85 FR 184 pg. 59427 - Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements; Correction
Type: RULEVolume: 85Number: 184Page: 59427
Page: 59427Docket number: [Docket No. FDA-2017-N-6381]
FR document: [FR Doc. 2020-18263 Filed 9-21-20; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 514
[Docket No. FDA-2017-N-6381]
RIN 0910-AH51
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, Linda.Walter-Grimm@fda.hhs.gov .
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:
| 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.
[FR Doc. 2020-18263 Filed 9-21-20; 8:45 am]
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