5 results found
https://www.federalregister.gov/documents/2024/01/09/2023-28857/health-data-technology-and…

…nition C. Exceptions 1. Infeasibility a. Infeasibility Exception—Uncontrollable Events Condition b. Infeasibility Exception—Third Party Seeking Modification Use Summary of Finalized Policy: Third Party Seeking Modification Use Condition c. Infeasibility Exception—Manner Exception…

https://www.federalregister.gov/public-inspection/2023-28857/health-data-technology-and-in…

…nition C. Exceptions 1. Infeasibility a. Infeasibility Exception—Uncontrollable Events Condition b. Infeasibility Exception—Third Party Seeking Modification Use Summary of Finalized Policy: Third Party Seeking Modification Use Condition c. Infeasibility Exception—Manner Exception…

https://www.federalregister.gov/documents/2023/04/18/2023-07229/health-data-technology-and…

…nition B. Exceptions 1. Infeasibility a. Infeasibility Exception—Uncontrollable Events Condition b. Third Party Seeking Modification Use c. Manner Exception Exhausted 2. Manner Exception—TEFCA Reasonable and Necessary Activities a. Background b. TEFCA Condition for the “Manner” E…

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…