New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications, 48950 [2018-21147]
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48950
Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Rules and Regulations
Dated: September 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
File No.
Product name
136–116 ...
PURINA WORM-ARESTTM Litter Pack
Premix (fenbendazole).
PURINA SAF-T-BLOC
BG Medicated Feed
Block (poloxalene,
6.6%).
[FR Doc. 2018–21146 Filed 9–27–18; 8:45 am]
BILLING CODE 4164–01–P
140–869 ...
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 520, 522, 524, and 558
[Docket No. FDA–2018–N–0002]
New Animal Drugs; Withdrawal of
Approval of New Animal Drug
Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notification of withdrawal.
The Food and Drug
Administration (FDA) is withdrawing
approval of 12 new animal drug
applications (NADAs) at the sponsor’s
request because these products are no
longer manufactured or marketed.
DATES: Withdrawal of approval is
effective October 9, 2018.
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: Virbac
AH, Inc., 3200 Meacham Blvd., Ft.
Worth, TX 76137, has requested that
FDA withdraw approval of the NADAs
listed in the following table because the
products are no longer manufactured or
marketed:
SUMMARY:
Product name
011–779 ...
PURINA PIGEMIA 100
(colloidal ferric oxide).
PURINA Horse Wormer
Medicated
(thiabendazole).
PURINA 6 DAY WORMKILL Feed Premix
(coumaphos).
PURINA GRUB-KILL
Pour-on Cattle Insecticide (famphur).
STATYL Medicated Premix (nequinate).
PULVEX WORM CAPS
(piperazine phosphate
monohydrate).
PURINA BAN-WORM for
Pigs (pyrantel tartrate).
PULVEX Multipurpose
Worm Caps
(dichlorophene, toluene).
PURINA PIGEMIA Oral
(iron dextran complex).
CHECK-R-TON BM
(pyrantel tartrate).
040–205 ...
042–116 ...
043–215 ...
046–700 ...
091–260 ...
097–258 ...
daltland on DSKBBV9HB2PROD with RULES
21 CFR
section
File No.
102–942 ...
113–748 ...
135–941 ...
VerDate Sep<11>2014
17:35 Sep 27, 2018
522.1182
520.2380a
524.900
558.365
520.1804
558.485
520.580
520.1182
558.485
Jkt 244001
520.905d
520.1840
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 NADAs 011–779, 040–205,
042–116, 043–215, 046–700, 091–260,
097–258, 102–942, 113–748, 135–941,
136–116, and 140–869, and all
supplements and amendments thereto,
is hereby withdrawn, effective October
9, 2018.
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: September 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–21147 Filed 9–27–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Parts 1308, 1312
[Docket No. DEA–486]
Schedules of Controlled Substances:
Placement in Schedule V of Certain
FDA-Approved Drugs Containing
Cannabidiol; Corresponding Change to
Permit Requirements
Drug Enforcement
Administration, Department of Justice.
ACTION: Final order.
AGENCY:
With the issuance of this final
order, the Acting Administrator of the
Drug Enforcement Administration
places certain drug products that have
been approved by the Food and Drug
Administration (FDA) and which
contain cannabidiol (CBD) in schedule
V of the Controlled Substances Act
(CSA). Specifically, this order places
FDA-approved drugs that contain CBD
derived from cannabis and no more than
0.1 percent tetrahydrocannabinols in
schedule V. This action is required to
satisfy the responsibility of the Acting
Administrator under the CSA to place a
drug in the schedule he deems most
appropriate to carry out United States
obligations under the Single Convention
SUMMARY:
558.185
21 CFR
section
PO 00000
Frm 00046
Fmt 4700
Sfmt 4700
on Narcotic Drugs, 1961. Also consistent
therewith, DEA is adding such drugs to
the list of substances that may only be
imported or exported pursuant to a
permit.
DATES: Effective September 28, 2018.
FOR FURTHER INFORMATION CONTACT:
Kathy L. Federico, Regulatory Drafting
and Policy Support Section (DPW),
Diversion Control Division, Drug
Enforcement Administration; Mailing
Address: 8701 Morrissette Drive,
Springfield, Virginia 22152; Telephone:
(202) 598–6812.
SUPPLEMENTARY INFORMATION:
Background and Legal Authority
The United States is a party to the
Single Convention on Narcotic Drugs,
1961 (Single Convention), and other
international conventions designed to
establish effective control over
international and domestic traffic in
controlled substances. 21 U.S.C. 801(7).
The Single Convention entered into
force for the United States on June 24,
1967, after the Senate gave its advice
and consent to the United States’
accession. See Single Convention, 18
U.S.T. 1407. The enactment and
enforcement of the Controlled
Substances Act (CSA) are the primary
means by which the United States
carries out its obligations under the
Single Convention.1 Various provisions
of the CSA directly reference the Single
Convention. One such provision is 21
U.S.C. 811(d)(1), which relates to
scheduling of controlled substances.
As stated in subsection 811(d)(1), if
control of a substance is required ‘‘by
United States obligations under
international treaties, conventions, or
protocols in effect on October 27, 1970,
the Attorney General shall issue an
order controlling such drug under the
schedule he deems most appropriate to
carry out such obligations, without
regard to the findings required by
[subsections 811(a) or 812(b)] and
without regard to the procedures
prescribed by [subsections 811(a) and
(b)].’’ This provision is consistent with
the Supremacy Clause of the U.S.
Constitution (art. VI, sec. 2), which
provides that all treaties made under the
authority of the United States ‘‘shall be
the supreme Law of the Land.’’ In
accordance with this constitutional
1 See S. Rep. No. 91–613, at 4 (1969) (‘‘The United
States has international commitments to help
control the worldwide drug traffic. To honor those
commitments, principally those established by the
Single Convention on Narcotic Drugs of 1961, is
clearly a Federal responsibility.’’); Control of
Papaver Bracteatum, 1 Op. O.L.C. 93, 95 (1977)
(‘‘[A] number of the provisions of [the CSA] reflect
Congress’ intent to comply with the obligations
imposed by the Single Convention.’’).
E:\FR\FM\28SER1.SGM
28SER1
]]>Agencies
[Federal Register Volume 83, Number 189 (Friday, September 28, 2018)]
[Rules and Regulations]
[Page 48950]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21147]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 520, 522, 524, and 558
[Docket No. FDA-2018-N-0002]
New Animal Drugs; Withdrawal of Approval of New Animal Drug
Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of withdrawal.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of 12 new animal drug applications (NADAs) at the sponsor's request
because these products are no longer manufactured or marketed.
DATES: Withdrawal of approval is effective October 9, 2018.
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: Virbac AH, Inc., 3200 Meacham Blvd., Ft.
Worth, TX 76137, has requested that FDA withdraw approval of the NADAs
listed in the following table because the products are no longer
manufactured or marketed:
------------------------------------------------------------------------
File No. Product name 21 CFR section
------------------------------------------------------------------------
011-779............... PURINA PIGEMIA 100 522.1182
(colloidal ferric oxide).
040-205............... PURINA Horse Wormer 520.2380a
Medicated
(thiabendazole).
042-116............... PURINA 6 DAY WORM-KILL 558.185
Feed Premix (coumaphos).
043-215............... PURINA GRUB-KILL Pour-on 524.900
Cattle Insecticide
(famphur).
046-700............... STATYL Medicated Premix 558.365
(nequinate).
091-260............... PULVEX WORM CAPS 520.1804
(piperazine phosphate
monohydrate).
097-258............... PURINA BAN-WORM for Pigs 558.485
(pyrantel tartrate).
102-942............... PULVEX Multipurpose Worm 520.580
Caps (dichlorophene,
toluene).
113-748............... PURINA PIGEMIA Oral (iron 520.1182
dextran complex).
135-941............... CHECK-R-TON BM (pyrantel 558.485
tartrate).
136-116............... PURINA WORM-A-RESTTM 520.905d
Litter Pack Premix
(fenbendazole).
140-869............... PURINA SAF-T-BLOC BG 520.1840
Medicated Feed Block
(poloxalene, 6.6%).
------------------------------------------------------------------------
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 NADAs 011-779, 040-205, 042-116, 043-215, 046-700, 091-260, 097-258,
102-942, 113-748, 135-941, 136-116, and 140-869, and all supplements
and amendments thereto, is hereby withdrawn, effective October 9, 2018.
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: September 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21147 Filed 9-27-18; 8:45 am]
BILLING CODE 4164-01-P
