November 23, 2022 – Federal Register Recent Federal Regulation Documents

The Department of Labor (DOL) is submitting this Bureau of Labor Statistics (BLS)-sponsored information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.

The Food and Drug Administration (FDA or Agency) is developing a list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need (the 503B Bulks List). Drug products that outsourcing facilities compound using bulk drug substances on the 503B Bulks List can qualify for certain exemptions from the Federal Food, Drug, and Cosmetic Act (FD&C Act) provided certain conditions are met. This notice identifies two bulk drug substances that FDA has considered and proposes to include on the 503B Bulks List to compound three categories of compounded drug products: arginine hydrochloride (HCl) for oral use, lysine HCl for oral use, and lysine HCl for intravenous use in combination with FDA-approved, single-ingredient arginine HCl for intravenous use. This notice identifies three bulk drug substances that FDA has considered and proposes not to include on the 503B Bulks List: etomidate, furosemide, and rocuronium bromide. Additional bulk drug substances nominated for inclusion on this list are under consideration and may be the subject of future notices.

In accordance with the Federal Advisory Committee Act, this notice advises interested persons that the Federal Communications Commission's (FCC) Technological Advisory Council will hold a meeting on Thursday, December 8, 2022 in the Commission Meeting Room and available to the public via the internet at https://www.fcc.gov/live at 10 a.m.

In this notice, the EPA is notifying the public that it has found that the 2020 motor vehicle emissions budgets for volatile organic compounds (VOCs) and nitrogen oxides (NOX), submitted by the New York State Department of Environmental Conservation on November 29, 2021, for the 2008 national ambient air quality standard (NAAQS) for ozone (the Budgets), are adequate for transportation conformity purposes for the New York portion of the New York-Northern New Jersey-Long Island, NY-NJ-CT 8-hour ozone nonattainment area. This revision to the SIP included 2020 summer day VOC and NOX Budgets associated with the SIP's reasonable further progress demonstration.

In accordance with the Clean Air Act, as amended (CAA or the Act), EPA is providing notice of a proposed consent decree in Comit[eacute] Progreso de Lamont, et al. v. United States Environmental Protection Agency, et al., No. 3:21-cv-08733-WHA (N.D. Cal.). On November 10, 2021, Plaintiffs Comit[eacute] Progreso de Lamont, Committee for a Better Arvin, Committee for a Better Shafter, Central California Environmental Justice Network, Association of Irritated Residents, Medical Advocates for Healthy Air, National Parks Conservation Association, and Sierra Club filed a complaint in the United States District Court for the Northern District of California. Plaintiffs alleged that the Environmental Protection Agency (EPA or the Agency) failed to perform certain non-discretionary duties in accordance with the Act. These duties pertain to promulgation of a Federal Implementation Plan (FIP) for the San Joaquin Valley area of California to address certain remaining nonattainment plan requirements for the 1997, 2006, and 2012 PM2.5 national ambient air quality standards (NAAQS). The proposed consent decree would establish deadlines for EPA to sign notices of proposed and final actions.

The Federal Energy Regulatory Commission issues this final rule to require natural gas pipelines to submit all supporting statements, schedules and workpapers in native format (e.g., Microsoft Excel) with all links and formulas included when filing a Natural Gas Act section 4 rate case.