Department of Health and Human Services May 27, 2020 – Federal Register Recent Federal Regulation Documents

The Office of Human Services, Emergency Preparedness and Response (OHSEPR) is the emergency management office of the U.S. Department of Health and Human Services' (HHS) Administration for Children and Families (ACF). OHSEPR is requesting a 3-year extension of the Immediate Disaster Case Management Intake Assessment tool (OMB #0970-0461). The content of the form has not changed. There is one modification to the proposed use of resulting aggregate data, to include a use to advance research with a goal of developing a Quality Assurance/Performance Improvement process.

The Food and Drug Administration (FDA, the Agency, or we) is hosting a virtual public meeting entitled ``Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments,'' and an opportunity for public comment. This public meeting will take place virtually due to extenuating circumstances and will be held by webcast only.

The Food and Drug Administration (FDA or Agency) is announcing the availability of draft recommendations for new permitted daily exposures (PDEs) for the residual solvents 2-methyltetrahydrofuran, cyclopentyl methyl ether, and tert-butyl alcohol. The PDEs were developed according to the methods for establishing exposure limits included in the guidance for industry entitled ``Q3C Impurities: Residual Solvents.'' The recommendations were prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance is intended to recommend acceptable amounts for the listed residual solvents in pharmaceuticals for the safety of patients.