New Animal Drugs; Withdrawal of Approval of Abbreviated New Animal Drug Application, 45311 [2020-15761]
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Federal Register / Vol. 85, No. 145 / Tuesday, July 28, 2020 / Rules and Regulations
Poloxalene in grams/
ton
Indications for use
Limitations
(1) To deliver 1 to 2
grams per 100
pounds of body
weight.
Cattle: For prevention of legume (alfalfa, clover) and
wheat pasture bloat in cattle.
Dosage is 1 gram of poloxalene per 100 pounds of
body weight daily and continued during exposure
to bloat producing conditions. If bloating conditions
are severe, the dose is doubled. Treatment should
be started 2 to 3 days before exposure to bloatproducing conditions. Repeat dosage if animals
are exposed to bloat-producing conditions more
than 12 hours after the last treatment. Do not exceed the higher dosage levels in any 24-hour period.
45311
Sponsor
054771
(2) [Reserved]
§ 558. 500
[Amended]
(21 CFR 514.116), notice is given that
approval of ANADA 200–323, and all
supplements and amendments thereto,
is hereby withdrawn, effective July 28,
2020.
Elsewhere in this issue of the Federal
Register, FDA is amending the animal
drug regulations to reflect the voluntary
withdrawal of approval of these
applications.
24. In § 558.500, remove reserved
paragraphs (e)(1)(iii) and (iv).
■
Dated: July 15, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020–15760 Filed 7–27–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: July 15, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
Food and Drug Administration
[FR Doc. 2020–15761 Filed 7–27–20; 8:45 am]
BILLING CODE 4164–01–P
21 CFR Part 520
[Docket No. FDA–2020–N–0002]
DEPARTMENT OF THE TREASURY
New Animal Drugs; Withdrawal of
Approval of Abbreviated New Animal
Drug Application
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notification of withdrawal.
The Food and Drug
Administration (FDA) is withdrawing
approval of an abbreviated new animal
drug application (ANADA) at the
sponsor’s request because the product is
no longer manufactured or marketed.
DATES: Withdrawal of approval is
effective July 28, 2020.
FOR FURTHER INFORMATION CONTACT:
Sujaya Dessai, Center for Veterinary
Medicine (HFV–212), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–402–5761,
sujaya.dessai@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Hikma
International Pharmaceuticals LLC, P.O.
Box 182400, Bayader Wadi Seer,
Amman, Jordan 11118, has requested
that FDA withdraw approval of ANADA
200–323 for use of a 1-gram bolus of
phenylbutazone in horses because the
product is no longer manufactured or
marketed.
Therefore, under authority delegated
to the Commissioner of Food and Drugs
and in accordance with § 514.116 Notice
of withdrawal of approval of application
khammond on DSKJM1Z7X2PROD with RULES
SUMMARY:
VerDate Sep<11>2014
15:58 Jul 27, 2020
Jkt 250001
Office of Investment Security
31 CFR Parts 800 and 802
RIN 1505–AC63, 1505–AC64, 1505–AC65
Definition of ‘‘Principal Place of
Business’’; Filing Fees for Notices of
Certain Investments in the United
States by Foreign Persons and Certain
Transactions by Foreign Persons
Involving Real Estate in the United
States
Office of Investment Security,
Department of the Treasury.
ACTION: Final rule.
AGENCY:
The final rule makes a
clarifying revision to the definition of
‘‘principal place of business’’ and
adopts the interim rule establishing a
fee for parties filing a formal written
notice of a transaction for review by the
Committee on Foreign Investment in the
United States.
DATES: The final rule is effective on
August 27, 2020.
FOR FURTHER INFORMATION CONTACT: For
questions about this rule, contact: Laura
Black, Director of Investment Security
Policy and International Relations;
Meena R. Sharma, Deputy Director of
Investment Security Policy and
International Relations; David Shogren,
SUMMARY:
PO 00000
Frm 00009
Fmt 4700
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Senior Policy Advisor; or James Harris,
Senior Policy Advisor, at U.S.
Department of the Treasury, 1500
Pennsylvania Avenue NW, Washington,
DC 20220; telephone: (202) 622–3425;
email: CFIUS.FIRRMA@treasury.gov.
SUPPLEMENTARY INFORMATION:
I. Background
A. Definition of ‘‘Principal Place of
Business’’
On January 17, 2020, the Department
of the Treasury (Treasury Department)
published two interim rules, each
effective February 13, 2020, that
provided a definition for the term
‘‘principal place of business’’ as
applicable to transactions subject to
review by the Committee on Foreign
Investment in the United States (CFIUS
or the Committee). 85 FR 3112 (January
17, 2020); 85 FR 3158 (January 17,
2020). The preambles to the interim
rules provide background on this
definition. While the definition took
effect on February 13, 2020, the public
was provided an opportunity to
comment. The Treasury Department
received several comments, which are
discussed further below.
B. Filing Fees for Formal Written
Notices
On March 9, 2020, the Treasury
Department published a notice of
proposed rulemaking amending 31 CFR
part 800 and 31 CFR part 802 to
establish a fee for ‘‘covered
transactions’’ and ‘‘covered real estate
transactions,’’ respectively, that are filed
with CFIUS as formal written notices.
85 FR 13586 (March 9, 2020). The
public was provided an opportunity to
comment on the proposed rule and
several comments were received.
Following consideration of the public
comments, on April 29, 2020, the
Treasury Department published an
interim rule establishing filing fees,
effective May 1, 2020. 85 FR 23736
(April 29, 2020). As explained in the
preamble to the interim rule, subpart K
on filing fees was added to the
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]]>Agencies
[Federal Register Volume 85, Number 145 (Tuesday, July 28, 2020)]
[Rules and Regulations]
[Page 45311]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15761]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
[Docket No. FDA-2020-N-0002]
New Animal Drugs; Withdrawal of Approval of Abbreviated New
Animal Drug Application
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of withdrawal.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of an abbreviated new animal drug application (ANADA) at the sponsor's
request because the product is no longer manufactured or marketed.
DATES: Withdrawal of approval is effective July 28, 2020.
FOR FURTHER INFORMATION CONTACT: Sujaya Dessai, Center for Veterinary
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240-402-5761, [email protected].
SUPPLEMENTARY INFORMATION: Hikma International Pharmaceuticals LLC,
P.O. Box 182400, Bayader Wadi Seer, Amman, Jordan 11118, has requested
that FDA withdraw approval of ANADA 200-323 for use of a 1-gram bolus
of phenylbutazone in horses because the product is no longer
manufactured or marketed.
Therefore, under authority delegated to the Commissioner of Food
and Drugs and in accordance with Sec. 514.116 Notice of withdrawal of
approval of application (21 CFR 514.116), notice is given that approval
of ANADA 200-323, and all supplements and amendments thereto, is hereby
withdrawn, effective July 28, 2020.
Elsewhere in this issue of the Federal Register, FDA is amending
the animal drug regulations to reflect the voluntary withdrawal of
approval of these applications.
Dated: July 15, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-15761 Filed 7-27-20; 8:45 am]
BILLING CODE 4164-01-P
