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  4. ARO Q&A #1: Opinion submissions for exemption requests post ARO launch
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ARO Q&A #1: Opinion submissions for exemption requests post ARO launch

Scheduled Pinned Locked Moved Accelerated Review Options (AROs)
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  • D Offline
    D Offline
    danthony
    wrote on last edited by Jennifer Carroll
    #1

    Hi @agency and @manufacturer,

    As the ARO pilot launches, we will be posting questions we encounter and their answers so that we can all learn from each other. Here is the first question.

    Q: What are my options for an opinion submission for an exemption request when ARO launches?

    A: If you are fairly certain your messages are exempt, or would like them reviewed to exemption, please use our standard opinion service (i.e. 4-day initial turnaround, with subsequent 3-day revision turnarounds to get to exempt status, if necessary). Please note that for the ARO Pilot Launch in July, opinions are not currently eligible for AROs. The fee structure in the Features Detailer is provided for transparency purposes, but only the APS types identified in the document will be eligible for ARO in July. If you suspect your claims will need to be reviewed to PAAB acceptance, or decide to review to acceptance after learning your piece is not exempt, you can take advantage of the AROs as long as your piece meets the criteria for the APS types eligible for ARO, and further, the standards for ARO-2 if that is the option you want to use. Please note that similarly to before the ARO launch, if you choose to review to acceptance after an opinion for exemption is given, a new file with a new fee is required. However, in this case you'll be able to choose between the standard pathway and AROs.

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