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

---
identifier: "/us/fr/2020-18263"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements; Correction"
title_number: 0
title_name: "Federal Register"
section_number: "2020-18263"
section_name: "Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements; Correction"
positive_law: false
currency: "2020-09-22"
last_updated: "2020-09-22"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2020-18263"
document_type: "rule"
publication_date: "2020-09-22"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
cfr_references:
  - "21 CFR Part 514"
rin: "0910-AH51"
fr_citation: "85 FR 59427"
fr_volume: 85
docket_ids:
  - "Docket No. FDA-2017-N-6381"
effective_date: "2020-09-22"
fr_action: "Final rule; correction."
---

#  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, *[email protected]* .

**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 | Lower bound | Upper bound | Primary | Lower bound | Upper bound |
| --- | --- | --- | --- | --- | --- | --- |
| 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.