Rule2024-24820
New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address
Primary source
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Published
October 28, 2024
Effective
October 28, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 208 (Monday, October 28, 2024)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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: <a href="https://animaldrugsatfda.fda.gov/adafda/views/#/search">https://animaldrugsatfda.fda.gov/adafda/views/#/search</a>.
[[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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