Document ID: FDA-2017-N-6381-0007
Agency: fda
Document Type: Rule
Title: Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements; Correction
Posted Date: 2020-09-22T04:00Z

[Federal Register Volume 85, Number 184 (Tuesday, September 22, 2020)]
[Rules and Regulations]
[Page 59427]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-18263]

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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.

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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:

                                  Table 2--Executive Order 13771 Summary Table
                                 [In 2016 Dollars over an infinite time horizon]
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                                  Primary     Lower bound   Upper bound    Primary     Lower bound   Upper bound
                                    (7%)         (7%)          (7%)          (3%)         (3%)          (3%)
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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)
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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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