【求助】新建无菌灌装线 FDA申报

清歌一曲月如霜

请教论坛里的各位前辈，以下案例如何申报？
在A地已有无菌灌装生产线（），现在在B地新建另外的无菌灌装线，生产同一品种，需要向FDA申报场地变更，存在以下疑问：
1）属于哪种变更类型？
2）以哪种方式报告？
3）场地变更相应的技术要求及费用情况？
对于问题1，参考 Guidance for Industry_Changes to anApproved NDA or ANDA
Transfer of the manufacture of a finisheddrugproduct sterilized byterminal processes to a newly constructed facilityat adifferent manufacturingsite. Once this change has been approved, subsequentsite changes to thefacility for similar drug product types and processes maybesubmitted as achanges-being-effected-in-30-days supplement(see sectionVI.C.1.a).
推断变更归类为major change
对于问题2，参考Guidance for Industry_Changes to an Approved NDA or ANDA （questions & answers）
Q12: What is the recommendedreporting category for theaddition of a new aseptic filling line for sterileproducts?
A12: The addition of a newaseptic filling lineshould be reported in a prior approval supplement (section VI.B.4).
推断按照预先批准报告的形式报告
以上请问各位帮忙指正！如果是按照PAS报告，其详细流程是怎样的，费用情况以及资料要求等？
先谢谢啦！