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Table A: User Fee


3.2.2 2009-10 User Fee Reporting - User Fees Act
($ thousands)
Program Activity Fee Type1 Fee-setting Authority Date Last Modified 2009-10 Planning Years
Forecast
Revenue
Actual
Revenue
Full
Cost
2
Performance
Standard
Performance
Results
Fiscal
Year
Forecast
Revenue
Estimated
Full Cost
3
Food Safety and Nutrition Risk R CFIA Act 1998 30,001 31,203 229,137     2010-11 31,243 285,685
2011-12 31,240 277,661
2012-13 31,241 274,309
Zoonotic Risks R CFIA Act 1998 0 31 92,106     2010-11 0 87,963
2011-12 0 85,493
2012-13 0 84,461
Animal Health Risks and Production Systems R CFIA Act 1998 2,153 2,397 88,507     2010-11 2,400 84,527
2011-12 2,400 82,152
2012-13 2,400 81,161
Plant Health Risks and Production Systems R CFIA Act 1998 3,796 3,862 99,229     2010-11 3,867 94,767
2011-12 3,867 92,105
2012-13 3,867 90,993
Biodiversity Protection R CFIA Act 1998 350 448 10,544     2010-11 449 10,070
2011-12 449 9,787
2012-13 449 9,668
Integrated Regulatory Framework R CFIA Act 1998 0 80 11,768     2010-11 0 11,239
2011-12 0 10,923
2012-13 0 10,791
Domestic and International Market Access R CFIA Act 1998 17,266 15,350 35,832     2010-11 13,186 34,221
2011-12 14,192 33,259
2012-13 15,195 32,858
Internal Services R CFIA Act 1998 0 78 155,925     2010-11 0 148,910
2011-12 0 144,730
2012-13 0 142,981
Internal Services O Access to Information Act 1992 8 11 1,053     2010-11 11 1,005
2011-12 11 977
2012-13 11 965
Sub-Total   CFIA Act   53,566 53,449 793,047   2010-11 51,114 757,382
2011-12 52,147 736,110
2012-13 53,150 727,222
Sub-Total   Access to Information Act   8 11 1,053   2010-11 11 1,005
2011-12 11 977
2012-13 11 965
Total       53,574 53,460 794,100   2010-11 51,155 758,387
2011-12 52,158 737,087
2012-13 53,161 728,187

1. R=Regulating. O=Other products and services.

2. The full cost of the user fees' activites includes all direct and indirect expenditures. The full cost also includes services provided without charge by other government departments.

3. The figures are taken from the reference levels established by the Annual Reference Level Updated (ARLU) and the estimated amounts of services provided without charge by other government departments.

"A moratorium on increasing or adding new user fees was imposed when the Agency was created, due to industry concerns that the Agency would increase user fees to balance its budget rather than look for efficiencies. Because new fees could not be created, and existing fees could not be increased, the Agency has not consulted with stakeholders regarding service standards, and has not systematically measured performance over the last 15 years. By 2008, user fees recovered less than 9% of the cost of providing services. The moratorium was lifted in August 2009, and work began on reviewing and modernizing user fees and service standards in priority areas. During user fee modernization, the Agency must adhere to the User Fees Act, which came into force in 2004. The Act requires that the proposed services, service standards, and user fees and other information be presented to stakeholders for comment and subsequently submitted to both Houses of Parliament for review. The process from initial consultations to implementing the new fees via the CFIA Act is expected to take at least 1.5 years, at which time the Agency would begin performance measurement and reporting on service standards (expected summer 2011 for initial priority areas)."

Table B: External Fee
2009-2010 CFIA’s Performance Report on External Fees
External Fee Service Standard Performance Results 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. Notice of extension to be sent within 30 days of receipt of request. Of the 340 requests completed under the ATIA last fiscal year, 118 (35%) were completed under 30 days; 39 (11%) were completed in 31 to 60 days; 57 (17%) were completed in 61 to 120 days; and 126 (37%) were completed 121 or over. The service standard is established by the ATIA 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.
Destination Inspection Service1 (fresh fruits and vegetables) http://www.inspection.gc.ca/ english/fssa/frefra/dis/dise.shtml Goal is to achieve inspector response to 80% of the inspection requests within eight hours and 100% of requests within 24 hours by 2011. National results: 77.64% within 8 hours and 87.24% within 24 hours. Service standards were established for Destination Inspection Service, in consultation with Industry.
Veterinary Biologics Program Service Standards (The service standards refer to VBS calendar days, unless specified otherwise)   The Veterinary Biologics Section made significant progress in eliminating backlogs, and is now meeting service standards for all key indicators, with very few exceptions. To address stakeholders' concerns about capacity and timeliness of the regulatory approval process for animal health products, the CFIA Veterinary Biologics Section has participated in the Canadian Animal Health Products Regulatory Advisory Committee (CAHPRAC) since 2008 in collaboration with Health Canada's Veterinary Drugs Directorate.
Dossier Review (new submission, change in product formulation or change in label claim)   Met  
Canadian Manufacturers
1. Review initial submission and prepare response 1) Response time 4 months maximum Average response time is 3 months Met To address stakeholder concerns, a phased review system is in place which allows for submission review and response while information and data are pending.
2. Review supplemental data and prepare response 2) Response time 6 weeks maximum Average response time is 4 weeks Met  
American Manufacturers
3. Review initial submission and prepare response 3) Response time 4 months maximum Average response time is 3 months Met To address stakeholder concerns about timely availability of US manufactured products, a concurrent review system was introduced to allow for submission review and response while US licensure is being finalized.
4. Review supplemental data and prepare response 4) Response time 6 weeks maximum Average response time is 4 weeks Met  
Manufacturers from other countries
5. Review initial submission and prepare response 5) Response time 6 months maximum Average response time is 4 months Met  
6. Review supplemental data and prepare response 6) Response time 6 weeks maximum Average response time is 4 weeks Met  
Laboratory Testing
7. Each master cell line 7) Response time 4 months maximum Average response time is 3 months Met  
8. Each master seed culture 8) Response time 4 months maximum Average response time is 3 months Met  
9. Each pre-licensing serial tested, to a maximum of three 9) Response time is maximum 4 months Average response time is 3 months Met  
Facility Inspections/Audits
10. Canadian manufacturers 10) Annual Average is annual. Met  
11. Canadian importers 11) Minimum every 3 years Average is every three years Met  
12. American manufacturers 12) Minimum every 3 years Average is every three years Met For facilities which are inspected annually and licensed by the US Department of Agriculture, Animal and Plant Health Inspection Service (USDA-APHIS), VBS may inspect when the product is first licensed in Canada. Subsequent inspections will be arranged as necessary. VBS may request copies of inspection reports from USDA-APHIS.
13. Other non-Canadian manufacturers 13) Minimum every 4 years Average is every four years Met For facilities which are inspected regularly for Good Manufacturing Practices, VBS may inspect when the product is first licensed in Canada. Subsequent inspections will be arranged as necessary.
14. Issuance of Permits, Licenses and Export Certificates 14) Response time maximum 2 weeks Average response time is 2 weeks. Met  
Serial Release
15. If not tested 15) Response time maximum 5 days Average response time is 2–3 days. Met  
16. If tested 16) Response time maximum 35 days Average response time is 2 weeks.

Met.

Due to test scheduling and set up requirements, the average response time has consistently approached the maximum response time of 35 days.

 
17. Label Review and Approval 17) Response time maximum 4 weeks Average response time is 2 weeks.

Met

 
18. Advertising Review and Approval 18) Response time maximum 4 weeks Average response time is 2 weeks.

Met

To address stakeholder concerns, VBS is no longer reviewing and approving advertising.
19. Protocol Review for Efficacy/Safety Studies 19) Response time maximum 45 days Average response time is 30 days.

Met

 
20. Production Outline Revisions 20) Response time maximum 4 weeks Average response time is 2 weeks.

Met

 
21. Suspected Adverse Reactions 21) Response time maximum 4 weeks Average response time is 2 weeks.

Met

 
Application for Feed Registration and Ingredient Approval
i) Timeliness: For 90 percent or more of the applications received
  (a) Feed Section screens applications within ten days of receiving it.

N/A

 
  (b) For products requiring a review of efficacy data, a preliminary review is conducted within 10 days of the screening date, and the results of the review are communicated to the applicant.

N/A

 
  (c) Animal Feed Division conducts efficacy, livestock, human and environmental safety reviews and responds to applicant within 90 days.

28.6% of applications were completed within 90 days.

To address stakeholders concerns about capacity and timeliness of the regulatory approval process, the CFIA is working through the Canadian Animal Health Products Regulatory Advisory Committee (CAHPRAC).
  (d) The laboratory does a desk review of proposed method of analysis within 4 weeks of receiving it. If laboratory testing is required, it will be done within 12 weeks of receiving a suitable method and test samples depending on availability of specialized equipment.

N/A

 
(ii) Quality
  (a) The Feeds Regulations are consistently interpreted and applied in registration/approval decisions.

Met

 
  (b) Information is openly exchanged between clients and evaluation specialists.

Met

 
  (c) Analytical methods are evaluated for specificity, selectivity, reliability and accuracy, using internationally standardized method validation procedures.

Met

 

1 The reporting period is April 1, 2009 to Feb. 28, 2010