Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements; Correction
| Published date | 22 September 2020 |
| Citation | 85 FR 59427 |
| Record Number | 2020-18263 |
| Section | Rules and Regulations |
| Court | Food And Drug Administration |
59427
Federal Register / Vol. 85, No. 184 / Tuesday, September 22, 2020 / Rules and Regulations
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Matthew S. Borman,
Deputy Assistant Secretary for Export
Administration.
[FR Doc. 2020–18515 Filed 9–21–20; 8:45 am]
BILLING CODE 3510–33–P
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:
T
ABLE
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O
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13771 S
UMMARY
T
ABLE
[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.
[FR Doc. 2020–18263 Filed 9–21–20; 8:45 am]
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