[Federal Register Volume 81, Number 248 (Tuesday, December 27, 2016)]
[Rules and Regulations]
[Pages 94991-95025]
[FR Doc No: 2016-31083]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 556 and 558

[Docket No. FDA-2016-N-0002]

New Animal Drugs for Use in Animal Feed; Approval of New Animal
Drug Applications; Withdrawal of Approval of New Animal Drug
Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of 71 supplemental new animal drug
applications (NADAs) and 35 supplemental abbreviated new animal drug
applications (ANADAs) for revised labeling reflecting a change in
marketing status from over-the-counter (OTC) use to use by veterinary
feed directive (VFD) for antimicrobial drugs of importance to human
medicine administered to food-producing animals in medicated feed.
Where applicable, FDA is also withdrawing approval of those parts of
the NADAs that pertain to use of these antimicrobial drugs for growth
promotion indications. These actions are being taken at the sponsors'
requests because these particular medicated feeds will no longer be
manufactured or marketed. These applications were submitted in
voluntary compliance with the goals of FDA Center for Veterinary
Medicine's (CVM's) Judicious Use Initiative. In addition, the animal
drug regulations are being amended to reflect the voluntary withdrawal
of approval of certain entire NADAs and ANADAs that were affected by
this initiative. The animal drug regulations are also being amended to
reflect several non-substantive changes in format. These technical
amendments are being made to improve the consistency and readability of
the regulations.

DATES: This rule is effective December 30, 2016.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Supplemental Approval of Revised Labeling and Withdrawal of Approval
of Portions of NADAs Pertaining to Production Indications

    FDA is amending the animal drug regulations to reflect approval of
71 supplemental NADAs and 35 supplemental ANADAs for revised labeling
reflecting a change in marketing status from OTC use to use by VFD for
antimicrobial drugs of importance to human medicine administered to
food-producing animals in medicated feed. Where applicable, FDA is also
withdrawing approval of those parts of the NADAs that pertain to use of
these antimicrobial drugs for growth promotion indications. These
actions are being taken at the sponsors' requests because these
particular medicated feeds will no longer be manufactured or marketed.
    These applications were identified as being affected by guidance
for industry (GFI) #213, ``New Animal Drugs and New Animal Drug
Combination Products Administered in or on Medicated Feed or Drinking
Water of Food-Producing Animals: Recommendations for Drug Sponsors for
Voluntarily Aligning Product Use Conditions with GFI #209'', December
2013 (http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM299624.pdf). Their
change to VFD marketing status is consistent with FDA CVM's initiative
for the Judicious Use of Antimicrobials.
    The animal drug regulations for medicated feeds are also being
amended to reflect several non-substantive changes in format. These
technical amendments are being made to improve the consistency and
readability of the regulations.
    The affected applications for Type A medicated articles for which
supplemental applications with revised labeling were approved follow:

------------------------------------------------------------------------
      File No.           Animal drug product             Sponsor
------------------------------------------------------------------------
006-391.............  S.Q. 40%                  Huvepharma EOOD, 5th
                       (sulfaquinoxaline) Type   Floor, 3A Nikolay
                       A Medicated Article.      Haytov Str., 1113
                                                 Sophia, Bulgaria
                                                 (Huvepharma EOOD).
008-804.............  TM-50 or TM-100           Phibro Animal Health
                       (oxytetracycline) Type    Corp., GlenPointe
                       A Medicated Article.      Centre East, 3d Floor,
                                                 300 Frank W. Burr
                                                 Blvd., Suite 21,
                                                 Teaneck, NJ 07666
                                                 (Phibro Animal Health
                                                 Corp.).
010-092.............  GALLIMYCIN-100P           Cross Vetpharm Group
                       (erythromycin) Type A     Ltd., Broomhill Rd.,
                       Medicated Article.        Tallaght, Dublin 24,
                                                 Ireland (Cross Vetpharm
                                                 Group Ltd.).
010-918.............  HYGROMIX 8 (hygromycin    Elanco US Inc., 2500
                       B) Type A Medicated       Innovation Way,
                       Article.                  Greenfield, IN 46140
                                                 (Elanco US Inc.).
012-491.............  TYLAN (tylosin) Type A    Elanco US Inc.
                       Medicated Article.
033-950.............  Sulfamerazine In Fish     Zoetis Inc., 333 Portage
                       Grade.                    St., Kalamazoo, MI
                                                 49007 (Zoetis Inc.).
035-688.............  AUREOMIX S 40/40          Zoetis Inc.
                       (chlortetracycline and
                       sulfamethazine)
                       Granular Type A
                       Medicated Article.
035-805.............  AUREO S 700               Zoetis Inc.
                       (chlortetracycline and
                       sulfamethazine)
                       Granular Type A
                       Medicated Article.
038-439.............  TERRAMYCIN 200            Phibro Animal Health
                       (oxytetracycline) for     Corp.
                       Fish Type A Medicated
                       Article.
040-209.............  ROFENAID 40               Zoetis Inc.
                       (sulfadimethoxine and
                       ormetoprim) Type A
                       Medicated Article.

041-275.............  TYLAN 40 Sulfa-G          Elanco US Inc.
                       (tylosin and
                       sulfamethazine) Type A
                       Medicated Article.
041-647.............  AUREOMIX S 700-A          Zoetis Inc.
                       (chlortetracycline and
                       sulfamethazine) Type A
                       Medicated Article.
041-648.............  AUREOMIX S 700-D          Zoetis Inc.
                       (chlortetracycline and
                       sulfamethazine) Type A
                       Medicated Article.
041-649.............  AUREOMIX S 700-G          Zoetis Inc.
                       (chlortetracycline and
                       sulfamethazine) Type A
                       Medicated Article.
041-650.............  AUREOMIX S 700-E          Zoetis Inc.
                       (chlortetracycline and
                       sulfamethazine) Type A
                       Medicated Article.
041-651.............  AUREOMIX S 700-F          Zoetis Inc.
                       (chlortetracycline and
                       sulfamethazine) Type A
                       Medicated Article.
041-652.............  AUREOMIX S 700-C-2        Zoetis Inc.
                       (chlortetracycline and
                       sulfamethazine) Type A
                       Medicated Article.
041-653.............  AUREOMIX S 700-B          Zoetis Inc.
                       (chlortetracycline and
                       sulfamethazine) Type A
                       Medicated Article.
041-654.............  AUREOMIX S 700-H          Zoetis Inc.
                       (chlortetracycline and
                       sulfamethazine) Type A
                       Medicated Article.
046-415.............  Tylosin Type A Medicated  Zoetis Inc.
                       Article.
046-699.............  CHLORMAX                  Zoetis Inc.
                       (chlortetracycline)
                       Type A Medicated
                       Article.
048-480.............  CHLORATET                 Pharmgate LLC, 1015
                       (chlortetracycline)       Ashes Dr., Suite 102,
                       Type A Medicated          Wilmington, NC 28405
                       Article.                  (Pharmgate LLC).
048-761.............  AUREOMYCIN                Zoetis Inc.
                       (chlortetracycline)
                       Type A Medicated
                       Article.
049-287.............  CHLORACHEL                Zoetis Inc.
                       (chlortetracycline)Type
                       A Medicated Article.
091-749.............  TYLAN 40 Plus Sulfa-G     Zoetis Inc.
                       (tylosin and
                       sulfamethazine) Type A
                       Medicated Article.
092-286.............  CLTC-50 MR                Phibro Animal Health
                       (chlortetracycline)       Corp.
                       Type A Medicated
                       Article.
092-287.............  CLTC 100 MR               Phibro Animal Health
                       (chlortetracycline)       Corp.
                       Type A Medicated
                       Article.
094-975.............  NEO-TERRAMYCIN 100/100    Phibro Animal Health
                       (oxytetracycline and      Corp.
                       neomycin) Type A
                       Medicated Article.
095-143.............  TERRAMYCIN 10, 30, 50,    Phibro Animal Health
                       100, or 200               Corp.
                       (oxytetracycline) Type
                       A Medicated Article.
097-505.............  LINCOMIX 20 (lincomycin)  Zoetis Inc.
                       Type A Medicated
                       Article.
098-431.............  TYLAN 10 (tylosin)        Phibro Animal Health
                       Premix Type A Medicated   Corp.
                       Article.
100-901.............  PFICHLOR 100S             Zoetis Inc.
                       (chlortetracycline)
                       Milk Replacer Type A
                       Medicated Article.
125-933.............  ROMET-30 (ormetoprim and  Pharmaq AS.
                       sulfadimethoxine) Type
                       A Medicated Article.
126-050.............  APRALAN 75 (apramycin)    Elanco US Inc.
                       Type A Medicated
                       Article.
138-934.............  PENNCHLOR S 40/40         Pharmgate LLC.
                       (chlortetracycline and
                       sulfamethazine) Type A
                       medicated article.
138-935.............  PENNCHLOR 100 MR          Pharmgate LLC.
                       (chlortetracycline)
                       Type A Medicated
                       Article.
138-938.............  PENNOX 50, 100, or 200    Pharmgate LLC.
                       Hi-Flo, or 100-MR
                       (oxytetracycline) Type
                       A Medicated Article.
138-939.............  NEO-OXY 100/100 MR        Pharmgate LLC.
                       (oxytetracycline and
                       neomycin) Type A
                       Medicated Article.
140-976.............  NEOMIX 325 Milk Replacer  Zoetis Inc.
                       (neomycin) Type A
                       Medicated Article.
200-314.............  PENNCHLOR S               Pharmgate LLC.
                       (chlortetracycline and
                       sulfamethazine) Type A
                       Medicated Article.
200-484.............  TYLOVET 100 (tylosin)     Huvepharma.
                       Type A Medicated
                       Article.
200-510.............  DERACIN 100               Pharmgate LLC.
                       (chlortetracycline)
                       Type A Medicated
                       Article.
------------------------------------------------------------------------

    The affected applications for manufacturing combination drug
medicated feeds follow:

------------------------------------------------------------------------
        File No.           Animal drug product            Sponsor
------------------------------------------------------------------------
036-361................  CTC Sodium Sulfate       Zoetis Inc., 333
                          (chlortetracycline and   Portage St.,
                          sodium sulfate)/AMPROL   Kalamazoo, MI 49007
                          PLUS (amprolium and      (Zoetis Inc.).
                          ethopabate).
045-444................  CHLORMAX                 Zoetis Inc.
                          (chlortetracycline)/
                          DECCOX (decoquinate).
046-209................  CTC (chlortetracycline)/ Huvepharma EOOD, 5th
                          COYDEN (clopidol).       Floor, 3A Nikolay
                                                   Haytov Str., 1113
                                                   Sophia, Bulgaria
                                                   (Huvepharma EOOD).
092-507................  AUREOMYCIN               Zoetis Inc.
                          (chlortetracycline)/
                          ROBENZ (robenidine).
099-006................  TERRAMYCIN               Phibro Animal Health
                          (oxytetracycline)/       Corp., GlenPointe
                          COBAN (monensin).        Centre East, 3d
                                                   Floor, 300 Frank W.
                                                   Burr Blvd., Suite 21,
                                                   Teaneck, NJ 07666
                                                   (Phibro Animal Health
                                                   Corp.).
101-666................  TERRAMYCIN               Phibro Animal Health
                          (oxytetracycline)/       Corp.
                          ROBENZ (robenidine).

104-646................  TYLAN (tylosin)/         Elanco US Inc., 2500
                          RUMENSIN (monensin).     Innovation Way,
                                                   Greenfield, IN 46140
                                                   (Elanco US Inc.).
110-047................  TYLAN (tylosin)/         Phibro Animal Health
                          BANMINTH (pyrantel).     Corp.
116-044................  LINCOMIX (lincomycin)/   Phibro Animal Health
                          BANMINTH (pyrantel).     Corp.
121-553................  AUREOMYCIN               Zoetis Inc.
                          (chlortetracycline)/
                          COBAN (monensin).
138-870................  TYLAN (tylosin)/         Zoetis Inc.
                          RUMENSIN (monensin)/
                          MGA (melengestrol).
138-941................  LINCOMIX (lincomycin)/   Zoetis Inc.
                          BANMINTH (pyrantel).
138-992................  TYLAN (tylosin)/BOVATEC  Zoetis Inc.
                          (lasalocid)/MGA
                          (melengestrol).
138-995................  TYLAN (tylosin)/MGA      Zoetis Inc.
                          (melengestrol).
139-192................  TYLAN (tylosin)/MGA      Zoetis Inc.
                          (melengestrol).
140-448................  TERRAMYCIN               Phibro Animal Health
                          (oxytetracycline)/BIO-   Corp.
                          COX (salinomycin).
140-859................  AUREOMYCIN               Zoetis Inc.
                          (chlortetracycline)/
                          BIO-COX (salinomycin).
140-954................  LINCOMIX (lincomycin)/   Intervet, Inc.
                          SAFE-GUARD
                          (fenbendazole).
141-011................  CTC (chlortetracycline)/ Elanco US Inc.
                          DENAGARD (tiamulin).
141-054................  LINCOMIX (lincomycin)/   Merial, Inc., 3239
                          IVOMEC (ivermectin).     Satellite Blvd.,
                                                   Bldg. 500, Duluth, GA
                                                   30096-4640.
141-059................  CHLORMAX                 Zoetis Inc.
                          (chlortetracycline)/
                          BMD (bacitracin).
141-147................  CHLORMAX                 Zoetis Inc.
                          (chlortetracycline)/
                          DECCOX (decoquinate).
141-149................  TYLAN (tylosin)/         Zoetis Inc.
                          RUMENSIN (monensin)/
                          DECCOX (decoquinate).
141-172................  TYLAN (tylosin)/PAYLEAN  Elanco US Inc.
                          (ractopamine).
141-185................  AUREOMYCIN               Zoetis Inc.
                          (chlortetracycline)/
                          DECCOX (decoquinate).
141-201................  AUREOMYCIN               Zoetis Inc.
                          (chlortetracycline)/
                          CATTLYST (laidlomycin).
141-211................  TERRAMYCIN               Phibro Animal Health
                          (oxytetracycline)/       Corp.
                          (carbadox).
141-224................  TYLAN (tylosin)/         Elanco US Inc.
                          RUMENSIN (monensin)/
                          OPTAFLEXX
                          (ractopamine).
141-233................  TYLAN (tylosin)/         Elanco US Inc.
                          RUMENSIN (monensin)/
                          OPTAFLEXX
                          (ractopamine)/MGA
                          (melengestrol).
141-250................  AUREOMYCIN               Zoetis Inc.
                          (chlortetracycline)/
                          BOVATEC (lasalocid).
141-276................  TYLAN (tylosin)/         Intervet, Inc., 2
                          RUMENSIN (monensin)/     Giralda Farms,
                          ZILMAX (zilpaterol).     Madison, NJ 07940
                                                   (Intervet, Inc.).
141-280................  TYLAN (tylosin)/         Intervet, Inc.
                          RUMENSIN (monensin)/
                          ZILMAX (zilpaterol)/
                          MGA (melengestrol).
200-095................  AUREOMYCIN               Huvepharma EOOD.
                          (chlortetracycline)/
                          SACOX (salinomycin).
200-096................  TERRAMYCIN               Huvepharma EOOD.
                          (oxytetracycline)/
                          SACOX (salinomycin).
200-242................  AUREOMYCIN               Zoetis Inc.
                          (chlortetracycline)/
                          BMD (bacitracin).
200-261................  CHLORMAX                 Zoetis Inc.
                          (chlortetracycline)/
                          BIO-COX (salinomycin).
200-262................  CHLORMAX                 Zoetis Inc.
                          (chlortetracycline)/
                          SACOX (salinomycin).
200-263................  CHLORMAX                 Zoetis Inc.
                          (chlortetracycline)/
                          COBAN (monensin).
200-354................  PENNCHLOR                Pharmgate LLC, 1015
                          (chlortetracycline)/     Ashes Dr., Suite 102,
                          COBAN (monensin).        Wilmington, NC 28405
                                                   (Pharmgate LLC).
200-356................  PENNCHLOR                Pharmgate LLC.
                          (chlortetracycline)/
                          DENAGARD (tiamulin).
200-357................  PENNCHLOR                Pharmgate LLC.
                          (chlortetracycline)/
                          BIO-COX (salinomycin).
200-358................  PENNCHLOR                Pharmgate LLC.
                          (chlortetracycline)/
                          BMD (bacitracin).
200-359................  PENNCHLOR                Pharmgate LLC.
                          (chlortetracycline)/
                          DECCOX (decoquinate).
200-375................  TYLAN (tylosin)/         Elanco US Inc.
                          RUMENSIN (monensin)/
                          HEIFERMAX
                          (melengestrol).
200-424................  TYLAN (tylosin)/         Elanco US Inc.
                          RUMENSIN (monensin)/
                          OPTAFLEXX
                          (ractopamine)/
                          HEIFERMAX
                          (melengestrol).
200-427................  TYLAN (tylosin)/         Elanco US Inc.
                          HEIFERMAX 500
                          (melengestrol) Liquid.
200-430................  TYLAN (tylosin)/BOVATEC  Elanco US Inc.
                          (lasalocid)/HEIFERMAX
                          500 (melengestrol)
                          Liquid.
200-480................  TYLAN (tylosin)/         Elanco US Inc.
                          RUMENSIN (monensin)/
                          ZILMAX (zilpaterol)/
                          HEIFERMAX 500
                          (melengestrol).
200-530................  TYLOVET (tylosin)/       Huvepharma EOOD.
                          PAYLEAN (ractopamine).
200-531................  TYLOVET (tylosin)/       Huvepharma EOOD.
                          RUMENSIN (monensin).
200-532................  TYLOVET (tylosin)/MGA    Huvepharma EOOD.
                          (melengestrol).
200-533................  TYLOVET (tylosin)/       Huvepharma EOOD.
                          RUMENSIN (monensin)/
                          DECCOX (decoquinate).
200-534................  TYLOVET (tylosin)/       Huvepharma EOOD.
                          RUMENSIN (monensin)/
                          MGA (melengestrol).
200-535................  TYLOVET (tylosin)/       Huvepharma EOOD.
                          BOVATEC (lasalocid)/
                          MGA (melengestrol).
200-544................  TYLOVET (tylosin)/       Huvepharma EOOD.
                          RUMENSIN (monensin)/
                          ZILMAX (zilpaterol)/
                          MGA (melengestrol).
200-547................  TYLOVET (tylosin)/       Huvepharma EOOD.
                          RUMENSIN (monensin)/
                          ZILMAX (zilpaterol).
200-558................  TYLAN (tylosin)/ENGAIN   Zoetis Inc.
                          (ractopamine).
200-561................  TYLAN (tylosin)/         Zoetis Inc.
                          RUMENSIN (monensin)/
                          ACTOGAIN (ractopamine).
200-562................  TYLAN (tylosin)/         Zoetis Inc.
                          RUMENSIN (monensin)/
                          ACTOGAIN (ractopamine).
200-566................  TYLOVET (tylosin)/       Huvepharma EOOD.
                          RUMENSIN (monensin).
200-567................  TYLOVET (tylosin)/       Huvepharma EOOD.
                          RUMENSIN (monensin).

200-583................  TYLOVET (tylosin)/       Zoetis Inc.
                          RUMENSIN (monensin)/
                          ACTOGAIN (ractopamine)/
                          MGA (melengestrol).
200-584................  TYLOVET (tylosin)/       Zoetis Inc.
                          ENGAIN (ractopamine).
200-585................  TYLOVET (tylosin)/       Zoetis Inc.
                          RUMENSIN (monensin)/
                          ACTOGAIN (ractopamine).
------------------------------------------------------------------------

    The animal drug regulations are also being amended to reflect
several non-substantive changes in format. These technical amendments
are being made to improve the consistency and readability of the
regulations.
    Elsewhere in this issue of the Federal Register, FDA is amending
the animal drug regulations to reflect approval of similar supplemental
NADAs and ANADAs changing the marketing status of antimicrobial drugs
administered to food-producing animals in medicated water.

II. Changes of Sponsorship

    Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140 has
informed FDA that it has transferred ownership of, and all rights and
interest in, NADA 141-110, providing for the manufacture of combination
drug medicated turkey feeds containing STAFAC (virginiamycin) and COBAN
(monensin) to Phibro Animal Health Corp., GlenPointe Centre East, 3d
Floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck, NJ 07666. As
provided in the regulatory text of this document, the animal drug
regulations are amended to reflect this change of sponsorship.

III. Withdrawals of Approval

    In addition, approval of the following applications for medicated
feeds containing antimicrobial drugs of importance to human medicine
administered to food-producing animals is being withdrawn at the
sponsors' requests because the products are no longer manufactured or
marketed:

------------------------------------------------------------------------
        File No.               Product name               Sponsor
------------------------------------------------------------------------
034-085................  LINCOMIX (lincomycin     Zoetis Inc., 333
                          hydrochloride            Portage St.,
                          monohydrate) Type A      Kalamazoo, MI 49007
                          Medicated Article.       (Zoetis Inc.).
035-287................  OM-5 Premix              Phibro Animal Health
                          (oleandomycin) Type A    Corp., GlenPointe
                          Medicated Article.       Centre East, 3d
                                                   Floor, 300 Frank W.
                                                   Burr Blvd., Suite 21,
                                                   Teaneck, NJ 07666
                                                   (Phibro Animal Health
                                                   Corp.).
046-668................  Penicillin G Procaine    Phibro Animal Health
                          50% Type A Medicated     Corp.
                          Article.
091-668................  CHLORMAX-SP 500          Zoetis Inc.
                          (chlortetracycline,
                          sulfamethazine,
                          penicillin G procaine)
                          Type A Medicated
                          Article.
108-116................  LINCOMIX (lincomycin)/   Phibro Animal Health
                          NICARB (nicarbazin).     Corp.
133-334................  Virginiamycin Type A     Zoetis Inc.
                          Medicated Article.
139-473................  STAFAC (virginiamycin)/  Huvepharma EOOD, 5th
                          STENEROL (halofuginone   Floor, 3A Nikolay
                          hydrobromide).           Haytov Str., 1113
                                                   Sophia, Bulgaria
                                                   (Huvepharma EOOD).
140-340................  LINCOMIX (lincomycin)/   Huvepharma EOOD.
                          STENOROL (halofuginone
                          hydrobromide).
140-443................  HYGROMIX 1.6             Zoetis Inc.
                          (hygromycin B) Type A
                          Medicated Article.
140-947................  LINCOMIX (lincomycin)/   Elanco US Inc., 2500
                          MAXIBAN (narasin and     Innovation Way,
                          nicarbazin).             Greenfield, IN 46140
                                                   (Elanco US Inc.).
141-090................  STAFAC (virginiamycin)/  Huvepharma EOOD.
                          CLINICOX (diclazuril).
200-171................  LINCOMIX (lincomycin)/   Planalquimica
                          NICARMIX (nicarbazin).   Industrial Ltda., Rua
                                                   das Magnolias nr.
                                                   2405, Jardim das
                                                   Bandeiras, CEP 13053-
                                                   120, Campinas, Sao
                                                   Paulo, Brazil.
200-569................  TYLAN (tylosin)/SACOX    Huvepharma EOOD.
                          (salinomycin).
200-570................  TYLOVET 100 (tylosin)/   Huvepharma EOOD.
                          BIO-COX (salinomycin).
200-580................  TYLOVET 100 (tylosin)/   Huvepharma EOOD.
                          SACOX (salinomycin).
------------------------------------------------------------------------

    Elsewhere in this issue of the Federal Register, FDA gave notice
that approval of NADAs 034-085, 035-287, 046-668, 091-668, 108-116,
133-334, 139-473, 140-340, 140-443, 140-947, and 141-090, and ANADAs
200-171, 200-569, 200-570, and 200-580, and all supplements and
amendments thereto, is withdrawn, effective January 6, 2017. As
provided in the regulatory text of this document, the animal drug
regulations are amended to reflect these voluntary withdrawals of
approval.
    This rule 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.

List of Subjects

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 and
redelegated to the Center for Veterinary Medicine, 21 CFR parts 556 and
558 are amended as follows:

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

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

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

Sec.  556.480  [Removed]

0
2. Remove Sec.  556.480.

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

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

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

0
4. In Sec.  558.4, in paragraph (d), in the Category I table, in the
column headings for ``Assay limits \1\ percent type A'' and ``Assay
limits percent \1\ type B/C \2\'', remove ``type'' and in its place add
``Type'', and remove the row entries for ``Erythromycin (thiocyanate
salt)'' and ``Oleandomycin''; and in the Category II table,
alphabetically add an entry for ``Erythromycin'' to read as follows:

Sec.  558.4  Requirement of a medicated feed mill license.

* * * * *
    (d) * * *

                                                   Category II
----------------------------------------------------------------------------------------------------------------
                                              Assay limits                                         Assay limits
                    Drug                       percent \1\          Type B maximum (100x)           percent \1\
                                                 Type A                                            Type B/C \2\
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Erythromycin...............................          85-115  4.625 g/lb (1.02%).................          75-125

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

0
5. In Sec.  558.58, remove and reserve paragraphs (e)(2), (7), and (8);
remove paragraphs (e)(10) and (11); and add paragraph (f) to read as
follows:

Sec.  558.58  Amprolium and ethopabate.

* * * * *
    (f) Amprolium and ethopabate may also be used in combination with:
    (1) [Reserved]
    (2) [Reserved]
    (3) Chlortetracycline as in Sec.  558.128.
    (4) Lincomycin as in Sec.  558.325.
    (5) Virginiamycin as in Sec.  558.635.

0
6. Revise Sec.  558.59 to read as follows:

Sec.  558.59  Apramycin.

    (a) Specifications. Type A articles containing 75 grams apramycin
(as apramycin sulfate) per pound.
    (b) Sponsor. See No. 058198 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.52 of this chapter.
    (d) Conditions of use in swine--

----------------------------------------------------------------------------------------------------------------
                                   Combination in
       Apramycin grams/ton            grams/ton       Indications for use           Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------
(1) 150..........................  ..............  For control of porcine    Feed as the sole ration      058198
                                                    colibacillosis            for 14 consecutive
                                                    (weanling pig scours)     days. Withdraw 28 days
                                                    caused by susceptible     before slaughter.
                                                    strains of Escherichia
                                                    coli.
(2) [Reserved]...................
----------------------------------------------------------------------------------------------------------------

0
7. In Sec.  558.76, redesignate paragraphs (e)(2)(iii) through (xvi) as
paragraphs (e)(2)(iv) through (xvii); and add new paragraph (e)(2)(iii)
to read as follows:

Sec.  558.76  Bacitracin methylenedisalicylate.

* * * * *
    (e) * * *
    (2) * * *
    (iii) Chlortetracycline as in Sec.  558.128.
* * * * *

0
8. Revise Sec.  558.128 to read as follows:

Sec.  558.128  Chlortetracycline.

    (a) Specifications. Type A medicated articles containing either
chlortetracycline calcium complex equivalent to chlortetracycline
hydrochloride, or for products intended for use in milk replacer,
chlortetracycline hydrochloride.
    (b) Approvals. See sponsors in Sec.  510.600(c) of this chapter for
use as in paragraph (e) of this section.
    (1) Nos. 054771: 50, 65, or 100 grams per pound (g/lb) Type A
medicated article.
    (2) No. 066104: 10, 20, 30, 50, 70, or 100 g/lb of Type A medicated
article.
    (3) No. 069254: 50, 90, or 100 g/lb of Type A medicated article.
    (c) Related tolerances. See Sec.  556.150 of this chapter.
    (d) Special considerations--(1) Federal law restricts medicated
feed containing this veterinary feed directive (VFD) drug to use by or
on the order of a licensed veterinarian. See Sec.  558.6 for additional
requirements.
    (2) The expiration date of VFDs for chlortetracycline medicated
feeds must not exceed 6 months from the date of issuance. VFDs for
chlortetracycline shall not be refilled.
    (3) In milk replacers or starter feed; include on labeling the
warning: ``A withdrawal period has not been established for this
product in preruminating calves. Do not use in calves to be processed
for veal.''
    (4) Manufacture for use in free-choice feeds as in paragraph
(e)(4)(iii) of this section must conform to Sec.  510.455 of this
chapter.
    (5) When manufactured for use as in paragraph (e)(5)(iii) of this
section, include on labeling the warning: ``Psittacosis, avian
chlamydiosis, or ornithosis is a reportable communicable disease,
transmissible between wild and domestic birds, other animals, and man.
Contact appropriate public health and regulatory officials.''
    (e) Conditions of use--(1) Chickens. It is used as follows:

----------------------------------------------------------------------------------------------------------------
                               Combination in
  Chlortetracycline amount        grams/ton        Indications for use          Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 100 to 200 g/ton.......  ..................  Chickens: For control    Feed continuously for<PHONE_NUMBER>04
                                                  of infectious            7 to 14 days. Do not           069254
                                                  synovitis caused by      feed to chickens
                                                  Mycoplasma synoviae      producing eggs for
                                                  susceptible to           human consumption.
                                                  chlortetracycline.

(ii) 100 to 200 g/ton......  Clopidol, 113.5...  Broiler and replacement  Feed continuously as            016592
                                                  chickens: As an aid in   the sole ration from
                                                  the prevention of        the time chicks are
                                                  coccidiosis caused by    placed in floor pens
                                                  Eimeria tenella, E.      for 7 to 14 days. Do
                                                  necatrix, E.             not feed to chickens
                                                  acervulina, E. maxima,   over 16 weeks of age.
                                                  E. mivati, and E.        Do not feed to
                                                  brunetti; and for        chickens producing
                                                  control of infectious    eggs for human
                                                  synovitis caused by M.   consumption.
                                                  synoviae susceptible     Chlortetracycline as
                                                  to chlortetracycline.    provided by No.
                                                                           054771; clopidol as
                                                                           provided by No.
                                                                           016592 in Sec.
                                                                           510.600(c) of this
                                                                           chapter.
(iii) 100 to 200 g/ton.....  Decoquinate, 27.2.  Chickens: For            Feed continuously for           054771
                                                  prevention of            7 to 14 days.
                                                  coccidiosis caused by    Bentonite should not
                                                  Eimeria tenella, E.      be used in
                                                  necatrix, E. mivati,     decoquinate feeds. Do
                                                  E. acervulina, E.        not feed to chickens
                                                  maxima, and E.           producing eggs for
                                                  brunetti; and for        human consumption.
                                                  control of infectious   Chlortetracycline and
                                                  synovitis caused by M,   decoquinate as
                                                  synoviae susceptible     provided by No.
                                                  to chlortetracycline.    054771 in Sec.
                                                                           510.600(c) of this
                                                                           chapter.
(iv) 100 g/ton.............  Robenidine, 30....  Broiler and fryer        Feed continuously as            054771
                                                  chickens: As an aid in   sole ration. Do not
                                                  the prevention of        use this product in
                                                  coccidiosis caused by    feeds conta.
                                                  E. mivati, E.           Chlortetracycline and
                                                  brunetti, E. tenella,    robenidine as
                                                  E. acervulina, E.        provided by No.
                                                  maxima, and E.           054771 in Sec.
                                                  necatrix; as an aid in   510.600(c) of this
                                                  the control of chronic   chapter.
                                                  respiratory disease
                                                  (CRD) caused by
                                                  Mycoplasma
                                                  gallisepticum
                                                  susceptible to
                                                  chlortetracycline; and
                                                  as an aid in the
                                                  control of infectious
                                                  synovitis caused by M.
                                                  synoviae susceptible
                                                  to chlortetracycline.
(v) 200 to 400 g/ton.......  ..................  Chickens: For the        Feed continuously for<PHONE_NUMBER>04
                                                  control of chronic       7 to 14 days. Do not           069254
                                                  respiratory disease      feed to chickens
                                                  (CRD) and air sac        producing eggs for
                                                  infection caused by M.   human consumption.
                                                  gallisepticum and
                                                  Escherichia coli
                                                  susceptible to
                                                  chlortetracycline.
(vi) 200 g/ton.............  Amprolium, 227 and  For chickens where       Use in low calcium              054771
                              ethopabate, 3.6.    immunity to              feed containing 0.8%
                                                  coccidiosis is not       dietary calcium and
                                                  desired: For             1.5% sodium sulfate;
                                                  prevention of            feed continuously as
                                                  coccidiosis; and for     sole ration for 7 to
                                                  treatment of chronic     14 days; do not feed
                                                  respiratory disease      to chickens producing
                                                  (CRD) caused by M.       eggs for human
                                                  gallisepticum            consumption.
                                                  susceptible to           Chlortetracycline as
                                                  chlortetracycline.       provided by No.
                                                                           054771; amprolium and
                                                                           ethopabate as
                                                                           provided by No.
                                                                           016592 in Sec.
                                                                           510.600(c) of this
                                                                           chapter.
(vii) 200 g/ton............  Decoquinate, 27.2.  Broilers: As an aid in   Feed continuously as            054771
                                                  the prevention of        the sole ration for
                                                  coccidiosis caused by    no more than 8 weeks.
                                                  Eimeria tenella, E.      Use in low calcium
                                                  necatrix, E.             feed containing 0.8%
                                                  acervulina, E. mivati,   dietary calcium.
                                                  E. maxima, and E.        Bentonite should not
                                                  brunetti; and for the    be used in
                                                  treatment of chronic     decoquinate feeds. Do
                                                  respiratory disease      not feed to chickens
                                                  (air sac infection)      producing eggs for
                                                  and the prevention of    human consumption.
                                                  synovitis.              Chlortetracycline and
                                                                           decoquinate as
                                                                           provided by No.
                                                                           054771 in Sec.
                                                                           510.600(c) of this
                                                                           chapter.
(viii) 200 g/ton...........  Robenidine 30.....  Broiler and fryer        Feed continuously as            054771
                                                  chickens: As an aid in   sole ration. Do not
                                                  the prevention of        use this product in
                                                  coccidiosis caused by    feeds containing
                                                  E. mivati, E.            bentonite. Do not
                                                  brunetti, E. tenella,    feed to chickens
                                                  E. acervulina, E.        producing eggs for
                                                  maxima, and E.           human consumption.
                                                  necatrix; as an aid in   Withdraw 5 days prior
                                                  the control of chronic   to slaughter.
                                                  respiratory disease     Chlortetracycline and
                                                  (CRD) caused by M.       robenidine as
                                                  gallisepticum            provided by No.
                                                  susceptible to           054771 in Sec.
                                                  chlortetracycline; and   510.600(c) of this
                                                  as an aid in the         chapter.
                                                  control of infectious
                                                  synovitis caused by M.
                                                  synoviae susceptible
                                                  to chlortetracycline.
(ix) 500 g/ton.............  ..................  Chickens: For the        1. Feed for 5 days. To<PHONE_NUMBER>54
                                                  reduction of mortality   sponsor No. 054771
                                                  due to E. coli           under NADA 048-761
                                                  infections susceptible   and No. 069254 under
                                                  to chlortetracycline.    ANADA 200-510: zero
                                                                           withdrawal time.
                                                                          2. Feed for 5 days;             054771
                                                                           withdraw 24 hours              066104
                                                                           prior to slaughter.            069254
                                                                           Do not feed to
                                                                           chickens producing
                                                                           eggs for human
                                                                           consumption.

(x) 500 g/ton..............  Monensin, 90 to     Chickens: As an aid in   Feed for 5 days as the<PHONE_NUMBER>54
                              110.                the reduction of         sole ration. Do not
                                                  mortality due to E.      feed to laying
                                                  coli infections          chickens. Not to be
                                                  susceptible to           fed continuously for
                                                  chlortetracycline; and   more than 5 days. Do
                                                  as an aid in the         not feed to chickens
                                                  prevention of            over 16 weeks of age.
                                                  coccidiosis caused by    Withdraw 24 hours
                                                  Eimeria tenella, E.      before slaughter. See
                                                  necatrix, E.             Sec.   558.355(d) of
                                                  acervulina, E. maxima,   this chapter.
                                                  E. brunetti, and E.      Chlortetracycline as
                                                  mivati.                  provided by No.
                                                                           054771; monensin as
                                                                           provided by No.
                                                                           058198 in Sec.
                                                                           510.600(c) of this
                                                                           chapter.
(xi) 500 g/ton.............  Robenidine, 30....  Broiler and fryer        Feed continuously as            054771
                                                  chickens: As an aid in   sole ration for up to
                                                  the prevention of        5 days. Do not use
                                                  coccidiosis caused by    this product in feeds
                                                  Eimeria mivati, E.       containing bentonite.
                                                  brunetti, E. tenella,    Do not feed to
                                                  E. acervulina, E.        chickens producing
                                                  maxima, and E.           eggs for human
                                                  necatrix; as an aid in   consumption. Withdraw
                                                  the reduction of         5 days prior to
                                                  mortality due to E.      slaughter.
                                                  coli susceptible to     Chlortetracycline and
                                                  chlortetracycline.       robenidine as
                                                                           provided by No.
                                                                           054771 in Sec.
                                                                           510.600(c) of this
                                                                           chapter.
(xii) 500 g/ton............  Salinomycin, 40 to  Broiler chickens: As an  For use in low calcium<PHONE_NUMBER>71
                              60.                 aid in the prevention    feeds containing 0.8%          069254
                                                  of coccidiosis caused    calcium. Not approved
                                                  by Eimeria tenella, E.   for use with pellet
                                                  necatrix, E.             binders. Not to be
                                                  acervulina, E. maxima,   fed continuously for
                                                  E. brunetti, and E.      more than 5 days. Do
                                                  mivati; and as an aid    not feed to laying
                                                  in the reduction of      chickens producing
                                                  mortality due to E.      eggs for human
                                                  coli susceptible to      consumption. Withdraw
                                                  chlortetracycline.       24 hours before
                                                                           slaughter. May be
                                                                           fatal if accidentally
                                                                           fed to adult turkeys
                                                                           or horses.
                                                                           Chlortetracycline as
                                                                           provided by Nos.
                                                                           054771 or 069254;
                                                                           salinomycin as
                                                                           provided by Nos.
                                                                           054771 or 016592 in
                                                                           Sec.   510.600(c) of
                                                                           this chapter.
----------------------------------------------------------------------------------------------------------------

    (2) Turkeys. It is used as follows:

----------------------------------------------------------------------------------------------------------------
                               Combination in
  Chlortetracycline amount        grams/ton        Indications for use          Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 200 g/ton..............  ..................  Turkeys: For control of  Feed continuously for           054771
                                                  infectious synovitis     7 to 14 days. Do not           066104
                                                  caused by M. synoviae    feed to turkeys                069254
                                                  susceptible to           producing eggs for
                                                  chlortetracycline.       human consumption.
(ii) 400 g/ton.............  ..................  1. Turkeys: For control  Feed continuously for           054771
                                                  of hexamitiasis caused   7 to 14 days. Do not           066104
                                                  by Hexamita              feed to turkeys                069254
                                                  meleagridis              producing eggs for
                                                  susceptible to           human consumption.
                                                  chlortetracycline.
                             ..................  2. Turkey poults not     ......................          054771
                                                  over 4 weeks of age:                                    066104
                                                  For reduction of                                        069254
                                                  mortality due to
                                                  paratyphoid caused by
                                                  Salmonella typhimurium
                                                  susceptible to
                                                  chlortetracycline.
(iii) 25 mg/lb of body       ..................  Turkeys: For control of  Feed continuously for           054771
 weight.                                          complicating bacterial   7 to 14 days. Do not           066104
                                                  organisms associated     feed to turkeys                069254
                                                  with bluecomb            producing eggs for
                                                  (transmissible           human consumption.
                                                  enteritis; coronaviral
                                                  enteritis) susceptible
                                                  to chlortetracycline.
----------------------------------------------------------------------------------------------------------------

    (3) Swine. It is used as follows:

----------------------------------------------------------------------------------------------------------------
                               Combination in
  Chlortetracycline amount        grams/ton        Indications for use          Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 50 to 100 g/ton........  ..................  Swine: For reducing the  ......................          054771
                                                  incidence of cervical                                   066104
                                                  lymphadenitis (jowl                                     069254
                                                  abscesses) caused by
                                                  Group E Streptococci
                                                  susceptible to
                                                  chlortetracycline.

(ii) 400 g/ton.............  ..................  Breeding swine: For the  Feed continuously for           054771
                                                  control of               not more than 14 days.         066104
                                                  leptospirosis                                           069254
                                                  (reducing the
                                                  incidence of abortion
                                                  and shedding of
                                                  leptospirae) caused by
                                                  Leptospira pomona
                                                  susceptible to
                                                  chlortetracycline.
(iii) 10 mg/lb of body       ..................  Swine: For treatment of  Feed approximately 400          054771
 weight.                                          bacterial enteritis      g/ton, varying with            066104
                                                  caused by Escherichia    body weight and feed           069254
                                                  coli and S.              consumption to
                                                  choleraesuis and         provide 10 mg/lb per
                                                  bacterial pneumonia      day. Feed for not
                                                  caused by Pasteurella    more than 14 days.
                                                  multocida susceptible    Withdraw 5 d prior to
                                                  to chlortetracycline;    slaughter for sponsor
                                                  for the control of       No. 069254 in Sec.
                                                  porcine proliferative    510.600(c) of this
                                                  enteropathies            chapter.
                                                  (ileitis) caused by
                                                  Lawsonia
                                                  intracellularis
                                                  susceptible to
                                                  chlortetracycline.
(iv) 10 mg/lb of body        Bacitracin          Swine: For treatment of  Feed approximately 400          054771
 weight.                      methylenedisalicy   bacterial enteritis      g/ton, varying with
                              late, 10 to 30.     caused by E. coli and    body weight and feed
                                                  S. choleraesuis and      consumption to
                                                  bacterial pneumonia      provide 10 mg/lb per
                                                  caused by P. multocida   day. Feed for not
                                                  susceptible to           more than 14 days.
                                                  chlortetracycline; for
                                                  the control of porcine
                                                  proliferative
                                                  enteropathies
                                                  (ileitis) caused by
                                                  Lawsonia
                                                  intracellularis
                                                  susceptible to
                                                  chlortetracycline; and
                                                  for increased rate of
                                                  weight gain and
                                                  improved feed
                                                  efficiency.
(v) 10 mg/lb of body weight  Bacitracin          Swine: For treatment of  Feed chlortetracycline          069254
                              methylenedisalicy   bacterial enteritis      at approximately 400
                              late, 10 to 30.     caused by E. coli and    g/ton of feed,
                                                  S. choleraesuis and      varying with body
                                                  bacterial pneumonia      weight and food
                                                  caused by P. multocida   consumption, to
                                                  susceptible to           provide 10 mg/lb of
                                                  chlortetracycline; and   body weight. Feed for
                                                  for increased rate of    not more than 14
                                                  weight gain and          days. Withdraw 5 d
                                                  improved feed            prior to slaughter
                                                  efficiency.              for sponsor No.
                                                                           069254. Bacitracin
                                                                           methylenedisalicylate
                                                                           provided by No.
                                                                           054771;
                                                                           chlortetracycline
                                                                           provided by Nos.
                                                                           054771 and 069254 in
                                                                           Sec.   510.600(c) of
                                                                           this chapter.
(vi) 500 to 4,000 to         Tiamulin hydrogen   For control of swine     Feed continuously as            058198
 provide 10 mg/lb of body     fumarate, 35.       dysentery associated     the sole ration for            069254
 weight daily.                                    with Brachyspira         14 days. Withdraw
                                                  (formerly Serpulina or   medicated feed 2 days
                                                  Treponema)               before slaughter.
                                                  hyodysenteriae           Tiamulin as provided
                                                  susceptible to           by Nos. 058198 or
                                                  tiamulin and for         069254in Sec.
                                                  treatment of swine       510.600(c) of this
                                                  bacterial enteritis      chapter.
                                                  caused by E. coli and
                                                  Salmonella
                                                  choleraesuis sensitive
                                                  to chlortetracycline
                                                  and treatment of
                                                  bacterial pneumonia
                                                  caused by P. multocida
                                                  sensitive to
                                                  chlortetracycline.
----------------------------------------------------------------------------------------------------------------

    (4) Cattle. It is used as follows:

----------------------------------------------------------------------------------------------------------------
                                  Combination in
   Chlortetracycline amount         grams/ton        Indications for use        Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 0.5 mg/lb of body weight    .................  Beef cattle (over 700   Withdraw 48 hours              054771
 daily.                                             lb): For control of     prior to slaughter.           066104
                                                    active infection of     To sponsor Nos.               069254
                                                    anaplasmosis caused     054771 and 069254:
                                                    by Anaplasma            Zero withdrawal time.
                                                    marginale susceptible
                                                    to chlortetracycline.

(ii) 25 to 1,100 to provide     Lasalocid, 30 to   Pasture cattle          Feed continuously on           054771
 0.5 mg/lb of body weight        600.               (slaughter, stocker,    a hand-fed basis 0.5
 daily.                                             feeder cattle, beef     mg chlortetracycline
                                                    replacement heifers)    per lb. body weight
                                                    over 700 pounds: For    per day and not less
                                                    control of active       than 60 mg or more
                                                    infection of            than 300 mg
                                                    anaplasmosis caused     lasalocid per head
                                                    by A. marginale         daily in at least 1
                                                    susceptible to          pound of feed. Daily
                                                    chlortetracycline;      lasalocid intakes in
                                                    and for increased       excess of 200 mg/
                                                    rate of weight gain.    head/day in pasture
                                                                            cattle have not been
                                                                            shown to be more
                                                                            effective than 200
                                                                            mg lasalocid/head/
                                                                            day. Do not allow
                                                                            horses or other
                                                                            equines access to
                                                                            feeds containing
                                                                            lasalocid. No
                                                                            withdrawal period is
                                                                            required. A
                                                                            withdrawal period
                                                                            has not been
                                                                            established for this
                                                                            product in pre-
                                                                            ruminating calves.
                                                                            Do not use in calves
                                                                            to be processed for
                                                                            veal. See Sec.
                                                                            558.311(d) of this
                                                                            chapter. Lasalocid
                                                                            as provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(iii) 0.5 to 2.0 mg/lb of body  .................  Beef cattle and         In free-choice cattle          054771
 weight daily.                                      nonlactating dairy      feeds such as feed
                                                    cattle: As an aid in    blocks or salt-
                                                    the control of active   mineral mixes
                                                    infection of            manufactured from
                                                    anaplsmosis caused by   approved Type A
                                                    A. marginale            articles. See
                                                    susceptible to          paragraph (d)(4) of
                                                    chlortetracycline.      this section.
(iv) 10 mg/lb of body weight    .................  1. Calves, beef and     Feed approximately<PHONE_NUMBER>04
 daily.                                             nonlactating dairy      400 g/ton, varying            069254
                                                    cattle: For treatment   with body weight and
                                                    of bacterial            feed consumption to
                                                    enteritis caused by     provide 10 mg/lb per
                                                    Escherichia coli and    day. Treat for not
                                                    bacterial pneumonia     more than 5 days. In
                                                    caused by Pasteurella   feed including milk
                                                    multocida organisms     replacers withdraw
                                                    susceptible to          10 days prior to
                                                    chlortetracycline.      slaughter. To
                                                                            sponsor No. 069254:
                                                                            zero withdrawal
                                                                            time. See paragraph
                                                                            (d)(3) of this
                                                                            section.
                                                   2. Calves (up to 250    See paragraph (d)(3)           054771
                                                    lb): For the            of this section.              066104
                                                    treatment of                                          069254
                                                    bacterial enteritis
                                                    caused by E. coli
                                                    susceptible to
                                                    chlortetracycline.
(v) 10 mg/lb of body weight     Laidlomycin, 5...  Cattle fed in           Feed continuously at           054771
 daily.                                             confinement for         a rate of 30 to 75
                                                    slaughter: For          mg laidlomycin
                                                    treatment of            propionate potassium
                                                    bacterial enteritis     per head per day for
                                                    caused by E. coli and   not more than 5
                                                    bacterial pneumonia     days. A withdrawal
                                                    caused by P.            period has not been
                                                    multocida organisms     established for this
                                                    susceptible to          product in pre-
                                                    chlortetracycline;      ruminating calves.
                                                    and for increased       Do not use in calves
                                                    rate of weight and      to be processed for
                                                    improved feed           veal. See Sec.
                                                    efficiency.             558.305(d) of this
                                                                            chapter. Laidlomycin
                                                                            as provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(vi) 10 mg/lb of body weight    Laidlomycin, 5 to  Cattle fed in           Feed continuously at           054771
 daily.                          10.                confinement for         a rate of 30 to 75
                                                    slaughter: For          mg laidlomycin
                                                    treatment of            propionate potassium
                                                    bacterial enteritis     per head per day for
                                                    caused by E. coli and   not more than 5
                                                    bacterial pneumonia     days. A withdrawal
                                                    caused by P.            period has not been
                                                    multocida organisms     established for this
                                                    susceptible to          product in pre-
                                                    chlortetracycline;      ruminating calves.
                                                    and for improved feed   Do not use in calves
                                                    efficiency.             to be processed for
                                                                            veal. See Sec.
                                                                            558.305(d) of this
                                                                            chapter. Laidlomycin
                                                                            as provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(vii) 500 to 2,000 to provide   Lasalocid, 10 to   Cattle fed in           Feed continuously in           054771
 10 mg/lb of body weight daily.  30.                confinement for         complete feed for
                                                    slaughter: For          not more than 5 days
                                                    treatment of            to provide 10 mg
                                                    bacterial enteritis     chlortetracycline
                                                    caused by E. coli and   per lb. body weight
                                                    bacterial pneumonia     per day and not less
                                                    caused by P.            than 100 mg or more
                                                    multocida organisms     than 360 mg
                                                    susceptible to          lasalocid per head
                                                    chlortetracycline;      per day. Do not
                                                    and for improved feed   allow horses or
                                                    efficiency.             other equines access
                                                                            to feeds containing
                                                                            lasalocid. No
                                                                            withdrawal period is
                                                                            required. A
                                                                            withdrawal period
                                                                            has not been
                                                                            established for this
                                                                            product in pre-
                                                                            ruminating calves.
                                                                            Do not use in calves
                                                                            to be processed for
                                                                            veal. See Sec.
                                                                            558.311(d) of this
                                                                            chapter. Lasalocid
                                                                            as provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.

(viii) 500 to 1,200 to provide  Lasalocid, 25 to   Cattle fed in           Feed continuously in           054771
 10 mg/lb of body weight daily.  30.                confinement for         complete feed for
                                                    slaughter: For          not more than 5 days
                                                    treatment of            to provide 10 mg
                                                    bacterial enteritis     chlortetracycline
                                                    caused by E. coli and   per lb. body weight
                                                    bacterial pneumonia     per day and not less
                                                    caused by P.            than 250 mg or more
                                                    multocida organisms     than 360 mg
                                                    susceptible to          lasalocid per head
                                                    chlortetracycline;      per day. Do not
                                                    and for increased       allow horses or
                                                    rate of weight gain     other equines access
                                                    and improved feed       to feeds containing
                                                    efficiency.             lasalocid. No
                                                                            withdrawal period is
                                                                            required. A
                                                                            withdrawal period
                                                                            has not been
                                                                            established for this
                                                                            product in pre-
                                                                            ruminating calves.
                                                                            Do not use in calves
                                                                            to be processed for
                                                                            veal. See Sec.
                                                                            558.311(d) of this
                                                                            chapter. Lasalocid
                                                                            as provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(ix) 500 to 4,000 to provide    Lasalocid, 30 to   Pasture cattle          Feed continuously on           054771
 10 mg/lb of body weight daily.  600.               (slaughter, stocker,    a hand-fed basis for
                                                    feeder cattle, dairy    not more than 5 days
                                                    and beef replacement    to provide 10 mg
                                                    heifers): For           chlortetracycline
                                                    treatment of            per lb. body weight
                                                    bacterial enteritis     per day and not less
                                                    caused by E. coli and   than 60 mg or more
                                                    bacterial pneumonia     than 300 mg
                                                    caused by P.            lasalocid per head
                                                    multocida organisms     per day. Daily
                                                    susceptible to          lasalocid intakes in
                                                    chlortetracycline;      excess of 200 mg/
                                                    and for increased       head/day in pasture
                                                    rate of weight gain     cattle have not been
                                                    and improved feed       shown to be more
                                                    efficiency.             effective than 200
                                                                            mg lasalocid/head/
                                                                            day. Do not allow
                                                                            horses or other
                                                                            equines access to
                                                                            feeds containing
                                                                            lasalocid. No
                                                                            withdrawal period is
                                                                            required. A
                                                                            withdrawal period
                                                                            has not been
                                                                            established for this
                                                                            product in pre-
                                                                            ruminating calves.
                                                                            Do not use in calves
                                                                            to be processed for
                                                                            veal. See Sec.
                                                                            558.311(d) of this
                                                                            chapter. Lasalocid
                                                                            as provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(x) 500 to 4,000 g/ton........  .................  Calves, beef and        Feed continuously for          054771
                                                    nonlactating dairy      not more than 5 days          069254
                                                    cattle: For the         to provide 10 mg/lb
                                                    treatment of            body weight per day.
                                                    bacterial enteritis     To sponsor No.
                                                    caused by E. coli and   054771 under NADA
                                                    bacterial pneumonia     046-699: 24-hour
                                                    caused by P.            withdrawal period.
                                                    multocida susceptible   To sponsor No.
                                                    to chlortetracycline.   054771 under NADA
                                                                            048-761 and No.
                                                                            069254 under ANADA
                                                                            200-510: Zero
                                                                            withdrawal period.
(xi) 500 to 4,000.............  Decoquinate, 12.9  Calves, beef and non-   Feed at a rate of 1g           054771
                                 to 90.8.           lactating dairy         chlortetracycline             069254
                                                    cattle: For the         per 100 lb body
                                                    treatment of            weight/day and 22.7
                                                    bacterial enteritis     mg decoquinate per
                                                    caused by E. coli and   100 lb of body
                                                    bacterial pneumonia     weight/day for not
                                                    caused by P.            more than 5 days.
                                                    multocida susceptible   When it is fully
                                                    to chlortetracycline;   consumed, resume
                                                    and for the             feeding 22.7 mg
                                                    prevention of           decoquinate per 100
                                                    coccidiosis caused by   lb of body weight/
                                                    Eimeria bovis and E.    day for a total of
                                                    zuernii.                28 days to prevent
                                                                            coccidiosis.
                                                                            Withdraw 24 hours
                                                                            prior to slaughter.
                                                                            A withdrawal period
                                                                            has not been
                                                                            established for this
                                                                            product in pre-
                                                                            ruminating calves.
                                                                            Do not use in calves
                                                                            to be processed for
                                                                            veal. Do not feed to
                                                                            animals producing
                                                                            milk for food.
                                                                            Decoquinate as
                                                                            provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(xii) 4,000 to 20,000 g/ton...  .................  Calves, beef and        As a top dress,                054771
                                                    nonlactating dairy      varying with body
                                                    cattle: For the         weight and feed
                                                    treatment of            consumption, to
                                                    bacterial enteritis     provide 10 mg/lb per
                                                    caused by E. coli and   day. Treat for not
                                                    bacterial pneumonia     more than 5 days.
                                                    caused by P.            See paragraph (d)(3)
                                                    multocida organisms     of this section.
                                                    susceptible to
                                                    chlortetracycline.

(xiii) 4,000 to 20,000 g/ton..  Decoquinate, 90.8  Calves, beef and non-   Administer as a top            054771
                                 to 535.7.          lactating dairy         dress supplement or
                                                    cattle: For the         mix into the daily
                                                    treatment of            ration to provide
                                                    bacterial enteritis     22.7 mg decoquinate
                                                    caused by E. coli and   per 100 lb of body
                                                    bacterial pneumonia     weight per day and 1
                                                    caused by P.            g chlortetracycline
                                                    multocida susceptible   per 100 lb body
                                                    to chlortetracycline;   weight/day for not
                                                    and for the             more than 5 days.
                                                    prevention of           When it is fully
                                                    coccidiosis caused by   consumed, resume
                                                    E. bovis and E.         feeding 22.7 mg
                                                    zuernii.                decoquinate per 100
                                                                            lb of body weight/
                                                                            day for a total of
                                                                            28 days to prevent
                                                                            coccidiosis.
                                                                            Withdraw 24 hours
                                                                            prior to slaughter.
                                                                            A withdrawal period
                                                                            has not been
                                                                            established for this
                                                                            product in pre-
                                                                            ruminating calves.
                                                                            Do not use in calves
                                                                            to be processed for
                                                                            veal. Do not feed to
                                                                            animals producing
                                                                            milk for food.
                                                                            Decoquinate as
                                                                            provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(xiv) 70 mg/head/day..........  .................  Growing cattle (over    See paragraph (d)(3)           054771
                                                    400 lb): For            of this section.              066104
                                                    reduction of                                          069254
                                                    incidence of liver
                                                    abscesses.
(xv) 350 mg/head/day..........  .................  1. Beef cattle: For     Withdraw 48 h prior<PHONE_NUMBER>04
                                                    control of bacterial    to slaughter. To              069254
                                                    pneumonia associated    sponsor No. 054771
                                                    with shipping fever     under NADA 046-699:
                                                    complex caused by       48-hour withdrawal
                                                    Pasteurella spp.        time. To sponsor No.
                                                    susceptible to          054771 under NADA
                                                    chlortetracycline.      048-761 and No.
                                                                            069254 under ANADA
                                                                            200-510: zero
                                                                            withdrawal period.
                                                   2. Beef cattle (under   Withdraw 48 h prior<PHONE_NUMBER>04
                                                    700 lb): For control    to slaughter. To              069254
                                                    of active infection     sponsor No. 054771
                                                    of anaplasmosis         under NADA 046-699:
                                                    caused by A.            48-hour withdrawal
                                                    marginale susceptible   time. To sponsor No.
                                                    to chlortetracycline.   054771 under NADA
                                                                            048-761 and No.
                                                                            069254 under ANADA
                                                                            200-510: zero
                                                                            withdrawal time.
(xvi) 350 mg/head/day.........  Laidlomycin, 5...  Cattle fed in           Feed continuously at           054771
                                                    confinement for         a rate of 30 to 75
                                                    slaughter: For          mg laidlomycin
                                                    control of bacterial    propionate potassium
                                                    pneumonia associated    per head per day. A
                                                    with shipping fever     withdrawal period
                                                    complex caused by       has not been
                                                    Pasteurella spp.        established for this
                                                    susceptible to          product in pre-
                                                    chlortetracycline;      ruminating calves.
                                                    and for increased       Do not use in calves
                                                    rate of weight and      to be processed for
                                                    improved feed           veal. See Sec.
                                                    efficiency.             558.305(d) of this
                                                                            chapter. Laidlomycin
                                                                            as provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(xvii) 350 mg/head/day........  Laidlomycin, 5 to  Cattle fed in           Feed continuously at           054771
                                 10.                confinement for         a rate of 30 to 75
                                                    slaughter: For          mg laidlomycin
                                                    control of bacterial    propionate potassium
                                                    pneumonia associated    per head per day. A
                                                    with shipping fever     withdrawal period
                                                    complex caused by       has not been
                                                    Pasteurella spp.        established for this
                                                    susceptible to          product in pre-
                                                    chlortetracycline;      ruminating calves.
                                                    and for improved feed   Do not use in calves
                                                    efficiency.             to be processed for
                                                                            veal. See Sec.
                                                                            558.305(d) of this
                                                                            chapter. Laidlomycin
                                                                            as provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(xviii) 25 to 42.2 g/ton to     Lasalocid, 25 to   Cattle under 700        Feed continuously in           054771
 provide 350 mg/head/day.        30.                pounds fed in           complete feed at a
                                                    confinement for         rate of 350 mg
                                                    slaughter: For          chlortetracycline
                                                    control of active       and not less than
                                                    infection of            250 mg nor more than
                                                    anaplasmosis caused     360 mg lasalocid per
                                                    by A. marginale         head daily. Do not
                                                    susceptible to          allow horses or
                                                    chlortetracycline;      other equines access
                                                    and for increased       to feeds containing
                                                    rate of weight gain     lasalocid. No
                                                    and improved feed       withdrawal period is
                                                    efficiency.             required. A
                                                                            withdrawal period
                                                                            has not been
                                                                            established for this
                                                                            product in pre-
                                                                            ruminating calves.
                                                                            Do not use in calves
                                                                            to be processed for
                                                                            veal. See Sec.
                                                                            558.311(d) of this
                                                                            chapter. Lasalocid
                                                                            as provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.

(xix) 25 to 42.2 g/ton to       Lasalocid, 25 to   Cattle fed in           Feed continuously in           054771
 provide 350 mg/head/day.        30.                confinement for         complete feed at a
                                                    slaughter: For          rate of 350 mg
                                                    control of bacterial    chlortetracycline
                                                    pneumonia associated    and not less than
                                                    with shipping fever     250 mg nor more than
                                                    complex caused by P.    360 mg lasalocid per
                                                    multocida organisms     head daily. Do not
                                                    susceptible to          allow horses or
                                                    chlortetracycline;      other equines access
                                                    and for increased       to feeds containing
                                                    rate of weight gain     lasalocid. No
                                                    and improved feed       withdrawal period is
                                                    efficiency.             required. A
                                                                            withdrawal period
                                                                            has not been
                                                                            established for this
                                                                            product in pre-
                                                                            ruminating calves.
                                                                            Do not use in calves
                                                                            to be processed for
                                                                            veal. See Sec.
                                                                            558.311(d) of this
                                                                            chapter. Lasalocid
                                                                            as provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(xx) 25 to 100 g/ton to         Lasalocid, 10 to   Cattle under 700        Feed continuously in           054771
 provide 350 mg/head/day.        30.                pounds fed in           complete feed at a
                                                    confinement for         rate of 350 mg
                                                    slaughter: For          chlortetracycline
                                                    control of active       and not less than
                                                    infection of            100 mg nor more than
                                                    anaplasmosis caused     360 mg lasalocid per
                                                    by A. marginale         head daily. Do not
                                                    susceptible to          allow horses or
                                                    chlortetracycline;      other equines access
                                                    and for improved feed   to feeds containing
                                                    efficiency.             lasalocid. No
                                                                            withdrawal period is
                                                                            required. A
                                                                            withdrawal period
                                                                            has not been
                                                                            established for this
                                                                            product in pre-
                                                                            ruminating calves.
                                                                            Do not use in calves
                                                                            to be processed for
                                                                            veal. See Sec.
                                                                            558.311(d) of this
                                                                            chapter. Lasalocid
                                                                            as provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(xxi) 25 to 100 g/ton to        Lasalocid, 10 to   Cattle fed in           Feed continuously in           054771
 provide 350 mg/head/day.        30.                confinement for         complete feed at a
                                                    slaughter: For          rate of 350 mg
                                                    control of bacterial    chlortetracycline
                                                    pneumonia associated    and not less than
                                                    with shipping fever     100 mg nor more than
                                                    complex caused by P.    360 mg lasalocid per
                                                    multocida organisms     head daily. Do not
                                                    susceptible to          allow horses or
                                                    chlortetracycline;      other equines access
                                                    and for improved feed   to feeds containing
                                                    efficiency.             lasalocid. No
                                                                            withdrawal period is
                                                                            required. A
                                                                            withdrawal period
                                                                            has not been
                                                                            established for this
                                                                            product in pre-
                                                                            ruminating calves.
                                                                            Do not use in calves
                                                                            to be processed for
                                                                            veal. See Sec.
                                                                            558.311(d) of this
                                                                            chapter. Lasalocid
                                                                            as provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(xxii) 25 to 700 to provide     Lasalocid, 30 to   Pasture cattle          Feed continuously on           054771
 350 mg/head/day.                600.               (slaughter, stocker,    a hand-fed basis at
                                                    feeder cattle, dairy    a rate of 350 mg
                                                    and beef replacement    chlortetracycline
                                                    heifers): For control   and not less than 60
                                                    of bacterial            mg nor more than 300
                                                    pneumonia associated    mg lasalocid per
                                                    with shipping fever     head per day in at
                                                    complex caused by P.    least 1 pound of
                                                    multocida organisms     feed. Daily
                                                    susceptible to          lasalocid intakes in
                                                    chlortetracycline;      excess of 200 mg/
                                                    and for increased       head/day in pasture
                                                    rate of weight gain.    cattle have not been
                                                                            shown to be more
                                                                            effective than 200
                                                                            mg lasalocid/head/
                                                                            day. Do not allow
                                                                            horses or other
                                                                            equines access to
                                                                            feeds containing
                                                                            lasalocid. No
                                                                            withdrawal period is
                                                                            required. A
                                                                            withdrawal period
                                                                            has not been
                                                                            established for this
                                                                            product in pre-
                                                                            ruminating calves.
                                                                            Do not use in calves
                                                                            to be processed for
                                                                            veal. See Sec.
                                                                            558.311(d) of this
                                                                            chapter. Lasalocid
                                                                            as provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.

(xxiii) 25 to 700 to provide    Lasalocid, 30 to   Pasture cattle          Feed continuously on           054771
 350 mg/head/day.                600.               (slaughter, stocker,    a hand-fed basis at
                                                    feeder cattle, beef     a rate of 350 mg
                                                    replacement heifers)    chlortetracycline
                                                    under 700 pounds: For   and not less than 60
                                                    control of active       mg nor more than 300
                                                    infection of            mg lasalocid per
                                                    anaplasmosis caused     head per day in at
                                                    by A. marginale         least 1 pound of
                                                    susceptible to          feed. Daily
                                                    chlortetracycline;      lasalocid intakes in
                                                    and for increased       excess of 200 mg/
                                                    rate of weight gain.    head/day in pasture
                                                                            cattle have not been
                                                                            shown to be more
                                                                            effective than 200
                                                                            mg lasalocid/head/
                                                                            day. Do not allow
                                                                            horses or other
                                                                            equines access to
                                                                            feeds containing
                                                                            lasalocid. No
                                                                            withdrawal period is
                                                                            required. A
                                                                            withdrawal period
                                                                            has not been
                                                                            established for this
                                                                            product in pre-
                                                                            ruminating calves.
                                                                            Do not use in calves
                                                                            to be processed for
                                                                            veal. See Sec.
                                                                            558.311(d) of this
                                                                            chapter. Lasalocid
                                                                            as provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(xxiv) 25 to 2,800 to provide   Lasalocid, 30 to   Beef cattle weighing    Hand feed                      054771
 350 mg/head/day.                181.8.             up to 800 pounds: For   continuously at a
                                                    control of bacterial    rate of 350 mg
                                                    pneumonia associated    chlortetracycline
                                                    with shipping fever     and 1 mg lasalocid
                                                    complex caused by       per 2.2 lb. body
                                                    Pasteurella spp.        weight daily to
                                                    susceptible to          cattle with a
                                                    chlortetracycline;      maximum of 360 mg of
                                                    and for the control     lasalocid per head
                                                    of coccidiosis caused   per day. Do not
                                                    by E. bovis and E.      allow horses or
                                                    zuernii.                other equines access
                                                                            to feeds containing
                                                                            lasalocid. No
                                                                            withdrawal period is
                                                                            required. A
                                                                            withdrawal period
                                                                            has not been
                                                                            established for this
                                                                            product in pre-
                                                                            ruminating calves.
                                                                            Do not use in calves
                                                                            to be processed for
                                                                            veal. See Sec.
                                                                            558.311(d) of this
                                                                            chapter. Lasalocid
                                                                            as provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(xxv) 500 to 4,000 to provide   Lasalocid, 30 to   Cattle weighing up to   Hand feed                      054771
 350 mg/head/day.                181.8.             800 pounds: For the     continuously at a
                                                    treatment of            rate of 350 mg
                                                    bacterial enteritis     chlortetracycline
                                                    caused by E. coli and   and 1 mg lasalocid
                                                    bacterial pneumonia     per 2.2 lb. body
                                                    caused by P.            weight daily to
                                                    multocida susceptible   cattle with a
                                                    to chlortetracycline;   maximum of 360 mg of
                                                    and for the control     lasalocid per head
                                                    of coccidiosis caused   per day. Do not
                                                    by E. bovis and E.      allow horses or
                                                    zuernii.                other equines access
                                                                            to feeds containing
                                                                            lasalocid. No
                                                                            withdrawal period is
                                                                            required. A
                                                                            withdrawal period
                                                                            has not been
                                                                            established for this
                                                                            product in pre-
                                                                            ruminating calves.
                                                                            Do not use in calves
                                                                            to be processed for
                                                                            veal. See Sec.
                                                                            558.311(d) of this
                                                                            chapter. Lasalocid
                                                                            as provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
----------------------------------------------------------------------------------------------------------------

    (5) Minor species. It is used as follows:

----------------------------------------------------------------------------------------------------------------
     Chlortetracycline amount            Indications for use                Limitations               Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 80 mg/head/day................  Breeding sheep; reducing the   .............................          054771
                                     incidence of (vibrionic)                                             066104
                                     abortion caused by                                                   069254
                                     Campylobacter fetus
                                     infection susceptible to
                                     chlortetracycline.
(ii) 200 to 400 g/ton.............  Ducks: For the control and     Feed in complete ration to             054771
                                     treatment of fowl cholera      provide from 8 to 28 mg/lb
                                     caused by Pasteurella          of body weight per day,
                                     multocida susceptible to       depending upon age and
                                     chlortetracycline.             severity of disease, for not