Vol. 132, No. 41 — October 10, 1998
Therapeutic Products Programme — Regulations Amending the Food and Drug Regulations (Schedule 733: Changes to Marketed New Drugs) — Notice of Withdrawal
The Therapeutic Products Programme (TPP) of Health Canada is withdrawing a regulatory proposal (Schedule 733) to amend the Food and Drug Regulations. The intent of this proposal was to introduce in the Food and Drug Regulations a graduated system of regulatory requirements for changes to new drugs marketed in Canada. This proposal was prepublished in the Canada Gazette, Part I, on March 1, 1997.
The Therapeutic Products Programme has developed and refined over the past few years a policy entitled "Changes to Marketed New Drug Products". The amendments proposed in Schedule 733 would have incorporated this policy into the Food and Drug Regulations. However, international standards are rapidly evolving. The result is difficulty in drafting a regulation that is current with international standards yet flexible enough to adapt to a rapidly changing international regulatory environment. This led the Therapeutic Products Programme to withdraw the proposed amendments.
Instead, the Therapeutic Products Programme will modify its Changes to Marketed New Drug Products policy within our current regulatory authority. The revisions will reflect comments received from stakeholders including those received following the publication of the proposal in the Canada Gazette, Part I, on March 1, 1997. The revised policy will be available on the TPP Web site. The Therapeutic Products Programme will undertake meaningful and effective consultations with clients and other affected parties on future changes to the policy. The TPP will continue to consider the international standards in this area such as the United States Scale-up and Post-Approval Changes (SUPAC) guidances adopted by the Food and Drug Administration.
Enquiries may be directed to Julie Gervais, Regulatory Associate, Policy Division, Bureau of Policy and Coordination, Therapeutic Products Programme, Health Protection Building, Address Locator 0702B1, Tunney's Pasture, Ottawa, Ontario K1A 0L2, julie_gervais@hc-sc.gc.ca (Electronic mail).
September 25, 1998
DANN M. MICHOLS
Director General
Therapeutic Products Programme
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Therapeutic Products Programme — Regulations Amending the Medical Devices Regulations (Schedule 1088: Diagnostic Products Related to Blood Screening) — Notice of Withdrawal
The Therapeutic Products Programme of Health Canada is withdrawing a proposal (Schedule 1088) to amend the old Medical Devices Regulations. The intent of this amendment was to subject the following products to the requirements of Part V of the old Medical Devices Regulations:
— blood grouping reagents, including red blood cell (A and B), kits and automated analysers;
— tissue typing (HLA) reagents, kits and automated analysers; and
— kits for the detection of infection by: cytomegalovirus (CMV), Epstein Barr virus (EBV), hepatitis B viruses (HBV), hepatitis C viruses (HCV), human T-lymphotropic viruses (HTLV) and Treponema pallidum.
Part V of the old Medical Devices Regulations contained provisions requiring manufacturers to submit evidence of safety and effectiveness prior to advertising or selling the products in Canada.
New Medical Devices Regulations became effective on July 1, 1998. Therefore, this amendment is no longer required. Under the new Regulations, high risk medical devices (including the products listed above) are subject to a premarket review of their safety and effectiveness.
Enquiries may be directed to Julie Gervais, Regulatory Associate, Policy Division, Bureau of Policy and Coordination, Therapeutic Products Programme, Health Protection Building, Address Locator 0702B1, Tunney's Pasture, Ottawa, Ontario K1A 0L2, julie_gervais@hc-sc.gc.ca (Electronic mail).
September 25, 1998
DANN M. MICHOLS
Director General
Therapeutic Products Programme
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DEPARTMENT OF HUMAN RESOURCES DEVELOPMENT ACT
Change in Rate of Canada Pension Plan and Old Age Security Data Banks Search Fee
The Minister of Human Resources Development, pursuant to section 8 of the Department of Human Resources Development Act, Chapter 11 of the Statutes of Canada, 1996, hereby repeals the Canada Pension Plan and Old Age Security Data Banks Search Fee published in the Canada Gazette, Part I, on September 21, 1996, and makes the annexed Canada Pension Plan and Old Age Security Data Banks Search Fee Order.
APPLICATION
1. This fee applies to any person or organization that makes a request referred to in section 2 to the Department of Human Resources Development, other than
(a) a charitable organization; and
(b) a person who makes a request for non-commercial purposes.
FEE
2. The fee is payable for a request to conduct a search in the Canada Pension Plan and Old Age Security data banks at the time the request is made and is as follows:
(a) $10 per search when the number of searches in a single request is equal to or less than 300; or
(b) $8 per search when the number of searches in a single request is greater than 300 but does not exceed 1 000.
COMING INTO FORCE
3. This Order comes into force on October 15, 1998.
September 29, 1998
PIERRE S. PETTIGREW
Minister of Human
Resources Development
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RADIOCOMMUNICATION ACT
Notice No. DGTP-014-98 — Proposed Amendment to the Policy Framework for the Provision of Mobile Satellite Services
Introduction
The purpose of this notice is to solicit public comments on proposed revisions to the eligibility of service providers to offer services under the existing Mobile Satellite Policy Framework.
Background
In February 1998, Industry Canada amended the Policy Framework through Canada Gazette Notice No. DGTP-001-98 to implement Canada's commitment in the World Trade Organization (WTO) agreement on basic telecommunications services. This amendment removed the requirement that a Canadian provider of mobile satellite services hold equity participation in the satellite system.
Proposal
In the WTO agreement on basic telecommunications services, Canada has specified a schedule for liberalizing its national and international satellite services market whereby foreign satellite systems may be used to provide services to Canadians. Accordingly, under provisions of Bill C-17, An Act to Amend the Telecommunications Act and the Teleglobe Canada Reorganization and Divestiture Act, amendments have been made to the Telecommunications Act which exempt satellite earth stations from the Canadian ownership and control provisions of section 16 of the Act. These legislative changes require consequential changes to the Radiocommunication Regulations and satellite service licensing policies.
In the proposed amendments to the Radiocommunication Regulations, published in the Canada Gazette, Part I, on October 10, 1998, it is proposed that any service provider using domestic or foreign mobile satellite capacity but owning or operating its mobile earth stations (customer terminals) and gateways or feeder link earth stations may be authorized if the entity is eligible to hold a radio station licence as defined below:
"10.1 (3) Notwithstanding sections 9 and 10, the following persons, who operate an earth station in the mobile satellite service, are eligible to be issued, in respect of that earth station, a radio licence as a radiocommunication user, as a radiocommunication service provider other than a radiocommunication carrier, or a radiocommunication carrier:
(a) an individual who is
(i) a citizen within the meaning of subsection 2(1) of the Citizenship Act,
(ii) a permanent resident within the meaning of subsection 2(1) of the Immigration Act, or
(iii) a non-resident who has been issued an employment authorization under the Immigration Act;
(b) a corporation that is incorporated or continued under the laws of Canada or a province;
(c) a partnership or joint venture where each partner or co-venturer is eligible to be issued a radio licence under this subsection; and
(d) a Canadian government, whether federal, provincial or local, or an agency thereof."
Industry Canada is of the view that the liberalization of the licensing regime for earth stations of the mobile satellite service should not lag that for fixed satellite service. Further, there may be no compelling reason to require that mobile satellite service providers who provide the earth stations communicating with a foreign or domestic mobile satellite space station be Canadian owned and controlled.
Therefore Industry Canada proposes to amend the first criterion of Section 2 of the present Mobile Satellite Policy Framework as follows:
"the applicant (service provider) must be eligible to be issued a radio licence or a spectrum licence under the Radiocommunication Act;"
Invitation to Comment
Industry Canada invites interested parties to provide their views and comments as described below.
Submissions should be addressed to the Director General, Telecommunications Policy Branch, Industry Canada, 300 Slater Street, Ottawa, Ontario K1A 0C8, and must be received within 30 days after publication of this notice to receive full consideration. All representations should cite the Canada Gazette, Part I, notice publication date, title, and the notice reference number.
All submissions received in response to this notice will be made available for viewing by the public two weeks after the closing date of this notice, during normal business hours, at the Industry Canada Library, 235 Queen Street, West Tower, 3rd Floor, Ottawa and at the offices of Industry Canada in Moncton, Montréal, Toronto, Winnipeg and Vancouver, for a period of one year from the close of the comment period.
Respondents are strongly encouraged to provide their comments in electronic format (WordPerfect, Microsoft Word, Adobe PDF or ASCII TXT) to facilitate posting on the Department's Web site. Documents submitted via electronic media should be sent with a note specifying the software, version number and operating system used. All submissions should cite Canada Gazette notice reference number DGTP-014-98.
This Canada Gazette notice is available electronically via the Internet at the following address:
World Wide Web (WWW)
http://strategis.ic.gc.ca/spectrum
October 2, 1998
MICHAEL HELM
Director General
Telecommunications Policy
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CRIMINAL CODE
Pursuant to subsection 667(5) of the Criminal Code, I hereby designate the following persons as Fingerprint Examiners:
Trevor Crocker
Allan Palmer
Michael Stewart
of the Vancouver Police Department
September 8, 1998
JEAN T. FOURNIER
Deputy Solicitor General of Canada
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CRIMINAL CODE
Pursuant to subsection 667(5) of the Criminal Code, I hereby designate the following persons as Fingerprint Examiners:
Ian John Ronnie
of the Royal Canadian Mounted Police
Kevin F. Bennett
Joseph F. Ferrar
Glen MacLeod
of the Saint John Police Force
and revoke the designations of:
Frederick Morton
Robert Ryan
Janet Holt
of the Saint John Police Force
September 1, 1998
JEAN T. FOURNIER
Deputy Solicitor General of Canada
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CRIMINAL CODE
Pursuant to subsection 667(5) of the Criminal Code, I hereby designate the following person as a Fingerprint Examiner:
Allan Morrison
of the Metropolitan Toronto Police Force
and revoke the designation of:
Mark Thorpe
of the Metropolitan Toronto Police Force
September 10, 1998
JEAN T. FOURNIER
Deputy Solicitor General of Canada
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COMERICA BANK - CANADA
Notice is hereby given that, pursuant to subsection 48(1) of the Bank Act, an order to commence and carry on business was issued on September 22, 1998, approving the commencement and carrying on of business by Comerica Bank - Canada.
September 29, 1998
JOHN PALMER
Superintendent of Financial Institutions
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SWISS BANK CORPORATION (CANADA)
UNION BANK OF SWITZERLAND (CANADA)
Notice is hereby given of the issuance,
— pursuant to subsection 229(1) of the Bank Act, of letters patent amalgamating and continuing Swiss Bank Corporation (Canada) and Union Bank of Switzerland (Canada), as one bank under the name UBS Bank (Canada) and in French, Banque UBS (Canada), effective June 29, 1998; and
— pursuant to subsection 48(1) of the Bank Act, of an order to commence and carry on business approving the commencement and carrying on of business by the amalgamated bank, effective June 29, 1998.
September 29, 1998
JOHN PALMER
Superintendent of Financial Institutions
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TAX COURT OF CANADA ACT
Rules Amending the Tax Court of Canada Rules of Procedure respecting the Canada Pension Plan
Notice is hereby given, pursuant to subsection 22(3) (see footnote a) of the Tax Court of Canada Act, that the Rules Committee of the Tax Court of Canada, pursuant to section 20 (see footnote b) of that Act and subject to the approval of the Governor in Council, proposes to make the annexed Rules Amending the Tax Court of Canada Rules of Procedure respecting the Canada Pension Plan. The proposed Rules arise primarily out of the Income Tax Amendments Act, 1997, Statutes of Canada, 1998, c. 19, and, in particular, certain amendments to the Tax Court of Canada Act contained in that Act.
Any interested person may make representations in writing with respect to the proposed Rules within 60 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 Rules Committee, Tax Court of Canada, 200 Kent Street, 2nd Floor, Ottawa, Ontario K1A 0M1.
RULES AMENDING THE TAX COURT OF CANADA RULES OF PROCEDURE RESPECTING THE CANADA PENSION PLAN
1. Subsections 5(3) to (5) of the Tax Court of Canada Rules of Procedure respecting the Canada Pension Plan (see footnote 1) are replaced by the following:
(3) An appeal referred to in subsection (1) shall be made in writing and shall set out, in general terms, the reasons for the appeal and the relevant facts, but no special form of pleadings is required.
How Appeal Instituted
(4) An appeal shall be instituted by filing the original of the written appeal referred to in subsection (3) in the Registry.
(5) The written appeal referred to in subsection (3) shall be filed
(a) by depositing the original of the written appeal in the Registry;
(b) by mailing the original of the written appeal to the Registry; or
(c) by sending a copy of the written appeal by fax or electronic mail to the Registry.
Filing Date
(6) The date of filing of a written appeal in the Registry is deemed to be the day on which the written appeal is received by the Registry.
Electronic Filing
(7) Where a written appeal is filed in accordance with paragraph (5)(c), the party who instituted the proceeding or that party's counsel or agent shall forthwith send the original of the written appeal to the Registry.
Form of Appeal
(8) An appeal may be brought by a notice in the form set out in Schedule 5.
2. Schedule 5 to the Rules is replaced by the following:
SCHEDULE 5
(Section 5)
FORM OF NOTICE OF APPEAL
IN THE TAX COURT OF CANADA
In re the Canada Pension Plan
BETWEEN:
Appellant,
and
The Minister of National Revenue,
Respondent.
NOTICE OF APPEAL
| Notice of appeal | ||
|---|---|---|
| Notice of appeal is hereby given by (here insert name and full postal address of Appellant) .................................................. from |
||
| Applies to a ruling on request under par. 26.1(1) (d) or (e) C.P.P. | (i) | the ruling regarding a contribution, made by the Respondent on a request made to the Respondent on the (here insert the date the request for a ruling was made to the Respondent) ........... day of .............. to rule whether (here describe question ruled on by Respondent) which the Respondent ruled (here describe ruling made) and that ruling was communicated to the Appellant on the (here insert the date of mailing of the ruling) ............... day of |
| Applies to a decision made under s. 27.3 C.P.P. |
(ii) | the decision on a question, regarding a contribution, made by the Respondent on the Respondent's own initiative, namely, whether (here describe question determined by Respondent) which the Respondent decided by stating that (here describe decision made) and that decision was communicated to the Appellant on the (here insert the date of mailing of the decision) ....................................................day of |
| Applies to a decision on appeal under s. 27.1 C.P.P. |
(iii) | the decision of the Respondent on an appeal to the Respondent for the reconsideration of an assessment made on the (here insert the date of the appeal for reconsideration of the assessment) ......... day of whereby (here describe assessment that was appealed for reconsideration) and the decision of the Respondent on the reconsideration was that (here insert the decision made on the reconsideration of the assessment) which decision was communicated to the Appellant on the (here insert the date of mailing of the decision) day of |
A. Statement of Facts
(Here set out in consecutively numbered paragraphs a statement of the allegations of fact.)
B. The Reasons which the Appellant Intends to Submit
(Here set out the reasons on which the Appellant intends to rely.)
C. Address for Service
(Here set out the address for service of documents: (*)
(a) name and address of Appellant's counsel, if any; or
(b) name and address of Appellant's agent, if any.)
Dated at (city, town or village), this ............. day of (year) Signature of Appellant, Appellant's counsel or Appellant's agent
———
(*) If the Appellant is not represented by counsel or an agent, the address given at the commencement of the notice of appeal shall be the Appellant's address for service.
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R.S., 1985, c. 51 (4th Supp.), s. 7
S.C., 1996, c. 23, s. 184
SOR/90-689
NOTICE:
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