Health and Human Services Department Docket FDA-2022-N-1128 Proposed Rule

2022-19956: Defining Small Number of Animals for Minor Use Determination; Periodic Reassessment

Comment Period Closed

Public comment closed .

Get alerted when the next rule lands

New rules open for comment on their own schedule. Pick how you want to hear about them — we email you when one appears.

Alert me on new Health and Human Services Department rules or alert me on a subject

Publishing to members? Embed a live rule tracker on your own site — the proposed rules in your area and the comment deadlines closing on them, updating themselves. Free, one line of HTML.

Create a free account & build one →

Summary

The Food and Drug Administration (FDA, the Agency, or we) is proposing to revise the "small number of animals" definition for dogs and cats in our existing regulation for new animal drugs for minor use or minor species. The Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act) provides incentives to encourage animal drug sponsors to develop and seek FDA approval of drugs intended for use in minor animal species or for minor uses in major animal species. Congress provided a statutory definition of "minor use" that relies on the phrase "small number of animals" to characterize such use. We are proposing certain revisions to the definition of "small number of animals" based on our most recent reassessment of the small numbers, which we conducted from 2018 to 2019.

The agency’s own summary, as published.

What this changes

Amends 1 part of the Code of Federal Regulations — the standing rules this notice rewrites.

Don't miss the comment window

One Click Politics alerts you on every deadline, hearing, and rule change.

See all rules with comments due soon →