User Fees Reporting

User Fees

1- Health Products and Foods Branch (HPFB)

User Fee: Authority to Sell Drugs Fees

Fee Type: Regulatory (R)

Fee-setting Authority: Financial Administration Act (FAA)

Date Last Modified: Dec.1994

Performance Standards: 120 calendar days to update the Drug Product Database following notification

Performance Results: 98% within 120 calendar days


($ thousands)
2009-10 Planning Years
Forecast Revenue Actual Revenue Full Cost Fiscal Year Forecast Revenue Estimated Full Cost
$8,035 $7,644 $41,727 2010-11 $7,700 $42,895
2011-12 $7,916 $44,096
2012-13 $8,137 $45,331


User Fee: Certificates of Pharmaceutical Product (Drug Export) Fees

Fee Type: Other (O)

Fee-setting Authority: Ministerial authority to enter into contract

Date Last Modified: May 2000

Performance Standards: 5 working days to issue certificate

Performance Results: 25% within 5 working days


($ thousands)
2009-10 Planning Years
Forecast Revenue Actual Revenue Full Cost Fiscal Year Forecast Revenue Estimated Full Cost
$105 $107 $1,604 2010-11 $110 $1,649
2011-12 $113 $1,695
2012-13 $116 $1,742


User Fee: Drug Establishment Licensing Fees

Fee Type: R

Fee-setting Authority: FAA

Date Last Modified: Dec. 1997

Performance Standards: 250 calendar days to issue / renew licence

Performance Results: 92% within 250 calendar days


($ thousands)
2009-10 Planning Years
Forecast Revenue Actual Revenue Full Cost Fiscal Year Forecast Revenue Estimated Full Cost
$6,014 $5,866 $17,448 2010-11 $6,000 $17,936
2011-12 $6,168 $18,438
2012-13 $6,341 $18,955


User Fee: Drug Master File Fees

Fee Type: O

Fee-setting Authority: Ministerial authority to enter into contract

Date Last Modified: Jan. 1996

Performance Standards: 30 calendar days

Performance Results: 100% within 30 calendar days


($ thousands)
2009-10 Planning Years
Forecast Revenue Actual Revenue Full Cost Fiscal Year Forecast Revenue Estimated Full Cost
$130 $162 $659 2010-11 $170 $677
2011-12 $175 $696
2012-13 $180 $716


User Fee: Drug Submission Evaluation Fees (Pharmaceuticals & Biologic Products)

Fee Type: R

Fee-setting Authority: FAA

Date Last Modified: Aug. 1995

Performance Standards: Review time to first decision (calendar days)
Review 1 (average time in calendar days)

Pharmaceuticals
NDS: Priority NAS = 180
NDS: NAS = 300
NDS: Clin only = 300
NDS: Clin/C&M = 300
NDS: Priority Clin/C&M = 180
NDS: Labelling only = 60
ANDS: C&M/Labelling = 180
ANDS: Comp/C&M = 180
SNDS: Clin/C&M = 300
SNDS: Clin only = 300
SNDS: Comp/C&M = 180
SNDS: C&M/Labelling = 180
SNDS: Rx to OTC New INDIC = 300
SNDS: Rx to OTC No New Indication =180
SNDS: Labelling only = 60
SNDS-C: Clin only =300
SANDS: Comp/C&M = 180
SANDS: C&M/Labelling = 180
SANDS: Labelling only = 60
DIN A with data = 210
DIN A form only = 180
DIN D with data = 210
DIN D form only = 180

Biologics
NDS: Priority NAS = 180
NDS: NAS = 300
NDS: Clin/C&M = 300
ANDS: Comp/C&M = 180
SNDS: Priority Clin only = 180
SNDS: Clin/C&M = 300
SNDS: Clin only = 300
SNDS: Comp/C&M = 180
SNDS: C&M/Labelling = 180
SNDS: Labelling only = 60
SNDS: NOC-C Clin only = 200
DIN B with data = 210

DIN B form only = 180

Performance Results: Average review time to first decision
Review 1 (average time in calendar days)

Pharmaceuticals
NDS: Priority NAS = 246
NDS: NAS = 323
NDS: Clin only = 314
NDS: Clin/C&M = 311
NDS: Priority Clin/C&M = 180
NDS: Labelling only = 60
ANDS: C&M/Labelling = 203
ANDS: Comp/C&M = 255
SNDS: Clin/C&M = 280
SNDS: Clin only = 250
SNDS: Comp/C&M = 231
SNDS: C&M/Labelling = 184
SNDS: Rx to OTC New INDIC = 300
SNDS: Rx to OTC No New Indication =149
SNDS: Labelling only = 56
SNDS-C: Clin only = 260
SANDS: Comp/C&M = 262
SANDS: C&M/Labelling = 205
SANDS: Labelling only = 48
DIN A with data = 458
DIN A form only = 177
DIN D with data = 188
DIN D form only = 182

Biologics
NDS: Priority NAS = 229
NDS: NAS = 291
NDS: Clin/C&M = 327
ANDS: Comp/C&M = 180
SNDS: Priority Clin only = 194
SNDS: Clin/C&M = 300
SNDS: Clin only = 271
SNDS: Comp/C&M = 152
SNDS: C&M/Labelling = 164
SNDS: Labelling only = 60
SNDS: NOC-C Clin only = 198
DIN B with data = 82
DIN B form only = 123


($ thousands)
2009-10 Planning Years
Forecast Revenue Actual Revenue Full Cost Fiscal Year Forecast Revenue Estimated Full Cost
$21,000 $23,046 $83,200 2010-11 $23,000 $85,530
2011-12 $23,644 $87,924
2012-13 $24,306 $90,386


User Fee: Medical Device Licence Application Fees

Fee Type: R

Fee-setting Authority: FAA

Date Last Modified: Aug.1998

Performance Standards: Review time to first decision (calendar days)
Review 1 (average time in calendar days)
Class II = 15
Class II amendment = 15
Class II Private Label = 15
Class II Private Label amendment = 15
Class III = 60
Class III amendment = 60
Class IV = 75
Class IV amendment = 75

Performance Results: Average review time to first decision
Review 1 (average time in calendar days)
Class II = 11
Class II amendment = 11
Class II Private Label = 12
Class II Private Label amendment = 10
Class III = 86
Class III amendment = 82
Class IV = 114
Class IV amendment = 71


($ thousands)
2009-10 Planning Years
Forecast Revenue Actual Revenue Full Cost Fiscal Year Forecast Revenue Estimated Full Cost
$3,500 $3,721 $12,894 2010-11 $3,800 $13,255
2011-12 $3,906 $13,626
2012-13 $4,016 $14,007


User Fee: Fees for Right to Sell a Licensed Medical Device

Fee Type: R

Fee-setting Authority: FAA

Date Last Modified: Aug. 1998

Performance Standards: 20 calendar days from deadline for receipt of annual notification to update the Medical Devices Active License Listing (MDALL) database

Performance Results: 100% within 20 calendar days


($ thousands)
2009-10 Planning Years
Forecast Revenue Actual Revenue Full Cost Fiscal Year Forecast Revenue Estimated Full Cost
$1,800 $2,262 $8,080 2010-11 $1,800 $8,306
2011-12 $1,850 $8,539
2012-13 $1,902 $8,778


User Fee: Medical Device Establishment Licensing Fees

Fee Type: R

Fee-setting Authority: FAA

Date Last Modified: Jan 2000

Performance Standards: 120 calendar days to issue / renew licence

Performance Results: 99% issued within 120 days


($ thousands)
2009-10 Planning Years
Forecast Revenue Actual Revenue Full Cost Fiscal Year Forecast Revenue Estimated Full Cost
$2,700 $3,319 $8,081 2010-11 $3,000 $8,307
2011-12 $3,084 $8,540
2012-13 $3,170 $8,779


User Fee: Veterinary Drug Evaluation Fees

Fee Type: R

Fee-setting Authority: FAA

Date Last Modified: Mar. 1996

Performance Standards: Review time to first decision (calendar days)
NDS (including Priority Review) = 300
ABNDS = 300
SNDS = 240
SABNDS = 240
Admin = 90
DIN (including changes to DINs) = 120
NC = 90
ESC = 60
Labels = 45
Emergency Drug Release = 2

Performance Results: Average review time to first decision
NDS (including Priority Review) = 351
ABNDS = 246
SNDS = 233
SABNDS = 189
Admin = 87
DIN (including changes to DINs)= 127
NC = 108
ESC = 49
Labels = 54
Emergency Drug Release = 100% within 2 days


($ thousands)
2009-10 Planning Years
Forecast Revenue Actual Revenue Full Cost Fiscal Year Forecast Revenue Estimated Full Cost
$900 $644 $11,572 2010-11 $650 $11,896
2011-12 $670 $12,230
2012-13 $690 $12,572



($ thousands)
  2009-10 Planning Years
Forecast Revenue Actual Revenue Full Cost Fiscal Year Forecast Revenue Estimated Full Cost
Sub-Total (R) $43,949 $46,502 $183,001 2010-11 $45,950 $188,125
2011-12 $47,238 $193,393
2012-13 $48,562 $198,808
Sub-Total (O) $235 $269 $2,263 2010-11 $280 $2,326
2011-12 $288 $2,391
2012-13 $296 $2,458
Total $44,184 $46,771 $185,264 2010-11 $46,230 $190,451
2011-12 $47,526 $195,784
2012-13 $48,858 $201,266

B. Date Last Modified:

C. Other Information:

Acronyms

NDS: New Drug Submission

SNDS: Supplemental New Drug Submission

ANDS/ABNDS: Abbreviated New Drug Submission

SANDS/SABNDS: Supplemental Abbreviated New Drug Submission

DIN: Drug Identification Number Application

INDS: Investigational New Drug Submission

ESC: Experimental Studies Certificate

NC: Notifiable Change

NAS: New Active Substance

OTC: Over the Counter

Rx: Prescription

Clin: Clinical

Comp: Comparative Bio, Clinical or Pharmacodynamic

C&M: Chemistry and Manufacturing

NOC-C: Notice of Compliance with Conditions

Detailed performance targets
Human drugs: http://hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/mgmt-gest/mands_gespd_e.html

Medical Devices: http://hc-sc.gc.ca/dhp-mps/md-im/applic-demande/pol/mdlapp_demhim_pol_e.html

Veterinary drugs: http://www.hc-sc.gc.ca/dhp-mps/vet/applic-demande/index-eng.php

Detailed performance information: http://hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/docs/perform-rendement/index_e.html

Forecast and actual revenue are reported on a modified cash accounting basis.
Costing information was developed using the Program Activity Architecture coding structure as directed through Treasury Board.

The projected revenues have been adjusted down from the previous reporting year to reflect the projected revenues anticipated under the current fee regime. However, In April 2010, Health Canada's Proposal to update current user fees for regulatory activities related to human drugs and medical devices was tabled in Parliament, as required by the User Fees Act. The Senate Standing Committee on Social Affairs, Science and Technology undertook the review of the proposal, and recommended to the Senate that the proposal be approved with no changes. On May 26, 2010, the Senate adopted the report of its Committee, thereby concluding the Parliamentary review of Health Canada's Proposal. As fees are set in regulations, changes to existing regulations will be published in the Canada Gazette prior to the implementation of the new fees. The Department will continue to keep stakeholders informed of its progress.

As outlined in Health Canada's Proposal, the CPP fee and service standard will be reviewed separately.

Revised fees and service standards related to veterinary drug product activities are under development, but no specific proposals have been presented to stakeholders.


2- Pest Management Regulatory Agency (PMRA)

User Fee: Fees to be paid for Pest Control Product Application Examination Service

Fee Type: Regulatory (R)

Fee-setting Authority: Pest Control Products Act (PCPA)

Date Last Modified: April 1997

Performance Standards: Target is 90% of submissions in all categories to be processed within time shown.
http://www.pmra-arla.gc.ca/english/pdf/pro/pro9601-e.pdf

Category A
Standard - 550 days User Request Minor Use Registration (URMUR) - 365 days

Category B
Standard/priority - 365 days

Category C
Standard - 180 or 225 days

Category D
IMEP - 32 days OUI - 56 days URMULE - 60 days and Master Copy - 21 days

Category E
New Active - Food - 365 days New Active - Non-food - 165 days

Performance Results:

Category A = 74% overall while 80% of joint reviews were completed with established international standards.

Category B = 45% overall for the fiscal year, but 90% for submissions processed since January 1, 2010.

Category C = 84%

Category D = 80%

Category E = 13%


($ thousands)
2009-10 Planning Years
Forecast Revenue Actual Revenue Full Cost Fiscal Year Forecast Revenue Estimated Full Cost
$3,490 $4,541 $35,369 2010-11 $3,490 $30,990
2011-12 $3,490 $31,330
2012-13 $3,490 $29,114



User Fee: Fees to be paid for the right or privilege to manufacture or sell a pest control product in Canada and for establishing a Maximum Residue Limit in relation to a pest control product.

Fee Type: R

Fee-setting Authority: Financial Administration Act (FAA)

Date Last Modified: April 1997

Performance Standards: 100% of all fees for the right or privilege to manufacture or sell a pest control product in Canada are invoiced by April 30th of each fiscal year.

Performance Results: 100% of all invoices were issued by April 30, 2009.


($ thousands)
2009-10 Planning Years
Forecast Revenue Actual Revenue Full Cost Fiscal Year Forecast Revenue Estimated Full Cost
$4,500 $3,258 $25,377 2010-11 $4,500 $40,590
2011-12 $4,500 $40,320
2012-13 $4,500 $38,588




($ thousands)
2009-10 Planning Years
Forecast Revenue Actual Revenue Full Cost Fiscal Year Forecast Revenue Estimated Full Cost
Sub-Total (R) $7,990 $7,799 $60,746 2010-11 $7,990 $71,580
2011-12 $7,990 $71,620
2012-13 $7,990 $67,702
Sub-Total (O) 2010-11
2011-12
2012-13
Total $7,990 $7,799 $60,746 2010-11 $7,990 $71,580
2011-12 $7,990 $71,620
2012-13 $7,990 $67,702

3- Corporate Services Branch

User Fee: Fees charged for the processing of access requests filed under the Access to Information Act (ATIA)

Fee Type: Other products and services (O)

Fee-setting Authority: Access to Information Act

Date Last Modified: 1992

Performance Standards: Response provided within 30 days following receipt of request; response time may be extended pursuant to section 9 of the ATIA. ATIA: http://laws.justice.gc.ca/en/A-1/218072.html

Performance Results: During fiscal year 2009-2010, Health Canada completed processing 1504 (74.3%) of 2025 active requests.

Health Canada was able to respond within 30 days or less in 569 (38%) of completed cases. The remaining requests were completed within 31 to 60 days in 230 (15%) cases, 61 to 120 days in 219 (15%) cases and 121 or more days in 486 (32%) cases.


($ thousands)
2009-10 Planning Years
Forecast Revenue Actual Revenue Full Cost Fiscal Year Forecast Revenue Estimated Full Cost
$10 $18.6 $1,800 2010-11 $10 $1,800
2011-12 $10 $1,800
2012-13 $10 $1,800




($ thousands)
2009-10 Planning Years
Forecast Revenue Actual Revenue Full Cost Fiscal Year Forecast Revenue Estimated Full Cost
Sub-Total (R)       2010-11    
2011-12    
2012-13    
Sub-Total (O) 10 18.6 1,800 2010-11 10 1,800
2011-12 10 1,800
2012-13 10 1,800
Total 10 18.6 1,800 2010-11 10 1,800
2011-12 10 1,800
2012-13 10 1,800

B. Date Last Modified:

C. Other Information:

Projection based on actual revenue received during FY .Due to the nature and varying complexity of ATI requests, it is unknown what fees may be applicable until a request is processed. Under certain circumstances, fees may be waived.

Estimated direct cost associated with ATI requests.

User Fees Totals

Please note that according to prevailing legal opinion, where the corresponding fee introduction or most recent modification occurred prior to March 31, 2004:

  • the performance standard, if provided, may not have received parliamentary review; and

  • the performance standard, if provided, may not respect all establishment requirements under the UFA (e.g. international comparison; independent complaint address).

  • the performance result, if provided, is not legally subject to section 5.1 of the UFA regarding fee reductions for unachieved performance.

User Fees Totals
($ thousands)
2009-10 Planning Years
Forecast Revenue Actual Revenue Full Cost Fiscal Year Forecast Revenue Estimated Full Cost
Sub-Total (R) 51,939 54,301 243,747 2010-11 53,940 259,705
2011-12 55,228 265,013
2012-13 56,552 266,510
Sub-Total (O) 245 287.6 4,063 2010-11 290 4,126
2011-12 298 4,191
2012-13 306 4,258
Total 52,184 54,588.6 247,810 2010-11 54,230 263,831
2011-12 55,526 269,204
2012-13 56,858 270,768

External Fees

1- Healthy Environments and Consumer Safety Branch (HECSB)
External Fee Service Standard Performance Results Stakeholder Consultation
* National Dosimetry Services Product, Services and Fee Structure (NDS P, S&F) Provide timely, responsive and reliable customer services to 95,000 workers in over 12,500 groups: Provided timely, responsive and reliable customer services to over 95,000 workers in 12,500 groups. The standards were met as follows: NDS received approval for an increase in their client fees. The revised products, such as the new dosimeter products, Services and Fee schedule took effect on April 1, 2010.

NDS administered a client satisfaction questionnaire on the fee increase to 31 client groups of various group classifications and wearing frequencies (hospitals, dentists, veterinarians)

Based on feedback, about 90% of clients see the increase as reasonable, Over 90% of clients did not foresee a significant impact on their organization and 100% of clients did not foresee a change to their dosimetry requirements as a result of the increase.

NDS staff continued to be in daily contact with clients via phone, fax and e-mail. More than 53,000 requests were handled related to the client's product and service requirements.

These interactions allowed NDS to measure level of service satisfaction as well as insight into new requirements for products and services. The total number of complaints was 183, compared to 105 last year.

Client feedback (both complimentary and critical) was addressed as required. Additional information on service was obtained during regular contact with the client and, as required, through exit questionnaires.

On a basis of over 500,000 dosimeter readings in 2009-2010, NDS' satisfaction rate is more than 99.5% based on the ratio of complaints to results reported, which is comparable to last year.
i) Registration and inspections of incoming dosimeters within 48 hours i) > 99% Registration & inspection of incoming dosimeters within 48 hours
ii) Exposures over regulatory limits reported within 24 hours ii) 100% Exposures over regulatory limits reported within 24 hours
iii) Dosimeters leave NDS premises 10-13 working days prior to exchange date iii)> 99% Dosimeters leave NDS premises 10-13 working days prior to exchange date
iv) Message call backs (phone, e-mail) within 24 hours iv) > 95 % Message call backs done within 24 hours. 87% of incoming calls answered immediately.
v) Updated account information within 48 hours v) > 90 % Account information updated within 48 hours
vi) Additional request dosimeters shipped within 24 hours vi) > 99% Additional request dosimeters shipped within 24 hours
vii) Exposure Reports for regular service sent out within 10 days of dosimeter receipt vii) 97% Exposure Reports sent out within 10 days of dosimeter receipt
* Ship Sanitation Certificate Services

(Formerly known as Deratting Services)
Health Canada provides 7-day service in Standard Rate (Designated) Ports and all requests are responded to within 48 hours.
See Note 1 below.
646 Ship Sanitation Certificate Inspections were conducted in 2009-2010, out of which 511 were conducted at Standard Rate Ports. All requests were responded to within 48 hours. There were no changes to the service standards in 2009-2010. A new ship Sanitation Certificate program (replacing Deratting Certificate program) was implemented in 2007 in order to meet requirements of the World Health Organization International Health Regulations (2005). Prior to implementing an amended fee schedule for this program in 2008, impacted ship owners were consulted. No concerns were raised by stakeholders. The amended fees were published in Canada Gazette Part 1, in July 2008.
Cruise Ship Inspection Program Periodic inspection done a minimum of once a sailing season on ships in Canadian waters. Final reports submitted within 10 working days.
Re-inspection on any ships with scores of less than 85%.
See Note 2
78 Cruise Ship Inspections were conducted in 2009-2010.
All final reports were submitted within 10 working days.
2 Cruise Ships did not achieve the 85%.
Unable to re-inspect 1 of the 2 ships as it left Canadian waters immediately after initial inspection.
Minor changes were made to the Cruise Ship Administrative Guide, and were communicated to the Cruise Ship Industry. No concerns were raised by stakeholders. No changes were made to the fee schedule.

Due to efforts required for the Vancouver 2010 Winter Olympics, the Annual Industry Meeting with our partners was not held. In lieu of the meetings, industry received a summary report on our activities in 2009.
* Common Carrier Inspection (e.g. trains, ferries, airports/airlines, seaports) See Note 3 below. See Note 4 for reporting of Services Standards for Conveyance Inspection Programs. Conducted a review exercise of existing policy and guideline documents for Flight Kitchens, On Board and Off Board Passenger Train, Passenger Ferry Food and Sanitation Inspections and Potable Water Inspections, as well as the Cruise Ship Administrative Guide. Draft documents were shared with the industry stakeholders, and meetings were held with individual operators to discuss changes.

Given that the Environmental Health Bureau, Travelling Public Program of Health Canada played a vital role in food surveillance and emergency preparedness and response during the Vancouver 2010 Winter Olympics, we were unable to host our Annual Industry Meeting with our partners as we have done in past years. In lieu of the meetings, we presented each industry with a summary report on our activities in 2009.

Note 1: Service Standards for Ship Sanitation Certificate Services

Day of the Week Prior Notification Required
Weekday Service 24 hours
Weekend Service 48 hours
Regular Weekend Service For service on Saturday, notice must be received Thursday by 1300 hours local time.
For service on Sunday, notice must be received Friday by 1300 hours local time.
Holiday Weekend Service When Friday is the statutory holiday
- for service on Friday, notice must be received Wednesday by 1300 hours local time;
- for service on Saturday or Sunday, notice must be received Thursday by 1300 hours local time.

When Monday is the statutory holiday
- for service on Saturday, notice must be received Thursday by 1300 hours local time;
- for service on Sunday or Monday, notice must be received Friday by 1300 hours local time.

NOTE: The fee for short notice service i.e. less than 24 hours for week days, less than 48 hours for weekends, at both Standard Rate and Non-Standard Rate ports, will be the normal fee plus a 25% surcharge (ie. $937.50).

Note 2: Health Canada publishes scores obtained from the Cruise Ship Inspection Program at: http://www.hc-sc.gc.ca/hl-vs/travel-voyage/general/ship-navire-eng.php

Note 3: In regards to service standards, Cruise Ship and Common Carrier Inspections are performed following procedures and protocols that have been published and distributed to clients. Health Canada's protocols are consistent with programs in other countries. Copies of the inspection protocols for these programs may be requested by e-mail at: PHB_BSP@hc-sc.gc.ca

Note 4: Service Standards for Conveyance Inspection Program

Conveyance Inspection Program Service Standard Performance Result
* Passenger Train - On Board Periodic inspection done on each passenger train line as determined by MOU between Health Canada and passenger train industry.
Final inspection report provided to industry within 10 working days.
31 On-Board Passenger Train inspections were conducted in 2009-2010.
17 were announced inspections, 14 were unannounced. 30 out of 31 (97%) of final inspections reports were submitted within 10 working days of the inspection.
* Passenger Train - Off Board Sanitation inspection done twice a year.
Final report provided to industry within 10 working days
10 Off-Board Passenger Train inspections were conducted in 2009-2010.
1 announced and 1 unannounced inspection was conducted at each Employee Service Centre (ESC). All final reports (100%) were submitted within 10 working days of the inspection.
* Flight Kitchen Scheduled number of announced audits per year is based on the number of meals prepared by the kitchen.
Final audit inspection report provided within 10 working days of inspection.
22 Flight Kitchen audits were conducted in 2009-2010.
20 out of 22 (91%) final audit/inspection reports were submitted within 10 working days of the inspection.
* Ferry - On Board Food Unannounced inspections as per predetermined contractual obligations.
Final inspection report provided within 10 working days of inspection.
98 Food and Sanitation inspections were conducted on passenger ferries in 2009-2010.
88 out of 98 (90%) of final inspection reports were submitted within 10 working days of the inspection.
* Ferry - Potable Water Unannounced inspections as per predetermined contractual obligations.
100% of reports provided within 10 working days.
68 Potable Water inspections were conducted on passenger ferries in 2009-2010.
56 of 68 (82%) of final inspection reports were submitted within 10 working days of the inspection.

Note 5: In response to H1N1, HECSB worked closely with PHAC, the US - CDC Vessel Sanitation Program and the cruise line industry to develop advice particular to the cruise ships. HECSB in particular took the lead on the development and distribution of a cleaning and disinfection guide for cruise ships. HECSB also has a 1-800 number that the cruise lines can contact in the event they need advice and guidance.

HECSB has been participating in the development of the PHAC guidance to the cruise ship industry "Interim Guidance: Prevention and management of cases of influenza-like-illness (ILI) that may be due to pandemic (H1N1) 2009 influenza virus on cruise ships" available at http://www.phac-aspc.gc.ca/alert-alerte/h1n1/hp-ps/cs-pc-eng.php as well as the World Health Organization - "Interim WHO Technical advice for case management of pandemic (H1N1) 2009 on ships". In addition, HECSB, because of their experience with cruise ship inspections and outbreak investigations, has been facilitating the liaison with the cruise ship industry.

External Fee Service Standard Performance Result Stakeholder Consultation
* Medical Marihuana
Dried marihuana ($5.00 / gram)
Dried marihuana
Health Canada provides tested dried marihuana lots prior to distribution to authorized persons.
Dried marihuana
Test result requirements were met for all 14 lots distributed. Quality control test results are posted on Health Canada website.

The number of pouches distributed was 15,153. The number of returned pouches was 235. Return rate due to product non-satisfaction was 0.67%
Marihuana Medical Access Division (MMAD) and Medical Marihuana Production Division (MMPD) staff engages with clients on a daily basis through Canada Enquiries Centre. Over the fiscal year 2009-2010, the Marihuana Medical Access Program received 37,910 calls. These interactions with the Program's clients allowed MMAD and MMPD to assess the level of client satisfaction. These interactions are documented using a centralized electronic database.


There were no changes to the service standards in 2009-2010.
Cannabis seeds ($20.00 / packet of 30 seeds) Cannabis seeds
Health Canada provides tested marihuana seed lots prior to distribution to authorized persons.
Cannabis seeds
Test result requirements were met for the two (2) lots distributed in the fiscal year.

The number of seed packets distributed was 708.The number of returned seed packets was 9. Return rate was 1.3% (note that the return rate for seeds may not necessarily be due to non-satisfaction).
  Processing time
Health Canada processing time for orders is 14 working days (from the time the order is received to the delivery of shipment to the recipient).
Processing time was below service standard of 14 working days for all shipment orders of dried marihuana (total 5,469 shipment orders) and Cannabis seeds (total 411 shipment orders)

Other Information: N/A

2- Regions and Programs Branch (RAPB)
External Fee Service Standard Performance Result Stakeholder Consultation
*Employee Assistance Services (EAS)

(Fees are charged through contractual or formally-based agreements between HC and other departments, agencies and federally-regulated organizations.)

Services provided for fees includes:
-Employee Assistance Programs (EAP)
-Specialized Organizational Services (SOS)

n.b. The fees are not external but internal to federal government departments and agencies who transfer funds to HC in exchange for the services listed above. The fees are aligned with the overall costs of delivering the services including oversight, quality management, outsourcing, invoicing processing, financial and business processes, auditing of files, training of staff, in accordance to accreditation standards, and departmental support as well as accommodation costs. EAS aims at being 100% cost recovery.

No individual client or Canadian is being charged for these services.
As per formal agreement, varies depending on customer organization's requirements, needs and EAS capacity to meet service levels. As per results from customer surveys, client satisfaction surveys, Bell telephone reports, and data collected from affiliate mental health professionals, EAS is meeting all of the service standards outlined in the contractual agreements. i) Customers:
Federal departments and agencies comprise the majority of EAS' customer base, and they are consulted informally on a regular basis by account managers responsible for establishing strong customer relations, and by formal means including newsletters, bulletins, utilization reports, annual program plans, and quality assurance survey (every 2 years). Customers that are not Federal departments include a handful of government regulated organizations such as municipalities, school boards, etc.)

ii) Clients:
EAS is the largest provider of Employee Assistance Programs to the public sector. Client satisfaction is one of the most key indicators of service quality. For each service delivered, clients are informed that their feedback regarding service quality is valuable and appreciated. Current results of the Client Satisfaction Survey demonstrate that 98.5% of clients would use the service again if they were in need of support.

iii) Affiliates:
EAS' network of more than 750 affiliates ensures that EAS has the capacity to offer services across Canada within industry-standard timeframes. This network covers Canada from coast to coast, it forms an invaluable source of feedback regarding service provision with respect to the client base at large. A formal survey of the network is completed every 2 years. EAS' performance and quality improvement is responsive to the feedback collected, and addresses issues. For example, counsellors can submit requests for extensions via phone, fax or email as a result of this survey, and EAS' desire to accommodate the varying needs of affiliates.

iv) Legislating/Regulating Bodies:
As a government entity, many of EAS practices and procedures regarding finance, human resources and operational management are prescribed by specific policies, regulations and/or laws. As such, EAS is accountable to these rules and must, at regular intervals, report on: the usage of funds; adherence to key legislation, such as Official Languages, Financial Administration Act, and Privacy Act.

v) Staff:
Retention of knowledgeable and experienced staff has become a recognized problem in much of the federal public service. EAS, however, has consistently demonstrated a significantly higher level of staff retention when compared with the department as a whole.

EAS's open door policy regarding staff concerns and suggestions, commencing in September of 2009, on an annual basis, EAS will canvas all staff [including managers and supervisors] for their input regarding:
  • overall satisfaction with EAS and other relevant indicators used to measure staff satisfaction;
  • to what extent they are involved in decision making and where/how that can be improved;
  • the work environment in general; and
  • all other suggestions related to Performance and Quality Improvement
Service Standards include:
-Less than 5% of incoming to the Crisis and Referral Centre calls go to voicemail. -Current call volume that are directed to voicemail or choosing the option to hold the line to maintain call priority is 2.5%.
-First contact between mental health professional and client is 48 hours. -First contact between client and counsellor within 48 hours of original call is occurring over 95% of cases.
-First appointment within 3 to 5 business days. -First appointment within 5 business days is occurring in over 90% of cases.
-Client receives follow-up from counsellor 2 to 3 weeks after the last session. -The number of clients who received their follow-up from their counsellor in 2009-2010 was 42%. This statistic is somewhat skewed as there are cases when clients request that the counsellor not follow-up with them, and some clients may not have completed their counselling sessions when the survey was conducted.
-Helping 70% of clients achieve problem resolution within EAS short term counselling model. -EAS is helping clients achieve problem resolution without outside referral in 85% of cases.

Other Information: N/A

3- Health Products and Foods Branch (HPFB)
External Fee Service Standard Performance Result Stakeholder Consultation
Authority to Sell Drugs Fees 120 calendar days to update the Drug Product Database following notification 98% within 120 calendar days In April 2010, Health Canada's Proposal to update current user fees for regulatory activities related to human drugs and medical devices was tabled in Parliament, as required by the User Fees Act. The Senate Standing Committee on Social Affairs, Science and Technology undertook the review of the proposal, and recommended to the Senate that the proposal be approved with no changes. On May 26, 2010, the Senate adopted the report of its Committee, thereby concluding the Parliamentary review of Health Canada's Proposal.

As fees are set in regulations, changes to existing regulations will be published in the Canada Gazette prior to the implementation of the new fees. The Department will continue to keep stakeholders informed of its progress.

As outlined in Health Canada's Proposal, the CPP fee and service standard will be reviewed separately.
* Certificates of Pharmaceutical Product (Drug Export) Fees 5 working days to issue certificate 25% within 5 working days
Drug Establishment Licensing Fees 250 calendar days to issue / renew licence 92% within 250 calendar days
* Drug Master File Fees 30 calendar days 100% within 30 calendar days
Drug Submission Evaluation Fees (Pharmaceuticals & Biologic Products) Review 1 (average time in calendar days)
Pharmaceuticals
Review 1 (average time in calendar days)
Pharmaceuticals
NDS: Priority NAS = 180 NDS: Priority NAS = 246
NDS: NAS = 300 NDS: NAS = 323
NDS: Clin only = 300 NDS: Clin only = 314
NDS: Clin/C&M = 300 NDS: Clin/C&M = 311
NDS: Priority Clin/C&M = 180 NDS: Priority Clin/C&M = 180
NDS: Labelling only = 60 NDS: Labelling only = 60
ANDS: C&M/Labelling = 180 ANDS: C&M/Labelling = 203
ANDS: Comp/C&M = 180 ANDS: Comp/C&M = 255
SNDS: Clin/C&M = 300 SNDS: Clin/C&M = 280
SNDS: Clin only = 300 SNDS: Clin only = 250
SNDS: Comp/C&M = 180 SNDS: Comp/C&M = 231
SNDS: C&M/Labelling = 180 SNDS: C&M/Labelling = 184
SNDS: Rx to OTC New INDIC = 300 SNDS: Rx to OTC New INDIC = 300
SNDS: Rx to OTC No New Indication =180 SNDS: Rx to OTC No New Indication =149
SNDS: Labelling only = 60 SNDS: Labelling only = 56
SNDS-C: Clin only =300 SNDS-C: Clin only = 260
SANDS: Comp/C&M = 180 SANDS: Comp/C&M = 262
SANDS: C&M/Labelling = 180 SANDS: C&M/Labelling = 205
SANDS: Labelling only = 60 SANDS: Labelling only = 48
DIN A with data = 210 DIN A with data = 458
DIN A form only = 180 DIN A form only = 177
DIN D with data = 210 DIN D with data = 188
DIN D form only = 180 DIN D form only = 182
Biologics Biologics
NDS: Priority NAS = 180 NDS: Priority NAS = 180
NDS: NAS = 300 NDS: NAS = 291
NDS: Clin/C&M = 300 NDS: Clin/C&M = 327
ANDS: Comp/C&M = 180 ANDS: Comp/C&M = 180
SNDS: Priority Clin only = 180 SNDS: Priority Clin only = 194
SNDS: Clin/C&M = 300 SNDS: Clin/C&M = 300
SNDS: Clin only = 300 SNDS: Clin only = 271
SNDS: Comp/C&M = 180 SNDS: Comp/C&M = 152
SNDS: C&M/Labelling = 180 SNDS: C&M/Labelling = 164
SNDS: Labelling only = 60 SNDS: Labelling only = 60
SNDS: NOC-C Clin only = 200 SNDS: NOC-C Clin only = 198
DIN B with data = 210 DIN B form only = 180
DIN B with data = 82 DIN B form only = 123
Medical Device Licence Application Fees Review 1 (average time in calendar days) Review 1 (average time in calendar days)
Class II = 15 Class II = 11
Class II amendment = 15 Class II amendment = 11
Class II Private Label = 15 Class II Private Label = 12
Class II Private Label amendment = 15 Class II Private Label amendment = 10
Class III = 60 Class III = 86
Class III amendment = 60 Class III amendment = 82
Class IV = 75 Class IV = 114
Class IV amendment = 75 Class IV amendment = 71
Fees for Right to Sell a Licensed Medical Device 20 calendar days from deadline for receipt of annual notification to update the Medical Devices Active License Listing (MDALL) database 100% within 20 calendar days
Medical Device Establishment Licensing Fees 120 calendar days to issue / renew licence 99% issued within 120 days
Veterinary Drug Evaluation Fees Review time to first decision (calendar days) Review time to first decision (calendar days) Revised fees and service standards related to veterinary drug product activities are under development, but no specific proposals have been presented to stakeholders.
NDS (including Priority Review) = 300 NDS (including Priority Review) = 351
ABNDS = 300 ABNDS = 246
SNDS = 240 SNDS = 233
SABNDS = 240 SABNDS = 189
Admin = 90 Admin = 87
DIN (including changes to DINs) = 120 DIN (including changes to DINs)= 127
NC = 90 NC = 108
ESC = 60 ESC = 49
Labels = 45 Labels = 54
Emergency Drug Release = 2 Emergency Drug Release = 100% within 2 days

Other Information: N/A

4- Pest Management Regulatory Agency (PMRA)
External Fee Service Standard Performance Result Stakeholder Consultation
Fees to be paid for Pest Control Product Application Examination Service Target is 90% of submissions in all categories to be processed within time shown. www.pmra-arla.gc.ca/english/pdf/pro/pro9601-e.pdf   Formal stakeholder consultations are normally tied to a comprehensive review of User Fees. In the fiscal year 2009-2010, there were no formal consultations as no user fee reviews took place.
Category A
Standard − 550 days User Request Minor Use Registration (URMUR) − 365 days
Category A = 74% overall, but performance for global joint reviews was 80%
Category B
Standard/priority − 365 days
Category B = 45% overall for the fiscal year, but 90% for submissions processed since January 1, 2010
Category C
Standard − 180 or 225 days
Category C = 84%
Category D
IMEP − 32 days OUI − 56 days URMULE − 60 days and Master Copy − 21 days
Category D = 80%
Category E
New Active − Food − 365 days New Active − Non-food − 165 days
Category E = 13%
Fees to be paid for the right or privilege to manufacture or sell a pest control product in Canada and for establishing a Maximum Residue Limit in relation to a pest control product. Target is 100% of all fees for the right or privilege to manufacture or sell a pest control product in Canada are invoiced by April 30th of each fiscal year. Met performance target Formal stakeholder consultations are normally tied to a comprehensive review of User Fees. In the fiscal year 2009-2010, there were no formal consultations as no user fee reviews took place.

Other Information: N/A

5- Corporate Services Branch (CSB)
External Fee Service Standard Performance Result Stakeholder Consultation
* Fees charged for the processing of access requests filed under the Access to Information Act (ATIA) Response provided within 30 days following receipt of request; response time may be extended pursuant to section 9 of the ATIA.
ATIA: http://laws.justice.gc.ca/en/A-1/218072.html
During fiscal year 2009-2010, Health Canada completed processing 1504 (74.3%) of 2025 active requests.

Health Canada was able to respond within 30 days or less in 569 (38%) of completed cases. The remaining requests were completed within 31 to 60 days in 230 (15%) cases, 61 to 120 days in 219 (15%) cases and 121 or more days in 486 (32%) cases.
The service standard is established by the Access to Information Act and the Access to Information Regulations. Consultations with stakeholders were undertaken by the Department of Justice and the Treasury Board Secretariat for amendments done in 1986 and 1992.

Other Information: N/A

* Denotes fees set by contract.

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