udies, the use of a controlled human infection model to obtain evidence to support vaccine efficacy may be considered. However, many issues, including logistical, human subject protection, ethical, and scientific issues, would need to be satisfactorily addressed.”FDA has traditionally not endorsed the use of such “human challenge” trials and the continued inclusion of this point, even outside of the context of a public health emergency, may be expressing somewhat greater openness to the concept.Conclusion FDA’s new guidance reflects the agency’s continued interest in supporting the development of new and next-generation vaccines for COVID-19, even as the agency has shifted away from an emergency footing. At the same time, a number of issues for the future of COVID-19 vaccines are not covered by the guidance, and it remains to be seen whether the agency will develop a framework for annual updates to the vaccines that already have or will be granted full licensure. 88 Fed. Reg. 15,417. 88 Fed. Reg. 72,489, 72,491. 88 Fed. Reg. 72,489.Id. 2022 Guidance, p. 19. 2023 Guidance, p. 3. 2020 Guidance, p. 8. 2023 Guidance, p. 8. 2023 Guidance, p. 10. 2020 Guidance, p. 11. 2023 Guidance, p. 11. 2020 Guidance, p. 13. 2023 Guidance, p. 13. 2020 Guidance, p. 10; 2023 Guidance, p. 14. 2020 Guidance p. 16; 2023 Guidance p. 16. 2023 Guidance, p. 18. 2020 Guidance, p. 18. 2023 Guidance, p. 18.

The IRS recently published final regulationsregarding new mortality tables to be used for most qualified defined benefit plans. 88 Fed. Reg. 72,357 (Oct. 20, 2023). The new tables are effective for plan years starting in 2024. On the same day, the IRS also issued proposed regulations regarding the calculation of substitute mortality tables for plans that have sufficiently credible mortality experience. 88 Fed Reg. 72409.Below, we provide a high-level summary of these developments.Final Regulations Updating Mortality TablesFor background, actuaries generally use mortality assumptions when determining the value of pension liabilities. Under the Code, specific rules must be followed with regard to the mortality assumptions, with most qualified single-employer plans needing to use IRS-provided mortality tables to calculate funding requirements and the minimum value of lump sum distributions. The final regulations update the method used to determine those IRS-provided mortality tables.Back in 2017, the regulations updated how the mortality rates were determined. Those regulations provided that mortality rates would be calculated by using a base table

As reported in our January 4, 2023, blog item, on January 3, 2023, the U.S. Environmental Protection Agency (EPA) announced the release of a draft document entitled “Biofuels and the Environment: Third Triennial Report to Congress (External Review Draft)” for public comment. 88 Fed. Reg. 72. EPA’s Office of Research and Development (ORD) and Office of Air and Radiation (OAR), in consultation with the U.S. Departments of Agriculture (USDA) and Energy (DOE), prepared the document. The purpose of the report is to examine the effects of the Renewable Fuel Standard (RFS) Program on the environment, including the impacts to date and likely future impacts to the nation’s air, land, and water resources. The draft report focuses on the dominant biofuel sources in the United States: (1) domestic corn ethanol from corn starch; (2) domestic biodiesel from soybean oil; (3) domestic biodiesel from fats, oils, and greases (FOG); and (4) imported ethanol from Brazilian sugarcane. ERG, an EPA contractor, is organizing an independent external peer review of the draft report. The peer review meetings are open to anyone who would like to attend as an observer and will include a brief public comment period on the first day (February 24, 2023). Registration is required. Panel peer review meet

On January 3, 2023, the U.S. Environmental Protection Agency (EPA) announced the release of a draft document entitled Biofuels and the Environment: Third Triennial Report to Congress (External Review Draft) for public comment. 88 Fed. Reg. 72. EPA’s Office of Research and Development (ORD) and Office of Air and Radiation (OAR), in consultation with the U.S. Departments of Agriculture (USDA) and Energy (DOE), prepared the document. The draft report is responsive to Section 204 of the 2007 Energy Independence and Security Act (EISA). The purpose of the report is to examine the effects of the Renewable Fuel Standard (RFS) Program on the environment, including the impacts to date and likely future impacts to the nation’s air, land, and water resources. It focuses on the dominant biofuel sources in the United States: (1) domestic corn ethanol from corn starch; (2) domestic biodiesel from soybean oil; (3) domestic biodiesel from fats, oils, and greases (FOG); and (4) imported ethanol from Brazilian sugarcane. The draft report concludes that the RFS Program likely played a relatively minor role (0-0.4 billion gallons per year) in the growth of corn ethanol in the United States from 2002-2012 and may have played a more important r