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(ii) Burden for Subgroup Registration We are not proposing any changes to our currently approved subgroup registration burden (86 FR 65590) of 10 annual hours (20 responses at 0.5hr/response)

This blurring of lines may present regulatory challenges around when a product constitutes a drug

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10.1002/ijc.35278 2

E-cigarette use prevalence increased steadily from 2015/16 reaching 9.5% for current EC use in 2019/20 and thereafter more than doubled to 21.1% by 2020/21

RHCs and FQHC visits are generally paid at 80 percent of reasonable costs, and thus, they are subject to coinsurance for Medicare Part B enrollees