New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsors' Name and Addresses, 18114-18125 [2020-06688]
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Federal Register / Vol. 85, No. 63 / Wednesday, April 1, 2020 / Rules and Regulations
proposed rulemaking, providing an
opportunity for public comment.
will preempt in accordance with section
26(a) of the CPSA.
G. Regulatory Flexibility Act
K. Effective Date
The Regulatory Flexibility Act (RFA)
generally requires that agencies review
proposed and final rules for their
potential economic impact on small
entities, including small businesses, and
prepare regulatory flexibility analyses. 5
U.S.C. 603 and 604. The RFA applies to
any rule that is subject to notice and
comment procedures under section 553
of the APA. Id. As explained, the
Commission has determined that notice
and comment are not necessary for this
direct final rule. Thus, the RFA does not
apply. We also note the limited nature
of this document, which merely updates
the incorporation by reference to reflect
the mandatory CPSC standard that takes
effect under section 104 of the CPSIA.
Under the procedure set forth in
section 104(b)(4)(B) of the CPSIA, when
a voluntary standard organization
revises a standard upon which a
consumer product safety standard was
based, the revision becomes the CPSC
standard within 180 days of notification
to the Commission, unless the
Commission determines that the
revision does not improve the safety of
the product, or the Commission sets a
later date in the Federal Register. The
statutory effective date of 180 days falls
on July 4, 2020, a legal holiday and a
weekend. Therefore, the Commission is
setting the effective date of the rule on
the next business day, July, 6, 2020. As
discussed in the preceding section, this
is a direct final rule. Unless we receive
a significant adverse comment within 30
days, the rule will become effective on
July 6, 2020.
H. Paperwork Reduction Act
The standard for children’s folding
chairs and stools contains informationcollection requirements under the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501–3520). The revisions made
no changes to that section of the
standard. Thus, the revisions will have
no effect on the information-collection
requirements related to the standard.
I. Environmental Considerations
The Commission’s regulations
provide a categorical exclusion for the
Commission’s rules from any
requirement to prepare an
environmental assessment or an
environmental impact statement where
they ‘‘have little or no potential for
affecting the human environment.’’ 16
CFR 1021.5(c)(2). This rule falls within
the categorical exclusion, so no
environmental assessment or
environmental impact statement is
required.
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J. Preemption
Section 26(a) of the CPSA, 15 U.S.C.
2075(a), provides that where a consumer
product safety standard is in effect and
applies to a product, no state or political
subdivision of a state may either
establish or continue in effect a
requirement dealing with the same risk
of injury unless the state requirement is
identical to the federal standard. Section
26(c) of the CPSA also provides that
states or political subdivisions of states
may apply to the CPSC for an exemption
from this preemption under certain
circumstances. Section 104(b) of the
CPSIA deems rules issued there under
‘‘consumer product safety rules.’’
Therefore, once a rule issued under
section 104 of the CPSIA takes effect, it
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L. The Congressional Review Act
The Congressional Review Act (CRA;
5 U.S.C. 801–808) states that, before a
rule may take effect, the agency issuing
the rule must submit the rule, and
certain related information, to each
House of Congress and the Comptroller
General. 5 U.S.C. 801(a)(1). The
submission must indicate whether the
rule is a ‘‘major rule.’’ The CRA states
that the Office of Information and
Regulatory Affairs (OIRA) determines
whether a rule qualifies as a ‘‘major
rule.’’ Pursuant to the CRA, this rule
does not qualify as a ‘‘major rule,’’ as
defined in 5 U.S.C. 804(2). To comply
with the CRA, the Office of the General
Counsel will submit the required
information to each House of Congress
and the Comptroller General.
List of Subjects in 16 CFR Part 1232
Consumer protection, Imports,
Incorporation by reference, Infants and
children, Law enforcement, Safety,
Toys.
For the reasons stated above, the
Commission amends Title 16 CFR
chapter II as follows:
PART 1232—SAFETY STANDARD FOR
CHILDREN’S FOLDING CHAIRS AND
STOOLS
1. Revise the authority citation for part
1232 to read as follows:
■
Authority: Sec. 104, Pub. L. 110–314, 122
Stat. 3016 (15 U.S.C. 2056a); Sec 3, Pub. L.
112–28, 125 Stat. 273.
■
2. Revise § 1232.2 to read as follows:
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§ 1232.2 Requirements for children’s
folding chairs and stools.
Each children’s folding chair and
stool shall comply with all applicable
provisions of ASTM F2613–19,
Standard Consumer Safety
Specification for Children’s Chairs and
Stools, approved on November 1, 2019.
The Director of the Federal Register
approves this incorporation by reference
in accordance with 5 U.S.C. 552(a) and
1 CFR part 51. You may obtain a copy
of this ASTM standard from ASTM
International, 100 Barr Harbor Drive,
P.O. Box C700, West Conshohocken, PA
19428–2959 USA; phone: 610–832–
9585; www.astm.org. A read-only copy
of the standard is available for viewing
on the ASTM website at https://
www.astm.org/READINGLIBRARY/. You
may inspect a copy at the Division of
the Secretariat, U.S. Consumer Product
Safety Commission, Room 820, 4330
East-West Highway, Bethesda, MD
20814, telephone 301–504–7923, or at
the National Archives and Records
Administration (NARA). For
information on the availability of this
material at NARA, email fedreg.legal@
nara.gov, or go to: www.archives.gov/
federal-register/cfr/ibr-locations.html.
Alberta E. Mills,
Secretary, U.S. Consumer Product Safety
Commission.
[FR Doc. 2020–06334 Filed 3–31–20; 8:45 am]
BILLING CODE 6355–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 500, 510, 520, 522, 524,
526, 556, and 558
[Docket No. FDA–2019–N–0002]
New Animal Drugs; Approval of New
Animal Drug Applications; Withdrawal
of Approval of New Animal Drug
Applications; Change of Sponsor;
Change of Sponsors’ Name and
Addresses
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 2019. FDA is
informing the public of the availability
SUMMARY:
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Federal Register / Vol. 85, No. 63 / Wednesday, April 1, 2020 / Rules and Regulations
of summaries of the basis of approval
and of environmental review
documents, where applicable. The
animal drug regulations are also being
amended to make technical
amendments to improve the accuracy of
the regulations.
DATES:
This rule is effective March 30,
2020.
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
2019, 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
18115
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/
about-fda/center-veterinary-medicine/
cvm-foia-electronic-reading-room.
Marketing exclusivity and patent
information may be accessed in FDA’s
publication, Approved Animal Drug
Products Online (Green Book) at:
https://www.fda.gov/animal-veterinary/
products/approved-animal-drugproducts-green-book.
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TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING OCTOBER, NOVEMBER, AND
DECEMBER 2019
Approval date
File No.
Sponsor
Product name
Species
Effect of the action
October 11,
2019.
200–652
Huvepharma EOOD, 5th
Floor, 3A Nikolay
Haytov Str., 1113 Sophia, Bulgaria.
Monensin and
decoquinate Type B
and Type C medicated
feeds.
Cattle ..........
October 11,
2019.
200–653
Do ...................................
Monensin, tylosin phosphate, and
decoquinate Type B
and Type C medicated
feeds.
Cattle ..........
October 11,
2019.
200–654
Do ...................................
Monensin and tilmicosin
phosphate Type B and
Type C medicated
feeds.
Cattle ..........
October 11,
2019.
200–655
Do ...................................
Monensin and tilmicosin
phosphate Type B and
Type C medicated
feeds.
Cattle ..........
October 11,
2019.
200–656
Do ...................................
Monensin, tylosin phosphate, and
decoquinate Type B
and Type C medicated
feeds.
Cattle ..........
October 11,
2019.
200–658
Do ...................................
Monensin and
melengestrol acetate
Type C medicated
feeds.
Cattle ..........
October 11,
2019.
200–659
Do ...................................
Monensin, ractopamine
hydrochloride, and
melengestrol acetate
Type C medicated
feeds.
Cattle ..........
October 11,
2019.
200–660
Do ...................................
Monensin, tylosin phosphate, and
melengestrol acetate
Type C medicated
feeds.
Cattle ..........
Original approval for use of MONOVET 90
(monensin Type A medicated article) with
DECCOX (decoquinate) Type A medicated
articles in the manufacture of Type B and
Type C medicated feeds as a generic copy
of NADA 141–148
Original approval for use of MONOVET 90
(monensin Type A medicated article) with
TYLOVET (tylosin phosphate) and DECCOX
(decoquinate) Type A medicated articles in
the manufacture of Type B and Type C
medicated feeds as a generic copy of NADA
141–149
Original approval for use of MONOVET 90
(monensin Type A medicated article) with
TILMOVET (tilmicosin phosphate) Type A
medicated article in the manufacture of Type
B and Type C medicated feeds as a generic
copy of NADA 141–343
Original approval for use of MONOVET 90
(monensin Type A medicated article) with
PULMOTIL (tilmicosin phosphate) Type A
medicated article in the manufacture of Type
B and Type C medicated feeds as a generic
copy of NADA 141–343
Original approval for use of MONOVET 90
(monensin Type A medicated article) with
TYLAN (tylosin phosphate) and DECCOX
(decoquinate) Type A medicated articles in
the manufacture of Type B and Type C
medicated feeds as a generic copy of NADA
141–149
Original approval for use of MONOVET 90
(monensin Type A medicated article) with
MGA (melengestrol acetate Type A medicated article) in the manufacture of Type C
medicated feeds as a generic copy of NADA
125–476
Original approval for use of MONOVET 90
(monensin Type A medicated article) with
ACTOGAIN (ractopamine hydrochloride Type
A medicated article) and MGA (melengestrol
acetate Type A medicated articles) in the
manufacture of Type C medicated feeds as
a generic copy of NADA 141–234
Original approval for use of MONOVET 90
(monensin Type A medicated article) with
TYLOVET (tylosin phosphate) Type A medicated article, and MGA (melengestrol acetate Type A medicated article) in the manufacture of Type C medicated feeds as a generic copy of NADA 138–870
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Public
documents
FOI Summary.
FOI Summary.
FOI Summary.
FOI Summary.
FOI Summary.
FOI Summary.
FOI Summary.
FOI Summary.
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Federal Register / Vol. 85, No. 63 / Wednesday, April 1, 2020 / Rules and Regulations
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING OCTOBER, NOVEMBER, AND
DECEMBER 2019—Continued
Approval date
File No.
Sponsor
October 11,
2019.
200–661
Do ...................................
October 11,
2019.
200–662
October 29,
2019.
200–635
November 14,
2019.
141–518
November 20,
2019.
200–663
November 25,
2019.
141–513
December 9,
2019.
141–528
December 9,
2019.
200–546
December 19,
2019.
200–615
December 30,
2019.
111–636
December 30,
2019.
008–862
December 30,
2019.
013–076
Effect of the action
Monensin, tylosin phosphate, and
melengestrol acetate
Type C medicated
feeds.
Cattle ..........
FOI Summary.
Do ...................................
Monensin and
ractopamine hydrochloride Type B and
Type C medicated
feeds.
Cattle ..........
Mizner Bioscience LLC,
225 NE Mizner Blvd.,
Suite 760, Boca
Raton, FL 33432.
Intervet, Inc., 2 Giralda
Farms, Madison, NJ
07940.
Clomipramine Hydrochloride Tablets.
Dogs ...........
Original approval for use of MONOVET 90
(monensin Type A medicated article) with
TYLAN (tylosin phosphate) Type A medicated article, and MGA (melengestrol acetate Type A medicated article) in the manufacture of Type C medicated feeds as a generic copy of NADA 138–870
Original approval for use of MONOVET 90
(monensin Type A medicated article) with
ACTOGAIN (ractopamine hydrochloride Type
A medicated article) in the manufacture of
Type B and Type C medicated feeds as a
generic copy of NADA 141–225
Original approval as a generic copy of NADA
141–120
BRAVECTO PLUS
(fluralaner and
moxidectin topical solution) Solution.
Cats ............
FOI Summary.
Norbrook Laboratories
Ltd., Station Works,
County Down, Newry,
BT35 6JP, UK.
Kindred Biosciences,
Inc., 1555 Bayshore
Hwy., Suite 200, Burlingame, CA 94010.
Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140.
Bimeda Animal Health
Ltd., 1B The Herbert
Building, The Park,
Carrickmines, Dublin,
18, EI.
Vetoquinol USA, Inc.,
4250 N. Sylvania Ave.,
Fort Worth, TX 76137.
Zoetis Inc., 333 Portage
St., Kalamazoo, MI
49007.
Do ...................................
SELARID (selamectin)
Topical Solution.
Dogs and
cats.
Original approval for the prevention of heartworm disease and for the treatment of infections with intestinal roundworm and
hookworm; kills adult fleas and is indicated
for the treatment and prevention of flea infestations, and the treatment and control of
tick infestations for 2 months in cats and kittens
Original approval as a generic copy of NADA
141–152
ZIMETA (dipyrone injection).
Horses ........
Original approval for control of pyrexia in
horses
FOI Summary.
CREDELIO CAT
(lotilaner) Chewable
Tablets.
BIMAGARD 12.5%
(tiamulin hydrogen fumarate) Liquid Concentrate for Swine.
Cats ............
Original approval for killing adult fleas, and for
the treatment and prevention of flea infestations for 1 month in cats and kittens
Original approval as a generic copy of NADA
140–916
FOI Summary.
IMOXI (imidacloprid and
moxidectin) Topical
Solution for Dogs.
LINCOMIX (lincomycin
hydrochloride) Soluble
Powder.
TERRAMYCIN (oxytetracycline hydrochloride)
Soluble Powder.
TYLAN (tylosin tartrate)
Soluble.
Dogs ...........
Original approval as a generic copy of NADA
141–251
FOI Summary.
Honeybees
Supplemental approval of a tolerance for residues of lincomycin in honey
FOI Summary.
Honeybees
Supplemental approval of a tolerance for residues of oxytetracycline in honey
FOI Summary.
Honeybees
Supplemental approval of a tolerance for residues of tylosin in honey
FOI Summary.
Elanco US Inc. 2500 Innovation Way, Greenfield, IN 46140.
Norbrook Laboratories, Ltd., Station
Works, Newry BT35 6JP, Northern
Swine .........
Ireland, has requested that FDA
withdraw approval of the NADAs listed
in the following table because the
055–036
055–050
055–056
055–061
055–068
065–013
065–493
065–500
PRINCILLIN (ampicillin trihydrate) Capsules ...................................................................................................................
PRINCILLIN (ampicillin trihydrate) Soluble Powder .........................................................................................................
PRINCILLIN (ampicillin trihydrate) Bolus .........................................................................................................................
PRINCILLIN ‘‘125’’ For Oral Suspension .........................................................................................................................
BOVICLOX (cloxacillin benzathine) ..................................................................................................................................
Dihydrostreptomycin (dihydrostreptomycin sulfate) ..........................................................................................................
JETPEN (penicillin G benzathine and penicillin G procaine) Aqueous Suspension .......................................................
TANDEM PEN (penicillin G procaine) ..............................................................................................................................
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FOI Summary.
FOI Summary.
FOI Summary.
21 CFR
section
Product name
16:27 Mar 31, 2020
FOI Summary.
products are no longer manufactured or
marketed:
File No.
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documents
Species
II. Withdrawals of Approval
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Product name
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520.90c.
520.90e.
520.90f.
520.90d.
526.464b.
522.650.
522.1696a.
522.1696b.
Federal Register / Vol. 85, No. 63 / Wednesday, April 1, 2020 / Rules and Regulations
Elsewhere in this issue of the Federal
Register, FDA gave notice that approval
of NADAs 055–036, 055–050, 055–056,
055–061, 055–068, 065–013, 065–493,
and 065–500, and all supplements and
amendments thereto, is withdrawn,
effective March 30, 2020. As provided
in the regulatory text of this document,
the animal drug regulations are
amended to reflect these actions.
III. Changes of Sponsor
Cooperative Research Farms, Box 69,
Charlotteville, NY 12036, has informed
FDA that it has transferred ownership
of, and all rights and interest in,
approved NADA 119–253 for Cattle
Block M (monensin) a free-choice Type
C medicated cattle feed to Wildcat
Feeds, 215 NE Strait Ave., Topeka, KS
66616. Following this change of
sponsorship, Cooperative Research
Farms is no longer the sponsor of an
approved application.
Dechra, Ltd., Snaygill Industrial
Estate, Keighley Rd., Skipton, North
Yorkshire, BD23 2RW, United Kingdom,
has informed FDA that it has transferred
ownership of, and all rights and interest
in, approved ANADA 200–273 for
VETRO–GEN Veterinary Ophthalmic
Ointment to Putney, Inc., One
Monument Sq., suite 400, Portland, ME
04101.
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, approved NADA 141–
472 for virginiamycin and diclazuril
Type C medicated feed to Elanco US
Inc., 2500 Innovation Way, Greenfield,
IN 46140.
Accordingly, we are amending the
regulations to reflect these changes.
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IV. Change of Sponsors’ Name and
Addresses
Putney, Inc., One Monument Sq.,
suite 400, Portland, ME 04101, has
informed FDA that it has changed its
name and address to Dechra Veterinary
Products LLC, 7015 College Blvd., suite
525, Overland Park, KS 66211. In
addition, Virbac AH, Inc., 3200
Meacham Blvd., Ft. Worth, TX 76137
has informed FDA that it has changed
its address to PO Box 162059, Fort
Worth, TX 76161. Accordingly, we are
amending § 510.600(c) (21 CFR
510.600(c)) to reflect these changes.
V. Technical Amendments
FDA is making the following
amendments to improve the readability
and accuracy of the animal drug
regulations:
• The contact information in 21 CFR
500.1410, which provides for the
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incorporation by reference of the
residue assay method for n-methyl-2pyrrolidone, is being updated.
• We are removing entries for
‘‘Strategic Veterinary Pharmaceuticals,
Inc.’’ from the lists of sponsors of
approved applications in § 510.600(c)
and the drug labeler code for KC
Pharmacal from 21 CFR 520.260.
• The indications for use of
oxytetracycline soluble powder in
honey bees at 21 CFR 520.1660d are
amended to reflect current labeling.
• The single section for euthanasia
injectable solutions at 21 CFR 522.900 is
being removed and separate sections for
the active pharmaceutical ingredients
are added at 21 CFR 522.1697 and
522.2092.
• The section heading in 21 CFR
524.1742 for ‘‘N-(Mercaptomethyl)
phthalimide S-(O,O-dimethyl
phosphorodithioate) emulsifiable
liquid’’ is amended to read ‘‘Phosmet
emulsifiable liquid’’.
• The entries in 21 CFR parts 556 and
558 for coumaphos for which approval
of the last approved application was
withdrawn in 2018 (83 FR 48940,
September 28, 2018) are being removed.
• The entries in part 556 (21 CFR part
556) are being removed for tolerances of
residues of erythromycin in swine
tissues, of virginiamycin in turkey
tissues, and of new animal drugs for
which approval of their applications has
been withdrawn.
• Cross-references to related
approved uses of new animal drugs in
part 556 and to related tolerances for
drugs approved for use in foodproducing animals in 21 CFR parts 520,
522, 524, and 558 are being corrected.
• A redundant cross-reference for
related tolerances in 21 CFR 558.355 for
use of monensin in medicated feeds is
being removed and reserved.
• The acceptable daily intake of total
residues of ivermectin and tolerances
for residues of ivermectin in cattle liver
and muscle in § 556.344 are being
corrected.
• The acceptable daily intake of total
residues of tildipirosin in § 556.733 is
being corrected.
• The regulations in 21 CFR
520.2260b for sulfamethazine sustainedrelease boluses and in 21 CFR 522.1662a
for oxytetracycline hydrochloride
injection are being reformatted to
present the tolerance cross-reference in
a consistent location.
• Typographical errors are being
corrected wherever they have been
found.
VI. Legal Authority
This final rule is issued under section
512(i) of the Federal Food, Drug, and
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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 500
Animal drugs, Animal feeds, Cancer,
Incorporation by reference, Labeling,
Packaging and containers,
Polychlorinated biphenyls (PCBs).
21 CFR Parts 520, 522, 524, and 526
Animal drugs.
21 CFR Part 556
Animal drugs, Food.
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 500,
510, 520, 522, 524, 526, 556, and 558 are
amended as follows:
PART 500—GENERAL
1. The authority citation for part 500
continues to read as follows:
■
Authority: 21 U.S.C. 321, 331, 342, 343,
348, 351, 352, 353, 360b, 371, 379e.
2. In § 500.1410, revise paragraph (a)
to read as follows:
■
§ 500.1410
N-methyl-2-pyrrolidone.
(a) Standard for residues. No residues
of n-methyl-2-pyrrolidone may be found
in the uncooked edible tissues of cattle
as determined by a method entitled
‘‘Method of Analysis: N-methyl-2-
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pyrrolidone,’’ September 26, 2011,
Center for Veterinary Medicine, Food
and Drug Administration, which is
incorporated by reference with the
approval of the Director of the Federal
Register under 5 U.S.C. 522(a) and 1
CFR part 51. To obtain a copy of the
analytical method, please submit a
Freedom of Information request to:
https://www.accessdata.fda.gov/scripts/
foi/FOIRequest/requestinfo.cfm; or go
to: https://www.fda.gov/about-fda/
center-veterinary-medicine/cvm-foiaelectronic-reading-room. You may
inspect a copy at the office of the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852, 301–827–6860, between 9 a.m.
and 4 p.m., Monday through Friday or
at the National Archives and Records
Administration (NARA). For
information on the availability of this
material at NARA, email fedreg.legal@
nara.gov, or go to: www.archives.gov/
federal-register/cfr/ibr-locations.html.
*
*
*
*
*
PART 510—NEW ANIMAL DRUGS
3. The authority citation for part 510
continues to read as follows:
■
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
4. In § 510.600:
a. In the table in paragraph (c)(1):
i. Remove the entry for ‘‘Cooperative
Research Farms’’;
■ ii. Add entries for ‘‘Dechra Veterinary
Products LLC’’ and ‘‘Mizner Bioscience
LLC’’ in alphabetical order;
■ iii. Remove the entries for ‘‘Putney,
Inc.’’ and ‘‘Strategic Veterinary
Pharmaceuticals, Inc.’’;
■
■
■
iv. Revise the entry for ‘‘Virbac AH,
Inc.’’; and
■ v. Add an entry for ‘‘Wildcat Feeds’’
in alphabetical order; and
■ b. In the table in paragraph (c)(2):
■ i. Revise the entry for ‘‘026637’’;
■ ii. Remove the entry for ‘‘051267’’;
■ iii. Revise the entry for ‘‘051311’’;
■ iv. Remove the entry for ‘‘054628’’;
and
■ v. Add entries for ‘‘086039’’ and
‘‘086113’’ in numerical order.
The revisions and additions read as
follows:
■
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
*
*
(c) * * *
(1) * * *
*
*
Drug labeler
code
Firm name and address
*
*
*
*
*
*
Dechra Veterinary Products LLC, 7015 College Blvd., Suite 525, Overland Park, KS 66211 ...........................................................
*
*
*
*
*
*
*
Mizner Bioscience LLC, 225 NE Mizner Blvd., Suite 760, Boca Raton, FL 33432 ............................................................................
*
*
*
*
*
*
*
Virbac AH, Inc., PO Box 162059, Fort Worth, TX 76161 ...................................................................................................................
*
*
*
*
*
*
*
Wildcat Feeds, 215 NE Strait Ave., Topeka, KS 66616 .....................................................................................................................
*
*
*
*
*
*
*
026637
086039
051311
086113
*
(2) * * *
Drug labeler code
Firm name and address
*
*
026637 ............................................
*
*
*
*
Dechra Veterinary Products LLC, 7015 College Blvd., Suite 525, Overland Park, KS 66211.
*
*
*
051311 ............................................
*
*
*
Virbac AH, Inc., PO Box 162059, Fort Worth, TX 76161.
*
*
*
086039 ............................................
*
*
*
*
Mizner Bioscience LLC, 225 NE Mizner Blvd., Suite 760, Boca Raton, FL 33432.
*
*
*
086113 ............................................
*
*
*
Wildcat Feeds, 215 NE Strait Ave., Topeka, KS 66616.
*
*
*
*
*
*
*
jbell on DSKJLSW7X2PROD with RULES
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
5. The authority citation for part 520
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
*
§ 520.88c
*
§ § 520.90d and 520.90e
[Amended]
6. In § 520.88c(c), remove ‘‘§ 556.510’’
and in its place add ‘‘§ 556.38’’.
■
§ § 520.90b and 520.90c [Redesignated as
§§ 520.90a and 520.90b]
7. Redesignate §§ 520.90b and 520.90c
as §§ 520.90a and 520.90b.
■
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*
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■
[Removed]
8. Remove §§ 520.90d and 520.90e.
§ 520.90f [Redesignated as § 520.90c and
Amended]
9. Redesignate § 520.90f as § 520.90c
and in newly redesignated § 520.90c,
revise paragraphs (b) and (d) to read as
follows:
■
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§ 520.90c
Ampicillin boluses.
*
*
*
*
*
(b) Sponsor. See No. 054771 in
§ 510.600(c) of this chapter.
*
*
*
*
*
(d) Conditions of use in
nonruminating calves—(1) Amount. 5
milligrams per pound of body weight
twice daily not to exceed 4 days.
(2) Indications for use. Oral treatment
of bacterial enteritis (colibacillosis)
caused by E. coli.
(3) Limitations. Treated calves must
not be slaughtered for food during
treatment and for 7 days after the last
treatment. Federal law restricts this drug
to use by or on the order of a licensed
veterinarian.
§ 520.260
[Amended]
10. In § 520.260(b)(2), remove ‘‘No.
038782 for 884 or 1,768 milligram or
4.42 gram capsules;’’.
■
§ 520.455
[Amended]
11. In § 520.455(b), remove ‘‘No.
058198’’ and in its place add ‘‘Nos.
058198 and 086039’’.
■
§ 520.1660d
Oxytetracycline powder.
*
*
*
*
*
(d) * * *
(2) * * *
(ii) Indications for use. For control of
American foulbrood caused by
Paenibacillus larvae.
*
*
*
*
*
§ § 520.1696b, 520.1696c, and 520.1696d
[Redesignated as §§ 520.1696a, 520.1696b,
and 520.1696c]
12. Redesignate §§ 520.903d and
520.903e as §§ 520.903c and 520.903d.
16. Redesignate §§ 520.1696b,
520.1696c, and 520.1696d as
§§ 520.1696a, 520.1696b, and
520.1696c.
§ 520.1263c
§ 520.2218
§ § 520.903d and 520.903e [Redesignated
as §§ 520.903c and 520.903d]
■
[Redesignated as § 520.1263b]
■
■
§ 520.1286
§ 520.2260b
Lotilaner.
(a) Specifications. Each chewable
tablet contains:
(1) For use in dogs: 56.25, 112.5, 225,
450, or 900 milligrams (mg) lotilaner; or
(2) For use in cats: 12 or 48 mg
lotilaner.
(b) Sponsor. See No. 058198 in
§ 510.600(c) of this chapter.
(c) Conditions of use—(1) Dogs—(i)
Amount. Administer orally once a
month at the recommended minimum
dosage of 9 mg/lb (20 mg/kg).
(ii) Indications for use. Kills adult
fleas, and for the treatment and
prevention of flea infestations
(Ctenocephalides felis), and the
treatment and control of tick
infestations (Amblyomma americanum
(lone star tick), Dermacentor variabilis
(American dog tick), Ixodes scapularis
(black-legged tick), and Rhipicephalus
sanguineus (brown dog tick)) for 1
month in dogs and puppies 8 weeks of
age or older and weighing 4.4 pounds or
greater.
(iii) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
VerDate Sep<11>2014
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Jkt 250001
[Amended]
17. In § 520.2218(c), remove
‘‘§§ 556.670 and 556.685’’ and in its
place add ‘‘§§ 556.660, 556.670, and
556.685’’.
13. Redesignate § 520.1263c as
§ 520.1263b.
■ 14. Revise § 520.1286 to read as
follows:
■
jbell on DSKJLSW7X2PROD with RULES
(2) Cats—(i) Amount. Administer
orally once a month at the
recommended minimum dosage of 2.7
mg/lb (6 mg/kg).
(ii) Indications for use. Kills adult
fleas, and for the treatment and
prevention of flea infestations
(Ctenocephalides felis) for 1 month in
cats and kittens 8 weeks of age or older
and weighing 2 pounds or greater.
(iii) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
■ 15. In § 520.1660d, revise paragraph
(d)(2)(ii) to read as follows:
[Amended]
18. In § 520.2260b, redesignate
paragraphs (a) through (f) and (g) as
paragraphs (b) through (g) and (a),
respectively.
■ 19. In § 520.2455, add paragraph (b)(4)
to read as follows:
■
§ 520.2455
Tiamulin.
*
*
*
*
*
(b) * * *
(4) No. 061133 for product described
in paragraph (a)(2) of this section.
*
*
*
*
*
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
20. The authority citation for part 522
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
21. In § 522.650, revise paragraph (b)
to read as follows:
■
§ 522.650 Dihydrostreptomycin sulfate
injection.
*
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*
*
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*
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*
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18119
(b) Sponsor. See No. 054771 in
§ 510.600(c) of this chapter.
*
*
*
*
*
■ 22. Add § 522.728 to read as follows:
§ 522.728
Dipyrone.
(a) Specifications. Each milliliter of
solution contains 500 milligrams (mg)
dipyrone.
(b) Sponsor. See No. 086078 in
§ 510.600(c) of this chapter.
(c) Conditions of use in horses—(1)
Amount. Administer 30 mg per
kilogram of body weight (13.6 mg per
pound) by intravenous injection, once
or twice daily at a 12-hour interval for
up to 3 days.
(2) Indications for use. For control of
pyrexia in horses.
(3) Limitations. Do not use in horses
intended for human consumption. Do
not use in any food-producing animals,
including lactating dairy animals.
Federal law restricts this drug to use by
or on the order of a licensed
veterinarian.
§ 522.900
■
[Removed]
23. Remove § 522.900.
§ 522.1367
[Amended]
24. In § 522.1367(c)(1)(i), remove
‘‘§ 520.1350(c)’’ and in its place add
‘‘§ 520.1367(c)’’.
■
§ 522.1662a
[Amended]
25. In § 522.1662a:
a. Redesignate paragraphs (a) through
(e) as paragraphs (b) through (f);
■ b. Further redesignate newly
redesignated paragraphs (c)(3)(i)(a)
through (c) and (c)(3)(ii)(a) through (c)
as paragraphs (c)(3)(i)(A) through (C)
and (c)(3)(ii)(A) through (C),
respectively;
■ c. Further redesignate newly
redesignated paragraphs (e)(3)(i)(a)
through (c) as paragraphs (e)(3)(i)(A)
through (C);
■ d. Further redesignate newly
redesignated paragraphs (e)(3)(ii)(a) and
(b) and paragraphs (e)(3)(ii)(A) and (B);
■ e. Further redesignate newly
redesignated paragraphs (e)(3)(iii)(a)
through (c) as paragraphs (e)(3)(iii)(A)
through (C);
■ f. In newly redesignated paragraph
(e)(3)(iii)(C), remove ‘‘paragraph
(d)(3)(iii)(c) of this section’’ and in its
place add ‘‘this paragraph (e)(3)(iii)(C)’’;
■ g. Further redesignate newly
redesignated paragraphs (f)(3)(i)(a)
through (c) and (f)(3)(ii)(a) through (c) as
paragraphs (f)(3)(i)(A) through (C) and
(f)(3)(ii)(A) through (C), respectively;
■ h. Redesignate paragraphs (g)(3)(i)(a)
through (c) and (g)(3)(ii)(a) through (c)
as paragraphs (g)(3)(i)(A) through (C)
■
■
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and (g)(3)(ii)(A) through (C),
respectively; and
■ i. Redesignate paragraph (k) as
paragraph (j) and paragraph (l) as
paragraph (a).
§ 522.1696a
[Amended]
26. In § 522.1696a(b)(1) and (2) and
(d)(2)(iii), remove ‘‘, 055529,’’.
■
§ 522.1696b
[Amended]
27. In § 522.1696b:
a. In paragraph (b)(1), remove
‘‘016592, 054771, and 055529’’ and in
its place add ‘‘016592 and 054771’’;
■ b. Remove paragraphs (d)(2)(i)(A) and
(B); and
■ c. In paragraph (d)(2)(iii)(B), remove
‘‘Nos. 000859 and 055529’’ and in its
place add ‘‘No. 016592’’.
■ 28. Add § 522.1697 to read as follows:
■
■
§ 522.1697
jbell on DSKJLSW7X2PROD with RULES
Secobarbital and dibucaine.
(a) Specifications. Each milliliter (mL)
of solution contains 400 milligram (mg)
secobarbital sodium and 25 mg
dibucaine hydrochloride.
(b) Sponsor. See No. 054771 in
§ 510.600(c) of this chapter.
(c) Special considerations. Product
labeling shall bear the following
warning statements:
‘‘ENVIRONMENTAL HAZARD: This
product is toxic to wildlife. Birds and
mammals feeding on treated animals
may be killed. Euthanized animals must
be properly disposed of by deep burial,
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PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
30. The authority citation for part 524
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
Pentobarbital and phenytoin.
(a) Specifications. Each milliliter (mL)
of solution contains 390 milligrams (mg)
pentobarbital sodium and 50 mg
phenytoin sodium.
(b) Sponsors. See Nos. 000061,
051311, and 054925 in § 510.600(c) of
this chapter.
(c) Special considerations. Product
labeling shall bear the following
warning statements:
‘‘ENVIRONMENTAL HAZARD: This
product is toxic to wildlife. Birds and
mammals feeding on treated animals
may be killed. Euthanized animals must
be properly disposed of by deep burial,
incineration, or other method in
compliance with State and local laws, to
prevent consumption of carcass material
by scavenging wildlife.’’
(d) Conditions of use in dogs—(1)
Amount. Administer 1 mL per 10
pounds of body weight as a single, bolus
intravenous or intracardiac injection.
(2) Indications for use. For humane,
painless, and rapid euthanasia.
(3) Limitations. Do not use in animals
intended for food. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
■ 29. Add § 522.2092 to read as follows:
§ 522.2092
incineration, or other method in
compliance with State and local laws, to
prevent consumption of carcass material
by scavenging wildlife.’’
(d) Conditions of use in dogs—(1)
Amount. Administer 1 mL per 10
pounds of body weight as a single, bolus
intravenous injection.
(2) Indications for use. For humane,
painless, and rapid euthanasia.
(3) Limitations. Do not use in animals
intended for food. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
31. Add an undesignated center
heading before § 524.981 to read as
follows:
■
Fluocinolone Topical and Otic Dosage
Forms
■
32. Add § 524.1001 to read as follows:
§ 524.1001
Furalaner and moxidectin.
(a) Specifications. Each milliliter of
solution contains 280 milligram (mg)
furalaner and 14 mg moxidectin. Each
individually packaged tube contains
either 112.5 mg furalaner and 5.6 mg
moxidectin; 250 mg furalaner and 12.5
mg moxidectin; or 500 mg furalaner and
25 mg moxidectin.
(b) Sponsor. See No. 000061 in
§ 510.600(c) of this chapter.
(c) Conditions of use—(1) Amount.
Administer topically as a single dose
every 2 months to provide a minimum
dose of 18.2 mg/lb (40 mg/kg) fluralaner
and 0.9 mg/lb (2 mg/kg) moxidectin.
(2) Indications for use. For the
prevention of heartworm disease caused
by Dirofilaria immitis and for the
treatment of infections with intestinal
roundworm (Toxocara cati, 4th stage
larvae, immature adults, and adults) and
hookworm (Ancylostoma tubaeforme,
4th stage larvae, immature adults, and
adults); kills adult fleas and is indicated
for the treatment and prevention of flea
infestations (Ctenocephalides felis) and
the treatment and control of tick
infestations (Ixodes scapularis (blacklegged tick) and Dermacentor variabilis
(American dog tick)) for 2 months in
cats and kittens 6 months of age and
older and weighing 2.6 lb or greater.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
■ 33. In § 524.1146, revise paragraphs
(a) and (b) to read as follows:
PO 00000
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§ 524.1146
Imidacloprid and moxidectin.
(a) Specifications. Each milliliter of
solution contains:
(1) 100 milligrams (mg) imidacloprid
and 25 mg moxidectin; or
(2) 100 mg imidacloprid and 10 mg
moxidectin.
(b) Sponsors. See sponsor numbers in
§ 510.600(c) of this chapter as follows:
(1) Nos. 000859 and 017030 for use of
product described in paragraph (a)(1) of
this section as in paragraph (d)(1) of this
section.
(2) No. 000859 for use of product
described in paragraph (a)(2) of this
section as in paragraphs (d)(2) and (3) of
this section.
*
*
*
*
*
■ 34. In § 524.1742:
■ a. Revise the section heading;
■ b. Redesignate paragraphs (c) and (d)
as paragraphs (d) and (c), respectively;
■ c. Add a heading for the table in
newly redesignated paragraph (d)(1)
introductory text; and
■ d. Further redesignate newly
redesignated paragraphs (d)(1)(i)(a) and
(b) as paragraphs (d)(1)(i)(A) and (B).
The revision and addition reads as
follows:
§ 524.1742
Phosmet emulsifiable liquid.
*
*
*
*
*
(d) * * *
(1) * * *
Table 1 to Paragraph (d)(1)
*
*
*
*
*
§ 524.2098
[Amended]
35. In § 524.2098(b), remove ‘‘054771’’
and in its place add ‘‘Nos. 054771 and
055529’’.
■
PART 526—INTRAMAMMARY DOSAGE
FORM NEW ANIMAL DRUGS
36. The authority citation for part 526
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
§ 526.464b
■
[Removed]
37. Remove § 526.464b.
§ 526.464c
[Redesignated as § 526.464b]
38. Redesignate § 526.464c as
§ 526.464b.
■
PART 556—TOLERANCES FOR
RESIDUES OF NEW ANIMAL DRUGS
IN FOOD
39. The authority citation for part 556
continues to read as follows:
■
Authority: 21 U.S.C. 342, 360b, 371.
§ 556.40
[Amended]
40. In § 556.40(c), remove ‘‘§§ 520.90e,
520.90f, 522.90a, and 522.90b’’ and in
■
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*
§ 556.165
§ 556.510
[Amended]
41. In § 556.165(c), remove
‘‘§§ 526.464a, 526.464b, and 526.464c’’
and in its place add ‘‘§§ 526.464a and
526.464b’’.
■
§ 556.168
■
■
■
[Removed]
[Amended]
[Amended]
44. In § 556.304(c), remove
‘‘§§ 522.1077, 522.1079, and 522.1081’’
and in its place add ‘‘§§ 522.1079 and
522.1081’’.
[Amended]
45. In § 556.344:
a. In paragraph (a), remove ‘‘1 mg/kg’’
and in its place add ‘‘5 mg/kg’’;
■ b. In paragraph (b)(2)(i), remove ‘‘100
ppb’’ and in its place add ‘‘1.6 ppm’’;
and
■ c. In paragraph (b)(2)(ii), remove ‘‘10
ppb’’ and in its place add ‘‘650 ppb’’.
■ 46. In § 556.360, add paragraph (b)(3)
and revise paragraph (c) to read as
follows:
■
■
§ 556.360
*
*
*
*
(b) * * *
(3) Honey. 750 ppb.
(c) Related conditions of use. See
§§ 520.1263b, 522.1260, and 558.325 of
this chapter.
■ 47. In § 556.500, add paragraph (b)(6)
to read as follows:
*
Oxytetracycline.
*
*
(b) * * *
VerDate Sep<11>2014
*
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PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
56. The authority citation for part 558
continues to read as follows:
■
Authority: 21 U.S.C. 354, 360b, 360ccc,
360ccc–1, 371.
57. In § 558.55, add paragraph (d)(5)
to read as follows:
■
§ 558.55
Amprolium.
51. In § 556.685(c), remove
‘‘§§ 520.2325a, 520.2325b, and 558.586’’
and in its place add ‘‘§§ 520.2218,
520.2325a, 520.2325b, and 558.586’’.
§ 556.733
§ 558.76
§ 556.685
[Amended]
■
[Amended]
52. In § 556.733(a), remove ‘‘10 mg/kg’’
and in its place add ‘‘50 mg/kg’’.
■ 53. In § 556.746, add paragraph (b)(4)
to read as follows:
■
Tylosin.
*
*
*
*
*
(b) * * *
(4) Honey. 500 ppb.
*
*
*
*
*
§ 556.750
PO 00000
Zilpaterol.
*
Frm 00017
*
Fmt 4700
*
Sfmt 4700
Bacitracin methylenedisalicylate.
*
*
*
*
*
(e) * * *
(2) * * *
(vii) Fenbendazole as in § 558.258.
(viii) Halofuginone as in § 558.265.
*
*
*
*
*
(xi) Monensin as in § 558.355.
*
*
*
*
*
■
54. In § 556.750, remove paragraph
(b)(4).
■ 55. In § 556.765, revise paragraph
(b)(1) to read as follows:
*
*
§ 558.185
[Amended]
■
*
16:27 Mar 31, 2020
(b) * * *
(1) Cattle. (i) Liver (target tissue): 12
ppb.
(ii) Muscle: 10 ppb.
*
*
*
*
*
*
*
*
*
(d) * * *
(5) Permitted combinations.
Amprolium may also be used in
combination with:
(i) Virginiamycin as in § 558.635.
(ii) [Reserved]
■ 58. In § 558.76, revise paragraphs
(e)(2)(vii), (viii), and (xi) to read as
follows:
§ 556.765
*
[Amended]
50. In § 556.670, in paragraph (c),
remove ‘‘§§ 520.2260a, 520.2260b,
520.2260c, 520.2261a, 520.2261b,
522.2260, 558.140, and 558.630’’ and in
its place add ‘‘§§ 520.2218, 520.2260a,
520.2260b, 520.2260c, 520.2261a,
520.2261b, 522.2260, 558.140, and
558.630’’.
§ 556.746
Lincomycin.
*
§ 556.500
[Amended]
■
■
§ 556.344
§ 556.660
§ 556.670
43. In § 556.230, remove paragraph
(b)(3).
■
§ 556.304
[Amended]
48. In § 556.510(c), remove
‘‘520.1696b’’ and in its place add
‘‘520.1696a’’.
49. In § 556.660(c), remove
‘‘§ 558.582’’ and in its place add
‘‘§§ 520.2218 and 558.582’’.
42. Remove § 556.168.
§ 556.230
jbell on DSKJLSW7X2PROD with RULES
(6) Honey. 750 ppb.
*
*
*
*
its place add ‘‘§§ 520.90c, 522.90a, and
522.90b’’.
18121
[Removed]
59. Remove § 558.185.
60. In § 558.195, revise paragraph
(e)(2)(ii) to read as follows:
■
§ 558.195
*
Decoquinate.
*
*
(e) * * *
(2) * * *
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Decoquinate in
grams/ton
Combination in
grams/ton
Indications for use
Limitations
(ii) 12.9 to 90.8 ..
*
*
Monensin, 5 to 30 .......
*
*
Cattle fed in confinement for slaughter: For
prevention of coccidiosis caused by Eimeria
bovis and E. zuernii; and for improved feed
efficiency.
*
*
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. 016592 or 058198 in § 510.600(c) of this
chapter.
*
*
*
*
§ 558.342
■
*
*
*
*
*
61. In § 558.342, revise paragraph
(e)(1)(iv) to read as follows:
*
*
Melengestrol.
*
*
(e) * * *
*
(1) * * *
*
Combination in
grams/ton
Indications for use
Limitations
(iv) 0.25 to 0.5 ...
*
*
Monensin, 10 to 40 .....
*
*
Heifers fed in confinement for slaughter: For
increased rate of weight gain, improved feed
efficiency, and suppression of estrus (heat);
and for the prevention and control of coccidiosis due to Eimeria bovis and E. zuernii..
*
*
Add at the rate of 0.5 to 2 lb/head/day a medicated feed (liquid or dry) containing 0.125 to
1 mg melengestrol acetate/lb to a feed containing 10 to 40 g of monensin per ton to
provide 0.25 to 0.5 mg melengestrol acetate/
head/day and 0.14 to 0.42 mg monensin/lb
body weight, depending on severity of coccidiosis challenge, up to 480 mg monensin/
head/day. See § 558.355(d). Monensin as
provided by No. 016592 or 058198 in
§ 510.600(c) of this chapter.
*
*
*
§ 558.355
■
*
*
*
*
*
62. In § 558.355, remove and reserve
paragraph (e) and revise paragraph
(f)(4)(iv) to read as follows:
Monensin amount
*
(iv) 400 mg per pound of
block (0.088%).
*
*
*
*
*
*
Limitations
*
*
Pasture cattle (slaughter, stocker, feeder, and dairy and beef replacement
heifers): For increased rate of weight
gain.
*
*
*
Provide 50 to 200 mg of monensin (2 to 8 ounces of
block) per head per day, at least 1 block per 5
head of cattle. Feed blocks continuously. Do not
feed salt or mineral supplements in addition to the
blocks. Ingestion by cattle of monensin at levels of
600 mg per head per day and higher has been
fatal. The effectiveness of this block in cull cows
and bulls has not been established. See paragraph (d)(10)(i) of this section.
*
*
§ 558.500
■
*
*
*
*
*
63. In § 558.500, revise paragraph
(e)(2) to read as follows:
16:27 Mar 31, 2020
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058198
Monensin.
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*
(f) * * *
(4) * * *
*
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*
*
016592, 054771.
*
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head/day
*
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Ractopamine in
grams/ton
Combination in
grams/ton
Indications for use
Limitations
(i) 8.2 to 24.6 .....
.....................................
Feed continuously as sole ration during the
last 28 to 42 days on feed.
054771
058198
(ii) 8.2 to 24.6 .....
Monensin 10 to 40 to
provide 0.14 to 0.42
mg monensin/lb of
body weight, depending on severity
of coccidiosis challenge, up to 480
mg/head/day..
.....................................
Cattle fed in confinement for
slaughter: For increased rate of
weight gain and improved feed
efficiency during the last 28 to
42 days on feed.
Cattle fed in confinement for
slaughter: For increased rate of
weight gain and improved feed
efficiency during the last 28 to
42 days on feed, and for prevention and control of coccidiosis due to Eimeria bovis and
E. zuernii.
Cattle fed in confinement for
slaughter: For increased rate of
weight gain, improved feed efficiency, and increased carcass
leanness during the last 28 to
42 days on feed.
Cattle fed in confinement for
slaughter: For increased rate of
weight gain, improved feed efficiency, and increased carcass
leanness during the last 28 to
42 days on feed, and for prevention and control of coccidiosis due to Eimeria bovis and
E. zuernii.
Heifers fed in confinement for
slaughter: For increased rate of
weight gain, improved feed efficiency, and increased carcass
leanness during the last 28 to
42 days on feed, and for prevention and control of coccidiosis due to Eimeria bovis and
E. zuernii, and for suppression
of estrus (heat).
Feed continuously as sole ration during the
last 28 to 42 days on feed. See paragraph
§ 558.355(d). Ractopamine as provided by
No. 058198 or 054771; monensin as provided by No. 016592 or 058198 in
§ 510.600(c) of this chapter.
016592
054771
058198
Feed continuously as sole ration during the
last 28 to 42 days on feed. Not for animals
intended for breeding.
054771
058198
Feed continuously as sole ration during the
last 28 to 42 days on feed. Not for animals
intended for breeding. See paragraph
§ 558.355(d). Ractopamine as provided by
No. 058198 or 054771; monensin as provided by No. 016592 or 058198 in
§ 510.600(c) of this chapter.
016592
054771
058198
Feed continuously as sole ration during the
last 28 to 42 days on feed. Not for animals
intended for breeding. See §§ 558.342(d)
and 558.355(d). Melengestrol acetate as
provided by No. 058198 or 054771;
monensin as provided by No. 016592 or
058198 in § 510.600(c) of this chapter.
016592
054771
058198
Cattle fed in confinement for
slaughter: For increased rate of
weight gain and improved feed
efficiency during the last 28 to
42 days on feed.
Cattle fed in confinement for
slaughter: For increased rate of
weight gain and improved feed
efficiency during the last 28 to
42 days on feed, and for prevention and control of coccidiosis due to Eimeria bovis and
E. zuernii.
Top dress in a minimum of 1 lb of medicated
feed.
054771
058198
Top dress ractopamine in a minimum of 1 lb
of medicated feed during the last 28 to 42
days on feed. Not for animals intended for
breeding. See § 558.355(d). Ractopamine
as provided by No. 058198 or 054771;
monensin as provided by No. 016592 or
058198 in § 510.600(c) of this chapter.
016592
054771
058198
(iii) 9.8 to 24.6 ....
(iv) 9.8 to 24.6 ....
Monensin 10 to 40 to
provide 0.14 to 0.42
mg monensin/lb of
body weight, depending on severity
of coccidiosis challenge, up to 480
mg/head/day.
(v) 9.8 to 24.6 ....
Monensin 10 to 40 to
provide 0.14 to 0.42
mg monensin/lb of
body weight, depending on severity
of coccidiosis challenge, up to 480
mg/head/day, plus
melengestrol acetate to provide 0.25
to 0.5 mg/head/day.
.....................................
(vi) Not to exceed
800; to provide
70 to 400 mg/
head/day.
(vii) Not to exceed 800; to
provide 70 to
400 mg/head/
day.
Monensin 10 to 40 to
provide 0.14 to 0.42
mg monensin/lb of
body weight, depending on severity
of coccidiosis challenge, up to 480
mg/head/day.
*
§ 558.618
■
*
*
*
*
*
64. In § 558.618, revise paragraphs
(e)(2)(ii) and (iii) to read as follows:
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Tilmicosin
phosphate in
grams/ton
Federal Register / Vol. 85, No. 63 / Wednesday, April 1, 2020 / Rules and Regulations
Combination in
grams/ton
Indications for use
Limitations
*
(ii) 568 to 757
*
Monensin, 5 to 40 .......
*
*
Cattle fed in confinement for
slaughter: For improved feed efficiency; and for the control of
bovine
respiratory
disease
(BRD)
associated
with
Mannheimia
haemolytica,
Pasteurella
multocida,
and
Histophilus somni in groups of
cattle fed in confinement for
slaughter, where active BRD has
been diagnosed in at least 10
percent of the animals in the
group.
(iii) 568 to 757
Monensin, 10 to 40 .....
Cattle fed in confinement for
slaughter: For prevention and
control of coccidiosis due to
Eimeria bovis and E. zuernii;
and for the control of BRD associated
with
Mannheimia
haemolytica,
Pasteurella
multocida, and Histophilus somni
in groups of cattle fed in confinement for slaughter, where active
BRD has been diagnosed in at
least 10 percent of the animals
in the group.
*
*
Feed continuously for 14 days to provide 12.5
mg tilmicosin/kg of bodyweight/day. The
safety of tilmicosin has not been established
in cattle intended for breeding purposes.
This drug product is not approved for use in
female dairy cattle 20 months of age or
older. Use in these cattle may cause drug
residues in milk. This drug product is not
approved for use in calves intended to be
processed for veal. A withdrawal period has
not been established in pre-ruminating
calves. Cattle intended for human consumption must not be slaughtered within 28 days
of the last treatment with this drug product.
See § 558.355(d). Tilmicosin as provided by
No. 016592 or 058198; monensin as provided by No. 016592 or 058198 in
§ 510.600(c) of this chapter.
Feed continuously for 14 days to provide 12.5
mg tilmicosin/kg of bodyweight/day. The
safety of tilmicosin has not been established
in cattle intended for breeding purposes.
This drug product is not approved for use in
female dairy cattle 20 months of age or
older. Use in these cattle may cause drug
residues in milk. This drug product is not
approved for use in calves intended to be
processed for veal. A withdrawal period has
not been established in pre-ruminating
calves. Cattle intended for human consumption must not be slaughtered within 28 days
of the last treatment with this drug product.
See § 558.355(d). Tilmicosin as provided by
No. 016592 or 058198; monensin as provided by No. 016592 or 058198 in
§ 510.600(c) of this chapter.
§ 558.625
65. In § 558.625, revise paragraphs
(e)(2)(vi) and (ix) to read as follows:
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*
*
Tylosin.
*
*
Combination in
grams/ton
Indications for use
Limitations
*
(vi) 8 to 10 ..
*
Monensin, 5 to 30 plus
decoquinate, 13.6 to
22.7.
*
*
Cattle fed in confinement for
slaughter: For reduction of incidence of liver abscesses caused
by Fusobacterium necrophorum
and Arcanobacterium pyogenes;
for the prevention of coccidiosis
caused by Eimeria bovis and E.
zuernii; and for improved feed efficiency.
*
*
Feed continuously as the sole ration to provide
22.7 mg of decoquinate per 100 lb body
weight per day, 50 to 360 mg of monensin/
head/day, and 60 to 90 mg of tylosin/head/
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. A withdrawal time has not been
established for pre-ruminating calves. Do not
use in calves to be processed for veal.
Tylosin as provided by No. 016592 or
058198; monensin as provided by No.
016592 or 058198; decoquinate as provided
by No. 058198 in § 510.600(c) of this chapter. See §§ 558.311(d) and 558.355(d).
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*
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Tylosin
grams/ton
Combination in
grams/ton
*
(ix) 8 to 10 ..
*
Monensin, 10 to 40
plus melengestrol,
0.25 to 2.0.
*
Indications for use
Limitations
*
*
Heifers fed in confinement for
slaughter: For reduction of incidence of liver abscesses caused
by Fusobacterium necrophorum
and
Arcanobacterium
(Actinomyces) pyogenes; for prevention and control of coccidiosis
caused by Eimeria bovis and E.
zuernii; and for increased rate of
weight gain, improved feed efficiency, and suppression of estrus
(heat).
*
*
Feed continuously as sole ration to heifers at a
rate of 0.5 to 2 pounds per head per day to
provide
0.25
to
0.5
mg/head/day
melengestrol acetate and 0.14 to 0.42 mg
monensin/lb body weight per day, depending
on the severity of the coccidiosis challenge,
up to 480 mg/head/day and 60 to 90 mg/
head/day tylosin. The melengestrol acetate
portion of this Type C medicated feed must
be mixed into the complete feed containing
10 to 40 g/ton monensin and 8 to 10 g/ton
tylosin at feeding into the amount of complete
feed consumed by an animal per day. A withdrawal time has not been established for preruminating calves. Do not use in calves to be
processed for veal. Tylosin provided by No.
016592 or 058198; monensin as provided by
No. 016592 or 058198; melengestrol provided by No. 054771 or 058198 in
§ 510.600(c)
of
this
chapter.
See
§§ 558.342(d) and 558.355(d).
*
*
§ 558.635
66. In § 558.635, revise paragraph
(e)(1)(iv) to read as follows:
■
*
*
*
Virginiamycin.
*
*
*
Combination in
grams/ton
Indications for use
Limitations
*
(iv) 20 .................
*
Diclazuril, 0.91 ...........
*
*
Broiler chickens: For prevention of
necrotic enteritis caused by
Clostridium perfringens susceptible to virginiamycin; and for
the prevention of coccidiosis
caused by Eimeria tenella, E.
necatrix, E. acervulina, E.
brunetti, E. mitis (mivati), and
E. maxima. Because diclazuril
is effective against E. maxima
late in its life cycle, subclinical
intestinal lesions may be
present for a short time after infection. Diclazuril was shown in
studies to reduce lesions
scores and improve performance and health of birds challenged with E. maxima.
*
*
Feed continuously as the sole ration. Do not
use in hens producing eggs for human
food. Diclazuril as provided by No. 058198
in § 510.600(c) of this chapter.
*
*
*
*
*
*
*
Dated: March 25, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
*
*
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
21 CFR Parts 520, 522, and 526
BILLING CODE 4164–01–P
[Docket No. FDA–2019–N–0002]
New Animal Drugs; Withdrawal of
Approval of New Animal Drug
Applications
AGENCY:
Food and Drug Administration,
HHS.
16:27 Mar 31, 2020
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*
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*
ACTION:
*
058198
*
Notification of withdrawal.
The Food and Drug
Administration (FDA) is withdrawing
approval of eight new animal drug
applications (NADAs) at the sponsor’s
request because the products are no
longer manufactured or marketed.
SUMMARY:
Food and Drug Administration
[FR Doc. 2020–06688 Filed 3–30–20; 8:45 am]
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*
Virginiamycin
grams/ton
*
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Withdrawal of approval is
effective March 30, 2020
DATES:
FOR FURTHER INFORMATION CONTACT:
Sujaya Dessai, Center for Veterinary
Medicine (HFV–212), Food and Drug
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]]>Agencies
[Federal Register Volume 85, Number 63 (Wednesday, April 1, 2020)]
[Rules and Regulations]
[Pages 18114-18125]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-06688]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 500, 510, 520, 522, 524, 526, 556, and 558
[Docket No. FDA-2019-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications;
Withdrawal of Approval of New Animal Drug Applications; Change of
Sponsor; Change of Sponsors' Name and Addresses
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 2019. FDA
is informing the public of the availability
[[Page 18115]]
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 accuracy of the
regulations.
DATES: This rule is effective March 30, 2020.
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
2019, 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/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room. Marketing exclusivity and patent
information may be accessed in FDA's publication, Approved Animal Drug
Products Online (Green Book) at: https://www.fda.gov/animal-veterinary/products/approved-animal-drug-products-green-book.
Table 1--Original and Supplemental NADAs and ANADAs Approved During October, November, and December 2019
--------------------------------------------------------------------------------------------------------------------------------------------------------
Approval date File No. Sponsor Product name Species Effect of the action Public documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
October 11, 2019..... 200-652 Huvepharma EOOD, 5th Monensin and Cattle............ Original approval for use of FOI Summary.
Floor, 3A Nikolay decoquinate Type B MONOVET 90 (monensin Type A
Haytov Str., 1113 and Type C medicated article) with
Sophia, Bulgaria. medicated feeds. DECCOX (decoquinate) Type A
medicated articles in the
manufacture of Type B and
Type C medicated feeds as a
generic copy of NADA 141-148
October 11, 2019..... 200-653 Do................... Monensin, tylosin Cattle............ Original approval for use of FOI Summary.
phosphate, and MONOVET 90 (monensin Type A
decoquinate Type B medicated article) with
and Type C TYLOVET (tylosin phosphate)
medicated feeds. and DECCOX (decoquinate) Type
A medicated articles in the
manufacture of Type B and
Type C medicated feeds as a
generic copy of NADA 141-149
October 11, 2019..... 200-654 Do................... Monensin and Cattle............ Original approval for use of FOI Summary.
tilmicosin MONOVET 90 (monensin Type A
phosphate Type B medicated article) with
and Type C TILMOVET (tilmicosin
medicated feeds. phosphate) Type A medicated
article in the manufacture of
Type B and Type C medicated
feeds as a generic copy of
NADA 141-343
October 11, 2019..... 200-655 Do................... Monensin and Cattle............ Original approval for use of FOI Summary.
tilmicosin MONOVET 90 (monensin Type A
phosphate Type B medicated article) with
and Type C PULMOTIL (tilmicosin
medicated feeds. phosphate) Type A medicated
article in the manufacture of
Type B and Type C medicated
feeds as a generic copy of
NADA 141-343
October 11, 2019..... 200-656 Do................... Monensin, tylosin Cattle............ Original approval for use of FOI Summary.
phosphate, and MONOVET 90 (monensin Type A
decoquinate Type B medicated article) with TYLAN
and Type C (tylosin phosphate) and
medicated feeds. DECCOX (decoquinate) Type A
medicated articles in the
manufacture of Type B and
Type C medicated feeds as a
generic copy of NADA 141-149
October 11, 2019..... 200-658 Do................... Monensin and Cattle............ Original approval for use of FOI Summary.
melengestrol MONOVET 90 (monensin Type A
acetate Type C medicated article) with MGA
medicated feeds. (melengestrol acetate Type A
medicated article) in the
manufacture of Type C
medicated feeds as a generic
copy of NADA 125-476
October 11, 2019..... 200-659 Do................... Monensin, Cattle............ Original approval for use of FOI Summary.
ractopamine MONOVET 90 (monensin Type A
hydrochloride, and medicated article) with
melengestrol ACTOGAIN (ractopamine
acetate Type C hydrochloride Type A
medicated feeds. medicated article) and MGA
(melengestrol acetate Type A
medicated articles) in the
manufacture of Type C
medicated feeds as a generic
copy of NADA 141-234
October 11, 2019..... 200-660 Do................... Monensin, tylosin Cattle............ Original approval for use of FOI Summary.
phosphate, and MONOVET 90 (monensin Type A
melengestrol medicated article) with
acetate Type C TYLOVET (tylosin phosphate)
medicated feeds. Type A medicated article, and
MGA (melengestrol acetate
Type A medicated article) in
the manufacture of Type C
medicated feeds as a generic
copy of NADA 138-870
[[Page 18116]]
October 11, 2019..... 200-661 Do................... Monensin, tylosin Cattle............ Original approval for use of FOI Summary.
phosphate, and MONOVET 90 (monensin Type A
melengestrol medicated article) with TYLAN
acetate Type C (tylosin phosphate) Type A
medicated feeds. medicated article, and MGA
(melengestrol acetate Type A
medicated article) in the
manufacture of Type C
medicated feeds as a generic
copy of NADA 138-870
October 11, 2019..... 200-662 Do................... Monensin and Cattle............ Original approval for use of FOI Summary.
ractopamine MONOVET 90 (monensin Type A
hydrochloride Type medicated article) with
B and Type C ACTOGAIN (ractopamine
medicated feeds. hydrochloride Type A
medicated article) in the
manufacture of Type B and
Type C medicated feeds as a
generic copy of NADA 141-225
October 29, 2019..... 200-635 Mizner Bioscience Clomipramine Dogs.............. Original approval as a generic FOI Summary.
LLC, 225 NE Mizner Hydrochloride copy of NADA 141-120
Blvd., Suite 760, Tablets.
Boca Raton, FL 33432.
November 14, 2019.... 141-518 Intervet, Inc., 2 BRAVECTO PLUS Cats.............. Original approval for the FOI Summary.
Giralda Farms, (fluralaner and prevention of heartworm
Madison, NJ 07940. moxidectin topical disease and for the treatment
solution) Solution. of infections with intestinal
roundworm and hookworm; kills
adult fleas and is indicated
for the treatment and
prevention of flea
infestations, and the
treatment and control of tick
infestations for 2 months in
cats and kittens
November 20, 2019.... 200-663 Norbrook Laboratories SELARID (selamectin) Dogs and cats..... Original approval as a generic FOI Summary.
Ltd., Station Works, Topical Solution. copy of NADA 141-152
County Down, Newry,
BT35 6JP, UK.
November 25, 2019.... 141-513 Kindred Biosciences, ZIMETA (dipyrone Horses............ Original approval for control FOI Summary.
Inc., 1555 Bayshore injection). of pyrexia in horses
Hwy., Suite 200,
Burlingame, CA 94010.
December 9, 2019..... 141-528 Elanco US Inc., 2500 CREDELIO CAT Cats.............. Original approval for killing FOI Summary.
Innovation Way, (lotilaner) adult fleas, and for the
Greenfield, IN 46140. Chewable Tablets. treatment and prevention of
flea infestations for 1 month
in cats and kittens
December 9, 2019..... 200-546 Bimeda Animal Health BIMAGARD 12.5% Swine............. Original approval as a generic FOI Summary.
Ltd., 1B The Herbert (tiamulin hydrogen copy of NADA 140-916
Building, The Park, fumarate) Liquid
Carrickmines, Concentrate for
Dublin, 18, EI. Swine.
December 19, 2019.... 200-615 Vetoquinol USA, Inc., IMOXI (imidacloprid Dogs.............. Original approval as a generic FOI Summary.
4250 N. Sylvania and moxidectin) copy of NADA 141-251
Ave., Fort Worth, TX Topical Solution
76137. for Dogs.
December 30, 2019.... 111-636 Zoetis Inc., 333 LINCOMIX (lincomycin Honeybees......... Supplemental approval of a FOI Summary.
Portage St., hydrochloride) tolerance for residues of
Kalamazoo, MI 49007. Soluble Powder. lincomycin in honey
December 30, 2019.... 008-862 Do................... TERRAMYCIN Honeybees......... Supplemental approval of a FOI Summary.
(oxytetracycline tolerance for residues of
hydrochloride) oxytetracycline in honey
Soluble Powder.
December 30, 2019.... 013-076 Elanco US Inc. 2500 TYLAN (tylosin Honeybees......... Supplemental approval of a FOI Summary.
Innovation Way, tartrate) Soluble. tolerance for residues of
Greenfield, IN 46140. tylosin in honey
--------------------------------------------------------------------------------------------------------------------------------------------------------
II. Withdrawals of Approval
Norbrook Laboratories, Ltd., Station Works, Newry BT35 6JP,
Northern Ireland, has requested that FDA withdraw approval of the NADAs
listed in the following table because the products are no longer
manufactured or marketed:
------------------------------------------------------------------------
File No. Product name 21 CFR section
------------------------------------------------------------------------
055-036....... PRINCILLIN (ampicillin 520.90c.
trihydrate) Capsules.
055-050....... PRINCILLIN (ampicillin 520.90e.
trihydrate) Soluble Powder.
055-056....... PRINCILLIN (ampicillin 520.90f.
trihydrate) Bolus.
055-061....... PRINCILLIN ``125'' For Oral 520.90d.
Suspension.
055-068....... BOVICLOX (cloxacillin benzathine) 526.464b.
065-013....... Dihydrostreptomycin 522.650.
(dihydrostreptomycin sulfate).
065-493....... JETPEN (penicillin G benzathine 522.1696a.
and penicillin G procaine)
Aqueous Suspension.
065-500....... TANDEM PEN (penicillin G 522.1696b.
procaine).
------------------------------------------------------------------------
[[Page 18117]]
Elsewhere in this issue of the Federal Register, FDA gave notice
that approval of NADAs 055-036, 055-050, 055-056, 055-061, 055-068,
065-013, 065-493, and 065-500, and all supplements and amendments
thereto, is withdrawn, effective March 30, 2020. As provided in the
regulatory text of this document, the animal drug regulations are
amended to reflect these actions.
III. Changes of Sponsor
Cooperative Research Farms, Box 69, Charlotteville, NY 12036, has
informed FDA that it has transferred ownership of, and all rights and
interest in, approved NADA 119-253 for Cattle Block M (monensin) a
free-choice Type C medicated cattle feed to Wildcat Feeds, 215 NE
Strait Ave., Topeka, KS 66616. Following this change of sponsorship,
Cooperative Research Farms is no longer the sponsor of an approved
application.
Dechra, Ltd., Snaygill Industrial Estate, Keighley Rd., Skipton,
North Yorkshire, BD23 2RW, United Kingdom, has informed FDA that it has
transferred ownership of, and all rights and interest in, approved
ANADA 200-273 for VETRO-GEN Veterinary Ophthalmic Ointment to Putney,
Inc., One Monument Sq., suite 400, Portland, ME 04101.
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, approved NADA 141-472 for virginiamycin and
diclazuril Type C medicated feed to Elanco US Inc., 2500 Innovation
Way, Greenfield, IN 46140.
Accordingly, we are amending the regulations to reflect these
changes.
IV. Change of Sponsors' Name and Addresses
Putney, Inc., One Monument Sq., suite 400, Portland, ME 04101, has
informed FDA that it has changed its name and address to Dechra
Veterinary Products LLC, 7015 College Blvd., suite 525, Overland Park,
KS 66211. In addition, Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth,
TX 76137 has informed FDA that it has changed its address to PO Box
162059, Fort Worth, TX 76161. Accordingly, we are amending Sec.
510.600(c) (21 CFR 510.600(c)) to reflect these changes.
V. Technical Amendments
FDA is making the following amendments to improve the readability
and accuracy of the animal drug regulations:
The contact information in 21 CFR 500.1410, which provides
for the incorporation by reference of the residue assay method for n-
methyl-2-pyrrolidone, is being updated.
We are removing entries for ``Strategic Veterinary
Pharmaceuticals, Inc.'' from the lists of sponsors of approved
applications in Sec. 510.600(c) and the drug labeler code for KC
Pharmacal from 21 CFR 520.260.
The indications for use of oxytetracycline soluble powder
in honey bees at 21 CFR 520.1660d are amended to reflect current
labeling.
The single section for euthanasia injectable solutions at
21 CFR 522.900 is being removed and separate sections for the active
pharmaceutical ingredients are added at 21 CFR 522.1697 and 522.2092.
The section heading in 21 CFR 524.1742 for ``N-
(Mercaptomethyl) phthalimide S-(O,O-dimethyl phosphorodithioate)
emulsifiable liquid'' is amended to read ``Phosmet emulsifiable
liquid''.
The entries in 21 CFR parts 556 and 558 for coumaphos for
which approval of the last approved application was withdrawn in 2018
(83 FR 48940, September 28, 2018) are being removed.
The entries in part 556 (21 CFR part 556) are being
removed for tolerances of residues of erythromycin in swine tissues, of
virginiamycin in turkey tissues, and of new animal drugs for which
approval of their applications has been withdrawn.
Cross-references to related approved uses of new animal
drugs in part 556 and to related tolerances for drugs approved for use
in food-producing animals in 21 CFR parts 520, 522, 524, and 558 are
being corrected.
A redundant cross-reference for related tolerances in 21
CFR 558.355 for use of monensin in medicated feeds is being removed and
reserved.
The acceptable daily intake of total residues of
ivermectin and tolerances for residues of ivermectin in cattle liver
and muscle in Sec. 556.344 are being corrected.
The acceptable daily intake of total residues of
tildipirosin in Sec. 556.733 is being corrected.
The regulations in 21 CFR 520.2260b for sulfamethazine
sustained-release boluses and in 21 CFR 522.1662a for oxytetracycline
hydrochloride injection are being reformatted to present the tolerance
cross-reference in a consistent location.
Typographical errors are being corrected wherever they
have been found.
VI. 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 500
Animal drugs, Animal feeds, Cancer, Incorporation by reference,
Labeling, Packaging and containers, Polychlorinated biphenyls (PCBs).
21 CFR Parts 520, 522, 524, and 526
Animal drugs.
21 CFR Part 556
Animal drugs, Food.
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
500, 510, 520, 522, 524, 526, 556, and 558 are amended as follows:
PART 500--GENERAL
0
1. The authority citation for part 500 continues to read as follows:
Authority: 21 U.S.C. 321, 331, 342, 343, 348, 351, 352, 353,
360b, 371, 379e.
0
2. In Sec. 500.1410, revise paragraph (a) to read as follows:
Sec. 500.1410 N-methyl-2-pyrrolidone.
(a) Standard for residues. No residues of n-methyl-2-pyrrolidone
may be found in the uncooked edible tissues of cattle as determined by
a method entitled ``Method of Analysis: N-methyl-2-
[[Page 18118]]
pyrrolidone,'' September 26, 2011, Center for Veterinary Medicine, Food
and Drug Administration, which is incorporated by reference with the
approval of the Director of the Federal Register under 5 U.S.C. 522(a)
and 1 CFR part 51. To obtain a copy of the analytical method, please
submit a Freedom of Information request to: https://www.accessdata.fda.gov/scripts/foi/FOIRequest/requestinfo.cfm; or go
to: https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room. You may inspect a copy at the office of the
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852, 301-827-6860, between 9
a.m. and 4 p.m., Monday through Friday or at the National Archives and
Records Administration (NARA). For information on the availability of
this material at NARA, email [email protected], or go to:
www.archives.gov/federal-register/cfr/ibr-locations.html.
* * * * *
PART 510--NEW ANIMAL DRUGS
0
3. 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
4. In Sec. 510.600:
0
a. In the table in paragraph (c)(1):
0
i. Remove the entry for ``Cooperative Research Farms'';
0
ii. Add entries for ``Dechra Veterinary Products LLC'' and ``Mizner
Bioscience LLC'' in alphabetical order;
0
iii. Remove the entries for ``Putney, Inc.'' and ``Strategic Veterinary
Pharmaceuticals, Inc.'';
0
iv. Revise the entry for ``Virbac AH, Inc.''; and
0
v. Add an entry for ``Wildcat Feeds'' in alphabetical order; and
0
b. In the table in paragraph (c)(2):
0
i. Revise the entry for ``026637'';
0
ii. Remove the entry for ``051267'';
0
iii. Revise the entry for ``051311'';
0
iv. Remove the entry for ``054628''; and
0
v. Add entries for ``086039'' and ``086113'' in numerical order.
The revisions and additions 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
------------------------------------------------------------------------
* * * * * * *
Dechra Veterinary Products LLC, 7015 College Blvd., 026637
Suite 525, Overland Park, KS 66211.....................
* * * * * * *
Mizner Bioscience LLC, 225 NE Mizner Blvd., Suite 760, 086039
Boca Raton, FL 33432...................................
* * * * * * *
Virbac AH, Inc., PO Box 162059, Fort Worth, TX 76161.... 051311
* * * * * * *
Wildcat Feeds, 215 NE Strait Ave., Topeka, KS 66616..... 086113
* * * * * * *
------------------------------------------------------------------------
(2) * * *
----------------------------------------------------------------------------------------------------------------
Drug labeler code Firm name and address
----------------------------------------------------------------------------------------------------------------
* * * * * * *
026637................................. Dechra Veterinary Products LLC, 7015 College Blvd., Suite 525, Overland
Park, KS 66211.
* * * * * * *
051311................................. Virbac AH, Inc., PO Box 162059, Fort Worth, TX 76161.
* * * * * * *
086039................................. Mizner Bioscience LLC, 225 NE Mizner Blvd., Suite 760, Boca Raton, FL
33432.
* * * * * * *
086113................................. Wildcat Feeds, 215 NE Strait Ave., Topeka, KS 66616.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
5. The authority citation for part 520 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 520.88c [Amended]
0
6. In Sec. 520.88c(c), remove ``Sec. 556.510'' and in its place add
``Sec. 556.38''.
Sec. Sec. 520.90b and 520.90c [Redesignated as Sec. Sec. 520.90a
and 520.90b]
0
7. Redesignate Sec. Sec. 520.90b and 520.90c as Sec. Sec. 520.90a and
520.90b.
Sec. Sec. 520.90d and 520.90e [Removed]
0
8. Remove Sec. Sec. 520.90d and 520.90e.
Sec. 520.90f [Redesignated as Sec. 520.90c and Amended]
0
9. Redesignate Sec. 520.90f as Sec. 520.90c and in newly redesignated
Sec. 520.90c, revise paragraphs (b) and (d) to read as follows:
[[Page 18119]]
Sec. 520.90c Ampicillin boluses.
* * * * *
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
* * * * *
(d) Conditions of use in nonruminating calves--(1) Amount. 5
milligrams per pound of body weight twice daily not to exceed 4 days.
(2) Indications for use. Oral treatment of bacterial enteritis
(colibacillosis) caused by E. coli.
(3) Limitations. Treated calves must not be slaughtered for food
during treatment and for 7 days after the last treatment. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.
Sec. 520.260 [Amended]
0
10. In Sec. 520.260(b)(2), remove ``No. 038782 for 884 or 1,768
milligram or 4.42 gram capsules;''.
Sec. 520.455 [Amended]
0
11. In Sec. 520.455(b), remove ``No. 058198'' and in its place add
``Nos. 058198 and 086039''.
Sec. Sec. 520.903d and 520.903e [Redesignated as Sec. Sec. 520.903c
and 520.903d]
0
12. Redesignate Sec. Sec. 520.903d and 520.903e as Sec. Sec. 520.903c
and 520.903d.
Sec. 520.1263c [Redesignated as Sec. 520.1263b]
0
13. Redesignate Sec. 520.1263c as Sec. 520.1263b.
0
14. Revise Sec. 520.1286 to read as follows:
Sec. 520.1286 Lotilaner.
(a) Specifications. Each chewable tablet contains:
(1) For use in dogs: 56.25, 112.5, 225, 450, or 900 milligrams (mg)
lotilaner; or
(2) For use in cats: 12 or 48 mg lotilaner.
(b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Dogs--(i) Amount. Administer orally once
a month at the recommended minimum dosage of 9 mg/lb (20 mg/kg).
(ii) Indications for use. Kills adult fleas, and for the treatment
and prevention of flea infestations (Ctenocephalides felis), and the
treatment and control of tick infestations (Amblyomma americanum (lone
star tick), Dermacentor variabilis (American dog tick), Ixodes
scapularis (black-legged tick), and Rhipicephalus sanguineus (brown dog
tick)) for 1 month in dogs and puppies 8 weeks of age or older and
weighing 4.4 pounds or greater.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
(2) Cats--(i) Amount. Administer orally once a month at the
recommended minimum dosage of 2.7 mg/lb (6 mg/kg).
(ii) Indications for use. Kills adult fleas, and for the treatment
and prevention of flea infestations (Ctenocephalides felis) for 1 month
in cats and kittens 8 weeks of age or older and weighing 2 pounds or
greater.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
15. In Sec. 520.1660d, revise paragraph (d)(2)(ii) to read as follows:
Sec. 520.1660d Oxytetracycline powder.
* * * * *
(d) * * *
(2) * * *
(ii) Indications for use. For control of American foulbrood caused
by Paenibacillus larvae.
* * * * *
Sec. Sec. 520.1696b, 520.1696c, and 520.1696d [Redesignated as
Sec. Sec. 520.1696a, 520.1696b, and 520.1696c]
0
16. Redesignate Sec. Sec. 520.1696b, 520.1696c, and 520.1696d as
Sec. Sec. 520.1696a, 520.1696b, and 520.1696c.
Sec. 520.2218 [Amended]
0
17. In Sec. 520.2218(c), remove ``Sec. Sec. 556.670 and 556.685'' and
in its place add ``Sec. Sec. 556.660, 556.670, and 556.685''.
Sec. 520.2260b [Amended]
0
18. In Sec. 520.2260b, redesignate paragraphs (a) through (f) and (g)
as paragraphs (b) through (g) and (a), respectively.
0
19. In Sec. 520.2455, add paragraph (b)(4) to read as follows:
Sec. 520.2455 Tiamulin.
* * * * *
(b) * * *
(4) No. 061133 for product described in paragraph (a)(2) of this
section.
* * * * *
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
20. The authority citation for part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
21. In Sec. 522.650, revise paragraph (b) to read as follows:
Sec. 522.650 Dihydrostreptomycin sulfate injection.
* * * * *
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
* * * * *
0
22. Add Sec. 522.728 to read as follows:
Sec. 522.728 Dipyrone.
(a) Specifications. Each milliliter of solution contains 500
milligrams (mg) dipyrone.
(b) Sponsor. See No. 086078 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in horses--(1) Amount. Administer 30 mg per
kilogram of body weight (13.6 mg per pound) by intravenous injection,
once or twice daily at a 12-hour interval for up to 3 days.
(2) Indications for use. For control of pyrexia in horses.
(3) Limitations. Do not use in horses intended for human
consumption. Do not use in any food-producing animals, including
lactating dairy animals. Federal law restricts this drug to use by or
on the order of a licensed veterinarian.
Sec. 522.900 [Removed]
0
23. Remove Sec. 522.900.
Sec. 522.1367 [Amended]
0
24. In Sec. 522.1367(c)(1)(i), remove ``Sec. 520.1350(c)'' and in its
place add ``Sec. 520.1367(c)''.
Sec. 522.1662a [Amended]
0
25. In Sec. 522.1662a:
0
a. Redesignate paragraphs (a) through (e) as paragraphs (b) through
(f);
0
b. Further redesignate newly redesignated paragraphs (c)(3)(i)(a)
through (c) and (c)(3)(ii)(a) through (c) as paragraphs (c)(3)(i)(A)
through (C) and (c)(3)(ii)(A) through (C), respectively;
0
c. Further redesignate newly redesignated paragraphs (e)(3)(i)(a)
through (c) as paragraphs (e)(3)(i)(A) through (C);
0
d. Further redesignate newly redesignated paragraphs (e)(3)(ii)(a) and
(b) and paragraphs (e)(3)(ii)(A) and (B);
0
e. Further redesignate newly redesignated paragraphs (e)(3)(iii)(a)
through (c) as paragraphs (e)(3)(iii)(A) through (C);
0
f. In newly redesignated paragraph (e)(3)(iii)(C), remove ``paragraph
(d)(3)(iii)(c) of this section'' and in its place add ``this paragraph
(e)(3)(iii)(C)'';
0
g. Further redesignate newly redesignated paragraphs (f)(3)(i)(a)
through (c) and (f)(3)(ii)(a) through (c) as paragraphs (f)(3)(i)(A)
through (C) and (f)(3)(ii)(A) through (C), respectively;
0
h. Redesignate paragraphs (g)(3)(i)(a) through (c) and (g)(3)(ii)(a)
through (c) as paragraphs (g)(3)(i)(A) through (C)
[[Page 18120]]
and (g)(3)(ii)(A) through (C), respectively; and
0
i. Redesignate paragraph (k) as paragraph (j) and paragraph (l) as
paragraph (a).
Sec. 522.1696a [Amended]
0
26. In Sec. 522.1696a(b)(1) and (2) and (d)(2)(iii), remove ``,
055529,''.
Sec. 522.1696b [Amended]
0
27. In Sec. 522.1696b:
0
a. In paragraph (b)(1), remove ``016592, 054771, and 055529'' and in
its place add ``016592 and 054771'';
0
b. Remove paragraphs (d)(2)(i)(A) and (B); and
0
c. In paragraph (d)(2)(iii)(B), remove ``Nos. 000859 and 055529'' and
in its place add ``No. 016592''.
0
28. Add Sec. 522.1697 to read as follows:
Sec. 522.1697 Pentobarbital and phenytoin.
(a) Specifications. Each milliliter (mL) of solution contains 390
milligrams (mg) pentobarbital sodium and 50 mg phenytoin sodium.
(b) Sponsors. See Nos. 000061, 051311, and 054925 in Sec.
510.600(c) of this chapter.
(c) Special considerations. Product labeling shall bear the
following warning statements: ``ENVIRONMENTAL HAZARD: This product is
toxic to wildlife. Birds and mammals feeding on treated animals may be
killed. Euthanized animals must be properly disposed of by deep burial,
incineration, or other method in compliance with State and local laws,
to prevent consumption of carcass material by scavenging wildlife.''
(d) Conditions of use in dogs--(1) Amount. Administer 1 mL per 10
pounds of body weight as a single, bolus intravenous or intracardiac
injection.
(2) Indications for use. For humane, painless, and rapid
euthanasia.
(3) Limitations. Do not use in animals intended for food. Federal
law restricts this drug to use by or on the order of a licensed
veterinarian.
0
29. Add Sec. 522.2092 to read as follows:
Sec. 522.2092 Secobarbital and dibucaine.
(a) Specifications. Each milliliter (mL) of solution contains 400
milligram (mg) secobarbital sodium and 25 mg dibucaine hydrochloride.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Special considerations. Product labeling shall bear the
following warning statements: ``ENVIRONMENTAL HAZARD: This product is
toxic to wildlife. Birds and mammals feeding on treated animals may be
killed. Euthanized animals must be properly disposed of by deep burial,
incineration, or other method in compliance with State and local laws,
to prevent consumption of carcass material by scavenging wildlife.''
(d) Conditions of use in dogs--(1) Amount. Administer 1 mL per 10
pounds of body weight as a single, bolus intravenous injection.
(2) Indications for use. For humane, painless, and rapid
euthanasia.
(3) Limitations. Do not use in animals intended for food. Federal
law restricts this drug to use by or on the order of a licensed
veterinarian.
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
30. The authority citation for part 524 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
31. Add an undesignated center heading before Sec. 524.981 to read as
follows:
Fluocinolone Topical and Otic Dosage Forms
0
32. Add Sec. 524.1001 to read as follows:
Sec. 524.1001 Furalaner and moxidectin.
(a) Specifications. Each milliliter of solution contains 280
milligram (mg) furalaner and 14 mg moxidectin. Each individually
packaged tube contains either 112.5 mg furalaner and 5.6 mg moxidectin;
250 mg furalaner and 12.5 mg moxidectin; or 500 mg furalaner and 25 mg
moxidectin.
(b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. Administer topically as a single
dose every 2 months to provide a minimum dose of 18.2 mg/lb (40 mg/kg)
fluralaner and 0.9 mg/lb (2 mg/kg) moxidectin.
(2) Indications for use. For the prevention of heartworm disease
caused by Dirofilaria immitis and for the treatment of infections with
intestinal roundworm (Toxocara cati, 4th stage larvae, immature adults,
and adults) and hookworm (Ancylostoma tubaeforme, 4th stage larvae,
immature adults, and adults); kills adult fleas and is indicated for
the treatment and prevention of flea infestations (Ctenocephalides
felis) and the treatment and control of tick infestations (Ixodes
scapularis (black-legged tick) and Dermacentor variabilis (American dog
tick)) for 2 months in cats and kittens 6 months of age and older and
weighing 2.6 lb or greater.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
33. In Sec. 524.1146, revise paragraphs (a) and (b) to read as
follows:
Sec. 524.1146 Imidacloprid and moxidectin.
(a) Specifications. Each milliliter of solution contains:
(1) 100 milligrams (mg) imidacloprid and 25 mg moxidectin; or
(2) 100 mg imidacloprid and 10 mg moxidectin.
(b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this
chapter as follows:
(1) Nos. 000859 and 017030 for use of product described in
paragraph (a)(1) of this section as in paragraph (d)(1) of this
section.
(2) No. 000859 for use of product described in paragraph (a)(2) of
this section as in paragraphs (d)(2) and (3) of this section.
* * * * *
0
34. In Sec. 524.1742:
0
a. Revise the section heading;
0
b. Redesignate paragraphs (c) and (d) as paragraphs (d) and (c),
respectively;
0
c. Add a heading for the table in newly redesignated paragraph (d)(1)
introductory text; and
0
d. Further redesignate newly redesignated paragraphs (d)(1)(i)(a) and
(b) as paragraphs (d)(1)(i)(A) and (B).
The revision and addition reads as follows:
Sec. 524.1742 Phosmet emulsifiable liquid.
* * * * *
(d) * * *
(1) * * *
Table 1 to Paragraph (d)(1)
* * * * *
Sec. 524.2098 [Amended]
0
35. In Sec. 524.2098(b), remove ``054771'' and in its place add ``Nos.
054771 and 055529''.
PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS
0
36. The authority citation for part 526 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 526.464b [Removed]
0
37. Remove Sec. 526.464b.
Sec. 526.464c [Redesignated as Sec. 526.464b]
0
38. Redesignate Sec. 526.464c as Sec. 526.464b.
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
0
39. The authority citation for part 556 continues to read as follows:
Authority: 21 U.S.C. 342, 360b, 371.
Sec. 556.40 [Amended]
0
40. In Sec. 556.40(c), remove ``Sec. Sec. 520.90e, 520.90f, 522.90a,
and 522.90b'' and in
[[Page 18121]]
its place add ``Sec. Sec. 520.90c, 522.90a, and 522.90b''.
Sec. 556.165 [Amended]
0
41. In Sec. 556.165(c), remove ``Sec. Sec. 526.464a, 526.464b, and
526.464c'' and in its place add ``Sec. Sec. 526.464a and 526.464b''.
Sec. 556.168 [Removed]
0
42. Remove Sec. 556.168.
Sec. 556.230 [Amended]
0
43. In Sec. 556.230, remove paragraph (b)(3).
Sec. 556.304 [Amended]
0
44. In Sec. 556.304(c), remove ``Sec. Sec. 522.1077, 522.1079, and
522.1081'' and in its place add ``Sec. Sec. 522.1079 and 522.1081''.
Sec. 556.344 [Amended]
0
45. In Sec. 556.344:
0
a. In paragraph (a), remove ``1 [mu]g/kg'' and in its place add ``5
[mu]g/kg'';
0
b. In paragraph (b)(2)(i), remove ``100 ppb'' and in its place add
``1.6 ppm''; and
0
c. In paragraph (b)(2)(ii), remove ``10 ppb'' and in its place add
``650 ppb''.
0
46. In Sec. 556.360, add paragraph (b)(3) and revise paragraph (c) to
read as follows:
Sec. 556.360 Lincomycin.
* * * * *
(b) * * *
(3) Honey. 750 ppb.
(c) Related conditions of use. See Sec. Sec. 520.1263b, 522.1260,
and 558.325 of this chapter.
0
47. In Sec. 556.500, add paragraph (b)(6) to read as follows:
Sec. 556.500 Oxytetracycline.
* * * * *
(b) * * *
(6) Honey. 750 ppb.
* * * * *
Sec. 556.510 [Amended]
0
48. In Sec. 556.510(c), remove ``520.1696b'' and in its place add
``520.1696a''.
Sec. 556.660 [Amended]
0
49. In Sec. 556.660(c), remove ``Sec. 558.582'' and in its place add
``Sec. Sec. 520.2218 and 558.582''.
Sec. 556.670 [Amended]
0
50. In Sec. 556.670, in paragraph (c), remove ``Sec. Sec. 520.2260a,
520.2260b, 520.2260c, 520.2261a, 520.2261b, 522.2260, 558.140, and
558.630'' and in its place add ``Sec. Sec. 520.2218, 520.2260a,
520.2260b, 520.2260c, 520.2261a, 520.2261b, 522.2260, 558.140, and
558.630''.
Sec. 556.685 [Amended]
0
51. In Sec. 556.685(c), remove ``Sec. Sec. 520.2325a, 520.2325b, and
558.586'' and in its place add ``Sec. Sec. 520.2218, 520.2325a,
520.2325b, and 558.586''.
Sec. 556.733 [Amended]
0
52. In Sec. 556.733(a), remove ``10 [mu]g/kg'' and in its place add
``50 [mu]g/kg''.
0
53. In Sec. 556.746, add paragraph (b)(4) to read as follows:
Sec. 556.746 Tylosin.
* * * * *
(b) * * *
(4) Honey. 500 ppb.
* * * * *
Sec. 556.750 [Amended]
0
54. In Sec. 556.750, remove paragraph (b)(4).
0
55. In Sec. 556.765, revise paragraph (b)(1) to read as follows:
Sec. 556.765 Zilpaterol.
* * * * *
(b) * * *
(1) Cattle. (i) Liver (target tissue): 12 ppb.
(ii) Muscle: 10 ppb.
* * * * *
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
56. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
0
57. In Sec. 558.55, add paragraph (d)(5) to read as follows:
Sec. 558.55 Amprolium.
* * * * *
(d) * * *
(5) Permitted combinations. Amprolium may also be used in
combination with:
(i) Virginiamycin as in Sec. 558.635.
(ii) [Reserved]
0
58. In Sec. 558.76, revise paragraphs (e)(2)(vii), (viii), and (xi) to
read as follows:
Sec. 558.76 Bacitracin methylenedisalicylate.
* * * * *
(e) * * *
(2) * * *
(vii) Fenbendazole as in Sec. 558.258.
(viii) Halofuginone as in Sec. 558.265.
* * * * *
(xi) Monensin as in Sec. 558.355.
* * * * *
Sec. 558.185 [Removed]
0
59. Remove Sec. 558.185.
0
60. In Sec. 558.195, revise paragraph (e)(2)(ii) to read as follows:
Sec. 558.195 Decoquinate.
* * * * *
(e) * * *
(2) * * *
[[Page 18122]]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Combination in grams/
Decoquinate in grams/ton ton Indications for use Limitations Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * * * *
(ii) 12.9 to 90.8................... Monensin, 5 to 30...... Cattle fed in confinement Feed continuously as the 016592, 054771.
for slaughter: For sole ration to provide 22.7
prevention of coccidiosis mg of decoquinate per 100
caused by Eimeria bovis and lb of body weight per day
E. zuernii; and for and 50 to 360 mg of
improved feed efficiency. 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.
016592 or 058198 in Sec.
510.600(c) of this chapter.
* * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * *
0
61. In Sec. 558.342, revise paragraph (e)(1)(iv) to read as follows:
Sec. 558.342 Melengestrol.
* * * * *
(e) * * *
(1) * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
Combination in grams/
Melengestrol acetate in mg/head/day ton Indications for use Limitations Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * * * *
(iv) 0.25 to 0.5.................... Monensin, 10 to 40..... Heifers fed in confinement Add at the rate of 0.5 to 2 016592, 054771, 058198
for slaughter: For lb/head/day a medicated
increased rate of weight feed (liquid or dry)
gain, improved feed containing 0.125 to 1 mg
efficiency, and suppression melengestrol acetate/lb to
of estrus (heat); and for a feed containing 10 to 40
the prevention and control g of monensin per ton to
of coccidiosis due to provide 0.25 to 0.5 mg
Eimeria bovis and E. melengestrol acetate/head/
zuernii.. day and 0.14 to 0.42 mg
monensin/lb body weight,
depending on severity of
coccidiosis challenge, up
to 480 mg monensin/head/
day. See Sec. 558.355(d).
Monensin as provided by No.
016592 or 058198 in Sec.
510.600(c) of this chapter.
* * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * *
0
62. In Sec. 558.355, remove and reserve paragraph (e) and revise
paragraph (f)(4)(iv) to read as follows:
Sec. 558.355 Monensin.
* * * * *
(f) * * *
(4) * * *
----------------------------------------------------------------------------------------------------------------
Monensin amount Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(iv) 400 mg per pound of block Pasture cattle Provide 50 to 200 mg of 086113
(0.088%). (slaughter, monensin (2 to 8 ounces
stocker, feeder, of block) per head per
and dairy and beef day, at least 1 block
replacement per 5 head of cattle.
heifers): For Feed blocks
increased rate of continuously. Do not
weight gain. feed salt or mineral
supplements in addition
to the blocks. Ingestion
by cattle of monensin at
levels of 600 mg per
head per day and higher
has been fatal. The
effectiveness of this
block in cull cows and
bulls has not been
established. See
paragraph (d)(10)(i) of
this section.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
0
63. In Sec. 558.500, revise paragraph (e)(2) to read as follows:
Sec. 558.500 Ractopamine.
* * * * *
(e) * * *
(2) Cattle.
[[Page 18123]]
----------------------------------------------------------------------------------------------------------------
Combination in Indications for
Ractopamine in grams/ton grams/ton use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 8.2 to 24.6................ .................. Cattle fed in Feed continuously as 054771
confinement for sole ration during the 058198
slaughter: For last 28 to 42 days on
increased rate of feed.
weight gain and
improved feed
efficiency during
the last 28 to 42
days on feed.
(ii) 8.2 to 24.6............... Monensin 10 to 40 Cattle fed in Feed continuously as 016592
to provide 0.14 confinement for sole ration during the 054771
to 0.42 mg slaughter: For last 28 to 42 days on 058198
monensin/lb of increased rate of feed. See paragraph
body weight, weight gain and Sec. 558.355(d).
depending on improved feed Ractopamine as
severity of efficiency during provided by No. 058198
coccidiosis the last 28 to 42 or 054771; monensin as
challenge, up to days on feed, and provided by No. 016592
480 mg/head/day.. for prevention or 058198 in Sec.
and control of 510.600(c) of this
coccidiosis due chapter.
to Eimeria bovis
and E. zuernii.
(iii) 9.8 to 24.6.............. .................. Cattle fed in Feed continuously as 054771
confinement for sole ration during the 058198
slaughter: For last 28 to 42 days on
increased rate of feed. Not for animals
weight gain, intended for breeding.
improved feed
efficiency, and
increased carcass
leanness during
the last 28 to 42
days on feed.
(iv) 9.8 to 24.6............... Monensin 10 to 40 Cattle fed in Feed continuously as 016592
to provide 0.14 confinement for sole ration during the 054771
to 0.42 mg slaughter: For last 28 to 42 days on 058198
monensin/lb of increased rate of feed. Not for animals
body weight, weight gain, intended for breeding.
depending on improved feed See paragraph Sec.
severity of efficiency, and 558.355(d).
coccidiosis increased carcass Ractopamine as
challenge, up to leanness during provided by No. 058198
480 mg/head/day. the last 28 to 42 or 054771; monensin as
days on feed, and provided by No. 016592
for prevention or 058198 in Sec.
and control of 510.600(c) of this
coccidiosis due chapter.
to Eimeria bovis
and E. zuernii.
(v) 9.8 to 24.6................ Monensin 10 to 40 Heifers fed in Feed continuously as 016592
to provide 0.14 confinement for sole ration during the 054771
to 0.42 mg slaughter: For last 28 to 42 days on 058198
monensin/lb of increased rate of feed. Not for animals
body weight, weight gain, intended for breeding.
depending on improved feed See Sec. Sec.
severity of efficiency, and 558.342(d) and
coccidiosis increased carcass 558.355(d).
challenge, up to leanness during Melengestrol acetate
480 mg/head/day, the last 28 to 42 as provided by No.
plus melengestrol days on feed, and 058198 or 054771;
acetate to for prevention monensin as provided
provide 0.25 to and control of by No. 016592 or
0.5 mg/head/day. coccidiosis due 058198 in Sec.
to Eimeria bovis 510.600(c) of this
and E. zuernii, chapter.
and for
suppression of
estrus (heat).
(vi) Not to exceed 800; to .................. Cattle fed in Top dress in a minimum 054771
provide 70 to 400 mg/head/day. confinement for of 1 lb of medicated 058198
slaughter: For feed.
increased rate of
weight gain and
improved feed
efficiency during
the last 28 to 42
days on feed.
(vii) Not to exceed 800; to Monensin 10 to 40 Cattle fed in Top dress ractopamine 016592
provide 70 to 400 mg/head/day. to provide 0.14 confinement for in a minimum of 1 lb 054771
to 0.42 mg slaughter: For of medicated feed 058198
monensin/lb of increased rate of during the last 28 to
body weight, weight gain and 42 days on feed. Not
depending on improved feed for animals intended
severity of efficiency during for breeding. See Sec.
coccidiosis the last 28 to 42 558.355(d).
challenge, up to days on feed, and Ractopamine as
480 mg/head/day. for prevention provided by No. 058198
and control of or 054771; monensin as
coccidiosis due provided by No. 016592
to Eimeria bovis or 058198 in Sec.
and E. zuernii. 510.600(c) of this
chapter.
----------------------------------------------------------------------------------------------------------------
* * * * *
0
64. In Sec. 558.618, revise paragraphs (e)(2)(ii) and (iii) to read as
follows:
Sec. 558.618 Tilmicosin.
* * * * *
(e) * * *
(2) * * *
[[Page 18124]]
----------------------------------------------------------------------------------------------------------------
Tilmicosin phosphate in grams/ Combination in Indications for
ton grams/ton use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(ii) 568 to 757................ Monensin, 5 to 40. Cattle fed in Feed continuously for 016592
confinement for 14 days to provide 058198
slaughter: For 12.5 mg tilmicosin/kg
improved feed of bodyweight/day. The
efficiency; and safety of tilmicosin
for the control has not been
of bovine established in cattle
respiratory intended for breeding
disease (BRD) purposes. This drug
associated with product is not
Mannheimia approved for use in
haemolytica, female dairy cattle 20
Pasteurella months of age or
multocida, and older. Use in these
Histophilus somni cattle may cause drug
in groups of residues in milk. This
cattle fed in drug product is not
confinement for approved for use in
slaughter, where calves intended to be
active BRD has processed for veal. A
been diagnosed in withdrawal period has
at least 10 not been established
percent of the in pre-ruminating
animals in the calves. Cattle
group. intended for human
consumption must not
be slaughtered within
28 days of the last
treatment with this
drug product. See Sec.
558.355(d).
Tilmicosin as provided
by No. 016592 or
058198; monensin as
provided by No. 016592
or 058198 in Sec.
510.600(c) of this
chapter.
(iii) 568 to 757............... Monensin, 10 to 40 Cattle fed in Feed continuously for 016592
confinement for 14 days to provide 058198
slaughter: For 12.5 mg tilmicosin/kg
prevention and of bodyweight/day. The
control of safety of tilmicosin
coccidiosis due has not been
to Eimeria bovis established in cattle
and E. zuernii; intended for breeding
and for the purposes. This drug
control of BRD product is not
associated with approved for use in
Mannheimia female dairy cattle 20
haemolytica, months of age or
Pasteurella older. Use in these
multocida, and cattle may cause drug
Histophilus somni residues in milk. This
in groups of drug product is not
cattle fed in approved for use in
confinement for calves intended to be
slaughter, where processed for veal. A
active BRD has withdrawal period has
been diagnosed in not been established
at least 10 in pre-ruminating
percent of the calves. Cattle
animals in the intended for human
group. consumption must not
be slaughtered within
28 days of the last
treatment with this
drug product. See Sec.
558.355(d).
Tilmicosin as provided
by No. 016592 or
058198; monensin as
provided by No. 016592
or 058198 in Sec.
510.600(c) of this
chapter.
----------------------------------------------------------------------------------------------------------------
0
65. In Sec. 558.625, revise paragraphs (e)(2)(vi) and (ix) to read as
follows:
Sec. 558.625 Tylosin.
* * * * *
(e) * * *
(2) * * *
----------------------------------------------------------------------------------------------------------------
Combination in Indications for
Tylosin grams/ton grams/ton use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(vi) 8 to 10................... Monensin, 5 to 30 Cattle fed in Feed continuously as 016592
plus decoquinate, confinement for the sole ration to 054771
13.6 to 22.7. slaughter: For provide 22.7 mg of
reduction of decoquinate per 100 lb
incidence of body weight per day,
liver abscesses 50 to 360 mg of
caused by monensin/head/day, and
Fusobacterium 60 to 90 mg of tylosin/
necrophorum and head/day. Feed at
Arcanobacterium least 28 days during
pyogenes; for the period of exposure to
prevention of coccidiosis or when it
coccidiosis is likely to be a
caused by Eimeria hazard. Do not feed to
bovis and E. animals producing milk
zuernii; and for for food. Do not feed
improved feed to lactating dairy
efficiency. cattle. A withdrawal
time has not been
established for pre-
ruminating calves. Do
not use in calves to
be processed for veal.
Tylosin as provided by
No. 016592 or 058198;
monensin as provided
by No. 016592 or
058198; decoquinate as
provided by No. 058198
in Sec. 510.600(c)
of this chapter. See
Sec. Sec.
558.311(d) and
558.355(d).
[[Page 18125]]
* * * * * * *
(ix) 8 to 10................... Monensin, 10 to 40 Heifers fed in Feed continuously as 016592
plus confinement for sole ration to heifers 054771
melengestrol, slaughter: For at a rate of 0.5 to 2 058198
0.25 to 2.0. reduction of pounds per head per
incidence of day to provide 0.25 to
liver abscesses 0.5 mg/head/day
caused by melengestrol acetate
Fusobacterium and 0.14 to 0.42 mg
necrophorum and monensin/lb body
Arcanobacterium weight per day,
(Actinomyces) depending on the
pyogenes; for severity of the
prevention and coccidiosis challenge,
control of up to 480 mg/head/day
coccidiosis and 60 to 90 mg/head/
caused by Eimeria day tylosin. The
bovis and E. melengestrol acetate
zuernii; and for portion of this Type C
increased rate of medicated feed must be
weight gain, mixed into the
improved feed complete feed
efficiency, and containing 10 to 40 g/
suppression of ton monensin and 8 to
estrus (heat). 10 g/ton tylosin at
feeding into the
amount of complete
feed consumed by an
animal per day. A
withdrawal time has
not been established
for pre-ruminating
calves. Do not use in
calves to be processed
for veal. Tylosin
provided by No. 016592
or 058198; monensin as
provided by No. 016592
or 058198;
melengestrol provided
by No. 054771 or
058198 in Sec.
510.600(c) of this
chapter. See Sec.
Sec. 558.342(d) and
558.355(d).
* * * * * * *
----------------------------------------------------------------------------------------------------------------
0
66. In Sec. 558.635, revise paragraph (e)(1)(iv) to read as follows:
Sec. 558.635 Virginiamycin.
* * * * *
(e) * * *
(1) * * *
----------------------------------------------------------------------------------------------------------------
Combination in Indications for
Virginiamycin grams/ton grams/ton use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(iv) 20........................ Diclazuril, 0.91.. Broiler chickens: Feed continuously as 058198
For prevention of the sole ration. Do
necrotic not use in hens
enteritis caused producing eggs for
by Clostridium human food. Diclazuril
perfringens as provided by No.
susceptible to 058198 in Sec.
virginiamycin; 510.600(c) of this
and for the chapter.
prevention of
coccidiosis
caused by Eimeria
tenella, E.
necatrix, E.
acervulina, E.
brunetti, E.
mitis (mivati),
and E. maxima.
Because
diclazuril is
effective against
E. maxima late in
its life cycle,
subclinical
intestinal
lesions may be
present for a
short time after
infection.
Diclazuril was
shown in studies
to reduce lesions
scores and
improve
performance and
health of birds
challenged with
E. maxima.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
Dated: March 25, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-06688 Filed 3-30-20; 8:45 am]
BILLING CODE 4164-01-P
