…y exercises, in addition to providing standard step count and high-acceleration events that may indicate a fall. A temperature sensor monitors the skin temperature near the joint. TracPatch is described by the applicant as a 24/7 remote monitoring wearable device that captures a …

… instead interquartile ranges ( 90 FR 18099 ). The applicant summarized adverse events reported in Cauchy et al. (2011) and Crooks et al. (2022), as well as a multicenter retrospective cohort study and the AURLUMYN TM prescribing information. The applicant also referenced the NDA…

…ation of the notice of proposed rulemaking for OMB's review. OMB ( printed page 19396) assigned the ICR OMB Control Number 1291-0006 on October 15, 2015. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displa…