FDA Seeks Input on Biosimilar Fee Hike for 2028

2026-16296, Substances Generally Recognized as Safe

The Food and Drug Administration (FDA or we) is proposing to require the submission of generally recognized as safe (GRAS) notices for the use of a human or animal food substance purported to be GRAS under the conditions of its intended use under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

2026-14073, Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments

The FDA wants to make it easier for drug makers who work in several locations to register as one company instead of many. They’re also updating rules for foreign drug companies to match new laws about handling health threats. If you’re in drug manufacturing, get ready to comment by September 11, 2026, and keep an eye on possible paperwork changes that could affect your business.

2026-13047, Establishment Registration and Product Listing for Tobacco Products

The FDA wants to make sure all tobacco product makers, both in the U.S. and abroad, register their businesses and list their products. This new rule closes a big gap by including foreign companies, helping the FDA keep better track of tobacco products for public health. Comments on this proposal are open until September 14, 2026, so affected businesses should get ready to update their info and possibly face new costs.

2026-17498, Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Second Extension of Effective Date of Final Resolution of Drug Efficacy Study Implementation 7661

The Food and Drug Administration (FDA or Agency) is extending the effective date of the notice published in the Federal Register on May 27, 2026, entitled "Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Syntest D.S. and Syntest H.S. Tablets; Withdrawal of Hearing Requests; Final Resolution of Drug Efficacy Study Implementation 7661" (91 FR 31462) (the "May 2026 Notice"), as previously extended by the notice published in the Federal Register on June 26, 2026 (91 FR 38717) (the "June 2026 Notice"), by an additional 41 days. The effective date of the May 2026 Notice, which was previously extended to September 24, 2026, is hereby further extended to November 4, 2026. This further extension is necessary to allow FDA sufficient time to consider issues raised by interested parties.

2026-17401, Determination That CABAZITAXEL (Cabazitaxel) Solution (Injection), 60 Milligrams/6 Milliliters (10 Milligrams/Milliliter), Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

The Food and Drug Administration (FDA, Agency, or we) has determined that CABAZITAXEL (cabazitaxel) solution (injection), 60 milligrams (mg)/6 milliliters (mL) (10 mg/mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for Cabazitaxel (cabazitaxel) solution (injection), 60 mg/6 mL (10 mg/mL), if all other legal and regulatory requirements are met.

2026-17380, International Drug Scheduling; Single Convention on Narcotic Drugs; Convention on Psychotropic Substances; Clobromazolam (Phenazolam); Cychlorphine (N-Propionitrile Chlorphine); Desalkylgidazepam (Bromonordiazepam); Ethylbromazolam; Etomethazene (5-Methyl Etodesnitazene); Spirochlorphine (R6980); Etomidate; Medetomidine; Request for Comments

The FDA is asking the public to share their thoughts on eight drugs that might get new international rules to control their use and abuse. This affects doctors, patients, and drug makers because it could change how these drugs are used medically or restricted worldwide. Comments are open until September 3, 2026, so jump in and have your say before the deadline!

Previous: 2025-20653, Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Request for Comment; Occupant Anthropometry and Seating

The National Highway Traffic Safety Administration (NHTSA) is asking for approval to collect new info about how people’s body sizes and seating affect vehicle safety. This affects anyone involved in vehicle design and safety research, aiming to make cars safer and more comfortable. Comments on this plan are open until December 24, 2025, with no big costs expected for the public.

Next: 2025-20655, Pipeline Safety: Request for Special Permit; Southern Natural Gas Company, LLC (SNG)

Southern Natural Gas Company (SNG) asked for a special permit to skip some pipeline safety rules, but only if they follow new safety conditions. The government wants your thoughts on this by December 24, 2025, before deciding. This affects SNG’s operations and could change how they manage pipeline safety without extra costs right now.