturer must either agree to await patent expiry for its NOC to issue, or file a Notice of Allegation (NOA), including a detailed statement of the legal and factual basis of the allegation, alleging that the patent is not valid or setting out why its product would not infringe the patents listed against the drug. The second entry manufacturer must serve the NOA on the innovator who then decides whether to contest the allegation of non-infringement or invalidity. This provides the innovator with the opportunity to seek an order before the courts prohibiting the Minister of Health from issuing the NOC and allows the courts to determine the issue of that patent's application to the generic product.

It has recently become apparent that there can be situations where a second entry manufacturer could receive a NOC without complying with the Patented Medicines (Notice of Compliance) Regulations, even though a patent list for the innovator's version of the drug has been filed with the Minister of Health.

The present amendments are intended to clarify the law and reaffirm the application of the Patented Medicines (Notice of Compliance) Regulations. The changes require that all persons, when filing a submission for a NOC for a second version of a drug that contains a medicine that is found in another drug that is or has been marketed in Canada pursuant to a NOC and in respect of which a patent list has been submitted, comply with the Patented Medicines (Notice of Compliance) Regulations.

The transitional provision provides that persons who have already served a NOA under the current regulatory scheme do not need to serve a new NOA.

Alternatives

The present amendments are necessary to ensure that patent issues will be addressed in accordance with the policy intent underlying the Patented Medicines (Notice of Compliance) Regulations and maintain their integrity. No other alternatives were considered.

Benefits and Costs

The link between the patent status of a drug and approval for a second entry version of the drug is being reaffirmed. The amendments confirm the balance between providing effective enforcement of patent rights, while at the same time ensuring that second entry drugs can enter the market as soon as it is determined that they are not covered by a patent, or, where they are covered by a patent, immediately after patent expiry. Overall, since the amendments are designed to reaffirm the application of the existing Regulations, compliance costs to private sector parties should remain the same. Similarly, the amendments will not increase, and may reduce, the costs of administering the Regulations, and may also reduce the overall cost of adjudicating cases under the Regulations.

Consultation

The Patented Medicines (Notice of Compliance) Regulations were reviewed in 1998 (SOR/98-166), at which time extensive consultations were undertaken with stakeholders. At that time, comments were received from the Canadian Drug Manufacturers Association (CDMA), the Pharmaceutical Manufacturers Association of Canada (now Canada's Research-Based Pharmaceutical Companies), the industrial biotechnology association (BIOTECanada), consumer groups, various sectors of the health care industry, and provincial governments. Given that the present amendments do not reflect any change in policy, no further consultations with stakeholders have been conducted. Interested departments have co-operated closely in the development of this proposal.

Compliance and Enforcement

The courts and the Minister of Health will continue to exercise jurisdiction over these matters to ensure compliance, since they relate to various aspects of the regulatory review framework for granting marketing approval to competitive versions of patented drugs and disputes involving patent rights relating to those drugs.

Contact

Serge Dupont, Director General, Corporate Governance Branch, Industry Canada, West Tower, 5th Floor, 235 Queen Street, Ottawa, Ontario K1A 0H5, (613) 952-0211 (Telephone), (613) 952-1980 (Facsimile).

PROPOSED REGULATORY TEXT

Notice is hereby given that the Governor in Council, pursuant to subsection 55.2(4)(see footnote a) of the Patent Act, proposes to make the annexed Regulations Amending the Patented Medicines (Notice of Compliance) Regulations.

Any interested person may make representations concerning the proposed Regulations within 15 days after the date of publication of this notice. All such representations must be addressed to Serge Dupont, Director General, Corporate Governance Branch, Industry Canada, West Tower, 5th Floor, 235 Queen Street, Ottawa, Ontario K1A 0H5, (613) 952-0211 (Telephone), (613) 952-1980 (Facsimile), and cite the Canada Gazette, Part I, and the date of this notice.

Ottawa, July 27, 1999

MARC O'SULLIVAN
Assistant Clerk of the Privy Council

REGULATIONS AMENDING THE PATENTED MEDICINES (NOTICE OF COMPLIANCE) REGULATIONS

AMENDMENT

1. The portion of subsection 5(1)(see footnote 1) of the Patented Medicines (Notice of Compliance) Regulations(see footnote 2) before paragraph (a) is replaced by the following:

5. (1) If a person files or has filed a submission for a notice of compliance in respect of a drug that contains a medicine found in another drug that is or has been marketed in Canada pursuant to a notice of compliance issued to a first person and in respect of which a patent list has been submitted, the person shall, in the submission, with respect to each patent included on the register in respect of the other drug containing the medicine, where that drug has the same route of administration and a comparable strength and dosage form,

TRANSITIONAL PROVISION

2. Section 1 does not apply to a second person if, before the coming into force of these Regulations, that second person served a notice of allegation relating to their submission for a notice of compliance on a first person.

COMING INTO FORCE

3. These Regulations come into force on the day on which they are registered.

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Regulations Amending the National Energy Board Act Part VI (Oil and Gas) Regulations

Statutory Authority

National Energy Board Act

Sponsoring Agency

National Energy Board

REGULATORY IMPACT ANALYSIS STATEMENT

Description

The National Energy Board Act Part VI (Oil and Gas) Regulations ("the Regulations") prescribe the information that a person seeking to export oil from Canada must submit to the National Energy Board ("the Board") in order to obtain an oil export licence. In February 1996, the Minister of Natural Resources, pursuant to subsection 26(2) of the National Energy Board Act, requested that the Board develop a market-based procedure for the review of certain oil export licence applications. The Board then conducted a public inquiry into oil export procedures. After considering the views submitted by the public, the Board, in October 1996, advised the Minister that a market-based procedure incorporating a fair market access procedure similar to that employed for the consideration of applications to export electricity from Canada was suitable for crude oil export licencing applications. In December 1996, the Minister accepted the advice of the Board.

Following the Minister's acceptance of the Board's recommendations, the Board conducted consultations with a view to implementing a market-based procedure for its consideration of crude oil export licence applications. On December 17, 1997, the Board released its Memorandum of Guidance on the "Implementation of the Fair Market Access Procedure for the Licensing of Long-term Exports of Crude Oil and Equivalent". At the time of that release the Board noted the concern of parties that some provisions of the Regulations were not consistent with the new market-based approach to regulating the long-term exportation of crude oil from Canada. Therefore, the Board decided to recommend that amendments be made to the Regulations.

The amendments consist of new provisions which have the following effects on exports of light or heavy crude oil from Canada:

— the requirement that an applicant submit information respecting the applicant's oil supply supporting a proposed exportation will no longer apply to exports of light or heavy crude oil;

— an applicant for a licence to export light or heavy crude oil will not have to submit a description of the market to be served by the exporter;

— an applicant for a licence to export light or heavy crude oil will not have to submit details of the transportation arrangements pertaining to the export;

— an applicant for a licence to export light or heavy crude oil will not have to provide copies or details of each approval or authorization sought from a federal, provincial or state government concerning importation of oil into the country of destination, transportation services, tariffs and tolls, facilities and contractual arrangements necessary for the exportation of oil; and

— a new provision will require an applicant for a licence to export light or heavy crude oil to submit information concerning how the applicant has informed those persons who have demonstrated an interest in buying oil for consumption in Canada of the quantities and grades of oil available for sale by the Applicant and how the Applicant has afforded those persons who are interested in purchasing oil for consumption in Canada of an opportunity to purchase the oil on terms and conditions, including price, that are as favourable as the terms and conditions specified in the application.

There will be no changes to the application requirements for exports of refined oil from Canada.

Alternatives

Historically, little interest has been shown in export licenses for crude oil and the energy industry has shown a preference for renewable short-term export orders which have different information requirements. The status quo would require the submission to the Board of extensive information about the exporter and the export in order to obtain an oil export licence for crude oil. The level of information required to be submitted under the current Regulations is unnecessary under a market-based procedure. As they currently exist the Regulations may inhibit applicants from applying for oil export licences for crude oil and may distort commercial arrangements that would normally be made in connection with oil exports.

In order to balance the information requirements necessary under a market-based approach for both short-term and long-term exports, there is no alternative to amending the Regulations to remove unnecessary information requirements.

At the same time, it is necessary to ensure that willing Canadian purchasers of crude oil for domestic consumption will be assured of an opportunity to purchase oil at terms and conditions, including price, that are as favourable as any export arrangement that an exporter may wish to enter into. That requires the insertion of an additional provision into the Regulations.

Benefits and Costs

Canadian exporters of oil will benefit from less-onerous information requirements when applying for long-term export authorizations for crude oil and may therefore be more willing to make long-term export arrangements with buyers. Such long-term arrangements can enhance stability in both the producing, transportation and marketing sectors of the energy industry.

Costs

The only costs are those of the regulatory process necessary to amend the Regulations.

These amendments are fully compatible with Canada's obligations under the North American Free Trade Agreement.

These amendments have no impact on the year 2000 computer issue.

Consultation

Consultations have occurred with the affected public through the public inquiry process and have continued through the process leading up to the issuance of the Memorandum of Guidance, as well as afterwards. The draft amendments will be pre-published in the Canada Gazette, Part I, for 30 days and any comments made during that process will be considered.

Compliance and Enforcement

There are no particular compliance issues. Where an application is filed that contains numerous information deficiencies, the practice of the Board is to issue a deficiency letter to an Applicant and to stay the processing of the application until those deficiencies have been remedied. If the deficiencies are minor, the Board may continue processing but issue an information request for further particulars. The energy industry is well aware of the Board's practices in this regard.

Contacts

Mr. Hans Pols, Project Manager, Oil Export Licencing Procedures Review, Applications Business Unit, National Energy Board, 444 Seventh Avenue SW, Calgary, Alberta T2P 0X8, (403) 299-3189 (Telephone), (403) 292-5503 (Facsimile), Hans.Pols@neb.gc.ca (Electronic mail); or Mr. Barry Lynch, Team Leader, Oil/NGL, Commodities Business Unit, National Energy Board, 444 Seventh Avenue SW, Calgary, Alberta T2P 0X8, (403) 299-3197 (Telephone), (403) 292-5503 (Facsimile), blynch@zoser.neb.gc.ca (Electronic mail).

PROPOSED REGULATORY TEXT

Notice is hereby given that the Governor in Council, pursuant to subsection 119.01(1)(see footnote b) of the National Energy Board Act, proposes to make the annexed Regulations Amending the National Energy Board Act Part VI (Oil and Gas) Regulations.

Interested persons may make representations with respect to the proposed Regulations within 30 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Mr. Michel Mantha, Secretary, National Energy Board, 444 Seventh Avenue SW, Calgary, Alberta T2P 0X8.

Ottawa, July 27, 1999

MARC O'SULLIVAN
Assistant Clerk of the Privy Council

REGULATIONS AMENDING THE NATIONAL ENERGY BOARD ACT PART VI (OIL AND GAS) REGULATIONS

AMENDMENTS

1. Section 2 of the National Energy Board Act Part VI (Oil and Gas) Regulations(see footnote 3) is amended by adding the following in alphabetical order:

"light crude oil" means a substance that has a density equal to or less than 875.7 kg/m³ and is

(a) oil, other than refined petroleum products,

(b) a blend of oils, other than refined petroleum products, or

(c) a blend of oils, other than refined petroleum products, with refined petroleum products; (pétrole brut léger)

2. The portion of section 25 of the Regulations before paragraph (a) is replaced by the following:

25. Every applicant for a licence for the exportation of oil, other than a licence for the exportation of light crude oil or heavy crude oil, shall furnish to the Board all the information that is necessary for the Board to dispose of the application, including, unless otherwise authorized by the Board,

3. The Regulations are amended by adding the following after section 25:

25.1 Every applicant for a licence for the exportation of light crude oil or heavy crude oil shall furnish to the Board all the information that is necessary for the Board to dispose of the application, including, unless otherwise authorized by the Board,

(a) the terms that the applicant is requesting for the licence, including

(b) information respecting the applicant's oil market, including

(c) information respecting the potential environmental effects of the proposed exportation and any social effects that would be directly related to those environmental effects;

(d) a copy of, or details of the status of, each approval or authorization of a federal, provincial or state government as pertaining to environmental reviews; and

(e) a description detailing the manner in which the applicant

COMING INTO FORCE

4. These Regulations come into force on the day on which they are registered.

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Notices of Uninsured Deposits Regulations

Statutory Authority

Bank Act

Sponsoring Department

Office of the Superintendent of Financial Institutions

REGULATORY IMPACT ANALYSIS STATEMENT

Description

Section 43 of Bill C-82 (An Act to amend certain laws relating to financial institutions) authorizes the Governor in Council to make regulations regarding notices to be displayed by a bank that has received authorization to accept certain deposits without being a member of the Canada Deposit Insurance Corporation ("CDIC"). Bill C-82 received Royal Assent on April 25, 1997. Section 43 will come into force on a day fixed by order of the Governor in Council once the necessary regulations and CDIC by-laws are finalized.

The Notices of Uninsured Deposits Regulations require a bank that has received such authorization to:

— Post a notice that deposits made with it are not insured by CDIC. The notice is to be posted in a public area in each of its branches. The notice must be prominently displayed and clearly visible. Its size and content are specified in the Regulations; and

— Include the notice prominently in each of its advertisements in which it offers deposit facilities or solicits deposits.

Alternatives

Given that the legislation requires such notices and authorizes the Governor in Council to make regulations respecting them, no other alternative was considered.

Benefits and Costs

The proposed Regulations impose a minimal burden on a bank that obtains authorization from CDIC to take deposits without being a member of CDIC (referred to as "opting-out").

Once a bank opts out, it must prominently display a notice in a public area in each of its branches advising depositors that their deposits are not insured by CDIC. The notice must also appear prominently in each of its advertisements in which it offers deposit facilities or solicits deposits. These notices, together with the other consumer protection elements outlined in section 43 of Bill C-82, ensure that depositors are aware that deposits they make with the bank are not insured by CDIC.

Consultation

The Regulations have been reviewed and endorsed by the Department of Finance, the Department of Justice (Regulations Section), the Office of the Superintendent of Financial Institutions and CDIC.

CDIC has also conducted extensive industry consultation on issues relating to opting-out, including these Regulations.

In January 1998, CDIC sent copies of the legislation, CDIC's draft by-laws and the proposed Regulations to all of its members, their associations and other interested parties providing a 30-day comment period.

CDIC also met with a number of Canadian subsidiaries of foreign banks and with the Canadian Bankers Association.

CDIC received four comments regarding the proposed Regulations as a result of the consultation process. Comments focused on the following areas:

— The Regulations should provide specifics regarding the size and wording of the notice to be displayed in each branch; and

— The requirement that notices be included only in advertisements in which the bank expressly states that it offers deposit facilities or accepts deposits is too narrow. The wording should be broadened to cover advertising containing implicit statements to that effect. The notice requirement should also cover alternative distribution sites, such as the Internet site of an opted-out bank.

The Regulations have been redrafted to resolve these concerns. The size and wording of the notice to be posted in each branch is now included in the Regulations. The notice requirement regarding advertisements has been broadened. The term "advertisement" is not limited to those delivered via any particular means. The Regulations cover advertisements delivered via alternative means, such as an Internet site.

Compliance and Enforcement

The Office of the Superintendent of Financial Institutions will monitor compliance with these Regulations as part of its overall regulatory responsibility for banks.

Contact

Mr. Brian Long, Manager, Precedents and Guideline Support, Legislation and Precedents Division, Regulation Sector, Office of the Superintendent of Financial Institutions, Ottawa, Ontario K1A 0H2, (613) 990-8838 (Telephone), (613) 998-6716 (Facsimile), blong@osfi-bsif.gc.ca (Electronic mail).

PROPOSED REGULATORY TEXT

Notice is hereby given that the Governor in Council, pursuant to subsection 413.1(3)(see footnote c) of the Bank Act(see footnote d), proposes to make the annexed Notices of Uninsured Deposits Regulations.

Any interested persons may make representations concerning the proposed Regulations within 30 days after the date of publication of this notice. All such representations must be addressed to Mr. Charles P. Johnston, Regulations Officer, Legislation and Precedents Division, Office of the Superintendent of Financial Institutions, 255 Albert Street, Ottawa, Ontario K1A 0H2 and cite the Canada Gazette, Part I, and the date of this notice.

Ottawa, July 27, 1999

MARC O'SULLIVAN
Assistant Clerk of the Privy Council

NOTICES OF UNINSURED DEPOSITS REGULATIONS

NOTICES IN BRANCHES

1. (1) A bank to which paragraph 413(1)(b) of the Bank Act applies shall post in each of its branches at least one notice in the form set out in the schedule, which notice shall

(a) be 27.94 cm in height and 43.18 cm in width; and

(b) display letters having a font size of 120 points in the heading and a font size of 50 points in the remainder of the text.

(2) The notice shall be prominently displayed in such a manner that it is clearly visible in the area of the branch that is open to the public.

NOTICES IN ADVERTISEMENTS

2. (1) A bank to which paragraph 413(1)(b) of the Bank Act applies shall include a notice in the form set out in the schedule in each of its advertisements in which it offers deposit facilities or solicits deposits.

(2) The notice shall appear prominently in the advertisement in which it is included.

COMING INTO FORCE

3. These Regulations come into force on the day on which section 43 of An Act to amend certain laws relating to financial institutions, being chapter 15 of the Statutes of Canada, 1997, comes into force.

SCHEDULE
(Subsections 1(1) and 2(1))

NOTICE

Deposits with (name of bank) are NOT INSURED by the Canada Deposit Insurance Corporation

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Regulations Amending the Canadian Aviation Regulations (Parts VI and VII)

Statutory Authority

Aeronautics Act

Sponsoring Department

Department of Transport

REGULATORY IMPACT ANALYSIS STATEMENT

Description

These proposed Regulations Amending the Canadian Aviation Regulations (Parts VI and VII) comprise amendments to two regulations, dealing with aircraft maintenance procedures.

Canadian Aviation Regulations (CARs) Part VI (General Operating and Flight Rules)

CAR 605.84 (Aircraft Maintenance — General)

CAR 605.84 (Aircraft Maintenance — General) mandates compliance with airworthiness limitations and airworthiness directives or equivalent foreign notices for all owners and operators of aircraft operated under Subpart 5 (Aircraft Requirements) of CARs Part VI (General Operating and Flight Rules). An airworthiness directive is issued by the Minister as a supplement or replacement to conditions established in the type certificate for an aircraft or an aeronautical product (an aircraft engine, a propeller or an appliance for which a type certificate has been issued). The conditions for which an airworthiness directive must be issued are:

(a) the existence of an unsafe condition in an aeronautical product which is likely to exist or develop in other aeronautical products;

(b) the discovery, subsequent to the issue of a type certificate, that the certificated aeronautical product does not conform to the requirements of the basis of certification for the type design of the product;

(c) the need to modify or cancel the requirements of an airworthiness directive issued by a non-Canadian certifying authority because the airworthiness directive is inappropriate in the Canadian context for reasons related to the environment, safety, delayed receipt of an instruction issued by a foreign authority or reliance on foreign legislation; or

(d) because a condition, referred to above, has changed or ceased to exist, requiring a Canadian airworthiness directive, that is in force, to be modified or canceled.

As a policy, the Minister has not issued airworthiness directives against amateur-built aircraft. The proposed amendment to CAR 605.84 (Aircraft Maintenance — General) will recognize, in the CARs, that existing policy and will state that amateur-built aircraft are not required to be in compliance with airworthiness directives.

Canadian Aviation Regulations (CARs) Part VII (Commercial Air Services)

CAR 706.08 (Maintenance Control Manual (MCM))

CAR 706.08 (Maintenance Control Manual (MCM)) contains the requirements for an air operator, operating a commercial service under Part VII (Commercial Air Services), to establish, maintain and authorize the use of a Maintenance Control Manual (MCM). It covers conditions which govern the authorization and use of such a manual. Although it is implied in this regulation that the Minister has the authority and is required to approve an MCM, the authority is not explicitly stated. The proposed amendment to CAR 706.08 will add a paragraph stating that the Minister shall approve an air operator MCM and amendments to that manual where the Commercial Air Service Standards are met.

Alternatives

The intentions of these proposed changes are not achievable by non-regulatory means. During the consultations held at the Canadian Aviation Regulatory Advisory Council (CARAC) Technical Committee meetings, alternatives to regulation and alternative regulatory proposals were considered. The consensus was that, for these proposals, these Regulations represent the best avenue to serve both the Government and the aviation community.

Benefits and Costs

CAR 605.84 (Aircraft Maintenance — General)

The proposed amendment to CAR 605.84 will exempt owners and operators of amateur-built aircraft from the need to comply with airworthiness directives. The proposal recognizes a current Departmental policy.

Regulatory oversight of amateur-built aircraft is already well established under CAR 549 (Amateur-Built Aircraft) and associated standards. Departmental inspection of any amateur-built aircraft is required during fabrication and, after the final assembly has been completed, before the first flight. On-going maintenance requirements, which are common to all Canadian registered aircraft, also apply to amateur-built aircraft. Amateur-built aircraft are required to display, on the side of the fuselage, in a position and style readily visible to persons entering the aircraft, in both languages, a placard stating "This aircraft is operating with a Special Certificate of Airworthiness for Amateur-Built Aircraft". As well, during the period when initial operating restrictions apply, a similar placard must also be displayed stating that passengers are prohibited. The exemption of these aircraft from compliance with airworthiness directives will not change either the above provisions or current practices and will be in line with Transport Canada's New Recreational Aviation Policy (TP12781). This policy commits the Department to maintain the principle of a high level of aviation safety while making recreational aviation (including recreational activities involving amateur-built aircraft) more affordable and easier to enjoy.

Since the proposed amendment to CAR 605.84 acknowledges an existing policy, its net benefit-cost implications will not be significant. The explicit removal of the requirement to comply with airworthiness directives on aeronautical products installed in amateur-built aircraft is proposed in recognition of the conscious acceptance of risk by owner/pilots who operate these aircraft. For amateur-built aircraft enthusiasts, this proposed amendment with respect to airworthiness directives will assist in keeping recreational aviation activity priced within the budget of many who otherwise would not be able to pursue it.

CAR 706.08 (Maintenance Control Manual (MCM))

The recognition of existing Ministerial authority in the amendment to CAR 706.08 (Maintenance Control Manual (MCM)) will improve understanding of and compliance with the intent of these Regulations. It has no significant benefit-cost implications.

Benefits and Costs

Benefit-costs implications for CAR 605.84 (Aircraft Maintenance — General) and for CAR 706.08 (Maintenance Control Manual (MCM)) are generally not significant. Throughout the development of the aviation regulations and standards Transport Canada applies risk management concepts. Where there are risk implications the analysis of these proposed amendments has concluded that the imputed risk is acceptable in light of the expected benefits.

Consultation

Consultation on these proposed amendments to the Canadian Aviation Regulations has been carried out through the Canadian Aviation Regulation Advisory Council (CARAC). The actively participating members of the Aircraft Maintenance and Manufacturing Technical Committee of CARAC include the Aerospace Industries Association of Canada, Air B.C., Air Canada, the Air Transport Association of Canada, the Aircraft Owners and Pilots Association — Canada, the Association québécoise des transporteurs aériens incorporée, Bell Helicopter Textron Canada, Canadair Inc., Bombardier, Canadian Airlines International, the Canadian Business Aircraft Association, the Canadian Federation of AME Associations, the Canadian Owners and Pilots Association, the Canadian Sports Aviation Council, the Department of Justice, the Department of National Defence, De Havilland Canada Inc., the Experimental Aircraft Association — Canadian Council, Field Aviation Company Inc., Innotech Aviation Ltd., the International Association of Machinists and Aerospace Workers, the Ontario AME Association, the Recreational Aircraft Association, the Transportation Safety Board of Canada, and Pratt & Whitney Canada Inc. The Aircraft Maintenance and Manufacturing Technical Committee has reviewed these proposed amendments to Parts VI and VII of the CARs at meetings in 1997. The Committee recommended the adoption of these amendments.

These proposed amendments will affect regulations which had been under the purview of the General Operating and Flight Rules and Commercial Air Service Operations Technical Committees of CARAC. These Committees have been informed that the Technical Committee responsibility with respect to maintenance issues has been reassigned, for efficiency reasons, to the Aircraft Maintenance and Manufacturing Technical Committee. Their members were provided with the relevant documents for the proposed amendments to regulations affecting the Parts of the CARs formerly under the purview of each Technical Committee and were invited to attend the Aircraft Maintenance and Manufacturing Technical Committee meetings at which these amendments were to be discussed. They were also offered the opportunity to become members of the Aircraft Maintenance and Manufacturing Technical Committee in order to receive future mailings of Notices of Proposed Amendment (NPAs) suggesting changes to the CARs or to the associated Standards which would affect their interests. No objections to the changes proposed in these amendments were received from any members of either of these two Technical Committees.

Compliance and Enforcement

These Regulations will generally be enforced through the assessment of monetary penalties imposed under sections 7.6 to 8.2 of the Aeronautics Act or through suspension or cancellation of a Canadian aviation document.

Contact

The Chief, Regulatory Affairs, AARBH, Transport Canada, Safety and Security, Place de Ville, Tower C, Ottawa, Ontario K1A 0N8, (613) 990-1184 (Telephone), (613) 990-1198 (Facsimile), www.tc.gc.ca (Internet), (613) 993-7284 (Telephone, general inquiries) or 1-800-305-2059.

PROPOSED REGULATORY TEXT

Notice is hereby given that the Governor in Council, pursuant to section 4.9(see footnote e) of the Aeronautics Act, proposes to make the annexed Regulations Amending the Canadian Aviation Regulations (Parts VI and VII).

Interested persons may make representations concerning the proposed Regulations to the Minister of Transport within 30 days after the date of publication of this notice. All such representations should cite the Canada Gazette, Part I, and the date of publication of this notice. Each representation must be sent to the Chief, Regulatory Affairs (AARBH), Civil Aviation, Safety and Security Group, Transport Canada, Place de Ville, Tower C, Ottawa, Ontario K1A 0N8, (613) 993-7284 (Telephone, general inquiries) or 1-800-305-2059, (613) 990-1198 (Facsimile), http://www.tc.gc.ca (Internet).

Each representation should stipulate those parts of it that should not be disclosed pursuant to the Access to Information Act and, in particular, pursuant to sections 19 and 20 of that Act, the reason why those parts should not be disclosed and the period during which they should remain undisclosed. The representation should also stipulate those parts of it for which there is no objection to disclosure pursuant to the Access to Information Act.

Ottawa, July 27, 1999

MARC O'SULLIVAN
Assistant Clerk of the Privy Council

REGULATIONS AMENDING THE CANADIAN AVIATION REGULATIONS (PARTS VI AND VII)

AMENDMENTS

1. The portion of subsection 605.84(1) of the Canadian Aviation Regulations(see footnote 4) before subparagraph (c)(i) is replaced by the following:

605.84 (1) Subject to subsections (3) and (4), no person shall conduct a take-off or permit a take-off to be conducted in an aircraft that is in the legal custody and control of the person, other than an aircraft operated under a special certificate of airworthiness in the amateur-built classification, unless the aircraft

(a) is operated in accordance with any airworthiness limitations applicable to the aircraft type design;

(b) meets the requirements of any airworthiness directives issued under section 593.02; and

(c) except as provided in subsection (2), meets the requirements of any notices equivalent to airworthiness directives issued by

2. Section 706.08 of the Regulations is amended by adding the following after subsection (7):

(8) The Minister shall approve an air operator's MCM, and any amendments to that manual, if the requirements of the Commercial Air Service Standards are met.

COMING INTO FORCE

3. These Regulations come into force on the day on which they are registered.

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Footnote a

S.C., 1993, c. 2, s. 4

Footnote 1

SOR/98-166

Footnote 2

SOR/93-133

Footnote b

S.C., 1990, c. 7, s. 34

Footnote 3

S.C., 1990, c. 7, s. 34

Footnote c

S.C., 1997, c. 15, s. 43

Footnote d

S.C., 1991, c. 46

Footnote e

S.C., 1992, c. 4, s. 7

Footnote 4

SOR/96-433

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