5 results found
https://www.federalregister.gov/documents/2026/02/11/2026-02769/patient-protection-and-aff…

…d user fee estimates, the final user fee may be lower. We also note that if any events result in a deviation from our expectations of current conditions that would significantly change our estimates around costs, enrollment projections, or the finalization of proposed risk adjust…

https://www.federalregister.gov/documents/2025/08/04/2025-14681/medicare-program-hospital-…

… 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…