[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]


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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, 
george.haibel@fda.hhs.gov.

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..
 
                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *

    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


