Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements; Correction, 59427 [2020-18263]
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59427
Federal Register / Vol. 85, No. 184 / Tuesday, September 22, 2020 / Rules and Regulations
SUPPLEMENT NO. 4 TO PART 744—ENTITY LIST—Continued
Country
License
requirement
Entity
PremiAir Aerospace, a.k.a., the following one
alias:
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Aviation 3 Trebeck Street, Mayfair, London,
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ACTION:
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
Food and Drug Administration,
HHS.
Federal Register
citation
Presumption of denial ............
84 FR [INSERT FR PAGE
NUMBER] 9/22/20.
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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.
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
SUMMARY:
[FR Doc. 2020–18515 Filed 9–21–20; 8:45 am]
AGENCY:
For all items subject to the
EAR. (See § 744.11 of the
EAR).
*
Matthew S. Borman,
Deputy Assistant Secretary for Export
Administration.
License
review policy
20855, 240–402–5762, Linda.WalterGrimm@fda.hhs.gov.
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:
SUPPLEMENTARY INFORMATION:
TABLE 2—EXECUTIVE ORDER 13771 SUMMARY TABLE
[In 2016 Dollars over an infinite time horizon]
Primary
(7%)
Present Value of Costs ............................................
Present Value of Cost Savings ................................
Present Value of Net Costs .....................................
Annualized Costs .....................................................
Annualized Cost Savings .........................................
Annualized Net Costs ..............................................
$69,720
73,557
(3,837)
4,880
5,149
(269)
Lower bound
(7%)
Upper bound
(7%)
......................
......................
......................
......................
......................
......................
......................
......................
......................
......................
......................
......................
Primary
(3%)
$75,346
171,634
(96,287)
2,260
5,149
(2,889)
Dated: August 14, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020–18263 Filed 9–21–20; 8:45 am]
BILLING CODE 4164–01–P
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16:32 Sep 21, 2020
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Lower bound
(3%)
Upper bound
(3%)
]]>Agencies
[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.
-----------------------------------------------------------------------
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:
Table 2--Executive Order 13771 Summary Table
[In 2016 Dollars over an infinite time horizon]
----------------------------------------------------------------------------------------------------------------
Primary Lower bound Upper bound Primary Lower bound Upper bound
(7%) (7%) (7%) (3%) (3%) (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]
BILLING CODE 4164-01-P
