[Federal Register Volume 89, Number 208 (Monday, October 28, 2024)]
[Rules and Regulations]
[Pages 85423-85429]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-24820]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 516, 520, 522, 524, 529, 556, and 558

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


New Animal Drugs; 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), abbreviated new animal drug 
applications (ANADAs), and conditionally approved new animal drug 
applications (CNADAs) during April, May, and June 2024. The animal drug 
regulations are also being amended to improve their accuracy and 
readability.

DATES: This rule is effective October 28, 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, <a href="/cdn-cgi/l/email-protection#46012329342123680e272f24232a06202227682e2e3568212930"><span class="__cf_email__" data-cfemail="4d0a28223f2a2863052c242f28210d2b292c6325253e632a223b">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Approvals

    FDA is amending the animal drug regulations to reflect approval 
actions for NADAs, ANADAs, and CNADAs during April, May, and June 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 (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.

[[Page 85424]]



Table 1--Original and Supplemental NADAs, ANADAs, and CNADAs Approved During April, May, and June 2024 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
----------------------------------------------------------------------------------------------------------------
April 5, 2024............    141-043  Zoetis Inc, 333       SYNOVEX CHOICE       Supplemental           522.2478
                                       Portage St.,          (trenbolone          approval for
                                       Kalamazoo, MI 49007   acetate and          increased rate of
                                       (054771).             estradiol            weight gain in
                                                             benzoate) and        growing beef
                                                             SYNOVEX PRIMER       steers and heifers
                                                             (trenbolone          in a dry lot.
                                                             acetate and
                                                             estradiol
                                                             benzoate).
April 9, 2024............    141-550  Elanco US Inc., 2500  PRADALEX             Original approval      522.1860
                                       Innovation Way,       (pradofloxacin       for treatment of       556.530
                                       Greenfield, IN        injection).          bovine respiratory
                                       46140 (058198).                            disease and swine
                                                                                  respiratory
                                                                                  disease.
April 10, 2024...........    200-777  Felix                 Carprofen            Original approval       522.304
                                       Pharmaceuticals PVT   Injectable           as a generic copy
                                       Ltd., 25-28 North     Solution.            of NADA 141-199.
                                       Wall Quay, Dublin
                                       1, Ireland (086101).
April 25, 2024...........    200-728  Cronus Pharma         PIMOMEDIN            Original approval      520.1780
                                       Specialties India     (pimobendan)         as a generic copy
                                       Private Ltd., Plot    Tablets.             of NADA 141-033.
                                       No. 9(B), Survey
                                       No. 99/1, GMR
                                       Hyderabad Aviation
                                       SEZ Ltd.,
                                       Mamidipalle
                                       Village, Balapur
                                       Mandal, Shamshabad,
                                       Rangareddy,
                                       Hyderabad,
                                       Telangana, 500108,
                                       India (069043).
April 26, 2024...........    141-582  Warburton Technology  MULTIMIN 90 (zinc,   Original approval      522.2694
                                       Ltd., 36              copper, manganese,   as a supplemental
                                       Fitzwilliam Square,   and selenium         source of zinc,
                                       Dublin, Dublin,       injection).          copper, manganese,
                                       D02HX82, Ireland                           and selenium in
                                       (066679).                                  cattle.
May 8, 2024..............    200-780  Aurora                COCCIAID             Original approval       520.100
                                       Pharmaceutical,       (amprolium) for      as a generic copy
                                       Inc., 1196 Highway    Calves.              of NADA 013-149.
                                       3 South,
                                       Northfield, MN
                                       55057-3009 (051072).
May 9, 2024..............    200-782  Cronus Pharma         ENROPRO Silver Otic  Original approval       524.802
                                       Specialties India     (enrofloxacin/       as a generic copy
                                       Private Ltd., Plot    silver               of NADA 141-176.
                                       No. 9(B), Survey      sulfadiazine) Otic
                                       No. 99/1, GMR         Emulsion.
                                       Hyderabad Aviation
                                       SEZ Ltd.,
                                       Mamidipalle
                                       Village, Balapur
                                       Mandal, Shamshabad,
                                       Rangareddy,
                                       Hyderabad,
                                       Telangana, 500108,
                                       India (069043).
May 10, 2024.............    141-577  Vetoquinol USA,       UPCARD-CA1           Conditional            516.2475
                                       Inc., 4250 N          (torsemide oral      approval as
                                       Sylvania Ave., Fort   solution).           concurrent therapy
                                       Worth, TX 76137                            with pimobendan,
                                       (017030).                                  spironolactone,
                                                                                  and an angiotensin
                                                                                  converting enzyme
                                                                                  (ACE) inhibitor
                                                                                  for the management
                                                                                  of pulmonary edema
                                                                                  in dogs with
                                                                                  congestive heart
                                                                                  failure caused by
                                                                                  myxomatous mitral
                                                                                  valve disease
                                                                                  (MMVD).
May 16, 2024.............    200-781  Cronus Pharma         FLUNINE (flunixin    Original approval       522.970
                                       Specialties India     meglumine            as a generic copy
                                       Private Ltd., Plot    injection).          of NADA 101-479.
                                       No. 9(B), Survey
                                       No. 99/1, GMR
                                       Hyderabad Aviation
                                       SEZ Ltd.,
                                       Mamidipalle
                                       Village, Balapur
                                       Mandal, Shamshabad,
                                       Rangareddy,
                                       Hyderabad,
                                       Telangana, 500108,
                                       India (069043).
May 23, 2024.............    131-675  Intervet, Inc., 126   SAFE-GUARD 20%       Supplemental            558.258
                                       E Lincoln Ave.,       (fenbendazole)       approval for the
                                       Rahway, NJ 07065      Type A medicated     treatment and
                                       (000061).             article.             control of cecal
                                                                                  worms
                                                                                  (Aulonocephalus
                                                                                  spp.) in wild
                                                                                  quail.
June 4, 2024.............    138-255  Sparhawk              Iron Dextran 20%     Supplemental           522.1182
                                       Laboratories, Inc.,   Injection (iron      approval for the
                                       12340 Santa Fe        hydrogenated         prevention or
                                       Trail Dr., Lenexa,    dextran injection)   treatment of iron
                                       KS 66215 (058005).    Injectable           deficiency anemia
                                                             Solution.            in nursing piglets.
June 11, 2024............    200-787  ZyVet Animal Health,  Phenylpropanolamine  Original approval      520.1760
                                       Inc., 73 Route 31N,   Hydrochloride        for the control of
                                       Pennington, NJ        Chewable Tablets.    urinary
                                       08534 (086117).                            incontinence due
                                                                                  to urethral
                                                                                  sphincter
                                                                                  hypotonus in dogs
                                                                                  as a generic copy
                                                                                  of NADA 141-324.
June 17, 2024............    200-785  Felix                 Maropitant Citrate   Original approval      520.1315
                                       Pharmaceuticals PVT   Tablets              as a generic copy
                                       Ltd., 25-28 North     (maropitant          of NADA 141-262.
                                       Wall Quay, Dublin     citrate).
                                       1, IRELAND.
June 20, 2024............    200-784  ZyVet Animal Health,  Trimeprazine with    Original approval      520.2604
                                       Inc., 73 Route 31N,   prednisolone         as a generic copy
                                       Pennington, NJ        tablets.             of NADA 012-437.
                                       08534 (086117).
----------------------------------------------------------------------------------------------------------------

II. Change of Sponsor

    Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140 has 
informed FDA that it has transferred ownership of, and all rights and 
interest in, ANADA 200-582 for LONCOR 300 (florfenicol) Injectable 
Solution to Zoetis Inc, 333 Portage St., Kalamazoo, MI 49007. As 
provided in the regulatory text of this document, the animal drug 
regulations are amended to reflect this action.

III. Change of Sponsor Address

    Ivaoes Animal Health (drug labeler code 086064 in 21 CFR 
510.600(c)) has informed FDA that it has changed its address to 2101 W 
Atlantic Blvd., Suite 108, Pompano Beach, FL 33069. The entries in 
Sec.  510.600(c) 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.
    <bullet> 21 CFR 510.600 is amended to revise the entries for Ivaoes 
Animal Health Inc. in the lists of sponsors of approved applications 
and to add entries for Warburton Technology Ltd.

[[Page 85425]]

    <bullet> 21 CFR 516.1760 is being amended to provide for additional 
strengths of phenobarbital tablets.
    <bullet> 21 CFR 520.2130 is amended to revise body weights of dogs 
and cats for treatment with spinosad chewable tablets.
    <bullet> 21 CFR 520.2598 is being amended to reflect an additional 
strength trilostane capsule.
    <bullet> 21 CFR 522.772 is amended to revise specific parasite 
indications and to reflect the prescription marketing status of 
doramectin and levamisole injectable solution for use in cattle.
    <bullet> 21 CFR 522.970 is amended to reflect approved food-
producing animal species for separate sponsor products.
    <bullet> 21 CFR 522.1696b is amended to revise the preslaughter 
withdrawal period for cattle administered a penicillin G procaine 
aqueous suspension.
    <bullet> 21 CFR 529.1004 is amended to reflect approved conditions 
of use for formalin in finfish.
    <bullet> 21 CFR 529.1150 is amended to reflect approved conditions 
of use for hydrogen peroxide in freshwater-reared salmonids.
    <bullet> 21 CFR 556.275 is amended by adding a tolerance for 
residues of fenbendazole in edible tissues of quail established as a 
consequence of the supplemental approval of fenbendazole medicated 
quail feed.
    <bullet> 21 CFR 556.530 is added to provide tolerances for residues 
of pradofloxacin in edible tissues of cattle and swine.
    <bullet> 21 CFR 558.261 is being amended to reflect incorporation 
levels of florfenicol in medicated feed for freshwater-reared 
salmonids.
    <bullet> 21 CFR 558.450 is being amended to provide inclusion rates 
for oxytetracycline in medicated feed for finfish.

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 Part 516

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

21 CFR Parts 520, 522, 524, and 529

    Animal drugs.

21 CFR Part 556

    Animal drugs, Dairy products, Foods, Meat and meat products.

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, 516, 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(c):
0
a. In the table in paragraph (c)(1), revise the entry for ``Ivaoes 
Animal Health'' and add in alphabetical order an entry for ``Warburton 
Technology Ltd.''; and
0
b. In the table in paragraph (c)(2), add an entry in numerical order 
for ``066679'' and revise the entry for ``086064''.
    The revisions and additions read as follows:


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

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

------------------------------------------------------------------------
                                                           Drug labeler
                  Firm name and address                        code
------------------------------------------------------------------------
 
                              * * * * * * *
Ivaoes Animal Health, 2101 W Atlantic Blvd., Suite 108,           086064
 Pompano Beach, FL 33069................................
 
                              * * * * * * *
Warburton Technology Ltd., 36 Fitzwilliam Square, Dublin          066679
 2, Dublin, D02HX82, Ireland............................
 
                              * * * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
    Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                              * * * * * * *
066679..................  Warburton Technology Ltd., 36 Fitzwilliam
                           Square, Dublin 2, Dublin, D02HX82, Ireland.
 
                              * * * * * * *
086064..................  Ivaoes Animal Health, 2101 W Atlantic Blvd.,
                           Suite 108, Pompano Beach, FL 33069.
 
                              * * * * * * *
------------------------------------------------------------------------


[[Page 85426]]

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

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

    Authority:  21 U.S.C. 360ccc-1, 360ccc-2, 371.


0
4. In Sec.  516.1760, revise paragraph (a) to read as follows:


Sec.  516.1760   Phenobarbital.

    (a) Specifications. Each tablet contains 15, 16.2, 30, 32.4, 60, 
64.8, 97.2 or 100 milligrams (mg) phenobarbital.
* * * * *

0
5. Add Sec.  516.2475 to subpart E to read as follows:


Sec.  516.2475   Torsemide.

    (a) Specifications. Each milliliter of solution contains 0.2 
milligrams (mg) torsemide.
    (b) Sponsor. See No. 017030 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer orally once 
daily at a dose of 0.05 to 0.2 mg/lb (0.11 to 0.44 mg/kg) of 
bodyweight.
    (2) Indications for use. For use as concurrent therapy with 
pimobendan, spironolactone, and an angiotensin converting enzyme (ACE) 
inhibitor for the management of pulmonary edema in dogs with congestive 
heart failure caused by myxomatous mitral valve disease (MMVD).
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian. It is a violation of Federal law 
to use this product other than as directed in the labeling.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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


0
7. In Sec.  520.100, revise paragraph (b)(2), and remove paragraph 
(b)(3) to read as follows:


Sec.  520.100   Amprolium.

* * * * *
    (b) * * *
    (2) Nos. 051072 and 066104 for use of product described in 
paragraph (a)(1) of this section as in paragraph (d) of this section.
* * * * *

0
8. In Sec.  520.1315, revise paragraph (b) to read as follows:


Sec.  520.1315   Maropitant.

* * * * *
    (b) Sponsors. See Nos. 054771, 086101, and 086117 in Sec.  
510.600(c) of this chapter.
* * * * *

0
9. In Sec.  520.1760, revise paragraph (b) to read as follows:


Sec.  520.1760  Phenylpropanolamine.

* * * * *
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for 
use as in paragraph (c) of this section:
    (1) Nos. 055246 and 086117 for use of product described in 
paragraph (a)(1) of this section as in paragraphs (c)(1)(i) and (c)(2) 
and (3) of this section.
    (2) No. 055246 for use of product described in paragraph (a)(2) of 
this section as in paragraph (c)(1)(ii) and (c)(2) and)(3) of this 
section.
* * * * *

0
10. In Sec.  520.1780, revise paragraph (b) to read as follows:


Sec.  520.1780   Pimobendan tablets.

* * * * *
    (b) Sponsors. See Nos. 000010 and 069043 in Sec.  510.600(c) of 
this chapter.
* * * * *


Sec.  520.2130   [Amended]

0
11. In Sec.  520.2130:
0
a. In paragraph (d)(1)(ii), remove the text ``3.3 pounds'' and in its 
place add the text ``5.0 pounds''; and
0
b. In paragraph (d)(2)(ii), remove the text ``2 pounds'' and in its 
place add the text ``4.1 pounds''.

0
12. In Sec.  520.2598, revise paragraph (a) to read as follows:


Sec.  520.2598   Trilostane.

    (a) Specifications. Each capsule contains 5, 10, 20, 30, 60, or 120 
milligrams (mg) trilostane.
* * * * *

0
13. In Sec.  520.2604, revise paragraph (b) to read as follows:


Sec.  520.2604  Trimeprazine and prednisolone tablets.

* * * * *
    (b) Sponsors. See Nos. 054771 and 086117 in Sec.  510.600(c) of 
this chapter.
* * * * *

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

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

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


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


Sec.  522.304   Carprofen.

* * * * *
    (b) Sponsors. See Nos. 016729, 017033, 054771, 055529, 069043, and 
086101 in Sec.  510.600(c) of this chapter.
* * * * *

0
16. In Sec.  522.772:
0
a. Revise paragraph (d)(1)(ii); and
0
b. In paragraph (d)(1)(iii), add a sentence to the end of the 
paragraph.
    The revision and addition read as follows:


Sec.  522.772   Doramectin and levamisole.

* * * * *
    (d) * * *
    (1) * * *
    (ii) Indications for use. For treatment and control of 
gastrointestinal roundworms (adults and fourth stage larvae): 
Ostertagia ostertagi (including inhibited larvae), O. lyrata, 
Haemonchus placei, Trichostrongylus axei, T. colubriformis, T. 
longispicularis (adults only), Oncophora, Cooperia pectinata (adults 
only), C. punctata, C. surnabada, Bunostomum phlebotomum (adults only), 
Strongyloides papillosus (adults only), Oesophagostomum radiatum, 
Trichuris spp. (adults only) and Nematodirus helvetianus (adults only); 
lungworms (adults and fourth stage larvae): Dictyocaulus viviparus; 
eyeworms (adults): Thelazia spp.; grubs (parasitic stages): Hypoderma 
bovis and H. lineatum; sucking lice: Haematopinus eurysternus, 
Linognathus vituli, and Solenopotes capillatus; mange mites: Psoroptes 
bovis and Sarcoptes scabiei in beef cattle 2 months of age and older 
and replacement dairy heifers less than 20 months of age. Not for use 
in beef bulls intended for breeding over 1 year of age, dairy calves, 
and veal calves.
    (iii) * * * Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.
* * * * *


Sec.  522.955   [Amended]

0
17. In Sec.  522.955:
0
a. In paragraph (b)(3), remove the text ``Nos. 058005, 058198, and 
069043'' and in its place add the text ``Nos. 054771, 058005, and 
069043''; and
0
b. In paragraph (d)(1)(ii)(C), in the second sentence, remove the text 
``Nos. 000061, 058005, 058198, and 069043'' and in its place add the 
text ``Nos. 000061, 054771, 058005, and 069043''.

0
18. In Sec.  522.970, revise paragraphs (b)(1) and (3) to read as 
follows:


Sec.  522.970   Flunixin.

* * * * *
    (b) * * *
    (1) See Nos. 000061, 055529, and 061133 for use as in paragraph (e) 
of this section.
* * * * *

[[Page 85427]]

    (3) See Nos. 016592, 058198, and 069043 for use as in paragraphs 
(e)(1) and (2) of this section.
* * * * *

0
19. In Sec.  522.1182, revise introductory text of paragraph (b)(7) to 
read as follows:


Sec.  522.1182   Iron injection.

* * * * *
    (b) * * *
    (7) Nos. 016592, 042552, and 058005 for use product described in 
paragraph (a)(2) of this section as follows:
* * * * *

0
20. In Sec.  522.1696b, revise paragraph (d)(2)(iii)(B) to read as 
follows:


Sec.  522.1696b   Penicillin G procaine aqueous suspension.

* * * * *
    (d) * * *
    (2) * * *
    (iii) * * *
    (B) For Nos. 016592 and 055529: treatment should not exceed 4 
consecutive days. A withdrawal period has not been established for this 
product in pre-ruminating calves. Discontinue treatment for the 
following number of days before slaughter: cattle--14; sheep--9; and 
swine--7.
* * * * *

0
21. Add Sec.  522.1860 to read as follows:


Sec.  522.1860   Pradofloxacin.

    (a) Specifications. Each milliliter (mL) of solution contains 200 
milligrams (mg) pradofloxacin.
    (b) Sponsor. See No. 058198 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.530 of this chapter.
    (d) Conditions of use--(1) Cattle--(i) Amount. Administer a single 
dose of 10 mg/kg (2.3 mL/100 lb) body weight by subcutaneous injection.
    (ii) Indications for use. Cattle intended for slaughter (beef 
calves 2 months of age and older, growing beef steers, growing beef 
heifers, and beef bulls intended for slaughter), and in cattle intended 
for breeding less than 1 year of age (replacement beef and dairy 
heifers less than 1 year of age and beef and dairy bulls less than 1 
year of age): for the treatment of bovine respiratory disease 
associated with Mannheimia haemolytica, Pasteurella multocida, 
Histophilus somni, and Mycoplasma bovis.
    (iii) Limitations. Cattle intended for human consumption must not 
be slaughtered within 4 days of treatment. Not for use in female dairy 
cattle 1 year of age and older, including dry dairy cows; use in these 
cattle may cause drug residues in milk and/or in calves born to these 
cows. Not for use in beef calves less than 2 months of age, dairy 
calves, and veal calves. A withdrawal period has not been established 
for this product in pre-ruminating calves. Federal law restricts this 
drug to use by or on the order of a licensed veterinarian. Federal law 
prohibits the extralabel use of this drug in food-producing animals.
    (2) Swine--(i) Amount. Administer a single dose of 7.5 mg/kg (1.7 
mL/100 lb) body weight by intramuscular injection.
    (ii) Indications for use. Weaned swine intended for slaughter 
(nursery, growing, and finishing swine, boars intended for slaughter, 
barrows, gilts intended for slaughter, and sows intended for 
slaughter): for the treatment of swine respiratory disease associated 
with Bordetella bronchiseptica, Glaesserella (Haemophilus) parasuis, 
Pasteurella multocida, Streptococcus suis, and Mycoplasma 
hyopneumoniae.
    (iii) Limitations. Swine intended for human consumption must not be 
slaughtered within 2 days of treatment. Federal law restricts this drug 
to use by or on the order of a licensed veterinarian. Federal law 
prohibits the extralabel use of this drug in food-producing animals.

0
22. In Sec.  522.2478:
0
a. Redesignate paragraphs (a)(1)(i) and (ii) as paragraphs (a)(1)(ii) 
and (iii);
0
b. Add new paragraph (a)(1)(i);
0
c. Revise paragraphs (d)(1)(i)(A), (B), and (D); and
0
d. Add paragraph (d)(3).
    The revisions and additions read as follows:


Sec.  522.2478   Trenbolone acetate and estradiol benzoate.

    (a) * * *
    (1) * * *
    (i) 50 milligrams (mg) trenbolone acetate and 7 mg estradiol 
benzoate (one implant consisting of two pellets, each pellet containing 
25 mg trenbolone acetate and 3.5 mg estradiol benzoate) per implant 
dose.
* * * * *
    (d) * * *
    (1) * * *
    (i) * * *
    (A) An implant containing 100 mg trenbolone acetate and 14 mg 
estradiol benzoate as described in paragraph (a)(1)(ii) of this section 
for increased rate of weight gain in growing beef steers fed in 
confinement for slaughter and for increased rate of weight gain and 
improved feed efficiency in growing beef heifers fed in confinement for 
slaughter. For increased rate of weight gain for up to 200 days in a 
reimplantation program where an implant as described in paragraph 
(a)(1)(ii) of this section is the first implant and an implant as 
described in paragraph (a)(1)(ii) or (iii) or (a)(2)(ii) of this 
section is administered 60 to 120 days later.
    (B) An implant containing 200 mg trenbolone acetate and 28 mg 
estradiol benzoate as described in paragraph (a)(1)(iii) of this 
section for increased rate of weight gain and improved feed efficiency 
in growing beef steers fed in confinement for slaughter and for 
increased rate of weight gain in growing beef heifers fed in 
confinement for slaughter. For increased rate of weight gain for up to 
200 days in a reimplantation program where an implant as described in 
paragraph (a)(1)(ii) of this section is the first implant and an 
implant as described in paragraph (a)(1)(iii) of this section is 
administered 60 to 120 days later.
* * * * *
    (D) An extended-release implant containing 200 mg trenbolone 
acetate and 28 mg estradiol benzoate as described in paragraph 
(a)(2)(ii) of this section for increased rate of weight gain and 
improved feed efficiency for up to 200 days. For increased rate of 
weight gain for up to 200 days in a reimplantation program where an 
implant as described in paragraph (a)(1)(ii) of this section is the 
first implant and an implant as described in paragraph (a)(2)(ii) of 
this section is administered 60 to 120 days later.
* * * * *
    (3) Growing beef steers and heifers in a dry lot--(i) Amount and 
indications for use. (A) An implant containing 50 mg trenbolone acetate 
and 7 mg estradiol benzoate as described in paragraph (a)(1)(i) of this 
section for increased rate of weight gain in growing beef steers and 
heifers in a dry lot.
    (B) An implant containing 100 mg trenbolone acetate and 14 mg 
estradiol benzoate as described in paragraph (a)(1)(ii) of this section 
for increased rate of weight gain in growing beef steers and heifers in 
a dry lot.
    (ii) Limitations. Implant pellets subcutaneously in ear only. Not 
approved for repeated implantation (reimplantation) with this or any 
other cattle ear implant in growing beef steers and heifers in a dry 
lot. Safety and effectiveness following reimplantation have not been 
evaluated. Do not use in beef calves less than 2 months of age, dairy 
calves, and veal calves because effectiveness and safety have not been 
established. A withdrawal period has not been established for this 
product in pre-ruminating calves. Do not use in dairy cows or in 
animals intended for subsequent breeding. Use in these cattle

[[Page 85428]]

may cause drug residues in milk and/or in calves born to these cows.

0
23. Add Sec.  522.2694 to read as follows:


Sec.  522.2694   Zinc, copper, manganese, and selenium.

    (a) Specifications. Each milliliter (mL) of solution contains 60 
milligrams (mg) zinc as zinc oxide, 15 mg copper as copper carbonate, 
10 mg manganese as manganese carbonate, and 5 mg selenium as sodium 
selenite.
    (b) Sponsor. See No. 066679 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer a single dose by 
subcutaneous injection to cattle up to 1 year of age, 1 mL/100 lb 
bodyweight; to cattle from 1 to 2 years of age, 1 mL/150 lb bodyweight, 
and to cattle over 2 years of age, 1 mL/200 lb bodyweight.
    (2) Indications for use. As a supplemental source of zinc, copper, 
manganese, and selenium in cattle.
    (3) Limitations. Cattle must not be slaughtered for human food 
consumption within 14 days of the last treatment. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.

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

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

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


0
25. In Sec.  524.802, revise paragraph (b) to read as follows:


Sec.  524.802   Enrofloxacin and silver sulfadiazine otic emulsion.

* * * * *
    (b) Sponsors. See Nos. 058198 and 069043 in Sec.  510.600(c) of 
this chapter.
* * * * *

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

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

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

0
27. In Sec.  529.1004, in the table in paragraph (d)(2)(ii), revise 
footnote 1 to read as follows:


Sec.  529.1004  Formalin.

* * * * *
    (d) * * *
    (2) * * *
    (ii) * * *

------------------------------------------------------------------------
                               Administer in tanks
                               and raceways for up      Administer in
                                    to 1 hour       earthen ponds single
       Aquatic species        (microliter/liter or  treatment ([micro]L/
                                part per million          L or ppm)
                              ([micro]L/L or ppm))
------------------------------------------------------------------------
 
                              * * * * * * *
------------------------------------------------------------------------
\1\ Use the lower concentration when ponds are heavily loaded with
  phytoplankton or fish to avoid oxygen depletion due to the biological
  oxygen demand by decay of dead phytoplankton. Alternatively, a higher
  concentration may be used if dissolved oxygen is strictly monitored.

* * * * *

0
28. In Sec.  529.1150, revise paragraph (c)(1)(iv) to read as follows:


Sec.  529.1150   Hydrogen peroxide.

* * * * *
    (c) * * *
    (1) * * *
    (iv) Freshwater-reared salmonids for the treatment and control of 
Gyrodactylus spp: 100 mg/L for 30 minutes, or 50 mg/L for 60 minutes, 
in a continuous flow water supply or as a static bath once per day on 
alternate days for three treatments.
* * * * *

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

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

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


0
30. In Sec.  556.275, add paragraph (b)(6) to read as follows:


Sec.  556.275   Fenbendazole.

* * * * *
    (b) * * *
    (6) Quail. (i) Liver (target tissue): 6 ppm fenbendazole sulfone 
(marker residue).
    (ii) [Reserved]
* * * * *

0
31. Add Sec.  556.530 to subpart B to read as follows:


Sec.  556.530   Pradofloxacin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of 
pradofloxacin is 2 [micro]g/kg of body weight per day.
    (b) Tolerances. The tolerances for pradofloxacin (marker residue) 
are:
    (1) Cattle. Kidney (target tissue): 30 ppb.
    (2) Swine. Kidney (target tissue): 1 ppm.
    (c) Related conditions of use. See Sec.  522.1860 of this chapter.

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

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

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

0
32. In Sec.  558.258, add heading to paragraph (e)(1) and add paragraph 
(e)(5)(iv) to read as follows:


Sec.  558.258   Fenbendazole.

* * * * *
    (e) * * *
    (1) Turkeys.
* * * * *
    (5) * * *

----------------------------------------------------------------------------------------------------------------
                                     Fenbendazole
          Species/class             grams per ton      Indications for use           Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(iv) Wild quail..................             90.7  For the treatment and     Feed for 21 consecutive     000061
                                                     control of                days. Prior withdrawal
                                                     Gastrointestinal worms:   of feed is not
                                                     cecal worms               necessary.
                                                     (Aulonocephalus spp.).
----------------------------------------------------------------------------------------------------------------

* * * * *

0
33. In Sec.  558.261, revise paragraph (e)(2)(ii) to read as follows:


Sec.  558.261   Florfenicol.

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

[[Page 85429]]



----------------------------------------------------------------------------------------------------------------
   Florfenicol in grams/ton of feed          Indications for use                       Limitations
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(ii) 182 to 2,724....................  Freshwater-reared salmonids:     Feed as a sole ration for 10 consecutive
                                        for the control of mortality     days to deliver 10 to 15 mg florfenicol
                                        due to coldwater disease         per kg of fish. Feed containing
                                        associated with Flavobacterium   florfenicol shall not be fed for more
                                        psychrophilum and furunculosis   than 10 days. Following administration,
                                        associated with Aeromonas        fish should be reevaluated by a
                                        salmonicida.                     licensed veterinarian before initiating
                                                                         a further course of therapy. The
                                                                         effects of florfenicol on reproductive
                                                                         performance have not been determined.
                                                                         Feeds containing florfenicol must be
                                                                         withdrawn 15 days prior to slaughter.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

0
34. In Sec.  558.450, revise paragraphs (e)(5)(iv), (v), and (vi) to 
read as follows:


Sec.  558.450   Oxytetracycline.

* * * * *
    (5) * * *

----------------------------------------------------------------------------------------------------------------
       Oxytetracycline amount               Indications for use                  Limitations             Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(iv) 333 to 7,500 g/ton to provide   1. Freshwater-reared salmonids:   Administer in mixed ration for     066104
 2.5 to 3.75 g/100 lb of fish/day.    for control of ulcer disease      10 days. Do not liberate fish
                                      caused by Haemophilus piscium,    or slaughter fish for food for
                                      furunculosis caused by            21 days following the last
                                      Aeromonas salmonicida,            administration of medicated
                                      bacterial hemorrhagic             feed.
                                      septicemia caused by A.          ...............................
                                      hydrophila, and pseudomonas
                                      disease.
                                     2. Catfish: for control of        Administer in mixed ration for     066104
                                      bacterial hemorrhagic             10 days. Do not liberate fish
                                      septicemia caused by A.           or slaughter fish for food for
                                      hydrophila and pseudomonas        21 days following the last
                                      disease.                          administration of medicated
                                                                        feed. Do not administer when
                                                                        water temperature is below
                                                                        16.7 [deg]C (62 [deg]F).
(v) 500 to 7,500 g/ton to provide    1. Freshwater-reared salmonids:   Administer in mixed ration for     066104
 3.75 g/100 lb of fish/day.           for control of mortality due to   10 days. Do not liberate fish
                                      coldwater disease associated      or slaughter fish for food for
                                      with Flavobacterium               21 days following the last
                                      psychrophilum or for control of   administration of medicated
                                      mortality due to columnaris       feed.
                                      disease associated with
                                      Flavobacterium columnare.
                                     2. Freshwater-reared salmonids    Feed for 10 days. Immediate        066104
                                      weighing up to 55 grams: for      release is permitted following
                                      marking of the skeletal tissue.   last feeding of medicated feed.
                                     3. Catfish: for control of        Administer in mixed ration for     066104
                                      mortality due to columnaris       10 days. Do not liberate fish
                                      disease associated with           or slaughter fish for food for
                                      Flavobacterium columnare.         21 days following the last
                                                                        administration of medicated
                                                                        feed. Do not administer when
                                                                        water temperature is below
                                                                        16.7 [deg]C (62 [deg]F).
(vi) 1.25 to 25 g/kg to provide      Pacific salmon not over 30 grams  Administer medicated feed as       066104
 11.35 g/100 lb of fish/day.          body weight: for marking of the   the sole ration for 4
                                      skeletal tissue.                  consecutive days. Do not
                                                                        liberate for at least 7 days
                                                                        following last feeding of
                                                                        medicated feed.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

    Dated: October 21, 2024.
Eric Flamm,
Acting Associate Commissioner for Policy.
[FR Doc. 2024-24820 Filed 10-25-24; 8:45 am]
BILLING CODE 4164-01-P


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