Skip to Content

We invite you to try out our new beta eCFR site at We’ve made big changes to make the eCFR easier to use. Be sure to leave feedback using the 'Help' button on the bottom right of each page!


Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements; Correction

Document Details

Information about this document as published in the Federal Register.

Document Statistics
Document page views are updated periodically throughout the day and are cumulative counts for this document. Counts are subject to sampling, reprocessing and revision (up or down) throughout the day.
Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble


Food and Drug Administration, HHS.


Final rule; correction.


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.


Effective September 22, 2020.

Start Further Info


Linda Walter-Grimm, Center for Veterinary Medicine (HFV-240), Food and Drug Administration, 7519 Standish Pl., MPN4, Rm. 2666, Rockville, MD 20855, 240-402-5762,

End Further Info End Preamble Start Supplemental Information


In the Federal Register of July 29, 2020, (85 FR 45505), FDA published the final rule “Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements” with errors in table 2.

In FR Doc. 2020-15441, appearing on page 45509 in the Federal Register of July 29, 2020, the following corrections are made:

Table 2—Executive Order 13771 Summary Table

[In 2016 Dollars over an infinite time horizon]

Primary (7%)Lower bound (7%)Upper bound (7%)Primary (3%)Lower bound (3%)Upper bound (3%)
Present Value of Costs$69,720$75,346
Present Value of Cost Savings73,557171,634
Present Value of Net Costs(3,837)(96,287)
Annualized Costs4,8802,260
Annualized Cost Savings5,1495,149
Annualized Net Costs(269)(2,889)
Start Signature

Dated: August 14, 2020.

Lauren K. Roth,

Associate Commissioner for Policy.

End Signature End Supplemental Information

[FR Doc. 2020-18263 Filed 9-21-20; 8:45 am]