Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements; Correction
other · Food and Drug Administration · Rule · Published 2020-09-22 · Effective 2020-09-22 · 85 FR 59427
Document
Document number
2020-18263
Federal Register citation
85 FR 59427
CFR reference
21 CFR 514
Type
Rule
Action
Final rule; correction.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2020-09-22
Effective date
2020-09-22
HHS docket
Docket No. FDA-2017-N-6381
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is correcting a final rule that published in the Federal Register of July 29, 2020. That final rule requires electronic submission of certain postmarketing safety reports for approved new animal drugs and provides a procedure for requesting a temporary waiver of the electronic submission requirement. Table 2 of the final rule published with errors and this document corrects those errors. We are placing a corrected copy of the final rule in the docket.