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April 24, 2023

As proposed in 428.101(a)(3)(iii), to determine whether the manufacturer of the generic drug is a first applicant during the 180-day exclusivity period, or whether the manufacturer of the generic drug is a first approved applicant for a competitive generic drug therapy, CMS will refer to FDA website resources such as the Orange Book and may consult with FDA for technical assistance as needed

These findings reveal that there is still much more to do to protect everyoneespecially childrenfrom this completely preventable health hazard. During 20112014, the percentage of nonsmokers exposed to secondhand smoke did not decline significantly across most demographic subgroups

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