2020-18263. Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements; Correction

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; correction.

SUMMARY:

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.

DATES:

Effective September 22, 2020.

FOR FURTHER INFORMATION CONTACT:

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, [e-mail].

SUPPLEMENTARY 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 Savings	73,557			171,634
Present Value of Net Costs	(3,837)			(96,287)
Annualized Costs	4,880			2,260
Annualized Cost Savings	5,149			5,149
Annualized Net Costs	(269)			(2,889)

Dated: August 14, 2020.

Lauren K. Roth,

Associate Commissioner for Policy.