Animal Drug and Animal Generic Drug User Fee Amendments of 2023

New Title III (Supporting Animal and Human Health) was added, covering expanded reporting requirements for the animal drug user fee program, a change to the major species definition, and antimicrobial resistance reporting obligations.

The annual generic animal drug fee revenue target was increased from $18,336,340 to $25,000,000 for fiscal years 2024 through 2028.

A new Generic Investigational New Animal Drug File Fee of $50,000 was added, assessed when a person requests to establish such a file or makes the first submission to an existing file on or after October 1, 2023.

A new application fee type was added for conditional approval under section 571 of a new animal drug where an animal drug application has been previously approved for another intended use.

Fee allocation percentages for generic animal drugs were changed: one category decreased from 25 percent to 20 percent, and two categories increased from 37.5 percent to 40 percent each.

The old offset provision for generic animal drug fee collections was removed and replaced with a new Recovery of Collection Shortfalls mechanism that increases fees in fiscal years 2026-2028 by the amount any prior year's collections fell below authorized levels.

Inflation adjustment base year was changed from 2020 to 2025, and the metropolitan statistical area for cost indexing was changed from Baltimore to Arlington-Alexandria, reflecting FDA's headquarters relocation.

Section 301 adds detailed reporting requirements including data on staffing levels funded by fees versus budget authority, cost per full-time equivalent, average review hours by application type, and tracking of in-person versus virtual sponsor meetings for fiscal years 2024 and 2025.

Section 301 requires the Secretary to provide regular updates to Congress on reauthorization negotiations with regulated industry, within 30 days after each negotiation meeting.

Section 303 requires a report by December 31, 2023 on antimicrobial stewardship activities conducted by the Center for Veterinary Medicine during fiscal years 2019-2023, plus annual progress reports covering activities, missed targets, emerging challenges, and efforts to incentivize development of new drugs for bacterial diseases in animals.

The definition of major species in section 201(nn) was amended to allow removal of species from the list, not just addition, giving FDA flexibility to adjust the list of major food-producing animal species.

Two new definitions were added: generic investigational new animal drug meeting request and request to establish a generic investigational new animal drug file.

New language was added stating that a request to establish a generic investigational new animal drug file will be considered incomplete and not accepted for action until all fees owed by the person have been paid.