If this proposed rule is finalized, industry and FDA would incur cost savings from a reduction in the quantity and time burden of new animal drug labeling amendments and informal communications related to new animal drug labeling. There may be additional benefits to users of approved or conditionally approved new animal drugs from greater predictability and ease of reading new animal drug labeling in the form of time saved searching for content, as well as benefits to animal or human health, which we are unable to quantify.

We expect that new animal drug sponsors would incur one-time costs to read and understand the rule, revise standard operating procedures (SOPs) related to labeling, and train employees on the revised SOPs. New animal drug sponsors would also bear costs to update labeling and prepare supplemental labeling applications to conform to the proposed requirements. FDA would incur costs to review these supplemental applications.

FDA estimates that the annualized benefits over 10 years would range from $0.143 million to $0.243 million at a 2 percent discount rate, with a primary estimate of $0.193 million. The annualized costs would range from $2.16 million to $2.77 million at a 2 percent discount rate, with a primary estimate of $2.45 million.

Regulatory Impact Analysis

Labeling Requirements for Approved and Conditionally Approved New Animal Drugs (Proposed Rule) (PDF- 828 KB)
Federal Register: 89 FR 18262, March 12, 2024
Docket: FDA-2023-N-5160