`[Federal Register Volume 89, Number 231 (Monday, December 2, 2024)]
[Rules and Regulations]
[Pages 95101-95108]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-28061]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

[Docket No. FDA-2024-N-0002]


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

AGENCY: Food and Drug Administration, HHS.

[[Page 95102]]


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 July, August, and September 2024. The 
animal drug regulations are also being amended to improve their 
accuracy and readability.

DATES: This rule is effective December 2, 2024.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine, 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 July, August, and September 2024, 
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 and, for 
actions requiring review of safety or effectiveness data, summaries of 
the basis of approval under the Freedom of Information Act. 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 July, August, and September 2024 Requiring
                                     Evidence of Safety and/or Effectiveness
----------------------------------------------------------------------------------------------------------------
                                           Sponsor (drug                             Effect of the       21 CFR
      Date of approval        File No.   labeler code \1\)       Product name            action         section
----------------------------------------------------------------------------------------------------------------
July 2, 2024...............    200-788  Bimeda Animal        MOXISOLV Injection   Original approval     522.1450
                                         Health Ltd.          (moxidectin).        as a generic copy
                                         (061133).                                 of NADA 141-220.
July 8, 2024...............    200-771  Norbrook             FELANORM             Original approval     520.1372
                                         Laboratories, Ltd.   (methimazole) Oral   as a generic copy
                                         (055529).            Solution.            of NADA 141-292.
August 15, 2024............    200-770  Pharmgate Inc.       DERACIN              Original approval      558.128
                                         (069254).            (chlortetracycline   as a generic copy
                                                              ) and MGA            of NADA 141-530.
                                                              (melengestrol
                                                              acetate) Type C
                                                              medicated feeds.
August 26, 2024............    200-783  Huvepharma EOOD      COXIDIN 90           Original approval      558.355
                                         (016592).            (monensin) Type C    as a generic copy
                                                              medicated feeds.     of NADA 038-878
                                                                                   and NADA 130-736.
September 5, 2024..........    200-795  Felix                CARPROFEN Soft       Original approval      520.304
                                         Pharmaceuticals      Chewable Tablets     as a generic copy
                                         Pvt. Ltd. (086101).  (carprofen).         of NADA 141-111.
September 5, 2024..........    200-773  Cronus Pharma        TULAJECT 100         Original approval     522.2630
                                         Specialties India    (tulathromycin       as a generic copy
                                         Private Ltd.         injection)           of NADA 141-224.
                                         (069043).            Injectable
                                                              Solution.
September 10, 2024.........    200-774  Do.................  TULAJECT 25          Original approval          Do.
                                                              (tulathromycin       as a generic copy
                                                              injection)           of NADA 141-349.
                                                              Injectable
                                                              Solution.
September 19, 2024.........    141-585  Elanco US Inc.       ZENRELIA             Original approval     520.1136
                                         (058198).            (ilunocitinib        for control of
                                                              tablet).             pruritus
                                                                                   associated with
                                                                                   allergic
                                                                                   dermatitis and
                                                                                   control of atopic
                                                                                   dermatitis in dogs.
September 23, 2024.........    200-776  Pharmgate Inc.       DERACIN              Original approval      558.128
                                         (069254.             (chlortetracycline   as a generic copy
                                                              ), BOVATEC           of NADA 141-531.
                                                              (lasalocid), and
                                                              MGA (melengestrol
                                                              acetate) Type C
                                                              medicated feeds.
----------------------------------------------------------------------------------------------------------------
\1\ See 21 CFR 510.600(c) for sponsor addresses.

II. Withdrawals of Approval

    Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA 91767-1861 
(drug labeler code 054925) requested that FDA withdraw approval of the 
two 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 July, August, and September 2024
------------------------------------------------------------------------
   Date of withdrawal of                                        21 CFR
          approval            File No.      Product name        section
------------------------------------------------------------------------
August 8, 2024.............    130-872  Nitrofurazone          524.1580c
                                         Anesthetic Dressing
                                         (nitrofurazone and
                                         butacaine sulfate).
Do.........................    140-881  Nitrofurazone          524.1580a
                                         Soluble Dressing
                                         (nitrofurazone).
------------------------------------------------------------------------

III. Change of Sponsor

    Cephazone Pharma, LLC, 250 East Bonita Ave., Pomona, CA 91767 has 
informed FDA that it has transferred ownership of, and all rights and 
interest in, ANADA 200-420 for Ceftiofur Sodium Sterile Powder to 
Dechra Veterinary Products LLC, 7015 College Blvd., Suite 525, Overland 
Park, KS 66211. As provided in the regulatory text, the animal drug 
regulations are amended to reflect this action.

IV. Technical Amendments

    FDA is making the following amendments to improve the accuracy and 
readability of the animal drug regulations:
     21 CFR 510.600(c) is amended to remove Cephazone Pharma, 
LLC and Provetica LLC from the lists of sponsors of approved 
applications as these firms are no longer the sponsor of an approved 
application.
     21 CFR 520.522 is amended to reflect a 2023 change of 
sponsorship for cyclosporine oral solution.
     21 CFR 520.2090 is amended to revise the description of a 
tablet containing sarolaner, moxidectin, and pyrantel.

[[Page 95103]]

     21 CFR 522.2470 is being amended to reflect previous 
approval of additional indications for use of tiletamine and zolazepam.

V. Legal Authority

    This final rule is issued under section 512(i) of the Federal Food, 
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b(i)). 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, and 524

    Animal drugs.

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, 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.


Sec.  510.600  [Amended]

0
2. In Sec.  510.600, in the table in paragraph (c)(1), remove the 
entries for ``Cephazone Pharma, LLC'' and ``Provetica LLC''; and in the 
table in paragraph (c)(2), remove the entries for ``068330'' and 
``086097''.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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


Sec.  520.304  [Amended]

0
4. In Sec.  520.304, in paragraph (b)(2), add in numerical order the 
text ``086101''.


Sec.  520.522  [Amended]

0
5. In Sec.  520.522 in paragraph (b)(4), remove the text ``086097'' and 
add in its place the text ``013744''.

0
6. Add Sec.  520.1136 to read as follows:


Sec.  520.1136  Ilunocitinib.

    (a) Specifications. Each tablet contains 4.8, 6.4, 8.5, and 15 
milligrams (mg) ilunocitinib.
    (b) Sponsor. See No. 058198 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer orally 0.27 to 0.36 
mg ilunocitinib/lb (0.6 to 0.8 mg ilunocitinib/kg) body weight, once 
daily, with or without food.
    (2) Indications for use. For the control of pruritus associated 
with allergic dermatitis and control of atopic dermatitis in dogs at 
least 12 months of age.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.


Sec.  520.1372  [Redesignated as Sec.  520.1375]

0
7. Redesignate Sec.  520.1372 as Sec.  520.1375 and revise the section 
heading to read as follows:


Sec.  520.1375  Methimazole tablets.

* * * * *

0
8. Add Sec.  520.1376 to read as follows:


Sec.  520.1376  Methimazole solution.

    (a) Specifications. Each milliliter of solution contains 5 
milligrams (mg) methimazole.
    (b) Sponsor. See No. 055529 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in cats--(1) Amount. Administer a starting 
dose of 2.5 mg every 12 hours. Following 3 weeks of treatment, the dose 
should be titrated to effect based on individual serum total T4 (TT4) 
levels and clinical response. Dose adjustments should be made in 2.5 mg 
increments with a maximum dosage of 20 mg per day divided, not to 
exceed 10 mg as a single dose.
    (2) Indications for use. For the treatment of hyperthyroidism.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
9. In Sec.  520.2090, revise paragraph (a)(1) to read as follows:


Sec.  520.2090  Sarolaner, moxidectin, and pyrantel.

    (a) * * *
    (1) 3.0 milligrams (mg) sarolaner, 0.06 mg moxidectin, and 12.5 mg 
pyrantel (as pamoate salt);
* * * * *

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

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

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


0
11. In Sec.  522.313c, revise paragraph (b) to read as follows:


Sec.  522.313c  Ceftiofur sodium.

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

0
12. In Sec.  522.1450, revise paragraph (b) to read as follows:


Sec.  522.1450  Moxidectin solution.

* * * * *
    (b) Sponsors. See Nos. 055529, 058198, and 061133 in Sec.  
510.600(c) of this chapter.
* * * * *

0
13. In Sec.  522.2470, revise the section heading and paragraph (b) to 
read as follows:


Sec.  522.2470  Tiletamine and zolazepam.

* * * * *
    (b) Sponsors. See Nos. 017033, 051311, and 054771 in Sec.  
510.600(c) of this chapter.
* * * * *


Sec.  522.2630  [Amended]

0
14. In Sec.  522.2630, in paragraphs (b)(1) and (2), add in numerical 
order the text ``069043''.

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

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

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

Sec.  524.1580a  [Amended]

0
16. Amend Sec.  524.1580a in paragraph (b)(1) by removing the text 
``054925''.


Sec.  524.1580c  [Removed]

0
17. Remove Sec.  524.1580c.

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

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

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


0
19. In Sec.  558.128, revise paragraphs (e)(4)(ii), (vi), (viii), 
(xxviii), (xxxi), (xxxii), (xxxv), (xxxvi), (xxxix), (xli), (xlii), 
(l), (lii), (liv), (lvi), (lvii), (lix), and (lx) to read as follows:


Sec.  558.128  Chlortetracycline.

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

[[Page 95104]]



----------------------------------------------------------------------------------------------------------------
                                   Combination in      Indications for
    Chlortetracycline amount          grams/ton              use                  Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(ii) 5.83 to 14 g/ton to         Melengestrol        Growing beef        Melengestrol acetate Type C      054771
 provide 70 mg/head/day.          acetate, 0.25 to    heifers fed in      top-dress medicated feed        069254
                                  2 g/ton to          confinement for     must be top dressed or
                                  provide 0.25 to     slaughter (over     mixed at feeding with the
                                  0.5 mg              400 lb): For        Type C medicated feed
                                  melengestrol        reduction of the    containing 5.83 to 14 g/ton
                                  acetate per head    incidence of        chlortetracycline.
                                  per day.            liver abscesses,    Chlortetracycline as
                                                      increased rate of   provided by Nos. 054771 or
                                                      weight gain,        069254; melengestrol as
                                                      improved feed       provided by No. 054771 in
                                                      efficiency, and     Sec.   510.600(c) of this
                                                      suppression of      chapter.
                                                      estrus (heat).
 
                                                  * * * * * * *
(vi) 33.33 to 50 g/ton to        Melengestrol        Replacement beef    Melengestrol acetate Type C      054771
 provide 0.5 mg/lb of body        acetate, 0.5 to 2   heifers over 700    top-dress medicated feed        069254
 weight per day.                  g/ton to provide    lb: For control     must be top dressed or
                                  0.5 mg              of active           mixed at feeding with the
                                  melengestrol        infection of        Type C medicated feed
                                  acetate per head    anaplasmosis        containing 33.33 to 50 g/
                                  per day.            caused by           ton chlortetracycline.
                                                      Anaplasma           Feeding a Type C top-dress
                                                      marginale           medicated feed containing
                                                      susceptible to      melengestrol acetate shall
                                                      chlortetracycline   not exceed 24 days.
                                                      and for             Chlortetracycline as
                                                      suppression of      provided by Nos. 054771 or
                                                      estrus (heat).      069254; melengestrol as
                                                                          provided by No. 054771 in
                                                                          Sec.   510.600(c) of this
                                                                          chapter.
 
                                                  * * * * * * *
(viii) 25 to 1,100 g/ton to      Lasalocid, 30 to    Replacement beef    The melengestrol acetate         054771
 provide 0.5 mg/lb of body        600; melengestrol   heifers on          Type C top-dress medicated      069254
 weight daily.                    acetate, 0.5 to 2   pasture over 700    feed must be top dressed
                                  g/ton to provide    pounds: For         onto or mixed at feeding
                                  0.5 mg/head/day     control of active   with a Type C medicated
                                  melengestrol        infection of        feed containing 25 to 1,100
                                  acetate.            anaplasmosis        g/ton of chlortetracycline
                                                      caused by           and 30 to 600 g/ton
                                                      Anaplasma           lasalocid to provide 0.5 mg
                                                      marginale           chlortetracycline per lb
                                                      susceptible to      body weight per day and not
                                                      chlortetracycline   less than 60 mg or more
                                                      , increased rate    than 300 mg lasalocid per
                                                      of weight gain,     head per day in at least 1
                                                      and suppression     pound of feed. Do not
                                                      of estrus (heat).   exceed 24 days of feeding.
                                                                          See Sec.   558.311(d) of
                                                                          this chapter.
                                                                          Chlortetracycline as
                                                                          provided by Nos. 054771 or
                                                                          069254; lasalocid and
                                                                          melengestrol as provided by
                                                                          No. 054771 in Sec.
                                                                          510.600(c) of this chapter.
 
                                                  * * * * * * *
(xxviii) 500 to 4,000 g/ton to   Lasalocid, 30 to    Replacement dairy   The melengestrol acetate         054771
 provide 10 mg/lb of body         600: Melengestrol   heifers on          Type C top-dress medicated      069254
 weight daily.                    acetate, 0.5 to 2   pasture less than   feed must be top dressed
                                  g/ton to provide    20 months of age    onto or mixed at feeding
                                  0.5 mg/head/day     and replacement     with a Type C medicated
                                  melengestrol        beef heifers on     feed containing 500 to
                                  acetate.            pasture: For        4,000 g/ton of
                                                      treatment of        chlortetracycline and 30 to
                                                      bacterial           600 g/ton lasalocid to
                                                      enteritis caused    provide 10 mg
                                                      by Escherichia      chlortetracycline per lb
                                                      coli and            body weight per day and not
                                                      bacterial           less than 60 mg or more
                                                      pneumonia caused    than 300 mg lasalocid per
                                                      by Pasteurella      head per day in at least 1
                                                      multocida           pound of feed for not more
                                                      organisms           than 5 days. After
                                                      susceptible to      completing feeding of this
                                                      chlortetracycline   combination, continue
                                                      , increased rate    feeding a Type C top-dress
                                                      of weight gain,     medicated feed containing
                                                      and suppression     melengestrol acetate alone
                                                      of estrus (heat).   for a total time not
                                                                          exceeding 24 days of
                                                                          feeding. See Sec.
                                                                          558.311(d) of this chapter.
                                                                          Chlortetracycline as
                                                                          provided by Nos. 054771 or
                                                                          069254, lasalocid and
                                                                          melengestrol as provided by
                                                                          No. 054771 in Sec.
                                                                          510.600(c) of this chapter.
 
                                                  * * * * * * *
(xxxi) 500 to 4,000 g/ton to     Melengestrol        Growing beef        Melengestrol acetate Type C      054771
 provide 10 mg/lb of body         acetate, 0.25 to    heifers fed in      top-dress medicated feed        069254
 weight daily.                    2 g/ton to          confinement for     must be top dressed onto or
                                  provide 0.25 to     slaughter: For      mixed at feeding with a
                                  0.5 mg              the treatment of    Type C medicated feed
                                  melengestrol        bacterial           containing 500 to 4,000 g/
                                  acetate per head    enteritis caused    ton chlortetracycline for
                                  per day.            by Escherichia      not more than 5 days. After
                                                      coli and            completing feeding of this
                                                      bacterial           combination, continue
                                                      pneumonia caused    feeding a Type C top-dress
                                                      by Pasteurella      medicated feed containing
                                                      multocida           melengestrol acetate alone.
                                                      organisms           Chlortetracycline as
                                                      susceptible to      provided by Nos. 054771 or
                                                      chlortetracycline   069254; melengestrol as
                                                      , increased rate    provided by No. 054771 in
                                                      of weight gain,     Sec.   510.600(c) of this
                                                      improved feed       chapter.
                                                      efficiency, and
                                                      suppression of
                                                      estrus (heat).

[[Page 95105]]

 
(xxxii) 500 to 4,000 g/ton to    Melengestrol        Replacement dairy   Melengestrol acetate Type C      054771
 provide 10 mg/lb of body         acetate, 0.5 to 2   heifers less than   top-dress medicated feed        069254
 weight daily.                    g/ton to provide    20 months of age    must be top dressed or
                                  0.5 mg              and replacement     mixed at feeding with a
                                  melengestrol        beef heifers: For   Type C medicated feed
                                  acetate per head    the treatment of    containing 500 to 4,000 g/
                                  per day.            bacterial           ton chlortetracycline for
                                                      enteritis caused    not more than 5 days. After
                                                      by Escherichia      completing feeding of this
                                                      coli and            combination, continue
                                                      bacterial           feeding a Type C top-dress
                                                      pneumonia caused    medicated feed containing
                                                      by Pasteurella      melengestrol acetate alone
                                                      multocida           for a total time not
                                                      organisms           exceeding 24 days. Use in
                                                      susceptible to      dairy heifers less than 20
                                                      chlortetracycline   months of age may cause
                                                      , and for           drug residues in milk and/
                                                      suppression of      or in calves born to these
                                                      estrus (heat).      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.
                                                                          Chlortetracycline as
                                                                          provided by Nos. 054771 or
                                                                          069254; melengestrol as
                                                                          provided by No. 054771 in
                                                                          Sec.   510.600(c) of this
                                                                          chapter.
 
                                                  * * * * * * *
(xxxv) 4,000 to 20,000 g/ton to  Melengestrol        Growing beef        Top dress 0.5 to 2 pounds of     054771
 provide 10 mg/lb of body         acetate, 0.25 to    heifers fed in      this medicated feed             069254
 weight per day.                  2 g/ton to          confinement for     containing both drugs onto
                                  provide 0.25 to     slaughter: For      or mix at feeding with a
                                  0.5 mg              the treatment of    non-medicated feed for not
                                  melengestrol        bacterial           more than 5 days to provide
                                  acetate per head    enteritis caused    10 mg chlortetracycline per
                                  per day.            by Escherichia      pound of body weight per
                                                      coli and            day. After completing
                                                      bacterial           feeding of this
                                                      pneumonia caused    combination, continue
                                                      by Pasteurella      feeding a Type C top-dress
                                                      multocida           medicated feed containing
                                                      organisms           melengestrol acetate alone.
                                                      susceptible to      A withdrawal period has not
                                                      chlortetracycline   been established for this
                                                      , and for           product in pre-ruminating
                                                      increased rate of   calves. Do not use in
                                                      weight gain,        calves to be processed for
                                                      improved feed       veal. Chlortetracycline as
                                                      efficiency, and     provided by Nos. 054771 or
                                                      suppression of      069254; melengestrol as
                                                      estrus (heat).      provided by No. 054771 in
                                                                          Sec.   510.600(c) of this
                                                                          chapter.
(xxxvi) 4,000 to 20,000 g/ton    Melengestrol        Replacement dairy   Top dress 0.5 to 2 pounds of     054771
 to provide 10 mg/lb of body      acetate, 0.5 to 2   heifers less than   this medicated feed             069254
 weight per day.                  g/ton to provide    20 months of age    containing both drugs onto
                                  0.5 mg              and replacement     or mix at feeding with a
                                  melengestrol        beef heifers: For   non-medicated feed for not
                                  acetate per head    the treatment of    more than 5 days to provide
                                  per day.            bacterial           10 mg chlortetracycline per
                                                      enteritis caused    pound of body weight per
                                                      by Escherichia      day. After completing
                                                      coli and            feeding of this
                                                      bacterial           combination, continue
                                                      pneumonia caused    feeding a Type C top-dress
                                                      by Pasteurella      medicated feed containing
                                                      multocida           melengestrol acetate alone
                                                      organisms           for a total time not
                                                      susceptible to      exceeding 24 days. Use in
                                                      chlortetracycline   dairy heifers less than 20
                                                      , and for           months of age may cause
                                                      suppression of      drug residues in milk and/
                                                      estrus (heat).      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.
                                                                          Chlortetracycline as
                                                                          provided by Nos. 054771 or
                                                                          069254; melengestrol as
                                                                          provided by No. 054771 in
                                                                          Sec.   510.600(c) of this
                                                                          chapter.
 
                                                  * * * * * * *
(xxxix) 50 to 350 g/ton to       Melengestrol        Replacement beef    Melengestrol acetate Type C      054771
 provide 350 mg/head/day.         acetate, 0.5 to 2   heifers under 700   top-dress medicated feed        069254
                                  g/ton to provide    lb: For control     must be top dressed or
                                  0.5 mg              of active           mixed at feeding with the
                                  melengestrol        infection of        Type C medicated feed
                                  acetate per head    anaplasmosis        containing 50 to 350 g/ton
                                  per day.            caused by           chlortetracycline for up to
                                                      Anaplasma           24 days of feeding.
                                                      marginale           Chlortetracycline as
                                                      susceptible to      provided by Nos. 054771 or
                                                      chlortetracycline   069254; melengestrol as
                                                      and for             provided by No. 054771 in
                                                      suppression of      Sec.   510.600(c) of this
                                                      estrus (heat).      chapter.
 
                                                  * * * * * * *
(xli) 20 to 350 g/ton to         Melengestrol        Growing beef        Melengestrol acetate Type C      054771
 provide 350 mg/head/day.         acetate, 0.25 to    heifers fed in      top-dress medicated feed        069254
                                  2 g/ton to          confinement for     must be top dressed onto or
                                  provide 0.25 to     slaughter: For      mixed at feeding with the
                                  0.5 mg              control of          Type C medicated feed
                                  melengestrol        bacterial           containing 20 to 350 g/ton
                                  acetate per head    pneumonia           chlortetracycline.
                                  per day.            associated with     Chlortetracycline as
                                                      shipping fever      provided by Nos. 054771 or
                                                      complex caused by   069254; melengestrol as
                                                      Pasteurella spp.    provided by No. 054771 in
                                                      susceptible to      Sec.   510.600(c) of this
                                                      chlortetracycline   chapter.
                                                      , increased rate
                                                      of weight gain,
                                                      improved feed
                                                      efficiency, and
                                                      suppression of
                                                      estrus (heat).

[[Page 95106]]

 
(xlii) 20 to 350 g/ton to        Melengestrol        Replacement dairy   Melengestrol acetate Type C      054771
 provide 350 mg/head/day.         acetate, 0.5 to 2   heifers less than   top-dress medicated feed        069254
                                  g/ton to provide    20 months of age    must be top dressed or
                                  0.5 mg              and replacement     mixed at feeding with the
                                  melengestrol        beef heifers: For   Type C medicated feed
                                  acetate per head    control of          containing 20 to 350 g/ton
                                  per day.            bacterial           chlortetracycline. Feeding
                                                      pneumonia           a Type C top-dress
                                                      associated with     medicated feed containing
                                                      shipping fever      melengestrol acetate shall
                                                      complex caused by   not exceed 24 days of
                                                      Pasteurella spp.    feeding. Use in dairy
                                                      susceptible to      heifers less than 20 months
                                                      chlortetracycline   of age may cause drug
                                                      and suppression     residues in milk and/or in
                                                      of estrus (heat).   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. Chlortetracycline as
                                                                          provided by Nos. 054771 or
                                                                          069254; melengestrol as
                                                                          provided by No. 054771 in
                                                                          Sec.   510.600(c) of this
                                                                          chapter.
 
                                                  * * * * * * *
(l) 25 to 700 g/ton to provide   Lasalocid, 30 to    Replacement beef    The melengestrol acetate         054771
 350 mg/head/day.                 600; melengestrol   heifers on          Type C top-dress medicated      069254
                                  acetate, 0.5 to 2   pasture: For        feed must be top dressed
                                  g/ton to provide    control of          onto or mixed at feeding
                                  0.5 mg/head/day     bacterial           with a Type C medicated
                                  melengestrol        pneumonia           feed containing 25 to 700 g/
                                  acetate.            associated with     ton of chlortetracycline
                                                      shipping fever      and 30 to 600 g/ton
                                                      complex caused by   lasalocid to provide 350 mg
                                                      Pasteurella spp.    chlortetracycline per head
                                                      susceptible to      daily and not less than 60
                                                      chlortetracycline   mg or more than 300 mg
                                                      , increased rate    lasalocid per head daily in
                                                      of weight gain,     at least 1 pound of feed.
                                                      and suppression     Do not exceed 24 days of
                                                      of estrus (heat).   feeding. See Sec.
                                                                          558.311(d) of this chapter.
                                                                          Chlortetracycline as
                                                                          provided by Nos. 054771 or
                                                                          069254; lasalocid and
                                                                          melengestrol as provided by
                                                                          No. 054771 in Sec.
                                                                          510.600(c) of this chapter.
 
                                                  * * * * * * *
(lii) 25 to 700 g/ton to         Lasalocid, 30 to    Replacement beef    The melengestrol acetate         054771
 provide 350 mg/head/day.         600; melengestrol   heifers on          Type C top-dress medicated      069254
                                  acetate, 0.5 to 2   pasture under 700   feed must be top dressed
                                  g/ton to provide    pounds: For         onto or mixed at feeding
                                  0.5 mg/head/day     control of active   with a Type C medicated
                                  melengestrol        infection of        feed containing 25 to 700 g/
                                  acetate.            anaplasmosis        ton of chlortetracycline
                                                      caused by           and 30 to 600 g/ton
                                                      Anaplasma           lasalocid to provide 350 mg
                                                      marginale           chlortetracycline per head
                                                      susceptible to      daily and not less than 60
                                                      chlortetracycline   mg or more than 300 mg
                                                      , increased rate    lasalocid per head daily in
                                                      of weight gain,     at least 1 pound of feed.
                                                      and suppression     Do not exceed 24 days of
                                                      of estrus (heat).   feeding. See Sec.
                                                                          558.311(d) of this chapter.
                                                                          Chlortetracycline as
                                                                          provided by Nos. 054771 or
                                                                          069254; lasalocid and
                                                                          melengestrol as provided by
                                                                          No. 054771 in Sec.
                                                                          510.600(c) of this chapter.
 
                                                  * * * * * * *
(liv) 25 to 2,800 g/ton to       Lasalocid, 30 to    Growing beef        The melengestrol acetate         054771
 provide 350 mg/head/day.         181.8;              heifers fed in      Type C top-dress medicated      069254
                                  melengestrol        confinement for     feed must be top dressed
                                  acetate, 0.25 to    slaughter under     onto or mixed at feeding
                                  2 g/ton to          700 pounds: For     with a Type C medicated
                                  provide 0.25 to     control of active   feed containing 25 to 2,800
                                  0.5 mg/head/day     infection of        g/ton of chlortetracycline
                                  melengestrol        anaplasmosis        and 30 to 181.8 g/ton
                                  acetate.            caused by           lasalocid to provide 350 mg
                                                      Anaplasma           chlortetracycline per head
                                                      marginale           per day and 1 mg lasalocid
                                                      susceptible to      per 2.2 lb. of body weight
                                                      chlortetracycline   daily with a maximum of 360
                                                      , control of        mg lasalocid per head per
                                                      coccidiosis         day. See Sec.   558.311(d)
                                                      caused by Eimeria   of this chapter.
                                                      bovis and E.        Chlortetracycline as
                                                      zuernii,            provided by Nos. 054771 or
                                                      increased rate of   069254; lasalocid and
                                                      weight gain,        melengestrol as provided by
                                                      improved feed       No. 054771 in Sec.
                                                      efficiency, and     510.600(c) of this chapter.
                                                      suppression of
                                                      estrus (heat).
 
                                                  * * * * * * *
(lvi) 25 to 2,800 g/ton to       Lasalocid, 30 to    Growing beef        The melengestrol acetate         054771
 provide 350 mg/head/day.         181.8;              heifers fed in      Type C top-dress medicated      069254
                                  melengestrol        confinement for     feed must be top dressed
                                  acetate, 0.25 to    slaughter up to     onto or mixed at feeding
                                  2 g/ton to          800 pounds: For     with a Type C medicated
                                  provide 0.25 to     control of          feed containing 25 to 2,800
                                  0.5 mg/head/day     bacterial           g/ton of chlortetracycline
                                  melengestrol        pneumonia           and 30 to 181.8 g/ton
                                  acetate.            associated with     lasalocid to provide 350 mg
                                                      shipping fever      chlortetracycline per head
                                                      complex caused by   daily and 1 mg lasalocid
                                                      Pasteurella spp.    per 2.2 lb. of body weight
                                                      susceptible to      daily with a maximum of 360
                                                      chlortetracycline   mg lasalocid per head per
                                                      , control of        day. SeeSec.   558.311(d)
                                                      coccidiosis         of this chapter.
                                                      caused by Eimeria   Chlortetracycline as
                                                      bovis and E.        provided by Nos. 054771 or
                                                      zuernii,            069254; lasalocid and
                                                      increased rate of   melengestrol as provided by
                                                      weight gain,        No. 054771 in Sec.
                                                      improved feed       510.600(c) of this chapter.
                                                      efficiency, and
                                                      suppression of
                                                      estrus (heat).

[[Page 95107]]

 
(lvii) 25 to 2,800 g/ton to      Lasalocid, 30 to    Replacement beef    The melengestrol acetate         054771
 provide 350 mg/head/day.         181.8;              heifers up to 800   Type C top-dress medicated      069254
                                  melengestrol        pounds: For         feed must be top dressed
                                  acetate, 0.5 to 2   control of          onto or mixed at feeding
                                  g/ton to provide    bacterial           with a Type C medicated
                                  0.5 mg/head/day     pneumonia           feed containing 25 to 2,800
                                  melengestrol        associated with     g/ton of chlortetracycline
                                  acetate.            shipping fever      and 30 to 181.8 g/ton
                                                      complex caused by   lasalocid to provide 350 mg
                                                      Pasteurella spp.    chlortetracycline per head
                                                      susceptible to      daily and 1 mg lasalocid
                                                      chlortetracycline   per 2.2 lb. of body weight
                                                      , control of        daily with a maximum of 360
                                                      coccidiosis         mg lasalocid per head per
                                                      caused by Eimeria   day. Do not exceed 24 days
                                                      bovis and E.        of feeding. See Sec.
                                                      zuernii, and        558.311(d) of this chapter.
                                                      suppression of      Chlortetracycline as
                                                      estrus (heat).      provided by Nos. 054771 or
                                                                          069254; lasalocid and
                                                                          melengestrol as provided by
                                                                          No. 054771 in Sec.
                                                                          510.600(c) of this chapter.
 
                                                  * * * * * * *
(lix) 500 to 4,000 g/ton to      Lasalocid, 30 to    Growing beef        The melengestrol acetate         054771
 provide 10 mg/lb of body         181.8;              heifers fed in      Type C top-dress medicated      069254
 weight daily.                    melengestrol        confinement for     feed must be top dressed
                                  acetate, 0.25 to    slaughter up to     onto or mixed at feeding
                                  2 g/ton to          800 pounds: For     with a Type C medicated
                                  provide 0.25 to     the treatment of    feed containing 500 to
                                  0.5 mg/head/day     bacterial           4,000 g/ton of
                                  melengestrol        enteritis caused    chlortetracycline and 30 to
                                  acetate.            by Escherichia      181.8 g/ton lasalocid to
                                                      coli and            provide 10 mg
                                                      bacterial           chlortetracycline per lb of
                                                      pneumonia caused    body weight per day and 1
                                                      by Pasteurella      mg lasalocid per 2.2 lb of
                                                      multocida           body weight per day with a
                                                      organisms           maximum of 360 mg lasalocid
                                                      susceptible to      per head per day for not
                                                      chlortetracycline   more than 5 days of
                                                      , control of        feeding. After completing
                                                      coccidiosis         feeding of this
                                                      caused by Eimeria   combination, continue
                                                      bovis and E.        feeding a Type C top-dress
                                                      zuernii,            medicated feed containing
                                                      increased rate of   melengestrol acetate alone.
                                                      weight gain,        See Sec.   558.311(d) of
                                                      improved feed       this chapter.
                                                      efficiency, and     Chlortetracycline as
                                                      suppression of      provided by Nos. 054771 or
                                                      estrus (heat).      069254; lasalocid and
                                                                          melengestrol as provided by
                                                                          No. 054771 in Sec.
                                                                          510.600(c) of this chapter.
(lx) 500 to 4,000 g/ton to       Lasalocid, 30 to    Replacement dairy   The melengestrol acetate         054771
 provide 10 mg/lb of body         181.8;              heifers up to 800   Type C top-dress medicated      069254
 weight daily.                    melengestrol        pounds and less     feed must be top dressed
                                  acetate, 0.5 to 2   than 20 months of   onto or mixed at feeding
                                  g/ton to provide    age and             with a Type C medicated
                                  0.5 mg/head/day     replacement beef    feed containing 500 to
                                  melengestrol        heifers up to 800   4,000 g/ton of
                                  acetate.            pounds: For the     chlortetracycline and 30 to
                                                      treatment of        181.8 g/ton lasalocid to
                                                      bacterial           provide 10 mg
                                                      enteritis caused    chlortetracycline per lb of
                                                      by Escherichia      body weight per day and 1
                                                      coli and            mg lasalocid per 2.2 lb of
                                                      bacterial           body weight per day with a
                                                      pneumonia caused    maximum of 360 mg lasalocid
                                                      by Pasteurella      per head per day for not
                                                      multocida           more than 5 days. After
                                                      organisms           completing feeding of this
                                                      susceptible to      combination, continue
                                                      chlortetracycline   feeding a Type C top-dress
                                                      , control of        medicated feed containing
                                                      coccidiosis         melengestrol acetate alone.
                                                      caused by Eimeria   See Sec.   558.311(d) of
                                                      bovis and E.        this chapter.
                                                      zuernii, and        Chlortetracycline as
                                                      suppression of      provided by Nos. 054771 or
                                                      estrus (heat).      069254; lasalocid and
                                                                          melengestrol as provided by
                                                                          No. 054771 in Sec.
                                                                          510.600(c) of this chapter.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

0
20. In Sec.  558.355:
0
a. Revise paragraphs (b)(1) and (2);
0
b. Revise the headings for paragraphs (d)(9)(i) and (ii) and (d)(10)(i) 
and (ii);
0
c. Redesignate paragraph (f) as paragraph (e);
0
d. Revise newly redesignated paragraphs (e)(1)(i) and (ii), (e)(2)(i), 
and (e)(5);
0
e. Remove newly redesignated paragraph (e)(6); and
0
f. Redesignate newly redesignated paragraph (e)(7) as paragraph (e)(6).
    The revisions read as follows:


Sec.  558.355  Monensin.

* * * * *
    (b) * * *
    (1) No. 058198 for use as in paragraph (e) of this section.
    (2) No. 016592 for use of a Type A medicated article containing 
90.7 grams monensin, USP, per pound as in paragraphs (e)(1)(i), 
(e)(1)(ii), (e)(2)(i), (e)(3), (e)(4)(v), and (e)(5) of this section.
* * * * *
    (d) * * *
    (9) * * *
    (i) Cattle (as described in paragraphs (e)(3)(i) through (iii), 
(vi), and (vii); and (e)(4)(i) through (vi) of this section). * * *
    (ii) Dairy cows (as described in paragraphs (e)(3)(iv) and (v) of 
this section).* * *
    (10) * * *
    (i) Cattle (as described in paragraphs (e)(3)(i) through (iii), 
(vi), and (vii); and (e)(4)(i) through (vi) of this section). * * *
    (ii) Dairy cows (as described in paragraphs (e)(3)(iv) and (v) of 
this section).* * *
* * * * *
    (e) * * *
    (1) * * *

[[Page 95108]]



----------------------------------------------------------------------------------------------------------------
  Monensin in grams/ton   Combination in grams/ton  Indications for use           Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 90 to 110...........  ........................  Broiler chickens:    Feed continuously as the         016592
                                                     As an aid in the     sole ration. Not for            058198
                                                     prevention of        broiler breeder replacement
                                                     coccidiosis caused   chickens. Do not feed to
                                                     by E. necatrix, E.   chickens over 16 weeks of
                                                     tenella, E.          age. Do not feed to laying
                                                     acervulina, E.       chickens. In the absence of
                                                     brunetti, E.         coccidiosis in broiler
                                                     mivati, and E.       chickens the use of
                                                     maxima.              monensin with no withdrawal
                                                                          period may limit feed
                                                                          intake resulting in reduced
                                                                          weight gain. Do not allow
                                                                          horses, other equines,
                                                                          mature turkeys, or guinea
                                                                          fowl access to feed
                                                                          containing monensin.
                                                                          Ingestion of monensin by
                                                                          horses and guinea fowl has
                                                                          been fatal.
(ii) 90 to 110..........  ........................  Laying hen           Feed continuously as the         016592
                                                     replacement          sole ration. Not for            058198
                                                     chickens and layer   broiler breeder replacement
                                                     breeder              chickens. Do not feed to
                                                     replacement          chickens over 16 weeks of
                                                     chickens: As an      age. Do not feed to laying
                                                     aid in the           chickens. In the absence of
                                                     prevention of        coccidiosis in broiler
                                                     coccidiosis caused   chickens the use of
                                                     by E. necatrix, E.   monensin with no withdrawal
                                                     tenella, E.          period may limit feed
                                                     acervulina, E.       intake resulting in reduced
                                                     brunetti, E.         weight gain. Do not allow
                                                     mivati, and E.       horses, other equines,
                                                     maxima.              mature turkeys, or guinea
                                                                          fowl access to feed
                                                                          containing monensin.
                                                                          Ingestion of monensin by
                                                                          horses and guinea fowl has
                                                                          been fatal.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

    (2) * * *

----------------------------------------------------------------------------------------------------------------
  Monensin in grams/ton   Combination in grams/ton  Indications for use           Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 54 to 90............  ........................  Growing turkeys:     For growing turkeys only.        016592
                                                     For the prevention   Feed continuously as sole       058198
                                                     of coccidiosis       ration. Some strains of
                                                     caused by E.         turkey coccidia may be
                                                     adenoeides, E.       monensin tolerant or
                                                     meleagrimitis, and   resistant. Not for broiler
                                                     E.gallopavonis.      breeder replacement
                                                                          chickens. Do not feed to
                                                                          laying hens. Do not feed to
                                                                          chickens over 16 weeks of
                                                                          age. Monensin may interfere
                                                                          with development of
                                                                          immunity to turkey
                                                                          coccidiosis. Do not allow
                                                                          horses, other equines,
                                                                          mature turkeys, or guinea
                                                                          fowl access to feed
                                                                          containing monensin.
                                                                          Ingestion of monensin by
                                                                          horses and guinea fowl has
                                                                          been fatal.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

    (5) Minor species--

----------------------------------------------------------------------------------------------------------------
      Monensin in grams/ton            Indications for use                   Limitations                Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 73...........................  Growing bobwhite quail: For  Feed continuously as sole ration. Not     016592
                                    the prevention of            for broiler breeder replacement          058198
                                    coccidiosis caused by        chickens. Do not feed to laying
                                    Eimeria dispersa and E.      hens. Do not feed to chickens over
                                    lettyae.                     16 weeks of age. Do not allow
                                                                 horses, other equines, mature
                                                                 turkeys, or guinea fowl access to
                                                                 feed containing monensin. Ingestion
                                                                 of monensin by horses and guinea
                                                                 fowl has been fatal.
(ii) 20..........................  Goats maintained in          Feed continuously. Do not feed to         016592
                                    confinement: For the         lactating goats. See paragraph           058198
                                    prevention of coccidiosis    (d)(11) of this section for
                                    caused by Eimeria            provisions for monensin liquid Type
                                    crandallis, E.               C goat feeds.
                                    christenseni, and E.
                                    ninakohlyakimovae.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

    Dated: November 20, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-28061 Filed 11-29-24; 8:45 am]
BILLING CODE 4164-01-P`