responses/burden were re-categorized as "adjustments."
Inventory as of this Action
36 Months From Approved
This ICR collects information from
respondents who wish to make a drug legally available to
veterinarians and animal owners for the treatment of a minor animal
species (species other than cattle, horses, swine, chickens,
turkeys, dogs, and cats). Respondents to the collection are
sponsors of these products. FDA reviews the information collected
to identify potential problems concerning the safety and
effectiveness of the new animal drug.
USC 369ccc-2 Name of Law: Minor Use and Minor Species Animal
Our estimated burden for the
information collection reflects an overall increase of 401
reporting hours. We attribute this adjustment, generally, to an
increase in the number of submissions we received over the last few
years. We also reduced our burden hour estimate for drug experience
reports and distributor statements under 21 CFR 516.165 from 8
hours per submission to 5 hours per submission based on our
experience with this type of reporting.