New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship; Change of Sponsor's Name and Address, 14815-14827 [2021-05203]
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Federal Register / Vol. 86, No. 52 / Friday, March 19, 2021 / Rules and Regulations
humanitarian reasons or for other
purposes in the national interest, permit
the processing of travelers to the United
States not engaged in ‘‘essential travel.’’
Final rule; technical
amendments.
ACTION:
New Animal Drugs; Approval of New
Animal Drug Applications; Changes of
Sponsorship; Change of Sponsor’s
Name and Address
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 July,
August, and September 2020. FDA is
informing the public of the availability
of summaries of the basis of approval
and of environmental review
documents, where applicable. The
animal drug regulations are also being
amended to improve the accuracy and
readability of the regulations.
DATES: This rule is effective March 19,
2021.
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:
Food and Drug Administration,
Department of Health and Human
Services (HHS).
I. Approvals
FDA is amending the animal drug
regulations to reflect approval actions
Alejandro N. Mayorkas,
Secretary, U.S. Department of Homeland
Security.
[FR Doc. 2021–05877 Filed 3–18–21; 8:45 am]
BILLING CODE 9112–FP–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, 529,
556, and 558
[Docket No. FDA–2020–N–0002]
AGENCY:
SUMMARY:
for NADAs and ANADAs during July,
August, and September 2020, 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, 240–402–7500.
Persons with access to the internet may
obtain these documents at the CVM
FOIA Electronic Reading Room: https://
www.fda.gov/about-fda/centerveterinary-medicine/cvm-foiaelectronic-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/approvedanimal-drug-products-green-book.
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TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING JULY, AUGUST, AND
SEPTEMBER 2020
Species
Effect of the action
Public
documents
BRAVECTO 1-MONTH
(furalaner) Chews for
Dogs.
Dogs ...............
FOI Summary.
Ceva Sante Animale, 10
Avenue de la
Ballastie`re, 33500
Libourne, France.
CARDALIS
(spironolactone and
benazepril hydrochloride chewable tablets).
Dogs ...............
Cronus Pharma Specialities India Private Ltd.,
Sy No-99/1, GMR
Hyderabad Aviation
SEZ Ltd., Mamidipalli
Village, Shamshabad
Mandal, Ranga Reddy,
Hyderabad, Telangana,
501218, India.
Dechra Veterinary Products LLC, 7015 College
Blvd., Suite 525, Overland Park, KS 66211.
Pharmgate LLC, 1800 Sir
Tyler Dr., Wilmington,
NC 28405.
Carprofen Chewable Tablets.
Dogs ...............
Original approval for the treatment and
prevention of flea infestations, and
the treatment and control of tick infestations for 1 month in dogs and
puppies.
Original approval with concurrent therapy (e.g., furosemide, etc.) for the
management of clinical signs of mild,
moderate, or severe congestive heart
failure in dogs due to atrioventricular
valvular insufficiency (AVVI).
Original approval as a generic copy of
NADA 141–111.
Carprofen Tablets ............
Dogs ...............
Original approval as a generic copy of
NADA 140–035.
FOI Summary.
MAXIBAN (naracin and
nicarbazin) plus
PENNITRACIN MD
(bacitracin
methylenedisalicylate)
Type C medicated
feeds.
ZOASHIELD 25%
(zoalene Type A medicated article).
OVACYST (gonadorelin)
Injectable Solution.
Chickens ........
Original approval for increased rate of
weight gain, improved feed efficiency, and for the prevention of coccidiosis in broiler chickens.
FOI Summary.
Chickens, turkeys.
Original approval as a generic copy of
NADA 141–218.
FOI Summary.
Cattle ..............
Supplemental approval for fixed-time
artificial insemination (FTAI) in beef
cows and lactating dairy cows.
FOI Summary.
Approval date
File No.
July 9, 2020 ..........
141–532
Intervet, Inc., 2 Giralda
Farms, Madison, NJ
07940.
July 27, 2020 ........
141–538
July 29, 2020 ........
200–687
August 4, 2020 .....
200–681
September 9, 2020
141–529
September 18,
2020.
200–690
September 28,
2020.
200–069
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Sponsor
Pharmasone LLC, 1800
Sir Tyler Dr., Wilmington, NC 28405.
Bimeda Animal Health
Ltd., 1B The Herbert
Building, The Park,
Carrickmines, Dublin
18, Ireland.
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FOI Summary.
FOI Summary.
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TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING JULY, AUGUST, AND—Continued
SEPTEMBER 2020
Approval date
File No.
September 29,
2020.
200–528
Sponsor
Product name
Pharmgate, Inc, 1800 Sir
Tyler Dr., Wilmington,
NC 28405.
II. Changes of Sponsor
Elanco US Inc., 2500 Innovation Way,
Greenfield, IN 46140 has informed FDA
that it has transferred ownership of, and
all rights and interest in, NADA 141–
437 for OSNURIA (betamethasone
acetate, florfenicol, terbinafine) Otic Gel
to Dechra, Ltd., Snaygill Industrial
SAVALAN 60
(salinomycin sodium)
Type A medicated article.
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Original approval as a generic copy of
NADA 011–116.
FOI Summary.
Also, Bayer HealthCare LLC, Animal
Health Division, P.O. Box 390, Shawnee
Mission, KS 66201 has informed FDA
that it has transferred ownership of, and
all rights and interest in, the 39 NADAs
and 17 ANADAs listed below to Elanco
US Inc., 2500 Innovation Way,
Greenfield, IN 46140:
Product name
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
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............
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Chickens, quail
Public
documents
Effect of the action
Estate, Keighley Rd., Skipton, North
Yorkshire, BD23 2RW, United Kingdom.
Pharmasone LLC, 1800 Sir Tyler Dr.,
Wilmington, NC 28405 has informed
FDA that it has transferred ownership
of, and all rights and interest in,
ANADA 200–690 for ZOASHIELD 25%
(zoalene Type A medicated article) to
Elanco US Inc., 2500 Innovation Way,
Greenfield, IN 46140.
File No.
034–641
040–001
045–416
047–138
047–955
047–956
091–818
093–329
093–483
107–345
107–346
111–529
111–607
111–798
116–089
132–336
132–337
132–533
132–789
133–953
140–441
140–912
140–913
141–007
141–008
141–068
141–099
141–176
141–208
141–220
141–247
141–251
141–254
141–275
141–344
141–417
141–435
141–440
141–527
200–042
200–124
200–126
200–137
200–181
200–202
200–230
200–246
200–286
200–293
200–319
Species
TIGUVON (fenthion) Pour-On Cattle Insecticide.
MELDANE 2 (coumaphos) Type A Medicated Article.
TEVCODYNE (phenylbutazone) Injectable.
SPOTTON (fenthion) 20% Ready-to-Use Cattle Insecticide.
ROMPUN (xylazine hydrochloride) Injectable (20 mg).
ROMPUN (xylazine hydrochloride) Injectable (100 mg).
Phenylbutazone Tablets, USP 1 gram.
HAVASPAN (sulfamethazine) Prolonged Release Bolus; SULFASPAN (sulfamethazine) Prolonged Release Bolus.
SPECTAM (spectinomycin hydrochloride) Injectable Solution.
RINTAL (febantel) Paste.
RINTAL (febantel) Suspension.
EQUIMATE (fluprostenol sodium).
DRONCIT (praziquantel) 5.68% Injectable Solution.
DRONCIT (praziquantel) Canine Cestocide Tablets; DRONCIT (praziquantel) Feline Cestocide Tablets.
VELTRIM (clotrimazole) 1% Dermatologic Cream.
PROBAN (cythioate) Oral Liquid.
PROBAN (cythioate) Tablets.
STYQUIN (butamisole hydrochloride) Parenteral 1.1%.
PRO–SPOT (fenthion) Solution.
VERCOM (febantel and praziquantel) Paste Anthelmintic.
BAYTRIL (enrofloxacin) Antibacterial Tablets; BAYTRIL TASTE TABS (enrofloxacin) Antibacterial Tablets.
RINTAL (febantel) Tabs Anthelmintic Tablets.
BAYTRIL (enrofloxacin) Antibacterial Injectable Solution.
DRONTAL Plus (febantel, praziquantel, pyrantel pamoate) Taste Tablets.
DRONTAL (praziquantel and pyrantel pamoate) Tablets.
BAYTRIL 100 (enrofloxacin) Injectable Solution.
CYDECTIN (moxidectin) Pour-On for Beef and Dairy Cattle.
BAYTRIL (enrofloxacin and silver sulfadiazine) Otic Emulsion.
ADVANTAGE DUO (imidacloprid and ivermectin) Topical Solution.
CYDECTIN (moxidectin) Injectable Solution.
CYDECTIN (moxidectin) Oral Drench for Sheep.
ADVANTAGE MULTI (imidacloprid and moxidectin) Topical Solution for Dogs.
ADVANTAGE MULTI (imidacloprid and moxidectin) Topical Solution for Cats.
PROFENDER (emodepside and praziquantel) Topical Solution.
VERAFLOX (pradofloxacin) Oral Suspension for Cats.
CORAXIS (moxidectin) Topical Solution.
ADVANTUS (imidacloprid) Tablets.
CLARO (florfenicol, mometasone furoate, terbinafine) Otic Solution.
BAYTRIL 100 (enrofloxacin) CA1.
Ketamine Hydrochloride Injection, USP.
Flunixin Meglumine Injection.
Phenylbutazone 20% Injection.
GENTAMAX 100 (gentamicin sulfate) Solution.
AMIMAX E (amikacin sulfate) Solution.
PHOENECTIN (ivermectin) Liquid for Horses.
Guaifenesin Injection.
ANTHELBAN V (pyrantel pamoate) Equine Anthelmintic Suspension.
PHOENECTIN (ivermectin) Paste 1.87%.
Furosemide Injection 5%.
Acepromazine Maleate Injection.
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File No.
200–322
200–360
200–408
200–555
200–582
200–608
Product name
............
............
............
............
............
............
Butorphanol Tartrate Injection.
TIAGARD (tiamulin) Liquid Concentrate.
Butorphanol Tartrate Injection.
QUELLIN (carprofen) Tablets.
LONCOR 300 (florfenicol) Injectable Solution.
BAYTRIL (enrofloxacin) Soft Chewable Tablets.
Following these changes of
sponsorship, neither Bayer HealthCare
LLC nor Pharmasone LLC are the
sponsor of an approved application.
Accordingly, they will be removed from
the list of sponsors of approved
applications in 21 CFR 510.600(c). As
provided in the regulatory text, the
animal drug regulations are amended to
reflect these changes of sponsorship.
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III. Technical Amendments
FDA is making the following
amendments to improve the accuracy,
consistency, and readability of the
animal drug regulations:
• 21 CFR 520.905a is amended to
reflect the approved conditions of use
for fenbendazole suspension in laying
hens.
• 21 CFR 522.1182 is amended to
reflect the 2016 change of sponsorship
of an injectable ferric hydroxide product
in young piglets.
• 21 CFR 522.1193 is amended to
reflect the approved withdrawal period
for a clorsulon injectable solution
product.
• 21 CFR 522.1696a is amended to
reflect an associated limitation for a
penicillin G benzathine and penicillin G
procaine injectable suspension product.
• 21 CFR 522.1890 is amended to
reflect the current format for titling
regulations for injectable dosage form
new animal drugs.
• Entries in parts 556 and 558 (21
CFR parts 556 and 558) for a coumaphos
Type A medicated article are being
added. These sections were withdrawn
in error (85 FR 18114, April 1, 2020).
• Part 558 is amended to reflect
current naming and organization for
specifications and application sponsors.
• 21 CFR 558.261 is amended to
reflect an approved incorporation level
of florfenicol in medicated feed for fish.
• 21 CFR 558.311 for lasalocid in
medicated feed is amended to reflect a
current tabular organization by species.
• 21 CFR 558.355 is amended to
provide accurate cross references for
approved uses to special considerations
and label statements for monensin
medicated feeds.
• 21 CFR 558.450 is amended to add
two indications for use of
oxytetracycline in medicated feed for
fish that were removed during the
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recent codification of a supplemental
approval (84 FR 12491 at 12502, April
2, 2019).
• Part 558 is amended by removing
21 CFR 558.465, which is redundant
with 21 CFR 558.464. The cross
reference for poloxalene in part 556 is
amended to reflect this action.
• Part 558 is amended by adding 21
CFR 558.470 to reflect the approved
conditions of use of a polyoxyethylene
medicated feed block, which previously
had been removed from 21 CFR part 520
without being added to part 558.
• Typographical errors are being
corrected wherever they have been
found.
IV. Legal Authority
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. This 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 the
conditions of use of an approved or
conditionally approved new animal
drug and the name and address of the
drug’s sponsor in a ‘‘notice, which upon
publication shall be effective as a
regulation.’’ A notice published
pursuant to section 512(i) is not subject
to the notice-and-comment rulemaking
requirements of the Administrative
Procedure Act, 5 U.S.C. 551 et seq. See
section 512(i) of the FD&C Act; 21 CFR
10.40(e)(3); S. Rep. 90–1308, at 5 (1968).
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.’’
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List of Subjects
21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
21 CFR Parts 520, 522, 524, and 529
Animal drugs.
21 CFR Part 556
Animal drugs, 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 510,
520, 522, 524, 529, 556, and 558 are
amended as follows:
PART 510—NEW ANIMAL DRUGS
1. The authority citation for part 510
continues to read as follows:
■
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
§ 510.600
[Amended]
2. In § 510.600, in the table in
paragraph (c)(1), remove the entry for
‘‘Bayer HealthCare LLC’’ and in the
table in paragraph (c)(2), remove the
entry for ‘‘000859’’.
■
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
3. The authority citation for part 520
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
4. In § 520.304, add paragraph (a)(3),
revise paragraphs (b)(1) and (2), and add
paragraph (b)(3) to read as follows:
■
§ 520.304
Carprofen.
(a) * * *
(3) Each chewable tablet contains 25,
37.5, 50, 75, or 100 mg carprofen.
(b) * * *
(1) Nos. 017033, 054771, 055529, and
062250 for use of product described in
paragraphs (a)(1) and (2) of this section
as in paragraph (c) of this section.
(2) No. 058198 for use of product
described in paragraph (a)(1) of this
section as in paragraph (c) of this
section.
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(3) No. 069043 for use of product
described in paragraph (a)(3) of this
section as in paragraph (c) of this
section.
*
*
*
*
*
■ 5. In § 520.530, revise paragraph (b) to
read as follows:
§ 520.530
Cythioate oral liquid.
*
*
*
*
*
(b) Sponsor. See Nos. 054771 and
058198 in § 510.600 of this chapter.
*
*
*
*
*
■ 6. In § 520.531, revise paragraph (b)(1)
to read as follows:
§ 520.531
Cythioate tablets.
*
*
*
*
*
(b) * * *
(1) No. 058198 for use of 30- and 90mg tablets.
*
*
*
*
*
■ 7. In § 520.812, revise paragraph (b)(1)
to read as follows:
§ 520.812
Enrofloxacin.
*
*
*
*
*
(b) * * *
(1) No. 058198 for use of products
described in paragraphs (a)(1)(i) and
(a)(2) and (3) of this section.
*
*
*
*
*
■ 8. In § 520.903a, revise paragraph (b)
to read as follows:
§ 520.903a
*
*
*
*
(b) Sponsor. See No. 058198 in
§ 510.600(c) of this chapter.
*
*
*
*
*
■ 9. In § 520.903b, revise paragraph (b)
to read as follows:
Febantel suspension.
*
*
*
*
*
(b) Sponsor. See No. 058198 in
§ 510.600(c) of this chapter.
*
*
*
*
*
■ 10. In § 520.903c, revise paragraph (b)
to read as follows:
§ 520.903c
paste.
Febantel and praziquantel
*
*
*
*
*
(b) Sponsor. See No. 058198 in
§ 510.600(c) of this chapter.
*
*
*
*
*
■ 11. In § 520.903d, revise paragraph (b)
to read as follows:
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§ 520.903d
Febantel tablets.
*
*
*
*
*
(b) Sponsor. See No. 058198 in
§ 510.600(c) of this chapter.
*
*
*
*
*
■ 12. In § 520.905a, revise paragraph
(e)(5)(ii), remove paragraph (e)(5)(iii),
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§ 520.905a
Fenbendazole suspension.
*
*
*
*
*
(e) * * *
(5) * * *
(ii) Indications for use. For the
treatment and control of adult Ascaridia
galli in broiler chickens and
replacement chickens, and for the
treatment and control of adult A. galli
and Heterakis gallinarum in breeding
chickens and laying hens.
(6) * * *
(ii) Indications for use. For the
treatment and control of: Lungworms:
Adult Metastrongylus apri, Adult
Metastrongylus pudendotectus;
Gastrointestinal worms: Adult and
larvae (L3, L4 stages, liver, lung,
intestinal forms) large roundworms
(Ascaris suum), Adult nodular worms
(Oesophagostomum dentatum, O.
quadrispinulatum), Adult small
stomach worms (Hyostrongylus
rubidus), Adult and larvae (L2, L3, L4
stages—intestinal mucosal forms)
whipworms (Trichuris suis); and Kidney
worms: Adult and larvae Stephanurus
dentatus.
*
*
*
*
*
■ 13. Revise § 520.998 to read as
follows:
§ 520.998
Febantel paste.
*
§ 520.903b
and revise paragraph (e)(6)(ii) to read as
follows:
Fluralaner.
(a) Specifications. (1) Each chewable
tablet contains 112.5, 250, 500, 1,000, or
1,400 milligrams (mg) fluralaner.
(2) Each chewable tablet contains 45,
100, 200, 400, or 560 mg fluralaner.
(b) Sponsor. See No. 000061 in
§ 510.600(c) of this chapter.
(c) Conditions of use in dogs—(1)
Amount. Administer orally as a single
dose with food:
(i) Chewable tablets described in
paragraph (a)(1) of this section.
Administer every 12 weeks, an
appropriate combination of tablets to
provide a minimum dose of 11.4 mg per
pound (lb) (25 mg per kilogram (kg))
body weight. May be administered every
8 weeks in case of potential exposure to
Amblyomma americanum ticks.
(ii) Chewable tablets described in
paragraph (a)(2) of this section.
Administer monthly, an appropriate
combination of tablets to provide a
minimum dose of 4.5 mg/lb (10 mg/kg)
body weight.
(2) Indications for use—(i) Chewable
tablets described in paragraph (a)(1) of
this section. Kills adult fleas; for the
treatment and prevention of flea
infestations (Ctenocephalides felis), and
the treatment and control of tick
infestations [Ixodes scapularis (blacklegged tick), Dermacentor variabilis
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(American dog tick), and Rhipicephalus
sanguineus (brown dog tick)] for 12
weeks in dogs and puppies 6 months of
age and older, and weighing 4.4 lbs or
greater; and for the treatment and
control of Amblyomma americanum
(lone star tick) infestations for 8 weeks
in dogs and puppies 6 months of age
and older, and weighing 4.4 lbs or
greater.
(ii) Chewable tablets described in
paragraph (a)(2) of this section. Kills
adult fleas; for the treatment and
prevention of flea infestations (C. felis),
and the treatment and control of tick
infestations [I. scapularis (black-legged
tick), D. variabilis (American dog tick),
and R. sanguineus (brown dog tick)] for
1 month in dogs and puppies 8 weeks
of age and older, and weighing 4.4 lbs
or greater; and for the treatment and
control of A. americanum (lone star
tick) infestations for 1 month in dogs
and puppies 6 months of age and older,
and weighing 4.4 lbs or greater.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
■ 14. In § 520.1156, revise paragraph (b)
to read as follows:
§ 520.1156
Imidacloprid.
*
*
*
*
*
(b) Sponsor. See No. 058198 in
§ 510.600(c) of this chapter.
*
*
*
*
*
■ 15. In § 520.1192, revise paragraph
(b)(2) to read as follows:
§ 520.1192
Ivermectin paste.
*
*
*
*
*
(b) * * *
(2) Nos. 051311, 054925, 058198, and
061133 for use of a 1.87 percent paste
for use as in paragraph (e)(1) of this
section.
*
*
*
*
*
■ 16. In § 520.1195, revise paragraph
(b)(1) to read as follows:
§ 520.1195
Ivermectin liquid.
*
*
*
*
*
(b) * * *
(1) Nos. 000010, 054925, 058005, and
058198 for use of product described in
paragraph (a)(1) of this section as in
paragraphs (e)(1)(i), (e)(1)(ii)(A), and
(e)(1)(iii) of this section.
*
*
*
*
*
■ 17. In § 520.1454, revise paragraph (b)
to read as follows:
§ 520.1454
Moxidectin solution.
*
*
*
*
*
(b) Sponsor. See No. 058198 in
§ 510.600(c) of this chapter.
*
*
*
*
*
E:\FR\FM\19MRR1.SGM
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Federal Register / Vol. 86, No. 52 / Friday, March 19, 2021 / Rules and Regulations
§ 520.2138
18. In § 520.1720a, add paragraph
(b)(5) to read as follows:
■
§ 520.1720a
boluses.
Phenylbutazone tablets and
*
*
*
*
*
(b) * * *
(5) No. 058198 for use of 1-g tablets
in horses.
*
*
*
*
*
■ 19. In § 520.1860, revise paragraph (b)
to read as follows:
§ 520.1860
Pradofloxacin.
*
*
*
*
*
(b) Sponsor. See No. 058198 in
§ 510.600(c) of this chapter.
*
*
*
*
*
■ 20. In § 520.1870, revise paragraph (b)
to read as follows:
§ 520.1870
Praziquantel tablets.
*
*
*
*
*
(b) Sponsors. See sponsors in
§ 510.600(c) of this chapter.
(1) No. 058198 for use of product
described in paragraph (a)(1) of this
section as in paragraph (c)(1) of this
section and for use of product described
in paragraph (a)(2) of this section as in
paragraph (c)(2) of this section.
(2) No. 069043 for use of product
described in paragraph (a)(1) of this
section as in paragraphs (c)(1) of this
section.
*
*
*
*
*
■ 21. In § 520.1871, revise paragraph
(b)(1) to read as follows:
§ 520.1871
Praziquantel and pyrantel.
*
*
*
*
*
(b) * * *
(1) See No. 058198 for use of tablets
described in paragraph (a)(1) of this
section for use as in paragraph (d)(1) of
this section.
*
*
*
*
*
■ 22. In § 520.1872, revise paragraph (b)
to read as follows:
§ 520.1872 Praziquantel, pyrantel pamoate,
and febantel tablets.
*
*
*
*
*
(b) Sponsor. See No. 058198 in
§ 510.600(c) of this chapter.
*
*
*
*
*
■ 23. In § 520.2043, revise paragraph
(b)(2) to read as follows:
§ 520.2043
jbell on DSKJLSW7X2PROD with RULES
*
*
*
*
(b) * * *
(2) Nos. 054771, 058198, and 058829
for use of the products described in
paragraph (a)(2) of this section as in
paragraph (d)(2) of this section.
*
*
*
*
*
■ 24. Add § 520.2138 to read as follows:
VerDate Sep<11>2014
16:22 Mar 18, 2021
Jkt 253001
■
§ 520.2260b Sulfamethazine sustainedrelease boluses.
§ 522.812
*
*
*
*
(b) 22.5-gram bolus—(1) Sponsor. See
No. 058198 in § 510.600(c) of this
chapter for use of a 22.5-gram
sulfamethazine prolonged-release bolus.
*
*
*
*
*
(e) 22.5-gram bolus—(1) Sponsor. See
No. 058198 in § 510.600(c) of this
chapter for use of a 22.5-gram
sulfamethazine sustained release bolus.
*
*
*
*
*
■ 26. In § 520.2455, revise paragraphs
(b)(1) and (2) to read as follows:
§ 520.2455
*
*
*
*
(b) * * *
(1) No. 058198 for products described
in paragraphs (a)(1) and (3) of this
section.
(2) No. 066104 for the product
described in paragraph (a)(1) of this
section.
*
*
*
*
*
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
27. The authority citation for part 522
continues to read as follows:
■
PO 00000
Frm 00013
Fmt 4700
28. In § 522.23, revise paragraph (b) to
read as follows:
§ 522.23
Acepromazine.
*
*
*
*
*
(b) Sponsors. See Nos. 000010 and
058198 in § 510.600(c) of this chapter.
*
*
*
*
*
■ 29. In § 522.234, revise paragraph (b)
to read as follows:
§ 522.234
Butamisole.
*
*
*
*
*
(b) Sponsors. See Nos. 054771 and
058198 in § 510.600(c) of this chapter.
*
*
*
*
*
■ 30. In § 522.246, revise paragraphs
(b)(2) and (3) to read as follows:
§ 522.246
Butorphanol.
*
*
*
*
*
(b) * * *
(2) No. 058198 for use of the product
described in paragraph (a)(2) of this
section as in paragraph (d)(2) of this
section.
(3) Nos. 000061, 058198, and 059399
for use of the product described in
paragraph (a)(3) of this section as in
paragraph (d)(3) of this section.
*
*
*
*
*
■ 31. In § 522.812, revise paragraphs
(b)(1) and (2) to read as follows:
Enrofloxacin.
*
*
*
*
*
(b) * * *
(1) Nos. 017033, 055529, and 058198
for use of product described in
paragraph (a)(1) of this section as in
paragraph (e)(1) of this section; and
(2) Nos. 055529, 058198, and 061133
for use of product described in
paragraph (a)(2) of this section as in
paragraphs (e)(2) and (3) of this section.
*
*
*
*
*
■ 32. In § 522.955, revise paragraph
(b)(2) to read as follows:
§ 522.955
Florfenicol.
*
Tiamulin.
*
Pyrantel pamoate suspension.
*
Authority: 21 U.S.C. 360b.
Spironolactone and benazepril.
(a) Specifications. Each chewable
tablet contains 20 milligrams (mg)
spironolactone and 2.5 mg benazepril
hydrochloride, 40 mg spironolactone
and 5 mg benazepril hydrochloride, or
80 mg spironolactone and 10 mg
benazepril hydrochloride.
(b) Sponsor. See No. 013744 in
§ 510.600(c) of this chapter.
(c) Conditions of use in dogs—(1)
Amount. Administer orally once daily,
with food, at a dose of 0.9 mg per pound
(lb) (2 mg per kilogram (kg))
spironolactone and 0.11 mg/lb (0.25 mg/
kg) benazepril hydrochloride, according
to dog body weight using a suitable
combination of whole and/or half
tablets.
(2) Indications for use. With
concurrent therapy (e.g., furosemide,
etc.) for the management of clinical
signs of mild, moderate, or severe
congestive heart failure in dogs due to
atrioventricular valvular insufficiency
(AVVI).
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
■ 25. In § 520.2260b, add a heading for
paragraph (b), revise paragraph (b)(1),
add a heading for paragraph (e), and
revise paragraph (e)(1) to read as
follows:
*
14819
Sfmt 4700
*
*
*
*
(b) * * *
(2) Nos. 000061 and 058198 for use of
product described in paragraph (a)(2) of
this section as in paragraph (d)(1)(ii) of
this section.
*
*
*
*
*
■ 33. In § 522.970, revise paragraph
(b)(1) to read as follows:
§ 522.970
Flunixin.
*
*
*
*
*
(b) * * *
(1) See Nos. 000061, 016592, 055529,
058198, and 061133 for use as in
paragraph (e) of this section.
*
*
*
*
*
E:\FR\FM\19MRR1.SGM
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Federal Register / Vol. 86, No. 52 / Friday, March 19, 2021 / Rules and Regulations
34. In § 522.995, revise paragraph (b)
to read as follows:
■
§ 522.995
Fluprostenol.
*
*
*
*
*
(b) Sponsor. See No. 058198 in
§ 510.600(c) of this chapter.
*
*
*
*
*
■ 35. In § 522.1010, revise paragraph
(b)(3) to read as follows:
§ 522.1010
Furosemide.
§ 522.1696a Penicillin G benzathine and
penicillin G procaine suspension.
*
Gonadorelin.
*
*
*
*
(b) * * *
(3) Nos. 000010 and 061133 for use of
the 50-mg/mL product described in
paragraph (a)(3) of this section as in
paragraphs (e)(1)(i) and (v) of this
section.
*
*
*
*
*
■ 37. In § 522.1086, revise paragraph (b)
to read as follows:
Guaifenesin solution.
*
*
*
*
*
(b) Sponsors. See Nos. 037990 and
058198 in § 510.600(c) of this chapter.
*
*
*
*
*
■ 38. In § 522.1182, revise paragraph
(b)(1) introductory text to read as
follows:
Iron injection.
Ivermectin and clorsulon.
jbell on DSKJLSW7X2PROD with RULES
*
*
*
*
(e) * * *
(3) * * *
(i) Nos. 000010, 055529, and 061133:
Do not treat cattle within 21 days of
slaughter. No. 058005: Do not treat
cattle within 49 days of slaughter.
*
*
*
*
*
■ 40. In § 522.1222, revise paragraph (b)
to read as follows:
VerDate Sep<11>2014
16:22 Mar 18, 2021
Jkt 253001
§ 522.1720
Phenylbutazone.
*
*
*
*
*
(b) * * *
(2) Nos. 000061, 054771, 058198, and
061133 for use of product described in
paragraph (a)(2) of this section as in
paragraph (c) of this section.
*
*
*
*
*
■ 44. In § 522.1870, revise paragraph (b)
to read as follows:
Praziquantel.
*
*
*
*
*
(b) * * *
(1) Nos. 016592 and 042552 for use of
product described in paragraph (a)(1)(i)
of this section as follows:
*
*
*
*
*
■ 39. In § 522.1193, revise paragraph
(e)(3)(i) to read as follows:
*
*
*
*
*
(d) * * *
(2) * * *
(iii) Limitations. Not for use within 30
days of slaughter. For Nos. 000859 and
016592: A withdrawal period has not
been established for this product in preruminating calves. Do not use in calves
to be processed for veal.
■ 43. In § 522.1720, revise paragraph
(b)(2) to read as follows:
§ 522.1870
*
§ 522.1193
Moxidectin solution.
*
*
*
*
(b) Sponsor. See No. 058198 in
§ 510.600(c) of this chapter.
*
*
*
*
*
■ 42. In § 522.1696a, revise paragraph
(d)(2)(iii) to read as follows:
*
§ 522.1182
*
*
*
*
(b) Sponsors. See Nos. 017033,
054771, 058198, 059399, 063286, and
069043 in § 510.600(c) of this chapter.
*
*
*
*
*
■ 41. In § 522.1450, revise paragraph (b)
to read as follows:
*
*
*
*
*
(b) * * *
(3) No. 058198 as described in
paragraph (a)(2) of this section for use
as in paragraphs (d)(1), (d)(2)(i), and
(d)(3) of this section.
*
*
*
*
*
■ 36. In § 522.1077:
■ a. Revise paragraph (b)(3);
■ b. Remove paragraph (b)(4); and
■ c. Redesignate paragraph (b)(5) as
paragraph (b)(4).
The revision reads as follows:
§ 522.1086
Ketamine.
*
§ 522.1450
*
§ 522.1077
§ 522.1222
*
*
*
*
(b) Sponsors. See Nos. 058198 and
061133 in § 510.600(c) of this chapter.
*
*
*
*
*
■ 45. In § 522.1890, revise the section
heading to read as follows:
§ 522.1890
Prednisone suspension.
(d) Conditions of use. It is
administered as follows:
(1) Turkeys (1- to 3-day-old poults)
and chickens (newly hatched chicks)—
(i) Amounts and indications for use. (A)
Administer 5 mg per poult
subcutaneously as an aid in the control
of chronic respiratory disease (CRD)
associated with Escherichia coli in 1- to
3-day-old turkey poults.
(B) Administer 10 mg per poult as a
single subcutaneous injection in the
nape of the neck as an aid in the control
of airsacculitis associated with
Mycoplasma meleagridis sensitive to
spectinomycin in 1- to 3-day-old turkey
poults.
(C) Administer 2.5 to 5 mg per chick
as an aid in the control of mortality and
to lessen severity of infections caused
by M. synoviae, Salmonella
typhimurium, S. infantis, and E. coli.
(ii) Limitations. For use only in 1- to
3-day-old turkey poults and newly
hatched chicks.
(2) Dogs—(i) Amount. Administer 2.5
to 5.0 mg per pound of body weight by
intramuscular injection twice daily.
Treatment may be continued for 4 days.
(ii) Indications for use. For treatment
of infections caused by gram-negative
and gram-positive organisms susceptible
to spectinomycin.
(iii) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
■ 47. In § 522.2662, revise paragraph
(b)(3) to read as follows:
§ 522.2662
Xylazine.
*
*
*
*
*
(b) * * *
(3) Nos. 058198 and 061651 for use of
product described in paragraph (a)(1) of
this section as in paragraph (d)(1) of this
section; and product described in
paragraph (a)(2) of this section as in
paragraphs (d)(2), (d)(3)(i), (d)(3)(ii)(A),
and (d)(3)(iii) of this section.
*
*
*
*
*
46. Revise § 522.2120 to read as
follows:
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
§ 522.2120
■
■
Spectinomycin hydrochloride.
(a) Specifications. Each milliliter of
solution contains 100 milligrams (mg)
spectinomycin hydrochloride (as
spectinomycin dihydrochloride
pentahydrate).
(b) Sponsors. See sponsors in
§ 510.600(c) of this chapter:
(1) Nos. 016592 and 054771 for use as
in paragraph (d)(1) of this section; and
(2) No. 058198 for use as in paragraph
(d)(2) of this section.
(c) Related tolerances. See § 556.600
of this chapter.
PO 00000
Frm 00014
Fmt 4700
Sfmt 4700
48. The authority citation for part 524
continues to read as follows:
Authority: 21 U.S.C. 360b.
49. In § 524.450, revise paragraph (b)
to read as follows:
■
§ 524.450
Clotrimazole.
*
*
*
*
*
(b) Sponsor. See No. 058198 in
§ 510.600(c) of this chapter.
*
*
*
*
*
■ 50. In § 524.775, revise paragraph (b)
to read as follows:
E:\FR\FM\19MRR1.SGM
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§ 524.775
Emodepside and praziquantel.
*
*
*
*
*
(b) Sponsor. See No. 058198 in
§ 510.600(c) of this chapter.
*
*
*
*
*
■ 51. In § 524.802, revise paragraph (b)
to read as follows:
§ 524.802 Enrofloxacin and silver
sulfadiazine otic emulsion.
*
*
*
*
*
(b) Sponsor. See No. 058198 in
§ 510.600(c) of this chapter.
*
*
*
*
*
■ 52. In § 524.920, revise paragraphs
(b)(1) through (3) to read as follows:
§ 524.920
Fenthion.
*
*
*
*
(b) * * *
(1) No. 058198 for use of product
described in paragraph (a)(1)(i) of this
section as in paragraph (d)(1) of this
section.
(2) No. 058198 for use of product
described in paragraph (a)(1)(ii) of this
section as in paragraph (d)(2) of this
section.
(3) No. 058198 for use of products
described in paragraph (a)(2) of this
section as in paragraph (d)(3) of this
section.
*
*
*
*
*
■ 53. In § 524.955, revise paragraph (b)
to read as follows:
§ 524.955 Florfenicol, terbinafine, and
betamethasone acetate otic gel.
*
*
*
*
*
(b) Sponsor. See No. 043264 in
§ 510.600(c) of this chapter.
*
*
*
*
*
■ 54. In § 524.957, revise paragraph (b)
to read as follows:
§ 524.957 Florfenicol, terbinafine, and
mometasone otic solution.
*
*
*
*
*
(b) Sponsor. See No. 058198 in
§ 510.600(c) of this chapter.
*
*
*
*
*
■ 55. In § 524.1140, revise paragraph (b)
to read as follows:
§ 524.1140
jbell on DSKJLSW7X2PROD with RULES
§ 524.1450
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
Moxidectin.
*
*
*
*
(b) * * *
(1) No. 058198 for use of product
described in paragraph (a)(1) of this
section as in paragraph (d)(1) of this
section; and
(2) No. 058198 for use of product
described in paragraph (a)(2) of this
section as in paragraph (d)(2) of this
section.
*
*
*
*
*
PART 529—CERTAIN OTHER DOSAGE
FORM NEW ANIMAL DRUGS
58. The authority citation for part 529
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
59. In § 529.56, revise paragraph (b) to
read as follows:
■
§ 529.56
Amikacin.
*
*
*
*
*
(b) Sponsors. See Nos. 054771 and
058198 in § 510.600(c) of this chapter.
*
*
*
*
*
■ 60. In § 529.1044a, revise paragraph
(b) to read as follows:
§ 529.1044a
infusion.
Gentamicin solution for
*
*
*
*
*
(b) Sponsors. See Nos. 000061,
016592, 054628, 054771, 058005,
058198, and 061133 in § 510.600(c) of
this chapter.
*
*
*
*
*
PART 556—TOLERANCES FOR
RESIDUES OF NEW ANIMAL DRUGS
IN FOOD
61. The authority citation for part 556
continues to read as follows:
■
*
*
*
*
(b) Sponsor. See No. 058198 in
§ 510.600(c) of this chapter.
*
*
*
*
*
■ 56. In § 524.1146, revise paragraphs
(b)(1) through (3) to read as follows:
Authority: 21 U.S.C. 342, 360b, 371.
■
*
*
*
*
(b) * * *
(1) Nos. 017030 and 058198 for use of
product described in paragraph (a)(1) of
this section as in paragraph (d)(1) of this
section.
16:22 Mar 18, 2021
Jkt 253001
62. Add § 556.168 to read as follows:
§ 556.168
Imidacloprid and moxidectin.
*
VerDate Sep<11>2014
(ii) Eggs: 0.1 ppm.
(2) [Reserved]
(c) Related conditions of use. See
§ 558.185 of this chapter.
■ 63. In § 556.517, revise paragraph (c)
to read as follows:
Imidacloprid and ivermectin.
*
§ 524.1146
(2) Nos. 017030 and 058198 for use of
product described in paragraph (a)(2) of
this section as in paragraph (d)(2) of this
section.
(3) No. 058198 for use of product
described in paragraph (a)(2) of this
section as in paragraph (d)(3) of this
section.
*
*
*
*
*
■ 57. In § 524.1450, revise paragraphs
(b)(1) and (2) to read as follows:
*
*
14821
Coumaphos.
(a) [Reserved]
(b) Tolerances. The tolerances for
coumaphos (measured as coumaphos
and its oxygen analog, O,O-diethyl O-3chloro-4-methyl-2-oxo-2 H-1benzopyran-7-yl phosphate) are:
(1) Chickens. (i) Edible tissues
(excluding eggs): 1 ppm.
PO 00000
Frm 00015
Fmt 4700
Sfmt 4700
§ 556.517
Poloxalene.
*
*
*
*
*
(c) Related conditions of use. See
§§ 520.1840 and 558.464 of this chapter.
64. The authority citation for part 558
continues to read as follows:
■
Authority: 21 U.S.C. 354, 360b, 360ccc,
360ccc–1, 371.
65. In § 558.55:
a. Revise paragraph (a);
b. Redesignate paragraphs (b) and (d)
as paragraphs (d) and (e); and
■ c. Add new paragraph (b).
The revision and addition read as
follows:
■
■
■
§ 558.55
Amprolium.
(a) Specifications. Type A medicated
article containing 25 percent
amprolium.
(b) Sponsor. No. 016592 in
§ 510.600(c) of this chapter.
*
*
*
*
*
■ 66. In § 558.58:
■ a. Revise paragraph (b); and
■ b. Redesignate paragraphs (c) and (d)
as paragraphs (d) and (c).
The revision reads as follows:
§ 558.58
Amprolium and ethopabate.
*
*
*
*
*
(b) Sponsor. See No. 016592 in
§ 510.600(c) of this chapter.
*
*
*
*
*
■ 67. In § 558.68, revise paragraph (a) to
read as follows:
§ 558.68
Avilamycin.
(a) Specifications. Each pound of
Type A medicated article contains 45.4
or 90.7 grams of avilamycin.
*
*
*
*
*
■ 68. In § 558.76:
■ a. Revise paragraph (b);
■ b. Remove paragraph (c); and
■ c. Redesignate paragraphs (d) and (e)
as paragraphs (c) and (d).
The revision reads as follows:
§ 558.76
Bacitracin methylenedisalicylate.
*
*
*
*
*
(b) Sponsors. See sponsors in
§ 510.600(c) of this chapter as follows:
(1) No. 054771 for use of products in
paragraph (a)(1) of this section as in
paragraph (d) of this section.
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Federal Register / Vol. 86, No. 52 / Friday, March 19, 2021 / Rules and Regulations
(2) No. 069254 for use of product in
paragraph (a)(2) of this section as in
paragraph (d) of this section.
*
*
*
*
*
■ 69. In § 558.78, revise paragraph (b) to
read as follows:
§ 558.78
Bacitracin zinc.
*
*
*
*
*
(b) Sponsor. See No. 054771 in
§ 510.600(c) of this chapter.
*
*
*
*
*
■ 70. In § 558.95:
■ a. Revise paragraph (a);
■ b. Redesignate paragraphs (b) and (d)
as paragraphs (d) and (e);
■ c. Add new paragraph (b);
■ d. Add a heading for newly
redesignated paragraph (e)(5); and
■ e. Revise newly redesignated
paragraph (e)(5)(iii).
The revisions and additions read as
follows:
§ 558.95
§ 558.128
Chlortetracycline.
*
*
*
*
*
(b) Sponsors. See sponsors in
§ 510.600(c) of this chapter as follows:
*
*
*
*
*
■ 72. In § 558.140, revise paragraph (b)
introductory text to read as follows:
§ 558.140 Chlortetracycline and
sulfamethazine.
*
Bambermycins.
(a) Specifications. Type A medicated
articles containing 2, 4, or 10 grams
bambermycins per pound.
(b) Sponsors. See sponsors in
§ 510.600(c) of this chapter as follows:
*
*
*
*
(b) Sponsors. See sponsors in
§ 510.600(c) of this chapter as follows:
*
*
*
*
*
■ 73. In § 558.175:
■ a. Revise paragraph (d)(3); and
■
b. Remove paragraph (e).
The revision reads as follows:
§ 558.175
Clopidol.
*
*
*
*
*
(d) * * *
(3) Combinations. Clopidol may also
be used in combination with:
(i) Chlortetracycline as in § 558.128.
(ii) Lincomycin as in § 558.325.
■ 74. Add § 558.185 to read as follows:
§ 558.185
Coumaphos.
(a) Specifications. Type A medicated
articles containing 1.12, 2.0, 11.2, or 50
percent coumaphos.
(b) Sponsor. See No. 058198 in
§ 510.600(c) of this chapter.
(c) Related tolerances. See § 556.168
of this chapter.
(d) Special considerations. (1)
Labeling shall bear the following
warning: The active ingredient
coumaphos is a cholinesterase inhibitor.
Do not use this product on animals
simultaneously or within a few days
before or after treatment with, or
exposure to, cholinesterase-inhibiting
drugs, pesticides, or chemicals.
(2) See § 500.25 of this chapter.
(e) Conditions of use in laying
chickens.
Coumaphos in
grams per ton
Indications for use
Limitations
(1) 27.2 (0.003 percent).
Laying chickens: For control of capillary
worm (Capillaria obsignata) and as an
aid in control of common round worm
(Ascaridia galli) and cecal worm
(Heterakis gallinae).
Replacement pullets: For control of capillary worm (Capillaria obsignata) and
as an aid in control of common round
worm (Ascaridia galli) and cecal worm
(Heterakis gallinae).
Feed continuously as the sole ration for 14 days. If reinfection occurs, treatment
may be repeated, but not sooner than 3 weeks after the end of the previous treatment. Do not feed to chickens within 10 days of vaccination or other conditions of
stress..
058198
Feed continuously as the sole ration for from 10 to 14 days. Do not feed to chickens under 8 weeks of age or within 10 days of vaccination or other conditions of
stress. If birds are maintained on contaminated litter or exposed to infected birds,
a second 10- to 14-day treatment is recommended, but not sooner than 3 weeks
after the end of the previous treatment. If reinfection occurs after production begins, repeat treatment as recommended for laying flocks..
058198
(2) 36.3 (0.004 percent).
Sponsor
75. In § 558.195, revise paragraph (b)
to read as follows:
■
76. In § 558.258, revise paragraph (b)
to read as follows:
■
§ 558.195
§ 558.258
§ 558.261
■
Decoquinate.
*
*
*
*
*
(b) Sponsor. See No. 054771 in
§ 510.600(c) of this chapter.
*
*
*
*
*
Florfenicol in
grams/ton of feed
jbell on DSKJLSW7X2PROD with RULES
(1) No. 016592: 2, 4, and 10 grams per
pound for use as in paragraphs (e)(1)
through (4) of this section.
(2) No. 012286: 2 grams for use as in
paragraph (e)(2) of this section and 0.4
and 2 grams per pound for use as in
paragraph (e)(3) of this section.
*
*
*
*
*
(e) * * *
(5) Combinations. * * *
(iii) Clopidol as in § 558.175.
*
*
*
*
*
■ 71. In § 558.128, revise paragraph (b)
introductory text to read as follows:
Fenbendazole.
*
*
*
*
*
(b) Sponsor. See No. 000061 in
§ 510.600(c) of this chapter.
*
*
*
*
*
16:22 Mar 18, 2021
*
Jkt 253001
*
*
*
*
*
*
Feed as a sole ration for 10 consecutive days to deliver 10 to 15 mg florfenicol per kg of fish.
Feed containing florfenicol shall not be fed for more than 10 days. Following administration,
fish should be reevaluated by a licensed veterinarian before initiating a further course of
therapy. The effects of florfenicol on reproductive performance have not been determined.
Feeds containing florfenicol must be withdrawn 15 days prior to slaughter.
*
PO 00000
Florfenicol.
*
*
(e) * * *
(2) * * *
Limitations
*
*
*
(ii) 182 to 2,724 ..... Freshwater-reared salmonids: For the control
of mortality due to coldwater disease associated with Flavobacterium psychrophilum and
furunculosis associated with Aeromonas
salmonicida.
VerDate Sep<11>2014
*
Indications for use
*
77. In § 558.261, revise paragraph
(e)(2)(ii) to read as follows:
Frm 00016
*
Fmt 4700
*
Sfmt 4700
E:\FR\FM\19MRR1.SGM
*
19MRR1
*
Federal Register / Vol. 86, No. 52 / Friday, March 19, 2021 / Rules and Regulations
78. In § 558.295, revise paragraph (a)
to read as follows:
■
§ 558.295
Iodinated casein.
(a) Specifications. Type A medicated
article containing iodinated casein.
*
*
*
*
*
■ 79. In § 558.305, revise paragraph (b)
to read as follows:
§ 558.305
b. Add a heading and introductory
text for paragraph (e);
■ c. Revise paragraph (e)(1);
■ d. Redesignate paragraphs (e)(2)
through (5) as paragraphs (e)(5) through
(8);
■ e. Add new paragraphs (e)(2) through
(4); and
■ f. In the table in newly redesignated
paragraph (e)(6)(i), revise the last row.
The revisions and additions read as
follows:
■
Laidlomycin.
*
*
*
*
*
(b) Sponsor. See No. 054771 in
§ 510.600(c) of this chapter.
*
*
*
*
*
■ 80. In § 558.311:
■ a. Revise paragraphs (a), (b), and
(d)(7);
§ 558.311
Lasalocid.
(a) Specifications. Each pound of
Type A medicated article contains 68
grams (15 percent), 90.7 grams (20
percent), or 150 grams (33.1 percent)
14823
lasalocid as lasalocid sodium activity. A
minimum of 90 percent of lasalocid
activity is derived from lasalocid A.
(b) Sponsor. See No. 054771 in
§ 510.600(c) of this chapter.
*
*
*
*
*
(d) * * *
(7) Each use in a free-choice Type C
cattle feed as in paragraphs (e)(3)(vi)
through (e)(3)(viii) of this section must
be the subject of an approved NADA or
supplemental NADA as provided in
§ 510.455 of this chapter.
(e) Conditions of use. It is used as
follows:
(1) The conditions of use for chickens
are:
Lasalocid in
grams/ton
Combination in
grams/ton
Indications for use
Limitations
(i) 68 to 113 ..........
.........................................................
Feed continuously as the sole ration ............
054771
(ii) 68 ....................
Bacitracin methylenedisalicylate, 10
to 50.
Feed continuously as the sole ration. Bacitracin methylenedisalicylate provided by
No. 054771 in § 510.600(c) of this chapter.
054771
(iii) 68 to 113 ........
Bacitracin methylenedisalicylate, 4
to 50.
Feed continuously as the sole ration. Bacitracin methylenedisalicylate provided by
No. 054771 in § 510.600(c) of this chapter.
054771
(iv) 68 to 113 ........
Bacitracin zinc, 4 to 50 ...................
Feed continuously as the sole ration. Bacitracin zinc provided by No. 054771 in
§ 510.600(c) of this chapter.
054771
(v) 68 to 113 .........
Bambermycins, 1 to 2 .....................
Broiler or fryer chickens: For prevention of
coccidiosis caused by Eimeria tenella, E.
necatrix, E. acervulina, E. brunetti, E.
mivati, and E. maxima..
Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella, E.
necatrix, E. acervulina, E. brunetti, E.
mivati, and E. maxima; and for increased
rate of weight gain and improved feed efficiency..
Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella, E.
necatrix, E. acervulina, E. brunetti, E.
mivati, and E. maxima; and for improved
feed efficiency..
Broiler chickens. For prevention of coccidiosis caused by Eimeria tenella, E.
necatrix, E. acervulina, E. brunetti, E.
mivati, and E. maxima; and for increased
rate of weight gain and improved feed efficiency..
Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella, E.
necatrix, E. acervulina, E. brunetti, E.
mivati, and E. maxima; and for increased
rate of weight gain and improved feed efficiency..
Feed
continuously
as
sole
ration.
Bambermycins provided by No. 016592 in
§ 510.600(c) of this chapter.
016592
Sponsor
jbell on DSKJLSW7X2PROD with RULES
(2) The conditions of use for turkeys
are:
Lasalocid in
grams/ton
Combination in
grams/ton
Indications for use
Limitations
(i) 68 to 113 ..........
.........................................................
Feed continuously as sole ration ..................
054771
(ii) 68 to 113 .........
Bacitracin methylenedisalicylate, 4
to 50.
Feed continuously as the sole ration. Bacitracin methylenedisalicylate as provided
by No. 054771 in § 510.600(c) in this
chapter.
054771
(iii) 68 to 113 ........
Bacitracin zinc, 4 to 50 ...................
Growing turkeys; For prevention of coccidiosis caused by Eimeria meleagrimitis, E.
gallopavonis, and E. adenoeides..
Growing turkeys: For prevention of coccidiosis caused by E. meleagrimitis, E.
gallopavonis, and E. adenoeides; and for
increased rate of weight gain and improved feed efficiency..
Growing turkeys: For prevention of coccidiosis caused by E. meleagrimitis, E.
gallopavonis, and E. adenoeides; and for
increased rate of weight gain and improved feed efficiency..
Feed continuously as the sole ration. Bacitracin zinc as provided by No. 054771 in
§ 510.600(c) in this chapter.
054771
(3) The conditions of use for cattle
are—
VerDate Sep<11>2014
16:22 Mar 18, 2021
Jkt 253001
PO 00000
Frm 00017
Fmt 4700
Sfmt 4700
E:\FR\FM\19MRR1.SGM
19MRR1
Sponsor
14824
Federal Register / Vol. 86, No. 52 / Friday, March 19, 2021 / Rules and Regulations
Lasalocid amount
Indications for use
Limitations
(i) 10 to 30 grams/ton of feed .............
Cattle fed in confinement for slaughter: For
improved feed efficiency..
(ii) 25 to 30 grams/ton of feed ............
(iii) Not less than 60 mg or more than
300 mg of lasalocid per head per
day.
Cattle fed in confinement for slaughter: For
improved feed efficiency and increased rate
of weight gain..
Pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers): For increased rate of weight gain..
(iv) 1 mg lasalocid per 2.2 pounds (lb)
body weight per day.
Cattle up to 800 lb: For control of coccidiosis
caused by Eimeria bovis and E. zuernii..
(v) 1 mg lasalocid per 2.2 lb body
weight per day.
Replacement calves: For control of coccidiosis
caused by E. bovis and E. zuernii..
(vi) 1,440 grams/ton ............................
Pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers): For increased rate of weight gain..
Pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers): For increased rate of weight gain..
Pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers): for increased rate of weight gain..
Feed continuously in complete feed to provide not less than
100 milligrams (mg) nor more than 360 mg of lasalocid sodium activity per head per day.
Feed continuously in complete feed to provide not less than
250 mg nor more than 360 mg of lasalocid sodium activity
per head per day.
Feed continuously at a rate of not less than 60 mg or more
than 300 mg of lasalocid per head per day when on pasture. The drug must be contained in at least 1 pound of
feed. Daily intakes of lasalocid in excess of 200 mg/head/
day have not been shown to be more effective than 200
mg/head/day.
Hand feed continuously at a rate of 1 mg of lasalocid per 2.2
lb body weight per day to provide not more than 360 mg of
lasalocid per head per day.
In milk replacer powder, hand feed at a rate of 1 mg of
lasalocid per 2.2 lb body weight per day. A withdrawal period has not been established for lasalocid in pre-ruminating calves. Do not use in calves to be processed for
veal.
As a free-choice Type C medicated loose mineral, feed continuously at a rate of not less than 60 mg nor more than
200 mg of lasalocid per head per day.
As a free-choice Type C medicated mineral block, feed continuously at a rate of not less than 60 mg nor more than
200 mg of lasalocid per head per day.
As a free-choice Type C medicated protein block, feed continuously at a rate of not less than 60 mg nor more than
200 mg of lasalocid per head per day.
(vii) 1,440 grams/ton ...........................
(viii) 300 grams/ton .............................
Sponsor
054771
054771
054771
054771
054771
012286
017800
067949
(4) The conditions of use for minor
species are:
Lasalocid in
grams/ton
Indications for use
Limitations
(i) 20 to 30 ..........................................
Sheep maintained in confinement: For prevention of coccidiosis caused by Eimeria ovina,
E.
crandallis,
E.
ovinoidalis
(E.
ninakohlyakimovae), E. parva, and E.
intricata..
Chukar partridges: For prevention of coccidiosis caused by E. legionensis..
Rabbits: For prevention of coccidiosis caused
by E. stiedae..
Feed continuously in complete feed to provide not less than
15 milligrams (mg) nor more than 70 mg of lasalocid sodium activity per head per day depending on body weight.
054771
Feed continuously as sole ration up to 8 weeks of age ...........
054771
Feed continuously as sole ration up to 6 1/2 weeks of age ....
054771
(ii) 113 .................................................
(iii) 113 ................................................
*
*
*
(6) * * *
*
*
Sponsor
(i) * * *
Ingredient
Percent
*
*
*
*
*
Lasalocid liquid Type A medicated article (90.7 g/lb) 2 ...........................................................................................
*
*
*
*
§ 558.325
*
81. In § 558.325, revise paragraphs (b)
and (e)(1)(ix) to read as follows:
■
jbell on DSKJLSW7X2PROD with RULES
Lincomycin
grams/ton
Combination in
grams/ton
16:22 Mar 18, 2021
Jkt 253001
*
*
*
*
(b) Sponsor. See No. 054771 in
§ 510.600(c) of this chapter.
*
*
*
*
*
Indications for use
2 To provide 150 gm lasalocid per ton, use 1.652
lb (0.083%) of a lasalocid liquid Type A medicated
article containing 90.7 g/lb. If using a dry lasalocid
VerDate Sep<11>2014
Lincomycin.
*
PO 00000
Frm 00018
Fmt 4700
Sfmt 4700
0.083
*
........................
(e) * * *
(1) * * *
Limitations
Type A medicated article containing 68 g/lb, use,
use 2.206 lbs per ton (0.111%), replacing molasses.
If using a dry lasalocid Type A medicated article
*
International
feed No.
Sponsors
containing 90.7 g/lb, use 1.652 lbs per ton (0.083%),
adding molasses.
E:\FR\FM\19MRR1.SGM
19MRR1
14825
Federal Register / Vol. 86, No. 52 / Friday, March 19, 2021 / Rules and Regulations
Lincomycin
grams/ton
Combination in
grams/ton
*
(ix) 2 .....................
*
Salinomycin, 40
to 60.
*
*
*
*
Indications for use
Limitations
*
Broiler chickens: For the control of
necrotic enteritis caused or complicated by Clostridium spp. or
other organisms susceptible to
lincomycin, and for the prevention of coccidiosis caused by
Eimeria tenella, E. necatrix, E.
acervulina,
E
maxima,
E.
brunetti, and E. mivati.
*
*
*
*
Feed as the sole ration to broiler chickens. Do not feed to laying hens
producing eggs for human consumption. Not approved for use with
pellet binders. May be fatal if accidentally fed to adult turkeys or
horses. Not for use in laying hens, breeding chickens, or turkeys. Do
not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may
result in severe gastrointestinal effects. Salinomycin as provided by
No. 054771 in § 510.600 of this chapter.
*
*
*
*
82. In § 558.342, revise paragraph (b)
to read as follows:
■
§ 558.342
Melengestrol.
*
*
*
*
*
(b) Sponsor. See sponsors in
§ 510.600(c) of this chapter for use as in
paragraph (e) of this section.
*
*
*
*
*
83. In § 558.355, revise paragraphs (b)
introductory text, (d)(9)(i) and (ii), and
(d)(10)(i) and (ii) to read as follows:
■
§ 558.355
Monensin.
*
*
*
*
*
(b) Sponsors. See sponsors in
§ 510.600(c) of this chapter as follows:
*
*
*
*
*
(d) * * *
(9) * * *
Narasin and
nicarbazin
grams/ton
Combination in
grams/ton
*
(ii) 27 to 45 of
each drug.
*
Bacitracin
methylenedisalicylate, 4 to 50.
*
*
*
*
*
*
jbell on DSKJLSW7X2PROD with RULES
Oxytetracycline
amount
*
(iv) 3.75 g/100 lb of
fish/day.
VerDate Sep<11>2014
§ 558.363
Narasin.
(a) Specifications. Type A medicated
articles containing 36, 45, 54, 72, or 90
grams narasin per pound.
*
*
*
*
*
■ 85. In § 558.364, revise paragraph
(d)(1)(ii) to read as follows:
§ 558.364
*
Naracin and nicarbazin.
*
*
(d) * * *
(1) * * *
*
*
*
*
*
*
Feed continuously as sole ration. Do not feed to laying hens. Do not
allow turkeys, horses, or other equines access to formulations containing narasin. Ingestion of narasin by these species has been fatal.
For No. 054771: Withdraw 5 days before slaughter. For No. 069254:
Zero withdrawal period. Bacitracin methylenedisalicylate as provided
by Nos. 054771 and 069254 in § 510.600(c) of this chapter.
*
Nicarbazin.
*
section). See paragraphs (d)(6) and
(d)(7)(i), (vii), (viii), and (ix) of this
section. Paragraph (d)(7)(vii) of this
section does not apply to free-choice
Type C medicated feeds as defined in
§ 510.455 of this chapter.
*
*
*
*
*
■ 84. In § 558.363, revise paragraph (a)
to read as follows:
*
Broiler chickens: For the prevention
of coccidiosis caused by Eimeria
necatrix,
E.
tenella,
E.
acervulina, E. brunetti, E. mivati,
and E. maxima, and for increased rate of weight gain and
improved feed efficiency.
*
*
*
Sponsor
*
(b) Sponsors. See Nos. 058198,
060728, and 066104 in § 510.600(c) of
this chapter.
*
*
*
*
*
■ 87. In § 558.450, revise paragraph
(e)(5)(iv) to read as follows:
*
§ 558.450
*
Oxytetracycline.
*
*
(e) * * *
(5) * * *
*
*
Limitations
*
*
1. Freshwater-reared salmonids: For control of mortality due to coldwater disease associated with Flavobacterium
psychrophilum.
*
*
*
*
Administer in mixed ration for 10 days. Do not liberate fish or slaughter fish for food
for 21 days following the last administration of medicated feed..
Jkt 253001
PO 00000
Frm 00019
Fmt 4700
Sfmt 4700
E:\FR\FM\19MRR1.SGM
058198
069254
*
Indications for use
16:22 Mar 18, 2021
05477
*
Limitations
86. In § 558.366, revise paragraph (b)
to read as follows:
*
*
Indications for use
■
§ 558.366
*
(i) Cattle (as described in paragraphs
(f)(3)(i) through (iii), (vi), and (vii) and
(f)(4)(i) through (vi) of this section). See
paragraphs (d)(6) and (d)(7)(i) through
(v), (vii), and (viii) of this section.
(ii) Dairy cows (as described in
paragraphs (f)(3)(iv) and (v) of this
section). See paragraphs (d)(6) and
(d)(7)(i) through (iv), (vii), (viii), and (ix)
of this section.
*
*
*
*
*
(10) * * *
(i) Cattle (as described in paragraphs
(f)(3)(i) through (iii), (vi), and (vii) and
(f)(4)(i) through (vi) of this section). See
paragraphs (d)(6) and (d)(7)(i), (v), (vii),
and (viii) of this section. Paragraph
(d)(7)(vii) of this section does not apply
to free-choice Type C medicated feeds
as defined in § 510.455 of this chapter.
(ii) Dairy cows (as described in
paragraphs (f)(3)(iv) and (v) of this
*
*
*
Sponsors
Sponsor
19MRR1
066104
14826
Federal Register / Vol. 86, No. 52 / Friday, March 19, 2021 / Rules and Regulations
Oxytetracycline
amount
Indications for use
Limitations
Freshwater-reared
Oncorhynchus
mykiss: For control of mortality due to
columnaris disease associated with
Flavobacterium columnare.
3. Freshwater-reared salmonids weighing
up to 55 grams: For marking the skeletal tissue.
Administer in mixed ration for 10 days. Do not liberate fish or slaughter fish for food
for 21 days following the last administration of medicated feed..
066104
Feed for 10 days. Immediate release is permitted following last feeding of medicated feed..
066104
2.
*
§ 558.465
■
■
*
*
[Removed]
*
90. In § 558.485, revise paragraph (b)
introductory text to read as follows:
§ 558.500
§ 558.550
Pyrantel.
*
(a) Specifications. Each molassesbased block contains 2.2 percent
polyoxyethylene (23) lauryl ether.
(b) Sponsor. See No. 067949 in
§ 510.600(c) of this chapter.
(c) [Reserved]
(d) Conditions of use—(1) Amount. 2
grams of polyoxyethylene (23) lauryl
ether per 100 kilograms of body weight
per day (1 pound of block per 500
kilogram (1,100 pound) animal per day).
Initially, provide one block per five
head of cattle. Start treatment 10 to 14
days before exposure to bloat-producing
pastures.
(2) Indications for use. For reduction
of the incidence of bloat (alfalfa and
clover) in pastured cattle.
(3) Limitations. Administer freechoice to beef cattle and nonlactating
dairy cattle only. Do not allow cattle
access to other sources of salt while
being fed this product. Do not feed this
product to animals without adequate
forage/roughage consumption.
*
*
*
*
*
(b) Sponsors. See sponsors in
§ 510.600(c) of this chapter for use as
follows:
*
*
*
*
*
■ 91. In § 558.500, revise paragraph (b)
to read as follows:
§ 558.485
Polyoxyethylene.
*
93. In § 558.550:
a. Revise paragraphs (a), (b), (e)(1)(i),
and (e)(2)(i);
■ b. Add a heading for paragraph (e)(3);
■ c. Redesignate paragraphs (e)(3)(i)
through (iv) as paragraphs (e)(3)(ii)
through (v); and
■ d. Add new paragraph (e)(3)(i).
The revisions and additions read as
follows:
■
88. Remove § 558.465.
89. Add § 558.470 to read as follows:
§ 558.470
*
Sponsor
Ractopamine.
*
*
*
*
*
(b) Sponsor. See Nos. 054771 and
058198 in § 510.600(c) of this chapter.
*
*
*
*
*
■ 92. In § 558.515:
■ a. Revise paragraph (a);
■ b. Redesignate paragraphs (b), (d), and
(e) as paragraphs (d), (e), and (f); and
■ c. Add new paragraph (b).
The revision and addition read as
follows:
§ 558.515
Robenidine.
(a) Specifications. Type A medicated
articles containing 30 grams per pound.
(b) Sponsor. See No. 054771 in
§ 510.600(c) of this chapter.
*
*
*
*
*
■
■
Salinomycin.
(a) Specifications. Type A medicated
articles containing:
(1) 30 grams of salinomycin sodium
activity per pound; or
(2) 60 grams of salinomycin sodium
activity per pound.
(b) Sponsors. See sponsors in
§ 510.600(c) of this chapter as follows:
(1) No. 016592 for product described
in paragraph (a)(1) of this section.
(2) Nos. 016592 and 069254 for
product described in paragraph (a)(2) of
this section.
*
*
*
*
*
(e) * * *
(1) * * *
Salinomycin in
grams/ton
Combination in
grams/ton
Indications for use
Limitations
(i) 40 to 60 ............
............................
Broiler, roaster, and replacement
(breeder and layer) chickens: For
the prevention of coccidiosis
caused by Eimeria tenella, E.
necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati.
Feed continuously as sole ration. Do not feed to birds producing eggs
for human consumption. May be fatal if accidentally fed to adult turkeys or horses..
*
*
*
*
Sponsor
*
*
016592
069254
*
(2) * * *
Salinomycin in
grams/ton
Combination in
grams/ton
Indications for use
Limitations
(i) 50 .....................
............................
Quail: For the prevention of coccidiosis caused by Eimeria.
dispersa and E. lettyae.
Feed continuously as sole ration. Do not feed to birds producing eggs
for human consumption. May be fatal if accidentally fed to adult turkeys or horses..
jbell on DSKJLSW7X2PROD with RULES
*
*
(3) Combinations. * * *
(i) Avilamycin as in § 558.68.
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94. In § 558.555, revise paragraph (b)
to read as follows:
■
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Federal Register / Vol. 86, No. 52 / Friday, March 19, 2021 / Rules and Regulations
(b) Sponsor. See No. 066104 in
§ 510.600(c) of this chapter for use of
product described in paragraph (a)(1) of
this section as in paragraph (d) of this
section; for use of product described in
paragraph (a)(2) of this section as in
paragraph (e) of this section.
*
*
*
*
*
95. In § 558.575, revise paragraph (b)
introductory text to read as follows:
■
§ 558.575 Sulfadimethoxine and
ormetoprim.
*
*
*
*
*
(b) Sponsors. See sponsors in
§ 510.600(c) of this chapter as follows:
*
*
*
*
*
96. In § 558.600, revise paragraphs (a)
and (d) to read as follows:
■
§ 558.600
Thiabendazole.
(a) Specifications. Dry Type A
medicated articles containing 22, 44.1,
66.1, or 88.2 percent thiabendazole.
*
*
*
*
*
(d) Special considerations. (1) The
66.1 percent Type A medicated article is
solely for the manufacture of cane
molasses liquid Type B feed, which is
mixed in dry feeds.
(2) The 88.2 percent Type A
medicated article is used solely for the
manufacture of an aqueous slurry for
adding to a Type C dry cattle feed.
(3) Do not use in Type B or Type C
medicated feed containing bentonite.
*
*
*
*
*
■ 97. In § 558.612, revise paragraph (b)
to read as follows:
§ 558.612
*
Tiamulin.
*
*
*
*
(b) Sponsor. See No. 058198 in
§ 510.600(c) of this chapter.
*
*
*
*
*
■ 98. In § 558.618, revise paragraph (b)
to read as follows:
§ 558.618
Tilmicosin.
*
*
*
*
*
(b) Sponsor. See Nos. 016592 and
058198 in § 510.600(c) of this chapter.
*
*
*
*
*
■ 99. In § 558.680, revise paragraphs (b),
(d)(1)(i) and (v), and (d)(2)(i) to read as
follows:
§ 558.680
Zoalene.
*
*
*
*
*
(b) Sponsors. See Nos. 054771 and
058198 in § 510.600(c) of this chapter.
*
*
*
*
*
(d) * * *
(1) * * *
Zoalene in
grams/ton
Combination in
grams per ton
Indications for use
Limitations
(i) 36.3 to 113.5 .....
..............................
Replacement chickens: For development of active immunity to
coccidiosis.
Feed continuously as sole ration. Grower ration not to be fed to birds
over 14 weeks of age. Starter ration not to be fed to laying birds.
Growing conditions
Starter ration
grams per ton
Severe exposure ...........................
Light to moderate exposure ..........
113.5 (0.0125%) .........................................................
75.4–113.5 (0.0083%–0.0125%) ................................
Zoalene in
grams/ton
Combination in
grams per ton
*
(v) 113.5 .................
*
054771
058198
Grower ration
grams per ton
75.4–113.5 (0.0083%–0.0125%)
36.3–75.4 (0.004%–0.0083%)
Indications for use
Limitations
*
*
.............................. Broiler chickens: For prevention
and control of coccidiosis.
*
Sponsor
Sponsor
*
*
*
Feed continuously as sole ration. Not to be fed to laying birds
*
*
*
*
*
054771
058198
*
(2) * * *
Zoalene in
grams/ton
Combination in
grams per ton
Indications for use
Limitations
(i) 113.5 to 170.3 ..
............................
Growing turkeys: For prevention
and control of coccidiosis.
Feed continuously as sole ration. For turkeys grown for meat purposes
only. Not to be fed to laying birds..
*
*
*
*
*
*
*
*
Dated: March 4, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–05203 Filed 3–18–21; 8:45 a.m.]
*
*
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R05–OAR–2016–0321; FRL–10021–
50–Region 5]
jbell on DSKJLSW7X2PROD with RULES
BILLING CODE 4164–01–P
Air Plan Approval; Michigan; Partial
Approval and Partial Disapproval of
the Detroit SO2 Nonattainment Area
Plan
Environmental Protection
Agency (EPA).
AGENCY:
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ACTION:
054771
058198
*
Final rule.
The Environmental Protection
Agency (EPA) is partially approving and
partially disapproving a revision to the
Michigan State Implementation Plan
(SIP) for attaining the 2010 1-hour
primary sulfur dioxide (SO2) national
ambient air quality standard (NAAQS or
‘‘standard’’) for the Detroit SO2
nonattainment area (NAA). This SIP
revision (hereinafter called the ‘‘Detroit
SO2 plan’’ or ‘‘plan’’) includes
Michigan’s attainment demonstration
and other elements required under the
SUMMARY:
E:\FR\FM\19MRR1.SGM
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]]>Agencies
[Federal Register Volume 86, Number 52 (Friday, March 19, 2021)]
[Rules and Regulations]
[Pages 14815-14827]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-05203]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, 529, 556, and 558
[Docket No. FDA-2020-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications;
Changes of Sponsorship; Change of Sponsor's Name and Address
AGENCY: Food and Drug Administration, Department of Health and Human
Services (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 July, August, and September 2020. FDA is
informing the public of the availability of summaries of the basis of
approval and of environmental review documents, where applicable. The
animal drug regulations are also being amended to improve the accuracy
and readability of the regulations.
DATES: This rule is effective March 19, 2021.
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. Approvals
FDA is amending the animal drug regulations to reflect approval
actions for NADAs and ANADAs during July, August, and September 2020,
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, 240-402-7500. 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 July, August, and
September 2020
--------------------------------------------------------------------------------------------------------------------------------------------------------
Approval date File No. Sponsor Product name Species Effect of the action Public documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
July 9, 2020.............. 141-532 Intervet, Inc., 2 BRAVECTO 1-MONTH Dogs.................. Original approval for FOI Summary.
Giralda Farms, (furalaner) Chews the treatment and
Madison, NJ 07940. for Dogs. prevention of flea
infestations, and
the treatment and
control of tick
infestations for 1
month in dogs and
puppies.
July 27, 2020............. 141-538 Ceva Sante Animale, CARDALIS Dogs.................. Original approval FOI Summary.
10 Avenue de la (spironolactone and with concurrent
Ballasti[egrave]re, benazepril therapy (e.g.,
33500 Libourne, hydrochloride furosemide, etc.)
France. chewable tablets). for the management
of clinical signs of
mild, moderate, or
severe congestive
heart failure in
dogs due to
atrioventricular
valvular
insufficiency (AVVI).
July 29, 2020............. 200-687 Cronus Pharma Carprofen Chewable Dogs.................. Original approval as FOI Summary.
Specialities India Tablets. a generic copy of
Private Ltd., Sy No- NADA 141-111.
99/1, GMR Hyderabad
Aviation SEZ Ltd.,
Mamidipalli Village,
Shamshabad Mandal,
Ranga Reddy,
Hyderabad,
Telangana, 501218,
India.
August 4, 2020............ 200-681 Dechra Veterinary Carprofen Tablets.... Dogs.................. Original approval as FOI Summary.
Products LLC, 7015 a generic copy of
College Blvd., Suite NADA 140-035.
525, Overland Park,
KS 66211.
September 9, 2020......... 141-529 Pharmgate LLC, 1800 MAXIBAN (naracin and Chickens.............. Original approval for FOI Summary.
Sir Tyler Dr., nicarbazin) plus increased rate of
Wilmington, NC 28405. PENNITRACIN MD weight gain,
(bacitracin improved feed
methylenedisalicylat efficiency, and for
e) Type C medicated the prevention of
feeds. coccidiosis in
broiler chickens.
September 18, 2020........ 200-690 Pharmasone LLC, 1800 ZOASHIELD 25% Chickens, turkeys..... Original approval as FOI Summary.
Sir Tyler Dr., (zoalene Type A a generic copy of
Wilmington, NC 28405. medicated article). NADA 141-218.
September 28, 2020........ 200-069 Bimeda Animal Health OVACYST (gonadorelin) Cattle................ Supplemental approval FOI Summary.
Ltd., 1B The Herbert Injectable Solution. for fixed-time
Building, The Park, artificial
Carrickmines, Dublin insemination (FTAI)
18, Ireland. in beef cows and
lactating dairy cows.
[[Page 14816]]
September 29, 2020........ 200-528 Pharmgate, Inc, 1800 SAVALAN 60 Chickens, quail....... Original approval as FOI Summary.
Sir Tyler Dr., (salinomycin sodium) a generic copy of
Wilmington, NC 28405. Type A medicated NADA 011-116.
article.
--------------------------------------------------------------------------------------------------------------------------------------------------------
II. Changes of Sponsor
Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140 has
informed FDA that it has transferred ownership of, and all rights and
interest in, NADA 141-437 for OSNURIA (betamethasone acetate,
florfenicol, terbinafine) Otic Gel to Dechra, Ltd., Snaygill Industrial
Estate, Keighley Rd., Skipton, North Yorkshire, BD23 2RW, United
Kingdom.
Pharmasone LLC, 1800 Sir Tyler Dr., Wilmington, NC 28405 has
informed FDA that it has transferred ownership of, and all rights and
interest in, ANADA 200-690 for ZOASHIELD 25% (zoalene Type A medicated
article) to Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140.
Also, Bayer HealthCare LLC, Animal Health Division, P.O. Box 390,
Shawnee Mission, KS 66201 has informed FDA that it has transferred
ownership of, and all rights and interest in, the 39 NADAs and 17
ANADAs listed below to Elanco US Inc., 2500 Innovation Way, Greenfield,
IN 46140:
------------------------------------------------------------------------
File No. Product name
------------------------------------------------------------------------
034-641.................. TIGUVON (fenthion) Pour-On Cattle
Insecticide.
040-001.................. MELDANE 2 (coumaphos) Type A Medicated
Article.
045-416.................. TEVCODYNE (phenylbutazone) Injectable.
047-138.................. SPOTTON (fenthion) 20% Ready-to-Use Cattle
Insecticide.
047-955.................. ROMPUN (xylazine hydrochloride) Injectable
(20 mg).
047-956.................. ROMPUN (xylazine hydrochloride) Injectable
(100 mg).
091-818.................. Phenylbutazone Tablets, USP 1 gram.
093-329.................. HAVASPAN (sulfamethazine) Prolonged Release
Bolus; SULFASPAN (sulfamethazine) Prolonged
Release Bolus.
093-483.................. SPECTAM (spectinomycin hydrochloride)
Injectable Solution.
107-345.................. RINTAL (febantel) Paste.
107-346.................. RINTAL (febantel) Suspension.
111-529.................. EQUIMATE (fluprostenol sodium).
111-607.................. DRONCIT (praziquantel) 5.68% Injectable
Solution.
111-798.................. DRONCIT (praziquantel) Canine Cestocide
Tablets; DRONCIT (praziquantel) Feline
Cestocide Tablets.
116-089.................. VELTRIM (clotrimazole) 1% Dermatologic Cream.
132-336.................. PROBAN (cythioate) Oral Liquid.
132-337.................. PROBAN (cythioate) Tablets.
132-533.................. STYQUIN (butamisole hydrochloride) Parenteral
1.1%.
132-789.................. PRO-SPOT (fenthion) Solution.
133-953.................. VERCOM (febantel and praziquantel) Paste
Anthelmintic.
140-441.................. BAYTRIL (enrofloxacin) Antibacterial Tablets;
BAYTRIL TASTE TABS (enrofloxacin)
Antibacterial Tablets.
140-912.................. RINTAL (febantel) Tabs Anthelmintic Tablets.
140-913.................. BAYTRIL (enrofloxacin) Antibacterial
Injectable Solution.
141-007.................. DRONTAL Plus (febantel, praziquantel,
pyrantel pamoate) Taste Tablets.
141-008.................. DRONTAL (praziquantel and pyrantel pamoate)
Tablets.
141-068.................. BAYTRIL 100 (enrofloxacin) Injectable
Solution.
141-099.................. CYDECTIN (moxidectin) Pour-On for Beef and
Dairy Cattle.
141-176.................. BAYTRIL (enrofloxacin and silver
sulfadiazine) Otic Emulsion.
141-208.................. ADVANTAGE DUO (imidacloprid and ivermectin)
Topical Solution.
141-220.................. CYDECTIN (moxidectin) Injectable Solution.
141-247.................. CYDECTIN (moxidectin) Oral Drench for Sheep.
141-251.................. ADVANTAGE MULTI (imidacloprid and moxidectin)
Topical Solution for Dogs.
141-254.................. ADVANTAGE MULTI (imidacloprid and moxidectin)
Topical Solution for Cats.
141-275.................. PROFENDER (emodepside and praziquantel)
Topical Solution.
141-344.................. VERAFLOX (pradofloxacin) Oral Suspension for
Cats.
141-417.................. CORAXIS (moxidectin) Topical Solution.
141-435.................. ADVANTUS (imidacloprid) Tablets.
141-440.................. CLARO (florfenicol, mometasone furoate,
terbinafine) Otic Solution.
141-527.................. BAYTRIL 100 (enrofloxacin) CA1.
200-042.................. Ketamine Hydrochloride Injection, USP.
200-124.................. Flunixin Meglumine Injection.
200-126.................. Phenylbutazone 20% Injection.
200-137.................. GENTAMAX 100 (gentamicin sulfate) Solution.
200-181.................. AMIMAX E (amikacin sulfate) Solution.
200-202.................. PHOENECTIN (ivermectin) Liquid for Horses.
200-230.................. Guaifenesin Injection.
200-246.................. ANTHELBAN V (pyrantel pamoate) Equine
Anthelmintic Suspension.
200-286.................. PHOENECTIN (ivermectin) Paste 1.87%.
200-293.................. Furosemide Injection 5%.
200-319.................. Acepromazine Maleate Injection.
[[Page 14817]]
200-322.................. Butorphanol Tartrate Injection.
200-360.................. TIAGARD (tiamulin) Liquid Concentrate.
200-408.................. Butorphanol Tartrate Injection.
200-555.................. QUELLIN (carprofen) Tablets.
200-582.................. LONCOR 300 (florfenicol) Injectable Solution.
200-608.................. BAYTRIL (enrofloxacin) Soft Chewable Tablets.
------------------------------------------------------------------------
Following these changes of sponsorship, neither Bayer HealthCare
LLC nor Pharmasone LLC are the sponsor of an approved application.
Accordingly, they will be removed from the list of sponsors of approved
applications in 21 CFR 510.600(c). As provided in the regulatory text,
the animal drug regulations are amended to reflect these changes of
sponsorship.
III. Technical Amendments
FDA is making the following amendments to improve the accuracy,
consistency, and readability of the animal drug regulations:
21 CFR 520.905a is amended to reflect the approved
conditions of use for fenbendazole suspension in laying hens.
21 CFR 522.1182 is amended to reflect the 2016 change of
sponsorship of an injectable ferric hydroxide product in young piglets.
21 CFR 522.1193 is amended to reflect the approved
withdrawal period for a clorsulon injectable solution product.
21 CFR 522.1696a is amended to reflect an associated
limitation for a penicillin G benzathine and penicillin G procaine
injectable suspension product.
21 CFR 522.1890 is amended to reflect the current format
for titling regulations for injectable dosage form new animal drugs.
Entries in parts 556 and 558 (21 CFR parts 556 and 558)
for a coumaphos Type A medicated article are being added. These
sections were withdrawn in error (85 FR 18114, April 1, 2020).
Part 558 is amended to reflect current naming and
organization for specifications and application sponsors.
21 CFR 558.261 is amended to reflect an approved
incorporation level of florfenicol in medicated feed for fish.
21 CFR 558.311 for lasalocid in medicated feed is amended
to reflect a current tabular organization by species.
21 CFR 558.355 is amended to provide accurate cross
references for approved uses to special considerations and label
statements for monensin medicated feeds.
21 CFR 558.450 is amended to add two indications for use
of oxytetracycline in medicated feed for fish that were removed during
the recent codification of a supplemental approval (84 FR 12491 at
12502, April 2, 2019).
Part 558 is amended by removing 21 CFR 558.465, which is
redundant with 21 CFR 558.464. The cross reference for poloxalene in
part 556 is amended to reflect this action.
Part 558 is amended by adding 21 CFR 558.470 to reflect
the approved conditions of use of a polyoxyethylene medicated feed
block, which previously had been removed from 21 CFR part 520 without
being added to part 558.
Typographical errors are being corrected wherever they
have been found.
IV. Legal Authority
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. This 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 the conditions of use of an approved or conditionally approved new
animal drug and the name and address of the drug's sponsor in a
``notice, which upon publication shall be effective as a regulation.''
A notice published pursuant to section 512(i) is not subject to the
notice-and-comment rulemaking requirements of the Administrative
Procedure Act, 5 U.S.C. 551 et seq. See section 512(i) of the FD&C Act;
21 CFR 10.40(e)(3); S. Rep. 90-1308, at 5 (1968).
This document does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a ``rule of particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808. Likewise, this is not a rule subject to Executive
Order 12866, which defines a rule as ``an agency statement of general
applicability and future effect, which the agency intends to have the
force and effect of law, that is designed to implement, interpret, or
prescribe law or policy or to describe the procedure or practice
requirements of an agency.''
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Parts 520, 522, 524, and 529
Animal drugs.
21 CFR Part 556
Animal drugs, 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
510, 520, 522, 524, 529, 556, and 558 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for part 510 continues to read as follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
Sec. 510.600 [Amended]
0
2. In Sec. 510.600, in the table in paragraph (c)(1), remove the entry
for ``Bayer HealthCare LLC'' and in the table in paragraph (c)(2),
remove the entry for ``000859''.
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for part 520 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
4. In Sec. 520.304, add paragraph (a)(3), revise paragraphs (b)(1) and
(2), and add paragraph (b)(3) to read as follows:
Sec. 520.304 Carprofen.
(a) * * *
(3) Each chewable tablet contains 25, 37.5, 50, 75, or 100 mg
carprofen.
(b) * * *
(1) Nos. 017033, 054771, 055529, and 062250 for use of product
described in paragraphs (a)(1) and (2) of this section as in paragraph
(c) of this section.
(2) No. 058198 for use of product described in paragraph (a)(1) of
this section as in paragraph (c) of this section.
[[Page 14818]]
(3) No. 069043 for use of product described in paragraph (a)(3) of
this section as in paragraph (c) of this section.
* * * * *
0
5. In Sec. 520.530, revise paragraph (b) to read as follows:
Sec. 520.530 Cythioate oral liquid.
* * * * *
(b) Sponsor. See Nos. 054771 and 058198 in Sec. 510.600 of this
chapter.
* * * * *
0
6. In Sec. 520.531, revise paragraph (b)(1) to read as follows:
Sec. 520.531 Cythioate tablets.
* * * * *
(b) * * *
(1) No. 058198 for use of 30- and 90-mg tablets.
* * * * *
0
7. In Sec. 520.812, revise paragraph (b)(1) to read as follows:
Sec. 520.812 Enrofloxacin.
* * * * *
(b) * * *
(1) No. 058198 for use of products described in paragraphs
(a)(1)(i) and (a)(2) and (3) of this section.
* * * * *
0
8. In Sec. 520.903a, revise paragraph (b) to read as follows:
Sec. 520.903a Febantel paste.
* * * * *
(b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
* * * * *
0
9. In Sec. 520.903b, revise paragraph (b) to read as follows:
Sec. 520.903b Febantel suspension.
* * * * *
(b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
* * * * *
0
10. In Sec. 520.903c, revise paragraph (b) to read as follows:
Sec. 520.903c Febantel and praziquantel paste.
* * * * *
(b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
* * * * *
0
11. In Sec. 520.903d, revise paragraph (b) to read as follows:
Sec. 520.903d Febantel tablets.
* * * * *
(b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
* * * * *
0
12. In Sec. 520.905a, revise paragraph (e)(5)(ii), remove paragraph
(e)(5)(iii), and revise paragraph (e)(6)(ii) to read as follows:
Sec. 520.905a Fenbendazole suspension.
* * * * *
(e) * * *
(5) * * *
(ii) Indications for use. For the treatment and control of adult
Ascaridia galli in broiler chickens and replacement chickens, and for
the treatment and control of adult A. galli and Heterakis gallinarum in
breeding chickens and laying hens.
(6) * * *
(ii) Indications for use. For the treatment and control of:
Lungworms: Adult Metastrongylus apri, Adult Metastrongylus
pudendotectus; Gastrointestinal worms: Adult and larvae (L3, L4 stages,
liver, lung, intestinal forms) large roundworms (Ascaris suum), Adult
nodular worms (Oesophagostomum dentatum, O. quadrispinulatum), Adult
small stomach worms (Hyostrongylus rubidus), Adult and larvae (L2, L3,
L4 stages--intestinal mucosal forms) whipworms (Trichuris suis); and
Kidney worms: Adult and larvae Stephanurus dentatus.
* * * * *
0
13. Revise Sec. 520.998 to read as follows:
Sec. 520.998 Fluralaner.
(a) Specifications. (1) Each chewable tablet contains 112.5, 250,
500, 1,000, or 1,400 milligrams (mg) fluralaner.
(2) Each chewable tablet contains 45, 100, 200, 400, or 560 mg
fluralaner.
(b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. Administer orally as a
single dose with food:
(i) Chewable tablets described in paragraph (a)(1) of this section.
Administer every 12 weeks, an appropriate combination of tablets to
provide a minimum dose of 11.4 mg per pound (lb) (25 mg per kilogram
(kg)) body weight. May be administered every 8 weeks in case of
potential exposure to Amblyomma americanum ticks.
(ii) Chewable tablets described in paragraph (a)(2) of this
section. Administer monthly, an appropriate combination of tablets to
provide a minimum dose of 4.5 mg/lb (10 mg/kg) body weight.
(2) Indications for use--(i) Chewable tablets described in
paragraph (a)(1) of this section. Kills adult fleas; for the treatment
and prevention of flea infestations (Ctenocephalides felis), and the
treatment and control of tick infestations [Ixodes scapularis (black-
legged tick), Dermacentor variabilis (American dog tick), and
Rhipicephalus sanguineus (brown dog tick)] for 12 weeks in dogs and
puppies 6 months of age and older, and weighing 4.4 lbs or greater; and
for the treatment and control of Amblyomma americanum (lone star tick)
infestations for 8 weeks in dogs and puppies 6 months of age and older,
and weighing 4.4 lbs or greater.
(ii) Chewable tablets described in paragraph (a)(2) of this
section. Kills adult fleas; for the treatment and prevention of flea
infestations (C. felis), and the treatment and control of tick
infestations [I. scapularis (black-legged tick), D. variabilis
(American dog tick), and R. sanguineus (brown dog tick)] for 1 month in
dogs and puppies 8 weeks of age and older, and weighing 4.4 lbs or
greater; and for the treatment and control of A. americanum (lone star
tick) infestations for 1 month in dogs and puppies 6 months of age and
older, and weighing 4.4 lbs or greater.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
14. In Sec. 520.1156, revise paragraph (b) to read as follows:
Sec. 520.1156 Imidacloprid.
* * * * *
(b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
* * * * *
0
15. In Sec. 520.1192, revise paragraph (b)(2) to read as follows:
Sec. 520.1192 Ivermectin paste.
* * * * *
(b) * * *
(2) Nos. 051311, 054925, 058198, and 061133 for use of a 1.87
percent paste for use as in paragraph (e)(1) of this section.
* * * * *
0
16. In Sec. 520.1195, revise paragraph (b)(1) to read as follows:
Sec. 520.1195 Ivermectin liquid.
* * * * *
(b) * * *
(1) Nos. 000010, 054925, 058005, and 058198 for use of product
described in paragraph (a)(1) of this section as in paragraphs
(e)(1)(i), (e)(1)(ii)(A), and (e)(1)(iii) of this section.
* * * * *
0
17. In Sec. 520.1454, revise paragraph (b) to read as follows:
Sec. 520.1454 Moxidectin solution.
* * * * *
(b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
* * * * *
[[Page 14819]]
0
18. In Sec. 520.1720a, add paragraph (b)(5) to read as follows:
Sec. 520.1720a Phenylbutazone tablets and boluses.
* * * * *
(b) * * *
(5) No. 058198 for use of 1-g tablets in horses.
* * * * *
0
19. In Sec. 520.1860, revise paragraph (b) to read as follows:
Sec. 520.1860 Pradofloxacin.
* * * * *
(b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
* * * * *
0
20. In Sec. 520.1870, revise paragraph (b) to read as follows:
Sec. 520.1870 Praziquantel tablets.
* * * * *
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter.
(1) No. 058198 for use of product described in paragraph (a)(1) of
this section as in paragraph (c)(1) of this section and for use of
product described in paragraph (a)(2) of this section as in paragraph
(c)(2) of this section.
(2) No. 069043 for use of product described in paragraph (a)(1) of
this section as in paragraphs (c)(1) of this section.
* * * * *
0
21. In Sec. 520.1871, revise paragraph (b)(1) to read as follows:
Sec. 520.1871 Praziquantel and pyrantel.
* * * * *
(b) * * *
(1) See No. 058198 for use of tablets described in paragraph (a)(1)
of this section for use as in paragraph (d)(1) of this section.
* * * * *
0
22. In Sec. 520.1872, revise paragraph (b) to read as follows:
Sec. 520.1872 Praziquantel, pyrantel pamoate, and febantel tablets.
* * * * *
(b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
* * * * *
0
23. In Sec. 520.2043, revise paragraph (b)(2) to read as follows:
Sec. 520.2043 Pyrantel pamoate suspension.
* * * * *
(b) * * *
(2) Nos. 054771, 058198, and 058829 for use of the products
described in paragraph (a)(2) of this section as in paragraph (d)(2) of
this section.
* * * * *
0
24. Add Sec. 520.2138 to read as follows:
Sec. 520.2138 Spironolactone and benazepril.
(a) Specifications. Each chewable tablet contains 20 milligrams
(mg) spironolactone and 2.5 mg benazepril hydrochloride, 40 mg
spironolactone and 5 mg benazepril hydrochloride, or 80 mg
spironolactone and 10 mg benazepril hydrochloride.
(b) Sponsor. See No. 013744 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. Administer orally once
daily, with food, at a dose of 0.9 mg per pound (lb) (2 mg per kilogram
(kg)) spironolactone and 0.11 mg/lb (0.25 mg/kg) benazepril
hydrochloride, according to dog body weight using a suitable
combination of whole and/or half tablets.
(2) Indications for use. With concurrent therapy (e.g., furosemide,
etc.) for the management of clinical signs of mild, moderate, or severe
congestive heart failure in dogs due to atrioventricular valvular
insufficiency (AVVI).
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
25. In Sec. 520.2260b, add a heading for paragraph (b), revise
paragraph (b)(1), add a heading for paragraph (e), and revise paragraph
(e)(1) to read as follows:
Sec. 520.2260b Sulfamethazine sustained-release boluses.
* * * * *
(b) 22.5-gram bolus--(1) Sponsor. See No. 058198 in Sec.
510.600(c) of this chapter for use of a 22.5-gram sulfamethazine
prolonged-release bolus.
* * * * *
(e) 22.5-gram bolus--(1) Sponsor. See No. 058198 in Sec.
510.600(c) of this chapter for use of a 22.5-gram sulfamethazine
sustained release bolus.
* * * * *
0
26. In Sec. 520.2455, revise paragraphs (b)(1) and (2) to read as
follows:
Sec. 520.2455 Tiamulin.
* * * * *
(b) * * *
(1) No. 058198 for products described in paragraphs (a)(1) and (3)
of this section.
(2) No. 066104 for the product described in paragraph (a)(1) of
this section.
* * * * *
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
27. The authority citation for part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
28. In Sec. 522.23, revise paragraph (b) to read as follows:
Sec. 522.23 Acepromazine.
* * * * *
(b) Sponsors. See Nos. 000010 and 058198 in Sec. 510.600(c) of
this chapter.
* * * * *
0
29. In Sec. 522.234, revise paragraph (b) to read as follows:
Sec. 522.234 Butamisole.
* * * * *
(b) Sponsors. See Nos. 054771 and 058198 in Sec. 510.600(c) of
this chapter.
* * * * *
0
30. In Sec. 522.246, revise paragraphs (b)(2) and (3) to read as
follows:
Sec. 522.246 Butorphanol.
* * * * *
(b) * * *
(2) No. 058198 for use of the product described in paragraph (a)(2)
of this section as in paragraph (d)(2) of this section.
(3) Nos. 000061, 058198, and 059399 for use of the product
described in paragraph (a)(3) of this section as in paragraph (d)(3) of
this section.
* * * * *
0
31. In Sec. 522.812, revise paragraphs (b)(1) and (2) to read as
follows:
Sec. 522.812 Enrofloxacin.
* * * * *
(b) * * *
(1) Nos. 017033, 055529, and 058198 for use of product described in
paragraph (a)(1) of this section as in paragraph (e)(1) of this
section; and
(2) Nos. 055529, 058198, and 061133 for use of product described in
paragraph (a)(2) of this section as in paragraphs (e)(2) and (3) of
this section.
* * * * *
0
32. In Sec. 522.955, revise paragraph (b)(2) to read as follows:
Sec. 522.955 Florfenicol.
* * * * *
(b) * * *
(2) Nos. 000061 and 058198 for use of product described in
paragraph (a)(2) of this section as in paragraph (d)(1)(ii) of this
section.
* * * * *
0
33. In Sec. 522.970, revise paragraph (b)(1) to read as follows:
Sec. 522.970 Flunixin.
* * * * *
(b) * * *
(1) See Nos. 000061, 016592, 055529, 058198, and 061133 for use as
in paragraph (e) of this section.
* * * * *
[[Page 14820]]
0
34. In Sec. 522.995, revise paragraph (b) to read as follows:
Sec. 522.995 Fluprostenol.
* * * * *
(b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
* * * * *
0
35. In Sec. 522.1010, revise paragraph (b)(3) to read as follows:
Sec. 522.1010 Furosemide.
* * * * *
(b) * * *
(3) No. 058198 as described in paragraph (a)(2) of this section for
use as in paragraphs (d)(1), (d)(2)(i), and (d)(3) of this section.
* * * * *
0
36. In Sec. 522.1077:
0
a. Revise paragraph (b)(3);
0
b. Remove paragraph (b)(4); and
0
c. Redesignate paragraph (b)(5) as paragraph (b)(4).
The revision reads as follows:
Sec. 522.1077 Gonadorelin.
* * * * *
(b) * * *
(3) Nos. 000010 and 061133 for use of the 50-[mu]g/mL product
described in paragraph (a)(3) of this section as in paragraphs
(e)(1)(i) and (v) of this section.
* * * * *
0
37. In Sec. 522.1086, revise paragraph (b) to read as follows:
Sec. 522.1086 Guaifenesin solution.
* * * * *
(b) Sponsors. See Nos. 037990 and 058198 in Sec. 510.600(c) of
this chapter.
* * * * *
0
38. In Sec. 522.1182, revise paragraph (b)(1) introductory text to
read as follows:
Sec. 522.1182 Iron injection.
* * * * *
(b) * * *
(1) Nos. 016592 and 042552 for use of product described in
paragraph (a)(1)(i) of this section as follows:
* * * * *
0
39. In Sec. 522.1193, revise paragraph (e)(3)(i) to read as follows:
Sec. 522.1193 Ivermectin and clorsulon.
* * * * *
(e) * * *
(3) * * *
(i) Nos. 000010, 055529, and 061133: Do not treat cattle within 21
days of slaughter. No. 058005: Do not treat cattle within 49 days of
slaughter.
* * * * *
0
40. In Sec. 522.1222, revise paragraph (b) to read as follows:
Sec. 522.1222 Ketamine.
* * * * *
(b) Sponsors. See Nos. 017033, 054771, 058198, 059399, 063286, and
069043 in Sec. 510.600(c) of this chapter.
* * * * *
0
41. In Sec. 522.1450, revise paragraph (b) to read as follows:
Sec. 522.1450 Moxidectin solution.
* * * * *
(b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
* * * * *
0
42. In Sec. 522.1696a, revise paragraph (d)(2)(iii) to read as
follows:
Sec. 522.1696a Penicillin G benzathine and penicillin G procaine
suspension.
* * * * *
(d) * * *
(2) * * *
(iii) Limitations. Not for use within 30 days of slaughter. For
Nos. 000859 and 016592: A withdrawal period has not been established
for this product in pre-ruminating calves. Do not use in calves to be
processed for veal.
0
43. In Sec. 522.1720, revise paragraph (b)(2) to read as follows:
Sec. 522.1720 Phenylbutazone.
* * * * *
(b) * * *
(2) Nos. 000061, 054771, 058198, and 061133 for use of product
described in paragraph (a)(2) of this section as in paragraph (c) of
this section.
* * * * *
0
44. In Sec. 522.1870, revise paragraph (b) to read as follows:
Sec. 522.1870 Praziquantel.
* * * * *
(b) Sponsors. See Nos. 058198 and 061133 in Sec. 510.600(c) of
this chapter.
* * * * *
0
45. In Sec. 522.1890, revise the section heading to read as follows:
Sec. 522.1890 Prednisone suspension.
0
46. Revise Sec. 522.2120 to read as follows:
Sec. 522.2120 Spectinomycin hydrochloride.
(a) Specifications. Each milliliter of solution contains 100
milligrams (mg) spectinomycin hydrochloride (as spectinomycin
dihydrochloride pentahydrate).
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter:
(1) Nos. 016592 and 054771 for use as in paragraph (d)(1) of this
section; and
(2) No. 058198 for use as in paragraph (d)(2) of this section.
(c) Related tolerances. See Sec. 556.600 of this chapter.
(d) Conditions of use. It is administered as follows:
(1) Turkeys (1- to 3-day-old poults) and chickens (newly hatched
chicks)--(i) Amounts and indications for use. (A) Administer 5 mg per
poult subcutaneously as an aid in the control of chronic respiratory
disease (CRD) associated with Escherichia coli in 1- to 3-day-old
turkey poults.
(B) Administer 10 mg per poult as a single subcutaneous injection
in the nape of the neck as an aid in the control of airsacculitis
associated with Mycoplasma meleagridis sensitive to spectinomycin in 1-
to 3-day-old turkey poults.
(C) Administer 2.5 to 5 mg per chick as an aid in the control of
mortality and to lessen severity of infections caused by M. synoviae,
Salmonella typhimurium, S. infantis, and E. coli.
(ii) Limitations. For use only in 1- to 3-day-old turkey poults and
newly hatched chicks.
(2) Dogs--(i) Amount. Administer 2.5 to 5.0 mg per pound of body
weight by intramuscular injection twice daily. Treatment may be
continued for 4 days.
(ii) Indications for use. For treatment of infections caused by
gram-negative and gram-positive organisms susceptible to spectinomycin.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
47. In Sec. 522.2662, revise paragraph (b)(3) to read as follows:
Sec. 522.2662 Xylazine.
* * * * *
(b) * * *
(3) Nos. 058198 and 061651 for use of product described in
paragraph (a)(1) of this section as in paragraph (d)(1) of this
section; and product described in paragraph (a)(2) of this section as
in paragraphs (d)(2), (d)(3)(i), (d)(3)(ii)(A), and (d)(3)(iii) of this
section.
* * * * *
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
48. The authority citation for part 524 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
49. In Sec. 524.450, revise paragraph (b) to read as follows:
Sec. 524.450 Clotrimazole.
* * * * *
(b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
* * * * *
0
50. In Sec. 524.775, revise paragraph (b) to read as follows:
[[Page 14821]]
Sec. 524.775 Emodepside and praziquantel.
* * * * *
(b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
* * * * *
0
51. In Sec. 524.802, revise paragraph (b) to read as follows:
Sec. 524.802 Enrofloxacin and silver sulfadiazine otic emulsion.
* * * * *
(b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
* * * * *
0
52. In Sec. 524.920, revise paragraphs (b)(1) through (3) to read as
follows:
Sec. 524.920 Fenthion.
* * * * *
(b) * * *
(1) No. 058198 for use of product described in paragraph (a)(1)(i)
of this section as in paragraph (d)(1) of this section.
(2) No. 058198 for use of product described in paragraph (a)(1)(ii)
of this section as in paragraph (d)(2) of this section.
(3) No. 058198 for use of products described in paragraph (a)(2) of
this section as in paragraph (d)(3) of this section.
* * * * *
0
53. In Sec. 524.955, revise paragraph (b) to read as follows:
Sec. 524.955 Florfenicol, terbinafine, and betamethasone acetate otic
gel.
* * * * *
(b) Sponsor. See No. 043264 in Sec. 510.600(c) of this chapter.
* * * * *
0
54. In Sec. 524.957, revise paragraph (b) to read as follows:
Sec. 524.957 Florfenicol, terbinafine, and mometasone otic solution.
* * * * *
(b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
* * * * *
0
55. In Sec. 524.1140, revise paragraph (b) to read as follows:
Sec. 524.1140 Imidacloprid and ivermectin.
* * * * *
(b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
* * * * *
0
56. In Sec. 524.1146, revise paragraphs (b)(1) through (3) to read as
follows:
Sec. 524.1146 Imidacloprid and moxidectin.
* * * * *
(b) * * *
(1) Nos. 017030 and 058198 for use of product described in
paragraph (a)(1) of this section as in paragraph (d)(1) of this
section.
(2) Nos. 017030 and 058198 for use of product described in
paragraph (a)(2) of this section as in paragraph (d)(2) of this
section.
(3) No. 058198 for use of product described in paragraph (a)(2) of
this section as in paragraph (d)(3) of this section.
* * * * *
0
57. In Sec. 524.1450, revise paragraphs (b)(1) and (2) to read as
follows:
Sec. 524.1450 Moxidectin.
* * * * *
(b) * * *
(1) No. 058198 for use of product described in paragraph (a)(1) of
this section as in paragraph (d)(1) of this section; and
(2) No. 058198 for use of product described in paragraph (a)(2) of
this section as in paragraph (d)(2) of this section.
* * * * *
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
0
58. The authority citation for part 529 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
59. In Sec. 529.56, revise paragraph (b) to read as follows:
Sec. 529.56 Amikacin.
* * * * *
(b) Sponsors. See Nos. 054771 and 058198 in Sec. 510.600(c) of
this chapter.
* * * * *
0
60. In Sec. 529.1044a, revise paragraph (b) to read as follows:
Sec. 529.1044a Gentamicin solution for infusion.
* * * * *
(b) Sponsors. See Nos. 000061, 016592, 054628, 054771, 058005,
058198, and 061133 in Sec. 510.600(c) of this chapter.
* * * * *
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
0
61. The authority citation for part 556 continues to read as follows:
Authority: 21 U.S.C. 342, 360b, 371.
0
62. Add Sec. 556.168 to read as follows:
Sec. 556.168 Coumaphos.
(a) [Reserved]
(b) Tolerances. The tolerances for coumaphos (measured as coumaphos
and its oxygen analog, O,O-diethyl O-3- chloro-4-methyl-2-oxo-2 H-1-
benzopyran-7-yl phosphate) are:
(1) Chickens. (i) Edible tissues (excluding eggs): 1 ppm.
(ii) Eggs: 0.1 ppm.
(2) [Reserved]
(c) Related conditions of use. See Sec. 558.185 of this chapter.
0
63. In Sec. 556.517, revise paragraph (c) to read as follows:
Sec. 556.517 Poloxalene.
* * * * *
(c) Related conditions of use. See Sec. Sec. 520.1840 and 558.464
of this chapter.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
64. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
0
65. In Sec. 558.55:
0
a. Revise paragraph (a);
0
b. Redesignate paragraphs (b) and (d) as paragraphs (d) and (e); and
0
c. Add new paragraph (b).
The revision and addition read as follows:
Sec. 558.55 Amprolium.
(a) Specifications. Type A medicated article containing 25 percent
amprolium.
(b) Sponsor. No. 016592 in Sec. 510.600(c) of this chapter.
* * * * *
0
66. In Sec. 558.58:
0
a. Revise paragraph (b); and
0
b. Redesignate paragraphs (c) and (d) as paragraphs (d) and (c).
The revision reads as follows:
Sec. 558.58 Amprolium and ethopabate.
* * * * *
(b) Sponsor. See No. 016592 in Sec. 510.600(c) of this chapter.
* * * * *
0
67. In Sec. 558.68, revise paragraph (a) to read as follows:
Sec. 558.68 Avilamycin.
(a) Specifications. Each pound of Type A medicated article contains
45.4 or 90.7 grams of avilamycin.
* * * * *
0
68. In Sec. 558.76:
0
a. Revise paragraph (b);
0
b. Remove paragraph (c); and
0
c. Redesignate paragraphs (d) and (e) as paragraphs (c) and (d).
The revision reads as follows:
Sec. 558.76 Bacitracin methylenedisalicylate.
* * * * *
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter as
follows:
(1) No. 054771 for use of products in paragraph (a)(1) of this
section as in paragraph (d) of this section.
[[Page 14822]]
(2) No. 069254 for use of product in paragraph (a)(2) of this
section as in paragraph (d) of this section.
* * * * *
0
69. In Sec. 558.78, revise paragraph (b) to read as follows:
Sec. 558.78 Bacitracin zinc.
* * * * *
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
* * * * *
0
70. In Sec. 558.95:
0
a. Revise paragraph (a);
0
b. Redesignate paragraphs (b) and (d) as paragraphs (d) and (e);
0
c. Add new paragraph (b);
0
d. Add a heading for newly redesignated paragraph (e)(5); and
0
e. Revise newly redesignated paragraph (e)(5)(iii).
The revisions and additions read as follows:
Sec. 558.95 Bambermycins.
(a) Specifications. Type A medicated articles containing 2, 4, or
10 grams bambermycins per pound.
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter as
follows:
(1) No. 016592: 2, 4, and 10 grams per pound for use as in
paragraphs (e)(1) through (4) of this section.
(2) No. 012286: 2 grams for use as in paragraph (e)(2) of this
section and 0.4 and 2 grams per pound for use as in paragraph (e)(3) of
this section.
* * * * *
(e) * * *
(5) Combinations. * * *
(iii) Clopidol as in Sec. 558.175.
* * * * *
0
71. In Sec. 558.128, revise paragraph (b) introductory text to read as
follows:
Sec. 558.128 Chlortetracycline.
* * * * *
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter as
follows:
* * * * *
0
72. In Sec. 558.140, revise paragraph (b) introductory text to read as
follows:
Sec. 558.140 Chlortetracycline and sulfamethazine.
* * * * *
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter as
follows:
* * * * *
0
73. In Sec. 558.175:
0
a. Revise paragraph (d)(3); and
0
b. Remove paragraph (e).
The revision reads as follows:
Sec. 558.175 Clopidol.
* * * * *
(d) * * *
(3) Combinations. Clopidol may also be used in combination with:
(i) Chlortetracycline as in Sec. 558.128.
(ii) Lincomycin as in Sec. 558.325.
0
74. Add Sec. 558.185 to read as follows:
Sec. 558.185 Coumaphos.
(a) Specifications. Type A medicated articles containing 1.12, 2.0,
11.2, or 50 percent coumaphos.
(b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.168 of this chapter.
(d) Special considerations. (1) Labeling shall bear the following
warning: The active ingredient coumaphos is a cholinesterase inhibitor.
Do not use this product on animals simultaneously or within a few days
before or after treatment with, or exposure to, cholinesterase-
inhibiting drugs, pesticides, or chemicals.
(2) See Sec. 500.25 of this chapter.
(e) Conditions of use in laying chickens.
----------------------------------------------------------------------------------------------------------------
Coumaphos in grams per
ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(1) 27.2 (0.003 percent). Laying chickens: For Feed continuously as the sole ration for 14 058198
control of capillary days. If reinfection occurs, treatment may
worm (Capillaria be repeated, but not sooner than 3 weeks
obsignata) and as an aid after the end of the previous treatment. Do
in control of common not feed to chickens within 10 days of
round worm (Ascaridia vaccination or other conditions of stress..
galli) and cecal worm
(Heterakis gallinae).
(2) 36.3 (0.004 percent). Replacement pullets: For Feed continuously as the sole ration for from 058198
control of capillary 10 to 14 days. Do not feed to chickens under
worm (Capillaria 8 weeks of age or within 10 days of
obsignata) and as an aid vaccination or other conditions of stress.
in control of common If birds are maintained on contaminated
round worm (Ascaridia litter or exposed to infected birds, a
galli) and cecal worm second 10- to 14-day treatment is
(Heterakis gallinae). recommended, but not sooner than 3 weeks
after the end of the previous treatment. If
reinfection occurs after production begins,
repeat treatment as recommended for laying
flocks..
----------------------------------------------------------------------------------------------------------------
0
75. In Sec. 558.195, revise paragraph (b) to read as follows:
Sec. 558.195 Decoquinate.
* * * * *
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
* * * * *
0
76. In Sec. 558.258, revise paragraph (b) to read as follows:
Sec. 558.258 Fenbendazole.
* * * * *
(b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
* * * * *
0
77. In Sec. 558.261, revise paragraph (e)(2)(ii) to read as follows:
Sec. 558.261 Florfenicol.
* * * * *
(e) * * *
(2) * * *
----------------------------------------------------------------------------------------------------------------
Florfenicol in grams/ton of
feed Indications for use Limitations
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(ii) 182 to 2,724............. Freshwater-reared salmonids: Feed as a sole ration for 10 consecutive days to
For the control of mortality deliver 10 to 15 mg florfenicol per kg of fish.
due to coldwater disease Feed containing florfenicol shall not be fed for
associated with more than 10 days. Following administration,
Flavobacterium psychrophilum fish should be reevaluated by a licensed
and furunculosis associated veterinarian before initiating a further course
with Aeromonas salmonicida. of therapy. The effects of florfenicol on
reproductive performance have not been
determined. Feeds containing florfenicol must be
withdrawn 15 days prior to slaughter.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
[[Page 14823]]
0
78. In Sec. 558.295, revise paragraph (a) to read as follows:
Sec. 558.295 Iodinated casein.
(a) Specifications. Type A medicated article containing iodinated
casein.
* * * * *
0
79. In Sec. 558.305, revise paragraph (b) to read as follows:
Sec. 558.305 Laidlomycin.
* * * * *
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
* * * * *
0
80. In Sec. 558.311:
0
a. Revise paragraphs (a), (b), and (d)(7);
0
b. Add a heading and introductory text for paragraph (e);
0
c. Revise paragraph (e)(1);
0
d. Redesignate paragraphs (e)(2) through (5) as paragraphs (e)(5)
through (8);
0
e. Add new paragraphs (e)(2) through (4); and
0
f. In the table in newly redesignated paragraph (e)(6)(i), revise the
last row.
The revisions and additions read as follows:
Sec. 558.311 Lasalocid.
(a) Specifications. Each pound of Type A medicated article contains
68 grams (15 percent), 90.7 grams (20 percent), or 150 grams (33.1
percent) lasalocid as lasalocid sodium activity. A minimum of 90
percent of lasalocid activity is derived from lasalocid A.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
* * * * *
(d) * * *
(7) Each use in a free-choice Type C cattle feed as in paragraphs
(e)(3)(vi) through (e)(3)(viii) of this section must be the subject of
an approved NADA or supplemental NADA as provided in Sec. 510.455 of
this chapter.
(e) Conditions of use. It is used as follows:
(1) The conditions of use for chickens are:
----------------------------------------------------------------------------------------------------------------
Combination in grams/
Lasalocid in grams/ton ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 68 to 113.............. ...................... Broiler or fryer Feed continuously as 054771
chickens: For the sole ration.
prevention of
coccidiosis caused by
Eimeria tenella, E.
necatrix, E.
acervulina, E.
brunetti, E. mivati,
and E. maxima..
(ii) 68.................... Bacitracin Broiler chickens: For Feed continuously as 054771
methylenedisalicylate prevention of the sole ration.
, 10 to 50. coccidiosis caused by Bacitracin
Eimeria tenella, E. methylenedisalicylate
necatrix, E. provided by No.
acervulina, E. 054771 in Sec.
brunetti, E. mivati, 510.600(c) of this
and E. maxima; and chapter.
for increased rate of
weight gain and
improved feed
efficiency..
(iii) 68 to 113............ Bacitracin Broiler chickens: For Feed continuously as 054771
methylenedisalicylate prevention of the sole ration.
, 4 to 50. coccidiosis caused by Bacitracin
Eimeria tenella, E. methylenedisalicylate
necatrix, E. provided by No.
acervulina, E. 054771 in Sec.
brunetti, E. mivati, 510.600(c) of this
and E. maxima; and chapter.
for improved feed
efficiency..
(iv) 68 to 113............. Bacitracin zinc, 4 to Broiler chickens. For Feed continuously as 054771
50. prevention of the sole ration.
coccidiosis caused by Bacitracin zinc
Eimeria tenella, E. provided by No.
necatrix, E. 054771 in Sec.
acervulina, E. 510.600(c) of this
brunetti, E. mivati, chapter.
and E. maxima; and
for increased rate of
weight gain and
improved feed
efficiency..
(v) 68 to 113.............. Bambermycins, 1 to 2.. Broiler chickens: For Feed continuously as 016592
prevention of sole ration.
coccidiosis caused by Bambermycins provided
Eimeria tenella, E. by No. 016592 in Sec.
necatrix, E. 510.600(c) of this
acervulina, E. chapter.
brunetti, E. mivati,
and E. maxima; and
for increased rate of
weight gain and
improved feed
efficiency..
----------------------------------------------------------------------------------------------------------------
(2) The conditions of use for turkeys are:
----------------------------------------------------------------------------------------------------------------
Combination in grams/
Lasalocid in grams/ton ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 68 to 113.............. ...................... Growing turkeys; For Feed continuously as 054771
prevention of sole ration.
coccidiosis caused by
Eimeria
meleagrimitis, E.
gallopavonis, and E.
adenoeides..
(ii) 68 to 113............. Bacitracin Growing turkeys: For Feed continuously as 054771
methylenedisalicylate prevention of the sole ration.
, 4 to 50. coccidiosis caused by Bacitracin
E. meleagrimitis, E. methylenedisalicylate
gallopavonis, and E. as provided by No.
adenoeides; and for 054771 in Sec.
increased rate of 510.600(c) in this
weight gain and chapter.
improved feed
efficiency..
(iii) 68 to 113............ Bacitracin zinc, 4 to Growing turkeys: For Feed continuously as 054771
50. prevention of the sole ration.
coccidiosis caused by Bacitracin zinc as
E. meleagrimitis, E. provided by No.
gallopavonis, and E. 054771 in Sec.
adenoeides; and for 510.600(c) in this
increased rate of chapter.
weight gain and
improved feed
efficiency..
----------------------------------------------------------------------------------------------------------------
(3) The conditions of use for cattle are--
[[Page 14824]]
----------------------------------------------------------------------------------------------------------------
Lasalocid amount Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 10 to 30 grams/ton of feed......... Cattle fed in confinement Feed continuously in complete 054771
for slaughter: For feed to provide not less than
improved feed efficiency.. 100 milligrams (mg) nor more
than 360 mg of lasalocid
sodium activity per head per
day.
(ii) 25 to 30 grams/ton of feed........ Cattle fed in confinement Feed continuously in complete 054771
for slaughter: For feed to provide not less than
improved feed efficiency 250 mg nor more than 360 mg
and increased rate of of lasalocid sodium activity
weight gain.. per head per day.
(iii) Not less than 60 mg or more than Pasture cattle (slaughter, Feed continuously at a rate of 054771
300 mg of lasalocid per head per day. stocker, feeder cattle, not less than 60 mg or more
and dairy and beef than 300 mg of lasalocid per
replacement heifers): For head per day when on pasture.
increased rate of weight The drug must be contained in
gain.. at least 1 pound of feed.
Daily intakes of lasalocid in
excess of 200 mg/head/day
have not been shown to be
more effective than 200 mg/
head/day.
(iv) 1 mg lasalocid per 2.2 pounds (lb) Cattle up to 800 lb: For Hand feed continuously at a 054771
body weight per day. control of coccidiosis rate of 1 mg of lasalocid per
caused by Eimeria bovis 2.2 lb body weight per day to
and E. zuernii.. provide not more than 360 mg
of lasalocid per head per day.
(v) 1 mg lasalocid per 2.2 lb body Replacement calves: For In milk replacer powder, hand 054771
weight per day. control of coccidiosis feed at a rate of 1 mg of
caused by E. bovis and E. lasalocid per 2.2 lb body
zuernii.. weight per day. A withdrawal
period has not been
established for lasalocid in
pre-ruminating calves. Do not
use in calves to be processed
for veal.
(vi) 1,440 grams/ton................... Pasture cattle (slaughter, As a free-choice Type C 012286
stocker, feeder cattle, medicated loose mineral, feed
and dairy and beef continuously at a rate of not
replacement heifers): For less than 60 mg nor more than
increased rate of weight 200 mg of lasalocid per head
gain.. per day.
(vii) 1,440 grams/ton.................. Pasture cattle (slaughter, As a free-choice Type C 017800
stocker, feeder cattle, medicated mineral block, feed
and dairy and beef continuously at a rate of not
replacement heifers): For less than 60 mg nor more than
increased rate of weight 200 mg of lasalocid per head
gain.. per day.
(viii) 300 grams/ton................... Pasture cattle (slaughter, As a free-choice Type C 067949
stocker, feeder cattle, medicated protein block, feed
and dairy and beef continuously at a rate of not
replacement heifers): for less than 60 mg nor more than
increased rate of weight 200 mg of lasalocid per head
gain.. per day.
----------------------------------------------------------------------------------------------------------------
(4) The conditions of use for minor species are:
----------------------------------------------------------------------------------------------------------------
Lasalocid in grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 20 to 30........................... Sheep maintained in Feed continuously in complete 054771
confinement: For feed to provide not less than
prevention of coccidiosis 15 milligrams (mg) nor more
caused by Eimeria ovina, than 70 mg of lasalocid
E. crandallis, E. sodium activity per head per
ovinoidalis (E. day depending on body weight.
ninakohlyakimovae), E.
parva, and E. intricata..
(ii) 113............................... Chukar partridges: For Feed continuously as sole 054771
prevention of coccidiosis ration up to 8 weeks of age.
caused by E. legionensis..
(iii) 113.............................. Rabbits: For prevention of Feed continuously as sole 054771
coccidiosis caused by E. ration up to 6 1/2 weeks of
stiedae.. age.
----------------------------------------------------------------------------------------------------------------
* * * * *
(6) * * *
(i) * * *
---------------------------------------------------------------------------
\2\ To provide 150 gm lasalocid per ton, use 1.652 lb (0.083%)
of a lasalocid liquid Type A medicated article containing 90.7 g/lb.
If using a dry lasalocid Type A medicated article containing 68 g/
lb, use, use 2.206 lbs per ton (0.111%), replacing molasses. If
using a dry lasalocid Type A medicated article containing 90.7 g/lb,
use 1.652 lbs per ton (0.083%), adding molasses.
------------------------------------------------------------------------
International
Ingredient Percent feed No.
------------------------------------------------------------------------
* * * * * * *
Lasalocid liquid Type A medicated 0.083 ..............
article (90.7 g/lb) \2\................
------------------------------------------------------------------------
* * * * *
0
81. In Sec. 558.325, revise paragraphs (b) and (e)(1)(ix) to read as
follows:
Sec. 558.325 Lincomycin.
* * * * *
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
* * * * *
(e) * * *
(1) * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
Lincomycin grams/ton Combination in grams/ton Indications for use Limitations Sponsors
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 14825]]
* * * * * * *
(ix) 2........................ Salinomycin, 40 to 60.... Broiler chickens: For the Feed as the sole ration to broiler chickens. Do 05477
control of necrotic not feed to laying hens producing eggs for human
enteritis caused or consumption. Not approved for use with pellet
complicated by Clostridium binders. May be fatal if accidentally fed to
spp. or other organisms adult turkeys or horses. Not for use in laying
susceptible to lincomycin, hens, breeding chickens, or turkeys. Do not
and for the prevention of allow rabbits, hamsters, guinea pigs, horses, or
coccidiosis caused by ruminants access to feeds containing lincomycin.
Eimeria tenella, E. Ingestion by these species may result in severe
necatrix, E. acervulina, E gastrointestinal effects. Salinomycin as
maxima, E. brunetti, and E. provided by No. 054771 in Sec. 510.600 of this
mivati. chapter.
* * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * *
0
82. In Sec. 558.342, revise paragraph (b) to read as follows:
Sec. 558.342 Melengestrol.
* * * * *
(b) Sponsor. See sponsors in Sec. 510.600(c) of this chapter for
use as in paragraph (e) of this section.
* * * * *
0
83. In Sec. 558.355, revise paragraphs (b) introductory text,
(d)(9)(i) and (ii), and (d)(10)(i) and (ii) to read as follows:
Sec. 558.355 Monensin.
* * * * *
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter as
follows:
* * * * *
(d) * * *
(9) * * *
(i) Cattle (as described in paragraphs (f)(3)(i) through (iii),
(vi), and (vii) and (f)(4)(i) through (vi) of this section). See
paragraphs (d)(6) and (d)(7)(i) through (v), (vii), and (viii) of this
section.
(ii) Dairy cows (as described in paragraphs (f)(3)(iv) and (v) of
this section). See paragraphs (d)(6) and (d)(7)(i) through (iv), (vii),
(viii), and (ix) of this section.
* * * * *
(10) * * *
(i) Cattle (as described in paragraphs (f)(3)(i) through (iii),
(vi), and (vii) and (f)(4)(i) through (vi) of this section). See
paragraphs (d)(6) and (d)(7)(i), (v), (vii), and (viii) of this
section. Paragraph (d)(7)(vii) of this section does not apply to free-
choice Type C medicated feeds as defined in Sec. 510.455 of this
chapter.
(ii) Dairy cows (as described in paragraphs (f)(3)(iv) and (v) of
this section). See paragraphs (d)(6) and (d)(7)(i), (vii), (viii), and
(ix) of this section. Paragraph (d)(7)(vii) of this section does not
apply to free-choice Type C medicated feeds as defined in Sec. 510.455
of this chapter.
* * * * *
0
84. In Sec. 558.363, revise paragraph (a) to read as follows:
Sec. 558.363 Narasin.
(a) Specifications. Type A medicated articles containing 36, 45,
54, 72, or 90 grams narasin per pound.
* * * * *
0
85. In Sec. 558.364, revise paragraph (d)(1)(ii) to read as follows:
Sec. 558.364 Naracin and nicarbazin.
* * * * *
(d) * * *
(1) * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
Narasin and nicarbazin grams/
ton Combination in grams/ton Indications for use Limitations Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * * * *
(ii) 27 to 45 of each drug.... Bacitracin Broiler chickens: For the Feed continuously as sole ration. Do not feed to 058198
methylenedisalicylate, 4 prevention of coccidiosis laying hens. Do not allow turkeys, horses, or 069254
to 50. caused by Eimeria necatrix, other equines access to formulations containing
E. tenella, E. acervulina, narasin. Ingestion of narasin by these species
E. brunetti, E. mivati, and has been fatal. For No. 054771: Withdraw 5 days
E. maxima, and for increased before slaughter. For No. 069254: Zero
rate of weight gain and withdrawal period. Bacitracin
improved feed efficiency. methylenedisalicylate as provided by Nos. 054771
and 069254 in Sec. 510.600(c) of this chapter.
* * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * *
0
86. In Sec. 558.366, revise paragraph (b) to read as follows:
Sec. 558.366 Nicarbazin.
* * * * *
(b) Sponsors. See Nos. 058198, 060728, and 066104 in Sec.
510.600(c) of this chapter.
* * * * *
0
87. In Sec. 558.450, revise paragraph (e)(5)(iv) to read as follows:
Sec. 558.450 Oxytetracycline.
* * * * *
(e) * * *
(5) * * *
----------------------------------------------------------------------------------------------------------------
Oxytetracycline
amount Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(iv) 3.75 g/100 lb of 1. Freshwater-reared salmonids: Administer in mixed ration for 10 days. 066104
fish/day. For control of mortality due to Do not liberate fish or slaughter fish
coldwater disease associated with for food for 21 days following the last
Flavobacterium psychrophilum. administration of medicated feed..
[[Page 14826]]
2. Freshwater-reared Oncorhynchus Administer in mixed ration for 10 days. 066104
mykiss: For control of mortality Do not liberate fish or slaughter fish
due to columnaris disease for food for 21 days following the last
associated with Flavobacterium administration of medicated feed..
columnare.
3. Freshwater-reared salmonids Feed for 10 days. Immediate release is 066104
weighing up to 55 grams: For permitted following last feeding of
marking the skeletal tissue. medicated feed..
* * * * * * *
----------------------------------------------------------------------------------------------------------------
Sec. 558.465 [Removed]
0
88. Remove Sec. 558.465.
0
89. Add Sec. 558.470 to read as follows:
Sec. 558.470 Polyoxyethylene.
(a) Specifications. Each molasses-based block contains 2.2 percent
polyoxyethylene (23) lauryl ether.
(b) Sponsor. See No. 067949 in Sec. 510.600(c) of this chapter.
(c) [Reserved]
(d) Conditions of use--(1) Amount. 2 grams of polyoxyethylene (23)
lauryl ether per 100 kilograms of body weight per day (1 pound of block
per 500 kilogram (1,100 pound) animal per day). Initially, provide one
block per five head of cattle. Start treatment 10 to 14 days before
exposure to bloat-producing pastures.
(2) Indications for use. For reduction of the incidence of bloat
(alfalfa and clover) in pastured cattle.
(3) Limitations. Administer free-choice to beef cattle and
nonlactating dairy cattle only. Do not allow cattle access to other
sources of salt while being fed this product. Do not feed this product
to animals without adequate forage/roughage consumption.
0
90. In Sec. 558.485, revise paragraph (b) introductory text to read as
follows:
Sec. 558.485 Pyrantel.
* * * * *
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for
use as follows:
* * * * *
0
91. In Sec. 558.500, revise paragraph (b) to read as follows:
Sec. 558.500 Ractopamine.
* * * * *
(b) Sponsor. See Nos. 054771 and 058198 in Sec. 510.600(c) of this
chapter.
* * * * *
0
92. In Sec. 558.515:
0
a. Revise paragraph (a);
0
b. Redesignate paragraphs (b), (d), and (e) as paragraphs (d), (e), and
(f); and
0
c. Add new paragraph (b).
The revision and addition read as follows:
Sec. 558.515 Robenidine.
(a) Specifications. Type A medicated articles containing 30 grams
per pound.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
* * * * *
0
93. In Sec. 558.550:
0
a. Revise paragraphs (a), (b), (e)(1)(i), and (e)(2)(i);
0
b. Add a heading for paragraph (e)(3);
0
c. Redesignate paragraphs (e)(3)(i) through (iv) as paragraphs
(e)(3)(ii) through (v); and
0
d. Add new paragraph (e)(3)(i).
The revisions and additions read as follows:
Sec. 558.550 Salinomycin.
(a) Specifications. Type A medicated articles containing:
(1) 30 grams of salinomycin sodium activity per pound; or
(2) 60 grams of salinomycin sodium activity per pound.
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter as
follows:
(1) No. 016592 for product described in paragraph (a)(1) of this
section.
(2) Nos. 016592 and 069254 for product described in paragraph
(a)(2) of this section.
* * * * *
(e) * * *
(1) * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
Salinomycin in grams/ton Combination in grams/ton Indications for use Limitations Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
(i) 40 to 60.................. ......................... Broiler, roaster, and Feed continuously as sole ration. Do not feed to 016592
replacement (breeder and birds producing eggs for human consumption. May 069254
layer) chickens: For the be fatal if accidentally fed to adult turkeys or
prevention of coccidiosis horses..
caused by Eimeria tenella,
E. necatrix, E. acervulina,
E. maxima, E. brunetti, and
E. mivati.
* * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
(2) * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
Salinomycin in grams/ton Combination in grams/ton Indications for use Limitations Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
(i) 50........................ ......................... Quail: For the prevention of Feed continuously as sole ration. Do not feed to 016592
coccidiosis caused by birds producing eggs for human consumption. May 069254
Eimeria. dispersa and E. be fatal if accidentally fed to adult turkeys or
lettyae. horses..
* * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
(3) Combinations. * * *
(i) Avilamycin as in Sec. 558.68.
* * * * *
0
94. In Sec. 558.555, revise paragraph (b) to read as follows:
Sec. 558.555 Semduramicin.
* * * * *
[[Page 14827]]
(b) Sponsor. See No. 066104 in Sec. 510.600(c) of this chapter for
use of product described in paragraph (a)(1) of this section as in
paragraph (d) of this section; for use of product described in
paragraph (a)(2) of this section as in paragraph (e) of this section.
* * * * *
0
95. In Sec. 558.575, revise paragraph (b) introductory text to read as
follows:
Sec. 558.575 Sulfadimethoxine and ormetoprim.
* * * * *
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter as
follows:
* * * * *
0
96. In Sec. 558.600, revise paragraphs (a) and (d) to read as follows:
Sec. 558.600 Thiabendazole.
(a) Specifications. Dry Type A medicated articles containing 22,
44.1, 66.1, or 88.2 percent thiabendazole.
* * * * *
(d) Special considerations. (1) The 66.1 percent Type A medicated
article is solely for the manufacture of cane molasses liquid Type B
feed, which is mixed in dry feeds.
(2) The 88.2 percent Type A medicated article is used solely for
the manufacture of an aqueous slurry for adding to a Type C dry cattle
feed.
(3) Do not use in Type B or Type C medicated feed containing
bentonite.
* * * * *
0
97. In Sec. 558.612, revise paragraph (b) to read as follows:
Sec. 558.612 Tiamulin.
* * * * *
(b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
* * * * *
0
98. In Sec. 558.618, revise paragraph (b) to read as follows:
Sec. 558.618 Tilmicosin.
* * * * *
(b) Sponsor. See Nos. 016592 and 058198 in Sec. 510.600(c) of this
chapter.
* * * * *
0
99. In Sec. 558.680, revise paragraphs (b), (d)(1)(i) and (v), and
(d)(2)(i) to read as follows:
Sec. 558.680 Zoalene.
* * * * *
(b) Sponsors. See Nos. 054771 and 058198 in Sec. 510.600(c) of
this chapter.
* * * * *
(d) * * *
(1) * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
Combination in grams
Zoalene in grams/ton per ton Indications for use Limitations Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
(i) 36.3 to 113.5..... ..................... Replacement chickens: Feed continuously as sole ration. Grower ration not to be fed to 054771
For development of birds over 14 weeks of age. Starter ration not to be fed to laying 058198
active immunity to birds.
coccidiosis.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Growing conditions Starter ration grams per ton Grower ration grams per ton
----------------------------------------------------------------------------------------------------------------
Severe exposure................................... 113.5 (0.0125%).............. 75.4-113.5 (0.0083%-0.0125%)
Light to moderate exposure........................ 75.4-113.5 (0.0083%-0.0125%). 36.3-75.4 (0.004%-0.0083%)
----------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------------------------------------------
Combination in grams
Zoalene in grams/ton per ton Indications for use Limitations Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * * * *
(v) 113.5............. ..................... Broiler chickens: For Feed continuously as sole ration. Not to be fed to laying birds 054771
prevention and 058198
control of
coccidiosis.
* * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
(2) * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
Combination in grams per
Zoalene in grams/ton ton Indications for use Limitations Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
(i) 113.5 to 170.3............ ......................... Growing turkeys: For Feed continuously as sole ration. For turkeys 054771
prevention and control of grown for meat purposes only. Not to be fed to 058198
coccidiosis. laying birds..
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Dated: March 4, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-05203 Filed 3-18-21; 8:45 a.m.]
BILLING CODE 4164-01-P
