[Federal Register Volume 84, Number 63 (Tuesday, April 2, 2019)]
[Rules and Regulations]
[Pages 12491-12504]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06136]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 524, 528, 556, and 558

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


New Animal Drugs; Approval of New Animal Drug Applications; 
Changes of Sponsorship

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

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

SUMMARY: The Food and Drug Administration (FDA or we) is amending the 
animal drug regulations to reflect application-related actions for new 
animal drug applications (NADAs) and abbreviated new animal drug 
applications (ANADAs) during October, November, and December 2018. FDA 
is informing the public of the availability of summaries of the basis 
of approval and of environmental review documents, where applicable. 
The animal drug regulations are also being amended to make technical 
amendments to improve the readability of the regulations.

DATES: This rule is effective April 2, 2019.

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

SUPPLEMENTARY INFORMATION: 

I. Approval Actions

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

                        Table 1--Original and Supplemental NADAs and ANADAs Approved During October, November, and December 2018
--------------------------------------------------------------------------------------------------------------------------------------------------------
      Approval date       File No.         Sponsor              Product name             Species           Effect of the action      Public  documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
October 1, 2018.........   200-490  Dragon Fire Holding    Carprofen, Chewable    Dogs................  Original approval as a     FOI Summary.
                                     Co., Inc., 2619        Tablets.                                     generic copy of NADA 141-
                                     Skyway Dr., Grand                                                   111.
                                     Prairie, TX 75052.

[[Page 12492]]

 
October 15, 2018........   141-485  Zoetis Inc., 333       Lincomycin and         Chickens............  Original approval for use  FOI Summary.
                                     Portage St.,           clopidol, Type C                             of LINCOMIX (lincomycin)
                                     Kalamazoo, MI 49007.   medicated feeds.                             and COYDEN (clopidol)
                                                                                                         Type A medicated
                                                                                                         articles in the
                                                                                                         manufacture of Type C
                                                                                                         medicated broiler
                                                                                                         chicken feeds for the
                                                                                                         control of necrotic
                                                                                                         enteritis caused or
                                                                                                         complicated by
                                                                                                         Clostridium spp. or
                                                                                                         other organisms
                                                                                                         susceptible to
                                                                                                         lincomycin, and for the
                                                                                                         prevention of
                                                                                                         coccidiosis caused by
                                                                                                         Eimeria tenella, E.
                                                                                                         necatrix, E. acervulina,
                                                                                                         E maxima, E. brunetti,
                                                                                                         and E. mivati.
November 1, 2018........   200-627  Putney, Inc., One      Cyclosporine           Dogs................  Original approval as a     FOI Summary.
                                     Monument Sq., Suite    Capsules, USP                                generic copy of NADA 141-
                                     400, Portland, ME      MODIFIED.                                    218.
                                     04101.
November 6, 2018........   141-508  Elanco US Inc., 2500   EXPERIOR (lubabegron)  Cattle..............  Original approval for      FOI Summary EA/
                                     Innovation Way,        Type A medicated                             reduction of ammonia gas   FONSI.\1\
                                     Greenfield, IN 46140.  article to be used                           emissions per pound of
                                                            in the manufacture                           live weight and hot
                                                            of Type B and Type C                         carcass weight in beef
                                                            medicated feeds.                             steers and heifers fed
                                                                                                         in confinement for
                                                                                                         slaughter during the
                                                                                                         last 14 to 91 days on
                                                                                                         feed.
November 9, 2018........   141-502  Zoetis Inc., 333       REVOLUTION PLUS        Cats................  Original approval for the  FOI Summary.
                                     Portage St.,           (selamectin and                              prevention of heartworm
                                     Kalamazoo, MI 49007.   sarolaner topical                            disease caused by
                                                            solution).                                   Dirofilaria immitis.
                                                                                                         Kills adult fleas
                                                                                                         (Ctenocephalides felis)
                                                                                                         and is indicated for the
                                                                                                         treatment and prevention
                                                                                                         of flea infestations;
                                                                                                         the treatment and
                                                                                                         control of tick
                                                                                                         infestations with Ixodes
                                                                                                         scapularis (black-legged
                                                                                                         or deer tick), Amblyomma
                                                                                                         maculatum (Gulf Coast
                                                                                                         tick), and Dermacentor
                                                                                                         variabilis (American dog
                                                                                                         tick); the treatment and
                                                                                                         control of ear mite
                                                                                                         (Otodectes cynotis)
                                                                                                         infestations; and the
                                                                                                         treatment and control of
                                                                                                         roundworm (Toxocara
                                                                                                         cati) and intestinal
                                                                                                         hookworm (Ancylostoma
                                                                                                         tubaeforme) infections
                                                                                                         in cats and kittens 8
                                                                                                         weeks of age and older,
                                                                                                         and weighing 2.8 pounds
                                                                                                         or greater.
November 21, 2018.......   038-439  Phibro Animal Health,  TERRAMYCIN             Salmonids...........  Supplemental approval for  FOI Summary.
                                     Corp., GlenPointe      (oxytetracycline),                           marking the skeletal
                                     Centre East, 3d        Type A medicated                             tissue of freshwater-
                                     Floor, 300 Frank W.    article.                                     reared salmonids.
                                     Burr Blvd., Suite
                                     21, Teaneck, NJ
                                     07666.
December 4, 2018........   141-509  Boehringer Ingelheim   PEXION (imepitoin      Dogs................  Original approval for the  FOI Summary.
                                     Vetmedica, Inc.,       tablets).                                    treatment of noise
                                     2621 North Belt                                                     aversion in dogs.
                                     Highway, St. Joseph,
                                     MO 64506-2002.
December 19, 2018.......   200-629  Ceva Sante Animale,    MILBEGUARD             Dogs and cats.......  Original approval as a     FOI Summary.
                                     10 Avenue de la        (milbemycin oxime),                          generic copy of NADA 140-
                                     Ballasti[egrave]re,    Flavored Tablets.                            915.
                                     33500 Libourne,
                                     France.
December 27, 2018.......   141-511  LFB USA, Inc., 175     Bc2371 rDNA construct  R69 New Zealand       Original approval for      FOI Summary EA/
                                     Crossing Blvd.,        in R69 New Zealand     white rabbits.        expression of a gene for   FONSI.\1\
                                     Framingham, MA 01702.  white rabbits.                               recombinant human Factor
                                                                                                         VII (rhFVIIa) in R69 New
                                                                                                         Zealand white rabbits.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The Agency has carefully considered an environmental assessment (EA) of the potential environmental impact of this action and has made a finding of
  no significant impact (FONSI).

II. Change of Sponsorship

    Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sofia, 
Bulgaria, has informed FDA that it has transferred ownership of, and 
all rights and interest in, the following applications to Elanco US 
Inc., 2500 Innovation Way, Greenfield, IN 46140.

----------------------------------------------------------------------------------------------------------------
                                                                                                      21 CFR
              File No.                                       Product name                             section
----------------------------------------------------------------------------------------------------------------
140-951.............................  CLINACOX (diclazuril) Type A Medicated Article............         558.198
141-153.............................  CLINACOX (diclazuril)/BMD (bacitracin                              558.198
                                       methylenedisalicylate).
141-158.............................  CLINACOX (diclazuril)/FLAVOMYCIN (bambermycins)...........         558.198
141-194.............................  CLINACOX (diclazuril)/BMD (bacitracin                              558.198
                                       methylenedisalicylate).
----------------------------------------------------------------------------------------------------------------


[[Page 12493]]

    As provided in the regulatory text of this document, the animal 
drug regulations are amended to reflect these changes of sponsorship.

III. Technical Amendments

    We are reformatting the regulations in subpart B of part 558 for 
certain medicated feeds to present their approved conditions of use in 
the current tabular format. In addition, we are removing cross-
referencing citations for indications for use of combination drug 
medicated feeds wherever they have been used and in their place are 
adding the full text of the indications. These actions are being taken 
to improve the consistency and readability of the regulations.

IV. Legal Authority

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

List of Subjects

21 CFR Part 510

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

21 CFR Parts 520, 522, 524, and 528

    Animal drugs.

21 CFR Part 556

    Animal drugs, Foods.

21 CFR Part 558

    Animal drugs, Animal feeds.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
510, 520, 522, 524, 528, 556, and 558 are amended as follows:

PART 510--NEW ANIMAL DRUGS

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

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

0
2. In Sec.  510.600, in the table in paragraph (c)(1), revise the entry 
for ``AquaBounty Technologies, Inc.'' and alphabetically add an entry 
for ``Dragon Fire Holding Co., Inc.''; and in the table in paragraph 
(c)(2), numerically add an entry for ``076033'' and revise the entry 
for ``086053'' to read as follows:


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

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

------------------------------------------------------------------------
                                                           Drug labeler
                  Firm name and address                        code
------------------------------------------------------------------------
 
                              * * * * * * *
AquaBounty Technologies, Inc., 2 Mill and Main Pl.,               086053
 Suite 395, Maynard, MA 01754...........................
 
                              * * * * * * *
Dragon Fire Holding Co., Inc., 2619 Skyway Dr., Grand             076033
 Prairie, TX 75052......................................
 
                              * * * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
   Drug labeler  code                  Firm name and address
------------------------------------------------------------------------
 
                              * * * * * * *
076033..................  Dragon Fire Holding Co., Inc., 2619 Skyway
                           Dr., Grand Prairie, TX 75052.
 
                              * * * * * * *
086053..................  AquaBounty Technologies, Inc., 2 Mill and Main
                           Pl., Suite 395, Maynard, MA 01754.
 
                              * * * * * * *
------------------------------------------------------------------------

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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


Sec.  520.304  [Amended]

0
4. In Sec.  520.304, in paragraph (b)(1), remove ``054771, 026637, 
055529, and 062250'' and in its place add ``026637, 054771, 055529, 
062250, and 076033''.

0
5. In Sec.  520.522, revise paragraph (b) to read as follows:


Sec.  520.522  Cyclosporine.

* * * * *
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter.
    (1) No. 058198 for use of products described in paragraph (a) as in 
paragraph (d) of this section.

[[Page 12494]]

    (2) No. 026637 for use of product described in paragraph (a)(1) as 
in paragraph (d)(1) of this section.
* * * * *

0
6. Add Sec.  520.1150 to read as follows:


Sec.  520.1150  Imepitoin.

    (a) Specifications. Each tablet contains 100 or 400 milligrams (mg) 
imepitoin.
    (b) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer orally twice daily, 
approximately 12 hours apart, at a dose of 13.6 mg per pound (30 mg/kg) 
of body weight. Initiate therapy starting 2 days prior to the day of 
the expected noise event and continuing through the noise event.
    (2) Indications for use. For the treatment of noise aversion in 
dogs.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
7. Revise Sec.  520.1441 to read as follows:


Sec.  520.1441  Milbemycin.

    (a) Specifications. Each flavored tablet contains 2.3, 5.75, 11.5, 
or 23.0 milligrams (mg) of milbemycin oxime.
    (b) Sponsors. See Nos. 013744 and 058198 in Sec.  510.600(c) of 
this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. For hookworm, 
roundworm, and whipworm, administer 0.23 mg per pound (mg/lb) of body 
weight (0.5 mg per kilogram (mg/kg)). For heartworm, administer 0.05 
mg/lb of body weight (0.1 mg/kg). Administer once a month.
    (ii) Indications for use. For prevention of heartworm disease 
caused by Dirofilaria immitis, control of hookworm infections caused by 
Ancylostoma caninum, and removal and control of adult roundworm 
infections caused by Toxocara canis and Toxascaris leonina and whipworm 
infections caused by Trichuris vulpis in dogs and puppies 4 weeks of 
age or greater and 2 pounds body weight or greater.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Cats--(i) Amount. Administer 0.91 mg/lb of body weight (2.0 mg/
kg) once a month.
    (ii) Indications for use. For prevention of heartworm disease 
caused by Dirofilaria immitis and the removal of adult Toxocara cati 
(roundworm) and Ancylostoma tubaeforme (hookworm) infections in cats 6 
weeks of age or greater and 1.5 pounds body weight or greater.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

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

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

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


0
9. Amend Sec.  522.1662a by adding two sentences at the end of 
paragraph (h)(3)(iii) to read as follows:


Sec.  522.1662a  Oxytetracycline hydrochloride injection.

* * * * *
    (h) * * *
    (3) * * *
    (iii) * * * A withdrawal period has not been established for this 
product in preruminating calves. Do not use in calves to be processed 
for veal.
* * * * *

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

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

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


0
11. Add Sec.  524.2099 to read as follows:


Sec.  524.2099  Selamectin and sarolaner.

    (a) Specifications. Each milliliter (mL) of solution contains 60 
milligrams (mg) selamectin and 10 mg sarolaner. The drug is provided in 
single dose tubes containing 0.25, 0.5, or 1 mL of solution.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in cats--(1) Amount. Administer 2.7 mg 
selamectin per pound (/lb) (6 mg per kilogram (/kg)) of body weight and 
0.45 mg/lb sarolaner (1 mg/kg) by emptying the contents of the tube on 
the back of the animal at the base of the neck in front of the shoulder 
blades.
    (2) Indications for use. For the prevention of heartworm disease 
caused by Dirofilaria immitis. Kills adult fleas (Ctenocephalides 
felis) and is indicated for the treatment and prevention of flea 
infestations; the treatment and control of tick infestations with 
Ixodes scapularis (black-legged or deer tick), Amblyomma maculatum 
(Gulf Coast tick), and Dermacentor variabilis (American dog tick); the 
treatment and control of ear mite (Otodectes cynotis) infestations; and 
the treatment and control of roundworm (Toxocara cati) and intestinal 
hookworm (Ancylostoma tubaeforme) infections in cats and kittens 8 
weeks of age and older, and weighing 2.8 pounds or greater.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

PART 528--NEW ANIMAL DRUGS IN GENETICALLY ENGINEERED ANIMALS

0
12. The authority citation for part 528 continues to read as follows:

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


0
13. Add Sec.  528.1080 to read as follows:


Sec.  528.1080  Bc2371 recombinant deoxyribonucleic acid construct.

    (a) Specifications and intended use. A single copy of Bc2371, a 
human Factor VII recombinant deoxyribonucleic acid (rDNA) gene 
construct, located on chromosome 3p1.1-2 in a diploid line (R69) of 
hemizygous and homozygous New Zealand white rabbits (Oryctolagus 
cuniculus).
    (b) Sponsor. See No. 086047 in Sec.  510.600 of this chapter.
    (c) Conditions of use--(1) Intended use. The construct directs gene 
expression of recombinant human Factor VII (hFVII) in the mammary gland 
such that recombinant hFVII zymogen is present in the rabbit milk, 
enabling purification and activation of recombinant hFVIIa intended for 
the treatment of hemophilia A or B in humans with inhibitors to Factors 
VIII and IX.
    (2) Limitations. Food or feed from R69 rabbits is not permitted in 
the food or feed supply.

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

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

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


0
15. Add Sec.  556.370 to subpart B to read as follows:


Sec.  556.370  Lubabegron.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
lubabegron is 3 micrograms per kilogram of body weight per day.
    (b) Tolerance in cattle. The tolerance for lubabegron (marker 
residue) is:
    (1) Cattle--Liver (target tissue): 10 ppb.
    (2) [Reserved]
    (c) Related conditions of use. See Sec.  558.330 of this chapter.

[[Page 12495]]

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

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

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

0
17. In Sec.  558.4, in paragraph (d), in the ``Category I'' table, 
alphabetically add an entry for ``Lubabegron'' to read as follows:


Sec.  558.4  Requirement of a medicated feed mill license.

* * * * *
    (d) * * *

                                                   Category I
----------------------------------------------------------------------------------------------------------------
                                                Assay limits                                      Assay limits
                    Drug                      percent \1\ Type      Type B maximum  (200x)      percent \1\ Type
                                                     A                                              B/C \2\
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
Lubabegron.................................             87-107  908 g/ton....................      85-115/80-120
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

0
18. In Sec.  558.140, revise paragraphs (e)(1) and (2) to read as 
follows:


Sec.  558.140  Chlortetracycline and sulfamethazine.

* * * * *
    (e) * * *
    (1) Cattle--

----------------------------------------------------------------------------------------------------------------
   Chlortetracycline and sulfamethazine
                  amount                       Indications for use              Limitations            Sponsors
----------------------------------------------------------------------------------------------------------------
(i) To provide 350 milligrams per head     Beef cattle: For aid in the  Feed for 28 days; withdraw        054771
 per day each, chlortetracycline and        maintenance of weight        7 days prior to slaughter.       069254
 sulfamethazine.                            gains in the presence of     A withdrawal period has
                                            respiratory disease such     not been established for
                                            as shipping fever.           this product in pre-
                                                                         ruminating calves. Do not
                                                                         use in calves to be
                                                                         processed for veal.
(ii) [Reserved]
----------------------------------------------------------------------------------------------------------------

    (2) Swine--

----------------------------------------------------------------------------------------------------------------
   Chlortetracycline and sulfamethazine
                  amount                       Indications for use              Limitations            Sponsors
----------------------------------------------------------------------------------------------------------------
(i) 100 g/ton of feed each,                Swine: For reduction of the  Feed as the sole ration.          054771
 chlortetracycline and sulfamethazine.      incidence of cervical        Withdraw 15 days prior to        069254
                                            abscesses; treatment of      slaughter.
                                            bacterial swine enteritis
                                            (salmonellosis or necrotic
                                            enteritis caused by
                                            Salmonella choleraesuis
                                            and vibrionic dysentery);
                                            prevention of these
                                            diseases during times of
                                            stress; and maintenance of
                                            weight gains in the
                                            presence of atrophic
                                            rhinitis.
(ii) [Reserved]
----------------------------------------------------------------------------------------------------------------

* * * * *

0
19. In Sec.  558.175, revise paragraph (d) to read as follows:


Sec.  558.175  Clopidol.

* * * * *
    (d) Conditions of use--(1) Chickens--

----------------------------------------------------------------------------------------------------------------
Clopidol in  grams per   Combination in
          ton             grams per ton           Indications for use              Limitations         Sponsors
----------------------------------------------------------------------------------------------------------------
(i) 113.5.............  ................  Broiler chickens and re-placement   Do not feed to              016592
                                           chickens intended for use as        chickens over 16
                                           caged layers: As an aid in the      weeks of age.
                                           prevention of coccidiosis caused
                                           by Eimeria tenella, E. necatrix,
                                           E. acervulina, E. maxima, E.
                                           brunetti, and E. mivati.
(ii) 113.5............  Bacitracin        Broiler chickens: As an aid in the  Feed continuously as        016592
                         methylenedisali   prevention of coccidiosis caused    the sole ration from
                         cylate, 4 to 50.  by Eimeria tenella, E. necatrix,    the time chicks are
                                           E. acervulina, E. maxima, E.        placed in floor pens
                                           brunetti, and E. mivati, and for    until slaughter. Do
                                           increased rate of weight gain.      not feed to chickens
                                                                               over 16 weeks of
                                                                               age; bacitracin
                                                                               methylenedisalicylat
                                                                               e as provided by No.
                                                                               054771 in Sec.
                                                                               510.600(c) of this
                                                                               chapter.
(iii) 113.5...........  Bacitracin zinc,  Broiler chickens: As an aid in the  Feed continuously as        054771
                         5 to 25.          prevention of coccidiosis caused    sole ration;               016592
                                           by Eimeria tenella, E. necatrix,    bacitracin zinc as
                                           E. acervulina, E. maxima, E.        provided by No.
                                           brunetti, and E. mivati, and for    054771 in Sec.
                                           increased rate of weight gain and   510.600(c) of this
                                           improved feed efficiency.           chapter.
(iv) 113.5............  Bambermycins, 1   Broiler chickens: As an aid in      Feed continuously as        016592
                         to 2.             prevention of coccidiosis caused    the sole ration. Do
                                           by Eimeria tenella, E. necatrix,    not feed to chickens
                                           E. acervulina, E. maxima, E.        over 16 weeks of age.
                                           brunetti, and E. mivati; and for
                                           increased rate of weight gain and
                                           improved feed efficiency.

[[Page 12496]]

 
(v) 227...............  ................  Broiler and replacement chickens    Feed continuously as        016592
                                           intended for use as caged layers:   the sole ration;
                                           As an aid in the prevention of      feed up to 16 weeks
                                           coccidiosis caused by Eimeria       of age if intended
                                           tenella, E. necatrix, E.            for use as caged
                                           acervulina, E. maxima, E.           layers; withdraw 5
                                           brunetti, and E. mivati.            days before
                                                                               slaughter if given
                                                                               at the level of
                                                                               0.025 percent in
                                                                               feed or reduce level
                                                                               to 0.0125 percent 5
                                                                               days before
                                                                               slaughter.
(vi) 227..............  Bambermycins, 1   Broiler chickens: As an aid in      Feed continuously as        016592
                         to 2.             prevention of coccidiosis caused    sole ration until 5
                                           by Eimeria tenella, E. necatrix,    days before
                                           E. acervulina, E. maxima, E.        slaughter. Withdraw
                                           brunetti, and E. mivati; and for    5 days before
                                           increased rate of weight gain and   slaughter or feed
                                           improved feed efficiency.           113.5 g/ton clopidol
                                                                               and 1 to 2 g/ton
                                                                               bambermycins during
                                                                               those 5 days before
                                                                               slaughter. Do not
                                                                               feed to chickens
                                                                               over 16 weeks of age.
----------------------------------------------------------------------------------------------------------------

    (2) Turkeys--

----------------------------------------------------------------------------------------------------------------
Clopidol in  grams per   Combination in
          ton             grams per ton           Indications for use              Limitations         Sponsors
----------------------------------------------------------------------------------------------------------------
(i) 113.5 or 227......  ................  Turkeys: As an aid in the           For turkeys grown for       016592
                                           prevention of leucocytozoonosis     meat purposes only;
                                           caused by Leucocytozoon smithi.     feed continuously as
                                                                               the sole ration at
                                                                               0.0125 or 0.025
                                                                               percent clopidol
                                                                               depending on
                                                                               management
                                                                               practices, degree of
                                                                               exposure, and amount
                                                                               of feed eaten;
                                                                               withdraw 5 days
                                                                               before slaughter.
(ii) [Reserved]
----------------------------------------------------------------------------------------------------------------

    (3) Clopidol may also be used in combination with:
    (i)-(ii) [Reserved]
    (iii) Chlortetracycline as in Sec.  558.128.
    (iv) Lincomycin as in Sec.  558.325.

0
20. In Sec.  558.195, revise paragraphs (e)(1) through (3) to read as 
follows:


Sec.  558.195  Decoquinate.

* * * * *
    (e) * * *
    (1) Chickens--

--------------------------------------------------------------------------------------------------------------------------------------------------------
                               Combination in grams/
  Decoquinate in  grams/ton             ton                       Indications for use                            Limitations                   Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
(i) 27.2....................                           Broiler chickens: For prevention of        Do not feed to laying hens producing eggs       054771
                                                        coccidiosis caused by Eimeria tenella,     for human consumption.
                                                        E. necatrix, E. mivati, E. acervulina,
                                                        E. maxima, and E. brunetti.
(ii) 27.2...................  Bacitracin               Broiler chickens: For prevention of        Feed continuously as sole ration; do not        054771
                               methylenedisalicylate,   coccidiosis caused by Eimeria tenella,     feed to laying chickens. Bacitracin
                               4 to 50.                 E. necatrix, E. mivati, E. acervulina,     methylenedisalicylate as provided by No.
                                                        E. maxima, and E. brunetti; and for        054771 in Sec.   510.600(c) of this
                                                        increased rate of weight gain and          chapter.
                                                        improved feed efficiency.
(iii) 27.2..................  Bacitracin zinc, 10 to   Broiler chickens: For prevention of        Feed continuously as sole ration; do not        054771
                               50.                      coccidiosis caused by Eimeria tenella,     feed to laying chickens. Bacitracin zinc
                                                        E. necatrix, E. mivati, E. acervulina,     as provided by No. 054771 in Sec.
                                                        E. maxima, and E. brunetti.                510.600(c) of this chapter.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (2) Cattle--

--------------------------------------------------------------------------------------------------------------------------------------------------------
                               Combination in grams/
  Decoquinate in  grams/ton             ton                       Indications for use                            Limitations                   Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
(i) 12.9 to 90.8............                           Cattle (including ruminating and           Feed Type C feed or milk replacer to            054771
                                                        nonruminating calves and veal calves):     provide 22.7 milligrams (mg) per 100
                                                        For prevention of coccidiosis caused by    pounds (lb) of body weight (0.5 mg/kg)
                                                        Eimeria bovis and E. zuernii.              per day. Feed at least 28 days during
                                                                                                   periods of exposure to coccidiosis or
                                                                                                   when it is likely to be a hazard. Do not
                                                                                                   feed to cows producing milk for human
                                                                                                   consumption. See paragraph (d)(3) of
                                                                                                   this section.
(ii) 12.9 to 90.8...........  Monensin, 5 to 30......  Cattle fed in confinement for slaughter:   Feed only to cattle fed in confinement          054771
                                                        For prevention of coccidiosis caused by    for slaughter. Feed continuously as the
                                                        Eimeria bovis and E. zuernii; and for      sole ration to provide 22.7 mg of
                                                        improved feed efficiency.                  decoquinate per 100 lb of body weight
                                                                                                   per day and 50 to 360 mg of monensin per
                                                                                                   head per day. Feed at least 28 days
                                                                                                   during period of exposure to coccidiosis
                                                                                                   or when it is likely to be a hazard. Do
                                                                                                   not feed to animals producing milk for
                                                                                                   food. Do not feed to lactating dairy
                                                                                                   cattle. Also see paragraph (d)(1) of
                                                                                                   this section and Sec.
                                                                                                   558.355(d)(9)(i). Monensin as provided
                                                                                                   by No. 058198 in Sec.   510.600(c) of
                                                                                                   this chapter.

[[Page 12497]]

 
(iii) 90.9 to 535.7.........                           Cattle (including ruminating and           Feed Type C medicated feed supplements as       054771
                                                        nonruminating calves and veal calves):     a top dress or mix into the daily ration
                                                        For prevention of coccidiosis caused by    to provide 22.7 mg per 100 lb of body
                                                        Eimeria bovis and E. zuernii.              weight (0.5 mg/kg) per day. Feed at
                                                                                                   least 28 days during periods of exposure
                                                                                                   to coccidiosis or when it is likely to
                                                                                                   be a hazard. Do not feed to cows
                                                                                                   producing milk for food. See paragraph
                                                                                                   (d)(3) of this section.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (3) Minor species--

--------------------------------------------------------------------------------------------------------------------------------------------------------
                               Combination in grams/
  Decoquinate in grams/ton              ton                       Indications for use                            Limitations                   Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
(i) 12.9 to 90.8............  .......................  1. Young sheep: For the prevention of      Feed Type C feed or milk replacer at a          054771
                                                        coccidiosis caused by Eimeria              rate to provide 22.7 mg per 100 lb of
                                                        ovinoidalis, E. crandallis, E. parva,      body weight (0.5 mg per kg) per day;
                                                        and E. bakuensis.                          feed for at least 28 days during periods
                                                                                                   of exposure to coccidiosis or when it is
                                                                                                   likely to be a hazard. Do not feed to
                                                                                                   sheep producing milk for human
                                                                                                   consumption.
                              .......................  2. Young goats: For the prevention of      Feed Type C feed or milk replacer at a     ...........
                                                        coccidiosis caused by Eimeria              rate to provide 22.7 mg per 100 lb of
                                                        christenseni and E. ninakohlyakimovae.     body weight (0.5 mg per kg) per day;
                                                                                                   feed for at least 28 days during periods
                                                                                                   of exposure to coccidiosis or when it is
                                                                                                   likely to be a hazard. Do not feed to
                                                                                                   goats producing milk for human
                                                                                                   consumption.
(ii) 90.9 to 535.7..........  .......................  1. Young sheep: For the prevention of      Feed Type C medicated feed supplements as       054771
                                                        coccidiosis caused by Eimeria              a top dress or mix into the daily ration
                                                        ovinoidalis, E. crandallis, E. parva,      to provide 22.7 mg per 100 lb of body
                                                        and E. bakuensis.                          weight (0.5 mg per kg) per day; feed for
                                                                                                   at least 28 days during periods of
                                                                                                   exposure to coccidiosis or when it is
                                                                                                   likely to be a hazard. Do not feed to
                                                                                                   sheep producing milk for human
                                                                                                   consumption.
                              .......................  2. Young goats: For the prevention of      Feed Type C medicated feed supplements as  ...........
                                                        coccidiosis caused by Eimeria              a top dress or mix into the daily ration
                                                        christenseni and E. ninakohlyakimovae.     to provide 22.7 mg per 100 lb of body
                                                                                                   weight (0.5 mg per kg) per day; feed for
                                                                                                   at least 28 days during periods of
                                                                                                   exposure to coccidiosis or when it is
                                                                                                   likely to be a hazard. Do not feed to
                                                                                                   goats producing milk for human
                                                                                                   consumption.
--------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *


Sec.  Sec.  558.198 and 558.205  [Redesignated as Sec. Sec.  558.205 
and 558.198]

0
21. Redesignate Sec. Sec.  558.198 and 558.205 as Sec. Sec.  558.205 
and 558.198, respectively.

0
22. Revise newly redesignated Sec.  558.198 to read as follows:


Sec.  558.198  Dichlorvos.

    (a) Specifications. Each pound of Type A medicated article 
containing 3.1 or 9.6 percent dichlorvos.
    (b) Sponsor. See No. 054628 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.180 of this chapter.
    (d) Special considerations--(1) Dichlorvos is to be included in 
meal or mash or mixed with feed in crumble form only after the crumble 
feed has been manufactured. Do not mix in feeds to be pelleted nor with 
pelleted feed. Do not soak the feed or administer as wet mash. Feed 
must be dry when administered. Do not use in animals other than swine. 
Do not allow fowl access to feed containing this preparation or to 
feces from treated animals.
    (2) Dichlorvos is a cholinesterase inhibitor. Do not use this 
product in animals simultaneously or within a few days before or after 
treatment with or exposure to cholinesterase-inhibiting drugs, 
pesticides, or chemicals. If human or animal poisoning should occur, 
immediately consult a physician or a veterinarian. Atropine is 
antidotal.
    (3) Labeling for Type A articles and Type B feeds must include a 
statement that containers or materials used in packaging such Type A 
articles and Type B feeds are not to be reused and all such packaging 
materials must be destroyed after the product has been used.
    (e) Conditions of use. It is used in swine feed as follows:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                               Combination in grams/
    Dichlorvos grams/ton                ton                       Indications for use                            Limitations                   Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
(i) 348.....................                           Swine up to 70 pounds body weight: For     Feed as sole ration for 2 consecutive           054628
                                                        the removal and control of mature,         days. For swine from 70 pounds to market
                                                        immature, and/or fourth-stage larvae of    weight, feed as sole ration at the rate
                                                        the whipworm (Trichuris suis), nodular     of 8.4 pounds of feed per head until the
                                                        worm (Oesophagostomum sp.), large          medicated feed has been consumed. For
                                                        roundworm (Ascaris suum) and the thick     boars, open or bred gilts, and sows,
                                                        stomach worm (Ascarops strongylina) of     feed as sole ration at the rate of 4.2
                                                        the gastrointestinal tract.                pounds per head per day for 2
                                                                                                   consecutive days.

[[Page 12498]]

 
(ii) 479....................                           Boars, open or bred gilts, and sows: For   Feed as sole ration at the rate of 6            054628
                                                        the removal and control of mature,         pounds per head for one feeding.
                                                        immature, and/or fourth-stage larvae of
                                                        the whipworm (Trichuris suis), nodular
                                                        worm (Oesophagostomum sp.), large
                                                        roundworm (Ascaris suum) and the thick
                                                        stomach worm (Ascarops strongylina) of
                                                        the gastrointestinal tract.
(iii) 334 to 500............                           Pregnant swine: An aid in improving        Mix into a gestation feed to provide            054628
                                                        litter production efficiency by            1,000 milligrams per head daily during
                                                        increasing pigs born alive, birth          last 30 days of gestation.
                                                        weights, survival to market, and rate of
                                                        weight gain. Treatment also removes and
                                                        controls mature, immature and/or fourth
                                                        stage larvae of whipworm (Trichuris
                                                        suis), nodular worm (Oesophagostomum
                                                        spp.) large roundworm (Ascaris suum),
                                                        and the thick stomach worm (Ascarops
                                                        strongylina) occurring in the
                                                        gastrointestinal tract of the sow or
                                                        gilt.
--------------------------------------------------------------------------------------------------------------------------------------------------------


0
23. In newly redesignated Sec.  558.205, revise paragraphs (b) and 
(d)(1) and (2) to read as follows:


Sec.  558.205  Diclazuril.

* * * * *
    (b) Sponsor. See No. 058198 in Sec.  510.600(c) of this chapter.
* * * * *
    (d) * * *
    (1) Chickens. For chickens it is used as follows:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                               Combination in grams/
    Diclazuril grams/ton                ton                       Indications for use                            Limitations                   Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
(i) 0.91....................                           Broiler chickens: For the prevention of    Feed continuously. Not for use in hens          058198
                                                        coccidiosis caused by Eimeria tenella,     producing eggs for human food. Because
                                                        E. necatrix, E. acervulina, E. brunetti,   diclazuril is effective against E.
                                                        E. mitis (mivati), and E. maxima.          maxima later in its life cycle,
                                                                                                   subclinical intestinal lesions may be
                                                                                                   present for a short time after
                                                                                                   infection. Diclazuril was shown in
                                                                                                   studies to reduce lesion scores and
                                                                                                   improve performance and health of birds
                                                                                                   challenged with E. maxima.
(ii) 0.91...................  Bacitracin               Broiler chickens: For the prevention of    Feed continuously. Not for use in hens          058198
                               methylenedisalicylate,   coccidiosis caused by Eimeria tenella,     producing eggs for human food. Because
                               4 to 50.                 E. necatrix, E. acervulina, E. brunetti,   diclazuril is effective against E.
                                                        E. mitis (mivati), and E. maxima, and      maxima later in its life cycle,
                                                        for increased rate of weight gain and      subclinical intestinal lesions may be
                                                        improved feed efficiency.                  present for a short time after
                                                                                                   infection. Diclazuril was shown in
                                                                                                   studies to reduce lesion scores and
                                                                                                   improve performance and health of birds
                                                                                                   challenged with E. maxima. Bacitracin
                                                                                                   methylenedisalicylate as provided by No.
                                                                                                   054771 in Sec.   510.600(c) of this
                                                                                                   chapter.
(iii) 0.91..................  Bambermycins, 1 to 2...  Broiler chickens: For the prevention of    Feed continuously. Not for use in hens          058198
                                                        coccidiosis caused by Eimeria tenella,     producing eggs for human food. Because
                                                        E. necatrix, E. acervulina, E. brunetti,   diclazuril is effective against E.
                                                        E. mitis (mivati), and E. maxima, and      maxima later in its life cycle,
                                                        for increased rate of weight gain and      subclinical intestinal lesions may be
                                                        improved feed efficiency.                  present for a short time after
                                                                                                   infection. Diclazuril was shown in
                                                                                                   studies to reduce lesion scores and
                                                                                                   improve performance and health of birds
                                                                                                   challenged with E. maxima. Bambermycins
                                                                                                   as provided by No. 016592 in Sec.
                                                                                                   510.600(c) of this chapter.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (2) Turkeys. For turkeys it is used as follows:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                               Combination in grams/
    Diclazuril grams/ton                ton                       Indications for use                            Limitations                   Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
(i) 0.91....................                           Growing turkeys: For the prevention of     Feed continuously as the sole ration. Do        058198
                                                        coccidiosis caused by Eimeria              not feed to breeding turkeys. Not for
                                                        adenoeides, E. gallopavonis and E.         use in hens producing eggs for human
                                                        meleagrimitis.                             consumption.
(ii) 0.91...................  Bacitracin               Growing turkeys: For the prevention of     Feed continuously as the sole ration. Do        058198
                               methylenedisalicylate,   coccidiosis caused by Eimeria              not feed to breeding turkeys. Not for
                               4 to 50.                 adenoeides, E. gallopavonis and E.         use in hens producing eggs for human
                                                        meleagrimitis, and for increased rate of   consumption. Bacitracin
                                                        weight gain and improved feed              methylenedisalicylate as provided by No.
                                                        efficiency.                                054771 in Sec.   510.600(c) of this
                                                                                                   chapter.
(iii) 0.91..................  Bambermycins, 1 to 2...  Growing turkeys: For the prevention of     Feed continuously as the sole ration. Do        058198
                                                        coccidiosis caused by Eimeria              not feed to breeding turkeys. Not for
                                                        adenoeides, E. gallopavonis and E.         use in hens producing eggs for human
                                                        meleagrimitis, and for improved feed       consumption. Bambermycins as provided by
                                                        efficiency.                                No. 016592 in Sec.   510.600(c) of this
                                                                                                   chapter.

[[Page 12499]]

 
(iv) 0.91...................  Bambermycins, 2........  Growing turkeys: For the prevention of     Feed continuously as the sole ration. Do        058198
                                                        coccidiosis caused by Eimeria              not feed to breeding turkeys. Not for
                                                        adenoeides, E. gallopavonis and E.         use in hens producing eggs for human
                                                        meleagrimitis, and for increased rate of   consumption. Bambermycins as provided by
                                                        weight gain and improved feed              No. 016592 in Sec.   510.600(c) of this
                                                        efficiency.                                chapter.
--------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *

0
24. In Sec.  558.258, revise paragraph (e)(2) to read as follows:


Sec.  558.258  Fenbendazole.

* * * * *
    (e) * * *
    (2) Swine.

--------------------------------------------------------------------------------------------------------------------------------------------------------
  Fenbendazole in grams per     Combination in grams
             ton                      per ton                     Indications for use                            Limitations                   Sponsors
--------------------------------------------------------------------------------------------------------------------------------------------------------
(i) 10 to 300 (to provide 9                            For the removal and control of adult       Feed as the sole ration                         000061
 milligrams per kilogram (mg/                           stage lungworms (Metastrongylus apri and
 kg) of body weight) given                              M. pudendotectus); adult and larvae (L3,
 over a 3- to 12-day period..                           4 stages--liver, lung, intestinal forms)
                                                        large roundworms (Ascaris suum); adult
                                                        stage nodular worms (Oesophagostomum
                                                        dentatum, O. quadrispinulatum); adult
                                                        stage small stomach worms (Hyostrongylus
                                                        rubidus); adult and larvae (L2, 3, 4
                                                        stages--intestinal mucosal forms)
                                                        whipworms (Trichuris suis); adult and
                                                        larvae kidney worms (Stephanurus
                                                        dentatus).
(ii) 10 to 300 (to provide 9  Bacitracin               Growing/finishing swine: For the removal   Feed as the sole ration. Under conditions       054771
 mg/kg of body weight)..       methylenedisalicylate,   and control of adult stage lungworms       of continued exposure to parasites,
                               10 to 30.                (Metastrongylus apri and M.                retreatment may be needed after 4 to 6
                                                        pudendotectus); adult and larvae (L3, 4    weeks. Bacitracin methylenedisalicylate
                                                        stages--liver, lung, intestinal forms)     as provided by No. 054771 in Sec.
                                                        large roundworms (Ascaris suum); adult     510.600(c) of this chapter
                                                        stage nodular worms (Oesophagostomum
                                                        dentatum, O. quadrispinulatum); adult
                                                        stage small stomach worms (Hyostrongylus
                                                        rubidus); adult and larvae (L2, 3, 4
                                                        stages--intestinal mucosal forms)
                                                        whipworms (Trichuris suis); adult and
                                                        larvae kidney worms (Stephanurus
                                                        dentatus); and for increased rate of
                                                        weight gain and improved feed
                                                        efficiency.
(iii) 10 to 300 (to provide   Bacitracin               1. Growing/finishing swine: For the        1. Growing/finishing swine: Feed as sole        054771
 9 mg/kg of body weight)..     methylenedisalicylate,   removal and control of adult stage         ration. Not for use in growing and
                               250.                     lungworms (Metastrongylus apri and M.      finishing swine that weigh more than 250
                                                        pudendotectus); adult and larvae (L3, 4    lbs. Diagnosis of swine dysentery should
                                                        stages--liver, lung, intestinal forms)     be confirmed by a veterinarian when
                                                        large roundworms (Ascaris suum); adult     results are not satisfactory. Under
                                                        stage nodular worms (Oesophagostomum       conditions of continued exposure to
                                                        dentatum, O. quadrispinulatum); adult      parasites, retreatment may be needed
                                                        stage small stomach worms (Hyostrongylus   after 4 to 6 weeks. Bacitracin
                                                        rubidus); adult and larvae (L2, 3, 4       methylenedisalicylate as provided by No.
                                                        stages--intestinal mucosal forms)          054771 in Sec.   510.600(c) of this
                                                        whipworms (Trichuris suis); adult and      chapter
                                                        larvae kidney worms (Stephanurus
                                                        dentatus); and for control of swine
                                                        dysentery associated with Treponema
                                                        hyodysenteriae on premises with a
                                                        history of swine dysentery, but where
                                                        signs of disease have not yet occurred;
                                                        or following an approved treatment of
                                                        the disease condition.
                                                       2. Pregnant sows: For the removal and      2. Pregnant sows: Feed as sole ration.
                                                        control of adult stage lungworms           Diagnosis of clostridial enteritis
                                                        (Metastrongylus apri and M.                should be confirmed by a veterinarian
                                                        pudendotectus); adult and larvae (L3, 4    when results are not satisfactory. Under
                                                        stages--liver, lung, intestinal forms)     conditions of continued exposure to
                                                        large roundworms (Ascaris suum); adult     parasites, retreatment may be needed
                                                        stage nodular worms (Oesophagostomum       after 4 to 6 weeks. Bacitracin
                                                        dentatum, O. quadrispinulatum); adult      methylenedisalicylate as provided by No.
                                                        stage small stomach worms (Hyostrongylus   054771 in Sec.   510.600(c) of this
                                                        rubidus); adult and larvae (L2, 3, 4       chapter.
                                                        stages--intestinal mucosal forms)
                                                        whipworms (Trichuris suis); adult and
                                                        larvae kidney worms (Stephanurus
                                                        dentatus); for control of clostridial
                                                        enteritis in suckling pigs caused by
                                                        Clostridium perfringens.
--------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *

0
25. In Sec.  558.300, revise paragraph (e) to read as follows:


Sec.  558.300  Ivermectin.

* * * * *
    (e) Conditions of use in swine. It is used in feed as follows:

[[Page 12500]]



--------------------------------------------------------------------------------------------------------------------------------------------------------
                               Combination in grams/
   Ivermectin in grams/ton              ton                       Indications for use                            Limitations                   Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
(1) 1.8.....................                           Weaned, growing-finishing swine: For       Feed as the only feed for 7 consecutive         050604
                                                        treatment and control of                   days to provide 0.1 milligrams per
                                                        gastrointestinal roundworms (Ascaris       kilograms (mg/kg) of body weight per
                                                        suum, adults and fourth-stage larvae;      day. Withdraw 5 days before slaughter.
                                                        Ascarops strongylina, adults;
                                                        Hyostrongylus rubidus, adults and fourth-
                                                        stage larvae; Oesophagostomum spp.,
                                                        adults and fourth-stage larvae);
                                                        kidneyworms (Stephanurus dentatus,
                                                        adults and fourth-stage larvae);
                                                        lungworms (Metastrongylus spp., adults);
                                                        threadworms (Strongyloides ransomi,
                                                        adults and somatic larvae); lice
                                                        (Haematopinus suis); and mange mites
                                                        (Sarcoptes scabiei var. suis).
(2) 1.8.....................  Bacitracin               Weaned, growing-finishing swine: For       Feed as the only feed for 7 consecutive         050604
                               methylenedisalicylate,   treatment and control of                   days to provide 0.1 mg/kg of body weight
                               10 to 30.                gastrointestinal roundworms (Ascaris       per day. Withdraw 5 days before
                                                        suum, adults and fourth-stage larvae;      slaughter.
                                                        Ascarops strongylina, adults;
                                                        Hyostrongylus rubidus, adults and fourth-
                                                        stage larvae; Oesophagostomum spp.,
                                                        adults and fourth-stage larvae);
                                                        kidneyworms (Stephanurus dentatus,
                                                        adults and fourth-stage larvae);
                                                        lungworms (Metastrongylus spp., adults);
                                                        threadworms (Strongyloides ransomi,
                                                        adults and somatic larvae); lice
                                                        (Haematopinus suis); and mange mites
                                                        (Sarcoptes scabiei var. suis); and for
                                                        increased rate of weight gain and
                                                        improved feed efficiency.
(3) 1.8.....................  Bacitracin               Weaned, growing-finishing swine: For       Feed as the only feed for 7 consecutive         050604
                               methylenedisalicylate,   treatment and control of                   days to provide 0.1 mg/kg of body weight
                               250.                     gastrointestinal roundworms (Ascaris       per day. Withdraw 5 days before
                                                        suum, adults and fourth-stage larvae;      slaughter.
                                                        Ascarops strongylina, adults;
                                                        Hyostrongylus rubidus, adults and fourth-
                                                        stage larvae; Oesophagostomum spp.,
                                                        adults and fourth-stage larvae);
                                                        kidneyworms (Stephanurus dentatus,
                                                        adults and fourth-stage larvae);
                                                        lungworms (Metastrongylus spp., adults);
                                                        threadworms (Strongyloides ransomi,
                                                        adults and somatic larvae); lice
                                                        (Haematopinus suis); and mange mites
                                                        (Sarcoptes scabiei var. suis); and for
                                                        control of swine dysentery associated
                                                        with Treponema hyodysenteriae on
                                                        premises with a history of swine
                                                        dysentery, but where symptoms have not
                                                        yet occurred, or following an approved
                                                        treatment of disease condition.
(4) 1.8 to 11.8.............                           Adult and breeding swine: For treatment    Feed as the only feed for 7 consecutive         050604
                                                        and control of gastrointestinal            days to provide 0.1 mg/kg of body weight
                                                        roundworms (Ascaris suum, adults and       per day. Withdraw 5 days before
                                                        fourth-stage larvae; Ascarops              slaughter.
                                                        strongylina, adults; Hyostrongylus
                                                        rubidus, adults and fourth-stage larvae;
                                                        Oesophagostomum spp., adults and fourth-
                                                        stage larvae); kidneyworms (Stephanurus
                                                        dentatus, adults and fourth-stage
                                                        larvae); lungworms (Metastrongylus spp.,
                                                        adults); threadworms (Strongyloides
                                                        ransomi, adults and somatic larvae, and
                                                        prevention of transmission of infective
                                                        larvae to piglets, via the colostrum or
                                                        milk, when fed during gestation); lice
                                                        (Haematopinus suis); and mange mites
                                                        (Sarcoptes scabiei var. suis).
(5) 1.8 to 11.8.............  Bacitracin               Pregnant sows: For treatment and control   Feed as the only feed for 7 consecutive         050604
                               methylenedisalicylate,   of gastrointestinal roundworms (Ascaris    days to provide 0.1 mg/kg of body weight
                               250.                     suum, adults and fourth-stage larvae;      per day. Withdraw 5 days before
                                                        Ascarops strongylina, adults;              slaughter. Feed bacitracin
                                                        Hyostrongylus rubidus, adults and fourth-  methylenedisalicylate Type C medicated
                                                        stage larvae; Oesophagostomum spp.,        feed to sows from 14 days before through
                                                        adults and fourth-stage larvae);           21 days after farrowing on premises with
                                                        kidneyworms (Stephanurus dentatus,         a history of clostridial scours.
                                                        adults and fourth-stage larvae);
                                                        lungworms (Metastrongylus spp., adults);
                                                        threadworms (Strongyloides ransomi,
                                                        adults and somatic larvae, and
                                                        prevention of transmission of infective
                                                        larvae to piglets, via the colostrum or
                                                        milk, when fed during gestation); lice
                                                        (Haematopinus suis); and mange mites
                                                        (Sarcoptes scabiei var. suis); and for
                                                        control of clostridial enteritis caused
                                                        by Clostridium perfringens in suckling
                                                        piglets.

[[Page 12501]]

 
(6) 18.2 to 120.............                           Adult and breeding swine: For treatment    Top dress on daily ration for individual        050604
                                                        and control of gastrointestinal            treatment for 7 consecutive days to
                                                        roundworms (Ascaris suum, adults and       provide 0.1 mg/kg of body weight per
                                                        fourth-stage larvae; Ascarops              day. Withdraw 5 days before slaughter.
                                                        strongylina, adults; Hyostrongylus
                                                        rubidus, adults and fourth-stage larvae;
                                                        Oesophagostomum spp., adults and fourth-
                                                        stage larvae); kidneyworms (Stephanurus
                                                        dentatus, adults and fourth-stage
                                                        larvae); lungworms (Metastrongylus spp.,
                                                        adults); threadworms (Strongyloides
                                                        ransomi, adults and somatic larvae, and
                                                        prevention of transmission of infective
                                                        larvae to piglets, via the colostrum or
                                                        milk, when fed during gestation); lice
                                                        (Haematopinus suis); and mange mites
                                                        (Sarcoptes scabiei var. suis).
--------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *

0
26. In Sec.  558.325, add paragraph (e)(1)(iii) to read as follows:


Sec.  558.325  Lincomycin.

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

--------------------------------------------------------------------------------------------------------------------------------------------------------
                               Combination in grams/
    Lincomycin  grams/ton               ton                       Indications for use                            Limitations                   Sponsors
--------------------------------------------------------------------------------------------------------------------------------------------------------
 
                                                                      * * * * * * *
(iii) 2.....................  Clopidol, 113.5........  Broiler chickens: For the control of       Feed as the sole ration to broiler              054771
                                                        necrotic enteritis caused or complicated   chickens. Do not feed to chickens over
                                                        by Clostridium spp. or other organisms     16 weeks of age. Not for use in laying
                                                        susceptible to lincomycin, and as an aid   hens, breeding chickens, or turkeys. Do
                                                        in the prevention of cecal and             not allow rabbits, hamsters, guinea
                                                        intestinal coccidiosis caused by Eimeria   pigs, horses, or ruminants access to
                                                        tenella, E. necatrix, E. acervulina, E.    feeds containing lincomycin. Ingestion
                                                        maxima, E. brunetti, and E. mivati.        by these species may result in severe
                                                                                                   gastrointestinal effects. Clopidol as
                                                                                                   provided by No. 016592 in Sec.   510.600
                                                                                                   of this chapter.
 
                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *

0
27. Add Sec.  558.330 to read as follows:


Sec.  558.330  Lubabegron.

    (a) Specifications. Each pound of Type A medicated article contains 
4.54 grams (10 grams per kilogram) of lubabegron as lubabegron 
fumarate.
    (b) Sponsor. See No. 058198 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.370 of this chapter.
    (d) Conditions of use. It is used in cattle feed as follows:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                               Combination in grams/
    Lubabegron  grams/ton               ton                       Indications for use                            Limitations                   Sponsors
--------------------------------------------------------------------------------------------------------------------------------------------------------
(1) 1.25 to 4.54............                           Beef steers and heifers fed in             Feed 1.25 to 4.54 g/ton (1.39 to 5 ppm)         058198
                                                        confinement for slaughter: For reduction   of complete feed (90% dry matter basis)
                                                        of ammonia gas emissions per pound of      to provide 13 to 90 milligrams
                                                        live weight and hot carcass weight         lubabegron/head/day continuously. Do not
                                                        during the last 14 to 91 days on feed.     allow horses or other equines access to
                                                                                                   feed containing lubabegron. Not approved
                                                                                                   for use in breeding animals because
                                                                                                   safety and effectiveness have not been
                                                                                                   evaluated in these animals.
(ii) [Reserved]
--------------------------------------------------------------------------------------------------------------------------------------------------------


0
28. In Sec.  558.415, revise paragraph (d) to read as follows:


Sec.  558.415  Novobiocin.

* * * * *
    (d) Conditions of use. It is used in animal feeds as follows:
    (1) Chickens--

[[Page 12502]]



----------------------------------------------------------------------------------------------------------------
   Novobiocin amount              Indications for use                       Limitations                Sponsor
----------------------------------------------------------------------------------------------------------------
(i) To provide 6 to 7    Chickens: As an aid in the treatment  Administer feed which contains not         054771
 milligrams per pound     of breast blisters associated with    less than 200 grams of novobiocin
 (mg/lb) of body weight   staphylococcal infections             activity per ton of feed as the
 per day.                 susceptible to novobiocin.            sole ration for 5 to 7 days. Not
                                                                for laying chickens. Withdraw 4
                                                                days before slaughter.
(ii) To provide 10 to    Chickens: For the treatment of        Administer feed which contains not         054771
 14 mg/lb of body         staphylococcal synovitis and          less than 350 grams of novobiocin
 weight per day.          generalized staphylococcal            activity per ton of feed as the
                          infections susceptible to             sole ration for 5 to 7 days. Not
                          novobiocin.                           for laying chickens. Withdraw 4
                                                                days before slaughter.
----------------------------------------------------------------------------------------------------------------

    (2) Turkeys--

----------------------------------------------------------------------------------------------------------------
   Novobiocin amount              Indications for use                       Limitations                Sponsor
----------------------------------------------------------------------------------------------------------------
(i) To provide 4 to 5    Turkeys: As an aid in the treatment   Administer feed which contains not         054771
 mg/lb of body weight     of breast blisters associated with    less than 200 grams of novobiocin
 per day.                 staphylococcal infections             activity per ton of feed as the
                          susceptible to novobiocin.            sole ration for 5 to 7 days. Not
                                                                for laying turkeys. Withdraw 4 days
                                                                before slaughter.
(ii) To provide 5 to 8   Turkeys: As an aid in the control of  Administer feed which contains not         054771
 mg/lb of body weight     recurring outbreaks of fowl cholera   less than 200 grams of novobiocin
 per day.                 caused by strains of Pasteurella      activity per ton of feed as the
                          multocida susceptible to novobiocin   sole ration for 5 to 7 days. Not
                          following initial treatment with 7    for laying turkeys. Withdraw 4 days
                          to 8 mg/lb of body weight per day.    before slaughter.
(iii) To provide 7 to 8  Turkeys: For the treatment of         Administer feed which contains not         054771
 mg/lb of body weight     staphylococcal synovitis and          less than 350 grams of novobiocin
 per day.                 generalized staphylococcal            activity per ton of feed as the
                          infections susceptible to             sole ration for 5 to 7 days. Not
                          novobiocin; and treatment of acute    for laying turkeys. Withdraw 4 days
                          outbreaks of fowl cholera caused by   before slaughter.
                          strains of Pasteurella multocida
                          susceptible to novobiocin.
----------------------------------------------------------------------------------------------------------------

    (3) Minor species--

----------------------------------------------------------------------------------------------------------------
   Novobiocin amount              Indications for use                       Limitations                Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 350 grams per ton.   Ducks: For the control of infectious  Administer as the sole ration for 5        054771
                          serositis and fowl cholera in ducks   to 7 days. Continue medication for
                          caused by Pasteurella anatipestifer   14 days if necessary. Repeat if
                          and P. multocida, susceptible to      reinfection occurs. Discontinue use
                          novobiocin.                           at least 3 days before slaughter.
                                                                Not for use in laying ducks.
(ii) To provide 20 mg/   Mink: For the treatment of            Administer feed which contains not         054771
 lb of body weight per    generalized infections, abscesses,    less than 200 grams of novobiocin
 day.                     or urinary infections caused by       activity per ton of feed as the
                          staphylococcal or other novobiocin    sole ration for 7 days.
                          sensitive organisms.
----------------------------------------------------------------------------------------------------------------


0
29. In Sec.  558.450, redesignate paragraphs (e)(5)(iii), (iv), and (v) 
as paragraphs (e)(v), (iii), and (iv) respectively; and revise newly 
redesignated paragraphs (e)(5)(iv) and (v) to read as follows:


Sec.  558.450  Oxytetracycline.

* * * * *
    (e) * * *
    (5) * * *

----------------------------------------------------------------------------------------------------------------
Oxytetracycline  amount           Indications for use                       Limitations                Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(iv) 3.75 g/100 lb of    * * *                                 * * *                                      066104
 fish/day.               3. Freshwater-reared salmonids        Feed for 10 days. Immediate release
                          weighing up to 55 grams: For          is permitted following the last
                          marking the skeletal tissue.          feeding of medicated feed.
(v) 11.35 g/100 lb of    Pacific salmon not over 30 grams      Administer medicated feed as the           066104
 fish/day.                body weight: For marking of           sole ration for 4 consecutive days.
                          skeletal tissue.                      Do not liberate for at least 7 days
                                                                following last feeding of medicated
                                                                feed.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

0
30. In Sec.  558.575, revise paragraphs (b) and (e) to read as follows:


Sec.  558.575  Sulfadimethoxine and ormetoprim.

* * * * *
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for 
use as in paragraph (d) of this section:
    (1) No. 054771 for use of the product described in paragraph (a)(1) 
as in paragraphs (e)(1), (e)(2)(i), and (e)(3)(i) through (iii) of this 
section.
    (2) No. 015331 for use of the product described in paragraph (a)(2) 
as in paragraphs (e)(3)(iv) and (v) of this section.
* * * * *
    (e) Conditions of use. It is used in animal feeds as follows:
    (1) Chickens--

[[Page 12503]]



----------------------------------------------------------------------------------------------------------------
 Sulfadimethoxine  and
 ormetoprim  grams/ton            Indications for use                       Limitations                Sponsors
----------------------------------------------------------------------------------------------------------------
(i) Sulfadimethoxine,    Broiler chickens: As an aid in the    Feed as sole ration. Withdraw 5 days       054771
 113.5; ormetoprim,       prevention of coccidiosis caused by   before slaughter.
 68.1.                    all Eimeria species known to be
                          pathogenic to chickens, namely, E.
                          tenella, E. necatrix, E.
                          acervulina, E. brunetti, E. mivati,
                          and E. maxima, and bacterial
                          infections due to Heterakis
                          gallinarum (infectious coryza),
                          Escherichia coli (colibacillosis)
                          and Pasteurella multocida (fowl
                          cholera).
(ii) Sulfadimethoxine,   Replacement chickens: As an aid in    Feed as sole ration. Do not feed to        054771
 113.5; ormetoprim,       the prevention of coccidiosis         chickens over 16 weeks (112 days)
 68.1.                    caused by all Eimeria species known   of age. Withdraw 5 days before
                          to be pathogenic to chickens,         slaughter.
                          namely, E. tenella, E. necatrix, E.
                          acervulina, E. brunetti, E. mivati,
                          and E. maxima, and bacterial
                          infections due to Heterakis
                          gallinarum (infectious coryza),
                          Escherichia coli (colibacillosis)
                          and Pasteurella multocida (fowl
                          cholera).
----------------------------------------------------------------------------------------------------------------

    (2) Turkeys--

----------------------------------------------------------------------------------------------------------------
 Sulfadimethoxine  and
 ormetoprim  grams/ton            Indications for use                       Limitations                Sponsors
----------------------------------------------------------------------------------------------------------------
(i) Sulfadimethoxine,    Turkeys: As an aid in the prevention  Do not feed to turkeys producing           054771
 56.75; ormetoprim,       of coccidiosis caused by all          eggs for food. Withdraw 5 days
 34.05.                   Eimeria species known to be           before slaughter.
                          pathogenic to turkeys, namely, E.
                          adenoeides, E. gallopavonis, and E.
                          meleagrimitis and bacterial
                          infection due to Pasteurella
                          multocida (fowl cholera).
(ii) [Reserved]
----------------------------------------------------------------------------------------------------------------

    (3) Minor species--

----------------------------------------------------------------------------------------------------------------
 Sulfadimethoxine  and
   ormetoprim amount              Indications for use                       Limitations                Sponsors
----------------------------------------------------------------------------------------------------------------
(i) Sulfadimethoxine,    Ducks, including breeding ducks: As   Feed as sole ration for 7 days.            054771
 227; ormetoprim, 136.2   an aid in the control of bacterial    Medication should be started at the
 grams/ton of feed.       infections due to Pasteurella         first signs of infection. Do not
                          multocida (fowl cholera).             feed to ducks producing eggs for
                                                                food. Withdraw 5 days before
                                                                slaughter.
(ii) Sulfadimethoxine,   Ducks: As an aid in the control of    Feed as a sole ration for 7 days.
 454; ormetoprim, 272.4   bacterial infections due to           Medication should be started at the
 grams/ton of feed.       Escherichia coli, Riemerella          first signs of infection. Not for
                          anatipestifer, and severe challenge   breeding ducks. Do not feed to
                          of Pasteurella multocida (fowl        ducks producing eggs for food.
                          cholera).                             Withdraw 5 days before slaughter.
(iii) Sulfadimethoxine,  Chukar partridges: For prevention of  Feed continuously to young birds up        054771
 113.5; ormetoprim,       coccidiosis caused by Eimeria         to 8 weeks of age as sole ration.
 68.1 grams/ton of        kofoidi and E. legionensis.
 feed.
(iv) 50 milligrams (mg)  Salmonids: For the control of         Administer for 5 consecutive days.         015331
 of active ingredients    furunculosis in salmonids (trout      Withdraw 42 days before release as
 per kilogram of body     and salmon) caused by Aeromonas       stocker fish or slaughter.
 weight per day.          salmonicida strains susceptible to
                          sulfadimethoxine and ormetoprim
                          combination.
(v) 50 mg of active      Catfish: For control of enteric       Administer for 5 consecutive days.         015331
 ingredients per          septicemia of catfish caused by       Withdraw 3 days before slaughter or
 kilogram of body         Edwardsiella ictaluri strains         release as stocker fish.
 weight per day.          susceptible to sulfadimethoxine and
                          ormetoprim combination.
----------------------------------------------------------------------------------------------------------------


0
30. Revise Sec.  558.600 to read as follows:


Sec.  558.600  Thiabendazole.

    (a) Specifications. Type A medicated articles containing 22, 44.1, 
66.1, and 88.2 percent thiabendazole. The 66.1 percent Type A is solely 
for the manufacture of cane molasses liquid Type B feed which is mixed 
in dry feeds. The 88.2 percent Type A is used solely for the 
manufacture of an aqueous slurry for adding to a Type C dry cattle 
feed.
    (b) Sponsor. See No. 050604 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.730 of this chapter.
    (d) Special considerations. Do not use in Type B or Type C 
medicated feed containing bentonite.
    (e) Conditions of use. It is used in medicated feed as follows:
    (1) Cattle--

----------------------------------------------------------------------------------------------------------------
 Thiabendazole  amount            Indications for use                       Limitations                Sponsor
----------------------------------------------------------------------------------------------------------------
(i) To provide 3 grams   Cattle: For control of infections of  Use 3 grams per 100 lb of body             050604
 per 100 lb of body       gastrointestinal roundworms           weight as a single dose. May repeat
 weight.                  (Trichostrongylus spp., Haemonchus    once in 2 to 3 weeks. Do not treat
                          spp., Ostertagia spp., Nematodirus    animals within 3 days of slaughter.
                          spp., Oesophagostomum radiatum).      Milk taken from treated animals
                                                                within 96 hours (8 milkings) after
                                                                the latest treatment must not be
                                                                used for food.

[[Page 12504]]

 
(ii) To provide 5 grams  Cattle: For control of severe         Administer 5 grams per 100 lb of           050604
 per 100 lb of body       infections of gastrointestinal        body weight at a single dose or
 weight.                  roundworms (Trichostrongylus spp.,    divided into 3 equal doses,
                          Haemonchus spp., Ostertagia spp.,     administered 1 dose each day, on
                          Nematodirus spp., Oesophagostomum     succeeding days. May repeat once in
                          radiatum); control of infections of   2 to 3 weeks. Do not treat animals
                          Cooperia spp.                         within 3 days of slaughter. Milk
                                                                taken from treated animals within
                                                                96 hours (8 milkings) after the
                                                                latest treatment must not be used
                                                                for food.
----------------------------------------------------------------------------------------------------------------

    (2) Swine--

----------------------------------------------------------------------------------------------------------------
Thiabendazole in grams/
          ton                     Indications for use                       Limitations                Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 45.4 to 908          Swine: As an aid in the prevention    Administer continuously feed               050604
                          of infections of large roundworms     containing 0.05 to 0.1 percent
                          (genus Ascaris).                      thiabendazole per ton for 2 weeks
                                                                followed by feed containing 0.005
                                                                to 0.02 percent thiabendazole per
                                                                ton for 8 to 14 weeks. Do not treat
                                                                animals within 30 days of
                                                                slaughter.
(ii) [Reserved]
----------------------------------------------------------------------------------------------------------------

    (3) Minor species--

----------------------------------------------------------------------------------------------------------------
    Thiabendazole  amount             Indications for use                    Limitations               Sponsor
----------------------------------------------------------------------------------------------------------------
(i) To provide 2 grams per     Sheep and goats: For control of    Use 2 grams per 100 lb of body          050604
 100 lb of body weight..        infections of gastrointestinal     weight at a single dose. Do not
                                roundworms (Trichostrongylus       treat animals within 30 days of
                                spp., Haemonchus spp.,             slaughter. Milk taken from
                                Ostertagia spp., Cooperia spp.;    treated animals within 96 hours
                                Nematodirus spp., Bunostomum       (8 milkings) after the latest
                                spp., Strongyloides spp.,          treatment must not be used for
                                Chabertia spp., and                food.
                                Oesophagostomum spp.); also
                                active against ova and larvae
                                passed by sheep from 3 hours to
                                3 days after the feed is
                                consumed (good activity against
                                ova and larvae of T.
                                colubriformis and axei,
                                Ostertagia spp., Nematodirus
                                spp., Strongyloides spp.; less
                                effective against those of
                                Haemonchus contortus and
                                Oesophagostomum spp.).
(ii) To provide 3 grams per    Goats: For control of severe       Administer 3 grams per 100 lb of        050604
 100 lb of body weight..        infections of gastrointestinal     body weight at a single dose. Do
                                roundworms (Trichostrongylus       not treat animals within 30 days
                                spp., Haemonchus spp.,             of slaughter. Milk taken from
                                Ostertagia spp., Cooperia spp.,    treated animals within 96 hours
                                Nematodirus spp., Bunostomum       (8 milkings) after the latest
                                spp., Strongyloides spp.,          treatment must not be used for
                                Chabertia spp., and                food.
                                Oesophagostomum spp.).
(iii) 454 grams/ton of feed..  Pheasants: For the treatment of    Feed continuously for 2 weeks (14       050604
                                gapeworms (Syngamus trachea).      days). Do not use treated
                                                                   pheasants for food for 21 days
                                                                   after last day of treatment.
                                                                   Fertility, hatchability, and
                                                                   other reproductive data are not
                                                                   available on use in breeding
                                                                   animals.
----------------------------------------------------------------------------------------------------------------


0
31. In Sec.  558.633, revise paragraph (e) to read as follows:


Sec.  558.633  Tylvalosin.

* * * * *
    (e) Conditions of use.

----------------------------------------------------------------------------------------------------------------
   Tylvalosin in  grams/ton           Indications for use                    Limitations               Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 38.6.....................  Swine: For the control of porcine  Feed continuously as the sole           066916
                                proliferative enteropathy (PPE)    ration for 14 consecutive days.
                                associated with Lawsonia
                                intracellularis infection in
                                groups of swine in buildings
                                experiencing an outbreak of PPE.
(ii) [Reserved]
----------------------------------------------------------------------------------------------------------------


    Dated: March 26, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-06136 Filed 4-1-19; 8:45 am]
BILLING CODE 4164-01-P


