Document ID: FDA-2018-N-0002-0002
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor’s Name
Posted Date: 2018-09-28T04:00Z

[Federal Register Volume 83, Number 189 (Friday, September 28, 2018)]
[Rules and Regulations]
[Pages 48940-48950]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21146]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 524, 529, 556, and 558

[Docket No. FDA-2018-N-0002]

New Animal Drugs; Approval of New Animal Drug Applications; 
Withdrawal of Approval of New Animal Drug Applications; Changes of 
Sponsorship; Change of a Sponsor's Name

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is amending the 
animal drug regulations to reflect application-related actions for new 
animal drug applications (NADAs) and abbreviated new animal drug 
applications (ANADAs) during January, February, and March 2018. FDA is 
informing the public of the availability

[[Page 48941]]

of summaries of the basis of approval and of environmental review 
documents, where applicable. The animal drug regulations are also being 
amended to reflect the withdrawal of approval of applications, changes 
of sponsorship of applications, and a change of a sponsor's name, and 
to make technical amendments to improve the accuracy of the 
regulations.

DATES: This rule is effective September 28, 2018, except for amendatory 
instructions 7 to 21 CFR 520.580, 18 to 21 CFR 520.905d, 20 to 21 CFR 
520.1182, 29 to 21 CFR 520.1840, 33 to 21 CFR 520.2380a, 37 to 21 CFR 
522.1182, 51 to 21 CFR 524.900, 62 to 21 CFR 558.185, 68 to 21 CFR 
558.365, and 70 to 21 CFR 558.485, which are effective October 9, 2018.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine (HFV-6), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-402-5689, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Approval Actions

    FDA is amending the animal drug regulations to reflect approval 
actions for NADAs and ANADAs during January, February, and March 2018, 
as listed in table 1. In addition, FDA is informing the public of the 
availability, where applicable, of documentation of environmental 
review required under the National Environmental Policy Act (NEPA) and, 
for actions requiring review of safety or effectiveness data, summaries 
of the basis of approval (FOI Summaries) under the Freedom of 
Information Act (FOIA). These public documents may be seen in the 
office of the Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 
between 9 a.m. and 4 p.m., Monday through Friday. Persons with access 
to the internet may obtain these documents at the CVM FOIA Electronic 
Reading Room: https://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm. Marketing 
exclusivity and patent information may be accessed in FDA's 
publication, Approved Animal Drug Products Online (Green Book) at: 
https://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.

                          Table 1--Original and Supplemental NADAs and ANADAs Approved During January, February, and March 2018
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                   Effect of the
          Approval date              File No.         Sponsor            Product name            Species               action          Public documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
January 5, 2018..................      141-449  Intervet, Inc., 2    SAFE-GUARD AquaSol   Chickens............  Supplemental         FOI Summary; EA/
                                                 Giralda Farms,       (fenbendazole oral                         approval for the     FONSI \1\.
                                                 Madison, NJ 07940.   suspension),                               treatment and
                                                                      Suspension                                 control of certain
                                                                      Concentrate.                               nematode worms in
                                                                                                                 laying hens; and
                                                                                                                 of a tolerance in
                                                                                                                 chicken eggs.
January 16, 2018.................      200-563  Norbrook             EPRIZERO             Cattle..............  Original approval    FOI Summary.
                                                 Laboratories,        (eprinomectin),                            as a generic copy
                                                 Ltd., Station        Pour-On for Beef                           of NADA 141-079.
                                                 Works, Newry BT35    and Dairy Cattle.
                                                 6JP, Northern
                                                 Ireland.
January 19, 2018.................      141-494  Elanco US Inc.,      CREDELIO             Dogs................  Original approval    FOI Summary.
                                                 2500 Innovation      (lotilaner),                               for killing adult
                                                 Way, Greenfield,     Chewable Tablet.                           fleas, and for the
                                                 IN 46140.                                                       treatment of flea
                                                                                                                 infestations and
                                                                                                                 the treatment and
                                                                                                                 control of tick
                                                                                                                 infestations in
                                                                                                                 dogs.
January 29, 2018.................      200-622  Pharmgate LLC, 1800  Chlortetracycline    Cattle..............  Original approval    FOI Summary.
                                                 Sir Tyler Dr.,       and decoquinate,                           as a generic copy
                                                 Wilmington, NC       Type C medicated                           of NADA 141-185.
                                                 28405.               feeds.
February 28, 2018................      141-482  Zoetis Inc., 333     LINCOMIX             Chickens............  Original approval    FOI Summary.
                                                 Portage St.,         (lincomycin) and                           for the control of
                                                 Kalamazoo, MI        ROBENZ (robenidine                         necrotic enteritis
                                                 49007.               hydrochloride),                            and for the
                                                                      Type C medicated                           prevention of
                                                                      feeds.                                     coccidiosis in
                                                                                                                 broiler chickens.
February 28, 2018................      141-483  Zoetis Inc., 333     LINCOMIX             Chickens............  Original approval    FOI Summary.
                                                 Portage St.,         (lincomycin) and                           for the control of
                                                 Kalamazoo, MI        DECCOX                                     necrotic enteritis
                                                 49007.               (decoquinate),                             and for the
                                                                      Type C medicated                           prevention of
                                                                      feeds.                                     coccidiosis in
                                                                                                                 broiler chickens.
March 2, 2018....................      141-484  Zoetis Inc., 333     LINCOMIX             Chickens............  Original approval    FOI Summary.
                                                 Portage St.,         (lincomycin) and                           for the control of
                                                 Kalamazoo, MI        BIO-COX                                    necrotic enteritis
                                                 49007.               (salinomycin                               and for the
                                                                      sodium), Type C                            prevention of
                                                                      medicated feeds.                           coccidiosis in
                                                                                                                 broiler chickens.
March 5, 2018....................      141-489  Zoetis Inc., 333     LINCOMIX             Chickens............  Original approval    FOI Summary.
                                                 Portage St.,         (lincomycin) and                           for the control of
                                                 Kalamazoo, MI        ZOAMIX (zoalene),                          necrotic enteritis
                                                 49007.               Type C medicated                           and for the
                                                                      feeds.                                     prevention and
                                                                                                                 control of
                                                                                                                 coccidiosis in
                                                                                                                 broiler chickens.
March 8, 2018....................      141-492  Merial, Inc., 3239   CENTRAGARD           Cats................  Original approval    FOI Summary.
                                                 Satellite Blvd.,     (eprinomectin and                          for the prevention
                                                 Bldg. 500, Duluth,   praziquantel                               of heartworm
                                                 GA 30096-4640.       transdermal                                disease, and for
                                                                      solution).                                 the treatment and
                                                                                                                 control of
                                                                                                                 roundworms,
                                                                                                                 hookworms, and
                                                                                                                 tapeworms in cats
                                                                                                                 and kittens.
March 26, 2018...................      141-491  Zoetis Inc., 333     LINCOMIX             Chickens............  Original approval    FOI Summary.
                                                 Portage St.,         (lincomycin) and                           for the control of
                                                 Kalamazoo, MI        COBAN (monensin),                          necrotic enteritis
                                                 49007.               Type C medicated                           and as an aid in
                                                                      feeds.                                     the prevention of
                                                                                                                 coccidiosis in
                                                                                                                 broiler chickens.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The Agency has carefully considered an environmental assessment (EA) of the potential environmental impact of this action and has made a finding of
  no significant impact (FONSI).

[[Page 48942]]

II. Change of Sponsorship

    Agri Laboratories Ltd., P.O. Box 3103, St. Joseph, MO 64503 has 
informed FDA that it has transferred ownership of, and all rights and 
interest in, the following applications to Huvepharma EOOD, 5th Floor, 
3A Nikolay Haytov Str., 1113 Sofia, Bulgaria:

------------------------------------------------------------------------
           File No.                   Product name        21 CFR section
------------------------------------------------------------------------
200-030......................  DI-METHOX                       520.2220a
                                (sulfadimethoxine) 12.5%
                                Solution.
200-031......................  DI-METHOX                       520.2220a
                                (sulfadimethoxine)
                                Soluble Powder.
200-037......................  LEGACY (gentamicin              529.1044a
                                sulfate) Solution.
200-038......................  DI-METHOX                        522.2220
                                (sulfadimethoxine)
                                Injection 40%.
200-049......................  TETRA-BAC 324                   520.2345d
                                (tetracycline
                                hydrochloride) Soluble
                                Powder.
200-061......................  FLU-NIX (flunixin                 522.970
                                meglumine) Injection.
200-066......................  AGRIMYCIN-343                   520.1660d
                                (oxytetracycline
                                hydrochloride) Soluble
                                Powder.
200-128......................  AGRIMYCIN-200                   522.1660a
                                (oxytetracycline
                                dihydrate) Injection.
200-185......................  GEN-GARD (gentamicin            520.1044c
                                sulfate) Soluble Powder.
200-225......................  PROHIBIT (levamisole            520.1242a
                                hydrochloride) Soluble
                                Drench Powder.
200-271......................  Levamisole Phosphate             522.1242
                                Injection.
200-407......................  Lincomycin-Spectinomycin         520.1265
                                (lincomycin
                                hydrochloride/
                                spectinomycin
                                dihydrochloride
                                pentahydrate) Water
                                Soluble Powder.
------------------------------------------------------------------------

    Following this withdrawal of approval, Agri Laboratories Ltd. is no 
longer the sponsor of an approved application. Accordingly, it will be 
removed from the list of sponsors of approved applications in Sec.  
510.600(c) (21 CFR 510.600(c)).
    Strategic Veterinary Pharmaceuticals, Inc., 100 NW Airport Rd., St. 
Joseph, MO 64503 has informed FDA that it has transferred ownership of, 
and all rights and interest in, the following applications to Cronus 
Pharma LLC, 2 Tower Center Blvd., Suite 1101, East Brunswick, NJ 08816:

------------------------------------------------------------------------
           File No.                   Product name        21 CFR section
------------------------------------------------------------------------
011-531......................  DIZAN (dithiazanine              520.763a
                                iodide) Tablets.
011-674......................  DIZAN (dithiazanine              520.763b
                                iodide) Powder.
012-469......................  DIZAN (dithiazanine              520.763c
                                iodide) Suspension with
                                Piperazine Citrate.
031-512......................  ATGARD (dichlorvos) Swine         558.205
                                Wormer.
033-803......................  TASK (dichlorvos) Dog             520.600
                                Anthelmintic.
035-918......................  EQUIGARD; VERDISOL                520.596
                                (dichlorvos).
039-483......................  BIO-TAL (thiamylal               522.2424
                                sodium) Injection.
040-848......................  ATGARD C (dichlorvos)             558.205
                                Swine Wormer.
043-606......................  ATGARD V (dichlorvos)             558.205
                                Swine Wormer.
045-143......................  OXYJECT (oxytetracycline        522.1662a
                                hydrochloride) Injection.
047-278......................  BIO-MYCIN OXY-TET 50            522.1662a
                                (oxytetracycline
                                hydrochloride) Injection.
047-712......................  BIZOLIN-100; BIZOLIN-200         522.1720
                                (phenylbutazone)
                                Injection.
048-010......................  ANAPLEX (dichlorophene            520.580
                                and toluene) Canine and
                                Feline Wormer Caps.
048-237......................  EQUIGEL (dichlorvos).....         520.602
048-271......................  TASK (dichlorvos) Tablets         520.598
049-032......................  ATGARD C (dichlorvos)             558.205
                                Premix 9.6%.
065-461......................  ANACETIN                         520.390a
                                (chloramphenicol)
                                Tablets.
065-481......................  Calf Scour Boluses                520.443
                                (chlortetracycline
                                hydrochloride).
065-486......................  CTC Bisulfate                     520.441
                                (chlortetracycline
                                bisulfate) Soluble
                                Powder.
065-491......................  MEDICHOL                         520.390a
                                (chloramphenicol)
                                Tablets.
092-837......................  NEMACIDE                         520.622b
                                (diethylcarbamazine
                                citrate) Oral Syrup.
093-516......................  BIZOLIN (phenylbutazone)         522.1720
                                Injection 20%.
097-452......................  OXYJECT 100                     522.1662a
                                (oxytetracycline
                                hydrochloride) Injection.
098-569......................  MEDACIDE-SDM                     522.2220
                                (sulfadimethoxine)
                                Injection 10%.
099-618......................  BIZOLIN (phenylbutazone)        520.1720a
                                1-G Bolus.
108-963......................  MEDAMYCIN                       522.1662a
                                (oxytetracycline
                                hydrochloride)
                                Injectable Solution.
117-689......................  NEUROSYN (primidone)             520.1900
                                Tablets.
125-797......................  Nitrofurazone Dressing...       524.1580a
126-236......................  Nitrofurazone Soluble           524.1580b
                                Powder.
126-676......................  D & T (dichlorophene and          520.580
                                toluene) Worm Capsules.
127-627......................  NEMACIDE; NEMACIDE-C             520.622a
                                (diethylcarbamazine
                                citrate) Tablets.
128-069......................  NEMACIDE                         520.622c
                                (diethylcarbamazine
                                citrate) Chewable
                                Tablets.
132-028......................  ANESTATAL (thiamylal             522.2424
                                sodium) Injectable
                                Solution.
135-771......................  Methylprednisolene               520.1408
                                Tablets.
136-212......................  Methylprednisolone               522.1410
                                Acetate Injection.
137-310......................  Gentamicin Sulfate               522.1044
                                Injectable Solution.
138-869......................  Triamcinolone Acetonide          522.2483
                                Suspension.
140-442......................  Xylazine HCl Injection...        522.2662
200-023......................  Gentamicin Sulfate               522.1044
                                Solution 100 mg/mL.
200-029......................  Ketamine Hydrochloride           522.1222
                                Injection.
200-165......................  SDM (sulfadimethoxine)          520.2220a
                                Concentrated Solution
                                12.5%.
------------------------------------------------------------------------

[[Page 48943]]

    The animal drug regulations are being amended to reflect these 
changes of sponsorship.

III. Withdrawals of Approval

    Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth, TX 76137 has 
requested that FDA withdraw approval of the NADAs listed in the 
following table because the products are no longer manufactured or 
marketed:

------------------------------------------------------------------------
           File No.                   Product name        21 CFR section
------------------------------------------------------------------------
011-779......................  PURINA PIGEMIA 100               522.1182
                                (colloidal ferric oxide).
040-205......................  PURINA Horse Wormer             520.2380a
                                Medicated
                                (thiabendazole).
042-116......................  PURINA 6 DAY WORM-KILL            558.185
                                Feed Premix (coumaphos).
043-215......................  PURINA GRUB-KILL Pour-on          524.900
                                Cattle Insecticide
                                (famphur).
046-700......................  STATYL (nequinate)                558.365
                                Medicated Premix.
091-260......................  PULVEX WORM CAPS                 520.1804
                                (piperazine phosphate
                                monohydrate).
097-258......................  PURINA BAN-WORM for Pigs          558.485
                                (pyrantel tartrate).
102-942......................  PULVEX Multipurpose Worm          520.580
                                Caps (dichlorophene,
                                toluene).
113-748......................  PURINA PIGEMIA Oral (iron        520.1182
                                dextran complex).
135-941......................  CHECK-R-TON BM (pyrantel          558.485
                                tartrate).
136-116......................  PURINA WORM-A-RESTTM             520.905d
                                Litter Pack Premix
                                (fenbendazole).
140-869......................  PURINA SAF-T-BLOC BG             520.1840
                                Medicated Feed Block
                                (poloxalene, 6.6%).
------------------------------------------------------------------------

    Elsewhere in this issue of the Federal Register, FDA gave notice 
that approval of NADAs 011-779, 040-205, 042-116, 043-215, 046-700, 
091-260, 097-258, 102-942, 113-748, 135-941, 136-116, and 140-869, and 
all supplements and amendments thereto, is withdrawn, effective October 
9, 2018. As provided in the regulatory text of this document, the 
animal drug regulations are amended to reflect these actions.

IV. Technical Amendments

    JBS United Animal Health II LLC, 322 S Main St., Sheridan, IN 46069 
has informed FDA that it has changed its name to United-AH II LLC. 
Accordingly, we are amending Sec.  510.600(c) to reflect this change.
    We are also making technical amendments to update the scientific 
name of a pathogenic bacterium and to accurately list the 
concentrations of new animal drug ingredients in combination drug 
medicated feeds. These actions are being taken to improve the accuracy 
of the regulations.

V. Legal Authority

    This final rule is issued under section 512(i) of the Federal Food, 
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b(i)), which requires 
Federal Register publication of ``notice[s] . . . effective as a 
regulation,'' of the conditions of use of approved new animal drugs. 
This rule sets forth technical amendments to the regulations to codify 
recent actions on approved new animal drug applications and corrections 
to improve the accuracy of the regulations, and as such does not impose 
any burden on regulated entities.
    Although denominated a rule pursuant to the FD&C Act, this document 
does not meet the definition of ``rule'' in 5 U.S.C. 804(3)(A) because 
it is a ``rule of particular applicability.'' Therefore, it is not 
subject to the congressional review requirements in 5 U.S.C. 801-808. 
Likewise, this is not a rule subject to Executive Order 12866, which 
defines a rule as ``an agency statement of general applicability and 
future effect, which the agency intends to have the force and effect of 
law, that is designed to implement, interpret, or prescribe law or 
policy or to describe the procedure or practice requirements of an 
agency.''

List of Subjects

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Parts 520, 522, 524, and 529

    Animal drugs.

21 CFR Part 556

    Animal drugs, Foods.

21 CFR Part 558

    Animal drugs, Animal feeds.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
510, 520, 522, 524, 529, 556, and 558 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for part 510 continues to read as follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

0
2. In Sec.  510.600, in the table in paragraph (c)(1), remove the entry 
for ``JBS United Animal Health II LLC'', and alphabetically add an 
entry for ``United-AH II LLC''; and in the table in paragraph (c)(2), 
revise the entry for ``051233'' to read as follows:

Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c) * * *
    (1) * * *

[[Page 48944]]

------------------------------------------------------------------------
                                                           Drug labeler
                  Firm name and address                        code
------------------------------------------------------------------------
 
                              * * * * * * *
United-AH II LLC, 322 S Main St., Sheridan, IN 46069....          051233
 
                              * * * * * * *
 
                              * * * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
    Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                              * * * * * * *
051233..................  United-AH II LLC, 322 S Main St., Sheridan, IN
                           46069
 
                              * * * * * * *
------------------------------------------------------------------------

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for part 520 continues to read as follows:

    Authority:  21 U.S.C. 360b.

Sec.  520.390a   [Amended]

0
4. In Sec.  520.390a, in paragraph (b)(1)(i), remove ``054628'' and in 
its place add ``069043''.

Sec.  520.441  [Amended]

0
5. In Sec.  520.441, in paragraph (b)(3), remove ``069254 and 076475'' 
and in its place add ``069043, 069254, and 076475''.

Sec.  520.443  [Amended]

0
6. In Sec.  520.443, in paragraph (b), remove ``054628'' and in its 
place add ``069043''.

Sec.  520.580  [Amended]

0
7. In Sec.  520.580, in paragraph (b)(1), remove ``051311''; and in 
paragraph (b)(2), remove ``000061 and 054771'', and in its place add 
``000061, 054771, and 069043''.

Sec.  520.600   [Redesignated as Sec.  520.596]

0
8. Redesignate Sec.  520.600 as Sec.  520.596 and revise newly 
redesignated Sec.  520.596 to read as follows:

Sec.  520.596  Dichlorvos powder.

    (a) Specifications--(1) Each 2-ounce packet contains 2.27 grams (4 
percent) dichlorvos.
    (2) Each milligram of powder contains 2.27 milligrams (mg) 
dichlorvos.
    (b) Sponsor. See No. 069043 in Sec.  510.600(c) of this chapter for 
use of the product described in paragraph (a)(1) of this section as in 
paragraph (d)(1) of this section and the product described in paragraph 
(a)(2) of this section as in paragraph (d)(2) of this section.
    (c) Related tolerances. See Sec.  556.180 of this chapter.
    (d) Conditions of use--(1) Swine (adult gilts, sows, and boars)--
(i) Amount. Add powder to the indicated amount of feed and administered 
shortly after mixing, as follows:

----------------------------------------------------------------------------------------------------------------
                                                                             Pounds of mixed
                                                         Pounds of feed to      feed to be     Number of pigs to
               Weight of animal in pounds                  be mixed with     administered to     be treated per
                                                          each 0.08 ounce     each pig as a      0.08 ounce of
                                                           of dichlorvos     single treatment      dichlorvos
----------------------------------------------------------------------------------------------------------------
20-30..................................................                  4               0.33                 12
31-40..................................................                  5               0.56                  9
41-60..................................................                  6               1.00                  6
61-80..................................................                  5               1.00                  5
81-100.................................................                  4               1.00                  4
                                                                        16               4.00                  4
----------------------------------------------------------------------------------------------------------------

    (ii) Indications for use. For the removal and control of sexually 
mature (adult), sexually immature and/or 4th stage larvae of the 
whipworm (Trichuris suis), nodular worms (Oesophagostomum spp.), large 
round-worm (Ascaris suum), and the mature thick stomach worm (Ascarops 
strongylina) occurring in the lumen of the gastrointestinal tract of 
pigs, boars, and open or bred gilts and sows.
    (iii) Limitations. Do not use this product on animals either 
simultaneously or within a few days before or after treatment with or 
exposure to cholinesterase inhibiting drugs, pesticides, or chemicals. 
The preparation should be mixed thoroughly with the feed on a clean, 
impervious surface. Do not allow swine access to feed other than that 
containing the preparation until treatment is complete. Do not treat 
pigs with signs of scours until these signs subside or are alleviated 
by proper medication. Resume normal feeding schedule afterwards. Swine 
may be retreated in 4 to 5 weeks.
    (2) Horses--(i) Amount. Administer in the grain portion of the 
ration at a dosage of 14.2 to 18.5 mg per pound of body weight as a 
single dose. Administered at one-half of the single

[[Page 48945]]

recommended dosage and repeated 8 to 12 hours later in the treatment of 
very aged, emaciated, or debilitated subjects or those reluctant to 
consume medicated feed. In suspected cases of severe ascarid infection 
sufficient to cause concern over mechanical blockage of the intestinal 
tract, the split dosage should be used.
    (ii) Indications for use. For the removal and control of bots 
(Gastrophilus intestinalis, G. nasalis), large strongyles (Strongylus 
vulgaris, S. equinus, S. edentatus), small strongyles (of the genera 
Cyathostomum, Cylicocercus, Cylicocyclus, Cylicodontophorus, 
Triodontophorus, Poteriostomum, Gyalocephalus), pinworms (Oxyuris 
equi), and large roundworm (Parascaris equorum) in horses including 
ponies and mules. Not for use in foals (sucklings and young weanlings).
    (iii) Limitations. Do not use in horses which are severely 
debilitated, suffering from diarrhea or severe constipation, infectious 
disease, toxemia, or colic. Do not administer in conjunction with or 
within 1 week of administration of muscle relaxant drugs, phenothiazine 
derived tranquilizers or central nervous system depressant drugs. 
Horses should not be subjected to insecticide treatment for 5 days 
prior to or after treating with the drug. Do not administer to horses 
afflicted with chronic alveolar emphysema (heaves) or related 
respiratory conditions. The product is a cholinesterase inhibitor and 
should not be used simultaneously or within a few days before or after 
treatment with or exposure to cholinesterase inhibiting drugs, 
pesticides or chemicals. Do not use in animals other than horses, 
ponies, and mules. Do not use in horses, ponies, and mules intended for 
food purposes. Do not allow fowl access to feed containing this 
preparation or to fecal excrement from treated animals.

0
9. Add Sec.  520.598 to read as follows:

Sec.  520.598   Dichlorvos tablets.

    (a) Specifications. Each tablet contains 2, 5, 10, or 20 milligrams 
(mg) dichlorvos.
    (b) Sponsor. See No. 069043 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs, puppies, cats, and kittens--(1) 
Amount. Administer orally at 5 mg dichlorvos per pound of body weight.
    (2) Indications for use--(i) Dogs and puppies: Removal and control 
of intestinal roundworms (Toxocara canis and Toxascaris leonina) and 
hookworms (Ancylostoma caninum and Uncinaria stenocephala).
    (ii) Cats and kittens: Removal and control of intestinal roundworms 
(Toxocara cati and Toxascaris leonina) and hookworms (Ancylostoma 
tubaeforme and Uncinaria stenocephala).
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
10. Add Sec.  520.600 to read as follows:

Sec.  520.600  Dichlorvos capsules and pellets.

    (a) Specifications. Each capsule contains 2.27 milligrams (mg) (4 
percent) dichlorvos.
    (b) Sponsor. See No. 069043 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer any 
combination of capsules and/or pellets so that the animal receives a 
single dose equaling 12 to 15 mg of dichlorvos per pound of body 
weight.
    (2) Indications for use. For removal of Toxocara canis and 
Toxascaris leonina (roundworms), Ancylostoma caninum and Uncinaria 
stenocephala (hookworms), and Trichuris vulpis (whipworm) residing in 
the lumen of the gastrointestinal tract.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
11. Add Sec.  520.602 to read as follows:

Sec.  520.602  Dichlorvos gel.

    (a) Specifications. Each milligram (mg) of gel contains 2.27 
milligrams (mg) dichlorvos.
    (b) Sponsor. See No. 069043 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. Administer 20 mg per 
kilogram of body weight for the removal of bots and ascarids. Repeat 
administration every 21 to 28 days for the control of bots and 
ascarids. For the control of bots only, the repeat dosage is 10 
milligrams per kilogram of body weight every 21 to 28 days during bot 
fly season.
    (2) Indications for use. For the removal and control of first, 
second, and third instar bots (Gastrophilus intestinalis and G. 
nasalis), sexually mature and sexually immature (4th stage) ascarids 
(Parascaris equorum) in horses and foals.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

Sec.  520.622a   [Amended]

0
12. In Sec.  520.622a, in paragraph (a)(6), remove ``054628'' and in 
its place add ``069043''.

Sec.  520.622b   [Amended]

0
13. In Sec.  520.622b, in paragraph (c)(2), remove ``054628'' and in 
its place add ``069043''.

Sec.  520.622c  [Amended]

0
14. In Sec.  520.622c, in paragraph (b)(6), remove ``054628'' and in 
its place add ``069043''.

Sec.  520.763a  [Amended]

0
15. In Sec.  520.763a, in paragraph (b), remove ``054628'' and in its 
place add ``069043''.

Sec.  520.763b  [Amended]

0
16. In Sec.  520.763b, in paragraph (b), remove ``000010'' and in its 
place add ``069043''.

Sec.  520.763c   [Amended]

0
17. In Sec.  520.763c, in paragraph (b), remove ``054628'' and in its 
place add ``069043''.

0
18. In Sec.  520.905d, revise paragraphs (a) and (b) to read as 
follows:

Sec.  520.905d  Fenbendazole powder.

    (a) Specifications. Each 2-ounce packet contains 2.27 grams (4 
percent) fenbendazole.
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
* * * * *

Sec.  520.1044c   [Amended]

0
19. In Sec.  520.1044c, in paragraph (b)(2), remove ``057561'' and in 
its place add ``016592''.

Sec.  520.1182  [Removed]

0
20. Remove Sec.  520.1182.

Sec.  520.1242a  [Amended]

0
21. In Sec.  520.1242a, in paragraph (b)(3), remove ``057561'' and in 
its place add ``016592''.

Sec.  520.1263c  [Amended]

0
22. In Sec.  520.1263c, in paragraph (b)(1), remove ``Nos. 016592 and 
054771'' and in its place add ``No. 054771''; and in paragraph (b)(2), 
remove ``Nos. 054925, 061623, and 076475'' and in its place add ``Nos. 
016592, 054925, 061623, and 076475''.

Sec.  520.1265  [Amended]

0
23. In Sec.  520.1265, in paragraph (b)(2), remove ``057561'' and in 
its place add ``016592''.

0
24. Add Sec.  520.1286 to read as follows:

Sec.  520.1286  Lotilaner.

    (a) Specifications. Each chewable tablet contains 56.25, 112.5, 
225, 450, or 900 milligrams (mg) lotilaner.
    (b) Sponsor. See No. 058198 in Sec.  510.600(c) of this chapter.

[[Page 48946]]

    (c) Conditions of use in dogs--(1) Amount. Administer orally once a 
month at the recommended minimum dosage of 9 mg/lb (20 mg/kg).
    (2) Indications for use. Kills adult fleas, and for the treatment 
of flea infestations (Ctenocephalides felis), and the treatment and 
control of tick infestations (Amblyomma americanum (lone star tick), 
Dermacentor variabilis (American dog tick), Ixodes scapularis (black-
legged tick), and Rhipicephalus sanguineus (brown dog tick)) for 1 
month in dogs and puppies 8 weeks of age or older and weighing 4.4 
pounds or greater.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

Sec.  520.1408   [Amended]

0
25. In Sec.  520.1408, in paragraph (b)(1), remove ``054628'' and in 
its place add ``069043''.

Sec.  520.1660d  [Amended]

0
26. In Sec.  520.1660d, in paragraph (b)(4), remove ``No. 057561'' and 
in its place add ``No. 016592''.

Sec.  20.1720a  [Amended]

0
27. In Sec.  520.1720a, in paragraph (b)(2), remove ``Nos. 054628 and 
069043'' and in its place add ``No. 069043''.

Sec.  520.1804  [Removed]

0
28. Remove Sec.  520.1804.

Sec.  520.1840  [Amended]

0
29. In Sec.  520.1840, remove paragraph (b)(2), redesignate paragraphs 
(b)(3) and (4) as paragraphs (b)(2) and (3), and remove paragraph 
(d)(4).

Sec.  520.1900   [Amended]

0
30. In Sec.  520.1900, in paragraph (b)(1), remove ``054628'' and in 
its place add ``069043''.

Sec.  520.2220a   [Amended]

0
31. In Sec.  520.2220a, in paragraph (b)(1), remove ``Nos. 016592, 
054628, 054771, 054925, and 057561'' and in its place add ``Nos. 
016592, 054771, 054925, and 069043''; and in paragraph (b)(2), remove 
``Nos. 054771, 054925, 057561, 058829, 061623, and 066104'' and in its 
place add ``Nos. 016592, 054771, 054925, 058829, 061623, and 066104''.

Sec.  520.2345d  [Amended]

0
32. In Sec.  520.2345d, in paragraph (b)(4), remove ``Nos. 054925, 
057561, 061623, and 076475'' and in its place add ``Nos. 016592, 
054925, 061623, and 076475''.

Sec.  520.2380a  [Amended]

0
33. In Sec.  520.2380a, remove and reserve paragraphs (b)(1) and 
(d)(1)(i).

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
34. The authority citation for part 522 continues to read as follows:

    Authority:  21 U.S.C. 360b.

Sec.  522.970  [Amended]

0
35. In Sec.  522.970, in paragraph (b)(1), remove ``Nos. 000061, 
000859, 055529, 057561, and 061623'' and in its place add ``Nos. 
000061, 000859, 016592, 055529, and 061623''.

Sec.  522.1044  [Amended]

0
36. In Sec.  522.1044, in paragraph (b)(3), remove ``054628'' and in 
its place add ``069043''.

Sec.  522.1182  [Amended]

0
37. In Sec.  522.1182, in paragraph (b)(4), remove ``Nos. 051311 and 
054771'' and in its place add ``No. 054771''.

Sec.  522.1222  [Amended]

0
38. In Sec.  522.1222, in paragraph (b), remove ``Nos. 000859, 026637, 
054628, 054771, 059399, and 063286'' and in its place add ``Nos. 
000859, 026637, 054771, 059399, 063286, and 069043''.

Sec.  522.1242  [Amended]

0
39. In Sec.  522.1242, in paragraph (b), remove ``057561'' and in its 
place add ``016592''.

Sec.  522.1410  [Amended]

0
40. In Sec.  522.1410, in paragraph (b), remove ``054628 and 054771'' 
and in its place add ``054771 and 069043''.

Sec.  522.1660a  [Amended]

0
41. In Sec.  522.1660a, in paragraph (b), remove ``057561,''.

Sec.  522.1662a  [Amended]

0
42. In Sec.  522.1662a, in paragraphs (a)(2), (b)(2), (g)(2), and 
(h)(2), remove ``054628'' and in its place add ``069043''.

Sec.  522.1720  [Amended]

0
43. In Sec.  522.1720, in paragraph (b)(3), remove ``054628 and 
058005'' and in its place add ``058005 and 069043''.

Sec.  522.2220  [Amended]

0
44. In Sec.  522.2220, in paragraph (b)(1), remove ``054628'' and in 
its place add ``069043''; and in paragraph (b)(3), remove ``Nos. 
016592, 057561, and 061623'' and in its place add ``Nos. 016592 and 
061623''.

Sec.  522.2424  [Amended]

0
45. In Sec.  522.2424, in paragraph (b), remove ``054628 and 054771'' 
and in its place add ``054771 and 069043''.

Sec.  522.2483  [Amended]

0
46. In Sec.  522.2483, in paragraph (b), remove ``054628'' and in its 
place add ``069043''.

Sec.  522.2662  [Amended]

0
47. In Sec.  522.2662, in paragraph (b)(1), remove ``054628'' and in 
its place add ``069043''.

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

0
48. The authority citation for part 524 continues to read as follows:

    Authority: 21 U.S.C. 360b.

0
49. In Sec.  524.814, revise paragraph (b) to read as follows:

Sec.  524.814  Eprinomectin.

* * * * *
    (b) Sponsors. See Nos. 050604 and 055529 in Sec.  510.600(c) of 
this chapter.
* * * * *

0
50. Add Sec.  524.815 to read as follows:

Sec.  524.815  Eprinomectin and praziquantel.

    (a) Specifications. Each milliliter (mL) of solution contains 4 
milligrams (mg) eprinomectin and 83 mg praziquantel.
    (b) Sponsor. See No. 050604 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in cats--(1) Amount. Using the 0.3 mL and 0.9 
mL unit applicators, administer a minimum dose of 0.23 mg eprinomectin 
per pound body weight and 4.55 mg praziquantel per pound body weight by 
topical application on the dorsal midline between the base of the skull 
and the shoulder blades.
    (2) Indications for use. For the prevention of heartworm disease 
caused by Dirofilaria immitis, and for the treatment and control of 
roundworms (adult and fourth stage larval Toxocara cati), hookworms 
(adult and fourth stage larval Ancylostoma tubaeforme; adult 
Ancylostoma braziliense), and tapeworms (adult Dipylidium caninum and 
Echinococcus multilocularis), in cats and kittens 7 weeks of age and 
older and 1.8 lbs or greater.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

Sec.  524.900  [Amended]

0
51. In Sec.  524.900, in paragraph (b), remove ``Nos. 000061 and 
051311'' and in its place add ``No. 000061''.

[[Page 48947]]

Sec.  524.1580a  [Amended]

0
52. In Sec.  524.1580a, in paragraph (b)(1), remove ``Nos. 054628, 
054925, 058005, 059051, and 061623'' and in its place add ``Nos. 
054925, 058005, 059051, 061623, and 069043''.

Sec.  524.1580b  [Amended]

0
53. In Sec.  524.1580b, in paragraph (b), remove ``054628 and 059051'' 
and in its place add ``059051 and 069043''.

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

0
54. The authority citation for part 529 continues to read as follows:

    Authority: 21 U.S.C. 360b.

Sec.  529.1044a  [Amended]

0
55. In Sec.  529.1044a, in paragraph (b), remove ``Nos. 000061, 000859, 
054628, 054771, 057561, 058005, and 061623'' and in its place add 
``Nos. 000061, 000859, 016592, 054628, 054771, 058005, and 061623''.

PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

0
56. The authority citation for part 556 continues to read as follows:

    Authority:  21 U.S.C. 342, 360b, 371.

0
57. In Sec.  556.275, add paragraph (b)(3)(ii) to read as follows:

Sec.  556.275  Fenbendazole.

* * * * *
    (b) * * *
    (3) * * *
    (ii) Eggs. The tolerance for fenbendazole sulfone (the marker 
residue) is 1.8 ppm.
* * * * *

Sec.  556.440  [Removed]

0
58. Remove Sec.  556.440.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
59. The authority citation for part 558 continues to read as follows:

    Authority:  21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.

Sec.  558.4   [Amended]

0
60. In Sec.  558.4, in paragraph (d), in the ``Category I'' table, 
remove the row entry for ``Nequinate''.

Sec.  558.128  [Amended]

0
61. In Sec.  558.128, in paragraphs (e)(4)(xi) and (xiii), in the 
``Indications for use'' column, remove ``P. multocida'' and in its 
place add ``P. multocida organisms''.

0
62. In Sec.  558.185, revise paragraph (b), remove paragraph (e)(1), 
and redesignate paragraphs (e)(2) and (3) as paragraphs (e)(1) and (2).
    The revision reads as follows:

Sec.  558.185  Coumaphos.

* * * * *
    (b) Sponsor. See No. 000859 in Sec.  510.600(c) of this chapter.
* * * * *

Sec.  558.195  [Amended]

0
63. In Sec.  558.195, remove and reserve paragraph (e)(2)(v).

0
64. In Sec.  558.205, revise paragraph (a); redesignate paragraphs (b) 
through (d) as paragraphs (c) through (e); and add new paragraph (b).
    The revision and addtion read as follows:

Sec.  558.205  Dichlorvos.

    (a) Specifications. Type A medicated articles containing 3.1 or 9.6 
percent dichlorvos.
    (b) Sponsor. See No. 069043 in Sec.  510.600(c) of this chapter.
* * * * *

0
65. In Sec.  558.311, revise paragraph (e)(5) to read as follows:

Sec.  558.311  Lasalocid.

* * * * *
    (e) * * *
    (5) Lasalocid may also be used in combination with:
    (i) Chlortetracycline as in Sec.  558.128.
    (ii) Melengestrol as in Sec.  558.342.
    (iii) Oxytetracycline as in Sec.  558.450.
    (iv) Tylosin alone or in combination with melengestrol acetate as 
in Sec.  558.625.
    (v) Virginiamycin as in Sec.  558.635.

0
66. In Sec.  558.325, redesignate paragraph (e)(1)(ii) as paragraph 
(e)(1)(v); add reserved paragraphs (e)(1)(ii), (iii), and (vi); and add 
paragraphs (e)(1)(iv), (vii), (viii), (ix), and (x) to read as follows:

Sec.  558.325  Lincomycin.

* * * * *
    (e) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
                                 Combination in
     Lincomycin grams/ton           grams/ton      Indications for use           Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(ii) [Reserved]
(iii) [Reserved]
(iv) 2........................  Decoquinate,      Broiler chickens: For  Feed as the sole ration.         054771
                                 2.72.             the control of         Do not use in feeds
                                                   necrotic enteritis     containing bentonite. Not
                                                   caused or              for use in laying hens,
                                                   complicated by         breeding chickens, or
                                                   Clostridium spp. or    turkeys. Do not allow
                                                   other organisms        rabbits, hamsters, guinea
                                                   susceptible to         pigs, horses, or
                                                   lincomycin; and for    ruminants access to feeds
                                                   the prevention of      containing lincomycin.
                                                   coccidiosis caused     Ingestion by these
                                                   by Eimeria tenella,    species may result in
                                                   E. necatrix, E.        severe gastrointestinal
                                                   acervulina, E.         effects. Decoquinate as
                                                   brunetti, E. mivati,   provided by No. 054771 in
                                                   and E. maxima.         Sec.   510.600 of this
                                                                          chapter.
 
                                                  * * * * * * *
(vi) [Reserved]
(vii) 2.......................  Monensin, 90 to   Broiler chickens: For  Feed as the sole ration.         054771
                                 110.              the control of         Must be thoroughly mixed
                                                   necrotic enteritis     in feeds before use. Do
                                                   caused or              not feed undiluted. Not
                                                   complicated by         for use in laying hens,
                                                   Clostridium spp. or    breeding chickens, or
                                                   other organisms        turkeys. Do not allow
                                                   susceptible to         horses, or other equines,
                                                   lincomycin, and as     mature turkeys, or guinea
                                                   an aid the             fowl access to feed
                                                   prevention of          containing monensin.
                                                   coccidiosis caused     Ingestion of monensin by
                                                   by Eimeria necatrix,   horses and guinea fowl
                                                   E. tenella, E.         has been fatal. Do not
                                                   acervulina, E.         allow rabbits, hamsters,
                                                   brunetti, E. mivati,   guinea pigs, horses, or
                                                   and E. maxima.         ruminants access to feeds
                                                                          containing lincomycin.
                                                                          Ingestion by these
                                                                          species may result in
                                                                          severe gastrointestinal
                                                                          effects. Monensin as
                                                                          provided by No. 058198 in
                                                                          Sec.   510.600 of this
                                                                          chapter.

[[Page 48948]]

 
(viii) 2......................  Robenidine        Broiler chickens: For  Feed as the sole ration.         054771
                                 hydrochloride,    the control of         Do not use in feeds
                                 30.               necrotic enteritis     containing bentonite. Do
                                                   caused or              not feed to laying hens
                                                   complicated by         producing eggs for human
                                                   Clostridium spp. or    consumption. Not for use
                                                   other organisms        in laying hens, breeding
                                                   susceptible to         chickens, or turkeys. Do
                                                   lincomycin, and as     not allow rabbits,
                                                   an aid in the          hamsters, guinea pigs,
                                                   prevention of          horses, or ruminants
                                                   coccidiosis caused     access to feeds
                                                   by Eimeria mivati,     containing lincomycin.
                                                   E. brunetti, E.        Ingestion by these
                                                   tenella, E.            species may result in
                                                   acervulina, E.         severe gastrointestinal
                                                   maxima, and E.         effects. Withdraw 5 days
                                                   necatrix.              prior to slaughter. Type
                                                                          C feed containing
                                                                          robenidine hydrochloride
                                                                          must be fed within 50
                                                                          days from the date of
                                                                          manufacture. Robenidine
                                                                          hydrochloride as provided
                                                                          by No. 054771 in Sec.
                                                                          510.600 of this chapter.
(ix) 2........................  Salinomycin       Broiler chickens: For  Feed as the sole ration to       054771
                                 sodium, 40 to     the control of         broiler chickens. Do not
                                 60.               necrotic enteritis     feed to laying hens
                                                   caused or              producing eggs for human
                                                   complicated by         consumption. Not approved
                                                   Clostridium spp. or    for use with pellet
                                                   other organisms        binders. May be fatal if
                                                   susceptible to         accidentally fed to adult
                                                   lincomycin, and for    turkeys or horses. Not
                                                   the prevention of      for use in laying hens,
                                                   coccidiosis caused     breeding chickens, or
                                                   by Eimeria tenella,    turkeys. Do not allow
                                                   E. necatrix, E.        rabbits, hamsters, guinea
                                                   acervulina, E          pigs, horses, or
                                                   maxima, E. brunetti,   ruminants access to feeds
                                                   and E. mivati.         containing lincomycin.
                                                                          Ingestion by these
                                                                          species may result in
                                                                          severe gastrointestinal
                                                                          effects. Salinomycin
                                                                          sodium as provided by No.
                                                                          054771 in Sec.   510.600
                                                                          of this chapter.
(x) 2.........................  Zoalene, 113.5..  Broiler chickens: For  Feed as the sole ration          054771
                                                   the control of         from the time chicks are
                                                   necrotic enteritis     placed in floor pens
                                                   caused or              until slaughtered for
                                                   complicated by         meat. Not for use in
                                                   Clostridium spp. or    laying hens, breeding
                                                   other organisms        chickens, or turkeys. Do
                                                   susceptible to         not allow rabbits,
                                                   lincomycin; and for    hamsters, guinea pigs,
                                                   the prevention and     horses, or ruminants
                                                   control of             access to feeds
                                                   coccidiosis.           containing lincomycin.
                                                                          Ingestion by these
                                                                          species may result in
                                                                          severe gastrointestinal
                                                                          effects. Zoalene as
                                                                          provided by No. 054771 in
                                                                          Sec.   510.600 of this
                                                                          chapter.
----------------------------------------------------------------------------------------------------------------

* * * * *

0
67. In Sec.  558.342, in paragraph (e)(1), revise the table headings, 
add paragraphs (e)(1)(iii) and (iv), and remove paragraphs (e)(1)(v) 
through (xi); and in paragraph (e)(2), redesignate paragraphs (e)(2)(i) 
through (iii) as paragraphs (e)(2)(ii) through (iv) and add new 
paragraph (e)(2)(i).
    The revisions and additions read as follows:

Sec.  558.342  Melengestrol.

* * * * *
    (e) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
 Melengestrol  acetate in  mg/   Combination  in
           head/day                 grams/ton      Indications for use           Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(iii) 0.25 to 0.5.............  Lasalocid, 10 to  Heifers fed in         Add at the rate of 0.5 to        054771
                                 30.               confinement for        2.0 lb/head/day a               058198
                                                   slaughter: For         medicated feed (liquid or
                                                   increased rate of      dry) containing 0.125 to
                                                   weight gain,           1.0 mg melengestrol
                                                   improved feed          acetate/lb to a feed
                                                   efficiency, and        containing 10 to 30 g of
                                                   suppression of         lasalocid per ton to
                                                   estrus (heat); and     provide 0.25 to 0.5 mg
                                                   for control of         melengestrol acetate and
                                                   coccidiosis caused     100 to 360 milligrams of
                                                   by Eimeria bovis and   lasalocid per head/day.
                                                   Eimeria zuernii.       See Sec.   558.311(d) of
                                                                          this chapter. Lasalocid
                                                                          as provided by No. 054771
                                                                          in Sec.   510.600(c) of
                                                                          this chapter.
(iv) 0.25 to 0.5..............  Monensin, 10 to   Heifers fed in         Add at the rate of 0.5 to        054771
                                 40.               confinement for        2.0 lb/head/day a               058198
                                                   slaughter: For         medicated feed (liquid or
                                                   increased rate of      dry) containing 0.125 to
                                                   weight gain,           1.0 mg melengestrol
                                                   improved feed          acetate/lb to a feed
                                                   efficiency, and        containing 10 to 40 g of
                                                   suppression of         monensin per ton to
                                                   estrus (heat); and     provide 0.25 to 0.5 mg
                                                   for the prevention     melengestrol acetate/head/
                                                   and control of         day and 0.14 to 0.42 mg
                                                   coccidiosis due to     monensin/lb body weight,
                                                   Eimeria bovis and E.   depending on severity of
                                                   zuernii.               coccidiosis challenge, up
                                                                          to 480 mg monensin/head/
                                                                          day. See Sec.
                                                                          558.355(d) of this
                                                                          chapter. Monensin as
                                                                          provided by No. 058198 in
                                                                          Sec.   510.600(c) of this
                                                                          chapter.
----------------------------------------------------------------------------------------------------------------

    (2) * * *
    (i) Oxytetracycline as in Sec.  558.450.
* * * * *

Sec.  558.365  [Removed]

0
68. Remove Sec.  558.365.

Sec.  558.450  [Amended]

0
69. In Sec.  558.450, in paragraph (e)(5)(iv) entries 1 and 2, remove 
``A. liquefaciens'' and in its place add ``A. hydrophila''.

0
70. Revise Sec.  558.485 to read as follows:

Sec.  558.485  Pyrantel.

    (a) Specifications. Type A medicated articles containing 48 or 80 
grams per pound pyrantel tartrate.
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for 
uses as in paragraph (e) of this section.
    (1) No. 066104: 48 and 80 grams per pound for use as in paragraph 
(e)(1) of this section.
    (2) Nos. 017135 and 054771: 48 grams per pound for use as in 
paragraph (e)(2) of this section.
    (c) Related tolerances. See Sec.  556.560 of this chapter.

[[Page 48949]]

    (d) Special considerations--(1) See Sec.  500.25 of this chapter. 
Consult a veterinarian before using in severely debilitated animals.
    (2) Do not mix in Type B or Type C medicated feeds containing 
bentonite.
    (e) Conditions of use--(1) Swine--

----------------------------------------------------------------------------------------------------------------
         Pyrantel  grams/ton              Indications for use                 Limitations              Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 96..............................  Swine: As an aid in the      Feed continuously as the sole          066104
                                       prevention of migration      ration in a Type C feed.
                                       and establishment of large   Withdraw 24 hours prior to
                                       roundworm (Ascaris suum)     slaughter.
                                       infections; aid in the
                                       prevention of
                                       establishment of nodular
                                       worm (Oesophagostomum)
                                       infections.
(ii) 96.............................  Swine: For the removal and   Feed for 3 days as the sole            066104
                                       control of large roundworm   ration in a Type C feed.
                                       (Ascaris suum) infections.   Withdraw 24 hours prior to
                                                                    slaughter.
(iii) 800...........................  Swine: For the removal and   Feed as the sole ration for a          066104
                                       control of large roundworm   single therapeutic treatment in
                                       (Ascaris suum) and nodular   Type C feed at a rate of 1 lb
                                       worm (Oesophagostomum)       of feed per 40 lb of body
                                       infections.                  weight for animals up to 200
                                                                    lb, and 5 lb of feed per head
                                                                    for animals 200 lb or over.
                                                                    Withdraw 24 hours prior to
                                                                    slaughter.
----------------------------------------------------------------------------------------------------------------

    (2) Horses--

----------------------------------------------------------------------------------------------------------------
         Pyrantel  grams/ton              Indications for use                 Limitations              Sponsor
----------------------------------------------------------------------------------------------------------------
To provide 1.2 mg/lb body weight....  Prevention of Strongylus     Feed continuously. Administer          017135
                                       vulgaris larval              either as a top-dress (not to         054771
                                       infections; control of       exceed 20,000 g/ton) or mixed
                                       adult large strongyles (S.   in the horse's daily grain
                                       vulgaris, and S.             ration (not to exceed 1,200 g/
                                       edentatus), adult and 4th    ton) during the time that the
                                       stage larvae small           animal is at risk of exposure
                                       strongyles (Cyathostomum     to internal parasites. Not for
                                       spp., Cylicocyclus spp.,     use in horses intended for
                                       Cylicostephanus spp.,        food. Consult your veterinarian
                                       Cylicodontophorus spp.,      before using in severely
                                       Poteriostomum spp., and      debilitated animals and for
                                       Triodontophorus spp.),       assistance in the diagnosis,
                                       adult and 4th stage larvae   treatment, and control of
                                       pinworms (Oxyuris equi),     parasitism.
                                       and adult and 4th stage
                                       larvae ascarids
                                       (Parascaris equorum).
----------------------------------------------------------------------------------------------------------------

    (3) Pyrantel may also be used in combination with:
    (i) Carbadox as in Sec.  558.115.
    (ii) Lincomycin as in Sec.  558.325.
    (iii) Tylosin as in Sec.  558.625.

0
71. In Sec.  558.625, revise paragraphs (e)(2)(ii) and (iii) to read as 
follows:

Sec.  558.625   Tylosin.

* * * * *
    (e) * * *
    (2) * * *

----------------------------------------------------------------------------------------------------------------
                                 Combination  in
      Tylosin  grams/ton            grams/ton      Indications for use           Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(ii) 8 to 10..................  Lasalocid, 100    Heifers fed in         Feed continuously as sole        016592
                                 to 1440; plus     confinement for        ration. Feed to heifers         054771
                                 melengestrol,     slaughter: For         at the rate of 0.5 to 2.0       058198
                                 0.25 to 2.0.      reduction of           pound(s) per head per day
                                                   incidence of liver     (specify one level) to
                                                   abscesses caused by    provide 0.25 to 0.5 mg
                                                   Fusobacterium          melengestrol acetate per
                                                   necrophorum and        head per day (specify one
                                                   Arcanobacterium        level), 100 to 360 mg
                                                   pyogenes; and for      lasalocid per head per
                                                   increased rate of      day (specify one level),
                                                   weight gain,           and 90 mg tylosin per
                                                   improved feed          head per day. This Type C
                                                   efficiency, and        product may be top
                                                   suppression of         dressed onto or mixed
                                                   estrus (heat).         into a complete feed
                                                                          prior to feeding. Tylosin
                                                                          as provided by Nos.
                                                                          016592 and 058198;
                                                                          lasalocid as provided by
                                                                          No. 054771; melengestrol
                                                                          as provided by Nos.
                                                                          054771 and 058198 in Sec.
                                                                            510.600(c) of this
                                                                          chapter. See Sec.  Sec.
                                                                          558.311(d) and 558.342(d)
                                                                          in this chapter.
(iii) 8 to 10.................  Melengestrol,     Heifers fed in         Feed continuously as sole        016592
                                 0.25 to 2.0.      confinement for        ration. Each pound              054771
                                                   slaughter: For         contains 0.125 to 1.0 mg        058198
                                                   reduction of           melengestrol acetate and
                                                   incidence of liver     45 to 180 mg of tylosin.
                                                   abscesses caused by    Feed to heifers at a rate
                                                   Fusobacterium          of 0.5 to 2.0 pounds per
                                                   necrophorum and        head per day to provide
                                                   Arcanobacterium        0.25 to 0.5 mg
                                                   pyogenes; and for      melengestrol acetate and
                                                   increased rate of      60 to 90 mg tylosin per
                                                   weight gain,           head per day. Prior to
                                                   improved feed          feeding, this Type C
                                                   efficiency, and        product must be top-
                                                   suppression of         dressed onto a complete
                                                   estrus (heat).         feed or mixed into the
                                                                          amount of complete feed
                                                                          consumed by an animal per
                                                                          day. Tylosin provided by
                                                                          Nos. 016592 and 058198;
                                                                          melengestrol provided by
                                                                          Nos. 054771 and 058198 in
                                                                          Sec.   510.600(c) of this
                                                                          chapter. See Sec.
                                                                          558.342(d) in this
                                                                          chapter.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

[[Page 48950]]

    Dated: September 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21146 Filed 9-27-18; 8:45 am]
 BILLING CODE 4164-01-P