Eligibility for the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species; Request for Comments

Issuing agencies

Abstract

The Food and Drug Administration (FDA, we, or the Agency) is soliciting comments on our current policy on eligibility for indexing. Indexing is the process of adding an unapproved drug for a minor species to our index of legally marketed unapproved new animal drugs for minor species (the Index). Except for in some early non-food life stages, members of a food-producing minor species are not eligible for indexing, even if a subset of animals within a food-producing minor species is not intended to be consumed by humans or food-producing animals. Specifically, we are requesting comment on this policy.