New Animal Drugs; Withdrawal of Approval of a New Animal Drug Application; Withdrawal of Approval of Abbreviated New Animal Drug Applications, 4210-4211 [2020-00422]
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Federal Register / Vol. 85, No. 16 / Friday, January 24, 2020 / Rules and Regulations
Avilamycin
in grams/ton
Indications for use
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(ii) 13.6 to 40.9 ..........
(iii) 13.6 to 40.9 .........
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(v) 13.6 to 40.9 ..........
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Salinomycin sodium, 40 to 60 ......... Feed as the sole ration for 21 consecutive days. Feed to chickens that are at risk of developing, but not yet showing clinical signs of, necrotic enteritis associated with Clostridium perfringens. Avilamycin has not been demonstrated to be effective in broiler
chickens showing clinical signs of necrotic enteritis prior to the start of medication. To
assure responsible antimicrobial drug use in broiler chickens, treatment administration
must begin on or before 18 days of age. The safety of avilamycin has not been established in chickens intended for breeding purposes. May be fatal if fed to adult turkeys or
to horses. Not approved for use with pellet binders. Do not feed to laying hens producing eggs for human consumption. Salinomycin as provided by No. 016592 in
§ 510.600(c) of this chapter.
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28. In § 558.355, revise paragraphs (b)
and (f)(6)(i) to read as follows:
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Monensin.
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(b) Sponsors. See sponsors in
§ 510.600(c) of this chapter for use as in
paragraph (f) of this section.
(1) No. 058198 for use as in paragraph
(f) of this section.
(2) No. 016592 for use of a Type A
medicated article containing 90.7 grams
Indications for use
Limitations
(i) 20 ......................
For the prevention of coccidiosis caused
by Eimeria crandallis, E. christenseni,
and E. ninakohlyakimovae.
Feed only to goats being fed in confinement. Do not feed to lactating goats. See
paragraph (d)(11) of this section for provisions for monensin liquid Type C goat
feeds.
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§ 558.625
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[Amended]
29. Amend § 558.625:
a. By removing ‘‘monensin as
provided by No. 058198’’ and adding in
its place ‘‘monensin as provided by Nos.
016592 or 058198’’ in the ‘‘Limitations’’
column, in:
■ 1. Paragraph (e)(2)(iv),
■ 2. Paragraph (e)(2)(v),
■ 3. Paragraph (e)(2)(x),
■ 4. Paragraph (e)(2)(xi),
■ 5. Paragraph (e)(2)(xii), and
■ 6. Paragraph (e)(2)(xiii); and
■ b. By adding ‘‘016592’’ in numerical
order in the ‘‘Sponsors’’ column in:
■ 1. Paragraph (e)(2)(x),
■ 2. Paragraph (e)(2)(xi),
■ 3. Paragraph (e)(2)(xii), and
■
■
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4. Paragraph (e)(2)(xiii).
[FR Doc. 2020–00421 Filed 1–23–20; 8:45 am]
058198
058198
Sponsor
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Dated: January 9, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
058198
monensin, USP, per pound as in
paragraphs (f)(3), (f)(4)(vi), and (f)(6) of
this section.
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(f) * * *
(6) * * *
Monensin
in grams/ton
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Sponsor
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Monensin, 90 to 110 ........................ Feed as the sole ration for 21 consecutive days. Feed to chickens that are at risk of developing, but not yet showing clinical signs of, necrotic enteritis associated with Clostridium perfringens in broiler chickens. Avilamycin has not been demonstrated to be effective in broiler chickens showing clinical signs of necrotic enteritis prior to the start of
medication. To assure responsible antimicrobial drug use in broiler chickens, treatment
administration must begin on or before 18 days of age. Do not feed to chickens over 16
weeks of age. The safety of avilamycin has not been established in chickens intended
for breeding purposes. Do not allow horses or other equines access to feed containing
avilamycin and monensin. Ingestion of monensin by horses has been fatal. Do not feed
to chickens producing eggs for human consumption. Monensin as provided by No.
058198 in § 510.600(c) of this chapter.
Narasin, 54 to 90 ............................. Feed as the sole ration for 21 consecutive days. Feed to chickens that are at risk of developing, but not yet showing clinical signs of, necrotic enteritis associated with Clostridium perfringens. Avilamycin has not been demonstrated to be effective in broiler
chickens showing clinical signs of necrotic enteritis prior to the start of medication. To
assure responsible antimicrobial drug use in broiler chickens, treatment administration
must begin on or before 18 days of age. The safety of avilamycin has not been established in chickens intended for breeding purposes. Do not allow adult turkeys, horses,
or other equines access to narasin formulations. Ingestion of narasin by these species
has been fatal. Do not feed to chickens producing eggs for human consumption.
Narasin as provided by No. 058198 in § 510.600(c) of this chapter.
■
§ 558.355
Limitations
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058198
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 520, 522, and 529
BILLING CODE 4164–01–P
PO 00000
[Docket No. FDA–2019–N–0002]
New Animal Drugs; Withdrawal of
Approval of a New Animal Drug
Application; Withdrawal of Approval of
Abbreviated New Animal Drug
Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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Notification of withdrawal.
24JAR1
Federal Register / Vol. 85, No. 16 / Friday, January 24, 2020 / Rules and Regulations
The Food and Drug
Administration (FDA) is withdrawing
approval of a new animal drug
application (NADA) and two
abbreviated new animal drug
applications (ANADAs) at the sponsors’
request because the products are no
longer manufactured or marketed.
SUMMARY:
Withdrawal of approval is
applicable February 3, 2020.
DATES:
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.
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA–446]
Schedules of Controlled Substances:
Placement of 5F-ADB, 5F-AMB, 5FAPINACA, ADB-FUBINACA, MDMBCHMICA and MDMB-FUBINACA in
Schedule I
Drug Enforcement
Administration, Department of Justice.
ACTION: Final rule.
AGENCY:
Dated: January 9, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
The Drug Enforcement
Administration places methyl 2-(1-(5fluoropentyl)-1H-indazole-3carboxamido)-3,3-dimethylbutanoate
[5F-ADB; 5F-MDMB-PINACA]; methyl
2-(1-(5-fluoropentyl)-1H-indazole-3carboxamido)-3-methylbutanoate [5FAMB]; N-(adamantan-1-yl)-1-(5fluoropentyl)-1H-indazole-3carboxamide [5F-APINACA, 5F-AKB48];
N-(1-amino-3,3-dimethyl-1-oxobutan-2yl)-1-(4-fluorobenzyl)-1H-indazole-3carboxamide [ADB-FUBINACA]; methyl
2-(1-(cyclohexylmethyl)-1H-indole-3carboxamido)-3,3-dimethylbutanoate
[MDMB-CHMICA, MMB-CHMINACA];
and methyl 2-(1-(4-fluorobenzyl)-1Hindazole-3-carboxamido)-3,3dimethylbutanoate [MDMBFUBINACA], including their salts,
isomers, and salts of isomers whenever
the existence of such salts, isomers, and
salts of isomers is possible, in schedule
I of the Controlled Substances Act. This
action continues the imposition of the
regulatory controls and administrative,
civil, and criminal sanctions applicable
to schedule I controlled substances on
persons who handle (manufacture,
distribute, import, export, engage in
research, conduct instructional
activities or chemical analysis, or
possess), or propose to handle 5F-ADB,
5F-AMB, 5F-APINACA, ADBFUBINACA, MDMB-CHMICA, and
MDMB-FUBINACA.
DATES: Effective: January 24, 2020.
FOR FURTHER INFORMATION CONTACT:
Scott A. Brinks, Regulatory Drafting and
Policy Support Section, Diversion
Control Division, Drug Enforcement
Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia
22152; Telephone: (202) 598–6812.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2020–00422 Filed 1–23–20; 8:45 am]
Legal Authority
BILLING CODE 4164–01–P
The Controlled Substances Act (CSA)
provides that proceedings for the
issuance, amendment, or repeal of the
scheduling of any drug or other
SUMMARY:
Fleming
Laboratories, Inc., P.O. Box 34384,
Charlotte, NC 28234, has requested that
FDA withdraw approval of NADA 010–
005 for use of WAZINE (dipiperazine
sulfate and piperazine hydrochloride)
Soluble Powders because the product is
no longer manufactured or marketed.
Also, Halocarbon Products Corp.,
6525 The Corners Pkwy., Suite 200,
Peachtree Corners, GA 30092, has
requested that FDA withdraw approval
of ANADA 200–200 for use of
Halothane USP (halothane) because the
product is no longer manufactured or
marketed.
Lastly, Mylan Institutional LLC, 4901
Hiawatha Dr., Rockford, IL 61103, has
requested that FDA withdraw approval
of ANADA 200–472 for use of
Fomepizole Injection 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
(21 CFR 514.116), notice is given that
approval of NADA 010–005 and
ANADAs 200–200 and 200–472, and all
supplements and amendments thereto,
is hereby withdrawn, effective February
3, 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.
SUPPLEMENTARY INFORMATION:
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DEPARTMENT OF JUSTICE
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4211
substance may be initiated by the
Attorney General (1) on his own motion;
(2) at the request of the Secretary of the
Department of Health and Human
Services (HHS); 1 or (3) on the petition
of any interested party. 21 U.S.C. 811(a).
This action was initiated on the
Attorney General’s own motion, as
delegated to the Administrator of the
DEA, and is supported by, inter alia, a
recommendation from the Assistant
Secretary for Health of HHS and an
evaluation of all relevant data by the
DEA. This action continues the
imposition of the regulatory controls
and administrative, civil, and criminal
sanctions of schedule I controlled
substances on any person who handles
or proposes to handle 5F-ADB, 5F-AMB,
5F-APINACA, ADB-FUBINACA,
MDMB-CHMICA and MDMBFUBINACA.
Background
On April 10, 2017, DEA published an
order in the Federal Register amending
21 CFR 1308.11(h) to temporarily place
the six synthetic cannabinoids (SCs)
methyl 2-(1-(5-fluoropentyl)-1Hindazole-3-carboxamido)-3,3dimethylbutanoate [5F-ADB; 5F-MDMBPINACA]; methyl 2-(1-(5-fluoropentyl)1H-indazole-3-carboxamido)-3methylbutanoate [5F-AMB]; N(adamantan-1-yl)-1-(5-fluoropentyl)-1Hindazole-3-carboxamide [5F-APINACA,
5F-AKB48]; N-(1-amino-3,3-dimethyl-1oxobutan-2-yl)-1-(4-fluorobenzyl)-1Hindazole-3-carboxamide [ADBFUBINACA]; methyl 2-(1(cyclohexylmethyl)-1H-indole-3carboxamido)-3,3-dimethylbutanoate
[MDMB-CHMICA, MMB-CHMINACA];
and methyl 2-(1-(4-fluorobenzyl)-1Hindazole-3-carboxamido)-3,3dimethylbutanoate [MDMB-FUBINACA]
in schedule I of the CSA pursuant to the
temporary scheduling provisions of 21
U.S.C. 811(h). 82 FR 17119. That
temporary scheduling order was
effective on the date of publication, and
was based on findings by the former
Acting Administrator of the DEA
(Acting Administrator) that the
temporary scheduling of these six SCs
was necessary to avoid an imminent
hazard to the public safety pursuant to
21 U.S.C. 811(h)(1). Section 201(h)(2) of
1 As set forth in a memorandum of understanding
entered into by the Food and Drug Administration
(FDA) and the National Institute on Drug Abuse
(NIDA), the FDA acts as the lead agency within the
Department of Health and Human Services (HHS)
in carrying out the Secretary’s scheduling
responsibilities under the CSA, with the
concurrence of NIDA. 50 FR 9518, Mar. 8, 1985.
The Secretary of the HHS has delegated to the
Assistant Secretary for Health of the HHS the
authority to make domestic drug scheduling
recommendations. 58 FR 35460, July 1, 1993.
E:\FR\FM\24JAR1.SGM
24JAR1
]]>Agencies
[Federal Register Volume 85, Number 16 (Friday, January 24, 2020)]
[Rules and Regulations]
[Pages 4210-4211]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00422]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 520, 522, and 529
[Docket No. FDA-2019-N-0002]
New Animal Drugs; Withdrawal of Approval of a New Animal Drug
Application; Withdrawal of Approval of Abbreviated New Animal Drug
Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of withdrawal.
-----------------------------------------------------------------------
[[Page 4211]]
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of a new animal drug application (NADA) and two abbreviated new animal
drug applications (ANADAs) at the sponsors' request because the
products are no longer manufactured or marketed.
DATES: Withdrawal of approval is applicable February 3, 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: Fleming Laboratories, Inc., P.O. Box 34384,
Charlotte, NC 28234, has requested that FDA withdraw approval of NADA
010-005 for use of WAZINE (dipiperazine sulfate and piperazine
hydrochloride) Soluble Powders because the product is no longer
manufactured or marketed.
Also, Halocarbon Products Corp., 6525 The Corners Pkwy., Suite 200,
Peachtree Corners, GA 30092, has requested that FDA withdraw approval
of ANADA 200-200 for use of Halothane USP (halothane) because the
product is no longer manufactured or marketed.
Lastly, Mylan Institutional LLC, 4901 Hiawatha Dr., Rockford, IL
61103, has requested that FDA withdraw approval of ANADA 200-472 for
use of Fomepizole Injection 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 NADA 010-005 and ANADAs 200-200 and 200-472, and all supplements and
amendments thereto, is hereby withdrawn, effective February 3, 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: January 9, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-00422 Filed 1-23-20; 8:45 am]
BILLING CODE 4164-01-P
