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And the bottom line is this: I will not allow a generation of children to become addicted to nicotine through e-cigarettes. By trying to curtail access to vape, cigar, and cigarette products that appeal to youth, the FDA is aiming to drive down vaping and smoking rates in minors without adding any barriers for established smokers who want to move to vaping

In the March 31, 2020 COVID-19 IFC, we amended the definition of direct supervision for the duration of the PHE for COVID-19 (85 FR 19245 through 19246) at 410.32(b)(3)(ii) to state that the necessary presence of the physician (or other practitioner) for direct supervision includes virtual presence through audio/video real-time communications technology

As is the case for pneumococcal, influenza and COVID-19 vaccine administration, under this proposal, a hepatitis B vaccine administration would not be considered an RHC or FQHC visit

In addition, pursuant to Section 903(a)(2)(C) of the FDCA, a tobacco product in package form is misbranded if its label does not include an accurate statement of the percentage of foreign and domestic grown tobacco used in the product

Accordingly, in 427.101(b)(2), we are proposing to codify the existing policy established in section 30.1 of the revised Medicare Part B Drug Inflation Rebate Guidance to exclude drugs and biological products described in section 1847A(c)(6)(C)(ii) of the Act from the definition of a Part B rebatable drug and not subject them to Part B inflation rebates