New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor's Name, 48940-48950 [2018-21146]
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48940
Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Rules and Regulations
Authority: 49 U.S.C. 106(g), 40113, 44701.
§ 39.13
[Amended]
2. The FAA amends § 39.13 by adding
the following new airworthiness
directive (AD):
■
2018–19–30 BAE Systems (Operations)
Limited: Amendment 39–19431; Docket
No. FAA–2018–0555; Product Identifier
2017–NM–152–AD.
(a) Effective Date
This AD is effective November 2, 2018.
(b) Affected ADs
None.
(c) Applicability
This AD applies to BAE Systems
(Operations) Limited Model 4101 airplanes,
certificated in any category, all serial
numbers.
(d) Subject
Air Transport Association (ATA) of
America Code 26, Fire protection.
(e) Reason
This AD was prompted by a report of an
improperly installed spacer around the
electrical pins in the cartridge connector for
the fire bottle extinguisher cartridge. We are
issuing this AD to detect and correct
excessive or missing spacers, which could
result in the fire extinguisher bottle not
discharging when required, possibly
resulting in damage to the airplane.
(f) Compliance
Comply with this AD within the
compliance times specified, unless already
done.
(g) Inspection
Within 12 months after the effective date
of this AD, do a general visual inspection of
the inside of the cartridge electrical
connector and the inside of the airplane
electrical connector in accordance with the
Accomplishment Instructions of the BAE
Systems (Operations) Limited Service
Bulletin J41–26–009, dated November 23,
2016.
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(h) Inspections After Maintenance
As of the effective date of this AD, before
further flight after each accomplishment of a
maintenance task involving disconnection or
(re-)connection of an electrical connector of
a fire bottle extinguisher cartridge, do a
general visual inspection of the inside of the
cartridge electrical connector and the inside
of the airplane electrical connector in
accordance with the Accomplishment
Instructions of BAE Systems (Operations)
Limited Service Bulletin J41–26–009, dated
November 23, 2016.
(i) Corrective Actions
(1) If, during any inspection as required by
paragraph (g) or (h) of this AD, as applicable,
more than one spacer is found inside the
cartridge electrical connector: Before further
flight, remove the excessive spacer(s) from
the inside of the cartridge electrical
connector in accordance with the
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Accomplishment Instructions of BAE
Systems (Operations) Limited Service
Bulletin J41–26–009, dated November 23,
2016.
(2) If, during any inspection as required by
paragraph (g) or (h) of this AD, as applicable,
one or more spacers are found inside the
airplane electrical connector: Before further
flight, remove all spacers from the inside of
the airplane electrical connector in
accordance with the Accomplishment
Instructions of BAE Systems (Operations)
Limited Service Bulletin J41–26–009, dated
November 23, 2016.
(3) If, during any inspection as required by
paragraph (g) or (h) of this AD, as applicable,
no blue spacer is found inside the cartridge
electrical connector body: Before further
flight, replace the cartridge in accordance
with the Accomplishment Instructions of the
BAE Systems (Operations) Limited Service
Bulletin J41–26–009, dated November 23,
2016.
(j) Other FAA AD Provisions
The following provisions also apply to this
AD:
(1) Alternative Methods of Compliance
(AMOCs): The Manager, International
Section, Transport Standards Branch, FAA,
has the authority to approve AMOCs for this
AD, if requested using the procedures found
in 14 CFR 39.19. In accordance with 14 CFR
39.19, send your request to your principal
inspector or local Flight Standards District
Office, as appropriate. If sending information
directly to the International Section, send it
to the attention of the person identified in
paragraph (k)(2) of this AD. Information may
be emailed to: 9-ANM-116-AMOCREQUESTS@faa.gov. Before using any
approved AMOC, notify your appropriate
principal inspector, or lacking a principal
inspector, the manager of the local flight
standards district office/certificate holding
district office.
(2) Contacting the Manufacturer: For any
requirement in this AD to obtain corrective
actions from a manufacturer, the action must
be accomplished using a method approved
by the Manager, International Section,
Transport Standards Branch, FAA; or the
European Aviation Safety Agency (EASA); or
BAE Systems (Operations) Limited’s EASA
Design Organization Approval (DOA). If
approved by the DOA, the approval must
include the DOA-authorized signature.
(k) Related Information
(1) Refer to Mandatory Continuing
Airworthiness Information (MCAI) EASA AD
2017–0212, dated October 25, 2017, for
related information. This MCAI may be
found in the AD docket on the internet at
https://www.regulations.gov by searching for
and locating Docket No. FAA–2018–0555.
(2) For more information about this AD,
contact Todd Thompson, Aerospace
Engineer, International Section, Transport
Standards Branch, FAA, 2200 South 216th
St., Des Moines, WA 98198; telephone and
fax 206–231–3228.
(l) Material Incorporated by Reference
(1) The Director of the Federal Register
approved the incorporation by reference
(IBR) of the service information listed in this
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paragraph under 5 U.S.C. 552(a) and 1 CFR
part 51.
(2) You must use this service information
as applicable to do the actions required by
this AD, unless this AD specifies otherwise.
(i) BAE Systems (Operations) Limited
Service Bulletin J41–26–009, dated
November 23, 2016.
(ii) Reserved.
(3) For service information identified in
this AD, contact BAE Systems (Operations)
Limited, Customer Information Department,
Prestwick International Airport, Ayrshire,
KA9 2RW, Scotland, United Kingdom;
telephone +44 1292 675207; fax +44 1292
675704; email RApublications@
baesystems.com; internet https://
www.baesystems.com/Businesses/
RegionalAircraft/index.htm.
(4) You may view this service information
at the FAA, Transport Standards Branch,
2200 South 216th St., Des Moines, WA. For
information on the availability of this
material at the FAA, call 206–231–3195.
(5) You may view this service information
that is incorporated by reference at the
National Archives and Records
Administration (NARA). For information on
the availability of this material at NARA, call
202–741–6030, or go to: https://
www.archives.gov/federal-register/cfr/ibrlocations.html.
Issued in Des Moines, Washington, on
September 14, 2018.
John P. Piccola,
Acting Director, System Oversight Division,
Aircraft Certification Service.
[FR Doc. 2018–20923 Filed 9–27–18; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, 529,
556, and 558
[Docket No. FDA–2018–N–0002]
New Animal Drugs; Approval of New
Animal Drug Applications; Withdrawal
of Approval of New Animal Drug
Applications; Changes of
Sponsorship; Change of a Sponsor’s
Name
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendments.
ACTION:
The Food and Drug
Administration (FDA or we) is
amending the animal drug regulations to
reflect application-related actions for
new animal drug applications (NADAs)
and abbreviated new animal drug
applications (ANADAs) during January,
February, and March 2018. FDA is
informing the public of the availability
SUMMARY:
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Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Rules and Regulations
of summaries of the basis of approval
and of environmental review
documents, where applicable. The
animal drug regulations are also being
amended to reflect the withdrawal of
approval of applications, changes of
sponsorship of applications, and a
change of a sponsor’s name, and to
make technical amendments to improve
the accuracy of the regulations.
This rule is effective September
28, 2018, except for amendatory
instructions 7 to 21 CFR 520.580, 18 to
21 CFR 520.905d, 20 to 21 CFR
520.1182, 29 to 21 CFR 520.1840, 33 to
21 CFR 520.2380a, 37 to 21 CFR
522.1182, 51 to 21 CFR 524.900, 62 to
21 CFR 558.185, 68 to 21 CFR 558.365,
and 70 to 21 CFR 558.485, which are
effective October 9, 2018.
DATES:
FOR FURTHER INFORMATION CONTACT:
George K. Haibel, Center for Veterinary
Medicine (HFV–6), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–5689,
george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Approval Actions
FDA is amending the animal drug
regulations to reflect approval actions
for NADAs and ANADAs during
January, February, and March 2018, as
listed in table 1. In addition, FDA is
informing the public of the availability,
where applicable, of documentation of
environmental review required under
the National Environmental Policy Act
(NEPA) and, for actions requiring
review of safety or effectiveness data,
summaries of the basis of approval (FOI
48941
Summaries) under the Freedom of
Information Act (FOIA). These public
documents may be seen in the office of
the Dockets Management Staff (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852, between 9 a.m. and 4 p.m.,
Monday through Friday. Persons with
access to the internet may obtain these
documents at the CVM FOIA Electronic
Reading Room: https://www.fda.gov/
AboutFDA/CentersOffices/Officeof
Foods/CVM/CVMFOIAElectronic
ReadingRoom/default.htm. Marketing
exclusivity and patent information may
be accessed in FDA’s publication,
Approved Animal Drug Products Online
(Green Book) at: https://www.fda.gov/
AnimalVeterinary/Products/
ApprovedAnimalDrugProducts/
default.htm.
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING JANUARY, FEBRUARY, AND MARCH
2018
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Approval date
File No.
Sponsor
Product name
Species
Effect of the action
Public
documents
Supplemental approval for the
treatment and control of certain nematode worms in laying hens; and of a tolerance
in chicken eggs.
Original approval as a generic
copy of NADA 141–079.
FOI Summary;
EA/FONSI 1.
Original approval for killing
adult fleas, and for the treatment of flea infestations and
the treatment and control of
tick infestations in dogs.
Original approval as a generic
copy of NADA 141–185.
FOI Summary.
Original approval for the control of necrotic enteritis and
for the prevention of coccidiosis in broiler chickens.
Original approval for the control of necrotic enteritis and
for the prevention of coccidiosis in broiler chickens.
Original approval for the control of necrotic enteritis and
for the prevention of coccidiosis in broiler chickens.
Original approval for the control of necrotic enteritis and
for the prevention and control of coccidiosis in broiler
chickens.
Original approval for the prevention of heartworm disease, and for the treatment
and control of roundworms,
hookworms, and tapeworms
in cats and kittens.
Original approval for the control of necrotic enteritis and
as an aid in the prevention
of coccidiosis in broiler
chickens.
FOI Summary.
January 5,
2018.
141–449
Intervet, Inc., 2 Giralda Farms,
Madison, NJ 07940.
SAFE–GUARD AquaSol
(fenbendazole oral suspension), Suspension Concentrate.
Chickens .........
January 16,
2018.
200–563
141–494
EPRIZERO (eprinomectin),
Pour-On for Beef and Dairy
Cattle.
CREDELIO (lotilaner),
Chewable Tablet.
Cattle ...............
January 19,
2018.
Norbrook Laboratories, Ltd.,
Station Works, Newry BT35
6JP, Northern Ireland.
Elanco US Inc., 2500 Innovation Way, Greenfield, IN
46140.
January 29,
2018.
200–622
141–482
February 28,
2018.
141–483
Zoetis Inc., 333 Portage St.,
Kalamazoo, MI 49007.
Chlortetracycline and
decoquinate, Type C medicated feeds.
LINCOMIX (lincomycin) and
ROBENZ (robenidine hydrochloride), Type C medicated
feeds.
LINCOMIX (lincomycin) and
DECCOX (decoquinate),
Type C medicated feeds.
Cattle ...............
February 28,
2018.
Pharmgate LLC, 1800 Sir
Tyler Dr., Wilmington, NC
28405.
Zoetis Inc., 333 Portage St.,
Kalamazoo, MI 49007.
March 2, 2018
141–484
Zoetis Inc., 333 Portage St.,
Kalamazoo, MI 49007.
Chickens .........
March 5, 2018
141–489
Zoetis Inc., 333 Portage St.,
Kalamazoo, MI 49007.
LINCOMIX (lincomycin) and
BIO–COX (salinomycin sodium), Type C medicated
feeds.
LINCOMIX (lincomycin) and
ZOAMIX (zoalene), Type C
medicated feeds.
March 8, 2018
141–492
Merial, Inc., 3239 Satellite
Blvd., Bldg. 500, Duluth, GA
30096–4640.
CENTRAGARD (eprinomectin
and praziquantel
transdermal solution).
Cats .................
March 26, 2018
141–491
Zoetis Inc., 333 Portage St.,
Kalamazoo, MI 49007.
LINCOMIX (lincomycin) and
COBAN (monensin), Type C
medicated feeds.
Chickens .........
Dogs ................
Chickens .........
Chickens .........
Chickens .........
FOI Summary.
FOI Summary.
FOI Summary.
FOI Summary.
FOI Summary.
FOI Summary.
FOI Summary.
1 The Agency has carefully considered an environmental assessment (EA) of the potential environmental impact of this action and has made a finding of no significant impact (FONSI).
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Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Rules and Regulations
II. Change of Sponsorship
Agri Laboratories Ltd., P.O. Box 3103,
St. Joseph, MO 64503 has informed FDA
that it has transferred ownership of, and
all rights and interest in, the following
applications to Huvepharma EOOD, 5th
File No.
200–030
200–031
200–037
200–038
200–049
200–061
200–066
200–128
200–185
200–225
200–271
200–407
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DI-METHOX (sulfadimethoxine) 12.5% Solution ...........................................................................................
DI-METHOX (sulfadimethoxine) Soluble Powder ..........................................................................................
LEGACY (gentamicin sulfate) Solution ..........................................................................................................
DI-METHOX (sulfadimethoxine) Injection 40% .............................................................................................
TETRA-BAC 324 (tetracycline hydrochloride) Soluble Powder ....................................................................
FLU-NIX (flunixin meglumine) Injection .........................................................................................................
AGRIMYCIN-343 (oxytetracycline hydrochloride) Soluble Powder ...............................................................
AGRIMYCIN-200 (oxytetracycline dihydrate) Injection ..................................................................................
GEN-GARD (gentamicin sulfate) Soluble Powder ........................................................................................
PROHIBIT (levamisole hydrochloride) Soluble Drench Powder ...................................................................
Levamisole Phosphate Injection ....................................................................................................................
Lincomycin-Spectinomycin (lincomycin hydrochloride/spectinomycin dihydrochloride pentahydrate) Water
Soluble Powder.
approved applications in § 510.600(c)
(21 CFR 510.600(c)).
Strategic Veterinary Pharmaceuticals,
Inc., 100 NW Airport Rd., St. Joseph,
MO 64503 has informed FDA that it has
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File No.
21 CFR
section
DIZAN (dithiazanine iodide) Tablets ..............................................................................................................
DIZAN (dithiazanine iodide) Powder .............................................................................................................
DIZAN (dithiazanine iodide) Suspension with Piperazine Citrate .................................................................
ATGARD (dichlorvos) Swine Wormer ...........................................................................................................
TASK (dichlorvos) Dog Anthelmintic .............................................................................................................
EQUIGARD; VERDISOL (dichlorvos) ............................................................................................................
BIO-TAL (thiamylal sodium) Injection ............................................................................................................
ATGARD C (dichlorvos) Swine Wormer ........................................................................................................
ATGARD V (dichlorvos) Swine Wormer ........................................................................................................
OXYJECT (oxytetracycline hydrochloride) Injection ......................................................................................
BIO-MYCIN OXY-TET 50 (oxytetracycline hydrochloride) Injection .............................................................
BIZOLIN–100; BIZOLIN–200 (phenylbutazone) Injection .............................................................................
ANAPLEX (dichlorophene and toluene) Canine and Feline Wormer Caps ..................................................
EQUIGEL (dichlorvos) ...................................................................................................................................
TASK (dichlorvos) Tablets .............................................................................................................................
ATGARD C (dichlorvos) Premix 9.6% ...........................................................................................................
ANACETIN (chloramphenicol) Tablets ..........................................................................................................
Calf Scour Boluses (chlortetracycline hydrochloride) ....................................................................................
CTC Bisulfate (chlortetracycline bisulfate) Soluble Powder ..........................................................................
MEDICHOL (chloramphenicol) Tablets .........................................................................................................
NEMACIDE (diethylcarbamazine citrate) Oral Syrup ....................................................................................
BIZOLIN (phenylbutazone) Injection 20% .....................................................................................................
OXYJECT 100 (oxytetracycline hydrochloride) Injection ...............................................................................
MEDACIDE–SDM (sulfadimethoxine) Injection 10% .....................................................................................
BIZOLIN (phenylbutazone) 1–G Bolus ..........................................................................................................
MEDAMYCIN (oxytetracycline hydrochloride) Injectable Solution ................................................................
NEUROSYN (primidone) Tablets ..................................................................................................................
Nitrofurazone Dressing ..................................................................................................................................
Nitrofurazone Soluble Powder .......................................................................................................................
D & T (dichlorophene and toluene) Worm Capsules ....................................................................................
NEMACIDE; NEMACIDE–C (diethylcarbamazine citrate) Tablets ................................................................
NEMACIDE (diethylcarbamazine citrate) Chewable Tablets ........................................................................
ANESTATAL (thiamylal sodium) Injectable Solution .....................................................................................
Methylprednisolene Tablets ...........................................................................................................................
Methylprednisolone Acetate Injection ............................................................................................................
Gentamicin Sulfate Injectable Solution ..........................................................................................................
Triamcinolone Acetonide Suspension ...........................................................................................................
Xylazine HCl Injection ....................................................................................................................................
Gentamicin Sulfate Solution 100 mg/mL .......................................................................................................
Ketamine Hydrochloride Injection ..................................................................................................................
SDM (sulfadimethoxine) Concentrated Solution 12.5% ................................................................................
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520.2220a
520.2220a
529.1044a
522.2220
520.2345d
522.970
520.1660d
522.1660a
520.1044c
520.1242a
522.1242
520.1265
transferred ownership of, and all rights
and interest in, the following
applications to Cronus Pharma LLC, 2
Tower Center Blvd., Suite 1101, East
Brunswick, NJ 08816:
Product name
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21 CFR
section
Product name
Following this withdrawal of
approval, Agri Laboratories Ltd. is no
longer the sponsor of an approved
application. Accordingly, it will be
removed from the list of sponsors of
011–531
011–674
012–469
031–512
033–803
035–918
039–483
040–848
043–606
045–143
047–278
047–712
048–010
048–237
048–271
049–032
065–461
065–481
065–486
065–491
092–837
093–516
097–452
098–569
099–618
108–963
117–689
125–797
126–236
126–676
127–627
128–069
132–028
135–771
136–212
137–310
138–869
140–442
200–023
200–029
200–165
Floor, 3A Nikolay Haytov Str., 1113
Sofia, Bulgaria:
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520.763a
520.763b
520.763c
558.205
520.600
520.596
522.2424
558.205
558.205
522.1662a
522.1662a
522.1720
520.580
520.602
520.598
558.205
520.390a
520.443
520.441
520.390a
520.622b
522.1720
522.1662a
522.2220
520.1720a
522.1662a
520.1900
524.1580a
524.1580b
520.580
520.622a
520.622c
522.2424
520.1408
522.1410
522.1044
522.2483
522.2662
522.1044
522.1222
520.2220a
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Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Rules and Regulations
The animal drug regulations are being
amended to reflect these changes of
sponsorship.
III. Withdrawals of Approval
Virbac AH, Inc., 3200 Meacham Blvd.,
Ft. Worth, TX 76137 has requested that
File No.
011–779
040–205
042–116
043–215
046–700
091–260
097–258
102–942
113–748
135–941
136–116
140–869
PURINA PIGEMIA 100 (colloidal ferric oxide) ...............................................................................................
PURINA Horse Wormer Medicated (thiabendazole) .....................................................................................
PURINA 6 DAY WORM–KILL Feed Premix (coumaphos) ...........................................................................
PURINA GRUB–KILL Pour-on Cattle Insecticide (famphur) .........................................................................
STATYL (nequinate) Medicated Premix ........................................................................................................
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) .........................................................................................................
PURINA WORM–A–RESTTM Litter Pack Premix (fenbendazole) ................................................................
PURINA SAF–T–BLOC BG Medicated Feed Block (poloxalene, 6.6%) ......................................................
Elsewhere in this issue of the Federal
Register, FDA gave notice 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 withdrawn,
effective October 9, 2018. As provided
in the regulatory text of this document,
the animal drug regulations are
amended to reflect these actions.
IV. Technical Amendments
JBS United Animal Health II LLC, 322
S Main St., Sheridan, IN 46069 has
informed FDA that it has changed its
name to United-AH II LLC. Accordingly,
we are amending § 510.600(c) to reflect
this change.
We are also making technical
amendments to update the scientific
name of a pathogenic bacterium and to
accurately list the concentrations of new
animal drug ingredients in combination
drug medicated feeds. These actions are
being taken to improve the accuracy of
the regulations.
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21 CFR
section
Product name
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animal drugs. This rule sets forth
technical amendments to the regulations
to codify recent actions on approved
new animal drug applications and
corrections to improve the accuracy of
the regulations, and as such does not
impose any burden on regulated
entities.
Although denominated a rule
pursuant to the FD&C Act, this
document does not meet the definition
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
it is a ‘‘rule of particular applicability.’’
Therefore, it is not subject to the
congressional review requirements in 5
U.S.C. 801–808. Likewise, this is not a
rule subject to Executive Order 12866,
which defines a rule as ‘‘an agency
statement of general applicability and
future effect, which the agency intends
to have the force and effect of law, that
is designed to implement, interpret, or
prescribe law or policy or to describe
the procedure or practice requirements
of an agency.’’
List of Subjects
V. Legal Authority
21 CFR Part 510
This final rule is issued under section
512(i) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
360b(i)), which requires Federal
Register publication of ‘‘notice[s] . . .
effective as a regulation,’’ of the
conditions of use of approved new
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
VerDate Sep<11>2014
FDA withdraw approval of the NADAs
listed in the following table because the
products are no longer manufactured or
marketed:
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21 CFR Parts 520, 522, 524, and 529
Animal drugs.
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522.1182
520.2380a
558.185
524.900
558.365
520.1804
558.485
520.580
520.1182
558.485
520.905d
520.1840
21 CFR Part 556
Animal drugs, Foods.
21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR parts 510,
520, 522, 524, 529, 556, and 558 are
amended as follows:
PART 510—NEW ANIMAL DRUGS
1. The authority citation for part 510
continues to read as follows:
■
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
2. In § 510.600, in the table in
paragraph (c)(1), remove the entry for
‘‘JBS United Animal Health II LLC’’, and
alphabetically add an entry for ‘‘UnitedAH II LLC’’; and in the table in
paragraph (c)(2), revise the entry for
‘‘051233’’ to read as follows:
■
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
*
*
(c) * * *
(1) * * *
E:\FR\FM\28SER1.SGM
28SER1
*
*
48944
Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Rules and Regulations
Drug labeler
code
Firm name and address
*
*
*
*
*
*
United-AH II LLC, 322 S Main St., Sheridan, IN 46069 .....................................................................................................................
*
051233
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
(2) * * *
Drug labeler
code
Firm name and address
*
051233 ............
*
*
*
United-AH II LLC, 322 S Main St., Sheridan, IN 46069
*
*
*
*
§ 520.443
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
[Amended]
§ 520.596
6. In § 520.443, in paragraph (b),
remove ‘‘054628’’ and in its place add
‘‘069043’’.
■
3. The authority citation for part 520
continues to read as follows:
■
§ 520.580
Authority: 21 U.S.C. 360b.
[Amended]
4. In § 520.390a, in paragraph (b)(1)(i),
remove ‘‘054628’’ and in its place add
‘‘069043’’.
7. In § 520.580, in paragraph (b)(1),
remove ‘‘051311’’; and in paragraph
(b)(2), remove ‘‘000061 and 054771’’,
and in its place add ‘‘000061, 054771,
and 069043’’.
§ 520.441
§ 520.600
§ 520.390a
■
[Amended]
■
[Amended]
5. In § 520.441, in paragraph (b)(3),
remove ‘‘069254 and 076475’’ and in its
place add ‘‘069043, 069254, and
076475’’.
■
[Redesignated as § 520.596]
8. Redesignate § 520.600 as § 520.596
and revise newly redesignated § 520.596
to read as follows:
■
Pounds of feed to
be mixed with
each 0.08
ounce of
dichlorvos
Weight of animal in pounds
daltland on DSKBBV9HB2PROD with RULES
20–30 .........................................................................................................................
31–40 .........................................................................................................................
41–60 .........................................................................................................................
61–80 .........................................................................................................................
81–100 .......................................................................................................................
(ii) Indications for use. For the
removal and control of sexually mature
(adult), sexually immature and/or 4th
stage larvae of the whipworm (Trichuris
suis), nodular worms
(Oesophagostomum spp.), large roundworm (Ascaris suum), and the mature
thick stomach worm (Ascarops
strongylina) occurring in the lumen of
the gastrointestinal tract of pigs, boars,
and open or bred gilts and sows.
VerDate Sep<11>2014
17:35 Sep 27, 2018
Jkt 244001
Frm 00040
Fmt 4700
Sfmt 4700
Pounds of mixed
feed to be
administered to
each pig as a
single treatment
4
5
6
5
4
16
(iii) Limitations. Do not use this
product on animals either
simultaneously or within a few days
before or after treatment with or
exposure to cholinesterase inhibiting
drugs, pesticides, or chemicals. The
preparation should be mixed thoroughly
with the feed on a clean, impervious
surface. Do not allow swine access to
feed other than that containing the
preparation until treatment is complete.
PO 00000
Dichlorvos powder.
(a) Specifications—(1) Each 2-ounce
packet contains 2.27 grams (4 percent)
dichlorvos.
(2) Each milligram of powder contains
2.27 milligrams (mg) dichlorvos.
(b) Sponsor. See No. 069043 in
§ 510.600(c) of this chapter for use of the
product described in paragraph (a)(1) of
this section as in paragraph (d)(1) of this
section and the product described in
paragraph (a)(2) of this section as in
paragraph (d)(2) of this section.
(c) Related tolerances. See § 556.180
of this chapter.
(d) Conditions of use—(1) Swine
(adult gilts, sows, and boars)—(i)
Amount. Add powder to the indicated
amount of feed and administered
shortly after mixing, as follows:
0.33
0.56
1.00
1.00
1.00
4.00
Number of pigs
to be treated
per 0.08
ounce of
dichlorvos
12
9
6
5
4
4
Do not treat pigs with signs of scours
until these signs subside or are
alleviated by proper medication.
Resume normal feeding schedule
afterwards. Swine may be retreated in 4
to 5 weeks.
(2) Horses—(i) Amount. Administer in
the grain portion of the ration at a
dosage of 14.2 to 18.5 mg per pound of
body weight as a single dose.
Administered at one-half of the single
E:\FR\FM\28SER1.SGM
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Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Rules and Regulations
recommended dosage and repeated 8 to
12 hours later in the treatment of very
aged, emaciated, or debilitated subjects
or those reluctant to consume medicated
feed. In suspected cases of severe
ascarid infection sufficient to cause
concern over mechanical blockage of the
intestinal tract, the split dosage should
be used.
(ii) Indications for use. For the
removal and control of bots
(Gastrophilus intestinalis, G. nasalis),
large strongyles (Strongylus vulgaris, S.
equinus, S. edentatus), small strongyles
(of the genera Cyathostomum,
Cylicocercus, Cylicocyclus,
Cylicodontophorus, Triodontophorus,
Poteriostomum, Gyalocephalus),
pinworms (Oxyuris equi), and large
roundworm (Parascaris equorum) in
horses including ponies and mules. Not
for use in foals (sucklings and young
weanlings).
(iii) Limitations. Do not use in horses
which are severely debilitated, suffering
from diarrhea or severe constipation,
infectious disease, toxemia, or colic. Do
not administer in conjunction with or
within 1 week of administration of
muscle relaxant drugs, phenothiazine
derived tranquilizers or central nervous
system depressant drugs. Horses should
not be subjected to insecticide treatment
for 5 days prior to or after treating with
the drug. Do not administer to horses
afflicted with chronic alveolar
emphysema (heaves) or related
respiratory conditions. The product is a
cholinesterase inhibitor and should not
be used simultaneously or within a few
days before or after treatment with or
exposure to cholinesterase inhibiting
drugs, pesticides or chemicals. Do not
use in animals other than horses,
ponies, and mules. Do not use in horses,
ponies, and mules intended for food
purposes. Do not allow fowl access to
feed containing this preparation or to
fecal excrement from treated animals.
■ 9. Add § 520.598 to read as follows:
daltland on DSKBBV9HB2PROD with RULES
§ 520.598
Dichlorvos tablets.
(a) Specifications. Each tablet
contains 2, 5, 10, or 20 milligrams (mg)
dichlorvos.
(b) Sponsor. See No. 069043 in
§ 510.600(c) of this chapter.
(c) Conditions of use in dogs, puppies,
cats, and kittens—(1) Amount.
Administer orally at 5 mg dichlorvos
per pound of body weight.
(2) Indications for use—(i) Dogs and
puppies: Removal and control of
intestinal roundworms (Toxocara canis
and Toxascaris leonina) and
hookworms (Ancylostoma caninum and
Uncinaria stenocephala).
(ii) Cats and kittens: Removal and
control of intestinal roundworms
VerDate Sep<11>2014
17:35 Sep 27, 2018
Jkt 244001
(Toxocara cati and Toxascaris leonina)
and hookworms (Ancylostoma
tubaeforme and Uncinaria
stenocephala).
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
■
10. Add § 520.600 to read as follows:
§ 520.600
Dichlorvos capsules and pellets.
(a) Specifications. Each capsule
contains 2.27 milligrams (mg) (4
percent) dichlorvos.
(b) Sponsor. See No. 069043 in
§ 510.600(c) of this chapter.
(c) Conditions of use in dogs—(1)
Amount. Administer any combination
of capsules and/or pellets so that the
animal receives a single dose equaling
12 to 15 mg of dichlorvos per pound of
body weight.
(2) Indications for use. For removal of
Toxocara canis and Toxascaris leonina
(roundworms), Ancylostoma caninum
and Uncinaria stenocephala
(hookworms), and Trichuris vulpis
(whipworm) residing in the lumen of
the gastrointestinal tract.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
■
11. Add § 520.602 to read as follows:
§ 520.602
Dichlorvos gel.
[Amended]
12. In § 520.622a, in paragraph (a)(6),
remove ‘‘054628’’ and in its place add
‘‘069043’’.
■
PO 00000
Frm 00041
Fmt 4700
Sfmt 4700
[Amended]
13. In § 520.622b, in paragraph (c)(2),
remove ‘‘054628’’ and in its place add
‘‘069043’’.
■
§ 520.622c
[Amended]
14. In § 520.622c, in paragraph (b)(6),
remove ‘‘054628’’ and in its place add
‘‘069043’’.
■
§ 520.763a
[Amended]
15. In § 520.763a, in paragraph (b),
remove ‘‘054628’’ and in its place add
‘‘069043’’.
■
§ 520.763b
[Amended]
16. In § 520.763b, in paragraph (b),
remove ‘‘000010’’ and in its place add
‘‘069043’’.
■
§ 520.763c
[Amended]
17. In § 520.763c, in paragraph (b),
remove ‘‘054628’’ and in its place add
‘‘069043’’.
■ 18. In § 520.905d, revise paragraphs
(a) and (b) to read as follows:
■
§ 520.905d
Fenbendazole powder.
(a) Specifications. Each 2-ounce
packet contains 2.27 grams (4 percent)
fenbendazole.
(b) Sponsor. See No. 000061 in
§ 510.600(c) of this chapter.
*
*
*
*
*
§ 520.1044c
(a) Specifications. Each milligram
(mg) of gel contains 2.27 milligrams
(mg) dichlorvos.
(b) Sponsor. See No. 069043 in
§ 510.600(c) of this chapter.
(c) Conditions of use in horses—(1)
Amount. Administer 20 mg per
kilogram of body weight for the removal
of bots and ascarids. Repeat
administration every 21 to 28 days for
the control of bots and ascarids. For the
control of bots only, the repeat dosage
is 10 milligrams per kilogram of body
weight every 21 to 28 days during bot
fly season.
(2) Indications for use. For the
removal and control of first, second, and
third instar bots (Gastrophilus
intestinalis and G. nasalis), sexually
mature and sexually immature (4th
stage) ascarids (Parascaris equorum) in
horses and foals.
(3) Limitations. Do not use in horses
intended for human consumption.
Federal law restricts this drug to use by
or on the order of a licensed
veterinarian.
§ 520.622a
§ 520.622b
48945
[Amended]
19. In § 520.1044c, in paragraph (b)(2),
remove ‘‘057561’’ and in its place add
‘‘016592’’.
■
§ 520.1182
■
[Removed]
20. Remove § 520.1182.
§ 520.1242a
[Amended]
21. In § 520.1242a, in paragraph (b)(3),
remove ‘‘057561’’ and in its place add
‘‘016592’’.
■
§ 520.1263c
[Amended]
22. In § 520.1263c, in paragraph (b)(1),
remove ‘‘Nos. 016592 and 054771’’ and
in its place add ‘‘No. 054771’’; and in
paragraph (b)(2), remove ‘‘Nos. 054925,
061623, and 076475’’ and in its place
add ‘‘Nos. 016592, 054925, 061623, and
076475’’.
■
§ 520.1265
[Amended]
23. In § 520.1265, in paragraph (b)(2),
remove ‘‘057561’’ and in its place add
‘‘016592’’.
■ 24. Add § 520.1286 to read as follows:
■
§ 520.1286
Lotilaner.
(a) Specifications. Each chewable
tablet contains 56.25, 112.5, 225, 450, or
900 milligrams (mg) lotilaner.
(b) Sponsor. See No. 058198 in
§ 510.600(c) of this chapter.
E:\FR\FM\28SER1.SGM
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Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Rules and Regulations
(c) Conditions of use in dogs—(1)
Amount. Administer orally once a
month at the recommended minimum
dosage of 9 mg/lb (20 mg/kg).
(2) Indications for use. Kills adult
fleas, and for the treatment of flea
infestations (Ctenocephalides felis), and
the treatment and control of tick
infestations (Amblyomma americanum
(lone star tick), Dermacentor variabilis
(American dog tick), Ixodes scapularis
(black-legged tick), and Rhipicephalus
sanguineus (brown dog tick)) for 1
month in dogs and puppies 8 weeks of
age or older and weighing 4.4 pounds or
greater.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
§ 520.2380a
§ 520.1408
■
[Amended]
33. In § 520.2380a, remove and
reserve paragraphs (b)(1) and (d)(1)(i).
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
§ 522.2483
34. The authority citation for part 522
continues to read as follows:
■
§ 522.970
35. In § 522.970, in paragraph (b)(1),
remove ‘‘Nos. 000061, 000859, 055529,
057561, and 061623’’ and in its place
add ‘‘Nos. 000061, 000859, 016592,
055529, and 061623’’.
■
■
§ 522.1222
§ 20.1720a
■
[Amended]
[Amended]
27. In § 520.1720a, in paragraph (b)(2),
remove ‘‘Nos. 054628 and 069043’’ and
in its place add ‘‘No. 069043’’.
38. In § 522.1222, in paragraph (b),
remove ‘‘Nos. 000859, 026637, 054628,
054771, 059399, and 063286’’ and in its
place add ‘‘Nos. 000859, 026637,
054771, 059399, 063286, and 069043’’.
§ 520.1804
§ 522.1242
[Amended]
■
■
[Removed]
§ 520.1840
[Amended]
29. In § 520.1840, remove paragraph
(b)(2), redesignate paragraphs (b)(3) and
(4) as paragraphs (b)(2) and (3), and
remove paragraph (d)(4).
■
§ 520.1900
[Amended]
§ 522.1410
[Amended]
40. In § 522.1410, in paragraph (b),
remove ‘‘054628 and 054771’’ and in its
place add ‘‘054771 and 069043’’.
■
§ 522.1660a
30. In § 520.1900, in paragraph (b)(1),
remove ‘‘054628’’ and in its place add
‘‘069043’’.
■
§ 520.2220a
[Amended]
39. In § 522.1242, in paragraph (b),
remove ‘‘057561’’ and in its place add
‘‘016592’’.
■
28. Remove § 520.1804.
[Amended]
41. In § 522.1660a, in paragraph (b),
remove ‘‘057561,’’.
■
§ 522.1662a
[Amended]
[Amended]
42. In § 522.1662a, in paragraphs
(a)(2), (b)(2), (g)(2), and (h)(2), remove
‘‘054628’’ and in its place add
‘‘069043’’.
■
31. In § 520.2220a, in paragraph (b)(1),
remove ‘‘Nos. 016592, 054628, 054771,
054925, and 057561’’ and in its place
add ‘‘Nos. 016592, 054771, 054925, and
069043’’; and in paragraph (b)(2),
remove ‘‘Nos. 054771, 054925, 057561,
058829, 061623, and 066104’’ and in its
place add ‘‘Nos. 016592, 054771,
054925, 058829, 061623, and 066104’’.
daltland on DSKBBV9HB2PROD with RULES
■
§ 522.1720
[Amended]
17:35 Sep 27, 2018
[Amended]
44. In § 522.2220, in paragraph (b)(1),
remove ‘‘054628’’ and in its place add
‘‘069043’’; and in paragraph (b)(3),
remove ‘‘Nos. 016592, 057561, and
061623’’ and in its place add ‘‘Nos.
016592 and 061623’’.
■
32. In § 520.2345d, in paragraph
(b)(4), remove ‘‘Nos. 054925, 057561,
061623, and 076475’’ and in its place
add ‘‘Nos. 016592, 054925, 061623, and
076475’’.
■
VerDate Sep<11>2014
[Amended]
43. In § 522.1720, in paragraph (b)(3),
remove ‘‘054628 and 058005’’ and in its
place add ‘‘058005 and 069043’’.
■
§ 522.2220
§ 520.2345d
Jkt 244001
PO 00000
Frm 00042
Fmt 4700
47. In § 522.2662, in paragraph (b)(1),
remove ‘‘054628’’ and in its place add
‘‘069043’’.
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
48. The authority citation for part 524
continues to read as follows:
■
37. In § 522.1182, in paragraph (b)(4),
remove ‘‘Nos. 051311 and 054771’’ and
in its place add ‘‘No. 054771’’.
26. In § 520.1660d, in paragraph
(b)(4), remove ‘‘No. 057561’’ and in its
place add ‘‘No. 016592’’.
■
[Amended]
36. In § 522.1044, in paragraph (b)(3),
remove ‘‘054628’’ and in its place add
‘‘069043’’.
§ 520.1660d
[Amended]
■
[Amended]
§ 522.1044
[Amended]
46. In § 522.2483, in paragraph (b),
remove ‘‘054628’’ and in its place add
‘‘069043’’.
■
§ 522.2662
Authority: 21 U.S.C. 360b.
[Amended]
45. In § 522.2424, in paragraph (b),
remove ‘‘054628 and 054771’’ and in its
place add ‘‘054771 and 069043’’.
■
§ 522.1182
[Amended]
§ 522.2424
■
25. In § 520.1408, in paragraph (b)(1),
remove ‘‘054628’’ and in its place add
‘‘069043’’.
■
[Amended]
Sfmt 4700
Authority: 21 U.S.C. 360b.
49. In § 524.814, revise paragraph (b)
to read as follows:
■
§ 524.814
Eprinomectin.
*
*
*
*
*
(b) Sponsors. See Nos. 050604 and
055529 in § 510.600(c) of this chapter.
*
*
*
*
*
■ 50. Add § 524.815 to read as follows:
§ 524.815
Eprinomectin and praziquantel.
(a) Specifications. Each milliliter (mL)
of solution contains 4 milligrams (mg)
eprinomectin and 83 mg praziquantel.
(b) Sponsor. See No. 050604 in
§ 510.600(c) of this chapter.
(c) Conditions of use in cats—(1)
Amount. Using the 0.3 mL and 0.9 mL
unit applicators, administer a minimum
dose of 0.23 mg eprinomectin per pound
body weight and 4.55 mg praziquantel
per pound body weight by topical
application on the dorsal midline
between the base of the skull and the
shoulder blades.
(2) Indications for use. For the
prevention of heartworm disease caused
by Dirofilaria immitis, and for the
treatment and control of roundworms
(adult and fourth stage larval Toxocara
cati), hookworms (adult and fourth stage
larval Ancylostoma tubaeforme; adult
Ancylostoma braziliense), and
tapeworms (adult Dipylidium caninum
and Echinococcus multilocularis), in
cats and kittens 7 weeks of age and
older and 1.8 lbs or greater.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
§ 524.900
[Amended]
51. In § 524.900, in paragraph (b),
remove ‘‘Nos. 000061 and 051311’’ and
in its place add ‘‘No. 000061’’.
■
E:\FR\FM\28SER1.SGM
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Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Rules and Regulations
§ 524.1580a
[Amended]
52. In § 524.1580a, in paragraph (b)(1),
remove ‘‘Nos. 054628, 054925, 058005,
059051, and 061623’’ and in its place
add ‘‘Nos. 054925, 058005, 059051,
061623, and 069043’’.
■
§ 524.1580b
53. In § 524.1580b, in paragraph (b),
remove ‘‘054628 and 059051’’ and in its
place add ‘‘059051 and 069043’’.
PART 529—CERTAIN OTHER DOSAGE
FORM NEW ANIMAL DRUGS
54. The authority citation for part 529
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
[Amended]
55. In § 529.1044a, in paragraph (b),
remove ‘‘Nos. 000061, 000859, 054628,
054771, 057561, 058005, and 061623’’
and in its place add ‘‘Nos. 000061,
000859, 016592, 054628, 054771,
058005, and 061623’’.
■
PART 556—TOLERANCES FOR
RESIDUES OF NEW ANIMAL DRUGS
IN FOOD
56. The authority citation for part 556
continues to read as follows:
■
Authority: 21 U.S.C. 342, 360b, 371.
57. In § 556.275, add paragraph
(b)(3)(ii) to read as follows:
■
§ 556.275
*
Fenbendazole.
*
*
(b) * * *
(3) * * *
*
[Removed]
58. Remove § 556.440.
§ 558.205
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
59. The authority citation for part 558
continues to read as follows:
■
Authority: 21 U.S.C. 354, 360b, 360ccc,
360ccc–1, 371.
§ 558.4
[Amended]
60. In § 558.4, in paragraph (d), in the
‘‘Category I’’ table, remove the row entry
for ‘‘Nequinate’’.
■
§ 558.128
§ 558.185
Coumaphos.
*
*
*
*
*
(b) Sponsor. See No. 000859 in
§ 510.600(c) of this chapter.
*
*
*
*
*
§ 558.195
*
[Amended]
61. In § 558.128, in paragraphs
(e)(4)(xi) and (xiii), in the ‘‘Indications
for use’’ column, remove ‘‘P. multocida’’
and in its place add ‘‘P. multocida
organisms’’.
■ 62. In § 558.185, revise paragraph (b),
remove paragraph (e)(1), and
redesignate paragraphs (e)(2) and (3) as
paragraphs (e)(1) and (2).
The revision reads as follows:
■
Combination
in grams/ton
*
(vi) [Reserved]
(vii) 2 ...........................
Decoquinate, 2.72 ....
*
Monensin, 90 to 110
17:35 Sep 27, 2018
Jkt 244001
*
Lasalocid.
*
*
*
*
*
(e) * * *
(5) Lasalocid may also be used in
combination with:
(i) Chlortetracycline as in § 558.128.
(ii) Melengestrol as in § 558.342.
(iii) Oxytetracycline as in § 558.450.
(iv) Tylosin alone or in combination
with melengestrol acetate as in
§ 558.625.
(v) Virginiamycin as in § 558.635.
■ 66. In § 558.325, redesignate
paragraph (e)(1)(ii) as paragraph
(e)(1)(v); add reserved paragraphs
(e)(1)(ii), (iii), and (vi); and add
paragraphs (e)(1)(iv), (vii), (viii), (ix),
and (x) to read as follows:
Lincomycin.
*
*
(e) * * *
(1) * * *
*
*
Limitations
*
*
Broiler chickens: For the control of necrotic
enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin; and for the prevention
of coccidiosis caused by Eimeria tenella,
E. necatrix, E. acervulina, E. brunetti, E.
mivati, and E. maxima.
*
§ 558.311
*
Indications for use
*
Dichlorvos.
(a) Specifications. Type A medicated
articles containing 3.1 or 9.6 percent
dichlorvos.
(b) Sponsor. See No. 069043 in
§ 510.600(c) of this chapter.
*
*
*
*
*
■ 65. In § 558.311, revise paragraph
(e)(5) to read as follows:
§ 558.325
[Amended]
63. In § 558.195, remove and reserve
paragraph (e)(2)(v).
*
(ii) [Reserved]
(iii) [Reserved]
(iv) 2 ............................
daltland on DSKBBV9HB2PROD with RULES
■
■
Lincomycin
grams/ton
VerDate Sep<11>2014
§ 556.440
64. In § 558.205, revise paragraph (a);
redesignate paragraphs (b) through (d)
as paragraphs (c) through (e); and add
new paragraph (b).
The revision and addtion read as
follows:
■
[Amended]
■
§ 529.1044a
(ii) Eggs. The tolerance for
fenbendazole sulfone (the marker
residue) is 1.8 ppm.
*
*
*
*
*
*
*
Sponsor
*
Feed as the sole ration. Do not use in feeds containing bentonite. Not for use in laying hens, breeding chickens, or turkeys. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to
feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects.
Decoquinate as provided by No. 054771 in
§ 510.600 of this chapter.
*
*
Feed as the sole ration. Must be thoroughly mixed in
feeds before use. Do not feed undiluted. Not for use
in laying hens, breeding chickens, or turkeys. Do not
allow horses, or other equines, mature turkeys, or
guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has
been fatal. Do not allow rabbits, hamsters, guinea
pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may
result in severe gastrointestinal effects. Monensin as
provided by No. 058198 in § 510.600 of this chapter.
PO 00000
E:\FR\FM\28SER1.SGM
Fmt 4700
Sfmt 4700
28SER1
054771
*
Broiler chickens: For the control of necrotic
enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin, and as an aid the prevention of coccidiosis caused by Eimeria
necatrix, E. tenella, E. acervulina, E.
brunetti, E. mivati, and E. maxima.
Frm 00043
48947
054771
48948
Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Rules and Regulations
Lincomycin
grams/ton
Combination
in grams/ton
Limitations
Feed as the sole ration. Do not use in feeds containing bentonite. Do not feed to laying hens producing eggs for human consumption. Not for use in
laying hens, breeding chickens, or turkeys. Do not
allow rabbits, hamsters, guinea pigs, horses, or
ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. Withdraw 5 days prior to slaughter. Type C feed containing robenidine hydrochloride
must be fed within 50 days from the date of manufacture. Robenidine hydrochloride as provided by
No. 054771 in § 510.600 of this chapter.
Feed as the sole ration to broiler chickens. Do not
feed to laying hens producing eggs for human consumption. Not approved for use with pellet binders.
May be fatal if accidentally fed to adult turkeys or
horses. Not for use in laying hens, breeding chickens, or turkeys. Do not allow rabbits, hamsters,
guinea pigs, horses, or ruminants access to feeds
containing lincomycin. Ingestion by these species
may result in severe gastrointestinal effects.
Salinomycin sodium as provided by No. 054771 in
§ 510.600 of this chapter.
Feed as the sole ration from the time chicks are
placed in floor pens until slaughtered for meat. Not
for use in laying hens, breeding chickens, or turkeys. Do not allow rabbits, hamsters, guinea pigs,
horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in
severe gastrointestinal effects. Zoalene as provided
by No. 054771 in § 510.600 of this chapter.
(viii) 2 ..........................
Robenidine hydrochloride, 30.
Broiler chickens: For the control of necrotic
enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin, and as an aid in the
prevention of coccidiosis caused by
Eimeria mivati, E. brunetti, E. tenella, E.
acervulina, E. maxima, and E. necatrix.
(ix) 2 ............................
Salinomycin sodium,
40 to 60.
Broiler chickens: For the control of necrotic
enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin, and for the prevention
of coccidiosis caused by Eimeria tenella,
E. necatrix, E. acervulina, E maxima, E.
brunetti, and E. mivati.
(x) 2 .............................
Zoalene, 113.5 ..........
Broiler chickens: For the control of necrotic
enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin; and for the prevention
and control of coccidiosis.
*
*
*
*
*
67. In § 558.342, in paragraph (e)(1),
revise the table headings, add
paragraphs (e)(1)(iii) and (iv), and
remove paragraphs (e)(1)(v) through (xi);
■
and in paragraph (e)(2), redesignate
paragraphs (e)(2)(i) through (iii) as
paragraphs (e)(2)(ii) through (iv) and
add new paragraph (e)(2)(i).
The revisions and additions read as
follows:
§ 558.342
*
Sponsor
*
Indications for use
Limitations
*
(iii) 0.25 to 0.5 .............
*
Lasalocid, 10 to 30 ...
*
*
Heifers fed in confinement for slaughter:
For increased rate of weight gain, improved feed efficiency, and suppression
of estrus (heat); and for control of coccidiosis caused by Eimeria bovis and
Eimeria zuernii.
(iv) 0.25 to 0.5 ............
Monensin, 10 to 40 ...
Heifers fed in confinement for slaughter:
For increased rate of weight gain, improved feed efficiency, and suppression
of estrus (heat); and for the prevention
and control of coccidiosis due to Eimeria
bovis and E. zuernii.
*
*
*
Add at the rate of 0.5 to 2.0 lb/head/day a medicated
feed (liquid or dry) containing 0.125 to 1.0 mg
melengestrol acetate/lb to a feed containing 10 to 30
g of lasalocid per ton to provide 0.25 to 0.5 mg
melengestrol acetate and 100 to 360 milligrams of
lasalocid per head/day. See § 558.311(d) of this
chapter. Lasalocid as provided by No. 054771 in
§ 510.600(c) of this chapter.
Add at the rate of 0.5 to 2.0 lb/head/day a medicated
feed (liquid or dry) containing 0.125 to 1.0 mg
melengestrol acetate/lb to a feed containing 10 to 40
g of monensin per ton to provide 0.25 to 0.5 mg
melengestrol acetate/head/day and 0.14 to 0.42 mg
monensin/lb body weight, depending on severity of
coccidiosis challenge, up to 480 mg monensin/head/
day. See § 558.355(d) of this chapter. Monensin as
provided by No. 058198 in § 510.600(c) of this chapter.
§ 558.365
■
[Removed]
§ 558.485
68. Remove § 558.365.
§ 558.450
[Amended]
69. In § 558.450, in paragraph
(e)(5)(iv) entries 1 and 2, remove ‘‘A.
■
VerDate Sep<11>2014
17:35 Sep 27, 2018
70. Revise § 558.485 to read as
follows:
■
Jkt 244001
Pyrantel.
(a) Specifications. Type A medicated
articles containing 48 or 80 grams per
pound pyrantel tartrate.
PO 00000
Frm 00044
Fmt 4700
Sfmt 4700
054771
054771
*
Combination
in grams/ton
liquefaciens’’ and in its place add ‘‘A.
hydrophila’’.
054771
Melengestrol.
*
*
(e) * * *
(1) * * *
Melengestrol
acetate in
mg/head/day
(2) * * *
(i) Oxytetracycline as in § 558.450.
*
*
*
*
*
daltland on DSKBBV9HB2PROD with RULES
Indications for use
Sponsor
054771
058198
054771
058198
(b) Sponsors. See sponsors in
§ 510.600(c) of this chapter for uses as
in paragraph (e) of this section.
(1) No. 066104: 48 and 80 grams per
pound for use as in paragraph (e)(1) of
this section.
(2) Nos. 017135 and 054771: 48 grams
per pound for use as in paragraph (e)(2)
of this section.
(c) Related tolerances. See § 556.560
of this chapter.
E:\FR\FM\28SER1.SGM
28SER1
Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Rules and Regulations
(d) Special considerations—(1) See
§ 500.25 of this chapter. Consult a
veterinarian before using in severely
debilitated animals.
48949
(2) Do not mix in Type B or Type C
medicated feeds containing bentonite.
(e) Conditions of use—(1) Swine—
Pyrantel
grams/ton
Indications for use
Limitations
(i) 96 ..................................
Swine: As an aid in the prevention of migration and
establishment of large roundworm (Ascaris suum)
infections; aid in the prevention of establishment
of nodular worm (Oesophagostomum) infections.
Swine: For the removal and control of large
roundworm (Ascaris suum) infections.
Swine: For the removal and control of large
roundworm (Ascaris suum) and nodular worm
(Oesophagostomum) infections.
Feed continuously as the sole ration in a Type C feed. Withdraw
24 hours prior to slaughter.
066104
Feed for 3 days as the sole ration in a Type C feed. Withdraw 24
hours prior to slaughter.
Feed as the sole ration for a single therapeutic treatment in Type
C feed at a rate of 1 lb of feed per 40 lb of body weight for animals up to 200 lb, and 5 lb of feed per head for animals 200 lb
or over. Withdraw 24 hours prior to slaughter.
066104
Pyrantel
grams/ton
Indications for use
Limitations
To provide 1.2 mg/lb body
weight.
Prevention of Strongylus vulgaris larval infections;
control of adult large strongyles (S. vulgaris, and
S. edentatus), adult and 4th stage larvae small
strongyles (Cyathostomum spp., Cylicocyclus spp.,
Cylicostephanus spp., Cylicodontophorus spp.,
Poteriostomum spp., and Triodontophorus spp.),
adult and 4th stage larvae pinworms (Oxyuris
equi), and adult and 4th stage larvae ascarids
(Parascaris equorum).
Feed continuously. Administer either as a top-dress (not to exceed 20,000 g/ton) or mixed in the horse’s daily grain ration
(not to exceed 1,200 g/ton) during the time that the animal is at
risk of exposure to internal parasites. Not for use in horses intended for food. Consult your veterinarian before using in severely debilitated animals and for assistance in the diagnosis,
treatment, and control of parasitism.
(ii) 96 .................................
(iii) 800 ..............................
Sponsor
066104
(2) Horses—
(3) Pyrantel may also be used in
combination with:
(i) Carbadox as in § 558.115.
(ii) Lincomycin as in § 558.325.
Tylosin
grams/ton
daltland on DSKBBV9HB2PROD with RULES
71. In § 558.625, revise paragraphs
(e)(2)(ii) and (iii) to read as follows:
■
(iii) 8 to 10 ...................
Melengestrol, 0.25 to
2.0.
Heifers fed in confinement for slaughter:
For reduction of incidence of liver abscesses caused by Fusobacterium
necrophorum
and
Arcanobacterium
pyogenes; and for increased rate of
weight gain, improved feed efficiency,
and suppression of estrus (heat).
VerDate Sep<11>2014
17:35 Sep 27, 2018
Jkt 244001
*
PO 00000
*
*
*
*
*
Feed continuously as sole ration. Feed to heifers at
the rate of 0.5 to 2.0 pound(s) per head per day
(specify one level) to provide 0.25 to 0.5 mg
melengestrol acetate per head per day (specify one
level), 100 to 360 mg lasalocid per head per day
(specify one level), and 90 mg tylosin per head per
day. This Type C product may be top dressed onto
or mixed into a complete feed prior to feeding.
Tylosin as provided by Nos. 016592 and 058198;
lasalocid as provided by No. 054771; melengestrol
as provided by Nos. 054771 and 058198 in
§ 510.600(c) of this chapter. See §§ 558.311(d) and
558.342(d) in this chapter.
Feed continuously as sole ration. Each pound contains
0.125 to 1.0 mg melengestrol acetate and 45 to 180
mg of tylosin. Feed to heifers at a rate of 0.5 to 2.0
pounds per head per day to provide 0.25 to 0.5 mg
melengestrol acetate and 60 to 90 mg tylosin per
head per day. Prior to feeding, this Type C product
must be top-dressed onto a complete feed or mixed
into the amount of complete feed consumed by an
animal per day. Tylosin provided by Nos. 016592
and 058198; melengestrol provided by Nos. 054771
and 058198 in § 510.600(c) of this chapter. See
§ 558.342(d) in this chapter.
*
*
Heifers fed in confinement for slaughter:
For reduction of incidence of liver abscesses caused by Fusobacterium
necrophorum
and
Arcanobacterium
pyogenes; and for increased rate of
weight gain, improved feed efficiency,
and suppression of estrus (heat).
Frm 00045
*
Fmt 4700
*
Sfmt 4700
E:\FR\FM\28SER1.SGM
017135
054771
Tylosin.
*
*
(e) * * *
(2) * * *
Limitations
*
Lasalocid, 100 to
1440; plus
melengestrol, 0.25
to 2.0.
*
*
Indications for use
*
(ii) 8 to 10 ...................
*
§ 558.625
(iii) Tylosin as in § 558.625.
Combination
in grams/ton
Sponsor
*
28SER1
Sponsor
*
016592
054771
058198
016592
054771
058198
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]
[Pages 48940-48950]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21146]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, 529, 556, and 558
[Docket No. FDA-2018-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications;
Withdrawal of Approval of New Animal Drug Applications; Changes of
Sponsorship; Change of a Sponsor's Name
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is amending the
animal drug regulations to reflect application-related actions for new
animal drug applications (NADAs) and abbreviated new animal drug
applications (ANADAs) during January, February, and March 2018. FDA is
informing the public of the availability
[[Page 48941]]
of summaries of the basis of approval and of environmental review
documents, where applicable. The animal drug regulations are also being
amended to reflect the withdrawal of approval of applications, changes
of sponsorship of applications, and a change of a sponsor's name, and
to make technical amendments to improve the accuracy of the
regulations.
DATES: This rule is effective September 28, 2018, except for amendatory
instructions 7 to 21 CFR 520.580, 18 to 21 CFR 520.905d, 20 to 21 CFR
520.1182, 29 to 21 CFR 520.1840, 33 to 21 CFR 520.2380a, 37 to 21 CFR
522.1182, 51 to 21 CFR 524.900, 62 to 21 CFR 558.185, 68 to 21 CFR
558.365, and 70 to 21 CFR 558.485, which are effective October 9, 2018.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-402-5689,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Approval Actions
FDA is amending the animal drug regulations to reflect approval
actions for NADAs and ANADAs during January, February, and March 2018,
as listed in table 1. In addition, FDA is informing the public of the
availability, where applicable, of documentation of environmental
review required under the National Environmental Policy Act (NEPA) and,
for actions requiring review of safety or effectiveness data, summaries
of the basis of approval (FOI Summaries) under the Freedom of
Information Act (FOIA). These public documents may be seen in the
office of the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,
between 9 a.m. and 4 p.m., Monday through Friday. Persons with access
to the internet may obtain these documents at the CVM FOIA Electronic
Reading Room: https://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm. Marketing
exclusivity and patent information may be accessed in FDA's
publication, Approved Animal Drug Products Online (Green Book) at:
https://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.
Table 1--Original and Supplemental NADAs and ANADAs Approved During January, February, and March 2018
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effect of the
Approval date File No. Sponsor Product name Species action Public documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
January 5, 2018.................. 141-449 Intervet, Inc., 2 SAFE-GUARD AquaSol Chickens............ Supplemental FOI Summary; EA/
Giralda Farms, (fenbendazole oral approval for the FONSI \1\.
Madison, NJ 07940. suspension), treatment and
Suspension control of certain
Concentrate. nematode worms in
laying hens; and
of a tolerance in
chicken eggs.
January 16, 2018................. 200-563 Norbrook EPRIZERO Cattle.............. Original approval FOI Summary.
Laboratories, (eprinomectin), as a generic copy
Ltd., Station Pour-On for Beef of NADA 141-079.
Works, Newry BT35 and Dairy Cattle.
6JP, Northern
Ireland.
January 19, 2018................. 141-494 Elanco US Inc., CREDELIO Dogs................ Original approval FOI Summary.
2500 Innovation (lotilaner), for killing adult
Way, Greenfield, Chewable Tablet. fleas, and for the
IN 46140. treatment of flea
infestations and
the treatment and
control of tick
infestations in
dogs.
January 29, 2018................. 200-622 Pharmgate LLC, 1800 Chlortetracycline Cattle.............. Original approval FOI Summary.
Sir Tyler Dr., and decoquinate, as a generic copy
Wilmington, NC Type C medicated of NADA 141-185.
28405. feeds.
February 28, 2018................ 141-482 Zoetis Inc., 333 LINCOMIX Chickens............ Original approval FOI Summary.
Portage St., (lincomycin) and for the control of
Kalamazoo, MI ROBENZ (robenidine necrotic enteritis
49007. hydrochloride), and for the
Type C medicated prevention of
feeds. coccidiosis in
broiler chickens.
February 28, 2018................ 141-483 Zoetis Inc., 333 LINCOMIX Chickens............ Original approval FOI Summary.
Portage St., (lincomycin) and for the control of
Kalamazoo, MI DECCOX necrotic enteritis
49007. (decoquinate), and for the
Type C medicated prevention of
feeds. coccidiosis in
broiler chickens.
March 2, 2018.................... 141-484 Zoetis Inc., 333 LINCOMIX Chickens............ Original approval FOI Summary.
Portage St., (lincomycin) and for the control of
Kalamazoo, MI BIO-COX necrotic enteritis
49007. (salinomycin and for the
sodium), Type C prevention of
medicated feeds. coccidiosis in
broiler chickens.
March 5, 2018.................... 141-489 Zoetis Inc., 333 LINCOMIX Chickens............ Original approval FOI Summary.
Portage St., (lincomycin) and for the control of
Kalamazoo, MI ZOAMIX (zoalene), necrotic enteritis
49007. Type C medicated and for the
feeds. prevention and
control of
coccidiosis in
broiler chickens.
March 8, 2018.................... 141-492 Merial, Inc., 3239 CENTRAGARD Cats................ Original approval FOI Summary.
Satellite Blvd., (eprinomectin and for the prevention
Bldg. 500, Duluth, praziquantel of heartworm
GA 30096-4640. transdermal disease, and for
solution). the treatment and
control of
roundworms,
hookworms, and
tapeworms in cats
and kittens.
March 26, 2018................... 141-491 Zoetis Inc., 333 LINCOMIX Chickens............ Original approval FOI Summary.
Portage St., (lincomycin) and for the control of
Kalamazoo, MI COBAN (monensin), necrotic enteritis
49007. Type C medicated and as an aid in
feeds. the prevention of
coccidiosis in
broiler chickens.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The Agency has carefully considered an environmental assessment (EA) of the potential environmental impact of this action and has made a finding of
no significant impact (FONSI).
[[Page 48942]]
II. Change of Sponsorship
Agri Laboratories Ltd., P.O. Box 3103, St. Joseph, MO 64503 has
informed FDA that it has transferred ownership of, and all rights and
interest in, the following applications to Huvepharma EOOD, 5th Floor,
3A Nikolay Haytov Str., 1113 Sofia, Bulgaria:
------------------------------------------------------------------------
File No. Product name 21 CFR section
------------------------------------------------------------------------
200-030...................... DI-METHOX 520.2220a
(sulfadimethoxine) 12.5%
Solution.
200-031...................... DI-METHOX 520.2220a
(sulfadimethoxine)
Soluble Powder.
200-037...................... LEGACY (gentamicin 529.1044a
sulfate) Solution.
200-038...................... DI-METHOX 522.2220
(sulfadimethoxine)
Injection 40%.
200-049...................... TETRA-BAC 324 520.2345d
(tetracycline
hydrochloride) Soluble
Powder.
200-061...................... FLU-NIX (flunixin 522.970
meglumine) Injection.
200-066...................... AGRIMYCIN-343 520.1660d
(oxytetracycline
hydrochloride) Soluble
Powder.
200-128...................... AGRIMYCIN-200 522.1660a
(oxytetracycline
dihydrate) Injection.
200-185...................... GEN-GARD (gentamicin 520.1044c
sulfate) Soluble Powder.
200-225...................... PROHIBIT (levamisole 520.1242a
hydrochloride) Soluble
Drench Powder.
200-271...................... Levamisole Phosphate 522.1242
Injection.
200-407...................... Lincomycin-Spectinomycin 520.1265
(lincomycin
hydrochloride/
spectinomycin
dihydrochloride
pentahydrate) Water
Soluble Powder.
------------------------------------------------------------------------
Following this withdrawal of approval, Agri Laboratories Ltd. is no
longer the sponsor of an approved application. Accordingly, it will be
removed from the list of sponsors of approved applications in Sec.
510.600(c) (21 CFR 510.600(c)).
Strategic Veterinary Pharmaceuticals, Inc., 100 NW Airport Rd., St.
Joseph, MO 64503 has informed FDA that it has transferred ownership of,
and all rights and interest in, the following applications to Cronus
Pharma LLC, 2 Tower Center Blvd., Suite 1101, East Brunswick, NJ 08816:
------------------------------------------------------------------------
File No. Product name 21 CFR section
------------------------------------------------------------------------
011-531...................... DIZAN (dithiazanine 520.763a
iodide) Tablets.
011-674...................... DIZAN (dithiazanine 520.763b
iodide) Powder.
012-469...................... DIZAN (dithiazanine 520.763c
iodide) Suspension with
Piperazine Citrate.
031-512...................... ATGARD (dichlorvos) Swine 558.205
Wormer.
033-803...................... TASK (dichlorvos) Dog 520.600
Anthelmintic.
035-918...................... EQUIGARD; VERDISOL 520.596
(dichlorvos).
039-483...................... BIO-TAL (thiamylal 522.2424
sodium) Injection.
040-848...................... ATGARD C (dichlorvos) 558.205
Swine Wormer.
043-606...................... ATGARD V (dichlorvos) 558.205
Swine Wormer.
045-143...................... OXYJECT (oxytetracycline 522.1662a
hydrochloride) Injection.
047-278...................... BIO-MYCIN OXY-TET 50 522.1662a
(oxytetracycline
hydrochloride) Injection.
047-712...................... BIZOLIN-100; BIZOLIN-200 522.1720
(phenylbutazone)
Injection.
048-010...................... ANAPLEX (dichlorophene 520.580
and toluene) Canine and
Feline Wormer Caps.
048-237...................... EQUIGEL (dichlorvos)..... 520.602
048-271...................... TASK (dichlorvos) Tablets 520.598
049-032...................... ATGARD C (dichlorvos) 558.205
Premix 9.6%.
065-461...................... ANACETIN 520.390a
(chloramphenicol)
Tablets.
065-481...................... Calf Scour Boluses 520.443
(chlortetracycline
hydrochloride).
065-486...................... CTC Bisulfate 520.441
(chlortetracycline
bisulfate) Soluble
Powder.
065-491...................... MEDICHOL 520.390a
(chloramphenicol)
Tablets.
092-837...................... NEMACIDE 520.622b
(diethylcarbamazine
citrate) Oral Syrup.
093-516...................... BIZOLIN (phenylbutazone) 522.1720
Injection 20%.
097-452...................... OXYJECT 100 522.1662a
(oxytetracycline
hydrochloride) Injection.
098-569...................... MEDACIDE-SDM 522.2220
(sulfadimethoxine)
Injection 10%.
099-618...................... BIZOLIN (phenylbutazone) 520.1720a
1-G Bolus.
108-963...................... MEDAMYCIN 522.1662a
(oxytetracycline
hydrochloride)
Injectable Solution.
117-689...................... NEUROSYN (primidone) 520.1900
Tablets.
125-797...................... Nitrofurazone Dressing... 524.1580a
126-236...................... Nitrofurazone Soluble 524.1580b
Powder.
126-676...................... D & T (dichlorophene and 520.580
toluene) Worm Capsules.
127-627...................... NEMACIDE; NEMACIDE-C 520.622a
(diethylcarbamazine
citrate) Tablets.
128-069...................... NEMACIDE 520.622c
(diethylcarbamazine
citrate) Chewable
Tablets.
132-028...................... ANESTATAL (thiamylal 522.2424
sodium) Injectable
Solution.
135-771...................... Methylprednisolene 520.1408
Tablets.
136-212...................... Methylprednisolone 522.1410
Acetate Injection.
137-310...................... Gentamicin Sulfate 522.1044
Injectable Solution.
138-869...................... Triamcinolone Acetonide 522.2483
Suspension.
140-442...................... Xylazine HCl Injection... 522.2662
200-023...................... Gentamicin Sulfate 522.1044
Solution 100 mg/mL.
200-029...................... Ketamine Hydrochloride 522.1222
Injection.
200-165...................... SDM (sulfadimethoxine) 520.2220a
Concentrated Solution
12.5%.
------------------------------------------------------------------------
[[Page 48943]]
The animal drug regulations are being amended to reflect these
changes of sponsorship.
III. Withdrawals of Approval
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 (nequinate) 558.365
Medicated Premix.
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%).
------------------------------------------------------------------------
Elsewhere in this issue of the Federal Register, FDA gave notice
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 withdrawn, effective October
9, 2018. As provided in the regulatory text of this document, the
animal drug regulations are amended to reflect these actions.
IV. Technical Amendments
JBS United Animal Health II LLC, 322 S Main St., Sheridan, IN 46069
has informed FDA that it has changed its name to United-AH II LLC.
Accordingly, we are amending Sec. 510.600(c) to reflect this change.
We are also making technical amendments to update the scientific
name of a pathogenic bacterium and to accurately list the
concentrations of new animal drug ingredients in combination drug
medicated feeds. These actions are being taken to improve the accuracy
of the regulations.
V. Legal Authority
This final rule is issued under section 512(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b(i)), which requires
Federal Register publication of ``notice[s] . . . effective as a
regulation,'' of the conditions of use of approved new animal drugs.
This rule sets forth technical amendments to the regulations to codify
recent actions on approved new animal drug applications and corrections
to improve the accuracy of the regulations, and as such does not impose
any burden on regulated entities.
Although denominated a rule pursuant to the FD&C Act, this document
does not meet the definition of ``rule'' in 5 U.S.C. 804(3)(A) because
it is a ``rule of particular applicability.'' Therefore, it is not
subject to the congressional review requirements in 5 U.S.C. 801-808.
Likewise, this is not a rule subject to Executive Order 12866, which
defines a rule as ``an agency statement of general applicability and
future effect, which the agency intends to have the force and effect of
law, that is designed to implement, interpret, or prescribe law or
policy or to describe the procedure or practice requirements of an
agency.''
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Parts 520, 522, 524, and 529
Animal drugs.
21 CFR Part 556
Animal drugs, Foods.
21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
510, 520, 522, 524, 529, 556, and 558 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for part 510 continues to read as follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
0
2. In Sec. 510.600, in the table in paragraph (c)(1), remove the entry
for ``JBS United Animal Health II LLC'', and alphabetically add an
entry for ``United-AH II LLC''; and in the table in paragraph (c)(2),
revise the entry for ``051233'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
[[Page 48944]]
------------------------------------------------------------------------
Drug labeler
Firm name and address code
------------------------------------------------------------------------
* * * * * * *
United-AH II LLC, 322 S Main St., Sheridan, IN 46069.... 051233
* * * * * * *
* * * * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * * * *
051233.................. United-AH II LLC, 322 S Main St., Sheridan, IN
46069
* * * * * * *
------------------------------------------------------------------------
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for part 520 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 520.390a [Amended]
0
4. In Sec. 520.390a, in paragraph (b)(1)(i), remove ``054628'' and in
its place add ``069043''.
Sec. 520.441 [Amended]
0
5. In Sec. 520.441, in paragraph (b)(3), remove ``069254 and 076475''
and in its place add ``069043, 069254, and 076475''.
Sec. 520.443 [Amended]
0
6. In Sec. 520.443, in paragraph (b), remove ``054628'' and in its
place add ``069043''.
Sec. 520.580 [Amended]
0
7. In Sec. 520.580, in paragraph (b)(1), remove ``051311''; and in
paragraph (b)(2), remove ``000061 and 054771'', and in its place add
``000061, 054771, and 069043''.
Sec. 520.600 [Redesignated as Sec. 520.596]
0
8. Redesignate Sec. 520.600 as Sec. 520.596 and revise newly
redesignated Sec. 520.596 to read as follows:
Sec. 520.596 Dichlorvos powder.
(a) Specifications--(1) Each 2-ounce packet contains 2.27 grams (4
percent) dichlorvos.
(2) Each milligram of powder contains 2.27 milligrams (mg)
dichlorvos.
(b) Sponsor. See No. 069043 in Sec. 510.600(c) of this chapter for
use of the product described in paragraph (a)(1) of this section as in
paragraph (d)(1) of this section and the product described in paragraph
(a)(2) of this section as in paragraph (d)(2) of this section.
(c) Related tolerances. See Sec. 556.180 of this chapter.
(d) Conditions of use--(1) Swine (adult gilts, sows, and boars)--
(i) Amount. Add powder to the indicated amount of feed and administered
shortly after mixing, as follows:
----------------------------------------------------------------------------------------------------------------
Pounds of mixed
Pounds of feed to feed to be Number of pigs to
Weight of animal in pounds be mixed with administered to be treated per
each 0.08 ounce each pig as a 0.08 ounce of
of dichlorvos single treatment dichlorvos
----------------------------------------------------------------------------------------------------------------
20-30.................................................. 4 0.33 12
31-40.................................................. 5 0.56 9
41-60.................................................. 6 1.00 6
61-80.................................................. 5 1.00 5
81-100................................................. 4 1.00 4
16 4.00 4
----------------------------------------------------------------------------------------------------------------
(ii) Indications for use. For the removal and control of sexually
mature (adult), sexually immature and/or 4th stage larvae of the
whipworm (Trichuris suis), nodular worms (Oesophagostomum spp.), large
round-worm (Ascaris suum), and the mature thick stomach worm (Ascarops
strongylina) occurring in the lumen of the gastrointestinal tract of
pigs, boars, and open or bred gilts and sows.
(iii) Limitations. Do not use this product on animals either
simultaneously or within a few days before or after treatment with or
exposure to cholinesterase inhibiting drugs, pesticides, or chemicals.
The preparation should be mixed thoroughly with the feed on a clean,
impervious surface. Do not allow swine access to feed other than that
containing the preparation until treatment is complete. Do not treat
pigs with signs of scours until these signs subside or are alleviated
by proper medication. Resume normal feeding schedule afterwards. Swine
may be retreated in 4 to 5 weeks.
(2) Horses--(i) Amount. Administer in the grain portion of the
ration at a dosage of 14.2 to 18.5 mg per pound of body weight as a
single dose. Administered at one-half of the single
[[Page 48945]]
recommended dosage and repeated 8 to 12 hours later in the treatment of
very aged, emaciated, or debilitated subjects or those reluctant to
consume medicated feed. In suspected cases of severe ascarid infection
sufficient to cause concern over mechanical blockage of the intestinal
tract, the split dosage should be used.
(ii) Indications for use. For the removal and control of bots
(Gastrophilus intestinalis, G. nasalis), large strongyles (Strongylus
vulgaris, S. equinus, S. edentatus), small strongyles (of the genera
Cyathostomum, Cylicocercus, Cylicocyclus, Cylicodontophorus,
Triodontophorus, Poteriostomum, Gyalocephalus), pinworms (Oxyuris
equi), and large roundworm (Parascaris equorum) in horses including
ponies and mules. Not for use in foals (sucklings and young weanlings).
(iii) Limitations. Do not use in horses which are severely
debilitated, suffering from diarrhea or severe constipation, infectious
disease, toxemia, or colic. Do not administer in conjunction with or
within 1 week of administration of muscle relaxant drugs, phenothiazine
derived tranquilizers or central nervous system depressant drugs.
Horses should not be subjected to insecticide treatment for 5 days
prior to or after treating with the drug. Do not administer to horses
afflicted with chronic alveolar emphysema (heaves) or related
respiratory conditions. The product is a cholinesterase inhibitor and
should not be used simultaneously or within a few days before or after
treatment with or exposure to cholinesterase inhibiting drugs,
pesticides or chemicals. Do not use in animals other than horses,
ponies, and mules. Do not use in horses, ponies, and mules intended for
food purposes. Do not allow fowl access to feed containing this
preparation or to fecal excrement from treated animals.
0
9. Add Sec. 520.598 to read as follows:
Sec. 520.598 Dichlorvos tablets.
(a) Specifications. Each tablet contains 2, 5, 10, or 20 milligrams
(mg) dichlorvos.
(b) Sponsor. See No. 069043 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs, puppies, cats, and kittens--(1)
Amount. Administer orally at 5 mg dichlorvos per pound of body weight.
(2) Indications for use--(i) Dogs and puppies: Removal and control
of intestinal roundworms (Toxocara canis and Toxascaris leonina) and
hookworms (Ancylostoma caninum and Uncinaria stenocephala).
(ii) Cats and kittens: Removal and control of intestinal roundworms
(Toxocara cati and Toxascaris leonina) and hookworms (Ancylostoma
tubaeforme and Uncinaria stenocephala).
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
10. Add Sec. 520.600 to read as follows:
Sec. 520.600 Dichlorvos capsules and pellets.
(a) Specifications. Each capsule contains 2.27 milligrams (mg) (4
percent) dichlorvos.
(b) Sponsor. See No. 069043 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. Administer any
combination of capsules and/or pellets so that the animal receives a
single dose equaling 12 to 15 mg of dichlorvos per pound of body
weight.
(2) Indications for use. For removal of Toxocara canis and
Toxascaris leonina (roundworms), Ancylostoma caninum and Uncinaria
stenocephala (hookworms), and Trichuris vulpis (whipworm) residing in
the lumen of the gastrointestinal tract.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
11. Add Sec. 520.602 to read as follows:
Sec. 520.602 Dichlorvos gel.
(a) Specifications. Each milligram (mg) of gel contains 2.27
milligrams (mg) dichlorvos.
(b) Sponsor. See No. 069043 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in horses--(1) Amount. Administer 20 mg per
kilogram of body weight for the removal of bots and ascarids. Repeat
administration every 21 to 28 days for the control of bots and
ascarids. For the control of bots only, the repeat dosage is 10
milligrams per kilogram of body weight every 21 to 28 days during bot
fly season.
(2) Indications for use. For the removal and control of first,
second, and third instar bots (Gastrophilus intestinalis and G.
nasalis), sexually mature and sexually immature (4th stage) ascarids
(Parascaris equorum) in horses and foals.
(3) Limitations. Do not use in horses intended for human
consumption. Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
Sec. 520.622a [Amended]
0
12. In Sec. 520.622a, in paragraph (a)(6), remove ``054628'' and in
its place add ``069043''.
Sec. 520.622b [Amended]
0
13. In Sec. 520.622b, in paragraph (c)(2), remove ``054628'' and in
its place add ``069043''.
Sec. 520.622c [Amended]
0
14. In Sec. 520.622c, in paragraph (b)(6), remove ``054628'' and in
its place add ``069043''.
Sec. 520.763a [Amended]
0
15. In Sec. 520.763a, in paragraph (b), remove ``054628'' and in its
place add ``069043''.
Sec. 520.763b [Amended]
0
16. In Sec. 520.763b, in paragraph (b), remove ``000010'' and in its
place add ``069043''.
Sec. 520.763c [Amended]
0
17. In Sec. 520.763c, in paragraph (b), remove ``054628'' and in its
place add ``069043''.
0
18. In Sec. 520.905d, revise paragraphs (a) and (b) to read as
follows:
Sec. 520.905d Fenbendazole powder.
(a) Specifications. Each 2-ounce packet contains 2.27 grams (4
percent) fenbendazole.
(b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
* * * * *
Sec. 520.1044c [Amended]
0
19. In Sec. 520.1044c, in paragraph (b)(2), remove ``057561'' and in
its place add ``016592''.
Sec. 520.1182 [Removed]
0
20. Remove Sec. 520.1182.
Sec. 520.1242a [Amended]
0
21. In Sec. 520.1242a, in paragraph (b)(3), remove ``057561'' and in
its place add ``016592''.
Sec. 520.1263c [Amended]
0
22. In Sec. 520.1263c, in paragraph (b)(1), remove ``Nos. 016592 and
054771'' and in its place add ``No. 054771''; and in paragraph (b)(2),
remove ``Nos. 054925, 061623, and 076475'' and in its place add ``Nos.
016592, 054925, 061623, and 076475''.
Sec. 520.1265 [Amended]
0
23. In Sec. 520.1265, in paragraph (b)(2), remove ``057561'' and in
its place add ``016592''.
0
24. Add Sec. 520.1286 to read as follows:
Sec. 520.1286 Lotilaner.
(a) Specifications. Each chewable tablet contains 56.25, 112.5,
225, 450, or 900 milligrams (mg) lotilaner.
(b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
[[Page 48946]]
(c) Conditions of use in dogs--(1) Amount. Administer orally once a
month at the recommended minimum dosage of 9 mg/lb (20 mg/kg).
(2) Indications for use. Kills adult fleas, and for the treatment
of flea infestations (Ctenocephalides felis), and the treatment and
control of tick infestations (Amblyomma americanum (lone star tick),
Dermacentor variabilis (American dog tick), Ixodes scapularis (black-
legged tick), and Rhipicephalus sanguineus (brown dog tick)) for 1
month in dogs and puppies 8 weeks of age or older and weighing 4.4
pounds or greater.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Sec. 520.1408 [Amended]
0
25. In Sec. 520.1408, in paragraph (b)(1), remove ``054628'' and in
its place add ``069043''.
Sec. 520.1660d [Amended]
0
26. In Sec. 520.1660d, in paragraph (b)(4), remove ``No. 057561'' and
in its place add ``No. 016592''.
Sec. 20.1720a [Amended]
0
27. In Sec. 520.1720a, in paragraph (b)(2), remove ``Nos. 054628 and
069043'' and in its place add ``No. 069043''.
Sec. 520.1804 [Removed]
0
28. Remove Sec. 520.1804.
Sec. 520.1840 [Amended]
0
29. In Sec. 520.1840, remove paragraph (b)(2), redesignate paragraphs
(b)(3) and (4) as paragraphs (b)(2) and (3), and remove paragraph
(d)(4).
Sec. 520.1900 [Amended]
0
30. In Sec. 520.1900, in paragraph (b)(1), remove ``054628'' and in
its place add ``069043''.
Sec. 520.2220a [Amended]
0
31. In Sec. 520.2220a, in paragraph (b)(1), remove ``Nos. 016592,
054628, 054771, 054925, and 057561'' and in its place add ``Nos.
016592, 054771, 054925, and 069043''; and in paragraph (b)(2), remove
``Nos. 054771, 054925, 057561, 058829, 061623, and 066104'' and in its
place add ``Nos. 016592, 054771, 054925, 058829, 061623, and 066104''.
Sec. 520.2345d [Amended]
0
32. In Sec. 520.2345d, in paragraph (b)(4), remove ``Nos. 054925,
057561, 061623, and 076475'' and in its place add ``Nos. 016592,
054925, 061623, and 076475''.
Sec. 520.2380a [Amended]
0
33. In Sec. 520.2380a, remove and reserve paragraphs (b)(1) and
(d)(1)(i).
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
34. The authority citation for part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 522.970 [Amended]
0
35. In Sec. 522.970, in paragraph (b)(1), remove ``Nos. 000061,
000859, 055529, 057561, and 061623'' and in its place add ``Nos.
000061, 000859, 016592, 055529, and 061623''.
Sec. 522.1044 [Amended]
0
36. In Sec. 522.1044, in paragraph (b)(3), remove ``054628'' and in
its place add ``069043''.
Sec. 522.1182 [Amended]
0
37. In Sec. 522.1182, in paragraph (b)(4), remove ``Nos. 051311 and
054771'' and in its place add ``No. 054771''.
Sec. 522.1222 [Amended]
0
38. In Sec. 522.1222, in paragraph (b), remove ``Nos. 000859, 026637,
054628, 054771, 059399, and 063286'' and in its place add ``Nos.
000859, 026637, 054771, 059399, 063286, and 069043''.
Sec. 522.1242 [Amended]
0
39. In Sec. 522.1242, in paragraph (b), remove ``057561'' and in its
place add ``016592''.
Sec. 522.1410 [Amended]
0
40. In Sec. 522.1410, in paragraph (b), remove ``054628 and 054771''
and in its place add ``054771 and 069043''.
Sec. 522.1660a [Amended]
0
41. In Sec. 522.1660a, in paragraph (b), remove ``057561,''.
Sec. 522.1662a [Amended]
0
42. In Sec. 522.1662a, in paragraphs (a)(2), (b)(2), (g)(2), and
(h)(2), remove ``054628'' and in its place add ``069043''.
Sec. 522.1720 [Amended]
0
43. In Sec. 522.1720, in paragraph (b)(3), remove ``054628 and
058005'' and in its place add ``058005 and 069043''.
Sec. 522.2220 [Amended]
0
44. In Sec. 522.2220, in paragraph (b)(1), remove ``054628'' and in
its place add ``069043''; and in paragraph (b)(3), remove ``Nos.
016592, 057561, and 061623'' and in its place add ``Nos. 016592 and
061623''.
Sec. 522.2424 [Amended]
0
45. In Sec. 522.2424, in paragraph (b), remove ``054628 and 054771''
and in its place add ``054771 and 069043''.
Sec. 522.2483 [Amended]
0
46. In Sec. 522.2483, in paragraph (b), remove ``054628'' and in its
place add ``069043''.
Sec. 522.2662 [Amended]
0
47. In Sec. 522.2662, in paragraph (b)(1), remove ``054628'' and in
its place add ``069043''.
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
48. The authority citation for part 524 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
49. In Sec. 524.814, revise paragraph (b) to read as follows:
Sec. 524.814 Eprinomectin.
* * * * *
(b) Sponsors. See Nos. 050604 and 055529 in Sec. 510.600(c) of
this chapter.
* * * * *
0
50. Add Sec. 524.815 to read as follows:
Sec. 524.815 Eprinomectin and praziquantel.
(a) Specifications. Each milliliter (mL) of solution contains 4
milligrams (mg) eprinomectin and 83 mg praziquantel.
(b) Sponsor. See No. 050604 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in cats--(1) Amount. Using the 0.3 mL and 0.9
mL unit applicators, administer a minimum dose of 0.23 mg eprinomectin
per pound body weight and 4.55 mg praziquantel per pound body weight by
topical application on the dorsal midline between the base of the skull
and the shoulder blades.
(2) Indications for use. For the prevention of heartworm disease
caused by Dirofilaria immitis, and for the treatment and control of
roundworms (adult and fourth stage larval Toxocara cati), hookworms
(adult and fourth stage larval Ancylostoma tubaeforme; adult
Ancylostoma braziliense), and tapeworms (adult Dipylidium caninum and
Echinococcus multilocularis), in cats and kittens 7 weeks of age and
older and 1.8 lbs or greater.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Sec. 524.900 [Amended]
0
51. In Sec. 524.900, in paragraph (b), remove ``Nos. 000061 and
051311'' and in its place add ``No. 000061''.
[[Page 48947]]
Sec. 524.1580a [Amended]
0
52. In Sec. 524.1580a, in paragraph (b)(1), remove ``Nos. 054628,
054925, 058005, 059051, and 061623'' and in its place add ``Nos.
054925, 058005, 059051, 061623, and 069043''.
Sec. 524.1580b [Amended]
0
53. In Sec. 524.1580b, in paragraph (b), remove ``054628 and 059051''
and in its place add ``059051 and 069043''.
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
0
54. The authority citation for part 529 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 529.1044a [Amended]
0
55. In Sec. 529.1044a, in paragraph (b), remove ``Nos. 000061, 000859,
054628, 054771, 057561, 058005, and 061623'' and in its place add
``Nos. 000061, 000859, 016592, 054628, 054771, 058005, and 061623''.
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
0
56. The authority citation for part 556 continues to read as follows:
Authority: 21 U.S.C. 342, 360b, 371.
0
57. In Sec. 556.275, add paragraph (b)(3)(ii) to read as follows:
Sec. 556.275 Fenbendazole.
* * * * *
(b) * * *
(3) * * *
(ii) Eggs. The tolerance for fenbendazole sulfone (the marker
residue) is 1.8 ppm.
* * * * *
Sec. 556.440 [Removed]
0
58. Remove Sec. 556.440.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
59. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
Sec. 558.4 [Amended]
0
60. In Sec. 558.4, in paragraph (d), in the ``Category I'' table,
remove the row entry for ``Nequinate''.
Sec. 558.128 [Amended]
0
61. In Sec. 558.128, in paragraphs (e)(4)(xi) and (xiii), in the
``Indications for use'' column, remove ``P. multocida'' and in its
place add ``P. multocida organisms''.
0
62. In Sec. 558.185, revise paragraph (b), remove paragraph (e)(1),
and redesignate paragraphs (e)(2) and (3) as paragraphs (e)(1) and (2).
The revision reads as follows:
Sec. 558.185 Coumaphos.
* * * * *
(b) Sponsor. See No. 000859 in Sec. 510.600(c) of this chapter.
* * * * *
Sec. 558.195 [Amended]
0
63. In Sec. 558.195, remove and reserve paragraph (e)(2)(v).
0
64. In Sec. 558.205, revise paragraph (a); redesignate paragraphs (b)
through (d) as paragraphs (c) through (e); and add new paragraph (b).
The revision and addtion read as follows:
Sec. 558.205 Dichlorvos.
(a) Specifications. Type A medicated articles containing 3.1 or 9.6
percent dichlorvos.
(b) Sponsor. See No. 069043 in Sec. 510.600(c) of this chapter.
* * * * *
0
65. In Sec. 558.311, revise paragraph (e)(5) to read as follows:
Sec. 558.311 Lasalocid.
* * * * *
(e) * * *
(5) Lasalocid may also be used in combination with:
(i) Chlortetracycline as in Sec. 558.128.
(ii) Melengestrol as in Sec. 558.342.
(iii) Oxytetracycline as in Sec. 558.450.
(iv) Tylosin alone or in combination with melengestrol acetate as
in Sec. 558.625.
(v) Virginiamycin as in Sec. 558.635.
0
66. In Sec. 558.325, redesignate paragraph (e)(1)(ii) as paragraph
(e)(1)(v); add reserved paragraphs (e)(1)(ii), (iii), and (vi); and add
paragraphs (e)(1)(iv), (vii), (viii), (ix), and (x) to read as follows:
Sec. 558.325 Lincomycin.
* * * * *
(e) * * *
(1) * * *
----------------------------------------------------------------------------------------------------------------
Combination in
Lincomycin grams/ton grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(ii) [Reserved]
(iii) [Reserved]
(iv) 2........................ Decoquinate, Broiler chickens: For Feed as the sole ration. 054771
2.72. the control of Do not use in feeds
necrotic enteritis containing bentonite. Not
caused or for use in laying hens,
complicated by breeding chickens, or
Clostridium spp. or turkeys. Do not allow
other organisms rabbits, hamsters, guinea
susceptible to pigs, horses, or
lincomycin; and for ruminants access to feeds
the prevention of containing lincomycin.
coccidiosis caused Ingestion by these
by Eimeria tenella, species may result in
E. necatrix, E. severe gastrointestinal
acervulina, E. effects. Decoquinate as
brunetti, E. mivati, provided by No. 054771 in
and E. maxima. Sec. 510.600 of this
chapter.
* * * * * * *
(vi) [Reserved]
(vii) 2....................... Monensin, 90 to Broiler chickens: For Feed as the sole ration. 054771
110. the control of Must be thoroughly mixed
necrotic enteritis in feeds before use. Do
caused or not feed undiluted. Not
complicated by for use in laying hens,
Clostridium spp. or breeding chickens, or
other organisms turkeys. Do not allow
susceptible to horses, or other equines,
lincomycin, and as mature turkeys, or guinea
an aid the fowl access to feed
prevention of containing monensin.
coccidiosis caused Ingestion of monensin by
by Eimeria necatrix, horses and guinea fowl
E. tenella, E. has been fatal. Do not
acervulina, E. allow rabbits, hamsters,
brunetti, E. mivati, guinea pigs, horses, or
and E. maxima. ruminants access to feeds
containing lincomycin.
Ingestion by these
species may result in
severe gastrointestinal
effects. Monensin as
provided by No. 058198 in
Sec. 510.600 of this
chapter.
[[Page 48948]]
(viii) 2...................... Robenidine Broiler chickens: For Feed as the sole ration. 054771
hydrochloride, the control of Do not use in feeds
30. necrotic enteritis containing bentonite. Do
caused or not feed to laying hens
complicated by producing eggs for human
Clostridium spp. or consumption. Not for use
other organisms in laying hens, breeding
susceptible to chickens, or turkeys. Do
lincomycin, and as not allow rabbits,
an aid in the hamsters, guinea pigs,
prevention of horses, or ruminants
coccidiosis caused access to feeds
by Eimeria mivati, containing lincomycin.
E. brunetti, E. Ingestion by these
tenella, E. species may result in
acervulina, E. severe gastrointestinal
maxima, and E. effects. Withdraw 5 days
necatrix. prior to slaughter. Type
C feed containing
robenidine hydrochloride
must be fed within 50
days from the date of
manufacture. Robenidine
hydrochloride as provided
by No. 054771 in Sec.
510.600 of this chapter.
(ix) 2........................ Salinomycin Broiler chickens: For Feed as the sole ration to 054771
sodium, 40 to the control of broiler chickens. Do not
60. necrotic enteritis feed to laying hens
caused or producing eggs for human
complicated by consumption. Not approved
Clostridium spp. or for use with pellet
other organisms binders. May be fatal if
susceptible to accidentally fed to adult
lincomycin, and for turkeys or horses. Not
the prevention of for use in laying hens,
coccidiosis caused breeding chickens, or
by Eimeria tenella, turkeys. Do not allow
E. necatrix, E. rabbits, hamsters, guinea
acervulina, E pigs, horses, or
maxima, E. brunetti, ruminants access to feeds
and E. mivati. containing lincomycin.
Ingestion by these
species may result in
severe gastrointestinal
effects. Salinomycin
sodium as provided by No.
054771 in Sec. 510.600
of this chapter.
(x) 2......................... Zoalene, 113.5.. Broiler chickens: For Feed as the sole ration 054771
the control of from the time chicks are
necrotic enteritis placed in floor pens
caused or until slaughtered for
complicated by meat. Not for use in
Clostridium spp. or laying hens, breeding
other organisms chickens, or turkeys. Do
susceptible to not allow rabbits,
lincomycin; and for hamsters, guinea pigs,
the prevention and horses, or ruminants
control of access to feeds
coccidiosis. containing lincomycin.
Ingestion by these
species may result in
severe gastrointestinal
effects. Zoalene as
provided by No. 054771 in
Sec. 510.600 of this
chapter.
----------------------------------------------------------------------------------------------------------------
* * * * *
0
67. In Sec. 558.342, in paragraph (e)(1), revise the table headings,
add paragraphs (e)(1)(iii) and (iv), and remove paragraphs (e)(1)(v)
through (xi); and in paragraph (e)(2), redesignate paragraphs (e)(2)(i)
through (iii) as paragraphs (e)(2)(ii) through (iv) and add new
paragraph (e)(2)(i).
The revisions and additions read as follows:
Sec. 558.342 Melengestrol.
* * * * *
(e) * * *
(1) * * *
----------------------------------------------------------------------------------------------------------------
Melengestrol acetate in mg/ Combination in
head/day grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(iii) 0.25 to 0.5............. Lasalocid, 10 to Heifers fed in Add at the rate of 0.5 to 054771
30. confinement for 2.0 lb/head/day a 058198
slaughter: For medicated feed (liquid or
increased rate of dry) containing 0.125 to
weight gain, 1.0 mg melengestrol
improved feed acetate/lb to a feed
efficiency, and containing 10 to 30 g of
suppression of lasalocid per ton to
estrus (heat); and provide 0.25 to 0.5 mg
for control of melengestrol acetate and
coccidiosis caused 100 to 360 milligrams of
by Eimeria bovis and lasalocid per head/day.
Eimeria zuernii. See Sec. 558.311(d) of
this chapter. Lasalocid
as provided by No. 054771
in Sec. 510.600(c) of
this chapter.
(iv) 0.25 to 0.5.............. Monensin, 10 to Heifers fed in Add at the rate of 0.5 to 054771
40. confinement for 2.0 lb/head/day a 058198
slaughter: For medicated feed (liquid or
increased rate of dry) containing 0.125 to
weight gain, 1.0 mg melengestrol
improved feed acetate/lb to a feed
efficiency, and containing 10 to 40 g of
suppression of monensin per ton to
estrus (heat); and provide 0.25 to 0.5 mg
for the prevention melengestrol acetate/head/
and control of day and 0.14 to 0.42 mg
coccidiosis due to monensin/lb body weight,
Eimeria bovis and E. depending on severity of
zuernii. coccidiosis challenge, up
to 480 mg monensin/head/
day. See Sec.
558.355(d) of this
chapter. Monensin as
provided by No. 058198 in
Sec. 510.600(c) of this
chapter.
----------------------------------------------------------------------------------------------------------------
(2) * * *
(i) Oxytetracycline as in Sec. 558.450.
* * * * *
Sec. 558.365 [Removed]
0
68. Remove Sec. 558.365.
Sec. 558.450 [Amended]
0
69. In Sec. 558.450, in paragraph (e)(5)(iv) entries 1 and 2, remove
``A. liquefaciens'' and in its place add ``A. hydrophila''.
0
70. Revise Sec. 558.485 to read as follows:
Sec. 558.485 Pyrantel.
(a) Specifications. Type A medicated articles containing 48 or 80
grams per pound pyrantel tartrate.
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for
uses as in paragraph (e) of this section.
(1) No. 066104: 48 and 80 grams per pound for use as in paragraph
(e)(1) of this section.
(2) Nos. 017135 and 054771: 48 grams per pound for use as in
paragraph (e)(2) of this section.
(c) Related tolerances. See Sec. 556.560 of this chapter.
[[Page 48949]]
(d) Special considerations--(1) See Sec. 500.25 of this chapter.
Consult a veterinarian before using in severely debilitated animals.
(2) Do not mix in Type B or Type C medicated feeds containing
bentonite.
(e) Conditions of use--(1) Swine--
----------------------------------------------------------------------------------------------------------------
Pyrantel grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 96.............................. Swine: As an aid in the Feed continuously as the sole 066104
prevention of migration ration in a Type C feed.
and establishment of large Withdraw 24 hours prior to
roundworm (Ascaris suum) slaughter.
infections; aid in the
prevention of
establishment of nodular
worm (Oesophagostomum)
infections.
(ii) 96............................. Swine: For the removal and Feed for 3 days as the sole 066104
control of large roundworm ration in a Type C feed.
(Ascaris suum) infections. Withdraw 24 hours prior to
slaughter.
(iii) 800........................... Swine: For the removal and Feed as the sole ration for a 066104
control of large roundworm single therapeutic treatment in
(Ascaris suum) and nodular Type C feed at a rate of 1 lb
worm (Oesophagostomum) of feed per 40 lb of body
infections. weight for animals up to 200
lb, and 5 lb of feed per head
for animals 200 lb or over.
Withdraw 24 hours prior to
slaughter.
----------------------------------------------------------------------------------------------------------------
(2) Horses--
----------------------------------------------------------------------------------------------------------------
Pyrantel grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
To provide 1.2 mg/lb body weight.... Prevention of Strongylus Feed continuously. Administer 017135
vulgaris larval either as a top-dress (not to 054771
infections; control of exceed 20,000 g/ton) or mixed
adult large strongyles (S. in the horse's daily grain
vulgaris, and S. ration (not to exceed 1,200 g/
edentatus), adult and 4th ton) during the time that the
stage larvae small animal is at risk of exposure
strongyles (Cyathostomum to internal parasites. Not for
spp., Cylicocyclus spp., use in horses intended for
Cylicostephanus spp., food. Consult your veterinarian
Cylicodontophorus spp., before using in severely
Poteriostomum spp., and debilitated animals and for
Triodontophorus spp.), assistance in the diagnosis,
adult and 4th stage larvae treatment, and control of
pinworms (Oxyuris equi), parasitism.
and adult and 4th stage
larvae ascarids
(Parascaris equorum).
----------------------------------------------------------------------------------------------------------------
(3) Pyrantel may also be used in combination with:
(i) Carbadox as in Sec. 558.115.
(ii) Lincomycin as in Sec. 558.325.
(iii) Tylosin as in Sec. 558.625.
0
71. In Sec. 558.625, revise paragraphs (e)(2)(ii) and (iii) to read as
follows:
Sec. 558.625 Tylosin.
* * * * *
(e) * * *
(2) * * *
----------------------------------------------------------------------------------------------------------------
Combination in
Tylosin grams/ton grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(ii) 8 to 10.................. Lasalocid, 100 Heifers fed in Feed continuously as sole 016592
to 1440; plus confinement for ration. Feed to heifers 054771
melengestrol, slaughter: For at the rate of 0.5 to 2.0 058198
0.25 to 2.0. reduction of pound(s) per head per day
incidence of liver (specify one level) to
abscesses caused by provide 0.25 to 0.5 mg
Fusobacterium melengestrol acetate per
necrophorum and head per day (specify one
Arcanobacterium level), 100 to 360 mg
pyogenes; and for lasalocid per head per
increased rate of day (specify one level),
weight gain, and 90 mg tylosin per
improved feed head per day. This Type C
efficiency, and product may be top
suppression of dressed onto or mixed
estrus (heat). into a complete feed
prior to feeding. Tylosin
as provided by Nos.
016592 and 058198;
lasalocid as provided by
No. 054771; melengestrol
as provided by Nos.
054771 and 058198 in Sec.
510.600(c) of this
chapter. See Sec. Sec.
558.311(d) and 558.342(d)
in this chapter.
(iii) 8 to 10................. Melengestrol, Heifers fed in Feed continuously as sole 016592
0.25 to 2.0. confinement for ration. Each pound 054771
slaughter: For contains 0.125 to 1.0 mg 058198
reduction of melengestrol acetate and
incidence of liver 45 to 180 mg of tylosin.
abscesses caused by Feed to heifers at a rate
Fusobacterium of 0.5 to 2.0 pounds per
necrophorum and head per day to provide
Arcanobacterium 0.25 to 0.5 mg
pyogenes; and for melengestrol acetate and
increased rate of 60 to 90 mg tylosin per
weight gain, head per day. Prior to
improved feed feeding, this Type C
efficiency, and product must be top-
suppression of dressed onto a complete
estrus (heat). feed or mixed into the
amount of complete feed
consumed by an animal per
day. Tylosin provided by
Nos. 016592 and 058198;
melengestrol provided by
Nos. 054771 and 058198 in
Sec. 510.600(c) of this
chapter. See Sec.
558.342(d) in this
chapter.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
[[Page 48950]]
Dated: September 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21146 Filed 9-27-18; 8:45 am]
BILLING CODE 4164-01-P
