New Animal Drug Applications; Sheep as a Minor Species
other · Food and Drug Administration · Rule · Published 2000-08-03 · Effective 2000-09-05 · 65 FR 47668
Document
Document number
00-19627
Federal Register citation
65 FR 47668
CFR reference
21 CFR 514
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2000-08-03
Effective date
2000-09-05
HHS docket
Docket No. 99N-2151
Abstract
The Food and Drug Administration (FDA) is amending its regulations to reclassify sheep as a minor species for all data collection purposes. This reclassification will allow sponsors of new animal drug applications (NADA's) to extrapolate human food safety data from a major species such as cattle to sheep. In particular, this will enable the extrapolation of the tolerances for residues of new animal drugs in cattle to sheep.