Vol. 133, No. 44 — October 30, 1999

Termination of the Administration, Management and Control of the Harbour of Baie des Ha! Ha! and Portions of the Harbour of Saguenay by the Canada Ports Corporation

Statutory Authority

Canada Ports Corporation Act

Sponsoring Agency

Canada Ports Corporation

REGULATORY IMPACT ANALYSIS STATEMENT

Description

The harbour of Baie des Ha! Ha! is currently administered by the Canada Ports Corporation as a non-corporate port, pursuant to the Canada Ports Corporation Act. A portion of the harbour of Saguenay is now a Canadian Port Authority pursuant to letters patent issued on May 1, 1999, in accordance with the Canada Marine Act. The remainder of the harbour of Saguenay is still administered by the Canada Ports Corporation as a non-corporate port.

This Order will terminate the administration, management and control by the Canada Ports Corporation of the harbour of Baie des Ha! Ha! and the remaining portions of the harbour of Saguenay.

Alternatives

Status quo — Retention of the administered area at issue would be commercially detrimental.

Benefits and Costs

This initiative will reduce administrative burden.

Consultation

The municipalities affected by the project (Chicoutimi and La Baie) are aware of the proposed changes and have not expressed any concerns.

Alcan Aluminium Limited, the major commercial entity operating in the harbour of Baie des Ha! Ha!, has been consulted and supports this initiative.

This initiative has also been approved by the directors of the Canada Ports Corporation, who are required by the Canada Ports Corporation Act to be representative of national, regional and local interests essential to port activities.

Early notice was not given in the Federal Regulatory Plan.

Compliance and Enforcement

The harbours will continue to be subject to the Navigable Waters Protection Act.

Contact

James Lynes, President and Chief Executive Officer, Canada Ports Corporation, Place de Ville, Tower C, 330 Sparks Street, Ottawa, Ontario K1A 0N6, (613) 957-6700.

PROPOSED REGULATORY TEXT

Notice is hereby given that the Governor in Council proposes

(a) pursuant to paragraph 34(1)(b)(see footnote a) of the Canada Ports Corporation Act, to terminate the administration, management and control by the Canada Ports Corporation of the harbour of Baie des Ha! Ha!, transferred to the Corporation by Order in Council P.C. 1975-624 of March 18, 1975(see footnote b); and

(b) pursuant to paragraph 34(1)(b)(see footnote c) of the Canada Ports Corporation Act, to terminate the administration, management and control by the Canada Ports Corporation of those portions of the harbour of Saguenay described in the annexed schedule.

Interested persons may make representations concerning the proposed termination 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 the President and Chief Executive Officer of the Canada Ports Corporation, 330 Sparks Street, Place de Ville, Tower C, Ottawa, Ontario K1A 0N6.

Ottawa, October 28, 1999

MARC O'SULLIVAN
Assistant Clerk of the Privy Council

SCHEDULE

The Canada Ports Corporation's administration, management and control of those portions of the harbour of Saguenay described hereafter is terminated.

The whole area of the Saguenay River and its banks within the following boundaries:

(a) starting at the point where the high water line intersects the line separating lots 13b and 14b in Range 1 in the official cadastre of Simard Township; thence in a southerly direction 180°00'00'' crossing the river to the high water line on the south bank; thence to the east along that high water line to the point at which it intersects an imaginary line located downstream from Sainte-Anne Bridge, seventy metres (70.00 m) away from and parallel to the centre of that bridge; thence along that imaginary line in a generally northerly direction to the point at which it intersects with the north bank of the Saguenay; thence toward the west along the high water line to the starting point; all as shown by the letter "A" on sheet 2 of 2 of the Plan prepared by Jean-Guy Tremblay, Land Surveyor, on May 26, 1998 and bearing Number 6163 in his minutes; and

(b) starting at the point where the high water line intersects the line separating the official cadastres for the townships of Bagot and Otis; thence in a northerly direction 0°00'00'' crossing the river to the high water line on the north bank; thence in a northwesterly direction along the high water line to the Pelletier River; thence along an imaginary line crossing that river in a generally southerly direction to Cap Ouest; thence in a generally southeasterly direction along an imaginary line crossing the mouth of Baie des Ha! Ha! to the starting point; all as shown by the letter "B" on sheet 2 of 2 in the Plan prepared by Jean-Guy Tremblay, Land Surveyor, on May 26, 1998 and bearing Number 6163 in his minutes.

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Regulations Amending the Coastal Fisheries Protection Regulations

Statutory Authority

Coastal Fisheries Protection Act

Sponsoring Department

Department of Fisheries and Oceans

REGULATORY IMPACT ANALYSIS STATEMENT

Description

This amendment to the Coastal Fisheries Protection Regulations (CFPR) will add 15 South Pacific countries to the list of flag states whose vessels are eligible to be licensed to enter Canadian waters and ports. These countries are: Australia, the Cook Islands, the Republic of Fiji, Kiribati, the Republic of the Marshall Islands, the Federated States of Micronesia, the Republic of Nauru, New Zealand, Niue, the Republic of Palau, Papua New Guinea, the Solomon Islands, the Kingdom of Tonga, Tuvalu, and the Independent State of Samoa.

Canada's policy grants port access to vessels from countries that have co-operated on conserving straddling fish stocks outside Canada's 200-mile limit. Vessels from countries that do not co-operate, will not have access.

Canada and the South Pacific countries mentioned above have been close allies on a number of international fisheries conservation initiatives, including the moratorium on large scale drift net fishing and the UN Agreement on Straddling and Highly Migratory Fish Stocks. They have also supported full participant status for Canada in the current negotiations on a convention for managing tuna stocks in the western and central Pacific Ocean.

New Zealand and the other South Pacific countries listed above comply with the CFPR criteria for inclusion on the list of countries eligible to be licensed for access to Canadian ports.

Alternatives

A regulatory amendment to include these countries on the list is the only means to allow the vessels to enter Canadian ports. All foreign fishing vessels or vessels servicing fishing vessels require a licence and only vessels registered in those countries listed in the Regulations are permitted to obtain licences.

Benefits and Costs

This amendment will reinforce Canada's strong fisheries conservation ties with these countries and strengthen co-operation with them on critical fisheries initiatives in international arenas.

Economic benefits in the form of offloading fees and added work for dock workers are also anticipated from transhipments of fish products by the fishing vessels of these countries through British Columbia ports. In addition, Canadian tuna vessels will benefit from reciprocal access to the ports of these countries, particularly in New Zealand. In the foreseeable future, the monetary value of such transactions is expected to be around $100,000.

The effect on wholesalers of fish would vary. If the supply of tuna is low, then the marginal amounts delivered by foreign vessels would increase business for them which would help absorb downward effects on prices. However, if supply is high, then increased deliveries would likely reduce prices paid to Canadian fishers and make sales more difficult, thereby negatively affecting wholesalers and fishers.

British Columbia shipyards and ship supply companies would also benefit somewhat from the few vessels which would land in British Columbia ports.

Consultation

The government of British Columbia supports the proposed amendment because the countries concerned supported Canada in combating the use of high seas drift nets in the North Pacific and the support of these countries is critical in realizing Canadian objectives in the negotiations under way for a new Pacific tuna convention.

The Western Fishboat Owners Association, which represents British Columbia tuna fishers, supports the proposed amendment but would prefer that tuna vessels from the designated countries do not sell into local markets for competitive reasons.

Compliance and Enforcement

There are no new compliance and enforcement measures required as a result of this initiative. The Minister has the authority to suspend or cancel a licence where it is ascertained that a fishing vessel from one of these countries has obtained a licence under false pretences.

Contact

A. J. Sarna, Multilateral Relations Division, International Directorate, Department of Fisheries and Oceans, 200 Kent Street, Ottawa, Ontario K1A 0E6, (613) 993-1897 (Telephone), (613) 993-5995 (Facsimile), sarnaa@dfo-mpo.gc.ca (Electronic mail).

PROPOSED REGULATORY TEXT

Notice is hereby given that the Governor in Council, pursuant to section 6(see footnote d) of the Coastal Fisheries Protection Act, proposes to make the annexed Regulations Amending the Coastal Fisheries Protection Regulations.

Any interested person may make representations concerning the proposed Regulations within 30 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, the date of this notice and must be addressed to A.J. Sarna, Multilateral Relations Division, International Directorate, Department of Fisheries and Oceans, 200 Kent Street, Ottawa, Ontario, K1A 0E6, Tel. (613) 993-1897, FAX: (613)993-5995, E-mail: sarnaa@dfo-mpo.gc.ca

Ottawa, October 28, 1999

MARC O'SULLIVAN
Assistant Clerk of the Privy Council

REGULATIONS AMENDING THE COASTAL FISHERIES PROTECTION REGULATIONS

AMENDMENTS

1. The table(see footnote 1) to paragraph 5(1)(a) of the Coastal Fisheries Protection Regulations(see footnote 2) is replaced by the following:

TABLE

Flag State
Australia
Bermuda
The Commonwealth of the Bahamas
Cook Islands
Faroe Islands
Federal Republic of Germany
The Federated States of Micronesia
The French Republic
The Grand Duchy of Luxembourg
Greenland
The Hellenic Republic
The Independent State of Samoa
Ireland
The Italian Republic
Japan
The Kingdom of Belgium
The Kingdom of Denmark
The Kingdom of the Netherlands
The Kingdom of Norway
The Kingdom of Spain
The Kingdom of Sweden
The Kingdom of Tonga
Kiribati
New Zealand
Niue
Papua New Guinea
The People's Republic of China
The Portuguese Republic
The Republic of Austria
The Republic of Bulgaria
The Republic of Cuba
The Republic of Cyprus
The Republic of Estonia
The Republic of Fiji
The Republic of Finland
The Republic of Iceland
The Republic of Korea
The Republic of Latvia
The Republic of Liberia
The Republic of Lithuania
The Republic of Malta
The Republic of the Marshall Islands
The Republic of Nauru
The Republic of Palau
The Republic of Poland
The Republic of Vanuatu
Romania
The Russian Federation
Solomon Islands
Tuvalu
The United Kingdom of Great Britain and Northern Ireland

COMING INTO FORCE

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

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Regulations Amending the Pacific Fishery Regulations, 1993

Statutory Authority

Fisheries Act

Sponsoring Department

Department of Fisheries and Oceans

REGULATORY IMPACT ANALYSIS STATEMENT

Description

This regulatory initiative will amend the Pacific Fishery Regulations, 1993, which are made pursuant to the Fisheries Act. The amendments will adjust the individual quota (IQ) fee for a licence to fish herring spawn on kelp and will represent the final step in the implementation of the progressive fee calculation formula begun in January 1996 in the Atlantic region and continued in January 1999 in the Pacific region. At those times, IQ licence fees were adjusted to be based on 3 percent for the first $50,000 of the quota's value, by using 1990-93 average prices, and 5 percent for the value over $50,000. The same is now being done for herring spawn on kelp licence fees which will result in a general reduction of approximately 8 percent in licence fees for these fishers.

The objective of this amendment is to complete the process of making fee calculation for these fisheries nationally consistent with the departmental position that licence holders who benefit from preferred access to a public resource should pay a fee that reflects the earning potential of that privilege.

Alternatives

The only alternative that could be considered was the status quo. This option, however, was considered unfair to herring spawn on kelp fishers, since this amendment will reduce their licence fees by an average of 8 percent. The status quo was also considered unfair to other IQ licence holders in Canada since their licence fees have already been converted to the progressive fee formula. This amendment is the only way to ensure that all IQ licence fees are based on the same calculation formula and are nationally consistent.

Benefits and Costs

The change to the fee for herring spawn on kelp licences will reduce the Department of Fisheries and Oceans revenues by $39,000 and will reduce the average licence fee from $12,846 to $11,846. This revenue reduction is negligible, however, and will be managed within existing resource levels.

Consultation

In 1995, when the progressive fee calculation formula was being developed and, in 1998, prior to the formula's implementation in the Pacific region for the geoduck, halibut and sablefish fisheries, all IQ licence holders, including herring spawn on kelp licensees, were involved in the extensive national consultations. Extensive consultation with the fishery advisory group for herring spawn on kelp licence holders was not considered necessary since licence fees are being reduced by an average of 8 percent by this amendment. In addition, since this initiative puts all IQ fishers on the same fee calculation scheme, consultation with the other IQ fishing groups unaffected by this initiative was not warranted.

Contact

Wendy Grider, Chief, Regulations Unit, Conservation and Protection Division, Operations Branch, Department of Fisheries and Oceans, 555 West Hastings Street, Vancouver, British Columbia V6B 5G3, (604) 666-6408 (Telephone), (604) 666-9136 (Facsimile).

PROPOSED REGULATORY TEXT

Notice is hereby given that the Governor in Council, pursuant to section 43 (see footnote e) of the Fisheries Act, proposes to make the annexed Regulations Amending the Pacific Fishery Regulations, 1993.

Any interested person may make representations concerning the proposed Regulations within 30 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, the date of this notice and must be addressed to Wendy Grider, Chief, Regulations Unit, Conservation and Protection Division, Operations Branch, Department of Fisheries and Oceans, 555 West Hastings St., Vancouver, BC V6B 5G3. (E-mail: GriderW@dfo-mpo.gc.ca).

Ottawa, October 28, 1999

MARC O'SULLIVAN
Assistant Clerk of the Privy Council

REGULATIONS AMENDING THE PACIFIC FISHERY REGULATIONS, 1993

AMENDMENTS

1. Subitem 3(11)(see footnote 3) of Part I of Schedule II to the Pacific Fishery Regulations, 1993(see footnote 4) is replaced by the following:

Item	Column I Registration or Licence	Column II Fee ($)
3.	Commercial Fishing Licences - annual
(11)	Category J - Herring Spawn on Kelp	1,770.00 multiplied by the number of tonnes of herring spawn on kelp authorized to be taken under the licence, minus 40% of that product where the product is less than 2,500.00, or minus 1,000.00 where the product is 2,500.00 or more.

COMING INTO FORCE

2. These Regulations come into force on the date on which they are registered.

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Regulations Amending the Food and Drug Regulations (1147 — Meclizine)

Statutory Authority

Food and Drugs Act

Sponsoring Department

Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

Description

Drugs for human and veterinary use listed in Part I of Schedule F to the Food and Drug Regulations require a prescription to be sold in Canada. Meclizine is currently listed on this schedule. This regulatory amendment proposes to remove meclizine and its salts in concentrations of 25 mg per dosage unit or less from Schedule F. This recommendation is based on the review of new scientific data submitted by a manufacturer to support their request to permit its sale as nonprescription drug.

Safety studies for meclizine were originally submitted to Health Canada in 1953 and the drug was approved for marketing in 1954 for symptomatic relief of nausea. However, in the early 1960s, there were concerns of a possible relationship between fetal malformations and the use of meclizine as an anti-nauseant in the treatment of pregnant women in the first trimester. These concerns gave rise to many studies in the 1960s to fully explore this association. Follow-up studies demonstrated that there was no statistically significant increase in the incidence of fetal malformations related to the use of meclizine. The manufacturer presented a comprehensive risk/benefit analysis, demonstrating satisfactorily that the use of meclizine for the labelled indications outweighed any potential risk that its use in self-medication may present.

Meclizine was originally approved for marketing in 1954, prior to the introduction of the New Drugs regulations. These regulations define a new drug as a drug that has not been sold, in Canada, for sufficient time and in sufficient quantity to establish the safety and effectiveness of that substance. Currently, meclizine is considered to be an "old drug." However, this proposal to switch meclizine 25 mg and less to nonprescription status is considered to be a new condition of use for meclizine. Therefore, meclizine for nonprescription use will be considered to be a new drug. Manufacturers of drugs containing meclizine for nonprescription use, will be required to meet all requirements of Division 8 (New Drugs) of the Food and Drug Regulations.

Rationale for the Change in Status — Schedule F

Schedule F unnecessarily restricts the availability of this drug to the public.

The evaluation of the known pharmacological and toxicological properties, reported adverse drug reactions and available literature submitted by a distributor of meclizine, resulted in a favourable benefit/risk review.

Meclizine dihydrochloride 25 mg has been available without a prescription in the United States for more than 40 years. The post-marketing surveillance data available supports the safe nonprescription use of this drug.

The symptoms of motion/travel sickness are easily recognized by those experiencing them. This condition lends itself to self-diagnosis and self-medication.

Alternatives

No other alternatives were considered.

The status quo is not considered acceptable as the above rationale does not support maintaining prescription status for this drug based on the new information available. The nonprescription recommendation was made by the Therapeutic Products Programme using established and publicly available criteria (Health Protection Branch Information Letter No. 781 — June 28, 1990).

Benefits and Costs

This proposed amendment will impact on the following sectors:

Public

The removal of the prescription requirement for meclizine 25 mg will provide the public with easier access to the product and the added convenience of self-medication.

Product labels will be required to bear appropriate directions and cautionary statements respecting the product's safe and proper use. This will provide the public with appropriate safety information.

The public will be required to pay directly for the product, which may have previously been covered by prescription drug insurance plans.

Pharmaceutical Industry

The Food and Drug Regulations limit the advertising of Schedule F drugs for human use, to name, quantity and price. With the de-scheduling of meclizine 25 mg, distributors will be able to advertise these products to the public.

Once this initiative comes into effect, meclizine 25 mg can no longer be sold with prescription labelling. Notice of this change in regulatory status has been communicated to the pharmaceutical industry through a direct mailing as well as through this publication. The mailings to the associations and affected distributors included a draft labelling standard to assist in revising product labels. This will allow all distributors of meclizine 25 mg sufficient time to obtain approval of their labelling change to market their products as nonprescription drugs prior to this deregulation becoming effective.

This proposal may have a negative impact on the other manufacturers of meclizine 25 mg, who may now require approval of their product under the more stringent safety and efficacy requirements for new drugs (Division 8 of the Food and Drug Regulations). This may also require submission of additional information for any significant changes to their product. In addition, this proposed change will prohibit the use of a "Pr" symbol on the label of meclizine and its salts in concentration of 25 mg and less.

Provincial Health Care Systems

A switch to nonprescription status may lead to lower costs for publicly funded drug benefit plans since most provinces have decided not to cover the cost of nonprescription drugs. As well, there may be a reduction in physician visits for the purposes of obtaining a prescription, leading to lower physician costs.

Consultation

Direct mailing of this regulatory proposal was provided to the provincial ministries of Health, medical and pharmacy licensing bodies and pharmaceutical industry associations. As well, a notice of intent was published in the Canada Gazette, Part I, on November 28, 1998, with a 45-day comment period as well as being posted on the Therapeutic Products Programme Web site under:

http://www.hc-sc.gc.ca/hpb-dgps/therapeut/zfiles/english/ schedule/earlycon/sch-1147.html

Four responses from stakeholders were received. The following suggestions and concerns were collated from stakeholders' comments:

Comment No. 1: Minor changes were suggested to the proposed labelling requirements and consumer information. Suggestions included clarifying the directions for use ("Dose may be repeated once daily as needed during journeys of several days") and expanding the warnings section to mention the potential for the drug to cause hypotension.

Response: The labelling suggestions will be reviewed. The labelling standard for meclizine will be finalized following the publication of this regulatory proposal in the Canada Gazette, Part II.

Comment No. 2: Meclizine dihydrochloride should not be considered as a new drug.

Response: The change in status to nonprescription is considered to be a new condition of use in Canada and therefore appropriate to warrant a New Drug classification.

Comment No. 3: Placement of Sale — Pharmacists should remain in control of the sale of meclizine dihydrochloride given the abuse potential.

Response: This decision falls within provincial/territorial jurisdiction. The National Drug Scheduling Advisory Committee (NDSAC), who reports to the National Association of Pharmacy Regulatory Authorities (NAPRA), makes recommendations on the place of sale of nonprescription drugs.

To address the concerns about product availability at the time of the switch, the effective date of this regulatory change will provide a 90-day delayed implementation from the date of publication in the Canada Gazette, Part II. This will allow manufacturers sufficient time to prepare for the product being introduced into the nonprescription drug market.

A further 30-day comment period will be provided upon prepublication in the Canada Gazette, Part I. http://www.canada. gc.ca/gazette/hompar1_e.html

Submit Comments

Compliance and Enforcement

This amendment does not alter existing compliance mechanisms under the provisions of the Food and Drugs Act and Food and Drug Regulations, enforced by Therapeutic Products Programme inspectors. Indirect enforcement is provided through complaints from the medical profession and competitors. Inspection mechanisms at both the federal and provincial levels will be maintained.

Contact

Karolyn Lui (at karolyn_lui@hc-sc.gc.ca), Bureau of Policy and Coordination, Therapeutic Products Programme, Holland Cross, Tower B, 2nd Floor, 1600 Scott Street, Address Locator 3102C5, Ottawa, Ontario K1A 1B6, (613) 941-3693 (Telephone), (613) 941-6458 (Facsimile).

PROPOSED REGULATORY TEXT

Notice is hereby given that the Governor in Council, pursuant to section 30 (see footnote f) of the Food and Drugs Act, proposes to make the annexed Regulations Amending the Food and Drug Regulations (1147 — Meclizine).

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 Karolyn Lui, Therapeutic Products Programme, Department of Health, Address Locator No. 3102C5, 1600 Scott Street, Holland Cross, Tower B, 2nd floor, Ottawa, Ontario K1A 1B6.

The representations should stipulate those parts of the representations 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 representations should also stipulate those parts of the representations for which there is consent to disclosure pursuant to the Access to Information Act.

Ottawa, October 28, 1999

MARC O'SULLIVAN
Assistant Clerk of the Privy Council

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1147 — MECLIZINE)

AMENDMENT

1. The reference to

Meclizine and its salts
Méclizine et ses sels(see footnote 5)

in Part II of Schedule F to the Food and Drug Regulations(see footnote 6) is replaced by the following:

Meclizine and its salts when sold in concentrations greater than 25 mg per dosage unit

Méclizine et ses sels s'ils sont vendus en une concentration supérieure à 25 mg par unité posologique

COMING INTO FORCE

2. These Regulations come into force 90 days after the day on which they are published in the Canada Gazette, Part II.

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Regulations Amending the Food and Drug Regulations (1148 — Cimetidine)

Statutory Authority

Food and Drugs Act

Sponsoring Department

Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

Description

Part I of Schedule F to the Food and Drug Regulations lists substances intended for human and veterinary use which require a prescription to be sold in Canada. The review and introduction of new drugs onto the Canadian market or the reassessment of marketed drugs necessitates periodic revisions to the schedule. This regulatory amendment proposes to remove from Schedule F cimetidine and its salts in concentrations of 200 mg per dosage unit or less when sold for the treatment of heartburn. The recommendation to change the status of cimetidine to nonprescription was based on established and publicly available criteria.

Cimetidine and its salts in concentrations of 100 mg per dosage unit or less was removed from Schedule F on September 17, 1997. The indications for use of cimetidine at concentrations up to 200 mg are identical to those for cimetidine at concentrations of 100 mg per dosage unit or less. At these concentrations, cimetidine is used for the treatment of episodic stomach discomfort (heartburn, acid indigestion, sour stomach, upset stomach) and for the prevention of nocturnal stomach discomfort and meal-related stomach discomfort. Several restrictions are proposed. The maximum daily dose of cimetidine is limited to 400 mg. The maximum duration of treatment without medical supervision is recommended to be two weeks. Appropriate directions and cautionary statements respecting the product's safe and proper use will appear on the product label.

Cimetidine has been marketed worldwide since 1976. It has been administered to more than 56 million patients in 24 countries. A large body of postmarketing surveillance data therefore exists to support the safety of this drug.

Rationale for the Change in Status — Schedule F

http://www.hc-sc.gc.ca/hpb-dgps/therapeut/zfiles/english/ policy/issued/listschf_e.html

Alternatives

The options outlined below provide an overview of the regulatory alternatives that were considered prior to the selection of option 3 as detailed in this proposal:

Benefits and Costs

This amendment will impact on the following sectors:

Public

Pharmaceutical Industry

Provincial Health Care System

Consultation

Direct mailing of this regulatory proposal was provided to the provincial ministries of Health, medical and pharmacy licensing bodies and pharmaceutical industry associations on December 3, 1998. A notice of intent was published in the Canada Gazette, Part I, on December 12, 1998, with a 45-day comment period, as well as being posted on the Therapeutic Products Programme Web site under:

http://www.hc-sc.gc.ca/hpb-dgps/therapeut/zfiles/english/ schedule/earlycon/sch-1148.html.

A draft labelling standard, which informs consumers about the product, was also sent to the affected manufacturers and pharmaceutical industry associations for comment.

A total of four responses from stakeholders were received. All were supportive of the proposal. The following suggestions and concerns were collated from stakeholders' comments:

Comment No. 1:

Comment No. 2:

Response:

Comment No. 3:

Response:

A further 30-day comment period will be provided upon prepublication in the Canada Gazette, Part I. The Internet address for public comments is:

http://www.canada.gc.ca/gazette/hompar1_e.html

Comments on this regulatory proposal may be submitted to the contact name and address below or alternatively, they may be submitted electronically through this link:

Submit Comments

Compliance and Enforcement

This amendment does not alter existing compliance mechanisms under the provisions of the Food and Drugs Act and Food and Drug Regulations, enforced by Therapeutic Products Programme inspectors. Indirect enforcement is provided through complaints from the medical profession and competitors. Inspection mechanisms at both the federal and provincial levels will be maintained.

Contact

Karolyn Lui, Bureau of Policy and Coordination, Therapeutic Products Directorate, Holland Cross Building, Tower B, 2nd Floor, 1600 Scott Street, Address Locator 3102C5, Ottawa, Ontario K1A 1B6, (613) 941-3693 (Telephone), (613) 941-6458 (Facsimile), karolyn_lui@hc-sc.gc.ca (Electronic mail).

PROPOSED REGULATORY TEXT

Notice is hereby given that the Governor in Council, pursuant to section 30 (see footnote g) of the Food and Drugs Act, proposes to make the annexed Regulations Amending the Food and Drug Regulations (1148 — Cimetidine).

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 Karolyn Lui, Therapeutic Products Programme, Department of Health, Address Locator No. 3102C5, 1600 Scott Street, Holland Cross, Tower B, 2nd floor, Ottawa, Ontario K1A 1B6.

The representations should stipulate those parts of the representations 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 representations should also stipulate those parts of the representations for which there is consent to disclosure pursuant to the Access to Information Act.

Ottawa, October 21, 1999

MARC O'SULLIVAN
Assistant Clerk of the Privy Council

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1148 — CIMETIDINE)

AMENDMENT

1. The reference to

Cimetidine and its salts when sold in concentrations greater than 100 mg of cimetidine per unit dose
Cimétidine et ses sels lorsqu'ils sont vendus en concentration supérieure à 100 mg de cimétidine par unité posologique(see footnote 7)

in Part I of Schedule F to the Food and Drug Regulations(see footnote 8) is replaced by the following:

Cimetidine and its salts, except when sold in concentrations of 200 mg or less per dosage unit and indicated for the treatment of heartburn

Cimétidine et ses sels, sauf s'ils sont vendus en une concentration de 200 mg ou moins par unité posologique pour le traitement des brûlures d'estomac

COMING INTO FORCE

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

[44-1-o]

Regulations Amending the Gun Shows Regulations

Statutory Authority

Firearms Act

Sponsoring Department

Department of Justice

REGULATORY IMPACT ANALYSIS STATEMENT

Description

These Regulations form part of a comprehensive regulatory package implementing the new statutory scheme for the control of firearms and other weapons provided for in the Firearms Act and a completely amended Part III of the Criminal Code.

The Regulations will defer the coming into force of the Gun Shows Regulations until January 1, 2003. Those Regulations would otherwise come into force on December 1, 1999. They are part of a comprehensive program for the control of firearms and other regulated weapons that is being phased in over a period of several years. The transitional period for the licensing of all firearms owners runs to January 1, 2001, and the period for the registration of all of their firearms runs to January 1, 2003.

Deferring the implementation of the Gun Shows Regulations until the end of both the licensing and registration phases will allow for a more orderly phasing-in of the various components of the program. In the interim, public safety will be protected by administrative monitoring and by the application of other relevant statutory and regulatory provisions. In particular, it should be noted that any sales or other transfers of firearms by either businesses or individuals, including those occurring during or as a result of gun shows, require an authorization from the chief firearms officer and the registration of the firearm to the new owner.

Alternatives

An amendment of the existing Regulations is the only means of deferring the implementation of the regulatory requirements.

Benefits and Costs

The deferral of the implementation of the Gun Shows Regulations will be highly beneficial to the organizers of these shows and to the exhibitors who participate in them. They will have more time to prepare for compliance with the new requirements, and, with the exhibitors all licensed and the firearms registered, the administrative impact of those requirements will be minimized. This will help to ensure an effective implementation of those Regulations.

Consultation

Consultations on these Regulations were undertaken with: provincial authorities, in particular the chief provincial and territorial firearms officers; federal departments involved in the implementation of the new law, in particular the Department of the Solicitor General — Royal Canadian Mounted Police, and Revenue Canada — Customs; representatives of police agencies and police associations; and the User Group on Firearms established by the Minister of Justice as an advisory body.

Prior to the making of the Regulations being amended, extensive consultations were undertaken with other concerned groups in addition to those enumerated above. These consultations included businesses, collectors, shooting clubs and other firearms groups involved in the organization of gun shows.

Compliance and Enforcement

The Regulations will result in a deferral in the implementation of certain Firearms Act Regulations, and no compliance mechanisms are therefore required.

Contact

Legal Counsel, Canadian Firearms Centre, Department of Justice, East Memorial Building, 284 Wellington Street, Ottawa, Ontario K1A 0H8, 1-800-731-4000 (Telephone), (613) 941-1991 (Facsimile).

PROPOSED REGULATORY TEXT

Notice is hereby given that the Governor in Council, pursuant to paragraph 117(g) of the Firearms Act (see footnote h), proposes to make the annexed Regulations Amending the Gun Shows Regulations.

All interested persons may, within 15 days after the date of publication of this notice, make representations concerning the proposed Regulations. All such representations should be addressed to Legal Counsel, Canadian Firearms Centre, Department of Justice, East Memorial Building, 284 Wellington Street, Ottawa (Ontario), K1A 0H8, 1-800-731-4000, (Telephone), (613) 941-1991 (Facsimile).

Ottawa, October 28, 1999

MARC O'SULLIVAN
Assistant Clerk of the Privy Council

REGULATIONS AMENDING THE GUN SHOWS REGULATIONS

AMENDMENT

1. Section 15(see footnote 9) of the Gun Shows Regulations(see footnote 10) is replaced by the following:

15. These Regulations come into force on January 1, 2003.

COMING INTO FORCE

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

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Regulations Amending the Order Declaring an Amnesty Period

Statutory Authority

Criminal Code

Sponsoring Department

Department of Justice

REGULATORY IMPACT ANALYSIS STATEMENT

Description

The Order being amended is part of the package of statutory and regulatory provisions implementing the new program for the control of firearms and other weapons. Bill C-68, now S.C., 1995, c. 39, comprised the Firearms Act and a completely amended Part III of the Criminal Code. It received Royal Assent on December 5, 1995. The Firearms Act and the supporting offence provisions in the Criminal Code establish a comprehensive program for licensing of individuals and businesses in possession of firearms, registration of all firearms, authorizations to transport and carry for restricted and prohibited firearms, and other mea-sures. This legislation, and the amnesty Order being amended, came into force on December 1, 1998.

The Order provided for an amnesty period to allow individuals and businesses to: (1) dispose lawfully, in the ways permitted by the Order, of those handguns that became prohibited when the new Part III of the Criminal Code came into force; (2) dispose lawfully of prohibited handgun barrels; and, (3) turn in or register unregistered restricted firearms. For more detailed information, see the description in the statement that accompanied the publication of the Order. The Order was registered as SOR/98-467, and was published in the Canada Gazette, Part II, Vol. 132, No. 20, at page 2734. The accompanying Regulatory Impact Analysis Statement begins at page 2737.

This amending Order will extend the amnesty period for prohibited handguns, prohibited handgun barrels and unregistered restricted firearms for a further 13 months, to January 1, 2001.

Alternatives

An amendment of the existing Order is the only means of extending the amnesty period. The amnesty Order being amended is necessary to provide the necessary immunity to individuals and businesses so that they can bring themselves into compliance with the law without incurring criminal liability.

Benefits and Costs

This amnesty program is intended to afford individuals and businesses in illegal possession of newly prohibited handguns and barrels, as well as unregistered restricted firearms, an opportunity to dispose of them safely and lawfully or, in appropriate cases involving unregistered restricted firearms, by registering them. The program began with the coming into force of the new and more comprehensive firearms control legislation. The first phase of implementation of that legislation runs to January 1, 2001, when everyone in possession of a firearm is required to have a licence. This universal licensing requirement is one of the primary features of the new legislative program. Extending the amnesty until January 1, 2001, will give the firearms owners affected the full transitional licensing period to take one of the actions provided for and bring themselves into compliance with the law. This will enhance overall compliance with the new firearms control program. The individuals and businesses affected will benefit directly, and there will also be a benefit to public safety that will result from the legalizing of these firearms and the overall furthering of the objectives of the legislation.

Consultation

Consultations on the regulatory package of which the Order being amended is a part were undertaken with: provincial authorities, in particular the chief firearms officers; federal departments involved in the implementation of the new law, in particular the Department of the Solicitor General, and including the Royal Canadian Mounted Police, and Revenue Canada — Customs; representatives of police agencies and police associations; technical experts; firearms instructors; groups concerned about firearms control; and, firearms user and industry groups, including the User Group on Firearms established by the Minister of Justice as an advisory body, firearms dealers, and individuals involved in all of the shooting sports. Consultations on the extension of the amnesty were conducted with the provincial and federal authorities responsible for the administration of the legislation.

Compliance and Enforcement

Only the grandfathered individual owners, as set out in subsections 12(6) and 12(7) of the Firearms Act, will be eligible for licences to possess prohibited handguns and they may only possess handguns also grandfathered by subsection 12(6). Only businesses with a prescribed purpose as set out in section 11 of the Act and section 22 of the Firearms Licences Regulations will be eligible for licences to possess prohibited handguns or prohibited handgun barrels. Only those individuals and businesses with the licence referred to in sections 7(b) and 8(b) of this Order will be eligible to register previously unregistered restricted firearms. Possession by an individual or a business of any of these items without a licence, and without a registration certificate in the case of prohibited handguns or restricted firearms, will be an offence contrary to sections 91, 92 and 94 of the Criminal Code.

Contact

Legal Counsel, Canadian Firearms Centre, Department of Justice, East Memorial Building, 284 Wellington Street, Ottawa, Ontario K1A 0H8, 1-800-731-4000 (Telephone), 613-941-1991 (Facsimile).

PROPOSED REGULATORY TEXT

Notice is hereby given that the Governor in Council, pursuant to section 117.14 of the Criminal Code, proposes to make the annexed Regulations Amending the Order Declaring an Amnesty Period.

All interested persons may, within 15 days after the date of publication of this notice, make representations concerning the proposed Regulations. All such representations should be addressed to Legal Counsel, Canadian Firearms Centre, Department of Justice, East Memorial Building, 284 Wellington Street, Ottawa (Ontario), K1A 0H8, 1-800-731-4000, (Telephone), (613) 941-1991 (Facsimile).

Ottawa, October 28, 1999

MARC O'SULLIVAN
Assistant Clerk of the Privy Council

REGULATIONS AMENDING THE ORDER DECLARING AN AMNESTY PERIOD

AMENDMENTS

1. The portion of section 2 of the Order Declaring an Amnesty Period(see footnote 11) before paragraph (a) is replaced by the following:

2. Any individual who, during the period beginning on December 1, 1998 and ending on December 31, 2000, is in possession of a prohibited handgun, other than a handgun referred to in subsection 12(6) of the Firearms Act, that was acquired and registered after February 14, 1995 and before December 1, 1998, cannot be found guilty of an offence under Part III of the Criminal Code by reason only of being in possession of that handgun while doing or prior to doing any of the following things:

2. The portion of section 3 of the Order before paragraph (a) is replaced by the following:

3. Any individual who is not an individual referred to in subsection 12(6) of the Firearms Act and who, during the period beginning on December 1, 1998 and ending on December 31, 2000, is in possession of a prohibited handgun referred to in that subsection that was acquired by the individual after February 14, 1995 and before December 1, 1998 and for which a registration certificate had been issued to or applied for by another individual under the former Act, cannot be found guilty of an offence under Part III of the Criminal Code by reason only of being in possession of that handgun while doing or prior to doing any of the following things:

3. The portion of section 4 of the Order before paragraph (a) is replaced by the following:

4. Any person who was the holder of a permit to carry on a business required under subsection 105(4) of the former Act and who, during the period beginning on December 1, 1998 and ending on December 31, 2000, is in possession of a prohibited handgun acquired on or before February 14, 1995 and reported to the Commissioner or to an authorized person under paragraph 105(1.1)(d) of the former Act, cannot be found guilty of an offence under Part III of the Criminal Code by reason only of being in possession of that handgun while doing or prior to doing any of the following things:

4. The portion of section 5 of the Order before paragraph (a) is replaced by the following:

5. Any person who was the holder of a permit to carry on a business required under subsection 105(4) of the former Act and who, during the period beginning on December 1, 1998 and ending on December 31, 2000, is in possession of a prohibited handgun acquired after February 14, 1995 and reported to the Commissioner or to an authorized person under paragraph 105(1.1)(d) of the former Act, cannot be found guilty of an offence under Part III of the Criminal Code by reason only of being in possession of that handgun while doing or prior to doing any of the following things:

5. The portion of section 6 of the Order before paragraph (a) is replaced by the following:

6. Any individual or business that, during the period beginning on December 1, 1998 and ending on December 31, 2000, is in possession of a handgun barrel referred to in paragraph (b) of the definition "prohibited device" in subsection 84(1) of the Criminal Code, cannot be found guilty of an offence under Part III of that Act by reason only of being in possession of that barrel while doing or prior to doing any of the following things:

6. The portion of section 7 of the Order before paragraph (a) is replaced by the following:

7. Any individual who, during the period beginning on December 1, 1998 and ending on December 31, 2000, is in possession of a restricted firearm for which no registration certificate was issued under subsection 109(7) of the former Act, cannot be found guilty of an offence under Part III of the Criminal Code by reason only of being in possession of that firearm while doing any of the following things:

7. The portion of section 8 of the Order before paragraph (a) is replaced by the following:

8. Any business that, during the period beginning on December 1, 1998 and ending on December 31, 2000, is in possession of a restricted firearm for which no registration certificate was issued under subsection 109(7) of the former Act, cannot be found guilty of an offence under Part III of the Criminal Code by reason only of being in possession of that firearm while doing any of the following things:

COMING INTO FORCE

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

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Footnote a

S.C. 1992, c. 1, s. 28

Footnote b

Not published

Footnote c

S.C. 1992, c. 1, s. 28

Footnote d

S.C. 1994, c. 14, s. 3

Footnote 1

SOR/96-309

Footnote 2

C.R.C., c. 413

Footnote e

S.C. 1991, c. 1, s. 12

Footnote 3

SOR/96-2

Footnote 4

SOR/93-54

Footnote f

S.C. 1994, c. 47, s. 117

Footnote 5

SOR/95-546

Footnote 6

C.R.C., c. 870

Footnote g

S.C. 1994, c. 47, s. 117

Footnote 7

SOR/97-407

Footnote 8

C.R.C., c. 870

Footnote h

S.C. 1995, c. 39

Footnote 9

SOR/99-111

Footnote 10

SOR/98-211

Footnote 11

SOR/98-467

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