Canada Gazette, Part I, Volume 148, Number 11: GOVERNMENT NOTICES
March 15, 2014
DEPARTMENT OF HEALTH
DEPARTMENT OF HEALTH ACT
Notice of annual increase of Health Canada's Drug Master Files and Certificate of a Pharmaceutical Product fees
Notice is hereby given that the Minister of Health, under the Ministerial Authority to Enter into Contract, hereby updates the fees that are payable for the provision of Drug Master Files and Certificate of a Pharmaceutical Product services by 2%, beginning April 1, 2014. These fees will continue to be updated annually, with an automatic 2% increase to align with the Drug Program's regulatory user fees.
This change is effective beginning on April 1, 2014. The current fees and the fees updated as of April 1, 2014, are listed below.
Any inquiries or comments about the updated fees can be directed to Diana Dowthwaite, Director General, Resource Management and Operations Directorate, Health Products and Food Branch, 613-957-6690 (telephone), cri_irc_consultations@hc-sc.gc.ca (email).
Services | Fee as of April 1, 2013 | Fee as of April 1, 2014 |
---|---|---|
Certificate of Pharmaceutical Product (or a supplemental copy of a Certificate of Pharmaceutical Product) | $78 | $80 |
Drug Master Files |
$408 | $416 |
Drug Master Files — letter of access |
$184 | $188 |
Drug Master Files — biannual updates |
$184 | $188 |
March 2, 2014
[11-1-o]
DEPARTMENT OF HEALTH
FINANCIAL ADMINISTRATION ACT
Notice of annual increase of fees
Notice is hereby given, under section 19.2 of the Financial Administration Act, that in keeping with section 4 of the 2011 Fees in Respect of Drugs and Medical Devices Regulations, every fee outlined by the Regulations is to be increased annually by 2%, rounded up to the nearest dollar.
This change was effective beginning on November 6, 2013. The revised fees and the fees updated as of April 1, 2014, are listed below.
Any inquiries or comments about the updated fees can be directed to Diana Dowthwaite, Director General, Resource Management and Operations Directorate, Health Products and Food Branch, 613-957-6690 (telephone), cri_irc_consultations@hc-sc.gc.ca (email).
Fee Category | Section in Fees in Respect of Drugs and Medical Devices Regulations | Fee with Penalties as of November 6, 2013 | Fee as of April 1, 2014 |
---|---|---|---|
PART 2 — DRUGS Fees For Examination Services — Schedule 1 |
|||
New active substance | 6 | $322,056 | |
Clinical or non-clinical data and chemistry and manufacturing data | 6 | $163,120 | |
Clinical or non-clinical data only | 6 | $76,132 | |
Comparative studies | 6 | $46,016 | |
|
6 | $23,910 | $24,388 |
|
6 | $22,557 | $23,008 |
Chemistry and manufacturing data only | 6 | $21,756 | |
|
6 | $15,144 | $15,447 |
Published data only | 6 | $18,041 | |
Switch status from prescription drug to non-prescription drug | 6 | $43,808 | |
Labelling only | 6 | $2,931 | |
Administrative submission | 6 | $303 | |
Disinfectants | 6 | $4,055 | |
Drug identification number application — labelling standards | 6 | $1,625 | |
Remission | |||
Remission processing fee | 11(1)(a)(iii) | $532 | |
Establishment Licence Fees Fabrication of Drugs — Schedule 2 |
|||
Basic fee | 19(1), 27, 28(1)(a), 28(2)(a) | $16,397 | |
Each additional category | 19(1)(a) | $4,108 | |
Dosage form classes | |||
2 classes | 19(1)(b) | $8,204 | |
3 classes | 19(1)(b) | $16,397 | |
4 classes | 19(1)(b) | $20,505 | |
5 classes | 19(1)(b) | $24,600 | |
6 classes | 19(1)(b) | $28,696 | |
Each additional class | 19(1)(b) | $1,646 | |
Sterile dosage forms | 19(1)(c) | $8,204 | |
Packing/Labelling of Drugs — Schedule 3 | |||
Basic fee | 20(1), 20(3)(a), 28(1)(b), 28(2)(b) | $10,963 | |
Each additional category | 20(1)(a) | $2,739 | |
Dosage form classes | |||
2 classes | 20(1)(b) | $5,467 | |
3 or more classes | 20(1)(b) | $8,204 | |
Importation and Distribution of Drugs — Schedule 4 | |||
Basic fee | 21(a), 22, 28(1)(c) and (d), 28(2)(c) and (d) | $6,836 | |
Each additional category | 21(a)(i), 22(a) | $1,710 | |
Dosage form classes | |||
2 classes | 21(a)(ii), 22(b) | $3,419 | |
3 or more classes | 21(a)(ii), 22(b) | $6,836 | |
Each fabricator | 21(b)(i) | $1,646 | |
Each additional dosage form class for each fabricator | 21(b)(ii) | $829 | |
Distribution or Wholesaling | |||
Distribution or wholesaling fee | 23 | $4,108 | |
Testing | |||
Testing fee | 24 | $2,739 | |
Drug Analysis — Schedule 5 | |||
Vaccines (1) | 25 | $27,327 | |
Drugs, not included in items 1, 6 and 9 of this Schedule, that are listed in Schedule D to the Food and Drugs Act | 25 | $10,932 | |
Drugs for human use that are prescription drugs, controlled drugs or narcotics | 25 | $8,204 | |
Drugs for human use, not included in any other item, for which a drug identification number has been assigned | 25 | $4,108 | |
Radiopharmaceuticals | 25 | $0 | |
PART 2 — DRUGS — Continued Establishment Licence Fees — Continued Drug Analysis — Schedule 5 — Continued |
|||
Whole blood and its components (6) | 25 | $0 | |
Hemodialysis products | 25 | $0 | |
Drugs that are labelled as disinfectants, including those listed in paragraph 9(f) of this Schedule, but excluding other drugs labelled as disinfectants of medical devices | 25 | $0 | |
Drugs that meet the requirements of a class monograph having one of the following titles (9) | |||
Acne therapies | 25 | $0 | |
Antidandruff products | 25 | $0 | |
Antiperspirants | 25 | $0 | |
Antiseptic skin cleaners | 25 | $0 | |
Athlete's foot treatments | 25 | $0 | |
Contact lens disinfectants 9(f) | 25 | $0 | |
Fluoride-containing anti-caries products | 25 | $0 | |
Medicated skin care products | 25 | $0 | |
Sunburn protectants | 25 | $0 | |
Throat lozenges | 25 | $0 | |
Fees for the Examination of Dealer's Licence Applications Dealer's Licence |
|||
Dealer's licence | 31(1) | $4,788 | |
Fees for Right to Sell Drugs | |||
Annual fee | 35(1) | $1,084 | |
PART 3 — MEDICAL DEVICE FEES Fees for the Examination of Medical Device Licence Applications Class II Medical Devices |
|||
Class II — Licence application | 39(1) | $373 | |
Class III Medical Devices — Schedule 6 | |||
Licence application | 40(1)(a), 41(a) | $5,361 | |
Licence application for near patient in vitro diagnostic device | 40(1)(a), 41(a) | $9,127 | |
Change referred to in paragraph 34(a) of the Medical Devices Regulations that relates to manufacturing | 40(1)(a), 41(a) | $1,349 | |
Any other change referred to in paragraph 34(a) or (b) of the Medical Devices Regulations | 40(1)(a), 41(a) | $5,021 | |
Class IV Medical Devices — Schedule 7 | |||
Licence application | 40(1)(b), 41(b) | $12,470 | |
Licence application for devices that contain human or animal tissue | 40(1)(b), 41(b) | $11,633 | |
Licence application for near patient in vitro diagnostic device | 40(1)(b), 41(b) | $21,257 | |
Change referred to in paragraph 34(a) of the Medical Devices Regulations that relates to manufacturing | 40(1)(b), 41(b) | $1,349 | |
Any other change referred to in paragraph 34(a) or (b) of the Medical Devices Regulations | 40(1)(b), 41(b) | $5,721 | |
Remission | |||
Remission processing fee | 44(1)(a)(iii) | $55 | |
Fee for Right to Sell Licensed Class II, III or IV Medical Devices | |||
Fee (if annual gross revenue of medical device sales is less than $20,000) | 48(1)(a) | $55 | |
Fee (in any other case) | 48(1)(b) | $351 | |
Fees for the Examination of an Application for an Establishment Licence | |||
Medical devices establishment licence | 51(1) | $7,641 |
March 2, 2014
[11-1-o]
DEPARTMENT OF INDIAN AFFAIRS AND NORTHERN DEVELOPMENT
CANADA PETROLEUM RESOURCES ACT
Results of the 2013-2014 Call for Bids for Exploration Licences in the Beaufort Sea and Mackenzie Delta
The Minister of Indian Affairs and Northern Development hereby gives notice pursuant to subsection 15(2) and section 19 of the Canada Petroleum Resources Act, R.S. 1985, c. 36, 2nd supplement, of the bid which was selected in response to the 2013-2014 Call for Bids for Exploration Licences in the Beaufort Sea and Mackenzie Delta. Once the winning bidder submits the issuance fee and work deposit, representing 25% of the work proposal bid, the winning bidder will be eligible to receive an exploration licence.
A summary of the terms and conditions applicable to the call was published in Part I of the Canada Gazette on October 19, 2013. The call closed at noon (MST) on February 25, 2014.
In accordance with the requirements set out in the 2013-2014 Call for Bids for Exploration Licences in the Beaufort Sea and Mackenzie Delta, the following bid has been selected:
Work proposal bid: | $1,000,000 |
---|---|
Work deposit: | $ 250,000 |
Issuance fee: | $ 750 |
Bidder: | Franklin Petroleum Canada Limited — 100% |
Designated representative: | Franklin Petroleum Canada Limited |
March 15, 2014
BERNARD VALCOURT, P.C., M.P.
Minister of Indian Affairs and Northern Development
[11-1-o]
DEPARTMENT OF INDIAN AFFAIRS AND NORTHERN DEVELOPMENT
NORTHWEST TERRITORIES AND NUNAVUT MINING REGULATIONS
Prospecting permits
Number | Location (N.T.S.) | Permittee |
---|---|---|
8416 | 025O07NW/025O07N.-O. | Peregrine Diamonds Ltd. |
8417 | 025O07SW/025O07S.-O. | Peregrine Diamonds Ltd. |
8418 | 025P07SE/025P07S.-E. | Peregrine Diamonds Ltd. |
8419 | 048A02NW/048A02N.-O. | MMG Resources Inc. |
8420 | 048A02NE/048A02N.-E. | MMG Resources Inc. |
8421 | 048A02SE/048A02S.-E. | MMG Resources Inc. |
8422 | 048A06SE/048A06S.-E. | MMG Resources Inc. |
8423 | 048A07SW/048A07S.-O. | MMG Resources Inc. |
8424 | 065I06NW/065I06N.-O. | Canadian North Resources and Development Corporation |
8425 | 065I16NW/065I16N.-O. | Canadian North Resources and Development Corporation |
8426 | 065I05NW/065I05N.-O. | Canadian North Resources and Development Corporation |
8427 | 065I05SE/065I05S.-E. | Canadian North Resources and Development Corporation |
8428 | 065I15NE/065I15N.-E. | Canadian North Resources and Development Corporation |
Number | Location (N.T.S.) | Permittee |
---|---|---|
7783 | 057D05NE/057D05N.-E. | Diamonds North Resources Ltd. |
7784 | 057S05NW/057S05N.-O. | Diamonds North Resources Ltd. |
7785 | 057D05SE/057D05S.-E. | Diamonds North Resources Ltd. |
7786 | 057D11SE/057D11S.-E. | Diamonds North Resources Ltd. |
7882 | 058G06SE/058G06S.-E. | David Dupre |
7910 | 047B09SW/047B09S.-O. | Advanced Explorations Inc. |
7928 | 039E13SW/039E13S.-O. | Mark Raguz |
7932 | 048E06NE/048E06N.-E. | Mark Raguz |
7933 | 048E07NW/048E07N.-O. | Mark Raguz |
7934 | 048E10NE/048E10N.-E. | Mark Raguz |
7936 | 048E10SE/048E10S.-E. | Mark Raguz |
7937 | 048E10SW/048E10S.-O. | Mark Raguz |
7938 | 048E11NE/048E11N.-E. | Mark Raguz |
7940 | 048E11SE/048E11S.-E. | Mark Raguz |
7941 | 048E11SW/048E11S.-O. | Mark Raguz |
7942 | 048H01NE/048H01N.-E. | Mark Raguz |
7945 | 058G06NE/058G06N.-E. | Mark Raguz |
7946 | 058H07NW/058H07N.-O. | Mark Raguz |
8104 | 046B10NE/046B10N.-E. | Vale Inco Ltd. |
8105 | 046B10SE/046B10S.-E. | Vale Inco Ltd. |
8184 | 056D02NE/056D02N.-E. | Reginald Olson |
8185 | 056D02SE/056D02S.-E. | Reginald Olson |
8187 | 056E06SW/056E06S.-O. | Reginald Olson |
8189 | 058C02NW/058C02N.-O. | David Dupre |
8191 | 058C06NE/058C06N.-E. | David Dupre |
8192 | 057C06SE/057C06S.-E. | David Dupre |
8193 | 058C07NW/058C07N.-O. | David Dupre |
8194 | 058C07SW/058C07S.-O. | David Dupre |
8241 | 049G12NE/049G12N.-E. | Jordon Saulnier |
8242 | 049G13SW/049G13S.-O. | Jordon Saulnier |
8243 | 059F14NE/059F14N.-E. | Jordon Saulnier |
8244 | 059G01NE/059G01N.-E. | Michel Saulnier |
8245 | 059G01NW/059G01N.-O. | Michel Saulnier |
8246 | 059G08NE/059G08N.-E. | Michel Saulnier |
8247 | 059G08SE/059G08S.-E. | Michel Saulnier |
8248 | 059G08SW/059G08S.-O. | Michel Saulnier |
8249 | 059H02NW/059H02N.-O. | Michel Saulnier |
8250 | 059H03NE/059H03N.-E. | Michel Saulnier |
8251 | 059H03NW/059H03N.-O. | Michel Saulnier |
8252 | 059H03SE/059H03S.-E. | Michel Saulnier |
8253 | 059H03SW/059H03S.-O. | Michel Saulnier |
8254 | 059H04NE/059H04N.-E. | Michel Saulnier |
8255 | 059H04NW/059H04N.-O. | Michel Saulnier |
8256 | 059H05NE/059H05N.-E. | Michel Saulnier |
8257 | 059H05NW/059H05N.-O. | Michel Saulnier |
8258 | 059H05SE/059H05S.-E. | Michel Saulnier |
8259 | 059H05SW/059H05S.-O. | Michel Saulnier |
8260 | 059H06NE/059H06N.-E. | Michel Saulnier |
8261 | 059H06NW/059H06N.-O. | Michel Saulnier |
8262 | 059H06SE/059H06S.-E. | Michel Saulnier |
8263 | 059H06SW/059H06S.-O. | Michel Saulnier |
8264 | 069E10NW/069E10N.-O. | Michel Saulnier |
8266 | 069E10SW/069E10S.-O. | Michel Saulnier |
8269 | 069F09SW/069F09S.-O. | Michel Saulnier |
8270 | 069F10NE/069F10N.-E. | Karen Saulnier |
8272 | 069F13SE/069F13S.-E. | Taina Saulnier |
8273 | 069F13SW/069F13S.-O. | Michel Saulnier |
8274 | 069F14NE/069F14N.-E. | Taina Saulnier |
8275 | 069F14NW/069F14N.-O. | Taina Saulnier |
8276 | 069F15NE/069F15N.-E. | Michel Saulnier |
8277 | 069F15NW/069F15N.-O. | Taina Saulnier |
8278 | 069G02SE/069G02S.-E. | Taina Saulnier |
8279 | 069G02SW/069G02S.-O. | Taina Saulnier |
8280 | 069G03NW/069G03N.-O. | Taina Saulnier |
8281 | 069G03SE/069G03S.-E. | Taina Saulnier |
8282 | 069G03SW/069G03S.-O. | Taina Saulnier |
8283 | 079E16NE/079E16N.-E. | Taina Saulnier |
8284 | 079E16SE/079E16S.-E. | Taina Saulnier |
8308 | 076L06SE/076L06S.-E. | MMG Resources Inc. |
8309 | 076L09NW/076L09N.-O. | MMG Resources Inc. |
8310 | 076L09SW/076L09S.-O. | MMG Resources Inc. |
8311 | 076L10SE/076L10S.-E. | MMG Resources Inc. |
8312 | 076L13NW/076L13N.-O. | MMG Resources Inc. |
8313 | 076L13SE/076L13S.-E. | MMG Resources Inc. |
8314 | 076L13SW/076L13S.-O. | MMG Resources Inc. |
8317 | 086I16NE/086I16N.-E. | MMG Resources Inc. |
8318 | 086I16SE/086I16S.-E. | MMG Resources Inc. |
8319 | 086P01NE/086P01N.-E. | MMG Resources Inc. |
8320 | 086P01SE/086P01S.-E. | MMG Resources Inc. |
8337 | 058C02SW/058C02S.-O. | Coltstar Ventures Inc. |
8338 | 058C03NE/058C03N.-E. | Coltstar Ventures Inc. |
8339 | 058C03SE/058C03S.-E. | Coltstar Ventures Inc. |
8356 | 076L16SE/076L16S.-E. | MMG Resources Inc. |
8357 | 076L16SW/076L16S.-O. | MMG Resources Inc. |
8358 | 076M14SE/076M14S.-E. | MMG Resources Inc. |
8359 | 076M04SW/076M04S.-O. | MMG Resources Inc. |
8360 | 076M04SE/076M04S.-E. | MMG Resources Inc. |
8361 | 076M05NE/076M05N.-E. | MMG Resources Inc. |
8362 | 076M05SE/076M05S.-E. | MMG Resources Inc. |
8363 | 076M05SW/076M05S.-O. | MMG Resources Inc. |
8382 | 076F06NW/076F06N.-O. | Stewart Blusson |
8383 | 076F06SW/076F06S.-O. | Stewart Blusson |
8384 | 076F05NW/076F05N.-O. | Stewart Blusson |
8385 | 076F05NE/076F05N.-E. | Stewart Blusson |
8386 | 076F12NW/076F12N.-O. | Stewart Blusson |
8387 | 076F12SW/076F12S.-O. | Stewart Blusson |
8388 | 076F12SE/076F12S.-E. | Stewart Blusson |
8389 | 076F12NE/076F12N.-E. | Stewart Blusson |
8390 | 076F11NW/076F11N.-O. | Stewart Blusson |
8391 | 076F11SW/076F11S.-O. | Stewart Blusson |
8392 | 076F14SW/076F14S.-O. | Stewart Blusson |
8393 | 076F13NW/076F13N.-O. | Stewart Blusson |
8394 | 076F13SW/076F13S.-O. | Stewart Blusson |
8395 | 076F13SE/076F13S.-E. | Stewart Blusson |
8396 | 076E08NE/076E08N.-E. | Stewart Blusson |
3. For information on expired prospecting permits, please contact the Nunavut Mining Recorder's Office at 867-975-4275 (telephone) or 867-975-4286 (fax).
JEFF MERCER
Supervising Mining Recorder
Nunavut
[11-1-o]
DEPARTMENT OF INDUSTRY
RADIOCOMMUNICATION ACT
Notice No. SMSE-007-14 — Decision to rescind Broadcasting Procedures and Rules Part 5 (BPR-5) and Broadcasting Procedures and Rules Part 6 (BPR-6)
Notice is hereby given that the following Broadcasting Procedures and Rules are being withdrawn and are no longer in force, effective immediately:
- Broadcasting Procedures and Rules Part 5 (BPR-5): Application Procedures and Rules for Digital Radio Broadcasting (DRB) Undertakings
BPR-5 provided application procedures and rules for DRB in the band 1452-1492 MHz, known as the L-band. In 2012, the Allotment Plan for Digital Radio Broadcasting (DRB) was rescinded through policy decision SP 1435 MHz, and other radio applications have been identified for the usage of this band.
- Broadcasting Procedures and Rules Part 6 (BPR-6): Application Procedures and Rules for Multipoint Distribution Television Broadcasting Undertakings (MDS-TV)
BPR-6 provided application procedures and rules for MDS-TV services in the band 2596-2686 MHz. This band was transitioned to Broadband Radio Service (BRS) following the implementation of policy decision DGTP-002-06.
General information
In making the decision to rescind the above-mentioned documents, the Department consulted with industry through the Radio Advisory Board of Canada (RABC).
Obtaining copies
Copies of this notice and of documents referred to herein are available electronically on Industry Canada's Spectrum Management and Telecommunications Web site at www.ic.gc.ca/spectrum.
Official versions of Canada Gazette notices can be viewed at www.gazette.gc.ca/rp-pr/p1/index-eng.html. Printed copies of the Canada Gazette can be ordered by telephoning the sales counter of Publishing and Depository Services at 613-941-5995 or 1-800-635-7943.
February 27, 2014
MARC DUPUIS
Director General
Engineering, Planning and Standards Branch
[11-1-o]
BANK OF CANADA
Statement of financial position as at December 31, 2013
ASSETS | Amount | Total |
---|---|---|
Cash and foreign deposits | 5.0 | |
Loans and receivables | ||
Securities purchased under resale agreements | 2,205.9 | |
Advances to members of the Canadian Payments Association | — | |
Advances to governments | — | |
Other receivables | 9.0 | |
2,214.9 | ||
Investments | ||
Treasury bills of Canada | 21,586.4 | |
Government of Canada bonds | 66,653.6 | |
Other investments | 337.1 | |
88,577.1 | ||
Property and equipment | 232.4 | |
Intangible assets | 52.2 | |
Other assets | 224.1 | |
Total assets | 91,305.7 |
LIABILITIES AND EQUITY | Amount | Total |
---|---|---|
Bank notes in circulation | 66,615.9 | |
Deposits | ||
Government of Canada | 22,329.9 | |
Members of the Canadian Payments Association | 186.7 | |
Other deposits | 1,306.9 | |
23,823.5 | ||
Liabilities in foreign currencies | ||
Government of Canada | — | |
Other | — | |
— | ||
Other liabilities | ||
Securities sold under repurchase agreements | — | |
Other liabilities | 431.1 | |
431.1 | ||
90,870.5 | ||
Equity | ||
Share capital | 5.0 | |
Statutory and special reserves | 125.0 | |
Available-for-sale reserve | 305.2 | |
Actuarial gains reserve | — | |
Retained earnings | — | |
435.2 | ||
Total Liabilities and Equity | 91,305.7 |
I declare that the foregoing return is correct according to the books of the Bank.
Ottawa, February 13, 2014
S. Vokey
Chief Accountant and Chief Financial Officer
I declare that the foregoing return is to the best of my knowledge and belief correct, and shows truly and clearly the financial position of the Bank, as required by section 29 of the Bank of Canada Act.
Ottawa, February 13, 2014
Tiff Macklem
Senior Deputy Governor
[11-1-o]
BANK OF CANADA
Statement of financial position as at January 31, 2014
ASSETS | Amount | Total |
---|---|---|
Cash and foreign deposits | 6.2 | |
Loans and receivables | ||
Securities purchased under resale agreements | — | |
Advances to members of the Canadian Payments Association | — | |
Advances to governments | — | |
Other receivables | 8.6 | |
8.6 | ||
Investments | ||
Treasury bills of Canada | 20,438.2 | |
Government of Canada bonds | 68,668.6 | |
Other investments | 346.7 | |
89,453.5 | ||
Property and equipment | 231.8 | |
Intangible assets | 51.3 | |
Other assets | 245.3 | |
Total assets | 89,996.7 |
LIABILITIES AND EQUITY | Amount | Total |
---|---|---|
Bank notes in circulation | 63,734.8 | |
Deposits | ||
Government of Canada | 23,846.2 | |
Members of the Canadian Payments Association | 207.2 | |
Other deposits | 1,238.7 | |
25,292.1 | ||
Liabilities in foreign currencies | ||
Government of Canada | — | |
Other | — | |
— | ||
Other liabilities | ||
Securities sold under repurchase agreements | — | |
Other liabilities | 524.1 | |
524.1 | ||
89,551.0 | ||
Equity | ||
Share capital | 5.0 | |
Statutory and special reserves | 125.0 | |
Available-for-sale reserve | 315.7 | |
Actuarial gains reserve | — | |
Retained earnings | — | |
445.7 | ||
Total Liabilities and Equity | 89,996.7 |
I declare that the foregoing return is correct according to the books of the Bank.
Ottawa, February 19, 2014
S. Vokey
Chief Accountant and Chief Financial Officer
I declare that the foregoing return is to the best of my knowledge and belief correct, and shows truly and clearly the financial position of the Bank, as required by section 29 of the Bank of Canada Act.
Ottawa, February 19, 2014
Stephen S. Poloz
Governor
[11-1-o]