[Federal Register Volume 86, Number 200 (Wednesday, October 20, 2021)]
[Rules and Regulations]
[Pages 57992-58016]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-22604]


=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 516, 520, 522, 526, 556 and 558

[Docket No. FDA-2021-N-0002]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

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

SUMMARY: The Food and Drug Administration (FDA or we) is amending the 
animal drug regulations to reflect application-related actions for new 
animal drug applications (NADAs), abbreviated new animal drug 
applications (ANADAs), and conditional new animal drug applications 
(cNADAs) during January, February, and March 2021. FDA is informing the 
public of the availability of summaries of the basis of approval and of 
environmental review documents, where applicable. The animal drug 
regulations are also being amended to improve the accuracy and 
readability of the regulations.

DATES: This rule is effective October 20, 2021.

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

SUPPLEMENTARY INFORMATION: 

I. Approvals

    FDA is amending the animal drug regulations to reflect approval 
actions for NADAs, ANADAs, and conditional approval actions for cNADAs 
during January, February, and March 2021, as listed in table 1. In 
addition, FDA is informing the public of the availability, where 
applicable, of documentation of environmental review required under the 
National Environmental Policy Act (NEPA) and, for actions requiring 
review of safety or effectiveness data, summaries of the basis of 
approval (FOI Summaries) under the Freedom of Information Act (FOIA). 
These public documents may be seen in the office of the Dockets 
Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday 
through Friday, 240-402-7500. Persons with access to the internet may 
obtain these documents at the CVM FOIA Electronic Reading Room: https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room. Marketing exclusivity and patent information may be 
accessed in FDA's publication, Approved Animal Drug Products Online 
(Green Book) at: https://www.fda.gov/animal-veterinary/products/approved-animal-drug-products-green-book.
    FDA has verified the website addresses as of the date this document 
publishes in the Federal Register, but websites are subject to change 
over time.

                          Table 1--Original and Supplemental NADAs and ANADAs Approved During January, February, and March 2021
--------------------------------------------------------------------------------------------------------------------------------------------------------
        Approval date           File No.         Sponsor              Product name            Species        Effect of the action     Public documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
January 8, 2021..............    141-336  ECO LLC, 344 Nassau    AIVLOSIN (62.5% w/w    Swine..............  Supplemental          FOI Summary.
                                           St., Princeton, NJ     tylvalosin as                               approval for the
                                           08540.                 tylvalosin tartrate)                        addition of
                                                                  Water Soluble                               Mycoplasma
                                                                  Granules.                                   hyopneumoniae to
                                                                                                              the list of
                                                                                                              pathogens for the
                                                                                                              control of swine
                                                                                                              respiratory disease
                                                                                                              indication.
January 11, 2021.............    141-526  Anivive Lifesciences,  LAVERDIA-CA1           Dogs...............  Conditional approval  FOI Summary.
                                           Inc., 3250 Airflite    (verdinexor tablets).                       for the treatment
                                           Way, Suite 400, Long                                               of lymphoma in dogs.
                                           Beach, CA 90807.
January 12, 2021.............    200-675  Huvepharma EOOD, 5th   Ractopamine            Cattle.............  Original approval as  FOI Summary.
                                           Floor, 3A Nikolay      hydrochloride and                           a generic copy of
                                           Haytov Str., 1113      monensin Type B and                         NADA 141-225.
                                           Sofia, Bulgaria.       Type C medicated
                                                                  feeds.
January 12, 2021.............    200-676  Do...................  Ractopamine            Cattle.............  Original approval as  FOI Summary.
                                                                  hydrochloride,                              a generic copy of
                                                                  monensin, and                               NADA 141-224.
                                                                  tylosin phosphate
                                                                  Type B and Type C
                                                                  medicated feeds.

[[Page 57993]]

 
January 12, 2021.............    200-677  Do...................  Ractopamine            Cattle.............  Original approval as  FOI Summary.
                                                                  hydrochloride,                              a generic copy of
                                                                  monensin, and                               NADA 141-234.
                                                                  melengestrol acetate
                                                                  Type C medicated
                                                                  feeds.
January 12, 2021.............    200-678  Do...................  Ractopamine            Cattle.............  Original approval as  FOI Summary.
                                                                  hydrochloride,                              a generic copy of
                                                                  monensin, tylosin                           NADA 141-233.
                                                                  phosphate, and
                                                                  melengestrol acetate
                                                                  Type C medicated
                                                                  feeds.
January 14, 2021.............    141-544  Pegasus Laboratories,  KBROVET-CA1            Dogs...............  Conditional approval  FOI Summary.
                                           Inc., 8809 Ely Rd.,    (potassium bromide                          for the control of
                                           Pensacola, FL 32514.   chewable tablets)                           seizures associated
                                                                  Chewable Tablet.                            with idiopathic
                                                                                                              epilepsy in dogs.
January 15, 2021.............    141-539  Neogen Corp., 944      THYROKARE              Dogs...............  Original approval     FOI Summary.
                                           Nandino Blvd.,         (levothyroxine                              for replacement
                                           Lexington, KY 40511.   sodium tablets).                            therapy for
                                                                                                              diminished thyroid
                                                                                                              function in dogs.
February 1, 2021.............    200-683  Huvepharma EOOD, 5th   Melengestrol acetate   Cattle.............  Original approval as  FOI Summary.
                                           Floor, 3A Nikolay      and monensin Type C                         a generic copy of
                                           Haytov Str., 1113      medicated feeds.                            NADA 125-476.
                                           Sofia, Bulgaria.
February 1, 2021.............    200-684  Do...................  Ractopamine            Cattle.............  Original approval as  FOI Summary.
                                                                  hydrochloride,                              a generic copy of
                                                                  monensin, and                               NADA 141-234.
                                                                  melengestrol acetate
                                                                  Type C medicated
                                                                  feeds.
February 1, 2021.............    200-685  Do...................  Melengestrol acetate,  Cattle.............  Original approval as  FOI Summary.
                                                                  monensin, and                               a generic copy of
                                                                  tylosin phosphate                           NADA 138-870.
                                                                  Type C medicated
                                                                  feeds.
February 1, 2021.............    200-686  Do...................  Monensin, ractopamine  Cattle.............  Original approval as  FOI Summary.
                                                                  hydrochloride,                              a generic copy of
                                                                  tylosin phosphate,                          NADA 141-233.
                                                                  and melengestrol
                                                                  acetate Type C
                                                                  medicated feeds.
February 8, 2021.............    200-466  Sparhawk               SPARMECTIN Plus        Cattle.............  Supplemental          FOI Summary.
                                           Laboratories, Inc.,    Clorsulon                                   approval reducing
                                           12340 Santa Fe Trail   (ivermectin and                             preslaughter
                                           Dr., Lenexa, KS        clorsulon) Injection.                       withdrawal period
                                           66215.                                                             to 21 days.
February 16, 2021............    200-506  Chanelle               ANIMEC PLUS            Cattle.............  Original approval as  FOI Summary.
                                           Pharmaceuticals        (ivermectin and                             a generic copy of
                                           Manufacturing Ltd.,    clorsulon) Injection.                       NADA 140-833.
                                           Loughrea, County
                                           Galway, Ireland.
February 18, 2021............    200-657  Bimeda Animal Health   MACROSYN               Cattle.............  Original approval as  FOI Summary.
                                           Ltd., 1B The Herbert   (tulathromycin                              a generic copy of
                                           Building, The Park,    injection)                                  NADA 141-244.
                                           Carrickmines, Dublin   Injectable Solution.
                                           18, Ireland.
February 18, 2021............    200-666  Elanco US Inc., 2500   INCREXXA               Cattle.............  Original approval as  FOI Summary.
                                           Innovation Way,        (tulathromycin                              a generic copy of
                                           Greenfield, IN 46140.  injection)                                  NADA 141-244.
                                                                  Injectable Solution.
February 26, 2021............    141-540  Pharmgate, Inc., 1800  PENNITRACIN MD         Turkeys............  Original approval     FOI Summary.
                                           Sir Tyler Dr.,         (bacitracin Type A                          for the prevention
                                           Wilmington, NC 28405.  medicated article)                          of coccidiosis
                                                                  and COBAN (monensin                         caused by Eimeria
                                                                  Type A medicated                            adenoeides, E.
                                                                  article) to be used                         meleagrimitis and
                                                                  in the manufacture                          E. gallopavonis,
                                                                  of Type C medicated                         and for increased
                                                                  feeds.                                      rate of weight gain
                                                                                                              and improved feed
                                                                                                              efficiency in
                                                                                                              growing turkeys.
March 11, 2021...............    200-699  Akorn Animal Health,   Dexmedetomidine        Dogs and cats......  Original approval as  FOI Summary.
                                           Inc., 1925 West        Hydrochloride                               a generic copy of
                                           Field Ct., Suite       Injection                                   NADA 141-267.
                                           300, Lake Forest, IL   (dexmedetomidine
                                           60045.                 hydrochloride).

[[Page 57994]]

 
March 15, 2021...............    141-530  Zoetis Inc., 333       MGA (melengestrol      Cattle.............  Original approval     FOI Summary.
                                           Portage St.,           acetate Type A                              for increased rate
                                           Kalamazoo, MI 49007.   medicated article)                          of weight gain,
                                                                  and AUREOMYCIN                              improved feed
                                                                  (chlortetracycline                          efficiency, and
                                                                  Type A medicated                            suppression of
                                                                  article) to be used                         estrus (heat) in
                                                                  in the manufacture                          replacement dairy
                                                                  of Type C medicated                         and beef heifers,
                                                                  feeds.                                      or growing beef
                                                                                                              heifers fed in
                                                                                                              confinement for
                                                                                                              slaughter receiving
                                                                                                              medicated feed
                                                                                                              containing
                                                                                                              chlortetracycline
                                                                                                              for the treatment
                                                                                                              of bacterial
                                                                                                              enteritis or
                                                                                                              pneumonia, control
                                                                                                              of bacterial
                                                                                                              pneumonia
                                                                                                              associated with
                                                                                                              shipping fever
                                                                                                              complex, reduction
                                                                                                              of incidence of
                                                                                                              liver abscesses,
                                                                                                              and control of
                                                                                                              active infection of
                                                                                                              anaplasmosis.
March 19, 2021...............    141-531  Do...................  MGA (melengestrol      Cattle.............  Original approval     FOI Summary.
                                                                  acetate Type A                              for suppression of
                                                                  medicated article),                         estrus (heat) in
                                                                  AUREOMYCIN                                  replacement dairy
                                                                  (chlortetracycline                          and beef heifers,
                                                                  Type A medicated                            or growing beef
                                                                  article), and                               heifers fed in
                                                                  BOVATEC (lasalocid                          confinement for
                                                                  Type A medicated                            slaughter receiving
                                                                  article) to be used                         medicated feed
                                                                  in the manufacture                          containing
                                                                  of Type C medicated                         chlortetracycline
                                                                  feeds.                                      for the treatment
                                                                                                              of bacterial
                                                                                                              enteritis or
                                                                                                              pneumonia, control
                                                                                                              of bacterial
                                                                                                              pneumonia
                                                                                                              associated with
                                                                                                              shipping fever
                                                                                                              complex, or control
                                                                                                              of active infection
                                                                                                              of anaplasmosis;
                                                                                                              and lasalocid for
                                                                                                              control of
                                                                                                              coccidiosis,
                                                                                                              increased rate of
                                                                                                              weight gain, and
                                                                                                              improved feed
                                                                                                              efficiency.
March 22, 2021...............    200-625  Bimeda Animal Health   KETOMED (ketoprofen)   Horses.............  Original approval as  FOI Summary.
                                           Ltd., 1B The Herbert   Sterile Solution.                           a generic copy of
                                           Building, The Park,                                                NADA 140-269.
                                           Carrickmines, Dublin
                                           18, Ireland.
March 24, 2021...............    132-872  Intervet, Inc., 2      SAFE-GUARD             Cattle.............  Supplemental          FOI Summary.
                                           Giralda Farms,         (fenbendazole) Paste                        approval providing
                                           Madison, NJ 07940.     10%.                                        for tolerances, a
                                                                                                              tissue withdrawal
                                                                                                              period, and a milk
                                                                                                              discard time in
                                                                                                              accordance with a
                                                                                                              repartitioning of
                                                                                                              the acceptable
                                                                                                              daily intake; and
                                                                                                              the addition of
                                                                                                              indications for
                                                                                                              fourth[dash]stage
                                                                                                              larvae of certain
                                                                                                              endoparasites.
--------------------------------------------------------------------------------------------------------------------------------------------------------

II. Changes of Sponsor

    The sponsors of the following approved applications have informed 
FDA that they have transferred ownership of, and all rights and 
interest in, these applications to another sponsor:

----------------------------------------------------------------------------------------------------------------
         File No.              Product name      Transferring sponsor       New sponsor         21 CFR section
----------------------------------------------------------------------------------------------------------------
141-175..................  CAPSTAR (nitenpyram)  Elanco US Inc., 2500  Sergeant's Pet Care   520.1510.
                            Tablets.              Innovation Way,       Products, Inc.,
                                                  Greenfield, IN        10077 S 134th St.,
                                                  46140.                Omaha, NE 68138.
141-120..................  CLOMICALM             Do..................  Virbac AH, Inc.,      520.455.
                            (clomipramine                               P.O. Box 162059,
                            hydrochloride)                              Fort Worth, TX
                            Tablets.                                    76161.
141-474..................  ITRAFUNGOL            Do..................  Do..................  520.1189.
                            (itraconazole oral
                            solution).
065-081..................  GO-DRY (penicillin G  G. C. Hanford Mfg.    HQ Specialty Pharma   526.1696.
                            procaine)             Co., P.O. Box 1017,   Corp., 120 Rte. 17
                            Intramammary          Syracuse, NY 13201.   North, Suite 130,
                            Infusion.                                   Paramus, NJ 07652.
200-335..................  Ampicillin Sodium     Do..................  Do..................  522.90c.
                            Powder for
                            Injection.
200-372..................  HAN-PEN (penicillin   Do..................  Do..................  520.1696a.
                            G potassium)
                            Soluble Powder.
065-071..................  Chlortetracycline     Huvepharma EOOD, 5th  Pharmgate Inc., 1800  520.441.
                            (chlortetracycline    Floor, 3A Nikolay     Sir Tyler Dr.,
                            hydrochloride)        Haytov Str., 1113     Wilmington, NC
                            Soluble Powder.       Sofia, Bulgaria.      28405.
065-440..................  CHLORONEX             Do..................  Do..................  Do.
                            (chlortetracycline
                            hydrochloride)
                            Soluble Powder.
200-441..................  A[dash]MYCIN          Do..................  Do..................  Do.
                            (chlortetracycline
                            hydrochloride)
                            Soluble Powder.
200-528..................  SAVALAN 60            Pharmgate Inc., 1800  Huvepharma EOOD, 5th  558.550.
                            (salinomycin          Sir Tyler Dr.,        Floor, 3A Nikolay
                            sodium) Type A        Wilmington, NC        Haytov Str., 1113
                            medicated article.    28405.                Sofia, Bulgaria.

[[Page 57995]]

 
200-237..................  Isoflurane, U.S.P...  Piramal Enterprises   Piramal Pharma Ltd.,  N/A.
                                                  Ltd., Ananta,         Ground Floor,
                                                  Agastya Corporate     Piramal Ananta,
                                                  Park, Opp Fire        Agastya Corporate
                                                  Brigade, Kamani       Park, Mumbai,
                                                  Junction, LBS Mag     Maharashtra,
                                                  Kurla (West),         400070, India.
                                                  Mumbai, 400070,
                                                  India.
----------------------------------------------------------------------------------------------------------------

    Following these changes of sponsorship, G. C. Hanford Manufacturing 
Co. and Piramal Enterprises Ltd. are no longer the sponsor of an 
approved application. Accordingly, the regulations in 21 CFR 510.600(c) 
are being amended to reflect these changes.

III. Technical Amendments

    FDA is making the following amendments to improve the accuracy, 
consistency, and readability of the animal drug regulations:
     21 CFR 510.600 is amended by revising the entries for 
Cronus Pharma Specialities India Private Ltd. to reflect the correct 
address for the firm.
     21 CFR 520.2090 is amended to reflect the current approved 
indications for use for sarolaner, moxidectin, and pyrantel tablets.
     21 CFR 522.970 is amended to reflect the approved species 
for a flunixin injectable solution.
     21 CFR 558.76 for use of bacitracin methylenedisalicylate 
in medicated feed is amended to reflect a current tabular format 
organized by species.
     21 CFR 558.128 is amended to reflect sponsors of 
combination medicated feeds containing chlortetracycline for which 
there is no preslaughter withdrawal period.
     21 CFR 558.355 for use of monensin in medicated feeds is 
amended to reflect the sponsor of an approved generic product and to 
remove a redundant condition of use.

IV. Legal Authority

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

List of Subjects

21 CFR Part 510

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

21 CFR Part 516

    Administrative practice and procedure, Animal drugs, Confidential 
business information, Reporting and recordkeeping requirements.

21 CFR Parts 520, 522, and 526

    Animal drugs.

21 CFR Part 556

    Animal drugs, Food.

21 CFR Part 558

    Animal drugs, Animal feeds.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, 21 CFR 
parts 510, 516, 520, 522, 526, 556, and 558 are amended as follows:

PART 510--NEW ANIMAL DRUGS

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

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


0
2. In Sec.  510.600:
0
a. In the table in paragraph (c)(1):
0
i. Add in alphabetical order an entry for ``Anivive Lifesciences, 
Inc.'';
0
ii. Revise the entry for ``Cronus Pharma Specialities India Private 
Ltd.'';
0
iii. Remove the entries for ``G. C. Hanford Manufacturing Co.'' and 
``Piramal Enterprises Ltd.''; and
0
iv. Add in alphabetical order an entry for ``Piramal Pharma Ltd.''; and
0
b. In the table in paragraph (c)(2):
0
i. Remove the entry for ``010515'';
0
ii. Revise the entries for ``065085'' and ``069043''; and
0
iii. Add in numerical order an entry for ``086121''.
    The revisions and additions read as follows:


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

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

------------------------------------------------------------------------
                                                           Drug labeler
                  Firm name and address                        code
------------------------------------------------------------------------
 
                              * * * * * * *
Anivive Lifesciences, Inc., 3250 Airflite Way, Suite              086121
 400, Long Beach, CA 90807..............................
 
                              * * * * * * *
Cronus Pharma Specialities India Private Ltd., Sy No-99/          069043
 1, M/s GMR Hyderabad Aviation SEZ Ltd., Mamidipalli
 Village, Shamshabad Mandal, Ranga Reddy, Hyderabad,
 Telangana, 501218, India...............................
 
                              * * * * * * *
Piramal Pharma Ltd., Ground Floor, Piramal Ananta,                065085
 Agastya Corporate Park, Mumbai, Maharashtra, 400070,
 India..................................................
 
 

[[Page 57996]]

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

    (2) * * *

------------------------------------------------------------------------
    Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                              * * * * * * *
065085..................  Piramal Pharma Ltd., Ground Floor, Piramal
                           Ananta, Agastya Corporate Park, Mumbai,
                           Maharashtra, 400070, India
 
                              * * * * * * *
069043..................  Cronus Pharma Specialities India Private Ltd.,
                           Sy No-99/1, M/s GMR Hyderabad Aviation SEZ
                           Ltd., Mamidipalli Village, Shamshabad Mandal,
                           Ranga Reddy, Hyderabad, Telangana, 501218,
                           India
 
                              * * * * * * *
086121..................  Anivive Lifesciences, Inc., 3250 Airflite Way,
                           Suite 400, Long Beach, CA 90807
 
                              * * * * * * *
------------------------------------------------------------------------

PART 516--NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES

0
3. The authority citation for part 516 continues to read as follows:

    Authority:  21 U.S.C. 360ccc, 360ccc-2, 371.


0
4. Add Sec.  516.1858 to subpart E to read as follows:


Sec.  516.1858  Potassium bromide.

    (a) Specifications. Each chewable tablet contains 250 or 500 
milligrams (mg) potassium bromide.
    (b) Sponsor. See No. 055246 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer 25 to 68 mg per 
kilogram (11 to 31 mg per pound) of body weight once daily. The dosage 
can be divided and should be adjusted to clinical response.
    (2) Indications for use. For the control of seizures associated 
with idiopathic epilepsy in dogs.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian. It is a violation of Federal law 
to use this product other than as directed in the labeling.

0
5. Add Sec.  516.2980 to subpart E to read as follows:


Sec.  516.2980  Verdinexor.

    (a) Specifications. Each tablet contains 2.5, 10, or 50 milligrams 
(mg) verdinexor.
    (b) Sponsor. See No. 086121 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer verdinexor tablets 
orally at an initial dose of 1.25 mg per kilogram (mg/kg) of body 
weight twice per week with at least 72 hours between doses. If 
tolerated after 2 weeks, increase the dose to 1.5 mg/kg twice per week 
with at least 72 hours between doses.
    (2) Indications for use. For the treatment of lymphoma in dogs.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian. It is a violation of Federal law 
to use this product other than as directed in the labeling.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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


0
7. In Sec.  520.441, revise paragraph (b)(1) to read as follows:


Sec.  520.441  Chlortetracycline powder.

* * * * *
    (b) * * *
    (1) Nos. 000010, 054771, and 069254 for use as in paragraph (d) of 
this section.
* * * * *

0
8. In Sec.  520.455, revise the section heading and paragraph (b) to 
read as follows:


Sec.  520. 455  Clomipramine.

* * * * *
    (b) Sponsors. See Nos. 051311 and 086039 in Sec.  510.600(c) of 
this chapter.
* * * * *

0
9. In Sec.  520.905c, revise paragraph (e)(2) to read as follows:


Sec.  520.905c  Fenbendazole paste.

* * * * *
    (e) * * *
    (2) Beef and dairy cattle--(i) Amount. Administer orally 2.3 mg/lb 
(5 mg/kg) body weight.
    (ii) Indications for use. For the treatment and control of: 
Lungworms: Adult (Dictyocaulus viviparus); Stomach worms: Adult brown 
stomach worms (Ostertagia ostertagi), adult and fourth-stage larvae 
barberpole worms (Haemonchus contortus), fourth-stage larvae barberpole 
worms (H. placei), and adult and fourth-stage larvae small stomach 
worms (Trichostrongylus axei); Intestinal worms (adult and fourth-stage 
larvae): Hookworms (Bunostomum phlebotomum), thread-necked intestinal 
worms (Nematodirus helvetianus), small intestinal worms (Cooperia 
punctata and C. oncophora), bankrupt worms (Trichostrongylus 
colubriformis), and nodular worms (Oesophagostomum radiatum).
    (iii) Limitations. Milk taken during treatment and for 96 hours 
after the last treatment must not be used for human consumption. Cattle 
must not be slaughtered for human consumption within 8 days following 
last treatment with this drug product. Not for use in beef calves less 
than 2 months of age, dairy calves, and veal calves. A withdrawal 
period has not been established for this product in preruminating 
calves.

0
10. In Sec.  520.1189, revise paragraph (b) to read as follows:


Sec.  520.1189  Itraconazole.

* * * * *
    (b) Sponsor. See No. 051311 in Sec.  510.600(c) of this chapter.
* * * * *

0
11. In Sec.  520.1248, revise paragraphs (b) and (c)(1) to read as 
follows:


Sec.  520.1248  Levothyroxine.

* * * * *

[[Page 57997]]

    (b) Sponsors. See Nos. 059051 and 061690 in Sec.  510.600(c) of 
this chapter.
    (c) * * *
    (1) Amount. Administer by mouth as follows:
    (i) No. 061690: 0.1 mg/10 pounds (lb) body weight (0.022 mg/
kilogram (kg)) as a single dose every 24 hours or as a divided dose 
every 12 hours.
    (ii) No. 059051: 0.1 mg/10 lb (0.01 mg/lb, 0.022 mg/kg) body weight 
twice daily.
* * * * *

0
12. In Sec.  520.1510, revise paragraph (b)(1) to read as follows:


Sec.  520. 1510  Nitenpyram.

* * * * *
    (b) * * *
    (1) No. 021091 for use as in paragraphs (d)(1)(i)(A), 
(d)(1)(ii)(A), and (d)(2) of this section.
* * * * *

0
13. In Sec.  520.1696a, revise paragraph (b) to read as follows:


Sec.  520.1696a   Penicillin G powder.

* * * * *
    (b) Sponsors. See Nos. 016592, 042791, 054771, 061133, and 076475 
in Sec.  510.600(c) of this chapter.
* * * * *

0
14. In Sec.  520.2090, revise paragraph (c)(2) to read as follows:


Sec.  520.2090   Sarolaner, moxidectin, and pyrantel.

* * * * *
    (c) * * *
    (2) Indications for use. For the prevention of heartworm disease 
caused by Dirofilaria immitis and for the treatment and control of 
roundworm (immature adult and adult Toxocara canis and adult Toxascaris 
leonina) and adult hookworm (Ancylostoma caninum and Uncinaria 
stenocephala) infections. Kills adult fleas (Ctenocephalides felis) and 
is indicated for the treatment and prevention of flea infestations, and 
the treatment and control of tick infestations with Amblyomma 
americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), 
Dermacentor variabilis (American dog tick), Ixodes scapularis (black-
legged tick), and Rhipicephalus sanguineus (brown dog tick) for 1 month 
in dogs and puppies 8 weeks of age and older, and weighing 2.8 pounds 
or greater.
* * * * *

0
15. In Sec.  520.2645, revise paragraph (d)(2) to read as follows:


Sec.  520.2645   Tylvalosin.

* * * * *
    (d) * * *
    (2) Indications for use. For control of porcine proliferative 
enteropathy (PPE) associated with Lawsonia intracellularis infection in 
groups of swine intended for slaughter in buildings experiencing an 
outbreak of PPE; and for control of swine respiratory disease (SRD) 
associated with Bordetella bronchiseptica, Haemophilus parasuis, 
Pasteurella multocida, Streptococcus suis, and Mycoplasma hyopneumoniae 
in groups of swine intended for slaughter in buildings experiencing an 
outbreak of SRD.
* * * * *

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

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

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


0
17. In Sec.  522.90c, revise paragraph (b) to read as follows:


Sec.  522.90c   Ampicillin sodium.

* * * * *
    (b) See Nos. 042791 and 054771 in Sec.  510.600(c) of this chapter.
* * * * *

0
18. In Sec.  522.558, revise paragraphs (b)(1) and to read as follows:


Sec.  522.558   Dexmedetomidine.

* * * * *
    (b) * * *
    (1) Nos. 026637 and 059399 for use of product described in 
paragraph (a)(2) of this section.
* * * * *

0
19. In Sec.  522.970, revise paragraph (b)(1) and add paragraph (b)(3) 
to read as follows:


Sec.  522.970   Flunixin.

* * * * *
    (b) * * *
    (1) See Nos. 000061, 055529, 058198, and 061133 for use as in 
paragraph (e) of this section.
* * * * *
    (3) See No. 016592 for use as in paragraphs (e)(1) and (e)(2) of 
this section.
* * * * *

0
20. In Sec.  522.1193, revise paragraphs (b) and (e)(2) and (3) to read 
as follows:


Sec.  522.1193   Ivermectin and clorsulon.

* * * * *
    (b) Sponsors. See Nos. 000010, 055529, 058005, 061133, and 061651 
in Sec.  510.600(c) of this chapter.
* * * * *
    (e) * * *
    (2) Indications for use. For the treatment and control of 
gastrointestinal nematodes (adults and fourth-stage larvae) (Haemonchus 
placei, Ostertagia ostertagi (including inhibited larvae), O. lyrata, 
Trichostrongylus axei, T. colubriformis, Cooperia oncophora, C. 
punctata, C. pectinata, Oesophagostomum radiatum, Nematodirus 
helvetianus (adults only), N. spathiger (adults only), Bunostomum 
phlebotomum; lungworms (adults and fourth-stage larvae) (Dictyocaulus 
viviparus); liver flukes (adults only) (Fasciola hepatica); cattle 
grubs (parasitic stages) (Hypoderma bovis, H. lineatum); sucking lice 
(Linognathus vituli, Haematopinus eurysternus, Solenopotes capillatus); 
mange mites (cattle scab) (Psoroptes ovis (syn. P. communis var. 
bovis), Sarcoptes scabiei var. bovis); and for control of infections of 
D. viviparus and O. radiatum for 28 days after treatment; O. ostertagi, 
T. axei, and C. punctata for 21 days after treatment; and H. placei and 
C. oncophora for 14 days after treatment.
    (3) Limitations. Do not treat cattle within 21 days of slaughter. 
Because a withdrawal time in milk has not been established, do not use 
in female dairy cattle of breeding age. A withdrawal period has not 
been established for this product in preruminating calves. Do not use 
in calves to be processed for veal.

0
21. In Sec.  522.1225, revise paragraph (b) to read as follows:


Sec.  522.1225   Ketoprofen.

* * * * *
    (b) Sponsors. See Nos. 054771 and 061133 in Sec.  510.600(c) of 
this chapter.
* * * * *

0
22. In Sec.  522.1696a, revise paragraph (d)(2)(iii) to read as 
follows:


Sec.  522.1696a   Penicillin G benzathine and penicillin G procaine 
suspension.

* * * * *
    (d) * * *
    (2) * * *
    (iii) Limitations. Not for use within 30 days of slaughter. For No. 
016592: A withdrawal period has not been established for this product 
in pre-ruminating calves. Do not use in calves to be processed for 
veal.

0
23. In Sec.  522.2630, revise paragraphs (b) and (d)(1)(iii)(A) to read 
as follows:


Sec.  522.2630   Tulathromycin.

* * * * *
    (b) Sponsors. See sponsor numbers in Sec.  510.600(c) of this 
chapter.
    (1) Nos. 054771, 058198, and 061133 for use of product described in 
paragraph (a)(1) as in paragraphs (d)(1)(i), (d)(1)(ii), 
(d)(1)(iii)(A), and (d)(2) of this section.
    (2) No. 054771 for use of product described in paragraph (a)(2) as 
in

[[Page 57998]]

paragraphs (d)(1)(i), (d)(1)(ii)(B), (d)(1)(iii)(B), and (d)(2) of this 
section.
* * * * *
    (d) * * *
    (1) * * *
    (iii) * * *
    (A) Cattle intended for human consumption must not be slaughtered 
within 18 days from the last treatment. This drug is not approved for 
use in female dairy cattle 20 months of age or older, including dry 
dairy cows. Use in these cattle may cause drug residues in milk and/or 
in calves born to these cows. Federal law restricts this drug to use by 
or on the order of a licensed veterinarian.
* * * * *

PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS

0
24. The authority citation for part 526 continues to read as follows:

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


0
25. In Sec.  526.1696, revise paragraph (b) to read as follows:


Sec.  526.1696   Penicillin G procaine.

* * * * *
    (b) See Nos. 042791 and 061133 in Sec.  510.600(c) of this chapter.
* * * * *

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

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

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


0
27. In Sec.  556.275:
0
a. Revise paragraph (b)(1)(ii);
0
b. Remove paragraph (b)(1)(iii); and
0
c. Remove and reserve paragraphs (b)(3)(ii), (b)(4)(ii), and 
(b)(5)(ii).
    The revision reads as follows:


Sec.  556.275   Fenbendazole.

* * * * *
    (b) * * *
    (1) * * *
    (ii) Milk: 0.22 ppm fenbendazole sulfoxide (marker residue).
* * * * *

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

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

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


0
29. In Sec.  558.76:
0
a. Revise paragraphs (a)(1) and (2) and (d)(1);
0
b. Redesignate paragraph (d)(2) as paragraph (d)(6); and
0
c. Add new paragraph (d)(2) and paragraphs (d)(3) through (5).
    The revisions and additions read as follows:


Sec.  558.76   Bacitracin methylenedisalicylate.

    (a) * * *
    (1) Type A medicated articles containing feed grade bacitracin 
methylenedisalicylate equivalent to 10, 25, 30, 40, 50, 60, or 75 grams 
bacitracin per pound.
    (2) Type A medicated article containing feed grade bacitracin 
methylenedisalicylate equivalent to 50 grams bacitracin per pound.
* * * * *
    (d) * * *
    (1) Chickens--

------------------------------------------------------------------------
Bacitracin in grams per   Indications for
          ton                   use           Limitations      Sponsor
------------------------------------------------------------------------
(i) 4 to 50............  Broiler and       Feed                   054771
                          replacement       continuously as       069254
                          chickens: For     sole ration.
                          increased rate
                          of weight gain
                          and improved
                          feed efficiency.
(ii) 10 to 25..........  Laying hens: For  Feed                   054771
                          increased egg     continuously as
                          production and    sole ration for
                          improved feed     the first 7
                          efficiency.       months of egg
                                            production.
(iii) 50...............  Broiler and       Feed                   054771
                          replacement       continuously as
                          chickens: As an   sole ration.
                          aid in the
                          prevention of
                          necrotic
                          enteritis
                          caused or
                          complicated by
                          Clostridium
                          spp. or other
                          organisms
                          susceptible to
                          bacitracin.
(iv) 100 to 200........  Broiler and       Feed                   054771
                          replacement       continuously as
                          chickens: As an   sole ration.
                          aid in the        Start at first
                          control of        clinical signs
                          necrotic          of disease.
                          enteritis         Vary dosage
                          caused or         based on
                          complicated by    severity of
                          Clostridium       infection.
                          spp. or other     Administer
                          organisms         continuously
                          susceptible to    for 5 to 7 days
                          bacitracin.       or as long as
                                            clinical signs
                                            persist, then
                                            reduce
                                            medication to
                                            prevention
                                            level (50 grams/
                                            ton).
------------------------------------------------------------------------

    (2) Turkeys--

------------------------------------------------------------------------
Bacitracin in grams per   Indications for
          ton                   use           Limitations      Sponsor
------------------------------------------------------------------------
(i) 4 to 50............  Growing turkeys:  Feed                   054771
                          For increased     continuously as       069254
                          rate of weight    sole ration.
                          gain and
                          improved feed
                          efficiency.
(ii) 200...............  Growing turkeys:  Feed                   054771
                          As an aid in      continuously as
                          the control of    the sole ration.
                          transmissible
                          enteritis
                          complicated by
                          organisms
                          susceptible to
                          bacitracin
                          methylenedisali
                          cylate.
------------------------------------------------------------------------

    (3) Swine--

------------------------------------------------------------------------
Bacitracin in grams per   Indications for
          ton                   use           Limitations      Sponsor
------------------------------------------------------------------------
(i) 10 to 30...........  Growing and       ................       054771
                          finishing
                          swine: For
                          increased rate
                          of weight gain
                          and improved
                          feed efficiency.

[[Page 57999]]

 
(ii) 250...............  Growing and       Feed as the sole       054771
                          finishing         ration. Feed
                          swine: For        250 grams per
                          control of        ton of complete
                          swine dysentery   feed on
                          (bloody scours)   premises with a
                          associated with   history of
                          Brachyspira       swine
                          hyodysenteriae    dysentery, but
                          in pigs up to     where signs of
                          250 lbs body      the disease
                          weight.           have not yet
                                            occurred or
                                            following an
                                            approved
                                            treatment of
                                            the disease
                                            condition.
                                            Diagnosis
                                            should be
                                            confirmed by a
                                            veterinarian a
                                            when results
                                            are not
                                            satisfactory.
(iii) 250..............  Pregnant sows:    As the sole            054771
                          For control of    ration. Feed to
                          clostridial       sows from 14
                          enteritis         days before
                          caused by         through 21 days
                          Clostridium       after farrowing
                          perfringens in    on premises
                          suckling          with a history
                          piglets.          of clostridial
                                            scours.
                                            Diagnosis
                                            should be
                                            confirmed by a
                                            veterinarian
                                            when results
                                            are not
                                            satisfactory.
------------------------------------------------------------------------

    (4) Cattle--

------------------------------------------------------------------------
                          Indications for
   Bacitracin amount            use           Limitations      Sponsor
------------------------------------------------------------------------
(i) 70 mg per head per   Beef steers and   Administer             054771
 day.                     heifers fed in    continuously          069254
                          confinement for   throughout the
                          slaughter: For    feeding period.
                          reduction in
                          the number of
                          liver
                          condemnations
                          due to
                          abscesses.
(ii) 250 mg per head     Beef steers and   Administer             054771
 per day.                 heifers fed in    continuously          069254
                          confinement for   for 5 days then
                          slaughter: For    discontinue for
                          reduction in      subsequent 25
                          the number of     days, repeat
                          liver             the pattern
                          condemnations     during the
                          due to            feeding period.
                          abscesses.
------------------------------------------------------------------------

    (5) Game birds--

------------------------------------------------------------------------
Bacitracin in grams per   Indications for
          ton                   use           Limitations      Sponsor
------------------------------------------------------------------------
(i) 4 to 50............  Growing           Feed                   054771
                          pheasants: For    continuously as       069254
                          increased rate    sole ration.
                          of weight gain
                          and improved
                          feed efficiency.
(ii) 5 to 20...........  Growing quail:    Feed                   054771
                          For increased     continuously as       069254
                          rate of weight    sole ration to
                          gain and          quail not over
                          improved feed     5 weeks of age.
                          efficiency in
                          quail not over
                          5 weeks of age.
(iii) 200..............  Growing quail:    Feed                   054771
                          For the           continuously as
                          prevention of     the sole ration.
                          ulcerative
                          enteritis in
                          growing quail
                          due to
                          Clostridium
                          colinum
                          susceptible to
                          bacitracin
                          methylenedisali
                          cylate.
------------------------------------------------------------------------

* * * * *

0
30. In Sec.  558.128, revise paragraphs (d)(4) and (e)(4) to read as 
follows:


Sec.  558.128   Chlortetracycline.

* * * * *
    (d) * * *
    (4) Manufacture for use in free-choice feeds as in paragraph 
(e)(4)(vi) of this section must conform to Sec.  510.455 of this 
chapter.
* * * * *
    (e) * * *
    (4) * * *

----------------------------------------------------------------------------------------------------------------
                                                                    Indications for
    Chlortetracycline amount          Combination in grams/ton            use           Limitations     Sponsor
----------------------------------------------------------------------------------------------------------------
(i) to provide 70 mg/head/day...  ...............................  Growing cattle    Feed to provide      054771
                                                                    (over 400 lb):    chlortetracycli     066104
                                                                    For reduction     ne at the rate      069254
                                                                    of liver          of 70 mg per
                                                                    condemnation      animal daily. A
                                                                    due to liver      withdrawal
                                                                    abscesses.        period has not
                                                                                      been
                                                                                      established in
                                                                                      pre-ruminating
                                                                                      calves. Do not
                                                                                      use in calves
                                                                                      to be processed
                                                                                      for veal.
(ii) 5.83 to 14 g/ton to provide  Melengestrol acetate, 0.25 to 2  Growing beef      Melengestrol         054771
 70 mg/head/day.                   g/ton to provide 0.25 to 0.5     heifers fed in    acetate Type C
                                   mg melengestrol acetate per      confinement for   top-dress
                                   head per day.                    slaughter (over   medicated feed
                                                                    400 lb): For      must be top
                                                                    reduction of      dressed onto or
                                                                    the incidence     mixed at
                                                                    of liver          feeding with
                                                                    abscesses,        the Type C
                                                                    increased rate    medicated feed
                                                                    of weight gain,   containing 5.83
                                                                    improved feed     to 14 g/ton
                                                                    efficiency, and   chlortetracycli
                                                                    suppression of    ne.
                                                                    estrus (heat).    Chlortetracycli
                                                                                      ne and
                                                                                      melengestrol as
                                                                                      provided by No.
                                                                                      054771 in Sec.
                                                                                       510.600(c) of
                                                                                      this chapter.

[[Page 58000]]

 
(iii) to provide 0.5 mg/lb of     ...............................  Beef cattle       Feed to provide      054771
 body weight daily.                                                 (over 700 lb):    chlortetracycli     066104
                                                                    For control of    ne at the rate      069254
                                                                    active            of 0.5 mg per
                                                                    infection of      pound of body
                                                                    anaplasmosis      weight daily in
                                                                    caused by         beef cattle
                                                                    Anaplasma         under 700
                                                                    marginale         pounds.
                                                                    susceptible to    Withdraw 48
                                                                    chlortetracycli   hours prior to
                                                                    ne.               slaughter. To
                                                                                      sponsor Nos.
                                                                                      054771 and
                                                                                      069254: Zero
                                                                                      withdrawal time.
(iv) 33.33 to 50 g/ton to         Melengestrol acetate, 0.5 to 2   Replacement beef  Melengestrol         054771
 provide 0.5 mg/lb of body         g/ton to provide 0.5 mg          heifers over      acetate Type C
 weight per day.                   melengestrol acetate per head    700 lb: For       top-dress
                                   per day.                         control of        medicated feed
                                                                    active            must be top
                                                                    infection of      dressed onto or
                                                                    anaplasmosis      mixed at
                                                                    caused by         feeding with a
                                                                    Anaplasma         Type C
                                                                    marginale         medicated feed
                                                                    susceptible to    containing
                                                                    chlortetracycli   33.33 to 50 g/
                                                                    ne and for        ton
                                                                    suppression of    chlortetracycli
                                                                    estrus (heat).    ne. Feeding a
                                                                                      Type C top-
                                                                                      dress medicated
                                                                                      feed containing
                                                                                      melengestrol
                                                                                      acetate shall
                                                                                      not exceed 24
                                                                                      days.
                                                                                      Chlortetracycli
                                                                                      ne and
                                                                                      melengestrol as
                                                                                      provided by No.
                                                                                      054771 in Sec.
                                                                                       510.600(c) of
                                                                                      this chapter.
(v) 25 to 1,100 g/ton to provide  Lasalocid, 30 to 600...........  Pasture cattle    Feed                 054771
 0.5 mg/lb of body weight daily.                                    (slaughter,       continuously on     069254
                                                                    stocker, feeder   a hand-fed
                                                                    cattle, beef      basis 0.5 mg
                                                                    replacement       chlortetracycli
                                                                    heifers) over     ne per lb. body
                                                                    700 pounds: For   weight per day
                                                                    control of        and not less
                                                                    active            than 60 mg or
                                                                    infection of      more than 300
                                                                    anaplasmosis      mg lasalocid
                                                                    caused by         per head daily
                                                                    Anaplasma         in at least 1
                                                                    marginale         pound of feed.
                                                                    susceptible to    Daily lasalocid
                                                                    chlortetracycli   intakes in
                                                                    ne; and for       excess of 200
                                                                    increased rate    mg/head/day in
                                                                    of weight gain.   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.
(vi) 25 to 1,100 g/ton to         Lasalocid, 30 to 600;            Replacement beef  The melengestrol     054771
 provide 0.5 mg/lb of body         melengestrol acetate, 0.5 to 2   heifers on        acetate Type C
 weight daily.                     g/ton to provide 0.5 mg/head/    pasture over      top-dress
                                   day melengestrol acetate.        700 pounds: For   medicated feed
                                                                    control of        must be top
                                                                    active            dressed onto or
                                                                    infection of      mixed at
                                                                    anaplasmosis      feeding with a
                                                                    caused by         Type C
                                                                    Anaplasma         medicated feed
                                                                    marginale         containing 25
                                                                    susceptible to    to 1,100 g/ton
                                                                    chlortetracycli   of
                                                                    ne, increased     chlortetracycli
                                                                    rate of weight    ne and 30 to
                                                                    gain, and         600 g/ton
                                                                    suppression of    lasalocid to
                                                                    estrus (heat).    provide 0.5 mg
                                                                                      chlortetracycli
                                                                                      ne per lb body
                                                                                      weight per day
                                                                                      and not less
                                                                                      than 60 mg or
                                                                                      more than 300
                                                                                      mg lasalocid
                                                                                      per head per
                                                                                      day in at least
                                                                                      1 pound of
                                                                                      feed. Do not
                                                                                      exceed 24 days
                                                                                      of feeding. See
                                                                                      Sec.
                                                                                      558.311(d) of
                                                                                      this chapter.
                                                                                      Chlortetracycli
                                                                                      ne, lasalocid,
                                                                                      and
                                                                                      melengestrol as
                                                                                      provided by No.
                                                                                      054771 in Sec.
                                                                                       510.600(c) of
                                                                                      this chapter.
(vii) to provide 0.5 to 2.0 mg/   ...............................  Beef cattle and   In free-choice       054771
 lb of body weight daily.                                           nonlactating      cattle feeds        069254
                                                                    dairy cattle:     such as feed
                                                                    As an aid in      blocks or salt-
                                                                    the control of    mineral mixes
                                                                    active            manufactured
                                                                    infection of      from approved
                                                                    anaplasmosis      Type A
                                                                    caused by         articles. See
                                                                    Anaplasma         paragraph
                                                                    marginale         (d)(4) of this
                                                                    susceptible to    section.
                                                                    chlortetracycli
                                                                    ne.

[[Page 58001]]

 
(viii) to provide 10 mg/lb of     ...............................  Calves, beef and  Feed                 054771
 body weight daily.                                                 nonlactating      approximately       066104
                                                                    dairy cattle:     400 g/ton,          069254
                                                                    For treatment     varying with
                                                                    of bacterial      body weight and
                                                                    enteritis         feed
                                                                    caused by         consumption to
                                                                    Escherichia       provide 10 mg/
                                                                    coli and          lb per day.
                                                                    bacterial         Treat for not
                                                                    pneumonia         more than 5
                                                                    caused by         days. To
                                                                    Pasteurella       sponsor No.
                                                                    multocida         054771 (NADAs
                                                                    organisms         048-761 and 046-
                                                                    susceptible to    699) and to
                                                                    chlortetracycli   sponsor No.
                                                                    ne.               069254 (ANADA
                                                                                      200-510): May
                                                                                      be mixed in the
                                                                                      cattle's daily
                                                                                      ration or
                                                                                      administered as
                                                                                      a top-dress. In
                                                                                      feed including
                                                                                      milk replacers
                                                                                      withdraw 10
                                                                                      days prior to
                                                                                      slaughter. To
                                                                                      sponsor Nos.
                                                                                      054771 and
                                                                                      069254: Zero
                                                                                      withdrawal
                                                                                      time. See
                                                                                      paragraph
                                                                                      (d)(3) of this
                                                                                      section.
(ix) to provide 10 mg/lb of body  ...............................  Calves (up to     A withdrawal         054771
 weight daily.                                                      250 lb): For      period has not      066104
                                                                    the treatment     been                069254
                                                                    of bacterial      established for
                                                                    enteritis         this product in
                                                                    caused by         pre-ruminating
                                                                    Escherichia       calves. Do not
                                                                    coli              use in calves
                                                                    susceptible to    to be processed
                                                                    chlortetracycli   for veal.
                                                                    ne.
(x) to provide 10 mg/lb of body   Laidlomycin, 5.................  Cattle fed in     Feed                 054771
 weight daily.                                                      confinement for   continuously at
                                                                    slaughter: For    a rate of 30 to
                                                                    treatment of      75 mg
                                                                    bacterial         laidlomycin
                                                                    enteritis         propionate
                                                                    caused by         potassium per
                                                                    Escherichia       head per day
                                                                    coli and          for not more
                                                                    bacterial         than 5 days. A
                                                                    pneumonia         withdrawal
                                                                    caused by         period has not
                                                                    Pasteurella       been
                                                                    multocida         established for
                                                                    organisms         this product in
                                                                    susceptible to    pre-ruminating
                                                                    chlortetracycli   calves. Do not
                                                                    ne; and for       use in calves
                                                                    increased rate    to be processed
                                                                    of weight and     for veal. See
                                                                    improved feed     Sec.
                                                                    efficiency.       558.305(d) of
                                                                                      this chapter.
                                                                                      Laidlomycin as
                                                                                      provided by No.
                                                                                      054771 in Sec.
                                                                                       510.600(c) of
                                                                                      this chapter.
(xi) to provide 10 mg/lb of body  Laidlomycin, 5 to 10...........  Cattle fed in     Feed                 054771
 weight daily.                                                      confinement for   continuously at
                                                                    slaughter: For    a rate of 30 to
                                                                    treatment of      75 mg
                                                                    bacterial         laidlomycin
                                                                    enteritis         propionate
                                                                    caused by         potassium per
                                                                    Escherichia       head per day
                                                                    coli and          for not more
                                                                    bacterial         than 5 days. A
                                                                    pneumonia         withdrawal
                                                                    caused by         period has not
                                                                    Pasteurella       been
                                                                    multocida         established for
                                                                    organisms         this product in
                                                                    susceptible to    pre-ruminating
                                                                    chlortetracycli   calves. Do not
                                                                    ne; and for       use in calves
                                                                    improved feed     to be processed
                                                                    efficiency.       for veal. See
                                                                                      Sec.
                                                                                      558.305(d) of
                                                                                      this chapter.
                                                                                      Laidlomycin as
                                                                                      provided by No.
                                                                                      054771 in Sec.
                                                                                       510.600(c) of
                                                                                      this chapter.
(xii) 500 to 2,000 to provide 10  Lasalocid, 10 to 30............  Cattle fed in     Feed                 054771
 mg/lb of body weight daily.                                        confinement for   continuously in     069254
                                                                    slaughter: For    complete feed
                                                                    treatment of      for not more
                                                                    bacterial         than 5 days to
                                                                    enteritis         provide 10 mg
                                                                    caused by         chlortetracycli
                                                                    Escherichia       ne per lb. body
                                                                    coli and          weight per day
                                                                    bacterial         and not less
                                                                    pneumonia         than 100 mg or
                                                                    caused by         more than 360
                                                                    Pasteurella       mg lasalocid
                                                                    multocida         per head per
                                                                    organisms         day. Do not
                                                                    susceptible to    allow horses or
                                                                    chlortetracycli   other equines
                                                                    ne; and for       access to feeds
                                                                    improved feed     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.

[[Page 58002]]

 
(xiii) to provide 10 mg/lb of     Lasalocid, 25 to 30............  Cattle fed in     Feed                 054771
 body weight daily.                                                 confinement for   continuously in     069254
                                                                    slaughter: For    complete feed
                                                                    treatment of      for not more
                                                                    bacterial         than 5 days to
                                                                    enteritis         provide 10 mg
                                                                    caused by         chlortetracycli
                                                                    Escherichia       ne per lb. body
                                                                    coli and          weight per day
                                                                    bacterial         and not less
                                                                    pneumonia         than 250 mg or
                                                                    caused by         more than 360
                                                                    Pasteurella       mg lasalocid
                                                                    multocida         per head per
                                                                    organisms         day. Do not
                                                                    susceptible to    allow horses or
                                                                    chlortetracycli   other equines
                                                                    ne; and for       access to feeds
                                                                    increased rate    containing
                                                                    of weight gain    lasalocid. No
                                                                    and improved      withdrawal
                                                                    feed efficiency.  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.
(xiv) 500 to 4,000 to provide 10  Lasalocid, 30 to 600...........  Pasture cattle    Feed                 054771
 mg/lb of body weight daily.                                        (slaughter,       continuously on     069254
                                                                    stocker, feeder   a hand-fed
                                                                    cattle, dairy     basis for not
                                                                    and beef          more than 5
                                                                    replacement       days to provide
                                                                    heifers): For     10 mg
                                                                    treatment of      chlortetracycli
                                                                    bacterial         ne per lb. body
                                                                    enteritis         weight per day
                                                                    caused by         and not less
                                                                    Escherichia       than 60 mg or
                                                                    coli and          more than 300
                                                                    bacterial         mg lasalocid
                                                                    pneumonia         per head per
                                                                    caused by         day in at least
                                                                    Pasteurella       1 pound of
                                                                    multocida         feed. Daily
                                                                    organisms         lasalocid
                                                                    susceptible to    intakes in
                                                                    chlortetracycli   excess of 200
                                                                    ne; and for       mg/head/day in
                                                                    increased rate    pasture cattle
                                                                    of weight gain.   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.
(xv) 500 to 4,000 g/ton to        Lasalocid, 30 to 600:            Replacement       The melengestrol     054771
 provide 10 mg/lb of body weight   Melengestrol acetate, 0.5 to 2   dairy heifers     acetate Type C
 daily.                            g/ton to provide 0.5 mg/head/    on pasture less   top-dress
                                   day melengestrol acetate.        than 20 months    medicated feed
                                                                    of age and        must be top
                                                                    replacement       dressed onto or
                                                                    beef heifers on   mixed at
                                                                    pasture: For      feeding with a
                                                                    treatment of      Type C
                                                                    bacterial         medicated feed
                                                                    enteritis         containing 500
                                                                    caused by         to 4,000 g/ton
                                                                    Escherichia       of
                                                                    coli and          chlortetracycli
                                                                    bacterial         ne and 30 to
                                                                    pneumonia         600 g/ton
                                                                    caused by         lasalocid to
                                                                    Pasteurella       provide 10 mg
                                                                    multocida         chlortetracycli
                                                                    organisms         ne per lb body
                                                                    susceptible to    weight per day
                                                                    chlortetracycli   and not less
                                                                    ne, increased     than 60 mg or
                                                                    rate of weight    more than 300
                                                                    gain, and         mg lasalocid
                                                                    suppression of    per head per
                                                                    estrus (heat).    day in at least
                                                                                      1 pound of feed
                                                                                      for not more
                                                                                      than 5 days.
                                                                                      After
                                                                                      completing
                                                                                      feeding of this
                                                                                      combination,
                                                                                      continue
                                                                                      feeding a Type
                                                                                      C top-dress
                                                                                      medicated feed
                                                                                      containing
                                                                                      melengestrol
                                                                                      acetate alone
                                                                                      for a total
                                                                                      time not
                                                                                      exceeding 24
                                                                                      days of
                                                                                      feeding. See
                                                                                      Sec.
                                                                                      558.311(d) of
                                                                                      this chapter.
                                                                                      Chlortetracycli
                                                                                      ne, lasalocid,
                                                                                      and
                                                                                      melengestrol as
                                                                                      provided by No.
                                                                                      054771 in Sec.
                                                                                       510.600(c) of
                                                                                      this chapter.

[[Page 58003]]

 
(xvi) 500 to 4,000 g/ton........  ...............................  Calves, beef and  Hand feed            054771
                                                                    nonlactating      continuously        069254
                                                                    dairy cattle:     for not more
                                                                    For the           than 5 days to
                                                                    treatment of      provide 10 mg/
                                                                    bacterial         lb body weight
                                                                    enteritis         per day. A
                                                                    caused by         withdrawal
                                                                    Escherichia       period has not
                                                                    coli and          been
                                                                    bacterial         established for
                                                                    pneumonia         this product in
                                                                    caused by         pre-ruminating
                                                                    Pasteurella       calves. Do not
                                                                    multocida         use in calves
                                                                    susceptible to    to be processed
                                                                    chlortetracycli   for veal. To
                                                                    ne.               sponsor No.
                                                                                      054771 under
                                                                                      NADA 046-699:
                                                                                      24-hour
                                                                                      withdrawal
                                                                                      period. To
                                                                                      sponsor No.
                                                                                      054771 under
                                                                                      NADA 048-761
                                                                                      and No. 069254
                                                                                      under ANADA 200-
                                                                                      510: Zero
                                                                                      withdrawal
                                                                                      period.
(xvii) 500 to 4,000 g/ton.......  Decoquinate, 12.9 to 90.8......  Calves, beef and  Feed at a rate       054771
                                                                    non-lactating     of 1g               069254
                                                                    dairy cattle:     chlortetracycli
                                                                    For the           ne per 100 lb
                                                                    treatment of      body weight/day
                                                                    bacterial         and 22.7 mg
                                                                    enteritis         decoquinate per
                                                                    caused by         100 lb of body
                                                                    Escherichia       weight/day for
                                                                    coli and          not more than 5
                                                                    bacterial         days. When it
                                                                    pneumonia         is fully
                                                                    caused by         consumed,
                                                                    Pasteurella       resume feeding
                                                                    multocida         22.7 mg
                                                                    organisms         decoquinate per
                                                                    susceptible to    100 lb of body
                                                                    chlortetracycli   weight/day for
                                                                    ne; and for the   a total of 28
                                                                    prevention of     days to prevent
                                                                    coccidiosis       coccidiosis. A
                                                                    caused by         withdrawal
                                                                    Eimeria bovis     period has not
                                                                    and E. zuernii.   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.
(xviii) 500 to 4,000 to provide   Melengestrol acetate, 0.25 to 2  Growing beef      Melengestrol         054771
 10 mg per pound of body weight.   g/ton to provide 0.25 to 0.5     heifers fed in    acetate Type C
                                   mg melengestrol acetate per      confinement for   top-dress
                                   head per day.                    slaughter: For    medicated feed
                                                                    the treatment     must be top
                                                                    of bacterial      dressed onto or
                                                                    enteritis         mixed at
                                                                    caused by         feeding with a
                                                                    Escherichia       Type C
                                                                    coli and          medicated feed
                                                                    bacterial         containing 500
                                                                    pneumonia         to 4,000 g/ton
                                                                    caused by         chlortetracycli
                                                                    Pasteurella       ne for not more
                                                                    multocida         than 5 days.
                                                                    organisms         After
                                                                    susceptible to    completing
                                                                    chlortetracycli   feeding of this
                                                                    ne, increased     combination,
                                                                    rate of weight    continue
                                                                    gain, improved    feeding a Type
                                                                    feed              C top-dress
                                                                    efficiency, and   medicated feed
                                                                    suppression of    containing
                                                                    estrus (heat).    melengestrol
                                                                                      acetate alone.
                                                                                      Chlortetracycli
                                                                                      ne and
                                                                                      melengestrol as
                                                                                      provided by No.
                                                                                      054771 in Sec.
                                                                                       510.600(c) of
                                                                                      this chapter.
(xix) 500 to 4,000 to provide 10  Melengestrol acetate, 0.5 to 2   Replacement       Melengestrol         054771
 mg per pound of body weight.      g/ton to provide 0.5 mg          dairy heifers     acetate Type C
                                   melengestrol acetate per head    less than 20      top-dress
                                   per day.                         months of age     medicated feed
                                                                    and replacement   must be top
                                                                    beef heifers:     dressed onto or
                                                                    For the           mixed at
                                                                    treatment of      feeding with a
                                                                    bacterial         Type C
                                                                    enteritis         medicated feed
                                                                    caused by         containing 500
                                                                    Escherichia       to 4,000 g/ton
                                                                    coli and          chlortetracycli
                                                                    bacterial         ne for not more
                                                                    pneumonia         than 5 days.
                                                                    caused by         After
                                                                    Pasteurella       completing
                                                                    multocida         feeding of this
                                                                    organisms         combination,
                                                                    susceptible to    continue
                                                                    chlortetracycli   feeding a Type
                                                                    ne, and for       C top-dress
                                                                    suppression of    medicated feed
                                                                    estrus (heat).    containing
                                                                                      melengestrol
                                                                                      acetate alone
                                                                                      for a total
                                                                                      time not
                                                                                      exceeding 24
                                                                                      days. Use in
                                                                                      dairy heifers
                                                                                      less than 20
                                                                                      months of age
                                                                                      may cause drug
                                                                                      residues in
                                                                                      milk and/or in
                                                                                      calves born to
                                                                                      these cows. A
                                                                                      withdrawal
                                                                                      period has not
                                                                                      been
                                                                                      established for
                                                                                      this product in
                                                                                      pre-ruminating
                                                                                      calves. Do not
                                                                                      use in calves
                                                                                      to be processed
                                                                                      for veal.
                                                                                      Chlortetracycli
                                                                                      ne and
                                                                                      melengestrol as
                                                                                      provided by No.
                                                                                      054771 in Sec.
                                                                                       510.600(c) of
                                                                                      this chapter.

[[Page 58004]]

 
(xx) 4,000 to 20,000 g/ton......  ...............................  Calves, beef and  Administer as a      054771
                                                                    nonlactating      top dress,          069254
                                                                    dairy cattle:     varying with
                                                                    For the           body weight and
                                                                    treatment of      feed
                                                                    bacterial         consumption, to
                                                                    enteritis         provide 10 mg/
                                                                    caused by         lb per day.
                                                                    Escherichia       Treat for not
                                                                    coli and          more than 5
                                                                    bacterial         days. A
                                                                    pneumonia         withdrawal
                                                                    caused by         period has not
                                                                    Pasteurella       been
                                                                    multocida         established for
                                                                    organisms         this product in
                                                                    susceptible to    pre-ruminating
                                                                    chlortetracycli   calves. Do not
                                                                    ne.               use in calves
                                                                                      to be processed
                                                                                      for veal.
(xxi) 4,000 to 20,000 g/ton.....  Decoquinate, 90.8 to 535.7.....  Calves, beef and  Feed at a rate       054771
                                                                    non-lactating     of 1g               069254
                                                                    dairy cattle:     chlortetracycli
                                                                    For the           ne per 100 lb
                                                                    treatment of      body weight/day
                                                                    bacterial         and 22.7 mg
                                                                    enteritis         decoquinate per
                                                                    caused by         100 lb of body
                                                                    Escherichia       weight/day for
                                                                    coli and          not more than 5
                                                                    bacterial         days. When it
                                                                    pneumonia         is fully
                                                                    caused by         consumed,
                                                                    Pasteurella       resume feeding
                                                                    multocida         22.7 mg
                                                                    organisms         decoquinate per
                                                                    susceptible to    100 lb of body
                                                                    chlortetracycli   weight/day for
                                                                    ne; and for the   a total of 28
                                                                    prevention of     days to prevent
                                                                    coccidiosis       coccidiosis. A
                                                                    caused by         withdrawal
                                                                    Eimeria bovis     period has not
                                                                    and E. zuernii.   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.
(xxii) 4,000 to 20,000 g/ton to   Melengestrol acetate, 0.25 to 2  Growing beef      Top dress 0.5 to     054771
 provide 10 mg/lb of body weight   g/ton to provide 0.25 to 0.5     heifers fed in    2 pounds of
 per day.                          mg melengestrol acetate per      confinement for   this medicated
                                   head per day.                    slaughter: For    feed containing
                                                                    the treatment     both drugs onto
                                                                    of bacterial      or mix at
                                                                    enteritis         feeding with a
                                                                    caused by         non-medicated
                                                                    Escherichia       feed for not
                                                                    coli and          more than 5
                                                                    bacterial         days. After
                                                                    pneumonia         completing
                                                                    caused by         feeding of this
                                                                    Pasteurella       combination,
                                                                    multocida         continue
                                                                    organisms         feeding a Type
                                                                    susceptible to    C top-dress
                                                                    chlortetracycli   medicated feed
                                                                    ne, and for       containing
                                                                    increased rate    melengestrol
                                                                    of weight gain,   acetate alone.
                                                                    improved feed     A withdrawal
                                                                    efficiency, and   period has not
                                                                    suppression of    been
                                                                    estrus (heat).    established for
                                                                                      this product in
                                                                                      pre-ruminating
                                                                                      calves. Do not
                                                                                      use in calves
                                                                                      to be processed
                                                                                      for veal.
                                                                                      Chlortetracycli
                                                                                      ne and
                                                                                      melengestrol as
                                                                                      provided by No.
                                                                                      054771 in Sec.
                                                                                       510.600(c) of
                                                                                      this chapter.
(xxiii) 4,000 to 20,000 g/ton to  Melengestrol acetate, 0.5 to 2   Replacement       Top dress 0.5 to     054771
 provide 10 mg/lb of body weight   g/ton to provide 0.5 mg          dairy heifers     2 pounds of
 per day.                          melengestrol acetate per head    less than 20      this medicated
                                   per day.                         months of age     feed containing
                                                                    and replacement   both drugs onto
                                                                    beef heifers:     or mix at
                                                                    For the           feeding with a
                                                                    treatment of      non-medicated
                                                                    bacterial         feed for not
                                                                    enteritis         more than 5
                                                                    caused by         days. After
                                                                    Escherichia       completing
                                                                    coli and          feeding of this
                                                                    bacterial         combination,
                                                                    pneumonia         continue
                                                                    caused by         feeding a Type
                                                                    Pasteurella       C top-dress
                                                                    multocida         medicated feed
                                                                    organisms         containing
                                                                    susceptible to    melengestrol
                                                                    chlortetracycli   acetate alone
                                                                    ne, and for       for a total
                                                                    suppression of    time not
                                                                    estrus (heat).    exceeding 24
                                                                                      days. Use in
                                                                                      dairy heifers
                                                                                      less than 20
                                                                                      months of age
                                                                                      may cause drug
                                                                                      residues in
                                                                                      milk and/or in
                                                                                      calves born to
                                                                                      these cows. A
                                                                                      withdrawal
                                                                                      period has not
                                                                                      been
                                                                                      established for
                                                                                      this product in
                                                                                      pre-ruminating
                                                                                      calves. Do not
                                                                                      use in calves
                                                                                      to be processed
                                                                                      for veal.
                                                                                      Chlortetracycli
                                                                                      ne and
                                                                                      melengestrol as
                                                                                      provided by No.
                                                                                      054771 in Sec.
                                                                                       510.600(c) of
                                                                                      this chapter.

[[Page 58005]]

 
(xxiv) to provide 350 mg/head/    ...............................  Beef cattle: For  Feed to provide      054771
 day.                                                               control of        chlortetracycli     066104
                                                                    bacterial         ne at the rate      069254
                                                                    pneumonia         of 350 mg per
                                                                    associated with   animal daily. A
                                                                    shipping fever    withdrawal
                                                                    complex caused    period has not
                                                                    by Pasteurella    been
                                                                    spp.              established for
                                                                    susceptible to    this product in
                                                                    chlortetracycli   pre-ruminating
                                                                    ne.               calves. Do not
                                                                                      use in calves
                                                                                      to be processed
                                                                                      for veal.
                                                                                      Withdrawal
                                                                                      periods: To
                                                                                      sponsor No.
                                                                                      054771 under
                                                                                      NADAs 046-699
                                                                                      and 049-287,
                                                                                      No. 066104
                                                                                      under NADA 092-
                                                                                      286, and No.
                                                                                      069254 under
                                                                                      NADA 048-480:
                                                                                      Withdraw 48
                                                                                      hours prior to
                                                                                      slaughter. To
                                                                                      sponsor No.
                                                                                      054771 under
                                                                                      NADA 048-761
                                                                                      and No. 069254
                                                                                      under NADA 138-
                                                                                      935 and ANADA
                                                                                      200-510: Zero
                                                                                      withdrawal
                                                                                      period.
(xxv) to provide 350 mg/head/day  ...............................  Beef cattle       Feed to provide      054771
                                                                    (under 700 lb):   chlortetracycli     066104
                                                                    For control of    ne at the rate      069254
                                                                    active            of 350 mg per
                                                                    infection of      animal daily. A
                                                                    anaplasmosis      withdrawal
                                                                    caused by         period has not
                                                                    Anaplasma         been
                                                                    marginale         established for
                                                                    susceptible to    this product in
                                                                    chlortetracycli   pre-ruminating
                                                                    ne.               calves. Do not
                                                                                      use in calves
                                                                                      to be processed
                                                                                      for veal.
                                                                                      Withdrawal
                                                                                      periods: To
                                                                                      sponsor No.
                                                                                      054771 under
                                                                                      NADAs 046-699
                                                                                      and 049-287,
                                                                                      No. 066104
                                                                                      under NADA 092-
                                                                                      286, and No.
                                                                                      069254 under
                                                                                      NADA 048-480:
                                                                                      Withdraw 48
                                                                                      hours prior to
                                                                                      slaughter. To
                                                                                      sponsor No.
                                                                                      054771 under
                                                                                      NADA 048-761
                                                                                      and No. 069254
                                                                                      under NADA 138-
                                                                                      935 and ANADA
                                                                                      200-510: Zero
                                                                                      withdrawal
                                                                                      period.
(xxvi) 50 to 350 g/ton to         Melengestrol acetate, 0.5 to 2   Replacement beef  Melengestrol         054771
 provide 350 mg/head/day.          g/ton to provide 0.5 mg          heifers under     acetate Type C
                                   melengestrol acetate per head    700 lb: For       top-dress
                                   per day.                         control of        medicated feed
                                                                    active            must be top
                                                                    infection of      dressed or
                                                                    anaplasmosis      mixed at
                                                                    caused by         feeding with
                                                                    Anaplasma         the Type C
                                                                    marginale         medicated feed
                                                                    susceptible to    containing 50
                                                                    chlortetracycli   to 350 g/ton
                                                                    ne and for        chlortetracycli
                                                                    suppression of    ne for up to 24
                                                                    estrus (heat).    days of
                                                                                      feeding. Do not
                                                                                      exceed 24 days
                                                                                      of feeding.
                                                                                      Chlortetracycli
                                                                                      ne and
                                                                                      melengestrol as
                                                                                      provided by No.
                                                                                      054771 in Sec.
                                                                                       510.600(c) of
                                                                                      this chapter.
(xxvii) 20 to 350 g/ton.........  ...............................  Beef cattle and   Feed to provide      054771
                                                                    replacement       chlortetracycli     069254
                                                                    dairy heifers:    ne at the rate
                                                                    For control of    of 350 mg per
                                                                    bacterial         head per day.
                                                                    pneumonia         This drug is
                                                                    associated with   not approved
                                                                    shipping fever    for use in
                                                                    complex caused    female dairy
                                                                    by Pasteurella    cattle 20
                                                                    spp.              months of age
                                                                    susceptible to    or older,
                                                                    chlortetracycli   including dry
                                                                    ne.               dairy cows. Use
                                                                                      in these cattle
                                                                                      may cause drug
                                                                                      residues in
                                                                                      milk and/or in
                                                                                      calves born to
                                                                                      these cows. A
                                                                                      withdrawal
                                                                                      period has not
                                                                                      been
                                                                                      established for
                                                                                      this product in
                                                                                      pre-ruminating
                                                                                      calves. Do not
                                                                                      use in calves
                                                                                      to be processed
                                                                                      for veal. To
                                                                                      sponsor No.
                                                                                      054771 under
                                                                                      NADA 048-761
                                                                                      and No. 069254
                                                                                      under ANADA 200-
                                                                                      510: Zero
                                                                                      withdrawal
                                                                                      period.
(xxviii) 20 to 350 g/ton to       Melengestrol acetate, 0.25 to 2  Growing beef      Melengestrol         054771
 provide 350 mg/head/day.          g/ton to provide 0.25 to 0.5     heifers fed in    acetate Type C
                                   mg melengestrol acetate per      confinement for   top-dress
                                   head per day.                    slaughter: For    medicated feed
                                                                    control of        must be top
                                                                    bacterial         dressed onto or
                                                                    pneumonia         mixed at
                                                                    associated with   feeding with
                                                                    shipping fever    the Type C
                                                                    complex caused    medicated feed
                                                                    by Pasteurella    containing 20
                                                                    spp.              to 350 g/ton
                                                                    susceptible to    chlortetracycli
                                                                    chlortetracycli   ne.
                                                                    ne, increased     Chlortetracycli
                                                                    rate of weight    ne and
                                                                    gain, improved    melengestrol as
                                                                    feed              provided by No.
                                                                    efficiency, and   054771 in Sec.
                                                                    suppression of     510.600(c) of
                                                                    estrus (heat).    this chapter.

[[Page 58006]]

 
(xxix) 20 to 350 g/ton to         Melengestrol acetate, 0.5 to 2   Replacement       Melengestrol         054771
 provide 350 mg/head/day.          g/ton to provide 0.5 mg          dairy heifers     acetate Type C
                                   melengestrol acetate per head    less than 20      top-dress
                                   per day.                         months of age     medicated feed
                                                                    and replacement   must be top
                                                                    beef heifers:     dressed or
                                                                    For control of    mixed at
                                                                    bacterial         feeding with
                                                                    pneumonia         the Type C
                                                                    associated with   medicated feed
                                                                    shipping fever    containing 20
                                                                    complex caused    to 350 g/ton
                                                                    by Pasteurella    chlortetracycli
                                                                    spp.              ne. Use in
                                                                    susceptible to    dairy heifers
                                                                    chlortetracycli   less than 20
                                                                    ne and            months of age
                                                                    suppression of    may cause drug
                                                                    estrus (heat).    residues in
                                                                                      milk and/or in
                                                                                      calves born to
                                                                                      these cows. A
                                                                                      withdrawal
                                                                                      period has not
                                                                                      been
                                                                                      established for
                                                                                      this product in
                                                                                      pre-ruminating
                                                                                      calves. Do not
                                                                                      use in calves
                                                                                      to be processed
                                                                                      for veal.
                                                                                      Chlortetracycli
                                                                                      ne and
                                                                                      melengestrol as
                                                                                      provided by No.
                                                                                      054771 in Sec.
                                                                                       510.600(c) of
                                                                                      this chapter.
(xxx) to provide 350 mg/head/day  Laidlomycin, 5.................  Cattle fed in     Feed                 054771
                                                                    confinement for   continuously at
                                                                    slaughter: For    a rate of 30 to
                                                                    control of        75 mg
                                                                    bacterial         laidlomycin
                                                                    pneumonia         propionate
                                                                    associated with   potassium per
                                                                    shipping fever    head per day. A
                                                                    complex caused    withdrawal
                                                                    by Pasteurella    period has not
                                                                    spp.              been
                                                                    susceptible to    established for
                                                                    chlortetracycli   this product in
                                                                    ne; and for       pre-ruminating
                                                                    increased rate    calves. Do not
                                                                    of weight and     use in calves
                                                                    improved feed     to be processed
                                                                    efficiency.       for veal. See
                                                                                      Sec.
                                                                                      558.305(d) of
                                                                                      this chapter.
                                                                                      Laidlomycin as
                                                                                      provided by No.
                                                                                      054771 in Sec.
                                                                                       510.600(c) of
                                                                                      this chapter.
(xxxi) to provide 350 mg/head/    Laidlomycin, 5 to 10...........  Cattle fed in     Feed                 054771
 day.                                                               confinement for   continuously at
                                                                    slaughter: For    a rate of 30 to
                                                                    control of        75 mg
                                                                    bacterial         laidlomycin
                                                                    pneumonia         propionate
                                                                    associated with   potassium per
                                                                    shipping fever    head per day. A
                                                                    complex caused    withdrawal
                                                                    by Pasteurella    period has not
                                                                    spp.              been
                                                                    susceptible to    established for
                                                                    chlortetracycli   this product in
                                                                    ne; and for       pre-ruminating
                                                                    improved feed     calves. Do not
                                                                    efficiency.       use in calves
                                                                                      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.
(xxxii) 25 to 42.2 g/ton to       Lasalocid, 25 to 30............  Cattle under 700  Feed                 054771
 provide 350 mg/head/day.                                           pounds fed in     continuously in     069254
                                                                    confinement for   complete feed
                                                                    slaughter: For    at a rate of
                                                                    control of        350 mg
                                                                    active            chlortetracycli
                                                                    infection of      ne and not less
                                                                    anaplasmosis      than 250 mg nor
                                                                    caused by         more than 360
                                                                    Anaplasma         mg lasalocid
                                                                    marginale         per head daily.
                                                                    susceptible to    Do not allow
                                                                    chlortetracycli   horses or other
                                                                    ne; and for       equines access
                                                                    increased rate    to feeds
                                                                    of weight gain    containing
                                                                    and improved      lasalocid. No
                                                                    feed efficiency.  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.
(xxxiii) 25 to 42.2 g/ton to      Lasalocid, 25 to 30............  Cattle fed in     Feed                 054771
 provide 350 mg/head/day.                                           confinement for   continuously in     069254
                                                                    slaughter: For    complete feed
                                                                    control of        at a rate of
                                                                    bacterial         350 mg
                                                                    pneumonia         chlortetracycli
                                                                    associated with   ne and not less
                                                                    shipping fever    than 250 mg nor
                                                                    complex caused    more than 360
                                                                    by Pasteurella    mg lasalocid
                                                                    multocida         per head daily.
                                                                    organisms         Do not allow
                                                                    susceptible to    horses or other
                                                                    chlortetracycli   equines access
                                                                    ne; and for       to feeds
                                                                    increased rate    containing
                                                                    of weight gain    lasalocid. No
                                                                    and improved      withdrawal
                                                                    feed efficiency.  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.

[[Page 58007]]

 
(xxxiv) 25 to 100 g/ton to        Lasalocid, 10 to 30............  Cattle under 700  Feed                 054771
 provide 350 mg/head/day.                                           pounds fed in     continuously in     069254
                                                                    confinement for   complete feed
                                                                    slaughter: For    at a rate of
                                                                    control of        350 mg
                                                                    active            chlortetracycli
                                                                    infection of      ne and not less
                                                                    anaplasmosis      than 100 mg nor
                                                                    caused by         more than 360
                                                                    Anaplasma         mg lasalocid
                                                                    marginale         per head daily.
                                                                    susceptible to    Do not allow
                                                                    chlortetracycli   horses or other
                                                                    ne; and for       equines access
                                                                    improved feed     to feeds
                                                                    efficiency.       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.
(xxxv) 25 to 100 g/ton to         Lasalocid, 10 to 30............  Cattle fed in     Feed                 054771
 provide 350 mg/head/day.                                           confinement for   continuously in     069254
                                                                    slaughter: For    complete feed
                                                                    control of        at a rate of
                                                                    bacterial         350 mg
                                                                    pneumonia         chlortetracycli
                                                                    associated with   ne and not less
                                                                    shipping fever    than 100 mg nor
                                                                    complex caused    more than 360
                                                                    by Pasteurella    mg lasalocid
                                                                    multocida         per head daily.
                                                                    organisms         Do not allow
                                                                    susceptible to    horses or other
                                                                    chlortetracycli   equines access
                                                                    ne; and for       to feeds
                                                                    improved feed     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.
(xxxvi) 25 to 700 to provide 350  Lasalocid, 30 to 600...........  Pasture cattle    Feed                 054771
 g/head/day.                                                        (slaughter,       continuously on     069254
                                                                    stocker, feeder   a hand-fed
                                                                    cattle, dairy     basis at a rate
                                                                    and beef          of 350 mg
                                                                    replacement       chlortetracycli
                                                                    heifers): For     ne and not less
                                                                    control of        than 60 mg nor
                                                                    bacterial         more than 300
                                                                    pneumonia         mg lasalocid
                                                                    associated with   per head per
                                                                    shipping fever    day in at least
                                                                    complex caused    1 pound of
                                                                    by Pasteurella    feed. Daily
                                                                    multocida         lasalocid
                                                                    organisms         intakes in
                                                                    susceptible to    excess of 200
                                                                    chlortetracycli   mg/head/day in
                                                                    ne; and for       pasture cattle
                                                                    increased rate    have not been
                                                                    of weight gain.   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.
(xxxvii) 25 to 700 g/ton to       Lasalocid, 30 to 600;            Replacement beef  The melengestrol     054771
 provide 350 mg/head/day.          melengestrol acetate, 0.5 to 2   heifers on        acetate Type C
                                   g/ton to provide 0.5 mg/head/    pasture: For      top-dress
                                   day melengestrol acetate.        control of        medicated feed
                                                                    bacterial         must be top
                                                                    pneumonia         dressed onto or
                                                                    associated with   mixed at
                                                                    shipping fever    feeding with a
                                                                    complex caused    Type C
                                                                    by Pasteurella    medicated feed
                                                                    spp.              containing 25
                                                                    susceptible to    to 700 g/ton of
                                                                    chlortetracycli   chlortetracycli
                                                                    ne, increased     ne and 30 to
                                                                    rate of weight    600 g/ton
                                                                    gain, and         lasalocid to
                                                                    suppression of    provide 350 mg
                                                                    estrus (heat).    chlortetracycli
                                                                                      ne per head
                                                                                      daily and not
                                                                                      less than 60 mg
                                                                                      or more than
                                                                                      300 mg
                                                                                      lasalocid per
                                                                                      head daily in
                                                                                      at least 1
                                                                                      pound of feed.
                                                                                      Do not exceed
                                                                                      24 days of
                                                                                      feeding. See
                                                                                      Sec.
                                                                                      558.311(d) of
                                                                                      this chapter.
                                                                                      Chlortetracycli
                                                                                      ne, lasalocid,
                                                                                      and
                                                                                      melengestrol as
                                                                                      provided by No.
                                                                                      054771 in Sec.
                                                                                       510.600(c) of
                                                                                      this chapter.

[[Page 58008]]

 
(xxxviii) 25 to 700 to provide    Lasalocid, 30 to 600...........  Pasture cattle    Feed                 054771
 350 mg/head/day.                                                   (slaughter,       continuously on     069254
                                                                    stocker, feeder   a hand-fed
                                                                    cattle, beef      basis at a rate
                                                                    replacement       of 350 mg
                                                                    heifers) under    chlortetracycli
                                                                    700 pounds: For   ne and not less
                                                                    control of        than 60 mg nor
                                                                    active            more than 300
                                                                    infection of      mg lasalocid
                                                                    anaplasmosis      per head per
                                                                    caused by         day in at least
                                                                    Anaplasma         1 pound of
                                                                    marginale         feed. Daily
                                                                    susceptible to    lasalocid
                                                                    chlortetracycli   intakes in
                                                                    ne; and for       excess of 200
                                                                    increased rate    mg/head/day in
                                                                    of weight gain.   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.
(xxxix) 25 to 700 g/ton to        Lasalocid, 30 to 600;            Replacement beef  The melengestrol     054771
 provide 350 mg/head/day.          melengestrol acetate, 0.5 to 2   heifers on        acetate Type C
                                   g/ton to provide 0.5 mg/head/    pasture under     top-dress
                                   day melengestrol acetate.        700 pounds: For   medicated feed
                                                                    control of        must be top
                                                                    active            dressed onto or
                                                                    infection of      mixed at
                                                                    anaplasmosis      feeding with a
                                                                    caused by         Type C
                                                                    Anaplasma         medicated feed
                                                                    marginale         containing 25
                                                                    susceptible to    to 700 g/ton of
                                                                    chlortetracycli   chlortetracycli
                                                                    ne, increased     ne and 30 to
                                                                    rate of weight    600 g/ton
                                                                    gain, and         lasalocid to
                                                                    suppression of    provide 350 mg
                                                                    estrus (heat).    chlortetracycli
                                                                                      ne per head
                                                                                      daily and not
                                                                                      less than 60 mg
                                                                                      or more than
                                                                                      300 mg
                                                                                      lasalocid per
                                                                                      head daily in
                                                                                      at least 1
                                                                                      pound of feed.
                                                                                      Do not exceed
                                                                                      24 days of
                                                                                      feeding. See
                                                                                      Sec.
                                                                                      558.311(d) of
                                                                                      this chapter.
                                                                                      Chlortetracycli
                                                                                      ne, lasalocid,
                                                                                      and
                                                                                      melengestrol as
                                                                                      provided by No.
                                                                                      054771 in Sec.
                                                                                       510.600(c) of
                                                                                      this chapter.
(xl) 25 to 2,800 to provide 350   Lasalocid, 30 to 181.8.........  Beef cattle       Hand feed            054771
 mg/head/day.                                                       weighing under    continuously at     069254
                                                                    700 pounds: For   a rate of 350
                                                                    control of        mg
                                                                    active            chlortetracycli
                                                                    infection of      ne and 1 mg
                                                                    anaplasmosis      lasalocid per
                                                                    caused by         2.2 lb. body
                                                                    Anaplasma         weight daily to
                                                                    marginale         cattle with a
                                                                    susceptible to    maximum of 360
                                                                    chlortetracycli   mg of lasalocid
                                                                    ne; and for the   per head per
                                                                    control of        day. Do not
                                                                    coccidiosis       allow horses or
                                                                    caused by         other equines
                                                                    Eimeria bovis     access to feeds
                                                                    and E. zuernii.   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.
                                                                                      Chlortetracycli
                                                                                      ne and
                                                                                      lasalocid as
                                                                                      provided by No.
                                                                                      054771 in Sec.
                                                                                       510.600(c) of
                                                                                      this chapter.
(xli) 25 to 2,80 g/ton to         Lasalocid, 30 to 181.8;          Growing beef      The melengestrol     054771
 provide 350 mg/head/day.          melengestrol acetate, 0.25 to    heifers fed in    acetate Type C
                                   2 g/ton to provide 0.25 to 0.5   confinement for   top-dress
                                   mg/head/day melengestrol         slaughter under   medicated feed
                                   acetate.                         700 pounds: For   must be top
                                                                    control of        dressed onto or
                                                                    active            mixed at
                                                                    infection of      feeding with a
                                                                    anaplasmosis      Type C
                                                                    caused by         medicated feed
                                                                    Anaplasma         containing 25
                                                                    marginale         to 2,800 g/ton
                                                                    susceptible to    of
                                                                    chlortetracycli   chlortetracycli
                                                                    ne, control of    ne and 30 to
                                                                    coccidiosis       181.8 g/ton
                                                                    caused by         lasalocid to
                                                                    Eimeria bovis     provide 350 mg
                                                                    and E. zuernii,   chlortetracycli
                                                                    increased rate    ne per head per
                                                                    of weight gain,   day and 1 mg
                                                                    improved feed     lasalocid per
                                                                    efficiency, and   2.2 lb. of body
                                                                    suppression of    weight daily
                                                                    estrus (heat).    with a maximum
                                                                                      of 360 mg
                                                                                      lasalocid per
                                                                                      head per day.
                                                                                      See Sec.
                                                                                      558.311(d) of
                                                                                      this chapter.
                                                                                      Chlortetracycli
                                                                                      ne, lasalocid,
                                                                                      and
                                                                                      melengestrol as
                                                                                      provided by No.
                                                                                      054771 in Sec.
                                                                                       510.600(c) of
                                                                                      this chapter.

[[Page 58009]]

 
(xlii) 25 to 2,800 to provide     Lasalocid, 30 to 181.8.........  Beef cattle       Hand feed            054771
 350 mg/head/day.                                                   weighing up to    continuously at     069254
                                                                    800 pounds: For   a rate of 350
                                                                    control of        mg
                                                                    bacterial         chlortetracycli
                                                                    pneumonia         ne and 1 mg
                                                                    associated with   lasalocid per
                                                                    shipping fever    2.2 lb. body
                                                                    complex caused    weight daily to
                                                                    by Pasteurella    cattle with a
                                                                    spp.              maximum of 360
                                                                    susceptible to    mg of lasalocid
                                                                    chlortetracycli   per head per
                                                                    ne; and for the   day. Do not
                                                                    control of        allow horses or
                                                                    coccidiosis       other equines
                                                                    caused by         access to feeds
                                                                    Eimeria bovis     containing
                                                                    and E. zuernii.   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.
(xliii) 25 to 2,800 g/ton to      Lasalocid, 30 to 181.8;          Growing beef      The melengestrol     054771
 provide 350 mg/head/day.          melengestrol acetate, 0.25 to    heifers fed in    acetate Type C
                                   2 g/ton to provide 0.25 to 0.5   confinement for   top-dress
                                   mg/head/day melengestrol         slaughter up to   medicated feed
                                   acetate.                         800 pounds: For   must be top
                                                                    control of        dressed onto or
                                                                    bacterial         mixed at
                                                                    pneumonia         feeding with a
                                                                    associated with   Type C
                                                                    shipping fever    medicated feed
                                                                    complex caused    containing 25
                                                                    by Pasteurella    to 2,800 g/ton
                                                                    spp.              of
                                                                    susceptible to    chlortetracycli
                                                                    chlortetracycli   ne and 30 to
                                                                    ne, control of    181.8 g/ton
                                                                    coccidiosis       lasalocid to
                                                                    caused by         provide 350 mg
                                                                    Eimeria bovis     chlortetracycli
                                                                    and E. zuernii,   ne per head
                                                                    increased rate    daily and 1 mg
                                                                    of weight gain,   lasalocid per
                                                                    improved feed     2.2 lb. of body
                                                                    efficiency, and   weight daily
                                                                    suppression of    with a maximum
                                                                    estrus (heat).    of 360 mg
                                                                                      lasalocid per
                                                                                      head per day.
                                                                                      See Sec.
                                                                                      558.311(d) of
                                                                                      this chapter.
                                                                                      Chlortetracycli
                                                                                      ne, lasalocid,
                                                                                      and
                                                                                      melengestrol as
                                                                                      provided by No.
                                                                                      054771 in Sec.
                                                                                       510.600(c) of
                                                                                      this chapter.
(xliv) 25 to 2,800 g/ton to       Lasalocid, 30 to 181.8;          Replacement beef  The melengestrol     054771
 provide 350 mg/head/day.          melengestrol acetate, 0.5 to 2   heifers up to     acetate Type C
                                   g/ton to provide 0.5 mg/head/    800 pounds: For   top-dress
                                   day melengestrol acetate.        control of        medicated feed
                                                                    bacterial         must be top
                                                                    pneumonia         dressed onto or
                                                                    associated with   mixed at
                                                                    shipping fever    feeding with a
                                                                    complex caused    Type C
                                                                    by Pasteurella    medicated feed
                                                                    spp.              containing 25
                                                                    susceptible to    to 2,800 g/ton
                                                                    chlortetracycli   of
                                                                    ne, control of    chlortetracycli
                                                                    coccidiosis       ne and 30 to
                                                                    caused by         181.8 g/ton
                                                                    Eimeria bovis     lasalocid to
                                                                    and E. zuernii,   provide 350 mg
                                                                    and suppression   chlortetracycli
                                                                    of estrus         ne per head
                                                                    (heat).           daily and 1 mg
                                                                                      lasalocid per
                                                                                      2.2 lb. of body
                                                                                      weight daily
                                                                                      with a maximum
                                                                                      of 360 mg
                                                                                      lasalocid per
                                                                                      head per day.
                                                                                      Do not exceed
                                                                                      24 days of
                                                                                      feeding. See
                                                                                      Sec.
                                                                                      558.311(d) of
                                                                                      this chapter.
                                                                                      Chlortetracycli
                                                                                      ne, lasalocid,
                                                                                      and
                                                                                      melengestrol as
                                                                                      provided by No.
                                                                                      054771 in Sec.
                                                                                       510.600(c) of
                                                                                      this chapter.
(xlv) 500 to 4,000 to provide 10  Lasalocid, 30 to 181.8.........  Cattle weighing   Hand feed            054771
 mg/head/day.                                                       up to 800         continuously        069254
                                                                    pounds: For the   for not more
                                                                    treatment of      than 5 days at
                                                                    bacterial         a rate of 10 mg
                                                                    enteritis         chlortetracycli
                                                                    caused by         ne and 1 mg
                                                                    Escherichia       lasalocid per
                                                                    coli and          2.2 lb. body
                                                                    bacterial         weight daily to
                                                                    pneumonia         cattle with a
                                                                    caused by         maximum of 360
                                                                    Pasteurella       mg of lasalocid
                                                                    multocida         per head per
                                                                    susceptible to    day. Do not
                                                                    chlortetracycli   allow horses or
                                                                    ne; and for the   other equines
                                                                    control of        access to feeds
                                                                    coccidiosis       containing
                                                                    caused by         lasalocid. No
                                                                    Eimeria bovis     withdrawal
                                                                    and E. zuernii.   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.

[[Page 58010]]

 
(xlvi) 500 to 4,000 g/ton to      Lasalocid, 30 to 181.8;          Growing beef      The melengestrol     054771
 provide 10 mg/lb of body weight   melengestrol acetate, 0.25 to    heifers fed in    acetate Type C
 daily.                            2 g/ton to provide 0.25 to 0.5   confinement for   top-dress
                                   mg/head/day melengestrol         slaughter up to   medicated feed
                                   acetate.                         800 pounds: For   must be top
                                                                    the treatment     dressed onto or
                                                                    of bacterial      mixed at
                                                                    enteritis         feeding with a
                                                                    caused by         Type C
                                                                    Escherichia       medicated feed
                                                                    coli and          containing 500
                                                                    bacterial         to 4,000 g/ton
                                                                    pneumonia         of
                                                                    caused by         chlortetracycli
                                                                    Pasteurella       ne and 30 to
                                                                    multocida         181.8 g/ton
                                                                    organisms         lasalocid to
                                                                    susceptible to    provide 10 mg
                                                                    chlortetracycli   chlortetracycli
                                                                    ne, control of    ne per lb of
                                                                    coccidiosis       body weight per
                                                                    caused by         day and 1 mg
                                                                    Eimeria bovis     lasalocid per
                                                                    and E. zuernii,   2.2 lb of body
                                                                    increased rate    weight per day
                                                                    of weight gain,   with a maximum
                                                                    improved feed     of 360 mg
                                                                    efficiency, and   lasalocid per
                                                                    suppression of    head per day
                                                                    estrus (heat).    for not more
                                                                                      than 5 days of
                                                                                      feeding. After
                                                                                      completing
                                                                                      feeding of this
                                                                                      combination,
                                                                                      continue
                                                                                      feeding a Type
                                                                                      C top-dress
                                                                                      medicated feed
                                                                                      containing
                                                                                      melengestrol
                                                                                      acetate alone.
                                                                                      See Sec.
                                                                                      558.311(d) of
                                                                                      this chapter.
                                                                                      Chlortetracycli
                                                                                      ne, lasalocid,
                                                                                      and
                                                                                      melengestrol as
                                                                                      provided by No.
                                                                                      054771 in Sec.
                                                                                       510.600(c) of
                                                                                      this chapter.
(xlvii) 500 to 4,000 g/ton to     Lasalocid, 30 to 181.8;          Replacement       The melengestrol     054771
 provide 10 mg/lb of body weight   melengestrol acetate, 0.5 to 2   dairy heifers     acetate Type C
 daily.                            g/ton to provide 0.5 mg/head/    up to 800         top-dress
                                   day melengestrol acetate.        pounds and less   medicated feed
                                                                    than 20 months    must be top
                                                                    of age and        dressed onto or
                                                                    replacement       mixed at
                                                                    beef heifers up   feeding with a
                                                                    to 800 pounds:    Type C
                                                                    For the           medicated feed
                                                                    treatment of      containing 500
                                                                    bacterial         to 4,000 g/ton
                                                                    enteritis         of
                                                                    caused by         chlortetracycli
                                                                    Escherichia       ne and 30 to
                                                                    coli and          181.8 g/ton
                                                                    bacterial         lasalocid to
                                                                    pneumonia         provide 10 mg
                                                                    caused by         chlortetracycli
                                                                    Pasteurella       ne per lb of
                                                                    multocida         body weight per
                                                                    organisms         day and 1 mg
                                                                    susceptible to    lasalocid per
                                                                    chlortetracycli   2.2 lb of body
                                                                    ne, control of    weight per day
                                                                    coccidiosis       with a maximum
                                                                    caused by         of 360 mg
                                                                    Eimeria bovis     lasalocid per
                                                                    and E. zuernii,   head per day
                                                                    and suppression   for not more
                                                                    of estrus         than 5 days.
                                                                    (heat).           After
                                                                                      completing
                                                                                      feeding of this
                                                                                      combination,
                                                                                      continue
                                                                                      feeding a Type
                                                                                      C top-dress
                                                                                      medicated feed
                                                                                      containing
                                                                                      melengestrol
                                                                                      acetate alone.
                                                                                      See Sec.
                                                                                      558.311(d) of
                                                                                      this chapter.
                                                                                      Chlortetracycli
                                                                                      ne, lasalocid,
                                                                                      and
                                                                                      melengestrol as
                                                                                      provided by No.
                                                                                      054771 in Sec.
                                                                                       510.600(c) of
                                                                                      this chapter.
----------------------------------------------------------------------------------------------------------------

* * * * *

0
31. In Sec.  558.342, revise paragraph (e)(1)(iv) to read as follows:


Sec.  558.342  Melengestrol.

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

----------------------------------------------------------------------------------------------------------------
  Melengestrol acetate in                                  Indications for
        mg/head/day          Combination in mg/head/day          use             Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(iv) 0.25 to 0.5..........  Monensin, 10 to 40.........  Heifers fed in      Add at the rate of  016592
                                                          confinement for     0.5 to 2.0 lb/     045771
                                                          slaughter: For      head/day a         058198
                                                          increased rate of   medicated feed
                                                          weight gain,        (liquid or dry)
                                                          improved feed       containing 0.125
                                                          efficiency, and     to 1.0 mg
                                                          suppression of      melengestrol
                                                          estrus (heat);      acetate/lb to a
                                                          and for the         feed containing
                                                          prevention and      10 to 40 g of
                                                          control of          monensin per ton
                                                          coccidiosis due     to provide 0.25
                                                          to Eimeria bovis    to 0.5 mg
                                                          and E. zuernii.     melengestrol
                                                                              acetate/head/day
                                                                              and 0.14 to 0.42
                                                                              mg monensin/lb
                                                                              body weight,
                                                                              depending on
                                                                              severity of
                                                                              coccidiosis
                                                                              challenge, up to
                                                                              480 mg monensin/
                                                                              head/day. See
                                                                              Sec.   558.355(d)
                                                                              of this chapter.
                                                                              Monensin as
                                                                              provided by No.
                                                                              016592 or 058198;
                                                                              melengestrol
                                                                              acetate as
                                                                              provided by No.
                                                                              016952, 054771,
                                                                              or 058198 in Sec.
                                                                                510.600(c) of
                                                                              this chapter.
 

[[Page 58011]]

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

* * * * *

0
32. In Sec.  558.355, revise paragraphs (b)(2), (f)(2)(ii), (f)(3), and 
(f)(4)(i) and (ii), remove paragraph (f)(4)(v), redesignate paragraph 
(f)(4)(vi) as paragraph (f)(4)(v) and revise it, and revise paragraphs 
(f)(6)(i) and (f)(7)(viii)
    The revisions read as follows:


Sec.  558.355  Monensin.

* * * * *
    (b) * * *
    (2) No. 016592 for use of a Type A medicated article containing 
90.7 grams monensin, USP, per pound as in paragraphs (f)(3), (f)(4)(v), 
and (f)(6) of this section.
* * * * *
    (f) * * *
    (2) * * *

----------------------------------------------------------------------------------------------------------------
                             Combination in grams/
   Monensin in  grams/ton             ton           Indications for use       Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(ii) 54 to 90..............  Bacitracin            Growing turkeys: For  Feed continuously as  058198
                              methylenedisalicyla   the prevention of     the sole ration.     069254
                              te, 4 to 50.          coccidiosis caused    The optimum level
                                                    by Eimeria            depends upon the
                                                    adenoeides, E.        severity of
                                                    meleagrimitis, and    coccidiosis
                                                    E. gallopavonis,      exposure. Do not
                                                    and for increased     allow horses, other
                                                    rate of weight gain   equines, mature
                                                    and improved feed     turkeys, or guinea
                                                    efficiency.           fowl access to feed
                                                                          containing
                                                                          monensin. Ingestion
                                                                          of monensin by
                                                                          horses and guinea
                                                                          fowl has been
                                                                          fatal. Some strains
                                                                          of turkey coccidia
                                                                          may be monensin
                                                                          tolerant or
                                                                          resistant. Monensin
                                                                          may interfere with
                                                                          development of
                                                                          immunity to turkey
                                                                          coccidiosis.
                                                                          Bacitracin
                                                                          methylenedisalicyla
                                                                          te as provided by
                                                                          No. 054771 or
                                                                          069254 in Sec.
                                                                          510.600(c) of this
                                                                          chapter.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

    (3) * * *

------------------------------------------------------------------------
                          Indications for
 Monensin in grams/ton          use          Limitations       Sponsor
------------------------------------------------------------------------
(i) 5 to 40............  Growing beef      Feed             016592
                          steers and        continuously    058198
                          heifers fed in    in complete
                          confinement for   feed at a rate
                          slaughter: For    of 50 to 480
                          improved feed     milligrams of
                          efficiency.       monensin per
                                            head per day.
                                            No additional
                                            improvement in
                                            feed
                                            efficiency has
                                            been shown
                                            from feeding
                                            monensin at
                                            levels greater
                                            than 30 grams
                                            per ton (360
                                            milligrams per
                                            head per day).
                                            See special
                                            labeling
                                            considerations
                                            in paragraph
                                            (d) of this
                                            section.
(ii) 10 to 40..........  Growing beef      Feed at a rate   016592
                          steers and        of 0.14 to      058198
                          heifers fed in    0.42 milligram
                          confinement for   per pound of
                          slaughter: For    body weight
                          prevention and    per day,
                          control of        depending upon
                          coccidiosis due   the severity
                          to Eimeria        of challenge,
                          bovis and E.      up to maximum
                          zuernii.          of 480
                                            milligrams per
                                            head per day.
                                            See special
                                            labeling
                                            considerations
                                            in paragraph
                                            (d) of this
                                            section.
(iii) 10 to 200........  Calves excluding  Feed at a rate   016592
                          veal calves:      of 0.14 to 1.0  058198
                          For prevention    milligram
                          and control of    monensin per
                          coccidiosis due   pound of body
                          to Eimeria        weight per
                          bovis and E.      day, depending
                          zuernii.          upon the
                                            severity of
                                            challenge, up
                                            to maximum of
                                            200 milligrams
                                            per head per
                                            day. See
                                            special
                                            labeling
                                            considerations
                                            in paragraph
                                            (d) of this
                                            section.
(iv) 11 to 22..........  Dairy cows: For   Feed             016592
                          increased milk    continuously    058198
                          production        to dry and
                          efficiency        lactating
                          (production of    dairy cows in
                          marketable        a total mixed
                          solids-           ration
                          corrected milk    (``complete
                          per unit of       feed''). See
                          feed intake).     special
                                            labeling
                                            considerations
                                            in paragraph
                                            (d) of this
                                            section.
(v) 11 to 400..........  Dairy cows: For   Feed             016592
                          increased milk    continuously    058198
                          production        to dry and
                          efficiency        lactating
                          (production of    dairy cows in
                          marketable        a component
                          solids-           feeding system
                          corrected milk    (including top
                          per unit of       dress). The
                          feed intake).     Type C
                                            medicated feed
                                            must be fed in
                                            a minimum of 1
                                            lb of feed to
                                            provide 185 to
                                            660 mg/head/
                                            day monensin
                                            to lactating
                                            cows or 115 to
                                            410 mg/head/
                                            day monensin
                                            to dry cows.
                                            See special
                                            labeling
                                            considerations
                                            in paragraph
                                            (d) of this
                                            section.

[[Page 58012]]

 
(vi) 15 to 400.........  Growing beef      For increased    016592
                          steers and        rate of weight  058198
                          heifers on        gain, feed at
                          pasture           a rate of 50
                          (stocker,         to 200
                          feeder, and       milligrams
                          slaughter) or     monensin per
                          in a dry lot      head per day
                          and replacement   in not less
                          beef and dairy    than 1 pound
                          heifers: For      of feed or,
                          increased rate    after the 5th
                          of weight gain,   day, feed at a
                          and for           rate of 400
                          prevention and    milligrams per
                          control of        head per day
                          coccidiosis due   every other
                          to Eimeria        day in not
                          bovis and E.      less than 2
                          zuernii.          pounds of
                                            feed. For
                                            prevention and
                                            control of
                                            coccidiosis,
                                            feed at a rate
                                            of 0.14 to
                                            0.42 milligram
                                            per pound of
                                            body weight
                                            per day,
                                            depending on
                                            severity of
                                            challenge, up
                                            to 200
                                            milligrams per
                                            head per day.
                                            During first 5
                                            days of
                                            feeding,
                                            cattle should
                                            receive no
                                            more than 100
                                            milligrams per
                                            day in not
                                            less than 1
                                            pound of feed.
                                            See special
                                            labeling
                                            considerations
                                            in paragraph
                                            (d) of this
                                            section.
(vii) 25 to 400........  Beef cows: For    Feed as          016592
                          improved feed     supplemental    058198
                          efficiency when   feed, either
                          receiving         hand-fed in a
                          supplemental      minimum of 1
                          feed, and for     pound of feed
                          the prevention    or mixed in a
                          and control of    total ration.
                          coccidiosis due   For improved
                          to Eimeria        feed
                          bovis and E.      efficiency,
                          zuernii.          feed
                                            continuously
                                            at a rate of
                                            50 to 200
                                            milligrams
                                            monensin per
                                            head per day.
                                            For prevention
                                            and control of
                                            coccidiosis,
                                            feed at a rate
                                            of 0.14 to
                                            0.42 milligram
                                            per pound of
                                            body weight
                                            per day,
                                            depending upon
                                            severity of
                                            challenge, up
                                            to a maximum
                                            of 200
                                            milligrams per
                                            head per day.
                                            During first 5
                                            days of
                                            feeding,
                                            cattle should
                                            receive no
                                            more than 100
                                            milligrams per
                                            head per day
                                            in not less
                                            than 1 pound
                                            of feed. See
                                            special
                                            labeling
                                            considerations
                                            in paragraph
                                            (d) of this
                                            section.
------------------------------------------------------------------------

    (4) * * *

----------------------------------------------------------------------------------------------------------------
            Monensin amount                 Indications for use          Limitations               Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 150 milligrams per pound of protein- Growing beef steers and   Provide 50 to 200        012286
 mineral block (0.033%).                  heifers on pasture        milligrams of monensin
                                          (stocker, feeder, and     (0.34 to 1.33 pounds
                                          slaughter) and            of block) per head per
                                          replacement beef          day, at least 1 block
                                          heifers on pasture: For   per 10 to 12 head of
                                          increased rate of         cattle. Roughage must
                                          weight gain, and for      be available at all
                                          prevention and control    times. Do not allow
                                          of coccidiosis caused     animals access to
                                          by Eimeria bovis and E.   other protein blocks,
                                          zuernii in pasture        salt or mineral, while
                                          cattle which may          being fed this
                                          require supplemental      product. See paragraph
                                          feed.                     (d)(10)(i) of this
                                                                    section.
(ii) 175 milligrams per pound of         Growing beef steers and   Provide 40 to 200        017800
 protein-mineral block (0.038%).          heifers on pasture        milligrams of monensin
                                          (stocker, feeder, and     (0.25 to 1.13 pounds
                                          slaughter): For           or 4 to 18 ounces of
                                          increased rate of         block) per head per
                                          weight gain.              day, at least 1 block
                                                                    per 4 head of cattle.
                                                                    Do not allow cattle
                                                                    access to salt or
                                                                    mineral while being
                                                                    fed this product.
                                                                    Ingestion by cattle of
                                                                    monensin at levels of
                                                                    600 milligrams per
                                                                    head per day and
                                                                    higher has been fatal.
                                                                    See paragraph
                                                                    (d)(10)(i) of this
                                                                    section.
 
                                                  * * * * * * *
(v) 1,620 grams per ton of mineral       Growing beef steers and   Feed at a rate of 50 to  016592
 granules as specified in paragraph       heifers on pasture        200 milligrams per      058198
 (f)(4)(v)(A) of this section.            (stocker, feeder, and     head per day. During
                                          slaughter) or in a dry    the first 5 days of
                                          lot and replacement       feeding, cattle should
                                          beef and dairy heifers:   receive no more than
                                          For increased rate of     100 milligrams per
                                          weight gain, and for      day. Do not feed
                                          prevention and control    additional salt or
                                          of coccidiosis due to     minerals. Do not mix
                                          Eimeria bovis and E.      with grain or other
                                          zuernii.                  feeds. Monensin is
                                                                    toxic to cattle when
                                                                    consumed at higher
                                                                    than approved levels.
                                                                    Stressed and/or feed-
                                                                    and/or water-deprived
                                                                    cattle should be
                                                                    adapted to the pasture
                                                                    and to unmedicated
                                                                    mineral supplement
                                                                    before using the
                                                                    monensin mineral
                                                                    supplement.
----------------------------------------------------------------------------------------------------------------

    (A) Specifications. Use as free-choice Type C medicated feed 
formulated as mineral granules as follows:

------------------------------------------------------------------------
                                                           International
                  Ingredient                    Percent      feed No.
------------------------------------------------------------------------
Monocalcium phosphate (21% phosphorus, 15%         29.49        6-01-082
 calcium)....................................
Sodium chloride (salt).......................      24.37        6-04-152
Dried cane molasses..........................       20.0        4-04-695
Ground limestone (33% calcium) or calcium          13.75        6-02-632
 carbonate (38% calcium).....................

[[Page 58013]]

 
Cane molasses................................        3.0        4-04-696
Processed grain by-products (as approved by          5.0  ..............
 AAFCO)......................................
Vitamin/trace mineral premix \1\.............        2.5  ..............
Monensin Type A article, 90.7 grams per pound       0.89  ..............
Antidusting oil..............................        1.0  ..............
------------------------------------------------------------------------
\1\ Content of vitamin and trace mineral premixes may be varied.
  However, they should be comparable to those used for other free-choice
  feeds. Formulation modifications require FDA approval prior to
  marketing. Selenium must comply with 21 CFR 573.920. Ethylenediamine
  dihydroiodide should comply with FDA Compliance Policy Guide Sec.
  651.100 (CPG 7125.18).

    (B) [Reserved]
* * * * *
    (6) * * *

------------------------------------------------------------------------
                          Indications for
 Monensin in grams/ton          use          Limitations       Sponsor
------------------------------------------------------------------------
(i) 20.................  Goats maintained  Feed             016592
                          in confinement:   continuously.   058198
                          For the           Do not feed to
                          prevention of     lactating
                          coccidiosis       goats. See
                          caused by         paragraph
                          Eimeria           (d)(11) of
                          crandallis, E.    this section
                          christenseni,     for provisions
                          and E.            for monensin
                          ninakohlyakimov   liquid Type C
                          ae.               goat feeds.
 
                              * * * * * * *
------------------------------------------------------------------------

    (7) * * *
    (viii) Ractopamine as in Sec.  558.500.
* * * * *

0
33. In Sec.  558.500, revise paragraphs (e)(2)(ii), (iv), (v), and 
(vii) to read as follows:


Sec.  558.500   Ractopamine.

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

----------------------------------------------------------------------------------------------------------------
                                                                  Indications for
   Ractopamine  in grams/ton         Combination in grams/ton           use          Limitations       Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(ii) 8.2 to 24.6 to provide 70   Monensin 10 to 40 to provide     Cattle fed in    Feed             016592
 to 430 mg/head/day.              0.14 to 0.42 mg monensin/lb of   confinement      continuously    054771
                                  body weight, depending on        for slaughter:   as sole ration  058198
                                  severity of coccidiosis          For increased    during the
                                  challenge, up to 480 mg/head/    rate of weight   last 28 to 42
                                  day.                             gain, improved   days on feed.
                                                                   feed             Not for
                                                                   efficiency,      animals
                                                                   and prevention   intended for
                                                                   and control of   breeding. See
                                                                   coccidiosis      special
                                                                   due to Eimeria   labeling
                                                                   bovis and E.     considerations
                                                                   zuernii during   in Sec.
                                                                   the last 28 to   558.355(d) of
                                                                   42 days on       this chapter.
                                                                   feed.            Ractopamine as
                                                                                    provided by
                                                                                    No. 016592,
                                                                                    054771, or
                                                                                    058198;
                                                                                    monensin as
                                                                                    provided by
                                                                                    No. 016592 or
                                                                                    058198 in Sec.
                                                                                      510.600(c)
                                                                                    of this
                                                                                    chapter.
 
                                                  * * * * * * *
(iv) 9.8 to 24.6 to provide 90   Monensin 10 to 40 to provide     Cattle fed in    Feed             016592
 to 430 mg/head/day.              0.14 to 0.42 mg monensin/lb of   confinement      continuously    054771
                                  body weight, depending on        for slaughter:   as sole ration  058198
                                  severity of coccidiosis          For increased    during the
                                  challenge, up to 480 mg/head/    rate of weight   last 28 to 42
                                  day.                             gain, improved   days on feed.
                                                                   feed             Not for
                                                                   efficiency,      animals
                                                                   increased        intended for
                                                                   carcass          breeding. See
                                                                   leanness, and    special
                                                                   prevention and   labeling
                                                                   control of       considerations
                                                                   coccidiosis      in Sec.
                                                                   due to Eimeria   558.355(d) of
                                                                   bovis and E.     this chapter.
                                                                   zuernii during   Ractopamine as
                                                                   the last 28 to   provided by
                                                                   42 days on       No. 016592,
                                                                   feed.            054771, or
                                                                                    058198;
                                                                                    monensin as
                                                                                    provided by
                                                                                    No. 016592 or
                                                                                    058198 in Sec.
                                                                                      510.600(c)
                                                                                    of this
                                                                                    chapter.
(v) 9.8 to 24.6 to provide 90    Monensin 10 to 40 to provide     Heifers fed in   Feed             016592
 to 430 mg/head/day.              0.14 to 0.42 mg monensin/lb of   confinement      continuously    054771
                                  body weight, depending on        for slaughter:   as sole ration  058198
                                  severity of coccidiosis          For increased    during the
                                  challenge, up to 480 mg/head/    rate of weight   last 28 to 42
                                  day, plus melengestrol acetate   gain, improved   days on feed.
                                  to provide 0.25 to 0.5 mg/head/  feed             Not for
                                  day.                             efficiency,      animals
                                                                   increased        intended for
                                                                   carcass          breeding. See
                                                                   leanness,        special
                                                                   prevention and   labeling
                                                                   control of       considerations
                                                                   coccidiosis      in Sec.  Sec.
                                                                   due to Eimeria    558.342(d)
                                                                   bovis and E.     and 558.355(d)
                                                                   zuernii, and     of this
                                                                   suppression of   chapter.
                                                                   estrus (heat)    Ractopamine as
                                                                   during the       provided by
                                                                   last 28 to 42    No. 016592,
                                                                   days on feed.    054771, or
                                                                                    058198;
                                                                                    monensin as
                                                                                    provided by
                                                                                    No. 016592 or
                                                                                    058198;
                                                                                    melengestrol
                                                                                    acetate as
                                                                                    provided by
                                                                                    No. 016592,
                                                                                    054771 or
                                                                                    058198 in Sec.
                                                                                      510.600(c)
                                                                                    of this
                                                                                    chapter.
 

[[Page 58014]]

 
                                                  * * * * * * *
(vii) Not to exceed 800; to      Monensin 10 to 40 to provide     Cattle fed in    Top dress        016592
 provide 70 to 400 mg/head/day.   0.14 to 0.42 mg monensin/lb of   confinement      ractopamine at  054771
                                  body weight, depending on        for slaughter:   a minimum of    058198
                                  severity of coccidiosis          For increased    1.0 lb/head/
                                  challenge, up to 480 mg/head/    rate of weight   day of
                                  day.                             gain, improved   medicated feed
                                                                   feed             continuously
                                                                   efficiency,      during the
                                                                   and prevention   last 28 to 42
                                                                   and control of   days on feed.
                                                                   coccidiosis      Not for
                                                                   due to Eimeria   animals
                                                                   bovis and E.     intended for
                                                                   zuernii during   breeding. See
                                                                   the last 28 to   special
                                                                   42 days on       labeling
                                                                   feed.            considerations
                                                                                    in Sec.
                                                                                    558.355(d) of
                                                                                    this chapter.
                                                                                    Ractopamine as
                                                                                    provided by
                                                                                    No. 016592,
                                                                                    054771, or
                                                                                    058198;
                                                                                    monensin as
                                                                                    provided by
                                                                                    No. 016592 or
                                                                                    058198 in Sec.
                                                                                      510.600(c)
                                                                                    of this
                                                                                    chapter.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

0
34. In Sec.  558. 550, revise paragraphs (a), (b), (e)(1)(i), and 
(e)(2)(i) to read as follows:


Sec.  558. 550   Salinomycin.

    (a) Specifications. Type A medicated articles containing 30 or 60 
grams of salinomycin sodium activity per pound.
    (b) Sponsor. See No. 016592 in Sec.  510.600(c) of this chapter for 
use as in paragraph (e) of this section.
* * * * *
    (e) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
 Salinomycin in grams/ton   Combination in grams/ton  Indications for use      Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 40 to 60..............  ........................  Broiler, roaster,    Feed continuously    016592
                                                       and replacement      as sole ration. Do
                                                       (breeder and         not feed to birds
                                                       layer) chickens:     producing eggs for
                                                       For the prevention   human consumption.
                                                       of coccidiosis       May be fatal if
                                                       caused by Eimeria    accidentally fed
                                                       tenella, E.          to adult turkeys
                                                       necatrix, E.         or horses.
                                                       acervulina, E.
                                                       maxima, E.
                                                       brunetti, and E.
                                                       mivati.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

    (2) * * *

----------------------------------------------------------------------------------------------------------------
                            Combination in grams per
 Salinomycin in grams/ton              ton            Indications for use      Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 50....................  ........................  Quail: For the       Feed continuously    016592
                                                       prevention of        as sole ration. Do
                                                       coccidiosis caused   not feed to birds
                                                       by Eimeria           producing eggs for
                                                       dispersa and E.      human consumption.
                                                       lettyae.             May be fatal if
                                                                            accidentally fed
                                                                            to adult turkeys
                                                                            or horses.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

0
35. In Sec.  558.625, revise paragraphs (e)(2)(i) and (e)(2)(ix) 
through (xiii) to read as follows:


Sec.  558.625  Tylosin.

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

----------------------------------------------------------------------------------------------------------------
                                     Combination in
        Tylosin grams/ton              grams/ton       Indications for use      Limitations          Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 8 to 10.....................  ...................  Beef cattle: For     Feed continuously    016592
                                                        reduction of         as the sole ration  054771
                                                        incidence of liver   to provide 60 to    058198
                                                        abscesses caused     90 mg/head/day      066104
                                                        by Fusobacterium     tylosin.
                                                        necrophorum and
                                                        Arcanobacterium
                                                        pyogenes.
 

[[Page 58015]]

 
                                                  * * * * * * *
(ix) 8 to 10....................  Monensin 10 to 40    Heifers fed in       Feed continuously    016592
                                   plus melengestrol    confinement for      as sole ration to   054771
                                   0.25 to 2.0.         slaughter: For       heifers at a rate   058198
                                                        reduction of         of 0.5 to 2 pounds
                                                        incidence of liver   per head per day
                                                        abscesses caused     to provide 0.25 to
                                                        by Fusobacterium     0.5 mg/head/day
                                                        necrophorum and      melengestrol
                                                        Arcanobacterium      acetate and 0.14
                                                        pyogenes; for        to 0.42 mg
                                                        prevention and       monensin/lb body
                                                        control of           weight per day,
                                                        coccidiosis caused   depending on the
                                                        by Eimeria bovis     severity of the
                                                        and E. zuernii;      coccidiosis
                                                        and for increased    challenge, up to
                                                        rate of weight       480 mg/head/day
                                                        gain, improved       and 60 to 90 mg/
                                                        feed efficiency,     head/day tylosin.
                                                        and suppression of   The melengestrol
                                                        estrus (heat).       acetate portion of
                                                                             this Type C
                                                                             medicated feed
                                                                             must be mixed into
                                                                             the complete feed
                                                                             containing 10 to
                                                                             40 g/ton monensin
                                                                             and 8 to 10 g/ton
                                                                             tylosin at feeding
                                                                             into the amount of
                                                                             complete feed
                                                                             consumed by an
                                                                             animal per day. A
                                                                             withdrawal time
                                                                             has not been
                                                                             established for
                                                                             pre-ruminating
                                                                             calves. Do not use
                                                                             in calves to be
                                                                             processed for
                                                                             veal. See Sec.
                                                                             Sec.   558.342(d)
                                                                             and 558.355(d) of
                                                                             this chapter.
                                                                             Tylosin provided
                                                                             by No. 016592 or
                                                                             058198; monensin
                                                                             as provided by No.
                                                                             016592 or 058198;
                                                                             melengestrol
                                                                             provided by No.
                                                                             016592, 054771, or
                                                                             058198 in Sec.
                                                                             510.600(c) of this
                                                                             chapter.
(x) 8 to 10.....................  Monensin 10 to 40    Cattle fed in        Feed continuously    016592
                                   plus ractopamine     confinement for      as sole ration to   054771
                                   8.2 to 24.6.         slaughter: For       provide 70 to 430   058198
                                                        reduction of         mg/head/day
                                                        incidence of liver   ractopamine and
                                                        abscesses caused     0.14 to 0.42 mg
                                                        by Fusobacterium     monensin/lb body
                                                        necrophorum and      weight per day,
                                                        Arcanobacterium      depending on the
                                                        pyogenes; for        severity of the
                                                        prevention and       coccidiosis
                                                        control of           challenge, up to
                                                        coccidiosis caused   480 mg/head/day
                                                        by Eimeria bovis     and 60 to 90 mg/
                                                        and E. zuernii;      head/day tylosin
                                                        and for increased    for the last 28 to
                                                        rate of weight       42 days on feed. A
                                                        gain and improved    withdrawal time
                                                        feed efficiency in   has not been
                                                        cattle fed in        established for
                                                        confinement for      pre-ruminating
                                                        slaughter for the    calves. Do not use
                                                        last 28 to 42 days   in calves to be
                                                        on feed.             processed for
                                                                             veal. See special
                                                                             labeling
                                                                             considerations in
                                                                             Sec.  Sec.
                                                                             558.355(d) and
                                                                             558.500(d) of this
                                                                             chapter. Tylosin
                                                                             provided by No.
                                                                             016592 or 058198;
                                                                             monensin as
                                                                             provided by No.
                                                                             016592 or 058198;
                                                                             ractopamine
                                                                             provided by No.
                                                                             016592, 054771, or
                                                                             058198 in Sec.
                                                                             510.600(c) of this
                                                                             chapter.
(xi) 8 to 10....................  Monensin 10 to 40    Cattle fed in        Feed a minimum of    016592
                                   plus ractopamine,    confinement for      1.0 lb/head/day     054771
                                   not to exceed 800.   slaughter: For       ractopamine Type C  058198
                                                        reduction of         top dress feed
                                                        incidence of liver   continuously to
                                                        abscesses caused     cattle fed in
                                                        by Fusobacterium     confinement for
                                                        necrophorum and      slaughter, to
                                                        Arcanobacterium      provide 70 to 400
                                                        pyogenes; for        mg/head/day
                                                        prevention and       ractopamine for
                                                        control of           the last 28 to 42
                                                        coccidiosis caused   days on feed. Feed
                                                        by Eimeria bovis     on top of a ration
                                                        and E. zuernii;      containing 10 to
                                                        and for increased    40 g/ton monensin
                                                        rate of weight       and 8 to 10 g/ton
                                                        gain and improved    tylosin phosphate,
                                                        feed efficiency in   to provide 0.14 to
                                                        cattle fed in        0.42 mg monensin/
                                                        confinement for      lb body weight/
                                                        slaughter for the    day, depending on
                                                        last 28 to 42 days   the severity of
                                                        on feed.             the coccidiosis
                                                                             challenge, up to
                                                                             480 mg/head/day
                                                                             and 60 to 90 mg/
                                                                             head/day tylosin.
                                                                             A withdrawal time
                                                                             has not been
                                                                             established for
                                                                             pre-ruminating
                                                                             calves. Do not use
                                                                             in calves to be
                                                                             processed for
                                                                             veal. See special
                                                                             labeling
                                                                             considerations in
                                                                             Sec.  Sec.
                                                                             558.355(d) and
                                                                             558.500(d) of this
                                                                             chapter. Tylosin
                                                                             provided by No.
                                                                             016592 or 058198;
                                                                             monensin as
                                                                             provided by No.
                                                                             016592 or 058198;
                                                                             ractopamine
                                                                             provided by No.
                                                                             016592, 054771, or
                                                                             058198 in Sec.
                                                                             510.600(c) of this
                                                                             chapter.

[[Page 58016]]

 
(xii) 8 to 10...................  Monensin 10 to 40    Cattle fed in        Feed continuously    016592
                                   plus ractopamine     confinement for      as sole ration to   054771
                                   9.8 to 24.6.         slaughter: For       provide 90 to 430   058198
                                                        reduction of         mg/head/day
                                                        incidence of liver   ractopamine and
                                                        abscesses caused     0.14 to 0.42 mg
                                                        by Fusobacterium     monensin/lb body
                                                        necrophorum and      weight per day,
                                                        Arcanobacterium      depending on the
                                                        pyogenes; for        severity of the
                                                        prevention and       coccidiosis
                                                        control of           challenge, up to
                                                        coccidiosis caused   480 mg/head/day
                                                        by Eimeria bovis     and 60 to 90 mg/
                                                        and E. zuernii;      head/day tylosin
                                                        and for increased    for the last 28 to
                                                        rate of weight       42 days on feed. A
                                                        gain, improved       withdrawal time
                                                        feed efficiency,     has not been
                                                        and increased        established for
                                                        carcass leanness     pre-ruminating
                                                        in cattle fed in     calves. Do not use
                                                        confinement for      in calves to be
                                                        slaughter for the    processed for
                                                        last 28 to 42 days   veal. See special
                                                        on feed.             labeling
                                                                             considerations in
                                                                             Sec.  Sec.
                                                                             558.355(d) and
                                                                             558.500(d) of this
                                                                             chapter. Tylosin
                                                                             as provided by No.
                                                                             016592 or 058198;
                                                                             monensin as
                                                                             provided by No.
                                                                             016592 or 058198;
                                                                             ractopamine as
                                                                             provided by No.
                                                                             016592, 054771, or
                                                                             058198 in Sec.
                                                                             510.600(c) of this
                                                                             chapter.
(xiii) 8 to 10..................  Monensin, 10 to 40   Heifers fed in       Feed continuously    016592
                                   plus ractopamine,    confinement for      as sole ration to   054771
                                   9.8 to 24.6, plus    slaughter: For       provide 90 to 430   058198
                                   melengestrol,        reduction of         mg/head/day
                                   0.125 to 1 mg/lb.    incidence of liver   ractopamine and
                                                        abscesses caused     0.14 to 0.42 mg
                                                        by Fusobacterium     monensin/lb body
                                                        necrophorum and      weight per day,
                                                        Arcanobacterium      depending on the
                                                        pyogenes; for        severity of the
                                                        prevention and       coccidiosis
                                                        control of           challenge, up to
                                                        coccidiosis caused   480 mg/head/day
                                                        by Eimeria bovis     and 60 to 90 mg/
                                                        and E. zuernii;      head/day tylosin
                                                        for increased rate   for the last 28 to
                                                        of weight gain,      42 days on feed.
                                                        improved feed        Feed melengestrol
                                                        efficiency, and      as a top dress or
                                                        increased carcass    mixed with a
                                                        leanness; and        complete ration at
                                                        suppression of       the rate of 0.5 to
                                                        estrus (heat) in     2.0 pound/head/day
                                                        heifers fed in       (specify one
                                                        confinement for      level) to provide
                                                        slaughter for the    0.25 to 0.5 mg
                                                        last 28 to 42 days   melengestrol
                                                        on feed.             acetate/head/day
                                                                             (specify one
                                                                             level). A
                                                                             withdrawal time
                                                                             has not been
                                                                             established for
                                                                             pre-ruminating
                                                                             calves. Do not use
                                                                             in calves to be
                                                                             processed for
                                                                             veal. See special
                                                                             labeling
                                                                             considerations in
                                                                             Sec.  Sec.
                                                                             558.342(d),
                                                                             558.355(d), and
                                                                             558.500(d) of this
                                                                             chapter. Tylosin
                                                                             provided by No.
                                                                             016592 or 058198;
                                                                             monensin as
                                                                             provided by No.
                                                                             016592 or 058198;
                                                                             ractopamine as
                                                                             provided by No.
                                                                             016592, 054771, or
                                                                             058198;
                                                                             melengestrol
                                                                             acetate as
                                                                             provided by No.
                                                                             016592 or 054771
                                                                             in Sec.
                                                                             510.600(c) of this
                                                                             chapter.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

    Dated: October 12, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-22604 Filed 10-19-21; 8:45 am]
 BILLING CODE 4164-01-P