New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor's Address
other · Food and Drug Administration · Rule · Published 2016-09-30 · Effective 2016-09-30 · 81 FR 67149
Document
Document number
2016-23230
Federal Register citation
81 FR 67149
CFR reference
21 CFR 510
Type
Rule
Action
Final rule; technical amendment.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2016-09-30
Effective date
2016-09-30
HHS docket
Docket No. FDA-2016-N-0002
Abstract
The Food and Drug Administration (FDA, we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July and August 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of a sponsor's address.