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Proposed
Regulations
for
Pre-Publication in Part I, Canada Gazette
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Statutory
Authority
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Medical
Devices Regulations, amendment (Schedule 1088: Diagnostic
Products Related to Blood Screening)
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.
With new
Medical Devices Regulations in effect since July 1, the
amendment is no longer required.
- Contact: 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. E-mail:
julie_gervais@hc-sc.gc.ca
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Food and Drugs
Act
Published in
Canada Gazette October 10, 1998
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Food and Drug
Regulations, amendment (Schedule 733: Changes to Marketed
New Drugs)
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 the proposal
was to introduce in the 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
Regulations. However, with international standards rapidly
evolving, the proposed amendments are being withdrawn.
Instead,
the Therapeutic Products Programme will modify its Changes
to Marketed New Drug Products policy within the 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.
- Contact: 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. E-mail:
julie_gervais@hc-sc.gc.ca
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Food and Drugs
Act
Published in
Canada Gazette October 10, 1998
|
Radiocommunication Regulations, amendment
The
proposed amendments would broaden the eligibility
requirements for licensing earth stations in the fixed and
mobile satellite services, to meet Canada's General
Agreement on Trade in Services Agreement on Basic
Telecommunications (GATS-ABT) commitments.
The
existing regulations require that radiocommunication
carriers be Canadian owned and controlled in terms of voting
shares, board membership and control of the corporation.
A new
provision would be added to the Regulations such that
Canadian ownership and control provisions to complement
provisions under the Telecommunications Act.
The new
provision would remove the requirement for Canadian
ownership and control of licence holders for earth stations
in fixed satellite service (FSS) and mobile satellite
service (MSS) that provide telecommunications services by
means of satellites.
The new
section of the Regulations would allow a service provider
that is not Canadian owned and controlled to be eligible to
hold a radio licence as a radiocommunication carrier for
earth stations in the fixed satellite service and the mobile
satellite service.
The new
provision would exclude:
- services, i.e.
over-the-air television, radio, and cable television,
regulated under the Broadcasting Act and measures
affecting such services, and
- telecommunications
services supplied for the transmission of services, i.e.
direct-to-home and direct-broadcasting Satellite,
regulated under the Broadcasting Act where such services
are intended for direct reception by the public.
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Radiocommunication Act, section 6
Published in
Canada Gazette October 10, 1998
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In the
case of the exclusions, in each case, the applicable
Canadian ownership and control requirements made under the
Broadcasting Act, Telecommunication Act or
Radiocommunication Act still apply. This is consistent
Canada's GATS-ABT commitments.
- Contact: Ronald Amero,
Director, Space and International Regulatory Activity
Directorate, Radiocommunication and Broadcasting
Regulatory Branch, Industry Canada, 300 Slater Street,
Ottawa, Ontario, K1A 0C8. Tel: 613-998-3759; Fax:
613-952-9871; e-mail: Amero.Ron@ic.gc.ca.
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General
Nuclear Safety and Control Regulations; Radiation Protection
Regulations; Class I Nuclear Facilities Regulations; Class
II Nuclear Facilities and Prescribed Equipment Regulations;
Uranium Mines and Mills Regulations; Nuclear Substances and
Radiation Devices Regulations; Packaging and Transport
Regulations; Nuclear Security Regulations; and Nuclear
Non-proliferation Import and Export Control Regulations
The
proposed amendments would introduce the new regulatory
regime under the Nuclear Safety and Control Act (NSC Act),
which was passed on March 20, 1997. Once the new regulatory
regime is put in place, the new legislation would establish
the Canadian Nuclear Safety Commission (CNSC) and replace
the existing Atomic Energy Control Board (AECB). With the
exception of the ex officio position on the Board, the
members and staff of the AECB will become the members and
staff of the CNSC.
In order
to simplify the transition from the current regulatory
system to the new regulatory system under the NSC Act, the
AECB has minimized the number of substantive changes in the
new regulations.
For the
most part, the new regulations consist of the requirements
that currently exist in the Atomic Energy Control Act (AEC
Act) of 1946, regulations or licence conditions, but in a
format compatible with the new Act.
Some new
regulatory requirements have been added, as follows:
- under the General Nuclear
Safety and Control Regulations, a requirement to provide
information on financial guarantees has been added.
Licence applicants will be required to describe their
financial guarantees and their plans for decommissioning
at the end of the life of the nuclear facility.
- Under the Radiation
Protection Regulations, new dose limits and action levels
would be established as follows: for nuclear energy
workers, 100 mSv for five years (i.e., an average of 20
mSv/year); for pregnant nuclear energy workers, 4 mSv;
and for members of the public, 1 mSv/year.
- under the Class I Nuclear
Facilities Regulations, which specify the requirements
for major facilities, such as reactors, high energy
accelerators and uranium processing plants, a five-year
recertification period is being introduced. Under this
new regulation, nuclear reactor operators will need to
have continuing training and testing to the same standard
as demonstrated for initial certification. Compliance
verification will consist of monitoring the licensee's
program, rather than having recertification exams given
by the Commission.
- under the Class II
Nuclear Facilities and Prescribed Equipment Regulations,
which cover low energy accelerators, irradiators and
radiation therapy installations, a requirement for
servicing licences would be introduced.
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Nuclear Safety
and Control Act
Published in
Canada Gazette October 10, 1998
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- under the Uranium Mines
and Mills Regulations, certain licence conditions would
be added.
- under the Nuclear
Substances and Radiation Devices Regulations, servicing
licences would be added and exemption values called
"scheduled quantities" would be generally smaller based
upon current radiation protection knowledge and new dose
limits.
- under the Packaging and
Transport Regulations, the major change is the
requirement for carriers to have a radiation protection
training program.
- under the Nuclear
Security Regulations, three new security measures would
be required at reactor sites in order to bring them up to
international standards. For example, licensees will be
required to continuously maintain, and in some cases,
install additional surveillance equipment in order to
provide accurate and timely alarm assessment. As well, an
alarm assessment system would be required for inner areas
where sensitive nuclear material are stored; more
specifically, a surveillance system would be required in
the inner area to allow the immediate assessment of the
cause of an alarm. Finally, licensees would be required
to search, or otherwise monitor, every person and thing
entering and leaving the protected area; these searches
can be carried out by technical means and are similar to
the standard of security provided at Canadian
airports.
- under the Nuclear
Non-Proliferation Import and Export Control Regulations,
the number of items for which import licences are
required would be increased.
- Contact: Ross Brown,
Manager, New Act Implementation Group, Atomic Energy
Control Board, 280 Slater Street, P.O. Box 1046, Ottawa,
Ontario, K1P 5S9. Tel: 613-995-1357; Fax: 613-995-5086;
e-mail: brown.r@atomcon.gc.ca.
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Minority
Investment (Banks) Regulations, amendment; Minority
Investment (Cooperative Credit Associations) Regulations;
Minority Investment (Insurance Companies) Regulations;
Minority Investment (Trust and Loan Companies)
Regulations
The
amendments rectify an omission in earlier amendments, as
well as make few minor technical changes requested by the
Standing Joint Committee for the Scrutiny of
Regulations.
On July
28, 1997, the Government promulgated revised Minority
Investment Regulations, which enhanced the ability of
federally regulated financial institutions (FRFIs) to make
less than controlling investments in permitted entities. The
revised Regulations enhanced the ability of financial
institutions to form alliances, enter new markets, and
compete more effectively in Canada and abroad.
The
promulgation of Bill C-82, among other things, extended the
list of permitted entities to include multi-activity type
entities. However, the authority to make less than
controlling investments in multi-activity type entities was
omitted from the revised Minority Investment Regulations. As
a result, the Government is amending the July 28, 1997,
Minority Investment Regulations to rectify this
situation.
The
Regulations amending the Minority Investment Regulations
also include a few minor technical changes which were
requested by the Standing Joint Committee for the Scrutiny
of Regulations.
- Contact: Charles P.
Johnston, Regulations Officer, Legislation and Precedents
Division, Office of the Superintendent of Financial
Institutions, 255 Albert Street, Ottawa, Ontario, K1A
0H2. Tel: 613-990-7472; Fax: 613-998-6716.
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Bank Act,
section 474
Published in
Canada Gazette October 10, 1998
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Exempt
from Pre-Publication
and
Approved
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Statutory
Authority
|
Tobacco
Regulations, amendment (SOR/98-509,
OIC 1998-1804)
The
proposed amendments revise the schedules to the Regulations,
which list the brands of tobacco products and cigarettes
eligible for exemption from marking requirements, to respect
changes to sales and marketing practices relating to brands
and volumes, in the tobacco industry. Several products have
been removed from the lists, while only one tobacco product
has been added.
The
brands listed in the Schedule I (tobacco products) are:
Aspen, Bronco, Canadian, Canadian Natural, Dickens and
Grant, Doral, Dorchester, Excel, Gauloises Blondes, Gitanes,
Gold Coast, GPC Approved, Imperial Special Blend, Islands,
Kent, Lucky Strike, Magna, Marathon, Mercer, Mild Seven,
Monte Carlo, Montreal Blend, River, and Viceroy.
The
brands of cigarettes listed in Schedule III are: Canadian
Gold, Old Port, and Vantage.
The
amendment comes into effect on October 8, 1998.
- Contact: Bill Anderson,
Project Officer, Excise Duties & Taxes Directorate,
Vanier Towers, Tower C, 7th Floor, 25 McArthur Road,
Vanier, Ontario, K1A 0L5. Tel: 613-957-7593; Fax:
613-954-2226.
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Excise
Tax Act , sections 60, 127 and 202
To be
published in Canada Gazette October 28, 1998
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Retirement Compensation Arrangements Regulations, No. 1,
amendment (SOR/98-510,
OIC 1998-1810
The
amendments ensure transitional pension coverage for that
portion of an employee's benefits no longer allowed under a
registered pension plan under income tax rules.
The
amendments are the companion pieces to the provisions of the
Regulations Respecting Transitional Coverage in the Case of
Divestiture of Service made pursuant to the Public Service
Superannuation Act that provide for pension coverage under
the Act for a maximum period of one year following the
divestiture of a service.
These
Regulations come into force on October 1, 1998.
- Contact: Joan M. Arnold,
Director, Pensions Legislation Development Group,
Pensions Division, Treasury Board Secretariat, Ottawa,
Ontario, K1A OR5. Tel: 613-952-3119.
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Special
Retirement Arrangements Act, subsections 4(2) and 16(1) and
paragraph 28(1)(i)
To be
published in Canada Gazette October 28, 1998
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Order Amending
the Schedule to the Family Orders and Agreements Enforcement
Assistance Act (SOR/98-511,
OIC 1998-1813)
The
Schedule to the Family Orders and Agreements Enforcement
Assistance Act, which became effective on May 1, 1997, lists
the licences which are subject to the licence denial
provisions of Part III of the Act. This Order is a technical
update of the references in the list for aviation and marine
licences.
Currently the Schedule also includes passports but they are
not affected by this Order.
The
licence denial scheme is a tool to facilitate enforcement of
support orders by the provinces and territories. At the
request of a provincial or territorial enforcement agency,
the federal government will withhold, refuse to renew or
suspend specific licences issued to an individual who has
failed to meet support obligations for three payment periods
or has accumulated arrears of a least $3000. Licence denial
is a measure of last resort when other enforcement actions
by the provincial or territorial support service have not
succeeded.
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Family Orders
and Agreements Enforcement, section 63
To be
published in Canada Gazette October 28, 1998
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The
technical changes include:
- with respect to aviation
licences, an update of references to take into account
the changes to the licensing scheme which occurred as the
result of the coming into effect of the Canadian Aviation
Regulations, under the Aeronautics Act;
- the deletion of certain
marine and aviation licences which are no longer required
to be on the list;
- with respect to marine
certificates, proposed changes to the licensing regime to
ensure that licence denial action may be taken in respect
of licences that continue to be valid and that were
issued under regulations repealed by the Crewing
Regulations and the Marine Certification Regulations
under the Canada Shipping Act in 1997.
The
amendment comes into effect October 8, 1998.
- Contact: Ken Duford,
Director, Family Law Assistance Section, Department of
Justice, Ottawa, Ontario, K1A 0H5. Tel:
613-998-5670.
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