[Federal Register Volume 89, Number 39 (Tuesday, February 27, 2024)]
[Rules and Regulations]
[Pages 14407-14412]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-03765]


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

Food and Drug Administration

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

[Docket No. FDA-2023-N-0002]


New Animal Drugs; Approval of New Animal Drug Applications; 
Withdrawal of Approval of New Animal Drug Applications, Change of 
Sponsor, Change of Sponsor Address

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

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

SUMMARY: The Food and Drug Administration (FDA or we) is amending the 
animal drug regulations to reflect application-related actions for new 
animal drug applications (NADAs) and abbreviated new animal drug 
applications (ANADAs) during October, November, and December 2023. The 
animal drug regulations are also being amended to improve their 
accuracy and readability.

DATES: This rule is effective February 27, 2024.

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 and ANADAs during October, November, and December 
2023, 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 (FOIA Summaries) under the Freedom of 
Information Act (FOIA). These documents, along with marketing 
exclusivity and patent information, may be obtained at Animal Drugs 
@FDA: https://animaldrugsatfda.fda.gov/adafda/views/#/search.

    Table 1--Original and Supplemental NADAs and ANADAs Approved During October, November, and December 2023
                                Requiring Evidence of Safety and/or Effectiveness
----------------------------------------------------------------------------------------------------------------
                                              Sponsor (drug                           Effect of the      21 CFR
       Date of approval          File No.     labeler code)       Product name           action         section
----------------------------------------------------------------------------------------------------------------
October 11, 2023..............    141-572  Virbac AH, Inc.,    AYRADIA             Original approval    520.1425
                                            P.O. Box 162059,    (metronidazole)     for the treatment
                                            Fort Worth, TX      oral solution.      of Giardia
                                            76161 (051311).                         duodenalis
                                                                                    infection in dogs.
October 13, 2023..............    141-336  ECO LLC, 344        AIVLOSIN            Supplemental         520.2645
                                            Nassau St.,         (tylvalosin         approval adding
                                            Princeton, NJ       tartrate) Water     females intended
                                            08540 (066916).     Soluble Granules.   for breeding to
                                                                                    approved classes
                                                                                    of swine.
October 20, 2023..............    141-564  Pharmgate Inc.,     PENNCHLOR           Original approval     558.128
                                            1800 Sir Tyler      (chlortetracyclin   for treatment of
                                            Rd., Wilmington,    e Type A            bacterial
                                            NC 28405 (069254).  medicated           enteritis and
                                                                article) and        pneumonia; and
                                                                RUMENSIN            for increased
                                                                (monensin Type A    rate of weight
                                                                medicated           gain or
                                                                article).           prevention and
                                                                                    control of
                                                                                    coccidiosis in
                                                                                    replacement beef
                                                                                    and dairy heifers.
November 8, 2023..............    200-758  Felix               Enrofloxacin        Original approval     522.812
                                            Pharmaceuticals     Injectable          for treatment and
                                            Pvt. Ltd., 25-28    Solution.           control of bovine
                                            North Wall Quay,                        respiratory
                                            Dublin 1, Ireland                       disease (BRD) in
                                            (086101).                               beef cattle and
                                                                                    non-lactating
                                                                                    dairy cattle and
                                                                                    swine respiratory
                                                                                    disease (SRD) and
                                                                                    control of
                                                                                    colibacillosis in
                                                                                    groups or pens of
                                                                                    weaned pigs, as a
                                                                                    generic copy of
                                                                                    NADA 141-068.

[[Page 14408]]

 
November 17, 2023.............    141-580  Orion Corp.,        BONQAT              Original approval    520.1892
                                            Orionintie 1,       (pregabalin) Oral   for alleviation
                                            02200 Espoo,        Solution.           of acute anxiety
                                            Finland (052483).                       and fear
                                                                                    associated with
                                                                                    transportation
                                                                                    and veterinary
                                                                                    visits in cats.
December 14, 2023.............    141-502  Zoetis Inc., 333    REVOLUTION PLUS     Supplemental         524.2099
                                            Portage St.,        (selamectin and     approval for the
                                            Kalamazoo, MI       sarolaner topical   treatment and
                                            49007 (054771).     solution).          control of tick
                                                                                    infestations with
                                                                                    Amblyomma
                                                                                    americanum (lone
                                                                                    star tick) in
                                                                                    cats and kittens
                                                                                    8 weeks of age
                                                                                    and older, and
                                                                                    weighing 2.8
                                                                                    pounds or greater.
December 21, 2023.............    200-760  Cronus Pharma       FLORFENIJECT        Original approval     522.955
                                            Specialties India   (florfenicol)       for treatment of
                                            Private Ltd., Sy    Injectable          bovine
                                            No-99/1, M/s GMR    Solution.           respiratory
                                            Hyderabad                               disease (BRD) and
                                            Aviation SEZ                            bovine
                                            Ltd., Mamidipalli                       interdigital
                                            Village,                                phlegmon; and for
                                            Shamshabad                              the control of
                                            Mandal, Ranga                           respiratory
                                            Reddy, Hyderabad,                       disease in cattle
                                            Telangana,                              at high risk of
                                            501218, India                           developing BRD,
                                            (069043).                               as a generic copy
                                                                                    of NADA 141-063.
December 22, 2023.............    200-762  Do................  CAROFENVET          Original approval     522.304
                                                                (carprofen)         for the relief of
                                                                Injectable          pain and
                                                                Solution.           inflammation
                                                                                    associated with
                                                                                    osteoarthritis
                                                                                    and for the
                                                                                    control of
                                                                                    postoperative
                                                                                    pain associated
                                                                                    with soft tissue
                                                                                    and orthopedic
                                                                                    surgeries, as a
                                                                                    generic copy of
                                                                                    NADA 141-199.
December 22, 2023.............    200-764  Do................  ENROPRO 22.7        Original approval     522.812
                                                                (enrofloxacin)      for the
                                                                Injectable          management of
                                                                Solution.           diseases in dogs
                                                                                    associated with
                                                                                    bacteria
                                                                                    susceptible to
                                                                                    enrofloxacin, as
                                                                                    a generic copy of
                                                                                    NADA 140-913.
December 22, 2023.............    200-765  Do................  ENROPRO 100         Original approval     522.812
                                                                (enrofloxacin)      for treatment and
                                                                Injectable          control of bovine
                                                                Solution.           respiratory
                                                                                    disease (BRD) in
                                                                                    beef cattle and
                                                                                    non-lactating
                                                                                    dairy cattle and
                                                                                    swine respiratory
                                                                                    disease (SRD) and
                                                                                    control of
                                                                                    colibacillosis in
                                                                                    groups or pens of
                                                                                    weaned pigs, as a
                                                                                    generic copy of
                                                                                    NADA 141-068.
----------------------------------------------------------------------------------------------------------------

II. Withdrawals of Approval

    ADM Animal Nutrition, Inc., 1000 North 30th St., Quincy, IL 62305-
3115 (drug labeler code 012286) requested that FDA withdraw approval of 
the four NADAs listed in table 2 because the products are no longer 
manufactured or marketed. As provided in the regulatory text of this 
document, the animal drug regulations are amended to reflect these 
actions.

   Table 2--Applications for Which Approval Was Voluntarily Withdrawn
               During October, November, and December 2023
------------------------------------------------------------------------
   Date of withdrawal of                                         21 CFR
          approval            File No.     New animal drug      section
------------------------------------------------------------------------
November 14, 2023..........    030-578  E-Z-EX Wormer Pellets        n/a
                                         (thiabendazole).
Do.........................    042-910  E-Z-EX WORMER            558.600
                                         MINTRATE Block
                                         (thiabendazole)
                                         Mineral Protein
                                         Block.
Do.........................    118-877  BAN-A-WORM (pyrantel         n/a
                                         tartrate) Ton Pack.
Do.........................    132-448  FLAVOMYCIN                558.95
                                         (bambermycins) Type
                                         A Medicated Article.
------------------------------------------------------------------------

III. Change of Sponsor

    The sponsors of the approved applications listed in table 3 have 
informed FDA that they have transferred ownership of, and all rights 
and interest in, these applications to another sponsor. The regulations 
cited in table 3 are amended to reflect these actions.

   Table 3--Applications for Which Ownership Was Transferred to Another Sponsor During October, November, and
                                                  December 2023
----------------------------------------------------------------------------------------------------------------
                                                  Transferring sponsor      New sponsor (drug
      File No.              Product name          (drug labeler code)         labeler code)       21 CFR section
----------------------------------------------------------------------------------------------------------------
200-237.............  Isoflurane, U.S.P.......  Piramal Pharma Ltd.,     Piramal Critical Care,         529.1186
                                                 Ground Floor, Piramal    Inc., 3850 Schelden
                                                 Ananta, Agastya          Circle, Bethlehem, PA
                                                 Corporate Park,          18017 (066794).
                                                 Mumbai, Maharashtra,
                                                 400070, India (065085).

[[Page 14409]]

 
200-576.............  Gentamicin Sulfate        Akorn Operating Co.      Domes Pharma S.A., ZAC        524.1044a
                       Ophthalmic Solution.      LLC, 5605 Centerpoint    de Champ Lamet, 3 rue
                                                 Ct., Suite A, Gurnee,    Andre Citroen, Pont-du-
                                                 IL 60031 (059399).       Chateau, Auvergne-
                                                                          Rh[ocirc]ne-Alpes,
                                                                          63430, France (086189).
200-670.............  SENERGY (selamectin)      Chanelle                 Virbac AH, Inc., P.O.          524.2098
                       Topical Solution.         Pharmaceuticals          Box 162059, Fort
                                                 Manufacturing Ltd.,      Worth, TX 76161
                                                 Loughrea, County         (051311).
                                                 Galway, Ireland
                                                 (061651).
200-700.............  PARASEDGE Multi for Dogs  Do.....................  Do.....................        524.1146
                       (Imidacloprid and
                       moxidectin).
200-701.............  PARASEDGE Multi for Cats  Do.....................  Do.....................        524.1146
                       (Imidacloprid and
                       moxidectin).
----------------------------------------------------------------------------------------------------------------

IV. Change of Sponsor Address

    Accord Healthcare, Inc. 1009 Slater Rd., Suite 210-B, Durham, NC 
27703 (drug labeler code 016729 in 21 CFR 510.600(c)) has informed FDA 
that it has changed its address to 126 E Lincoln Ave., Rahway, NJ 
07065. The entries in Sec.  510.600(c) are amended to reflect this 
action.

V. Technical Amendments

    FDA is making the following amendments to improve the accuracy of 
the animal drug regulations.
     21 CFR 520.1408 is revised to reflect all approved 
strengths of methylprednisolone tablets for dogs and cats.
     21 CFR 556.730 is removed because there are no approved 
products containing thiabendazole for use in food-producing animals.
     21 CFR 558.4(d) is being revised in the Category II table 
by removing the row entry for ``Thiabendazole'' because there are no 
longer any approved feed products for use in food-producing animals.
     21 CFR 558.128 is revised to reflect withdrawal periods 
for different applications approved for use of chlortetracycline in 
cattle feed.

VI. 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)). Although deemed 
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'' and 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.

List of Subjects

21 CFR Part 510

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

21 CFR Parts 520, 522, 524, and 529

    Animal drugs.

21 CFR Part 556

    Animal drugs, Food.

21 CFR Part 558

    Animal drugs, Animal feeds.

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

PART 510--NEW ANIMAL DRUGS

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

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


0
2. In Sec.  510.600, in the table in paragraph (c)(1), revise the entry 
for ``Accord Healthcare, Inc.''; and in the table in paragraph (c)(2), 
revise the entry for ``016729'' to read as follows:


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

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

------------------------------------------------------------------------
                                                           Drug labeler
                  Firm name and address                        code
------------------------------------------------------------------------
 
                              * * * * * * *
Accord Healthcare, Inc., 126 E Lincoln Ave., Rahway, NJ           016729
 07065..................................................
 
                              * * * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
     Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                              * * * * * * *
016729.....................  Accord Healthcare, Inc., 126 E Lincoln
                              Ave., Rahway, NJ 07065.
 
                              * * * * * * *
------------------------------------------------------------------------


[[Page 14410]]

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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


0
4. In Sec.  520.1408, revise paragraph (b) to read as follows:


Sec.  520.1408  Methylprednisolone.

* * * * *
    (b) Sponsors. See Nos. 054771 and 069043 in Sec.  510.600(c) of 
this chapter.
* * * * *

0
5. Add Sec.  520.1425 to read as follows:


Sec.  520.1425  Metronidazole.

    (a) Specifications. Each milliliter of suspension contains 125 
milligrams (mg) metronidazole.
    (b) Sponsor. See No. 051311 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer 25 mg per kilogram 
(11.3 mg per pound) of body weight twice daily for 5 consecutive days.
    (2) Indications for use. For the treatment of Giardia duodenalis 
infection in dogs.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
6. Add Sec.  520.1892 to read as follows:


Sec.  520.1892  Pregabalin.

    (a) Specifications. Each milliliter (mL) of solution contains 50 
milligrams (mg) pregabalin.
    (b) Sponsor. See No. 052483 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer orally as a single 
dose of 5 mg/kg (0.1 mL/kg) approximately 1.5 hours before the start of 
the transportation or veterinary visit.
    (2) Indications for use. For alleviation of acute anxiety and fear 
associated with transportation and veterinary visits.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
7. 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 and female swine intended for 
breeding in buildings experiencing an outbreak of PPE; and for control 
of swine respiratory disease (SRD) associated with Bordetella 
bronchiseptica, Glaesserella (Haemophilus) parasuis, Pasteurella 
multocida, Streptococcus suis, and Mycoplasma hyopneumoniae in groups 
of swine intended for slaughter and female swine intended for breeding 
in buildings experiencing an outbreak of SRD.
* * * * *

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

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

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


0
9. In Sec.  522.304, revise paragraph (b) to read as follows:


Sec.  522.304  Carprofen.

* * * * *
    (b) Sponsors. See Nos. 016729, 017033, 054771, 055529, and 069043 
in Sec.  510.600(c) of this chapter.
* * * * *

0
10. In Sec.  522.812, revise paragraphs (b)(1) and (2) to read as 
follows:


Sec.  522.812  Enrofloxacin.

* * * * *
    (b) * * *
    (1) Nos. 016729, 017033, 055529, 058198, 069043, and 086101 for use 
of product described in paragraph (a)(1) as in paragraph (e)(1) of this 
section; and
    (2) Nos. 051311, 055529, 058005, 058198, 061133, 069043, and 086101 
for use of product described in paragraph (a)(2) as in paragraphs 
(e)(2) and (3) of this section.
* * * * *

0
11. In Sec.  522.955, revise paragraph (b)(3) and the second sentence 
in paragraph (d)(1)(ii)(C) to read as follows:


Sec.  522.955  Florfenicol.

* * * * *
    (b) * * *
    (3) Nos. 058005, 058198, and 069043 for use of product described in 
paragraph (a)(2) of this section as in paragraph (d)(1)(ii) of this 
section.
* * * * *
    (d) * * *
    (1) * * *
    (ii) * * *
    (C) Limitations. * * * Nos. 000061, 058005, 058198, and 069043: 
Animals intended for human consumption must not be slaughtered within 
38 days of subcutaneous treatment. * * *
* * * * *

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

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

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


0
13. In 524.1044a, revise paragraph (b) to read as follows:


Sec.  524.1044a  Gentamicin ophthalmic solution.

* * * * *
    (b) Sponsors. See Nos. 000061 and 086189 in Sec.  510.600(c) of 
this chapter.
* * * * *

0
14. In 524.1146, revise paragraphs (b)(1) and (2) to read as follows:


Sec.  524.1146  Imidacloprid and moxidectin.

* * * * *
    (b) * * *
    (1) Nos. 017030, 051072, 051311, 055529, and 058198 for use of 
product described in paragraph (a)(1) of this section as in paragraph 
(d)(1) of this section.
    (2) Nos. 017030, 051072, 051311, 055529, and 058198 for use of 
product described in paragraph (a)(2) of this section as in paragraph 
(d)(2) of this section.
* * * * *

0
15. In 524.2098, revise paragraph (b) to read as follows:


Sec.  524.2098  Selamectin.

* * * * *
    (b) Sponsors. See Nos. 051072, 051311, 054771, 055529, and 061133 
in Sec.  510.600(c) of this chapter.
* * * * *

0
16. In 524.2099, revise paragraph (c)(2) to read as follows:


Sec.  524.2099  Selamectin and sarolaner.

* * * * *
    (c) * * *
    (2) Indications for use. For the prevention of heartworm disease 
caused by Dirofilaria immitis. Kills adult fleas (Ctenocephalides 
felis) and is indicated for the treatment and prevention of flea 
infestations; the treatment and control of tick infestations with 
Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast 
tick), Dermacentor variabilis (American dog tick), and Ixodes 
scapularis (black-legged tick), the treatment and control of ear mite 
(Otodectes cynotis) infestations; and the treatment and control of 
roundworm (Toxocara cati) and intestinal hookworm (Ancylostoma 
tubaeforme) infections in cats and kittens 8 weeks of age and older, 
and weighing 2.8 pounds or greater.
* * * * *

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

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


[[Page 14411]]


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


0
18. In Sec.  529.1186, revise paragraph (b) to read as follows:


Sec.  529.1186  Isoflurane.

* * * * *
    (b) Sponsors. See Nos. 017033, 054771, and 066794 in Sec.  
510.600(c) of this chapter.
* * * * *

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

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

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


Sec.  556.730  [Removed]

0
20. Remove Sec.  556.730.

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

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

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


Sec.  558.4  [Amended]

0
22. Amend Sec.  558.4, by removing the entry for ``Thiabendazole'' in 
the Category II'' table in paragraph (d).

0
23. In Sec.  558.95, revise paragraphs (b), (e)(2)(i) and (ii), and 
(e)(3)(i) and (ii) to read as follows:


Sec.  558.95  Bambermycins.

* * * * *
    (b) Sponsor. See No. 016592 in Sec.  510.600(c) of this chapter.
* * * * *
    (e) * * *
    (2) * * *

------------------------------------------------------------------------
 Bambermycins
 in grams/ton     Indications for use        Limitations        Sponsor
------------------------------------------------------------------------
(i) 1 to 2....  Growing turkeys: For    Feed continuously as      016592
                 improved feed           the sole ration.
                 efficiency.
(ii) 2........  Growing turkeys: For    Feed continuously as      016592
                 increased rate of       the sole ration.
                 weight gain and
                 improved feed
                 efficiency.
------------------------------------------------------------------------

    (3) * * *

------------------------------------------------------------------------
 Bambermycins
 in grams/ton     Indications for use        Limitations        Sponsor
------------------------------------------------------------------------
(i) 2.........  Growing-finishing       Feed continuously as      016592
                 swine: For increased    the sole ration.
                 rate of weight gain
                 and improved feed
                 efficiency.
(ii) 2 to 4...  Growing-finishing       Feed continuously as      016592
                 swine: For improved     the sole ration.
                 feed efficiency.
------------------------------------------------------------------------

* * * * *

0
24. In Sec.  558.128:
0
a. Revise paragraphs (e)(4)(xvi) and (xvii);
0
b. Redesignate paragraphs (e)(4)(xxi) through (lviii) as paragraphs 
(e)(4)(xxiii) through (lx); and
0
c. Add new paragraphs (e)(4)(xxi) and (xxii).
    The revision and additions read as follows:


Sec.  558.128  Chlortetracycline.

* * * * *
    (e) * * *
    (4) * * *

----------------------------------------------------------------------------------------------------------------
                                    Combination in grams/
     Chlortetracycline amount                ton           Indications for use        Limitations       Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(xvi) to provide 10 mg/lb of body   ....................  Calves, beef and       Feed approximately       054771
 weight daily.                                             nonlactating dairy     400 g/ton, varying      066104
                                                           cattle: For            with body weight        069254
                                                           treatment of           and feed
                                                           bacterial enteritis    consumption to
                                                           caused by              provide 10 mg/lb
                                                           Escherichia coli and   per day. Treat for
                                                           bacterial pneumonia    not more than 5
                                                           caused by              days. To sponsor
                                                           Pasteurella            No. 054771 (NADAs
                                                           multocida organisms    048-761 and 046-
                                                           susceptible to         699) and to sponsor
                                                           chlortetracycline.     No. 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 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.
                                                                                  See paragraph
                                                                                  (d)(3) of this
                                                                                  section.
(xvii) to provide 10 mg/lb of body  ....................  Calves (up to 250      A withdrawal period      066104
 weight daily.                                             lb): For the           has not been
                                                           treatment of           established for
                                                           bacterial enteritis    this product in pre-
                                                           caused by              ruminating calves.
                                                           Escherichia coli       Do not use in
                                                           susceptible to         calves to be
                                                           chlortetracycline.     processed for veal.
 

[[Page 14412]]

 
                                                  * * * * * * *
(xxi) 400 to 2,000 g/ton..........  Monensin, 15 to 84..  Replacement beef and   For replacement beef     069254
                                                           dairy heifers: For     and dairy heifers
                                                           treatment of           not currently being
                                                           bacterial enteritis    fed monensin: Feed
                                                           caused by              as the sole ration
                                                           Escherichia coli and   for not more than 5
                                                           bacterial pneumonia    days to provide 10
                                                           caused by              mg
                                                           Pasteurella            chlortetracycline
                                                           multocida              per pound of body
                                                           susceptible to         weight per day and
                                                           chlortetracycline;     0.14 to 0.42 mg
                                                           and for the            monensin per pound
                                                           prevention and         of body weight per
                                                           control of             day, depending upon
                                                           coccidiosis caused     severity of
                                                           by Eimeria bovis and   challenge, to
                                                           Eimeria zuernii.       provide 50 to 100
                                                                                  mg monensin per
                                                                                  head per day in a
                                                                                  minimum of 1 pound
                                                                                  of Type C medicated
                                                                                  feed. After 5 days,
                                                                                  continue to feed
                                                                                  monensin Type C
                                                                                  medicated feed
                                                                                  alone to provide 50
                                                                                  to 200 mg monensin
                                                                                  per head per day in
                                                                                  a minimum of 1
                                                                                  pound of Type C
                                                                                  medicated feed.
                                                                                 For replacement beef
                                                                                  and dairy heifers
                                                                                  currently being fed
                                                                                  monensin: Feed as
                                                                                  the sole ration for
                                                                                  not more than 5
                                                                                  days to provide 10
                                                                                  mg
                                                                                  chlortetracycline
                                                                                  per pound of body
                                                                                  weight per day and
                                                                                  0.14 to 0.42 mg
                                                                                  monensin per pound
                                                                                  of body weight per
                                                                                  day, depending upon
                                                                                  severity of
                                                                                  challenge, to
                                                                                  provide 50 to 200
                                                                                  mg monensin per
                                                                                  head per day in a
                                                                                  minimum of 1 pound
                                                                                  of Type C medicated
                                                                                  feed. After 5 days,
                                                                                  continue to feed
                                                                                  monensin Type C
                                                                                  medicated feed
                                                                                  alone.
                                                                                 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. A
                                                                                  withdrawal period
                                                                                  has not been
                                                                                  established for
                                                                                  this product in pre-
                                                                                  ruminating calves.
                                                                                  Do not use in
                                                                                  calves to be
                                                                                  processed for veal.
                                                                                 Monensin as provided
                                                                                  by No. 058198,
                                                                                  chlortetracycline
                                                                                  by No. 069254 in
                                                                                  Sec.   510.600(c)
                                                                                  of this chapter.
(xxii) 400 to 2,000 g/ton.........  Monensin, 15 to 400.  Replacement beef and   For replacement beef     069254
                                                           dairy heifers: For     and dairy heifers
                                                           treatment of           not currently being
                                                           bacterial enteritis    fed monensin: Feed
                                                           caused by              as the sole ration
                                                           Escherichia coli and   for not more than 5
                                                           bacterial pneumonia    days to provide 10
                                                           caused by              mg
                                                           Pasteurella            chlortetracycline
                                                           multocida              per pound of body
                                                           susceptible to         weight per day and
                                                           chlortetracycline;     50 to 100 mg
                                                           and for increased      monensin per head
                                                           rate of weight gain.   per day in a
                                                                                  minimum of 1 pound
                                                                                  of Type C medicated
                                                                                  feed. After 5 days,
                                                                                  continue to feed
                                                                                  monensin Type C
                                                                                  medicated feed
                                                                                  alone to provide 50
                                                                                  to 200 mg monensin
                                                                                  per head per day in
                                                                                  a minimum of 1
                                                                                  pound of Type C
                                                                                  medicated feed.
                                                                                 For replacement beef
                                                                                  and dairy heifers
                                                                                  currently being fed
                                                                                  monensin: Feed as
                                                                                  the sole ration for
                                                                                  not more than 5
                                                                                  days to provide 10
                                                                                  mg
                                                                                  chlortetracycline
                                                                                  per pound of body
                                                                                  weight per day and
                                                                                  50 to 200 mg
                                                                                  monensin per head
                                                                                  per day in a
                                                                                  minimum of 1 pound
                                                                                  of Type C medicated
                                                                                  feed. After 5 days,
                                                                                  continue to feed
                                                                                  monensin Type C
                                                                                  medicated feed
                                                                                  alone.
                                                                                 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. A
                                                                                  withdrawal period
                                                                                  has not been
                                                                                  established for
                                                                                  this product in pre-
                                                                                  ruminating calves.
                                                                                  Do not use in
                                                                                  calves to be
                                                                                  processed for veal.
                                                                                 Monensin as provided
                                                                                  by No. 058198,
                                                                                  chlortetracycline
                                                                                  by No. 069254 in
                                                                                  Sec.   510.600(c)
                                                                                  of this chapter.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

Sec.  558.600   [Removed]

0
25. Remove Sec.  558.600.

    Dated: February 20, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-03765 Filed 2-26-24; 8:45 am]
BILLING CODE 4164-01-P