Commonwealth Consolidated Acts Commonwealth Consolidated Acts(1) If a circumstance mentioned in column 1 of an item in the following table applies in relation to an application, then for the purposes of calculating the consideration period for the application, exclude the period beginning on the day mentioned in column 2 of the item and ending on the day mentioned in column 3 of the item.
Calculating excluded periods | |||
Item | Column 1 | Column 2 | Column 3 |
| If this circumstance applies: | exclude the period beginning on this day: | and ending on this day: |
1 | Information is requested from an applicant under section 33 or 45 | The day notice of the request is given | The earlier of: (a) the day a complete response is given to the Executive Director; or (b) the last day of the period specified in the notice in accordance with subsection 33(2) or 45(2) |
2 | Advice is sought from a prescribed body under section 34 or 46 | The day notice of the request is given | The earlier of: (a) the day a complete response is given to the Executive Director; or (b) the last day of the period specified in the notice in accordance with subsection 34(4) or 46(4) |
3 | Advice is sought from the Gene Technology Regulator under section 35 or 47 | The day notice of the request is given | The earlier of: (a) the day a complete response is given to the request; or (b) the last day of the period specified in the notice in accordance with subsection 35(3) or 47(3) |
4 | A draft assessment statement is given to an applicant under section 36 or 48 | The day the draft assessment statement is given | The earlier of: (a) the day a complete submission is given; or (b) the last day of the period specified in the notice in accordance with subsection 36(3) or 48(3) |
5 | Information is requested from an applicant under section 55 | The day notice of the request is given | The earlier of: (a) the day a complete response is given to the Executive Director; or (b) the last day of the period specified in the notice in accordance with subsection 55(2). |
6 | Advice is sought from a prescribed body under section 56 | The day notice of the request is given | The earlier of: (a) the day a complete response is given to the Executive Director; or (b) the last day of the period specified in the notice in accordance with subsection 56(3) |
7 | Advice is sought from the Gene Technology Regulator under section 57 | The day notice of the request is given | The earlier of: (a) the day a complete response is given to the request; or (b) the last day of the period specified in the notice in accordance with subsection 57(3) |
8 | Information is requested from an applicant under section 90 | The day notice of the request is given | The earlier of: (a) the day a complete response is given to the Executive Director; or (b) the last day of the period specified in the notice in accordance with subsection 90(2) |
9 | Information is requested from an applicant under section 106 | The day notice of the request is given | The earlier of: (a) the day a complete response is given to the request; or (b) the last day of the period specified in the notice in accordance with subsection 106(2) |
10 | A decision is made to not approve an application for information to be treated as confidential business information under paragraph 108(1)(b) | The day notice of the decision is given | The day the reconsideration and review rights under section 166 in relation to the decision have been exhausted or have expired |
10A | Information is requested from an applicant under section 113A | The day notice of the request is given | The earlier of: (a) the day a complete response is given to the request; or (b) the last day of the period specified in the notice in accordance with subsection 113A(2) |
11 | A notice is given to an applicant under subsection (3) of this section | The day the notice is given | The last day of the period specified in paragraph (3)(a) or (b) of this section |
12 | A circumstance prescribed by the rules for the purposes of this item | The day prescribed by the rules for the purposes of this item | The day prescribed by the rules for the purposes of this item |
(2) For the purposes of calculating the total number of days to be excluded from a consideration period for an application under subsection (1), if a day in a period to be excluded under an item in the table in that subsection overlaps with a day in another period calculated for the same or a different item, that day must only be counted once.
(3) If the Executive Director receives information covered by subsection (4), the Executive Director may, by written notice given to the applicant, exclude a period from the calculation of the consideration period equal to the following:
(a) for information relating to an application for an assessment certificate, a variation of a term of an assessment certificate or a variation of a term of an Inventory listing--20 working days after the day the notice is given;
(b) for information relating to an application for a commercial evaluation authorisation or a variation to a term of a commercial evaluation authorisation--10 working days after the day the notice is given.
(4) Information is covered by this subsection if:
(a) the information is given to the Executive Director in relation to an application before a decision has been made on the application; and
(b) the information is about hazards to human health or the environment relating to the application; and
(c) the Executive Director is satisfied that in considering the application, having regard to the information would involve significant additional time and effort.