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.
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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, Linda.Walter-Grimm@fda.hhs.gov.
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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 Savings||73,557||171,634|
|Present Value of Net Costs||(3,837)||(96,287)|
|Annualized Cost Savings||5,149||5,149|
|Annualized Net Costs||(269)||(2,889)|
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Dated: August 14, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-18263 Filed 9-21-20; 8:45 am]
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