New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship, 12491-12504 [2019-06136]
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12491
Federal Register / Vol. 84, No. 63 / Tuesday, April 2, 2019 / Rules and Regulations
was less than $500,000, adjusted for
inflation.
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■ 4. In § 112.161, revise paragraph (b) to
read as follows:
§ 112.161 What general requirements
apply to records required under this part?
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(b) Records required under
§§ 112.7(b), 112.30(b), 112.50(b)(2), (4),
and (6), 112.60(b)(2), 112.140(b)(1) and
(2), and 112.150(b)(1), (4), and (6), must
be reviewed, dated, and signed, within
a reasonable time after the records are
made, by a supervisor or responsible
party.
PART 117—CURRENT GOOD
MANUFACTURING PRACTICE,
HAZARD ANALYSIS, AND RISKBASED PREVENTIVE CONTROS FOR
HUMAN FOOD
5. The authority citation for part 117
continues to read as follows:
■
Authority: 21 U.S.C. 331, 342, 343, 350d
note, 350g, 350g note, 371, 374; 42 U.S.C.
243, 264, 271.
6. In § 117.126, revise paragraph (b)(5)
to read as follows:
(c) * * *
(5) The written procedures for
monitoring the implementation of the
preventive controls as required by
§ 507.40(a);
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■ 9. In § 507.130, revise paragraph
(c)(2)(ii) to read as follows:
§ 507.130 Conducting supplier verification
activities for raw materials and other
ingredients.
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(c) * * *
(2) * * *
(ii) A statement that the facility is in
compliance with State, local, county,
tribal, or other applicable non-Federal
food safety laws, including relevant
laws and regulations of foreign
countries.
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Dated: March 26, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–06141 Filed 4–1–19; 8:45 am]
BILLING CODE 4164–01–P
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§ 117.126
Food safety plan.
Food and Drug Administration
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(b) * * *
(5) The written procedures for
monitoring the implementation of the
preventive controls as required by
§ 117.145(a);
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21 CFR Parts 510, 520, 522, 524, 528,
556, and 558
[Docket No. FDA–2018–N–0002]
PART 507—CURRENT GOOD
MANUFACTURING PRACTICE,
HAZARD ANALYSIS, AND RISKBASED PREVENTIVE CONTROLS FOR
FOOD FOR ANIMALS
7. The authority citation for part 507
continues to read as follows:
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8. In § 507.31, revise paragraph (c)(5)
to read as follows:
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Food safety plan.
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New Animal Drugs; Approval of New
Animal Drug Applications; Changes of
Sponsorship
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 October,
November, and December 2018. FDA is
informing the public of the availability
SUMMARY:
Authority: 21 U.S.C. 331, 342, 343, 350d
note, 350g, 350g note, 371, 374; 42 U.S.C.
243, 264, 271.
§ 507.31
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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of summaries of the basis of approval
and of environmental review
documents, where applicable. The
animal drug regulations are also being
amended to make technical
amendments to improve the readability
of the regulations.
DATES:
This rule is effective April 2,
2019.
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
October, November, and December
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/CVMFOIAElect
ronicReadingRoom/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/ApprovedAnimal
DrugProducts/default.htm.
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TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING OCTOBER, NOVEMBER, AND
DECEMBER 2018
Approval date
File No.
October 1, 2018
200–490
VerDate Sep<11>2014
Sponsor
Product name
Dragon Fire Holding
Co., Inc., 2619 Skyway Dr., Grand Prairie, TX 75052.
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Tablets.
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Species
Effect of the action
Dogs ..........
Original approval as a generic copy of NADA
141–111.
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Public
documents
FOI Summary.
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Federal Register / Vol. 84, No. 63 / Tuesday, April 2, 2019 / Rules and Regulations
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING OCTOBER, NOVEMBER, AND
DECEMBER 2018—Continued
Approval date
File No.
Sponsor
Product name
October 15, 2018
141–485
Zoetis Inc., 333 Portage
St., Kalamazoo, MI
49007.
November 1,
2018.
200–627
November 6,
2018.
141–508
Putney, Inc., One
Monument Sq., Suite
400, Portland, ME
04101.
Elanco US Inc., 2500
Innovation Way,
Greenfield, IN 46140.
November 9,
2018.
141–502
Zoetis Inc., 333 Portage
St., Kalamazoo, MI
49007.
November 21,
2018.
038–439
December 4,
2018.
141–509
December 19,
2018.
200–629
December 27,
2018.
141–511
Phibro Animal Health,
Corp., GlenPointe
Centre East, 3d
Floor, 300 Frank W.
Burr Blvd., Suite 21,
Teaneck, NJ 07666.
Boehringer Ingelheim
Vetmedica, Inc., 2621
North Belt Highway,
St. Joseph, MO
64506–2002.
Ceva Sante Animale,
10 Avenue de la
Ballastie`re, 33500
Libourne, France.
LFB USA, Inc., 175
Crossing Blvd., Framingham, MA 01702.
Public
documents
Species
Effect of the action
Lincomycin and
clopidol, Type C
medicated feeds.
Chickens ...
FOI Summary.
Cyclosporine Capsules,
USP MODIFIED.
Dogs ..........
Original approval for use of LINCOMIX (lincomycin) and COYDEN (clopidol) Type A medicated articles in the manufacture of Type C
medicated broiler chicken feeds 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.
Original approval as a generic copy of NADA
141–218.
EXPERIOR
(lubabegron) Type A
medicated article to
be used in the manufacture of Type B and
Type C medicated
feeds.
REVOLUTION PLUS
(selamectin and
sarolaner topical solution).
Cattle .........
Original approval for reduction of ammonia gas
emissions per pound of live weight and hot
carcass weight in beef steers and heifers fed
in confinement for slaughter during the last 14
to 91 days on feed.
FOI Summary
EA/FONSI.1
Cats ...........
FOI Summary.
TERRAMYCIN (oxytetracycline), Type A
medicated article.
Salmonids
Original approval for the prevention of heartworm disease caused by Dirofilaria immitis.
Kills adult fleas (Ctenocephalides felis) and is
indicated for the treatment and prevention of
flea infestations; the treatment and control of
tick infestations with Ixodes scapularis (blacklegged or deer tick), Amblyomma maculatum
(Gulf Coast tick), and Dermacentor variabilis
(American dog tick); the treatment and control
of ear mite (Otodectes cynotis) infestations;
and the treatment and control of roundworm
(Toxocara cati) and intestinal hookworm
(Ancylostoma tubaeforme) infections in cats
and kittens 8 weeks of age and older, and
weighing 2.8 pounds or greater.
Supplemental approval for marking the skeletal
tissue of freshwater-reared salmonids.
PEXION (imepitoin tablets).
Dogs ..........
Original approval for the treatment of noise
aversion in dogs.
FOI Summary.
MILBEGUARD
(milbemycin oxime),
Flavored Tablets.
Dogs and
cats.
Original approval as a generic copy of NADA
140–915.
FOI Summary.
Bc2371 rDNA construct
in R69 New Zealand
white rabbits.
R69 New
Zealand
white rabbits.
Original approval for expression of a gene for
recombinant human Factor VII (rhFVIIa) in
R69 New Zealand white rabbits.
FOI Summary
EA/FONSI.1
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).
II. Change of Sponsorship
Huvepharma EOOD, 5th Floor, 3A
Nikolay Haytov Str., 1113 Sofia,
Bulgaria, has informed FDA that it has
transferred ownership of, and all rights
and interest in, the following
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File No.
140–951
141–153
141–158
141–194
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VerDate Sep<11>2014
applications to Elanco US Inc., 2500
Innovation Way, Greenfield, IN 46140.
21 CFR
section
Product name
CLINACOX
CLINACOX
CLINACOX
CLINACOX
(diclazuril) Type A Medicated Article ...................................................................................................
(diclazuril)/BMD (bacitracin methylenedisalicylate) .............................................................................
(diclazuril)/FLAVOMYCIN (bambermycins) .........................................................................................
(diclazuril)/BMD (bacitracin methylenedisalicylate) .............................................................................
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558.198
558.198
558.198
558.198
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Federal Register / Vol. 84, No. 63 / Tuesday, April 2, 2019 / Rules and Regulations
As provided in the regulatory text of
this document, the animal drug
regulations are amended to reflect these
changes of sponsorship.
III. Technical Amendments
We are reformatting the regulations in
subpart B of part 558 for certain
medicated feeds to present their
approved conditions of use in the
current tabular format. In addition, we
are removing cross-referencing citations
for indications for use of combination
drug medicated feeds wherever they
have been used and in their place are
adding the full text of the indications.
These actions are being taken to
improve the consistency and readability
of the regulations.
IV. 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 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, 528, 556, and 558 are
amended as follows:
PART 510—NEW ANIMAL DRUGS
1. The authority citation for part 510
continues to read as follows:
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Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
2. In § 510.600, in the table in
paragraph (c)(1), revise the entry for
‘‘AquaBounty Technologies, Inc.’’ and
alphabetically add an entry for ‘‘Dragon
Fire Holding Co., Inc.’’; and in the table
in paragraph (c)(2), numerically add an
entry for ‘‘076033’’ and revise the entry
for ‘‘086053’’ to read as follows:
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§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
21 CFR Parts 520, 522, 524, and 528
Animal drugs.
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21 CFR Part 556
Animal drugs, Foods.
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(c) * * *
(1) * * *
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Drug labeler
code
Firm name and address
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AquaBounty Technologies, Inc., 2 Mill and Main Pl., Suite 395, Maynard, MA 01754 ......................................................................
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Dragon Fire Holding Co., Inc., 2619 Skyway Dr., Grand Prairie, TX 75052 ......................................................................................
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086053
076033
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(2) * * *
Drug labeler
code
Firm name and address
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076033 ............
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Dragon Fire Holding Co., Inc., 2619 Skyway Dr., Grand Prairie, TX 75052.
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086053 ............
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AquaBounty Technologies, Inc., 2 Mill and Main Pl., Suite 395, Maynard, MA 01754.
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PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
3. The authority citation for part 520
continues to read as follows:
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Authority: 21 U.S.C. 360b.
VerDate Sep<11>2014
16:30 Apr 01, 2019
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§ 520.304
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[Amended]
§ 520.522
4. In § 520.304, in paragraph (b)(1),
remove ‘‘054771, 026637, 055529, and
062250’’ and in its place add ‘‘026637,
054771, 055529, 062250, and 076033’’.
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5. In § 520.522, revise paragraph (b) to
read as follows:
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Cyclosporine.
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(b) Sponsors. See sponsors in
§ 510.600(c) of this chapter.
(1) No. 058198 for use of products
described in paragraph (a) as in
paragraph (d) of this section.
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(2) No. 026637 for use of product
described in paragraph (a)(1) as in
paragraph (d)(1) of this section.
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■ 6. Add § 520.1150 to read as follows:
§ 520.1150
Imepitoin.
(a) Specifications. Each tablet
contains 100 or 400 milligrams (mg)
imepitoin.
(b) Sponsor. See No. 000010 in
§ 510.600(c) of this chapter.
(c) Conditions of use—(1) Amount.
Administer orally twice daily,
approximately 12 hours apart, at a dose
of 13.6 mg per pound (30 mg/kg) of
body weight. Initiate therapy starting 2
days prior to the day of the expected
noise event and continuing through the
noise event.
(2) Indications for use. For the
treatment of noise aversion in dogs.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
■ 7. Revise § 520.1441 to read as
follows:
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§ 520.1441
Milbemycin.
(a) Specifications. Each flavored tablet
contains 2.3, 5.75, 11.5, or 23.0
milligrams (mg) of milbemycin oxime.
(b) Sponsors. See Nos. 013744 and
058198 in § 510.600(c) of this chapter.
(c) Conditions of use—(1) Dogs—(i)
Amount. For hookworm, roundworm,
and whipworm, administer 0.23 mg per
pound (mg/lb) of body weight (0.5 mg
per kilogram (mg/kg)). For heartworm,
administer 0.05 mg/lb of body weight
(0.1 mg/kg). Administer once a month.
(ii) Indications for use. For prevention
of heartworm disease caused by
Dirofilaria immitis, control of
hookworm infections caused by
Ancylostoma caninum, and removal and
control of adult roundworm infections
caused by Toxocara canis and
Toxascaris leonina and whipworm
infections caused by Trichuris vulpis in
dogs and puppies 4 weeks of age or
greater and 2 pounds body weight or
greater.
(iii) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
(2) Cats—(i) Amount. Administer 0.91
mg/lb of body weight (2.0 mg/kg) once
a month.
(ii) Indications for use. For prevention
of heartworm disease caused by
Dirofilaria immitis and the removal of
adult Toxocara cati (roundworm) and
Ancylostoma tubaeforme (hookworm)
infections in cats 6 weeks of age or
greater and 1.5 pounds body weight or
greater.
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16:30 Apr 01, 2019
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(iii) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
8. The authority citation for part 522
continues to read as follows:
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Authority: 21 U.S.C. 360b.
9. Amend § 522.1662a by adding two
sentences at the end of paragraph
(h)(3)(iii) to read as follows:
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§ 522.1662a
injection.
Oxytetracycline hydrochloride
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(h) * * *
(3) * * *
(iii) * * * A withdrawal period has
not been established for this product in
preruminating calves. Do not use in
calves to be processed for veal.
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PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
10. The authority citation for part 524
continues to read as follows:
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Authority: 21 U.S.C. 360b.
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11. Add § 524.2099 to read as follows:
§ 524.2099
Selamectin and sarolaner.
(a) Specifications. Each milliliter (mL)
of solution contains 60 milligrams (mg)
selamectin and 10 mg sarolaner. The
drug is provided in single dose tubes
containing 0.25, 0.5, or 1 mL of solution.
(b) Sponsor. See No. 054771 in
§ 510.600(c) of this chapter.
(c) Conditions of use in cats—(1)
Amount. Administer 2.7 mg selamectin
per pound (/lb) (6 mg per kilogram (/kg))
of body weight and 0.45 mg/lb sarolaner
(1 mg/kg) by emptying the contents of
the tube on the back of the animal at the
base of the neck in front of the shoulder
blades.
(2) Indications for use. For the
prevention of heartworm disease caused
by Dirofilaria immitis. Kills adult fleas
(Ctenocephalides felis) and is indicated
for the treatment and prevention of flea
infestations; the treatment and control
of tick infestations with Ixodes
scapularis (black-legged or deer tick),
Amblyomma maculatum (Gulf Coast
tick), and Dermacentor variabilis
(American dog tick); the treatment and
control of ear mite (Otodectes cynotis)
infestations; and the treatment and
control of roundworm (Toxocara cati)
and intestinal hookworm (Ancylostoma
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tubaeforme) infections in cats and
kittens 8 weeks of age and older, and
weighing 2.8 pounds or greater.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
PART 528—NEW ANIMAL DRUGS IN
GENETICALLY ENGINEERED
ANIMALS
12. The authority citation for part 528
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
■
13. Add § 528.1080 to read as follows:
§ 528.1080 Bc2371 recombinant
deoxyribonucleic acid construct.
(a) Specifications and intended use. A
single copy of Bc2371, a human Factor
VII recombinant deoxyribonucleic acid
(rDNA) gene construct, located on
chromosome 3p1.1–2 in a diploid line
(R69) of hemizygous and homozygous
New Zealand white rabbits (Oryctolagus
cuniculus).
(b) Sponsor. See No. 086047 in
§ 510.600 of this chapter.
(c) Conditions of use—(1) Intended
use. The construct directs gene
expression of recombinant human
Factor VII (hFVII) in the mammary
gland such that recombinant hFVII
zymogen is present in the rabbit milk,
enabling purification and activation of
recombinant hFVIIa intended for the
treatment of hemophilia A or B in
humans with inhibitors to Factors VIII
and IX.
(2) Limitations. Food or feed from R69
rabbits is not permitted in the food or
feed supply.
PART 556—TOLERANCES FOR
RESIDUES OF NEW ANIMAL DRUGS
IN FOOD
14. The authority citation for part 556
continues to read as follows:
■
Authority: 21 U.S.C. 342, 360b, 371.
15. Add § 556.370 to subpart B to read
as follows:
■
§ 556.370
Lubabegron.
(a) Acceptable daily intake (ADI). The
ADI for total residues of lubabegron is
3 micrograms per kilogram of body
weight per day.
(b) Tolerance in cattle. The tolerance
for lubabegron (marker residue) is:
(1) Cattle—Liver (target tissue): 10
ppb.
(2) [Reserved]
(c) Related conditions of use. See
§ 558.330 of this chapter.
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PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
16. The authority citation for part 558
continues to read as follows:
■
Authority: 21 U.S.C. 354, 360b, 360ccc,
360ccc–1, 371.
§ 558.4 Requirement of a medicated feed
mill license.
17. In § 558.4, in paragraph (d), in the
‘‘Category I’’ table, alphabetically add an
entry for ‘‘Lubabegron’’ to read as
follows:
*
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(d) * * *
*
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CATEGORY I
Assay limits
percent 1 Type A
Drug
*
*
*
Lubabegron .............................................................
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*
87–107
*
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*
908 g/ton .................................................................
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§ 558.140 Chlortetracycline and
sulfamethazine.
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18. In § 558.140, revise paragraphs
(e)(1) and (2) to read as follows:
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Assay limits
percent 1 Type
B/C 2
Type B maximum
(200x)
*
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85–115/80–120
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(e) * * *
(1) Cattle—
*
Chlortetracycline and sulfamethazine amount
Indications for use
Limitations
(i) To provide 350 milligrams per head per day
each, chlortetracycline and sulfamethazine.
Beef cattle: For aid in the maintenance of
weight gains in the presence of respiratory
disease such as shipping fever.
Feed for 28 days; withdraw 7 days prior to
slaughter. A withdrawal period has not been
established for this product in pre-ruminating
calves. Do not use in calves to be processed
for veal.
Chlortetracycline and sulfamethazine amount
Indications for use
Limitations
(i) 100 g/ton of feed each, chlortetracycline and
sulfamethazine.
Swine: For reduction of the incidence of cervical
abscesses; treatment of bacterial swine enteritis (salmonellosis or necrotic enteritis caused
by Salmonella choleraesuis and vibrionic dysentery); prevention of these diseases during
times of stress; and maintenance of weight
gains in the presence of atrophic rhinitis.
Feed as the sole ration. Withdraw 15 days prior
to slaughter.
Sponsors
054771
069254
(ii) [Reserved]
(2) Swine—
Sponsors
054771
069254
(ii) [Reserved]
*
§ 558.175
■
*
amozie on DSK9F9SC42PROD with RULES
*
*
*
*
19. In § 558.175, revise paragraph (d)
to read as follows:
Clopidol.
*
*
*
*
(d) Conditions of use—(1) Chickens—
Clopidol in
grams per ton
Combination in grams
per ton
Indications for use
Limitations
(i) 113.5 .................
........................................
Do not feed to chickens over 16 weeks of age ....
016592
(ii) 113.5 ................
Bacitracin
methylenedisalicylate,
4 to 50.
Broiler chickens and re-placement chickens intended for use as caged layers: As an aid in
the prevention of coccidiosis caused by
Eimeria tenella, E. necatrix, E. acervulina, E.
maxima, E. brunetti, and E. mivati.
Broiler chickens: As an aid in the prevention of
coccidiosis caused by Eimeria tenella, E.
necatrix, E. acervulina, E. maxima, E. brunetti,
and E. mivati, and for increased rate of weight
gain.
016592
(iii) 113.5 ...............
Bacitracin zinc, 5 to 25 ..
Feed continuously as the sole ration from the
time chicks are placed in floor pens until
slaughter. Do not feed to chickens over 16
weeks of age; bacitracin methylenedisalicylate
as provided by No. 054771 in § 510.600(c) of
this chapter.
Feed continuously as sole ration; bacitracin zinc
as provided by No. 054771 in § 510.600(c) of
this chapter.
(iv) 113.5 ...............
Bambermycins, 1 to 2 ...
Feed continuously as the sole ration. Do not feed
to chickens over 16 weeks of age.
016592
VerDate Sep<11>2014
16:30 Apr 01, 2019
Jkt 247001
Broiler chickens: As an aid in the prevention of
coccidiosis caused by Eimeria tenella, E.
necatrix, E. acervulina, E. maxima, E. brunetti,
and E. mivati, and for increased rate of weight
gain and improved feed efficiency.
Broiler chickens: As an aid in prevention of coccidiosis caused by Eimeria tenella, E. necatrix,
E. acervulina, E. maxima, E. brunetti, and E.
mivati; and for increased rate of weight gain
and improved feed efficiency.
PO 00000
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Fmt 4700
Sfmt 4700
E:\FR\FM\02APR1.SGM
02APR1
Sponsors
054771
016592
12496
Federal Register / Vol. 84, No. 63 / Tuesday, April 2, 2019 / Rules and Regulations
Clopidol in
grams per ton
Combination in grams
per ton
Indications for use
Limitations
(v) 227 ...................
........................................
Broiler and replacement chickens intended for
use as caged layers: As an aid in the prevention of coccidiosis caused by Eimeria tenella,
E. necatrix, E. acervulina, E. maxima, E.
brunetti, and E. mivati.
(vi) 227 ..................
Bambermycins, 1 to 2 ...
Broiler chickens: As an aid in prevention of coccidiosis caused by Eimeria tenella, E. necatrix,
E. acervulina, E. maxima, E. brunetti, and E.
mivati; and for increased rate of weight gain
and improved feed efficiency.
Feed continuously as the sole ration; feed up to
16 weeks of age if intended for use as caged
layers; withdraw 5 days before slaughter if
given at the level of 0.025 percent in feed or
reduce level to 0.0125 percent 5 days before
slaughter.
Feed continuously as sole ration until 5 days before slaughter. Withdraw 5 days before slaughter or feed 113.5 g/ton clopidol and 1 to 2 g/ton
bambermycins during those 5 days before
slaughter. Do not feed to chickens over 16
weeks of age.
Clopidol in
grams per ton
Combination in grams
per ton
Indications for use
Limitations
(i) 113.5 or 227 .....
........................................
Turkeys: As an aid in the prevention of
leucocytozoonosis caused by Leucocytozoon
smithi.
For turkeys grown for meat purposes only; feed
continuously as the sole ration at 0.0125 or
0.025 percent clopidol depending on management practices, degree of exposure, and
amount of feed eaten; withdraw 5 days before
slaughter.
Sponsors
016592
016592
(2) Turkeys—
Sponsors
016592
(ii) [Reserved]
(3) Clopidol may also be used in
combination with:
(i)–(ii) [Reserved]
(iii) Chlortetracycline as in § 558.128.
Decoquinate in
grams/ton
20. In § 558.195, revise paragraphs
(e)(1) through (3) to read as follows:
■
Combination in grams/
ton
(i) 27.2 ...................
(ii) 27.2 ..................
Bacitracin
methylenedisalicylate,
4 to 50.
(iii) 27.2 .................
Bacitracin zinc, 10 to 50
§ 558.195
(iv) Lincomycin as in § 558.325.
*
Decoquinate.
*
*
*
(e) * * *
(1) Chickens—
*
Indications for use
Limitations
Sponsor
Broiler chickens: For prevention of coccidiosis
caused by Eimeria tenella, E. necatrix, E.
mivati, E. acervulina, E. maxima, and E.
brunetti.
Broiler chickens: For prevention of coccidiosis
caused by Eimeria tenella, E. necatrix, E.
mivati, E. acervulina, E. maxima, and E.
brunetti; and for increased rate of weight gain
and improved feed efficiency.
Broiler chickens: For prevention of coccidiosis
caused by Eimeria tenella, E. necatrix, E.
mivati, E. acervulina, E. maxima, and E.
brunetti.
Do not feed to laying hens producing eggs for
human consumption.
054771
Feed continuously as sole ration; do not feed to
laying
chickens.
Bacitracin
methylenedisalicylate as provided by No.
054771 in § 510.600(c) of this chapter.
054771
Feed continuously as sole ration; do not feed to
laying chickens. Bacitracin zinc as provided by
No. 054771 in § 510.600(c) of this chapter.
054771
Indications for use
Limitations
Cattle (including ruminating and nonruminating
calves and veal calves): For prevention of coccidiosis caused by Eimeria bovis and E.
zuernii.
Feed Type C feed or milk replacer to provide
22.7 milligrams (mg) per 100 pounds (lb) of
body weight (0.5 mg/kg) per day. Feed at least
28 days during periods of exposure to coccidiosis or when it is likely to be a hazard. Do not
feed to cows producing milk for human consumption. See paragraph (d)(3) of this section.
Feed only to cattle fed in confinement for slaughter. Feed continuously as the sole ration to provide 22.7 mg of decoquinate per 100 lb of body
weight per day and 50 to 360 mg of monensin
per head per day. Feed at least 28 days during
period of exposure to coccidiosis or when it is
likely to be a hazard. Do not feed to animals
producing milk for food. Do not feed to lactating dairy cattle. Also see paragraph (d)(1) of
this section and § 558.355(d)(9)(i). Monensin
as provided by No. 058198 in § 510.600(c) of
this chapter.
(2) Cattle—
Decoquinate in
grams/ton
Combination in grams/
ton
(i) 12.9 to 90.8 ......
amozie on DSK9F9SC42PROD with RULES
(ii) 12.9 to 90.8 .....
VerDate Sep<11>2014
Monensin, 5 to 30 .........
16:30 Apr 01, 2019
Jkt 247001
Cattle fed in confinement for slaughter: For prevention of coccidiosis caused by Eimeria bovis
and E. zuernii; and for improved feed efficiency.
PO 00000
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E:\FR\FM\02APR1.SGM
02APR1
Sponsor
054771
054771
Federal Register / Vol. 84, No. 63 / Tuesday, April 2, 2019 / Rules and Regulations
Decoquinate in
grams/ton
Combination in grams/
ton
(iii) 90.9 to 535.7 ...
Indications for use
Limitations
Cattle (including ruminating and nonruminating
calves and veal calves): For prevention of coccidiosis caused by Eimeria bovis and E.
zuernii.
Feed Type C medicated feed supplements as a
top dress or mix into the daily ration to provide
22.7 mg per 100 lb of body weight (0.5 mg/kg)
per day. Feed at least 28 days during periods
of exposure to coccidiosis or when it is likely to
be a hazard. Do not feed to cows producing
milk for food. See paragraph (d)(3) of this section.
12497
Sponsor
054771
(3) Minor species—
Decoquinate in
grams/ton
Combination in grams/
ton
Indications for use
Limitations
(i) 12.9 to 90.8 ......
........................................
1. Young sheep: For the prevention of coccidiosis
caused by Eimeria ovinoidalis, E. crandallis, E.
parva, and E. bakuensis.
...............................
........................................
2. Young goats: For the prevention of coccidiosis
caused by Eimeria christenseni and E.
ninakohlyakimovae.
(ii) 90.9 to 535.7 ...
........................................
1. Young sheep: For the prevention of coccidiosis
caused by Eimeria ovinoidalis, E. crandallis, E.
parva, and E. bakuensis.
...............................
........................................
2. Young goats: For the prevention of coccidiosis
caused by Eimeria christenseni and E.
ninakohlyakimovae.
Feed Type C feed or milk replacer at a rate to
provide 22.7 mg per 100 lb of body weight (0.5
mg per kg) per day; feed for at least 28 days
during periods of exposure to coccidiosis or
when it is likely to be a hazard. Do not feed to
sheep producing milk for human consumption.
Feed Type C feed or milk replacer at a rate to
provide 22.7 mg per 100 lb of body weight (0.5
mg per kg) per day; feed for at least 28 days
during periods of exposure to coccidiosis or
when it is likely to be a hazard. Do not feed to
goats producing milk for human consumption.
Feed Type C medicated feed supplements as a
top dress or mix into the daily ration to provide
22.7 mg per 100 lb of body weight (0.5 mg per
kg) per day; feed for at least 28 days during
periods of exposure to coccidiosis or when it is
likely to be a hazard. Do not feed to sheep producing milk for human consumption.
Feed Type C medicated feed supplements as a
top dress or mix into the daily ration to provide
22.7 mg per 100 lb of body weight (0.5 mg per
kg) per day; feed for at least 28 days during
periods of exposure to coccidiosis or when it is
likely to be a hazard. Do not feed to goats producing milk for human consumption.
*
*
*
*
*
§ § 558.198 and 558.205 [Redesignated as
§§ 558.205 and 558.198]
21. Redesignate §§ 558.198 and
558.205 as §§ 558.205 and 558.198,
respectively.
■
22. Revise newly redesignated
§ 558.198 to read as follows:
■
§ 558.198
Dichlorvos.
(a) Specifications. Each pound of
Type A medicated article containing 3.1
or 9.6 percent dichlorvos.
(b) Sponsor. See No. 054628 in
§ 510.600(c) of this chapter.
Dichlorvos
grams/ton
Combination in grams/
ton
amozie on DSK9F9SC42PROD with RULES
(i) 348 ....................
VerDate Sep<11>2014
(c) Related tolerances. See § 556.180
of this chapter.
(d) Special considerations—(1)
Dichlorvos is to be included in meal or
mash or mixed with feed in crumble
form only after the crumble feed has
been manufactured. Do not mix in feeds
to be pelleted nor with pelleted feed. Do
not soak the feed or administer as wet
mash. Feed must be dry when
administered. Do not use in animals
other than swine. Do not allow fowl
access to feed containing this
preparation or to feces from treated
animals.
(2) Dichlorvos is a cholinesterase
inhibitor. Do not use this product in
16:30 Apr 01, 2019
Jkt 247001
Limitations
Swine up to 70 pounds body weight: For the removal and control of mature, immature, and/or
fourth-stage larvae of the whipworm (Trichuris
suis), nodular worm (Oesophagostomum sp.),
large roundworm (Ascaris suum) and the thick
stomach worm (Ascarops strongylina) of the
gastrointestinal tract.
Feed as sole ration for 2 consecutive days. For
swine from 70 pounds to market weight, feed
as sole ration at the rate of 8.4 pounds of feed
per head until the medicated feed has been
consumed. For boars, open or bred gilts, and
sows, feed as sole ration at the rate of 4.2
pounds per head per day for 2 consecutive
days.
Frm 00015
Fmt 4700
Sfmt 4700
054771
....................
054771
....................
animals simultaneously or within a few
days before or after treatment with or
exposure to cholinesterase-inhibiting
drugs, pesticides, or chemicals. If
human or animal poisoning should
occur, immediately consult a physician
or a veterinarian. Atropine is antidotal.
(3) Labeling for Type A articles and
Type B feeds must include a statement
that containers or materials used in
packaging such Type A articles and
Type B feeds are not to be reused and
all such packaging materials must be
destroyed after the product has been
used.
(e) Conditions of use. It is used in
swine feed as follows:
Indications for use
PO 00000
Sponsor
E:\FR\FM\02APR1.SGM
02APR1
Sponsor
054628
12498
Federal Register / Vol. 84, No. 63 / Tuesday, April 2, 2019 / Rules and Regulations
Dichlorvos
grams/ton
Combination in grams/
ton
(ii) 479 ...................
(iii) 334 to 500 .......
Indications for use
Limitations
Boars, open or bred gilts, and sows: For the removal and control of mature, immature, and/or
fourth-stage larvae of the whipworm (Trichuris
suis), nodular worm (Oesophagostomum sp.),
large roundworm (Ascaris suum) and the thick
stomach worm (Ascarops strongylina) of the
gastrointestinal tract.
Pregnant swine: An aid in improving litter production efficiency by increasing pigs born alive,
birth weights, survival to market, and rate of
weight gain. Treatment also removes and controls mature, immature and/or fourth stage larvae of whipworm (Trichuris suis), nodular worm
(Oesophagostomum spp.) large roundworm
(Ascaris suum), and the thick stomach worm
(Ascarops strongylina) occurring in the gastrointestinal tract of the sow or gilt.
Feed as sole ration at the rate of 6 pounds per
head for one feeding.
054628
Mix into a gestation feed to provide 1,000 milligrams per head daily during last 30 days of
gestation.
054628
23. In newly redesignated § 558.205,
revise paragraphs (b) and (d)(1) and (2)
to read as follows:
■
Diclazuril
grams/ton
§ 558.205
*
*
*
*
(b) Sponsor. See No. 058198 in
§ 510.600(c) of this chapter.
*
*
*
*
*
Combination in grams/
ton
(i) 0.91 ...................
Diclazuril.
*
(d) * * *
(1) Chickens. For chickens it is used
as follows:
Indications for use
Limitations
Broiler chickens: For the prevention of coccidiosis
caused by Eimeria tenella, E. necatrix, E.
acervulina, E. brunetti, E. mitis (mivati), and E.
maxima.
Feed continuously. Not for use in hens producing
eggs for human food. Because diclazuril is effective against E. maxima later in its life cycle,
subclinical intestinal lesions may be present for
a short time after infection. Diclazuril was
shown in studies to reduce lesion scores and
improve performance and health of birds challenged with E. maxima.
Feed continuously. Not for use in hens producing
eggs for human food. Because diclazuril is effective against E. maxima later in its life cycle,
subclinical intestinal lesions may be present for
a short time after infection. Diclazuril was
shown in studies to reduce lesion scores and
improve performance and health of birds challenged
with
E.
maxima.
Bacitracin
methylenedisalicylate as provided by No.
054771 in § 510.600(c) of this chapter.
Feed continuously. Not for use in hens producing
eggs for human food. Because diclazuril is effective against E. maxima later in its life cycle,
subclinical intestinal lesions may be present for
a short time after infection. Diclazuril was
shown in studies to reduce lesion scores and
improve performance and health of birds challenged with E. maxima. Bambermycins as provided by No. 016592 in § 510.600(c) of this
chapter.
(ii) 0.91 ..................
Bacitracin
methylenedisalicylate,
4 to 50.
Broiler chickens: For the prevention of coccidiosis
caused by Eimeria tenella, E. necatrix, E.
acervulina, E. brunetti, E. mitis (mivati), and E.
maxima, and for increased rate of weight gain
and improved feed efficiency.
(iii) 0.91 .................
Bambermycins, 1 to 2 ...
Broiler chickens: For the prevention of coccidiosis
caused by Eimeria tenella, E. necatrix, E.
acervulina, E. brunetti, E. mitis (mivati), and E.
maxima, and for increased rate of weight gain
and improved feed efficiency.
Sponsor
Sponsor
058198
058198
058198
(2) Turkeys. For turkeys it is used as
follows:
Diclazuril
grams/ton
Combination in grams/
ton
amozie on DSK9F9SC42PROD with RULES
(i) 0.91 ...................
(ii) 0.91 ..................
Bacitracin
methylenedisalicylate,
4 to 50.
(iii) 0.91 .................
Bambermycins, 1 to 2 ...
VerDate Sep<11>2014
16:30 Apr 01, 2019
Jkt 247001
Indications for use
Limitations
Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E.
gallopavonis and E. meleagrimitis.
Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E.
gallopavonis and E. meleagrimitis, and for increased rate of weight gain and improved feed
efficiency.
Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E.
gallopavonis and E. meleagrimitis, and for improved feed efficiency.
Feed continuously as the sole ration. Do not feed
to breeding turkeys. Not for use in hens producing eggs for human consumption.
Feed continuously as the sole ration. Do not feed
to breeding turkeys. Not for use in hens producing eggs for human consumption. Bacitracin
methylenedisalicylate as provided by No.
054771 in § 510.600(c) of this chapter.
Feed continuously as the sole ration. Do not feed
to breeding turkeys. Not for use in hens producing
eggs
for
human
consumption.
Bambermycins as provided by No. 016592 in
§ 510.600(c) of this chapter.
PO 00000
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Sfmt 4700
E:\FR\FM\02APR1.SGM
02APR1
Sponsor
058198
058198
058198
Federal Register / Vol. 84, No. 63 / Tuesday, April 2, 2019 / Rules and Regulations
Diclazuril
grams/ton
Combination in grams/
ton
Indications for use
Limitations
(iv) 0.91 .................
Bambermycins, 2 ...........
Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E.
gallopavonis and E. meleagrimitis, and for increased rate of weight gain and improved feed
efficiency.
Feed continuously as the sole ration. Do not feed
to breeding turkeys. Not for use in hens producing
eggs
for
human
consumption.
Bambermycins as provided by No. 016592 in
§ 510.600(c) of this chapter.
*
§ 558.258
■
*
*
*
*
*
24. In § 558.258, revise paragraph
(e)(2) to read as follows:
Fenbendazole in
grams per ton
Combination in grams
per ton
amozie on DSK9F9SC42PROD with RULES
(i) 10 to 300 (to
provide 9 milligrams per kilogram (mg/kg) of
body weight)
given over a 3to 12-day period..
(ii) 10 to 300 (to
provide 9 mg/kg
of body weight)..
Bacitracin
methylenedisalicylate,
10 to 30.
(iii) 10 to 300 (to
provide 9 mg/kg
of body weight)..
Bacitracin
methylenedisalicylate,
250.
§ 558.300
*
*
*
*
*
25. In § 558.300, revise paragraph (e)
to read as follows:
Jkt 247001
PO 00000
*
Frm 00017
*
Fmt 4700
058198
(2) Swine.
Limitations
Ivermectin.
*
Sponsor
*
For the removal and control of adult stage
lungworms (Metastrongylus apri and M.
pudendotectus); adult and larvae (L3, 4
stages—liver, lung, intestinal forms) large
roundworms (Ascaris suum); adult stage nodular worms (Oesophagostomum dentatum, O.
quadrispinulatum); adult stage small stomach
worms (Hyostrongylus rubidus); adult and larvae (L2, 3, 4 stages—intestinal mucosal forms)
whipworms (Trichuris suis); adult and larvae
kidney worms (Stephanurus dentatus).
Growing/finishing swine: For the removal and
control
of
adult
stage
lungworms
(Metastrongylus apri and M. pudendotectus);
adult and larvae (L3, 4 stages—liver, lung, intestinal forms) large roundworms (Ascaris
suum);
adult
stage
nodular
worms
(Oesophagostomum
dentatum,
O.
quadrispinulatum); adult stage small stomach
worms (Hyostrongylus rubidus); adult and larvae (L2, 3, 4 stages—intestinal mucosal forms)
whipworms (Trichuris suis); adult and larvae
kidney worms (Stephanurus dentatus); and for
increased rate of weight gain and improved
feed efficiency.
1. Growing/finishing swine: For the removal and
control
of
adult
stage
lungworms
(Metastrongylus apri and M. pudendotectus);
adult and larvae (L3, 4 stages—liver, lung, intestinal forms) large roundworms (Ascaris
suum);
adult
stage
nodular
worms
(Oesophagostomum
dentatum,
O.
quadrispinulatum); adult stage small stomach
worms (Hyostrongylus rubidus); adult and larvae (L2, 3, 4 stages—intestinal mucosal forms)
whipworms (Trichuris suis); adult and larvae
kidney worms (Stephanurus dentatus); and for
control of swine dysentery associated with
Treponema hyodysenteriae on premises with a
history of swine dysentery, but where signs of
disease have not yet occurred; or following an
approved treatment of the disease condition.
2. Pregnant sows: For the removal and control of
adult stage lungworms (Metastrongylus apri
and M. pudendotectus); adult and larvae (L3, 4
stages—liver, lung, intestinal forms) large
roundworms (Ascaris suum); adult stage nodular worms (Oesophagostomum dentatum, O.
quadrispinulatum); adult stage small stomach
worms (Hyostrongylus rubidus); adult and larvae (L2, 3, 4 stages—intestinal mucosal forms)
whipworms (Trichuris suis); adult and larvae
kidney worms (Stephanurus dentatus); for control of clostridial enteritis in suckling pigs
caused by Clostridium perfringens.
■
16:30 Apr 01, 2019
*
Indications for use
*
VerDate Sep<11>2014
Fenbendazole.
*
*
(e) * * *
12499
*
Sfmt 4700
Sponsors
Feed as the sole ration
000061
Feed as the sole ration. Under conditions of continued exposure to parasites, retreatment may
be needed after 4 to 6 weeks. Bacitracin
methylenedisalicylate as provided by No.
054771 in § 510.600(c) of this chapter
054771
1. Growing/finishing swine: Feed as sole ration.
Not for use in growing and finishing swine that
weigh more than 250 lbs. Diagnosis of swine
dysentery should be confirmed by a veterinarian when results are not satisfactory. Under
conditions of continued exposure to parasites,
retreatment may be needed after 4 to 6 weeks.
Bacitracin methylenedisalicylate as provided by
No. 054771 in § 510.600(c) of this chapter
054771
2. Pregnant sows: Feed as sole ration. Diagnosis
of clostridial enteritis should be confirmed by a
veterinarian when results are not satisfactory.
Under conditions of continued exposure to
parasites, retreatment may be needed after 4
to 6 weeks. Bacitracin methylenedisalicylate as
provided by No. 054771 in § 510.600(c) of this
chapter.
(e) Conditions of use in swine. It is
used in feed as follows:
E:\FR\FM\02APR1.SGM
02APR1
12500
Federal Register / Vol. 84, No. 63 / Tuesday, April 2, 2019 / Rules and Regulations
Ivermectin in
grams/ton
Combination in grams/
ton
(1) 1.8 ...................
(2) 1.8 ...................
Bacitracin
methylenedisalicylate,
10 to 30.
(3) 1.8 ...................
Bacitracin
methylenedisalicylate,
250.
(4) 1.8 to 11.8 .......
amozie on DSK9F9SC42PROD with RULES
(5) 1.8 to 11.8 .......
VerDate Sep<11>2014
Bacitracin
methylenedisalicylate,
250.
16:30 Apr 01, 2019
Jkt 247001
Indications for use
Limitations
Weaned, growing-finishing swine: For treatment
and control of gastrointestinal roundworms
(Ascaris suum, adults and fourth-stage larvae;
Ascarops strongylina, adults; Hyostrongylus
rubidus, adults and fourth-stage larvae;
Oesophagostomum spp., adults and fourthstage larvae); kidneyworms (Stephanurus
dentatus, adults and fourth-stage larvae);
lungworms (Metastrongylus spp., adults);
threadworms (Strongyloides ransomi, adults
and somatic larvae); lice (Haematopinus suis);
and mange mites (Sarcoptes scabiei var. suis).
Weaned, growing-finishing swine: For treatment
and control of gastrointestinal roundworms
(Ascaris suum, adults and fourth-stage larvae;
Ascarops strongylina, adults; Hyostrongylus
rubidus, adults and fourth-stage larvae;
Oesophagostomum spp., adults and fourthstage larvae); kidneyworms (Stephanurus
dentatus, adults and fourth-stage larvae);
lungworms (Metastrongylus spp., adults);
threadworms (Strongyloides ransomi, adults
and somatic larvae); lice (Haematopinus suis);
and mange mites (Sarcoptes scabiei var. suis);
and for increased rate of weight gain and improved feed efficiency.
Weaned, growing-finishing swine: For treatment
and control of gastrointestinal roundworms
(Ascaris suum, adults and fourth-stage larvae;
Ascarops strongylina, adults; Hyostrongylus
rubidus, adults and fourth-stage larvae;
Oesophagostomum spp., adults and fourthstage larvae); kidneyworms (Stephanurus
dentatus, adults and fourth-stage larvae);
lungworms (Metastrongylus spp., adults);
threadworms (Strongyloides ransomi, adults
and somatic larvae); lice (Haematopinus suis);
and mange mites (Sarcoptes scabiei var. suis);
and for control of swine dysentery associated
with Treponema hyodysenteriae on premises
with a history of swine dysentery, but where
symptoms have not yet occurred, or following
an approved treatment of disease condition.
Adult and breeding swine: For treatment and control of gastrointestinal roundworms (Ascaris
suum, adults and fourth-stage larvae; Ascarops
strongylina, adults; Hyostrongylus rubidus,
adults
and
fourth-stage
larvae;
Oesophagostomum spp., adults and fourthstage larvae); kidneyworms (Stephanurus
dentatus, adults and fourth-stage larvae);
lungworms (Metastrongylus spp., adults);
threadworms (Strongyloides ransomi, adults
and somatic larvae, and prevention of transmission of infective larvae to piglets, via the colostrum or milk, when fed during gestation); lice
(Haematopinus suis); and mange mites
(Sarcoptes scabiei var. suis).
Pregnant sows: For treatment and control of gastrointestinal roundworms (Ascaris suum, adults
and fourth-stage larvae; Ascarops strongylina,
adults; Hyostrongylus rubidus, adults and
fourth-stage larvae; Oesophagostomum spp.,
adults and fourth-stage larvae); kidneyworms
(Stephanurus dentatus, adults and fourth-stage
larvae); lungworms (Metastrongylus spp.,
adults); threadworms (Strongyloides ransomi,
adults and somatic larvae, and prevention of
transmission of infective larvae to piglets, via
the colostrum or milk, when fed during gestation); lice (Haematopinus suis); and mange
mites (Sarcoptes scabiei var. suis); and for
control of clostridial enteritis caused by Clostridium perfringens in suckling piglets.
Feed as the only feed for 7 consecutive days to
provide 0.1 milligrams per kilograms (mg/kg) of
body weight per day. Withdraw 5 days before
slaughter.
050604
Feed as the only feed for 7 consecutive days to
provide 0.1 mg/kg of body weight per day.
Withdraw 5 days before slaughter.
050604
Feed as the only feed for 7 consecutive days to
provide 0.1 mg/kg of body weight per day.
Withdraw 5 days before slaughter.
050604
Feed as the only feed for 7 consecutive days to
provide 0.1 mg/kg of body weight per day.
Withdraw 5 days before slaughter.
050604
Feed as the only feed for 7 consecutive days to
provide 0.1 mg/kg of body weight per day.
Withdraw 5 days before slaughter. Feed bacitracin methylenedisalicylate Type C medicated
feed to sows from 14 days before through 21
days after farrowing on premises with a history
of clostridial scours.
050604
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Federal Register / Vol. 84, No. 63 / Tuesday, April 2, 2019 / Rules and Regulations
Ivermectin in
grams/ton
Combination in grams/
ton
(6) 18.2 to 120 ......
Indications for use
Limitations
Adult and breeding swine: For treatment and control of gastrointestinal roundworms (Ascaris
suum, adults and fourth-stage larvae; Ascarops
strongylina, adults; Hyostrongylus rubidus,
adults
and
fourth-stage
larvae;
Oesophagostomum spp., adults and fourthstage larvae); kidneyworms (Stephanurus
dentatus, adults and fourth-stage larvae);
lungworms (Metastrongylus spp., adults);
threadworms (Strongyloides ransomi, adults
and somatic larvae, and prevention of transmission of infective larvae to piglets, via the colostrum or milk, when fed during gestation); lice
(Haematopinus suis); and mange mites
(Sarcoptes scabiei var. suis).
Top dress on daily ration for individual treatment
for 7 consecutive days to provide 0.1 mg/kg of
body weight per day. Withdraw 5 days before
slaughter.
*
§ 558.325
■
*
*
*
*
*
26. In § 558.325, add paragraph
(e)(1)(iii) to read as follows:
Lincomycin
grams/ton
Combination in grams/
ton
*
*
(iii) 2 ....................... Clopidol, 113.5 ..............
*
*
■
*
*
*
Feed as the sole ration to broiler chickens. Do
not feed to chickens over 16 weeks of age. 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. Clopidol as provided by No. 016592 in
§ 510.600 of this chapter.
*
Lubabegron.
*
*
grams (10 grams per kilogram) of
lubabegron as lubabegron fumarate.
(b) Sponsor. See No. 058198 in
§ 510.600(c) of this chapter.
(c) Related tolerances. See § 556.370
of this chapter.
Combination in grams/
ton
(1) 1.25 to 4.54 ......
(1) * * *
*
*
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 cecal and intestinal coccidiosis caused by Eimeria tenella,
E. necatrix, E. acervulina, E. maxima, E.
brunetti, and E. mivati.
*
050604
*
Limitations
(a) Specifications. Each pound of
Type A medicated article contains 4.54
Lubabegron
grams/ton
*
Indications for use
*
*
*
*
27. Add § 558.330 to read as follows:
§ 558.330
Lincomycin.
*
*
(e) * * *
Sponsor
*
Sponsors
054771
*
(d) Conditions of use. It is used in
cattle feed as follows:
Indications for use
Limitations
Beef steers and heifers fed in confinement for
slaughter: For reduction of ammonia gas emissions per pound of live weight and hot carcass
weight during the last 14 to 91 days on feed.
Feed 1.25 to 4.54 g/ton (1.39 to 5 ppm) of complete feed (90% dry matter basis) to provide 13
to 90 milligrams lubabegron/head/day continuously. Do not allow horses or other equines access to feed containing lubabegron. Not approved for use in breeding animals because
safety and effectiveness have not been evaluated in these animals.
Sponsors
058198
(ii) [Reserved]
28. In § 558.415, revise paragraph (d)
to read as follows:
amozie on DSK9F9SC42PROD with RULES
■
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*
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*
Novobiocin.
*
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*
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*
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(d) Conditions of use. It is used in
animal feeds as follows:
(1) Chickens—
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Novobiocin amount
Indications for use
Limitations
Sponsor
(i) To provide 6 to 7 milligrams
per pound (mg/lb) of body
weight per day.
Chickens: As an aid in the treatment of breast blisters
associated with staphylococcal infections susceptible
to novobiocin.
(ii) To provide 10 to 14 mg/lb of
body weight per day.
Chickens: For the treatment of staphylococcal synovitis
and generalized staphylococcal infections susceptible
to novobiocin.
Administer feed which contains not less than 200 grams
of novobiocin activity per ton of feed as the sole ration for 5 to 7 days. Not for laying chickens. Withdraw
4 days before slaughter.
Administer feed which contains not less than 350 grams
of novobiocin activity per ton of feed as the sole ration for 5 to 7 days. Not for laying chickens. Withdraw
4 days before slaughter.
054771
054771
(2) Turkeys—
Novobiocin amount
Indications for use
Limitations
(i) To provide 4 to 5 mg/lb of
body weight per day.
Turkeys: As an aid in the treatment of breast blisters
associated with staphylococcal infections susceptible
to novobiocin.
(ii) To provide 5 to 8 mg/lb of
body weight per day.
Turkeys: As an aid in the control of recurring outbreaks
of fowl cholera caused by strains of Pasteurella
multocida susceptible to novobiocin following initial
treatment with 7 to 8 mg/lb of body weight per day.
Turkeys: For the treatment of staphylococcal synovitis
and generalized staphylococcal infections susceptible
to novobiocin; and treatment of acute outbreaks of
fowl cholera caused by strains of Pasteurella
multocida susceptible to novobiocin.
Administer feed which contains not less than 200 grams
of novobiocin activity per ton of feed as the sole ration for 5 to 7 days. Not for laying turkeys. Withdraw
4 days before slaughter.
Administer feed which contains not less than 200 grams
of novobiocin activity per ton of feed as the sole ration for 5 to 7 days. Not for laying turkeys. Withdraw
4 days before slaughter.
Administer feed which contains not less than 350 grams
of novobiocin activity per ton of feed as the sole ration for 5 to 7 days. Not for laying turkeys. Withdraw
4 days before slaughter.
(iii) To provide 7 to 8 mg/lb of
body weight per day.
Sponsor
054771
054771
054771
(3) Minor species—
Indications for use
Limitations
(i) 350 grams per ton.
Novobiocin amount
Ducks: For the control of infectious serositis and fowl
cholera in ducks caused by Pasteurella anatipestifer
and P. multocida, susceptible to novobiocin.
(ii) To provide 20 mg/lb of body
weight per day.
Mink: For the treatment of generalized infections, abscesses, or urinary infections caused by staphylococcal or other novobiocin sensitive organisms.
Administer as the sole ration for 5 to 7 days. Continue
medication for 14 days if necessary. Repeat if reinfection occurs. Discontinue use at least 3 days before
slaughter. Not for use in laying ducks.
Administer feed which contains not less than 200 grams
of novobiocin activity per ton of feed as the sole ration for 7 days.
29. In § 558.450, redesignate
paragraphs (e)(5)(iii), (iv), and (v) as
paragraphs (e)(v), (iii), and (iv)
respectively; and revise newly
redesignated paragraphs (e)(5)(iv) and
(v) to read as follows:
■
Oxytetracycline
amount
*
(iv) 3.75 g/100 lb of fish/day.
(v) 11.35 g/100 lb of fish/day.
*
*
*
30. In § 558.575, revise paragraphs (b)
and (e) to read as follows:
amozie on DSK9F9SC42PROD with RULES
§ 558.575 Sulfadimethoxine and
ormetoprim.
*
*
VerDate Sep<11>2014
*
*
16:30 Apr 01, 2019
Jkt 247001
*
*
(b) Sponsors. See sponsors in
§ 510.600(c) of this chapter for use as in
paragraph (d) of this section:
(1) No. 054771 for use of the product
described in paragraph (a)(1) as in
paragraphs (e)(1), (e)(2)(i), and (e)(3)(i)
through (iii) of this section.
PO 00000
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054771
*
*
*
*
* * *
Feed for 10 days. Immediate release is permitted following the last feeding of medicated feed.
Administer medicated feed as the sole ration for 4 consecutive days. Do not liberate for at least 7 days following last feeding of medicated feed.
■
*
*
*
*
*
* * *
3. Freshwater-reared salmonids weighing up to 55
grams: For marking the skeletal tissue.
Pacific salmon not over 30 grams body weight: For
marking of skeletal tissue.
*
054771
Oxytetracycline.
*
*
(e) * * *
(5) * * *
Limitations
*
*
*
Indications for use
*
*
§ 558.450
Sponsor
*
Sponsor
066104
066104
*
(2) No. 015331 for use of the product
described in paragraph (a)(2) as in
paragraphs (e)(3)(iv) and (v) of this
section.
*
*
*
*
*
(e) Conditions of use. It is used in
animal feeds as follows:
(1) Chickens—
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Sulfadimethoxine
and ormetoprim
grams/ton
12503
Indications for use
Limitations
Broiler chickens: As an aid in the prevention of coccidiosis caused by all Eimeria species known to be pathogenic to chickens, namely, E. tenella, E. necatrix, E.
acervulina, E. brunetti, E. mivati, and E. maxima, and
bacterial infections due to Heterakis gallinarum (infectious coryza), Escherichia coli (colibacillosis) and
Pasteurella multocida (fowl cholera).
Replacement chickens: As an aid in the prevention of
coccidiosis caused by all Eimeria species known to
be pathogenic to chickens, namely, E. tenella, E.
necatrix, E. acervulina, E. brunetti, E. mivati, and E.
maxima, and bacterial infections due to Heterakis
gallinarum (infectious coryza), Escherichia coli
(colibacillosis) and Pasteurella multocida (fowl cholera).
Feed as sole ration. Withdraw 5 days before slaughter.
054771
Feed as sole ration. Do not feed to chickens over 16
weeks (112 days) of age. Withdraw 5 days before
slaughter.
054771
Indications for use
Limitations
Turkeys: As an aid in the prevention of coccidiosis
caused by all Eimeria species known to be pathogenic to turkeys, namely, E. adenoeides, E.
gallopavonis, and E. meleagrimitis and bacterial infection due to Pasteurella multocida (fowl cholera).
Do not feed to turkeys producing eggs for food. Withdraw 5 days before slaughter.
Indications for use
Limitations
Sulfadimethoxine,
227;
ormetoprim, 136.2 grams/ton of
feed.
Ducks, including breeding ducks: As an aid in the control of bacterial infections due to Pasteurella
multocida (fowl cholera).
054771
(ii)
Sulfadimethoxine,
454;
ormetoprim, 272.4 grams/ton of
feed.
Ducks: As an aid in the control of bacterial infections
due to Escherichia coli, Riemerella anatipestifer, and
severe challenge of Pasteurella multocida (fowl cholera).
Chukar partridges: For prevention of coccidiosis caused
by Eimeria kofoidi and E. legionensis.
Feed as sole ration for 7 days. Medication should be
started at the first signs of infection. Do not feed to
ducks producing eggs for food. Withdraw 5 days before slaughter.
Feed as a sole ration for 7 days. Medication should be
started at the first signs of infection. Not for breeding
ducks. Do not feed to ducks producing eggs for food.
Withdraw 5 days before slaughter.
Feed continuously to young birds up to 8 weeks of age
as sole ration.
Administer for 5 consecutive days. Withdraw 42 days
before release as stocker fish or slaughter.
015331
Administer for 5 consecutive days. Withdraw 3 days before slaughter or release as stocker fish.
015331
(i)
Sulfadimethoxine,
ormetoprim, 68.1.
113.5;
(ii)
Sulfadimethoxine,
ormetoprim, 68.1.
113.5;
Sponsors
(2) Turkeys—
Sulfadimethoxine
and ormetoprim
grams/ton
(i)
Sulfadimethoxine,
ormetoprim, 34.05.
56.75;
Sponsors
054771
(ii) [Reserved]
(3) Minor species—
Sulfadimethoxine
and ormetoprim amount
(i)
(iii)
Sulfadimethoxine,
113.5;
ormetoprim, 68.1 grams/ton of
feed.
(iv) 50 milligrams (mg) of active
ingredients per kilogram of
body weight per day.
(v) 50 mg of active ingredients
per kilogram of body weight per
day.
Salmonids: For the control of furunculosis in salmonids
(trout and salmon) caused by Aeromonas salmonicida
strains
susceptible
to
sulfadimethoxine
and
ormetoprim combination.
Catfish: For control of enteric septicemia of catfish
caused by Edwardsiella ictaluri strains susceptible to
sulfadimethoxine and ormetoprim combination.
30. Revise § 558.600 to read as
follows:
■
§ 558.600
Thiabendazole.
amozie on DSK9F9SC42PROD with RULES
(a) Specifications. Type A medicated
articles containing 22, 44.1, 66.1, and
88.2 percent thiabendazole. The 66.1
percent Type A is solely for the
manufacture of cane molasses liquid
Type B feed which is mixed in dry
feeds. The 88.2 percent Type A is used
solely for the manufacture of an aqueous
slurry for adding to a Type C dry cattle
feed.
(b) Sponsor. See No. 050604 in
§ 510.600(c) of this chapter.
Indications for use
Limitations
(i) To provide 3 grams per 100 lb
of body weight.
Cattle: For control of infections of gastrointestinal
roundworms (Trichostrongylus spp., Haemonchus
spp.,
Ostertagia
spp.,
Nematodirus
spp.,
Oesophagostomum radiatum).
Use 3 grams per 100 lb of body weight as a single
dose. May repeat once in 2 to 3 weeks. Do not treat
animals within 3 days of slaughter. Milk taken from
treated animals within 96 hours (8 milkings) after the
latest treatment must not be used for food.
16:30 Apr 01, 2019
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054771
(c) Related tolerances. See § 556.730
of this chapter.
(d) Special considerations. Do not use
in Type B or Type C medicated feed
containing bentonite.
(e) Conditions of use. It is used in
medicated feed as follows:
(1) Cattle—
Thiabendazole
amount
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Thiabendazole
amount
Indications for use
Limitations
(ii) To provide 5 grams per 100 lb
of body weight.
Cattle: For control of severe infections of gastrointestinal
roundworms
(Trichostrongylus
spp.,
Haemonchus spp., Ostertagia spp., Nematodirus
spp., Oesophagostomum radiatum); control of infections of Cooperia spp.
Administer 5 grams per 100 lb of body weight at a single dose or divided into 3 equal doses, administered
1 dose each day, on succeeding days. May repeat
once in 2 to 3 weeks. Do not treat animals within 3
days of slaughter. Milk taken from treated animals
within 96 hours (8 milkings) after the latest treatment
must not be used for food.
Indications for use
Limitations
Swine: As an aid in the prevention of infections of large
roundworms (genus Ascaris).
Administer continuously feed containing 0.05 to 0.1 percent thiabendazole per ton for 2 weeks followed by
feed containing 0.005 to 0.02 percent thiabendazole
per ton for 8 to 14 weeks. Do not treat animals within
30 days of slaughter.
Sponsor
050604
(2) Swine—
Thiabendazole in grams/ton
(i) 45.4 to 908
Sponsor
050604
(ii) [Reserved]
(3) Minor species—
Thiabendazole
amount
Indications for use
Limitations
(i) To provide 2 grams per 100 lb of body weight.
Sheep and goats: For control of infections of
gastrointestinal roundworms (Trichostrongylus
spp., Haemonchus spp., Ostertagia spp.,
Cooperia
spp.;
Nematodirus
spp.,
Bunostomum spp., Strongyloides spp.,
Chabertia spp., and Oesophagostomum spp.);
also active against ova and larvae passed by
sheep from 3 hours to 3 days after the feed is
consumed (good activity against ova and larvae of T. colubriformis and axei, Ostertagia
spp., Nematodirus spp., Strongyloides spp.;
less effective against those of Haemonchus
contortus and Oesophagostomum spp.).
Goats: For control of severe infections of gastrointestinal roundworms (Trichostrongylus spp.,
Haemonchus spp., Ostertagia spp., Cooperia
spp., Nematodirus spp., Bunostomum spp.,
Strongyloides spp., Chabertia spp., and
Oesophagostomum spp.).
Pheasants: For the treatment of gapeworms
(Syngamus trachea).
Use 2 grams per 100 lb of body weight at a single dose. Do not treat animals within 30 days
of slaughter. Milk taken from treated animals
within 96 hours (8 milkings) after the latest
treatment must not be used for food.
050604
Administer 3 grams per 100 lb of body weight at
a single dose. Do not treat animals within 30
days of slaughter. Milk taken from treated animals within 96 hours (8 milkings) after the latest treatment must not be used for food.
050604
Feed continuously for 2 weeks (14 days). Do
not use treated pheasants for food for 21
days after last day of treatment. Fertility,
hatchability, and other reproductive data are
not available on use in breeding animals.
050604
(ii) To provide 3 grams per 100 lb of body
weight..
(iii) 454 grams/ton of feed .....................................
31. In § 558.633, revise paragraph (e)
to read as follows:
■
§ 558.633
*
*
Tylvalosin.
*
(e) Conditions of use.
*
*
Tylvalosin in
grams/ton
Indications for use
Limitations
(i) 38.6 ...................................................................
Swine: For the control of porcine proliferative
enteropathy (PPE) associated with Lawsonia
intracellularis infection in groups of swine in
buildings experiencing an outbreak of PPE.
Feed continuously as the sole ration for 14 consecutive days.
(ii) [Reserved]
amozie on DSK9F9SC42PROD with RULES
Dated: March 26, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–06136 Filed 4–1–19; 8:45 am]
BILLING CODE 4164–01–P
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066916
]]>Agencies
[Federal Register Volume 84, Number 63 (Tuesday, April 2, 2019)]
[Rules and Regulations]
[Pages 12491-12504]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06136]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, 528, 556, and 558
[Docket No. FDA-2018-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications;
Changes of Sponsorship
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 October, November, and December 2018. FDA
is informing the public of the availability of summaries of the basis
of approval and of environmental review documents, where applicable.
The animal drug regulations are also being amended to make technical
amendments to improve the readability of the regulations.
DATES: This rule is effective April 2, 2019.
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 October, November, and December
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 October, November, and December 2018
--------------------------------------------------------------------------------------------------------------------------------------------------------
Approval date File No. Sponsor Product name Species Effect of the action Public documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
October 1, 2018......... 200-490 Dragon Fire Holding Carprofen, Chewable Dogs................ Original approval as a FOI Summary.
Co., Inc., 2619 Tablets. generic copy of NADA 141-
Skyway Dr., Grand 111.
Prairie, TX 75052.
[[Page 12492]]
October 15, 2018........ 141-485 Zoetis Inc., 333 Lincomycin and Chickens............ Original approval for use FOI Summary.
Portage St., clopidol, Type C of LINCOMIX (lincomycin)
Kalamazoo, MI 49007. medicated feeds. and COYDEN (clopidol)
Type A medicated
articles in the
manufacture of Type C
medicated broiler
chicken feeds 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.
November 1, 2018........ 200-627 Putney, Inc., One Cyclosporine Dogs................ Original approval as a FOI Summary.
Monument Sq., Suite Capsules, USP generic copy of NADA 141-
400, Portland, ME MODIFIED. 218.
04101.
November 6, 2018........ 141-508 Elanco US Inc., 2500 EXPERIOR (lubabegron) Cattle.............. Original approval for FOI Summary EA/
Innovation Way, Type A medicated reduction of ammonia gas FONSI.\1\
Greenfield, IN 46140. article to be used emissions per pound of
in the manufacture live weight and hot
of Type B and Type C carcass weight in beef
medicated feeds. steers and heifers fed
in confinement for
slaughter during the
last 14 to 91 days on
feed.
November 9, 2018........ 141-502 Zoetis Inc., 333 REVOLUTION PLUS Cats................ Original approval for the FOI Summary.
Portage St., (selamectin and prevention of heartworm
Kalamazoo, MI 49007. sarolaner topical disease caused by
solution). Dirofilaria immitis.
Kills adult fleas
(Ctenocephalides felis)
and is indicated for the
treatment and prevention
of flea infestations;
the treatment and
control of tick
infestations with Ixodes
scapularis (black-legged
or deer tick), Amblyomma
maculatum (Gulf Coast
tick), and Dermacentor
variabilis (American dog
tick); the treatment and
control of ear mite
(Otodectes cynotis)
infestations; and the
treatment and control of
roundworm (Toxocara
cati) and intestinal
hookworm (Ancylostoma
tubaeforme) infections
in cats and kittens 8
weeks of age and older,
and weighing 2.8 pounds
or greater.
November 21, 2018....... 038-439 Phibro Animal Health, TERRAMYCIN Salmonids........... Supplemental approval for FOI Summary.
Corp., GlenPointe (oxytetracycline), marking the skeletal
Centre East, 3d Type A medicated tissue of freshwater-
Floor, 300 Frank W. article. reared salmonids.
Burr Blvd., Suite
21, Teaneck, NJ
07666.
December 4, 2018........ 141-509 Boehringer Ingelheim PEXION (imepitoin Dogs................ Original approval for the FOI Summary.
Vetmedica, Inc., tablets). treatment of noise
2621 North Belt aversion in dogs.
Highway, St. Joseph,
MO 64506-2002.
December 19, 2018....... 200-629 Ceva Sante Animale, MILBEGUARD Dogs and cats....... Original approval as a FOI Summary.
10 Avenue de la (milbemycin oxime), generic copy of NADA 140-
Ballasti[egrave]re, Flavored Tablets. 915.
33500 Libourne,
France.
December 27, 2018....... 141-511 LFB USA, Inc., 175 Bc2371 rDNA construct R69 New Zealand Original approval for FOI Summary EA/
Crossing Blvd., in R69 New Zealand white rabbits. expression of a gene for FONSI.\1\
Framingham, MA 01702. white rabbits. recombinant human Factor
VII (rhFVIIa) in R69 New
Zealand white rabbits.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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).
II. Change of Sponsorship
Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sofia,
Bulgaria, has informed FDA that it has transferred ownership of, and
all rights and interest in, the following applications to Elanco US
Inc., 2500 Innovation Way, Greenfield, IN 46140.
----------------------------------------------------------------------------------------------------------------
21 CFR
File No. Product name section
----------------------------------------------------------------------------------------------------------------
140-951............................. CLINACOX (diclazuril) Type A Medicated Article............ 558.198
141-153............................. CLINACOX (diclazuril)/BMD (bacitracin 558.198
methylenedisalicylate).
141-158............................. CLINACOX (diclazuril)/FLAVOMYCIN (bambermycins)........... 558.198
141-194............................. CLINACOX (diclazuril)/BMD (bacitracin 558.198
methylenedisalicylate).
----------------------------------------------------------------------------------------------------------------
[[Page 12493]]
As provided in the regulatory text of this document, the animal
drug regulations are amended to reflect these changes of sponsorship.
III. Technical Amendments
We are reformatting the regulations in subpart B of part 558 for
certain medicated feeds to present their approved conditions of use in
the current tabular format. In addition, we are removing cross-
referencing citations for indications for use of combination drug
medicated feeds wherever they have been used and in their place are
adding the full text of the indications. These actions are being taken
to improve the consistency and readability of the regulations.
IV. 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 528
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, 528, 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), revise the entry
for ``AquaBounty Technologies, Inc.'' and alphabetically add an entry
for ``Dragon Fire Holding Co., Inc.''; and in the table in paragraph
(c)(2), numerically add an entry for ``076033'' and revise the entry
for ``086053'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Drug labeler
Firm name and address code
------------------------------------------------------------------------
* * * * * * *
AquaBounty Technologies, Inc., 2 Mill and Main Pl., 086053
Suite 395, Maynard, MA 01754...........................
* * * * * * *
Dragon Fire Holding Co., Inc., 2619 Skyway Dr., Grand 076033
Prairie, TX 75052......................................
* * * * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * * * *
076033.................. Dragon Fire Holding Co., Inc., 2619 Skyway
Dr., Grand Prairie, TX 75052.
* * * * * * *
086053.................. AquaBounty Technologies, Inc., 2 Mill and Main
Pl., Suite 395, Maynard, MA 01754.
* * * * * * *
------------------------------------------------------------------------
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. 520.304 [Amended]
0
4. In Sec. 520.304, in paragraph (b)(1), remove ``054771, 026637,
055529, and 062250'' and in its place add ``026637, 054771, 055529,
062250, and 076033''.
0
5. In Sec. 520.522, revise paragraph (b) to read as follows:
Sec. 520.522 Cyclosporine.
* * * * *
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter.
(1) No. 058198 for use of products described in paragraph (a) as in
paragraph (d) of this section.
[[Page 12494]]
(2) No. 026637 for use of product described in paragraph (a)(1) as
in paragraph (d)(1) of this section.
* * * * *
0
6. Add Sec. 520.1150 to read as follows:
Sec. 520.1150 Imepitoin.
(a) Specifications. Each tablet contains 100 or 400 milligrams (mg)
imepitoin.
(b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. Administer orally twice daily,
approximately 12 hours apart, at a dose of 13.6 mg per pound (30 mg/kg)
of body weight. Initiate therapy starting 2 days prior to the day of
the expected noise event and continuing through the noise event.
(2) Indications for use. For the treatment of noise aversion in
dogs.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
7. Revise Sec. 520.1441 to read as follows:
Sec. 520.1441 Milbemycin.
(a) Specifications. Each flavored tablet contains 2.3, 5.75, 11.5,
or 23.0 milligrams (mg) of milbemycin oxime.
(b) Sponsors. See Nos. 013744 and 058198 in Sec. 510.600(c) of
this chapter.
(c) Conditions of use--(1) Dogs--(i) Amount. For hookworm,
roundworm, and whipworm, administer 0.23 mg per pound (mg/lb) of body
weight (0.5 mg per kilogram (mg/kg)). For heartworm, administer 0.05
mg/lb of body weight (0.1 mg/kg). Administer once a month.
(ii) Indications for use. For prevention of heartworm disease
caused by Dirofilaria immitis, control of hookworm infections caused by
Ancylostoma caninum, and removal and control of adult roundworm
infections caused by Toxocara canis and Toxascaris leonina and whipworm
infections caused by Trichuris vulpis in dogs and puppies 4 weeks of
age or greater and 2 pounds body weight or greater.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
(2) Cats--(i) Amount. Administer 0.91 mg/lb of body weight (2.0 mg/
kg) once a month.
(ii) Indications for use. For prevention of heartworm disease
caused by Dirofilaria immitis and the removal of adult Toxocara cati
(roundworm) and Ancylostoma tubaeforme (hookworm) infections in cats 6
weeks of age or greater and 1.5 pounds body weight or greater.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
8. The authority citation for part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
9. Amend Sec. 522.1662a by adding two sentences at the end of
paragraph (h)(3)(iii) to read as follows:
Sec. 522.1662a Oxytetracycline hydrochloride injection.
* * * * *
(h) * * *
(3) * * *
(iii) * * * A withdrawal period has not been established for this
product in preruminating calves. Do not use in calves to be processed
for veal.
* * * * *
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
10. The authority citation for part 524 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
11. Add Sec. 524.2099 to read as follows:
Sec. 524.2099 Selamectin and sarolaner.
(a) Specifications. Each milliliter (mL) of solution contains 60
milligrams (mg) selamectin and 10 mg sarolaner. The drug is provided in
single dose tubes containing 0.25, 0.5, or 1 mL of solution.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in cats--(1) Amount. Administer 2.7 mg
selamectin per pound (/lb) (6 mg per kilogram (/kg)) of body weight and
0.45 mg/lb sarolaner (1 mg/kg) by emptying the contents of the tube on
the back of the animal at the base of the neck in front of the shoulder
blades.
(2) Indications for use. For the prevention of heartworm disease
caused by Dirofilaria immitis. Kills adult fleas (Ctenocephalides
felis) and is indicated for the treatment and prevention of flea
infestations; the treatment and control of tick infestations with
Ixodes scapularis (black-legged or deer tick), Amblyomma maculatum
(Gulf Coast tick), and Dermacentor variabilis (American dog tick); the
treatment and control of ear mite (Otodectes cynotis) infestations; and
the treatment and control of roundworm (Toxocara cati) and intestinal
hookworm (Ancylostoma tubaeforme) infections in cats and kittens 8
weeks of age and older, and weighing 2.8 pounds or greater.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
PART 528--NEW ANIMAL DRUGS IN GENETICALLY ENGINEERED ANIMALS
0
12. The authority citation for part 528 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
13. Add Sec. 528.1080 to read as follows:
Sec. 528.1080 Bc2371 recombinant deoxyribonucleic acid construct.
(a) Specifications and intended use. A single copy of Bc2371, a
human Factor VII recombinant deoxyribonucleic acid (rDNA) gene
construct, located on chromosome 3p1.1-2 in a diploid line (R69) of
hemizygous and homozygous New Zealand white rabbits (Oryctolagus
cuniculus).
(b) Sponsor. See No. 086047 in Sec. 510.600 of this chapter.
(c) Conditions of use--(1) Intended use. The construct directs gene
expression of recombinant human Factor VII (hFVII) in the mammary gland
such that recombinant hFVII zymogen is present in the rabbit milk,
enabling purification and activation of recombinant hFVIIa intended for
the treatment of hemophilia A or B in humans with inhibitors to Factors
VIII and IX.
(2) Limitations. Food or feed from R69 rabbits is not permitted in
the food or feed supply.
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
0
14. The authority citation for part 556 continues to read as follows:
Authority: 21 U.S.C. 342, 360b, 371.
0
15. Add Sec. 556.370 to subpart B to read as follows:
Sec. 556.370 Lubabegron.
(a) Acceptable daily intake (ADI). The ADI for total residues of
lubabegron is 3 micrograms per kilogram of body weight per day.
(b) Tolerance in cattle. The tolerance for lubabegron (marker
residue) is:
(1) Cattle--Liver (target tissue): 10 ppb.
(2) [Reserved]
(c) Related conditions of use. See Sec. 558.330 of this chapter.
[[Page 12495]]
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
16. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
0
17. In Sec. 558.4, in paragraph (d), in the ``Category I'' table,
alphabetically add an entry for ``Lubabegron'' to read as follows:
Sec. 558.4 Requirement of a medicated feed mill license.
* * * * *
(d) * * *
Category I
----------------------------------------------------------------------------------------------------------------
Assay limits Assay limits
Drug percent \1\ Type Type B maximum (200x) percent \1\ Type
A B/C \2\
----------------------------------------------------------------------------------------------------------------
* * * * * * *
Lubabegron................................. 87-107 908 g/ton.................... 85-115/80-120
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
0
18. In Sec. 558.140, revise paragraphs (e)(1) and (2) to read as
follows:
Sec. 558.140 Chlortetracycline and sulfamethazine.
* * * * *
(e) * * *
(1) Cattle--
----------------------------------------------------------------------------------------------------------------
Chlortetracycline and sulfamethazine
amount Indications for use Limitations Sponsors
----------------------------------------------------------------------------------------------------------------
(i) To provide 350 milligrams per head Beef cattle: For aid in the Feed for 28 days; withdraw 054771
per day each, chlortetracycline and maintenance of weight 7 days prior to slaughter. 069254
sulfamethazine. gains in the presence of A withdrawal period has
respiratory disease such not been established for
as shipping fever. this product in pre-
ruminating calves. Do not
use in calves to be
processed for veal.
(ii) [Reserved]
----------------------------------------------------------------------------------------------------------------
(2) Swine--
----------------------------------------------------------------------------------------------------------------
Chlortetracycline and sulfamethazine
amount Indications for use Limitations Sponsors
----------------------------------------------------------------------------------------------------------------
(i) 100 g/ton of feed each, Swine: For reduction of the Feed as the sole ration. 054771
chlortetracycline and sulfamethazine. incidence of cervical Withdraw 15 days prior to 069254
abscesses; treatment of slaughter.
bacterial swine enteritis
(salmonellosis or necrotic
enteritis caused by
Salmonella choleraesuis
and vibrionic dysentery);
prevention of these
diseases during times of
stress; and maintenance of
weight gains in the
presence of atrophic
rhinitis.
(ii) [Reserved]
----------------------------------------------------------------------------------------------------------------
* * * * *
0
19. In Sec. 558.175, revise paragraph (d) to read as follows:
Sec. 558.175 Clopidol.
* * * * *
(d) Conditions of use--(1) Chickens--
----------------------------------------------------------------------------------------------------------------
Clopidol in grams per Combination in
ton grams per ton Indications for use Limitations Sponsors
----------------------------------------------------------------------------------------------------------------
(i) 113.5............. ................ Broiler chickens and re-placement Do not feed to 016592
chickens intended for use as chickens over 16
caged layers: As an aid in the weeks of age.
prevention of coccidiosis caused
by Eimeria tenella, E. necatrix,
E. acervulina, E. maxima, E.
brunetti, and E. mivati.
(ii) 113.5............ Bacitracin Broiler chickens: As an aid in the Feed continuously as 016592
methylenedisali prevention of coccidiosis caused the sole ration from
cylate, 4 to 50. by Eimeria tenella, E. necatrix, the time chicks are
E. acervulina, E. maxima, E. placed in floor pens
brunetti, and E. mivati, and for until slaughter. Do
increased rate of weight gain. not feed to chickens
over 16 weeks of
age; bacitracin
methylenedisalicylat
e as provided by No.
054771 in Sec.
510.600(c) of this
chapter.
(iii) 113.5........... Bacitracin zinc, Broiler chickens: As an aid in the Feed continuously as 054771
5 to 25. prevention of coccidiosis caused sole ration; 016592
by Eimeria tenella, E. necatrix, bacitracin zinc as
E. acervulina, E. maxima, E. provided by No.
brunetti, and E. mivati, and for 054771 in Sec.
increased rate of weight gain and 510.600(c) of this
improved feed efficiency. chapter.
(iv) 113.5............ Bambermycins, 1 Broiler chickens: As an aid in Feed continuously as 016592
to 2. prevention of coccidiosis caused the sole ration. Do
by Eimeria tenella, E. necatrix, not feed to chickens
E. acervulina, E. maxima, E. over 16 weeks of age.
brunetti, and E. mivati; and for
increased rate of weight gain and
improved feed efficiency.
[[Page 12496]]
(v) 227............... ................ Broiler and replacement chickens Feed continuously as 016592
intended for use as caged layers: the sole ration;
As an aid in the prevention of feed up to 16 weeks
coccidiosis caused by Eimeria of age if intended
tenella, E. necatrix, E. for use as caged
acervulina, E. maxima, E. layers; withdraw 5
brunetti, and E. mivati. days before
slaughter if given
at the level of
0.025 percent in
feed or reduce level
to 0.0125 percent 5
days before
slaughter.
(vi) 227.............. Bambermycins, 1 Broiler chickens: As an aid in Feed continuously as 016592
to 2. prevention of coccidiosis caused sole ration until 5
by Eimeria tenella, E. necatrix, days before
E. acervulina, E. maxima, E. slaughter. Withdraw
brunetti, and E. mivati; and for 5 days before
increased rate of weight gain and slaughter or feed
improved feed efficiency. 113.5 g/ton clopidol
and 1 to 2 g/ton
bambermycins during
those 5 days before
slaughter. Do not
feed to chickens
over 16 weeks of age.
----------------------------------------------------------------------------------------------------------------
(2) Turkeys--
----------------------------------------------------------------------------------------------------------------
Clopidol in grams per Combination in
ton grams per ton Indications for use Limitations Sponsors
----------------------------------------------------------------------------------------------------------------
(i) 113.5 or 227...... ................ Turkeys: As an aid in the For turkeys grown for 016592
prevention of leucocytozoonosis meat purposes only;
caused by Leucocytozoon smithi. feed continuously as
the sole ration at
0.0125 or 0.025
percent clopidol
depending on
management
practices, degree of
exposure, and amount
of feed eaten;
withdraw 5 days
before slaughter.
(ii) [Reserved]
----------------------------------------------------------------------------------------------------------------
(3) Clopidol may also be used in combination with:
(i)-(ii) [Reserved]
(iii) Chlortetracycline as in Sec. 558.128.
(iv) Lincomycin as in Sec. 558.325.
0
20. In Sec. 558.195, revise paragraphs (e)(1) through (3) to read as
follows:
Sec. 558.195 Decoquinate.
* * * * *
(e) * * *
(1) Chickens--
--------------------------------------------------------------------------------------------------------------------------------------------------------
Combination in grams/
Decoquinate in grams/ton ton Indications for use Limitations Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
(i) 27.2.................... Broiler chickens: For prevention of Do not feed to laying hens producing eggs 054771
coccidiosis caused by Eimeria tenella, for human consumption.
E. necatrix, E. mivati, E. acervulina,
E. maxima, and E. brunetti.
(ii) 27.2................... Bacitracin Broiler chickens: For prevention of Feed continuously as sole ration; do not 054771
methylenedisalicylate, coccidiosis caused by Eimeria tenella, feed to laying chickens. Bacitracin
4 to 50. E. necatrix, E. mivati, E. acervulina, methylenedisalicylate as provided by No.
E. maxima, and E. brunetti; and for 054771 in Sec. 510.600(c) of this
increased rate of weight gain and chapter.
improved feed efficiency.
(iii) 27.2.................. Bacitracin zinc, 10 to Broiler chickens: For prevention of Feed continuously as sole ration; do not 054771
50. coccidiosis caused by Eimeria tenella, feed to laying chickens. Bacitracin zinc
E. necatrix, E. mivati, E. acervulina, as provided by No. 054771 in Sec.
E. maxima, and E. brunetti. 510.600(c) of this chapter.
--------------------------------------------------------------------------------------------------------------------------------------------------------
(2) Cattle--
--------------------------------------------------------------------------------------------------------------------------------------------------------
Combination in grams/
Decoquinate in grams/ton ton Indications for use Limitations Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
(i) 12.9 to 90.8............ Cattle (including ruminating and Feed Type C feed or milk replacer to 054771
nonruminating calves and veal calves): provide 22.7 milligrams (mg) per 100
For prevention of coccidiosis caused by pounds (lb) of body weight (0.5 mg/kg)
Eimeria bovis and E. zuernii. per day. Feed at least 28 days during
periods of exposure to coccidiosis or
when it is likely to be a hazard. Do not
feed to cows producing milk for human
consumption. See paragraph (d)(3) of
this section.
(ii) 12.9 to 90.8........... Monensin, 5 to 30...... Cattle fed in confinement for slaughter: Feed only to cattle fed in confinement 054771
For prevention of coccidiosis caused by for slaughter. Feed continuously as the
Eimeria bovis and E. zuernii; and for sole ration to provide 22.7 mg of
improved feed efficiency. decoquinate per 100 lb of body weight
per day and 50 to 360 mg of monensin per
head per day. Feed at least 28 days
during period of exposure to coccidiosis
or when it is likely to be a hazard. Do
not feed to animals producing milk for
food. Do not feed to lactating dairy
cattle. Also see paragraph (d)(1) of
this section and Sec.
558.355(d)(9)(i). Monensin as provided
by No. 058198 in Sec. 510.600(c) of
this chapter.
[[Page 12497]]
(iii) 90.9 to 535.7......... Cattle (including ruminating and Feed Type C medicated feed supplements as 054771
nonruminating calves and veal calves): a top dress or mix into the daily ration
For prevention of coccidiosis caused by to provide 22.7 mg per 100 lb of body
Eimeria bovis and E. zuernii. weight (0.5 mg/kg) per day. Feed at
least 28 days during periods of exposure
to coccidiosis or when it is likely to
be a hazard. Do not feed to cows
producing milk for food. See paragraph
(d)(3) of this section.
--------------------------------------------------------------------------------------------------------------------------------------------------------
(3) Minor species--
--------------------------------------------------------------------------------------------------------------------------------------------------------
Combination in grams/
Decoquinate in grams/ton ton Indications for use Limitations Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
(i) 12.9 to 90.8............ ....................... 1. Young sheep: For the prevention of Feed Type C feed or milk replacer at a 054771
coccidiosis caused by Eimeria rate to provide 22.7 mg per 100 lb of
ovinoidalis, E. crandallis, E. parva, body weight (0.5 mg per kg) per day;
and E. bakuensis. feed for at least 28 days during periods
of exposure to coccidiosis or when it is
likely to be a hazard. Do not feed to
sheep producing milk for human
consumption.
....................... 2. Young goats: For the prevention of Feed Type C feed or milk replacer at a ...........
coccidiosis caused by Eimeria rate to provide 22.7 mg per 100 lb of
christenseni and E. ninakohlyakimovae. body weight (0.5 mg per kg) per day;
feed for at least 28 days during periods
of exposure to coccidiosis or when it is
likely to be a hazard. Do not feed to
goats producing milk for human
consumption.
(ii) 90.9 to 535.7.......... ....................... 1. Young sheep: For the prevention of Feed Type C medicated feed supplements as 054771
coccidiosis caused by Eimeria a top dress or mix into the daily ration
ovinoidalis, E. crandallis, E. parva, to provide 22.7 mg per 100 lb of body
and E. bakuensis. weight (0.5 mg per kg) per day; feed for
at least 28 days during periods of
exposure to coccidiosis or when it is
likely to be a hazard. Do not feed to
sheep producing milk for human
consumption.
....................... 2. Young goats: For the prevention of Feed Type C medicated feed supplements as ...........
coccidiosis caused by Eimeria a top dress or mix into the daily ration
christenseni and E. ninakohlyakimovae. to provide 22.7 mg per 100 lb of body
weight (0.5 mg per kg) per day; feed for
at least 28 days during periods of
exposure to coccidiosis or when it is
likely to be a hazard. Do not feed to
goats producing milk for human
consumption.
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * *
Sec. Sec. 558.198 and 558.205 [Redesignated as Sec. Sec. 558.205
and 558.198]
0
21. Redesignate Sec. Sec. 558.198 and 558.205 as Sec. Sec. 558.205
and 558.198, respectively.
0
22. Revise newly redesignated Sec. 558.198 to read as follows:
Sec. 558.198 Dichlorvos.
(a) Specifications. Each pound of Type A medicated article
containing 3.1 or 9.6 percent dichlorvos.
(b) Sponsor. See No. 054628 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.180 of this chapter.
(d) Special considerations--(1) Dichlorvos is to be included in
meal or mash or mixed with feed in crumble form only after the crumble
feed has been manufactured. Do not mix in feeds to be pelleted nor with
pelleted feed. Do not soak the feed or administer as wet mash. Feed
must be dry when administered. Do not use in animals other than swine.
Do not allow fowl access to feed containing this preparation or to
feces from treated animals.
(2) Dichlorvos is a cholinesterase inhibitor. Do not use this
product in animals simultaneously or within a few days before or after
treatment with or exposure to cholinesterase-inhibiting drugs,
pesticides, or chemicals. If human or animal poisoning should occur,
immediately consult a physician or a veterinarian. Atropine is
antidotal.
(3) Labeling for Type A articles and Type B feeds must include a
statement that containers or materials used in packaging such Type A
articles and Type B feeds are not to be reused and all such packaging
materials must be destroyed after the product has been used.
(e) Conditions of use. It is used in swine feed as follows:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Combination in grams/
Dichlorvos grams/ton ton Indications for use Limitations Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
(i) 348..................... Swine up to 70 pounds body weight: For Feed as sole ration for 2 consecutive 054628
the removal and control of mature, days. For swine from 70 pounds to market
immature, and/or fourth-stage larvae of weight, feed as sole ration at the rate
the whipworm (Trichuris suis), nodular of 8.4 pounds of feed per head until the
worm (Oesophagostomum sp.), large medicated feed has been consumed. For
roundworm (Ascaris suum) and the thick boars, open or bred gilts, and sows,
stomach worm (Ascarops strongylina) of feed as sole ration at the rate of 4.2
the gastrointestinal tract. pounds per head per day for 2
consecutive days.
[[Page 12498]]
(ii) 479.................... Boars, open or bred gilts, and sows: For Feed as sole ration at the rate of 6 054628
the removal and control of mature, pounds per head for one feeding.
immature, and/or fourth-stage larvae of
the whipworm (Trichuris suis), nodular
worm (Oesophagostomum sp.), large
roundworm (Ascaris suum) and the thick
stomach worm (Ascarops strongylina) of
the gastrointestinal tract.
(iii) 334 to 500............ Pregnant swine: An aid in improving Mix into a gestation feed to provide 054628
litter production efficiency by 1,000 milligrams per head daily during
increasing pigs born alive, birth last 30 days of gestation.
weights, survival to market, and rate of
weight gain. Treatment also removes and
controls mature, immature and/or fourth
stage larvae of whipworm (Trichuris
suis), nodular worm (Oesophagostomum
spp.) large roundworm (Ascaris suum),
and the thick stomach worm (Ascarops
strongylina) occurring in the
gastrointestinal tract of the sow or
gilt.
--------------------------------------------------------------------------------------------------------------------------------------------------------
0
23. In newly redesignated Sec. 558.205, revise paragraphs (b) and
(d)(1) and (2) to read as follows:
Sec. 558.205 Diclazuril.
* * * * *
(b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
* * * * *
(d) * * *
(1) Chickens. For chickens it is used as follows:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Combination in grams/
Diclazuril grams/ton ton Indications for use Limitations Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
(i) 0.91.................... Broiler chickens: For the prevention of Feed continuously. Not for use in hens 058198
coccidiosis caused by Eimeria tenella, producing eggs for human food. Because
E. necatrix, E. acervulina, E. brunetti, diclazuril is effective against E.
E. mitis (mivati), and E. maxima. maxima later in its life cycle,
subclinical intestinal lesions may be
present for a short time after
infection. Diclazuril was shown in
studies to reduce lesion scores and
improve performance and health of birds
challenged with E. maxima.
(ii) 0.91................... Bacitracin Broiler chickens: For the prevention of Feed continuously. Not for use in hens 058198
methylenedisalicylate, coccidiosis caused by Eimeria tenella, producing eggs for human food. Because
4 to 50. E. necatrix, E. acervulina, E. brunetti, diclazuril is effective against E.
E. mitis (mivati), and E. maxima, and maxima later in its life cycle,
for increased rate of weight gain and subclinical intestinal lesions may be
improved feed efficiency. present for a short time after
infection. Diclazuril was shown in
studies to reduce lesion scores and
improve performance and health of birds
challenged with E. maxima. Bacitracin
methylenedisalicylate as provided by No.
054771 in Sec. 510.600(c) of this
chapter.
(iii) 0.91.................. Bambermycins, 1 to 2... Broiler chickens: For the prevention of Feed continuously. Not for use in hens 058198
coccidiosis caused by Eimeria tenella, producing eggs for human food. Because
E. necatrix, E. acervulina, E. brunetti, diclazuril is effective against E.
E. mitis (mivati), and E. maxima, and maxima later in its life cycle,
for increased rate of weight gain and subclinical intestinal lesions may be
improved feed efficiency. present for a short time after
infection. Diclazuril was shown in
studies to reduce lesion scores and
improve performance and health of birds
challenged with E. maxima. Bambermycins
as provided by No. 016592 in Sec.
510.600(c) of this chapter.
--------------------------------------------------------------------------------------------------------------------------------------------------------
(2) Turkeys. For turkeys it is used as follows:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Combination in grams/
Diclazuril grams/ton ton Indications for use Limitations Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
(i) 0.91.................... Growing turkeys: For the prevention of Feed continuously as the sole ration. Do 058198
coccidiosis caused by Eimeria not feed to breeding turkeys. Not for
adenoeides, E. gallopavonis and E. use in hens producing eggs for human
meleagrimitis. consumption.
(ii) 0.91................... Bacitracin Growing turkeys: For the prevention of Feed continuously as the sole ration. Do 058198
methylenedisalicylate, coccidiosis caused by Eimeria not feed to breeding turkeys. Not for
4 to 50. adenoeides, E. gallopavonis and E. use in hens producing eggs for human
meleagrimitis, and for increased rate of consumption. Bacitracin
weight gain and improved feed methylenedisalicylate as provided by No.
efficiency. 054771 in Sec. 510.600(c) of this
chapter.
(iii) 0.91.................. Bambermycins, 1 to 2... Growing turkeys: For the prevention of Feed continuously as the sole ration. Do 058198
coccidiosis caused by Eimeria not feed to breeding turkeys. Not for
adenoeides, E. gallopavonis and E. use in hens producing eggs for human
meleagrimitis, and for improved feed consumption. Bambermycins as provided by
efficiency. No. 016592 in Sec. 510.600(c) of this
chapter.
[[Page 12499]]
(iv) 0.91................... Bambermycins, 2........ Growing turkeys: For the prevention of Feed continuously as the sole ration. Do 058198
coccidiosis caused by Eimeria not feed to breeding turkeys. Not for
adenoeides, E. gallopavonis and E. use in hens producing eggs for human
meleagrimitis, and for increased rate of consumption. Bambermycins as provided by
weight gain and improved feed No. 016592 in Sec. 510.600(c) of this
efficiency. chapter.
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * *
0
24. In Sec. 558.258, revise paragraph (e)(2) to read as follows:
Sec. 558.258 Fenbendazole.
* * * * *
(e) * * *
(2) Swine.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fenbendazole in grams per Combination in grams
ton per ton Indications for use Limitations Sponsors
--------------------------------------------------------------------------------------------------------------------------------------------------------
(i) 10 to 300 (to provide 9 For the removal and control of adult Feed as the sole ration 000061
milligrams per kilogram (mg/ stage lungworms (Metastrongylus apri and
kg) of body weight) given M. pudendotectus); adult and larvae (L3,
over a 3- to 12-day period.. 4 stages--liver, lung, intestinal forms)
large roundworms (Ascaris suum); adult
stage nodular worms (Oesophagostomum
dentatum, O. quadrispinulatum); adult
stage small stomach worms (Hyostrongylus
rubidus); adult and larvae (L2, 3, 4
stages--intestinal mucosal forms)
whipworms (Trichuris suis); adult and
larvae kidney worms (Stephanurus
dentatus).
(ii) 10 to 300 (to provide 9 Bacitracin Growing/finishing swine: For the removal Feed as the sole ration. Under conditions 054771
mg/kg of body weight).. methylenedisalicylate, and control of adult stage lungworms of continued exposure to parasites,
10 to 30. (Metastrongylus apri and M. retreatment may be needed after 4 to 6
pudendotectus); adult and larvae (L3, 4 weeks. Bacitracin methylenedisalicylate
stages--liver, lung, intestinal forms) as provided by No. 054771 in Sec.
large roundworms (Ascaris suum); adult 510.600(c) of this chapter
stage nodular worms (Oesophagostomum
dentatum, O. quadrispinulatum); adult
stage small stomach worms (Hyostrongylus
rubidus); adult and larvae (L2, 3, 4
stages--intestinal mucosal forms)
whipworms (Trichuris suis); adult and
larvae kidney worms (Stephanurus
dentatus); and for increased rate of
weight gain and improved feed
efficiency.
(iii) 10 to 300 (to provide Bacitracin 1. Growing/finishing swine: For the 1. Growing/finishing swine: Feed as sole 054771
9 mg/kg of body weight).. methylenedisalicylate, removal and control of adult stage ration. Not for use in growing and
250. lungworms (Metastrongylus apri and M. finishing swine that weigh more than 250
pudendotectus); adult and larvae (L3, 4 lbs. Diagnosis of swine dysentery should
stages--liver, lung, intestinal forms) be confirmed by a veterinarian when
large roundworms (Ascaris suum); adult results are not satisfactory. Under
stage nodular worms (Oesophagostomum conditions of continued exposure to
dentatum, O. quadrispinulatum); adult parasites, retreatment may be needed
stage small stomach worms (Hyostrongylus after 4 to 6 weeks. Bacitracin
rubidus); adult and larvae (L2, 3, 4 methylenedisalicylate as provided by No.
stages--intestinal mucosal forms) 054771 in Sec. 510.600(c) of this
whipworms (Trichuris suis); adult and chapter
larvae kidney worms (Stephanurus
dentatus); and for control of swine
dysentery associated with Treponema
hyodysenteriae on premises with a
history of swine dysentery, but where
signs of disease have not yet occurred;
or following an approved treatment of
the disease condition.
2. Pregnant sows: For the removal and 2. Pregnant sows: Feed as sole ration.
control of adult stage lungworms Diagnosis of clostridial enteritis
(Metastrongylus apri and M. should be confirmed by a veterinarian
pudendotectus); adult and larvae (L3, 4 when results are not satisfactory. Under
stages--liver, lung, intestinal forms) conditions of continued exposure to
large roundworms (Ascaris suum); adult parasites, retreatment may be needed
stage nodular worms (Oesophagostomum after 4 to 6 weeks. Bacitracin
dentatum, O. quadrispinulatum); adult methylenedisalicylate as provided by No.
stage small stomach worms (Hyostrongylus 054771 in Sec. 510.600(c) of this
rubidus); adult and larvae (L2, 3, 4 chapter.
stages--intestinal mucosal forms)
whipworms (Trichuris suis); adult and
larvae kidney worms (Stephanurus
dentatus); for control of clostridial
enteritis in suckling pigs caused by
Clostridium perfringens.
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * *
0
25. In Sec. 558.300, revise paragraph (e) to read as follows:
Sec. 558.300 Ivermectin.
* * * * *
(e) Conditions of use in swine. It is used in feed as follows:
[[Page 12500]]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Combination in grams/
Ivermectin in grams/ton ton Indications for use Limitations Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
(1) 1.8..................... Weaned, growing-finishing swine: For Feed as the only feed for 7 consecutive 050604
treatment and control of days to provide 0.1 milligrams per
gastrointestinal roundworms (Ascaris kilograms (mg/kg) of body weight per
suum, adults and fourth-stage larvae; day. Withdraw 5 days before slaughter.
Ascarops strongylina, adults;
Hyostrongylus rubidus, adults and fourth-
stage larvae; Oesophagostomum spp.,
adults and fourth-stage larvae);
kidneyworms (Stephanurus dentatus,
adults and fourth-stage larvae);
lungworms (Metastrongylus spp., adults);
threadworms (Strongyloides ransomi,
adults and somatic larvae); lice
(Haematopinus suis); and mange mites
(Sarcoptes scabiei var. suis).
(2) 1.8..................... Bacitracin Weaned, growing-finishing swine: For Feed as the only feed for 7 consecutive 050604
methylenedisalicylate, treatment and control of days to provide 0.1 mg/kg of body weight
10 to 30. gastrointestinal roundworms (Ascaris per day. Withdraw 5 days before
suum, adults and fourth-stage larvae; slaughter.
Ascarops strongylina, adults;
Hyostrongylus rubidus, adults and fourth-
stage larvae; Oesophagostomum spp.,
adults and fourth-stage larvae);
kidneyworms (Stephanurus dentatus,
adults and fourth-stage larvae);
lungworms (Metastrongylus spp., adults);
threadworms (Strongyloides ransomi,
adults and somatic larvae); lice
(Haematopinus suis); and mange mites
(Sarcoptes scabiei var. suis); and for
increased rate of weight gain and
improved feed efficiency.
(3) 1.8..................... Bacitracin Weaned, growing-finishing swine: For Feed as the only feed for 7 consecutive 050604
methylenedisalicylate, treatment and control of days to provide 0.1 mg/kg of body weight
250. gastrointestinal roundworms (Ascaris per day. Withdraw 5 days before
suum, adults and fourth-stage larvae; slaughter.
Ascarops strongylina, adults;
Hyostrongylus rubidus, adults and fourth-
stage larvae; Oesophagostomum spp.,
adults and fourth-stage larvae);
kidneyworms (Stephanurus dentatus,
adults and fourth-stage larvae);
lungworms (Metastrongylus spp., adults);
threadworms (Strongyloides ransomi,
adults and somatic larvae); lice
(Haematopinus suis); and mange mites
(Sarcoptes scabiei var. suis); and for
control of swine dysentery associated
with Treponema hyodysenteriae on
premises with a history of swine
dysentery, but where symptoms have not
yet occurred, or following an approved
treatment of disease condition.
(4) 1.8 to 11.8............. Adult and breeding swine: For treatment Feed as the only feed for 7 consecutive 050604
and control of gastrointestinal days to provide 0.1 mg/kg of body weight
roundworms (Ascaris suum, adults and per day. Withdraw 5 days before
fourth-stage larvae; Ascarops slaughter.
strongylina, adults; Hyostrongylus
rubidus, adults and fourth-stage larvae;
Oesophagostomum spp., adults and fourth-
stage larvae); kidneyworms (Stephanurus
dentatus, adults and fourth-stage
larvae); lungworms (Metastrongylus spp.,
adults); threadworms (Strongyloides
ransomi, adults and somatic larvae, and
prevention of transmission of infective
larvae to piglets, via the colostrum or
milk, when fed during gestation); lice
(Haematopinus suis); and mange mites
(Sarcoptes scabiei var. suis).
(5) 1.8 to 11.8............. Bacitracin Pregnant sows: For treatment and control Feed as the only feed for 7 consecutive 050604
methylenedisalicylate, of gastrointestinal roundworms (Ascaris days to provide 0.1 mg/kg of body weight
250. suum, adults and fourth-stage larvae; per day. Withdraw 5 days before
Ascarops strongylina, adults; slaughter. Feed bacitracin
Hyostrongylus rubidus, adults and fourth- methylenedisalicylate Type C medicated
stage larvae; Oesophagostomum spp., feed to sows from 14 days before through
adults and fourth-stage larvae); 21 days after farrowing on premises with
kidneyworms (Stephanurus dentatus, a history of clostridial scours.
adults and fourth-stage larvae);
lungworms (Metastrongylus spp., adults);
threadworms (Strongyloides ransomi,
adults and somatic larvae, and
prevention of transmission of infective
larvae to piglets, via the colostrum or
milk, when fed during gestation); lice
(Haematopinus suis); and mange mites
(Sarcoptes scabiei var. suis); and for
control of clostridial enteritis caused
by Clostridium perfringens in suckling
piglets.
[[Page 12501]]
(6) 18.2 to 120............. Adult and breeding swine: For treatment Top dress on daily ration for individual 050604
and control of gastrointestinal treatment for 7 consecutive days to
roundworms (Ascaris suum, adults and provide 0.1 mg/kg of body weight per
fourth-stage larvae; Ascarops day. Withdraw 5 days before slaughter.
strongylina, adults; Hyostrongylus
rubidus, adults and fourth-stage larvae;
Oesophagostomum spp., adults and fourth-
stage larvae); kidneyworms (Stephanurus
dentatus, adults and fourth-stage
larvae); lungworms (Metastrongylus spp.,
adults); threadworms (Strongyloides
ransomi, adults and somatic larvae, and
prevention of transmission of infective
larvae to piglets, via the colostrum or
milk, when fed during gestation); lice
(Haematopinus suis); and mange mites
(Sarcoptes scabiei var. suis).
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * *
0
26. In Sec. 558.325, add paragraph (e)(1)(iii) to read as follows:
Sec. 558.325 Lincomycin.
* * * * *
(e) * * *
(1) * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
Combination in grams/
Lincomycin grams/ton ton Indications for use Limitations Sponsors
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * * * *
(iii) 2..................... Clopidol, 113.5........ Broiler chickens: For the control of Feed as the sole ration to broiler 054771
necrotic enteritis caused or complicated chickens. Do not feed to chickens over
by Clostridium spp. or other organisms 16 weeks of age. Not for use in laying
susceptible to lincomycin, and as an aid hens, breeding chickens, or turkeys. Do
in the prevention of cecal and not allow rabbits, hamsters, guinea
intestinal coccidiosis caused by Eimeria pigs, horses, or ruminants access to
tenella, E. necatrix, E. acervulina, E. feeds containing lincomycin. Ingestion
maxima, E. brunetti, and E. mivati. by these species may result in severe
gastrointestinal effects. Clopidol as
provided by No. 016592 in Sec. 510.600
of this chapter.
* * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * *
0
27. Add Sec. 558.330 to read as follows:
Sec. 558.330 Lubabegron.
(a) Specifications. Each pound of Type A medicated article contains
4.54 grams (10 grams per kilogram) of lubabegron as lubabegron
fumarate.
(b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.370 of this chapter.
(d) Conditions of use. It is used in cattle feed as follows:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Combination in grams/
Lubabegron grams/ton ton Indications for use Limitations Sponsors
--------------------------------------------------------------------------------------------------------------------------------------------------------
(1) 1.25 to 4.54............ Beef steers and heifers fed in Feed 1.25 to 4.54 g/ton (1.39 to 5 ppm) 058198
confinement for slaughter: For reduction of complete feed (90% dry matter basis)
of ammonia gas emissions per pound of to provide 13 to 90 milligrams
live weight and hot carcass weight lubabegron/head/day continuously. Do not
during the last 14 to 91 days on feed. allow horses or other equines access to
feed containing lubabegron. Not approved
for use in breeding animals because
safety and effectiveness have not been
evaluated in these animals.
(ii) [Reserved]
--------------------------------------------------------------------------------------------------------------------------------------------------------
0
28. In Sec. 558.415, revise paragraph (d) to read as follows:
Sec. 558.415 Novobiocin.
* * * * *
(d) Conditions of use. It is used in animal feeds as follows:
(1) Chickens--
[[Page 12502]]
----------------------------------------------------------------------------------------------------------------
Novobiocin amount Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) To provide 6 to 7 Chickens: As an aid in the treatment Administer feed which contains not 054771
milligrams per pound of breast blisters associated with less than 200 grams of novobiocin
(mg/lb) of body weight staphylococcal infections activity per ton of feed as the
per day. susceptible to novobiocin. sole ration for 5 to 7 days. Not
for laying chickens. Withdraw 4
days before slaughter.
(ii) To provide 10 to Chickens: For the treatment of Administer feed which contains not 054771
14 mg/lb of body staphylococcal synovitis and less than 350 grams of novobiocin
weight per day. generalized staphylococcal activity per ton of feed as the
infections susceptible to sole ration for 5 to 7 days. Not
novobiocin. for laying chickens. Withdraw 4
days before slaughter.
----------------------------------------------------------------------------------------------------------------
(2) Turkeys--
----------------------------------------------------------------------------------------------------------------
Novobiocin amount Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) To provide 4 to 5 Turkeys: As an aid in the treatment Administer feed which contains not 054771
mg/lb of body weight of breast blisters associated with less than 200 grams of novobiocin
per day. staphylococcal infections activity per ton of feed as the
susceptible to novobiocin. sole ration for 5 to 7 days. Not
for laying turkeys. Withdraw 4 days
before slaughter.
(ii) To provide 5 to 8 Turkeys: As an aid in the control of Administer feed which contains not 054771
mg/lb of body weight recurring outbreaks of fowl cholera less than 200 grams of novobiocin
per day. caused by strains of Pasteurella activity per ton of feed as the
multocida susceptible to novobiocin sole ration for 5 to 7 days. Not
following initial treatment with 7 for laying turkeys. Withdraw 4 days
to 8 mg/lb of body weight per day. before slaughter.
(iii) To provide 7 to 8 Turkeys: For the treatment of Administer feed which contains not 054771
mg/lb of body weight staphylococcal synovitis and less than 350 grams of novobiocin
per day. generalized staphylococcal activity per ton of feed as the
infections susceptible to sole ration for 5 to 7 days. Not
novobiocin; and treatment of acute for laying turkeys. Withdraw 4 days
outbreaks of fowl cholera caused by before slaughter.
strains of Pasteurella multocida
susceptible to novobiocin.
----------------------------------------------------------------------------------------------------------------
(3) Minor species--
----------------------------------------------------------------------------------------------------------------
Novobiocin amount Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 350 grams per ton. Ducks: For the control of infectious Administer as the sole ration for 5 054771
serositis and fowl cholera in ducks to 7 days. Continue medication for
caused by Pasteurella anatipestifer 14 days if necessary. Repeat if
and P. multocida, susceptible to reinfection occurs. Discontinue use
novobiocin. at least 3 days before slaughter.
Not for use in laying ducks.
(ii) To provide 20 mg/ Mink: For the treatment of Administer feed which contains not 054771
lb of body weight per generalized infections, abscesses, less than 200 grams of novobiocin
day. or urinary infections caused by activity per ton of feed as the
staphylococcal or other novobiocin sole ration for 7 days.
sensitive organisms.
----------------------------------------------------------------------------------------------------------------
0
29. In Sec. 558.450, redesignate paragraphs (e)(5)(iii), (iv), and (v)
as paragraphs (e)(v), (iii), and (iv) respectively; and revise newly
redesignated paragraphs (e)(5)(iv) and (v) to read as follows:
Sec. 558.450 Oxytetracycline.
* * * * *
(e) * * *
(5) * * *
----------------------------------------------------------------------------------------------------------------
Oxytetracycline amount Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(iv) 3.75 g/100 lb of * * * * * * 066104
fish/day. 3. Freshwater-reared salmonids Feed for 10 days. Immediate release
weighing up to 55 grams: For is permitted following the last
marking the skeletal tissue. feeding of medicated feed.
(v) 11.35 g/100 lb of Pacific salmon not over 30 grams Administer medicated feed as the 066104
fish/day. body weight: For marking of sole ration for 4 consecutive days.
skeletal tissue. Do not liberate for at least 7 days
following last feeding of medicated
feed.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
0
30. In Sec. 558.575, revise paragraphs (b) and (e) to read as follows:
Sec. 558.575 Sulfadimethoxine and ormetoprim.
* * * * *
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for
use as in paragraph (d) of this section:
(1) No. 054771 for use of the product described in paragraph (a)(1)
as in paragraphs (e)(1), (e)(2)(i), and (e)(3)(i) through (iii) of this
section.
(2) No. 015331 for use of the product described in paragraph (a)(2)
as in paragraphs (e)(3)(iv) and (v) of this section.
* * * * *
(e) Conditions of use. It is used in animal feeds as follows:
(1) Chickens--
[[Page 12503]]
----------------------------------------------------------------------------------------------------------------
Sulfadimethoxine and
ormetoprim grams/ton Indications for use Limitations Sponsors
----------------------------------------------------------------------------------------------------------------
(i) Sulfadimethoxine, Broiler chickens: As an aid in the Feed as sole ration. Withdraw 5 days 054771
113.5; ormetoprim, prevention of coccidiosis caused by before slaughter.
68.1. all Eimeria species known to be
pathogenic to chickens, namely, E.
tenella, E. necatrix, E.
acervulina, E. brunetti, E. mivati,
and E. maxima, and bacterial
infections due to Heterakis
gallinarum (infectious coryza),
Escherichia coli (colibacillosis)
and Pasteurella multocida (fowl
cholera).
(ii) Sulfadimethoxine, Replacement chickens: As an aid in Feed as sole ration. Do not feed to 054771
113.5; ormetoprim, the prevention of coccidiosis chickens over 16 weeks (112 days)
68.1. caused by all Eimeria species known of age. Withdraw 5 days before
to be pathogenic to chickens, slaughter.
namely, E. tenella, E. necatrix, E.
acervulina, E. brunetti, E. mivati,
and E. maxima, and bacterial
infections due to Heterakis
gallinarum (infectious coryza),
Escherichia coli (colibacillosis)
and Pasteurella multocida (fowl
cholera).
----------------------------------------------------------------------------------------------------------------
(2) Turkeys--
----------------------------------------------------------------------------------------------------------------
Sulfadimethoxine and
ormetoprim grams/ton Indications for use Limitations Sponsors
----------------------------------------------------------------------------------------------------------------
(i) Sulfadimethoxine, Turkeys: As an aid in the prevention Do not feed to turkeys producing 054771
56.75; ormetoprim, of coccidiosis caused by all eggs for food. Withdraw 5 days
34.05. Eimeria species known to be before slaughter.
pathogenic to turkeys, namely, E.
adenoeides, E. gallopavonis, and E.
meleagrimitis and bacterial
infection due to Pasteurella
multocida (fowl cholera).
(ii) [Reserved]
----------------------------------------------------------------------------------------------------------------
(3) Minor species--
----------------------------------------------------------------------------------------------------------------
Sulfadimethoxine and
ormetoprim amount Indications for use Limitations Sponsors
----------------------------------------------------------------------------------------------------------------
(i) Sulfadimethoxine, Ducks, including breeding ducks: As Feed as sole ration for 7 days. 054771
227; ormetoprim, 136.2 an aid in the control of bacterial Medication should be started at the
grams/ton of feed. infections due to Pasteurella first signs of infection. Do not
multocida (fowl cholera). feed to ducks producing eggs for
food. Withdraw 5 days before
slaughter.
(ii) Sulfadimethoxine, Ducks: As an aid in the control of Feed as a sole ration for 7 days.
454; ormetoprim, 272.4 bacterial infections due to Medication should be started at the
grams/ton of feed. Escherichia coli, Riemerella first signs of infection. Not for
anatipestifer, and severe challenge breeding ducks. Do not feed to
of Pasteurella multocida (fowl ducks producing eggs for food.
cholera). Withdraw 5 days before slaughter.
(iii) Sulfadimethoxine, Chukar partridges: For prevention of Feed continuously to young birds up 054771
113.5; ormetoprim, coccidiosis caused by Eimeria to 8 weeks of age as sole ration.
68.1 grams/ton of kofoidi and E. legionensis.
feed.
(iv) 50 milligrams (mg) Salmonids: For the control of Administer for 5 consecutive days. 015331
of active ingredients furunculosis in salmonids (trout Withdraw 42 days before release as
per kilogram of body and salmon) caused by Aeromonas stocker fish or slaughter.
weight per day. salmonicida strains susceptible to
sulfadimethoxine and ormetoprim
combination.
(v) 50 mg of active Catfish: For control of enteric Administer for 5 consecutive days. 015331
ingredients per septicemia of catfish caused by Withdraw 3 days before slaughter or
kilogram of body Edwardsiella ictaluri strains release as stocker fish.
weight per day. susceptible to sulfadimethoxine and
ormetoprim combination.
----------------------------------------------------------------------------------------------------------------
0
30. Revise Sec. 558.600 to read as follows:
Sec. 558.600 Thiabendazole.
(a) Specifications. Type A medicated articles containing 22, 44.1,
66.1, and 88.2 percent thiabendazole. The 66.1 percent Type A is solely
for the manufacture of cane molasses liquid Type B feed which is mixed
in dry feeds. The 88.2 percent Type A is used solely for the
manufacture of an aqueous slurry for adding to a Type C dry cattle
feed.
(b) Sponsor. See No. 050604 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.730 of this chapter.
(d) Special considerations. Do not use in Type B or Type C
medicated feed containing bentonite.
(e) Conditions of use. It is used in medicated feed as follows:
(1) Cattle--
----------------------------------------------------------------------------------------------------------------
Thiabendazole amount Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) To provide 3 grams Cattle: For control of infections of Use 3 grams per 100 lb of body 050604
per 100 lb of body gastrointestinal roundworms weight as a single dose. May repeat
weight. (Trichostrongylus spp., Haemonchus once in 2 to 3 weeks. Do not treat
spp., Ostertagia spp., Nematodirus animals within 3 days of slaughter.
spp., Oesophagostomum radiatum). Milk taken from treated animals
within 96 hours (8 milkings) after
the latest treatment must not be
used for food.
[[Page 12504]]
(ii) To provide 5 grams Cattle: For control of severe Administer 5 grams per 100 lb of 050604
per 100 lb of body infections of gastrointestinal body weight at a single dose or
weight. roundworms (Trichostrongylus spp., divided into 3 equal doses,
Haemonchus spp., Ostertagia spp., administered 1 dose each day, on
Nematodirus spp., Oesophagostomum succeeding days. May repeat once in
radiatum); control of infections of 2 to 3 weeks. Do not treat animals
Cooperia spp. within 3 days of slaughter. Milk
taken from treated animals within
96 hours (8 milkings) after the
latest treatment must not be used
for food.
----------------------------------------------------------------------------------------------------------------
(2) Swine--
----------------------------------------------------------------------------------------------------------------
Thiabendazole in grams/
ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 45.4 to 908 Swine: As an aid in the prevention Administer continuously feed 050604
of infections of large roundworms containing 0.05 to 0.1 percent
(genus Ascaris). thiabendazole per ton for 2 weeks
followed by feed containing 0.005
to 0.02 percent thiabendazole per
ton for 8 to 14 weeks. Do not treat
animals within 30 days of
slaughter.
(ii) [Reserved]
----------------------------------------------------------------------------------------------------------------
(3) Minor species--
----------------------------------------------------------------------------------------------------------------
Thiabendazole amount Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) To provide 2 grams per Sheep and goats: For control of Use 2 grams per 100 lb of body 050604
100 lb of body weight.. infections of gastrointestinal weight at a single dose. Do not
roundworms (Trichostrongylus treat animals within 30 days of
spp., Haemonchus spp., slaughter. Milk taken from
Ostertagia spp., Cooperia spp.; treated animals within 96 hours
Nematodirus spp., Bunostomum (8 milkings) after the latest
spp., Strongyloides spp., treatment must not be used for
Chabertia spp., and food.
Oesophagostomum spp.); also
active against ova and larvae
passed by sheep from 3 hours to
3 days after the feed is
consumed (good activity against
ova and larvae of T.
colubriformis and axei,
Ostertagia spp., Nematodirus
spp., Strongyloides spp.; less
effective against those of
Haemonchus contortus and
Oesophagostomum spp.).
(ii) To provide 3 grams per Goats: For control of severe Administer 3 grams per 100 lb of 050604
100 lb of body weight.. infections of gastrointestinal body weight at a single dose. Do
roundworms (Trichostrongylus not treat animals within 30 days
spp., Haemonchus spp., of slaughter. Milk taken from
Ostertagia spp., Cooperia spp., treated animals within 96 hours
Nematodirus spp., Bunostomum (8 milkings) after the latest
spp., Strongyloides spp., treatment must not be used for
Chabertia spp., and food.
Oesophagostomum spp.).
(iii) 454 grams/ton of feed.. Pheasants: For the treatment of Feed continuously for 2 weeks (14 050604
gapeworms (Syngamus trachea). days). Do not use treated
pheasants for food for 21 days
after last day of treatment.
Fertility, hatchability, and
other reproductive data are not
available on use in breeding
animals.
----------------------------------------------------------------------------------------------------------------
0
31. In Sec. 558.633, revise paragraph (e) to read as follows:
Sec. 558.633 Tylvalosin.
* * * * *
(e) Conditions of use.
----------------------------------------------------------------------------------------------------------------
Tylvalosin in grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 38.6..................... Swine: For the control of porcine Feed continuously as the sole 066916
proliferative enteropathy (PPE) ration for 14 consecutive days.
associated with Lawsonia
intracellularis infection in
groups of swine in buildings
experiencing an outbreak of PPE.
(ii) [Reserved]
----------------------------------------------------------------------------------------------------------------
Dated: March 26, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-06136 Filed 4-1-19; 8:45 am]
BILLING CODE 4164-01-P
