Guidance on information required Where actual costs are available per activity please record these. Alternatively record the proxies of time 1 Internal costs estimated X personnel cost. Include and note travel costs where significant. Where available record legal, technical, consumer etc. 2 Type of internal Do not record directly commercial costs e.g. product marketing. a cost is incurred for purposes additional to a novel food outcome, please assess apportionment of costs, 3 Apportionment with a reason. This includes actual costs of consultants or purchase of 4 External costs data and reports. Note separately costs of meetings with FSANZ, 5 Interactions with FSANZ providing additional information, or resubmitting, where appropriate. Fee for paid application 6 Direct costs Please use a separate activity costing for each. 8 More than 1 product? When did you start and finish, in months/years. 9 Time duration of the application? Any activities not included in the Please include, with a reason for carrying out the 10 activity cost sheet? activity E.g. data on opportunity costs. 11 Any other comments The activity and costing template used is in Appendix 1.6. Other considerations Several of the pilot study participants noted that they used information prepared for other jurisdictions, and that obtaining costings for this information would be problematic, and that even if it was able to be collated, apportioning to any one application was somewhat arbitrary. In addition to the internal costs, each company was also asked to document the cost recovery charged by FSANZ for their role in assessing the application. Methodology for expanded study The methodology developed above was extended to an additional six Group 1 companies. Two Group 1 companies declined to participate. Participants in the pilot and extended study are summarised as in Table 2 below by group type and location. Table 2 Participants in pilot and extended study by group type and country Group Companies Companies Companies Companies Companies approached: interviewed: approached: interviewed: interviewed: Australia Australia New New Zealand Total Zealand 1 pilot 3 3 0 0 3 out of 3 Group 1 expanded 6 4 2 1 5 out of 8 2 3 3 5 4 7 out of 8
Guidance on information required 1 Internal costs Where actual costs are available per activity please record these. Alternatively record the proxies of time estimated X personnel cost. Include and note travel costs where significant. 2 Type of internal Where available record legal, technical, consumer etc. Do not record directly commercial costs e.g. product marketing. 3 Apportionment a cost is incurred for purposes additional to a novel food outcome, please assess apportionment of costs, with a reason. 4 External costs This includes actual costs of consultants or purchase of data and reports. 5 Interactions with FSANZ Note separately costs of meetings with FSANZ, providing additional information, or resubmitting, where appropriate. 6 Direct costs Fee for paid application 8 More than 1 product? Please use a separate activity costing for each. 9 Time duration of the application? When did you start and finish, in months/years. 10 Any activities not included in the activity cost sheet? Please include, with a reason for carrying out the activity 11 Any other comments E.g. data on opportunity costs. The activity and costing template used is in Appendix 1.6. Other considerations Several of the pilot study participants noted that they used information prepared for other jurisdictions, and that obtaining costings for this information would be problematic, and that even if it was able to be collated, apportioning to any one application was somewhat arbitrary. In addition to the internal costs, each company was also asked to document the cost recovery charged by FSANZ for their role in assessing the application. Methodology for expanded study The methodology developed above was extended to an additional six Group 1 companies. Two Group 1 companies declined to participate. Participants in the pilot and extended study are summarised as in Table 2 below by group type and location. Table 2 Participants in pilot and extended study by group type and country Group Companies approached: Australia Companies interviewed: Australia Companies approached: New Zealand Companies interviewed: New Zealand Companies interviewed: Total 1 pilot 3 3 0 0 3 out of 3 Group 1 expanded 6 4 2 1 5 out of 8 2 3 3 5 4 7 out of 8
P1024%20Nuts%20and%20novels%20SD1%20Qualitative%20assess%20of%20costs%2c%20benefits.docx