Table 3: Prescribed timeframes for applications Timeframe (working days) Category 90 (r. 16) Accreditation Certification 90 (r. 14) DIR—limited and controlled, no significant 150 (r. 8) risk DIR—limited and controlled, significant 170 (r. 8) risk DIR—except for limited and controlled 255 (r. 8) releases DNIR 90 (r. 8) Licence variation 90 (r. 11A) DIR = dealing involving intentional release of a genetically modified organism into the environment; DNIR = contained dealing with a genetically modified organism not involving intentional release into the environment; r = regulation Operational achievements This section describes the achievements of delivering national gene technology regulation and performance against Outcome 7 (Health Infrastructure, Regulation, Safety and Quality) of the 2015–16 Department of Health PBS. It provides details of achievements on deliverables and performance indicators in the key of: assessments and authorisations under the Act monitoring of GMOs compliance with the Act consultation with stakeholders cooperation with relevant regulatory agencies operational changes arising from the 2013 response by all Australian governments to the 2011 review of the Act. Assessments and approvals Information on performance against deliverables and key performance indicators, as set out in the 2015–16 Department of Health PBS, is summarised in the second part of this chapter. In 2015–16, the OGTR received 1571 applications and notifications, as defined under the Act (Table 4). The timing and volume of applications each year can be influenced by a range of factors, including research grant funding cycles, seasonal agricultural factors and changes to legislation. Table 4: Applications and notifications, 2015–16 Ceased Under Application type Received Withdrawn Approveda Refused considerationb considerationc Accreditation 3 0 4 1 0 0 CCI declaration for DIR 7 0 4 0 0 8 licence CCI declaration for DNIR 1 0 0 0 0 5 licence
Table 3: Prescribed timeframes for applications Category Timeframe (working days) Accreditation 90 (r. 16) Certification 90 (r. 14) DIR—limited and controlled, no significant risk 150 (r. 8) DIR—limited and controlled, significant risk 170 (r. 8) DIR—except for limited and controlled releases 255 (r. 8) DNIR 90 (r. 8) Licence variation 90 (r. 11A) DIR = dealing involving intentional release of a genetically modified organism into the environment; DNIR = contained dealing with a genetically modified organism not involving intentional release into the environment; r = regulation Operational achievements This section describes the achievements of delivering national gene technology regulation and performance against Outcome 7 (Health Infrastructure, Regulation, Safety and Quality) of the 2015–16 Department of Health PBS. It provides details of achievements on deliverables and performance indicators in the key of: assessments and authorisations under the Act monitoring of GMOs compliance with the Act consultation with stakeholders cooperation with relevant regulatory agencies operational changes arising from the 2013 response by all Australian governments to the 2011 review of the Act. Assessments and approvals Information on performance against deliverables and key performance indicators, as set out in the 2015–16 Department of Health PBS, is summarised in the second part of this chapter. In 2015–16, the OGTR received 1571 applications and notifications, as defined under the Act (Table 4). The timing and volume of applications each year can be influenced by a range of factors, including research grant funding cycles, seasonal agricultural factors and changes to legislation. Table 4: Applications and notifications, 2015–16 Application type Received Withdrawn Approveda Refused Ceased considerationb Under considerationc Accreditation 3 0 4 1 0 0 CCI declaration for DIR licence 7 0 4 0 0 8 CCI declaration for DNIR licence 1 0 0 0 0 5
Operations%20of%20the%20Gene%20Technology%20Regulator%20Annual%20Report%202015-16.docx