Rule2023-26545
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 6, 2023
Effective
December 6, 2023
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 July, August, and September 2023. The animal drug regulations are also being amended to improve their accuracy and readability.
Full Text
<html>
<head>
<title>Federal Register, Volume 88 Issue 233 (Wednesday, December 6, 2023)</title>
</head>
<body><pre>
[Federal Register Volume 88, Number 233 (Wednesday, December 6, 2023)]
[Rules and Regulations]
[Pages 84696-84704]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-26545]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 516, 520, 522, 524, and 558
[Docket No. FDA-2023-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications;
Withdrawal of Approval of New Animal Drug Applications; Change of
Sponsor; Change of Sponsor Address
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is amending the
animal drug regulations to reflect application-related actions for new
animal drug applications (NADAs), abbreviated new animal drug
applications (ANADAs), and conditionally approved new animal drug
applications (CNADAs) during July, August, and September 2023. The
animal drug regulations are also being amended to improve their
accuracy and readability.
DATES: This rule is effective December 6, 2023.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-402-5689,
<a href="/cdn-cgi/l/email-protection#aaedcfc5d8cdcf84e2cbc3c8cfc6eacccecb84c2c2d984cdc5dc"><span class="__cf_email__" data-cfemail="5314363c2134367d1b323a31363f133537327d3b3b207d343c25">[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 July, August, and
September 2023, as listed in table 1. In addition, FDA is informing the
public of the availability, where applicable, of documentation of
environmental review required under the National Environmental Policy
Act (NEPA) and, for actions requiring review of safety or effectiveness
data, summaries of the basis of approval (FOIA Summaries) under the
Freedom of Information Act (FOIA). These documents, along with
marketing exclusivity and patent information, may be obtained at
AnimalDrugs@FDA: <a href="https://animaldrugsatfda.fda.gov/adafda/views/#/search">https://animaldrugsatfda.fda.gov/adafda/views/#/search</a>.
Table 1--Original and Supplemental NADAs, ANADAs, and CNADAs Approved During July, August, and September 2023
Requiring Evidence of Safety and/or Effectiveness
----------------------------------------------------------------------------------------------------------------
Effect of the
Approval date File No. Sponsor Product name action 21 CFR section
----------------------------------------------------------------------------------------------------------------
July 6, 2023................. 200-752 Cronus Pharma DEXMEDVET Original 522.558
Specialties (dexmedetomidi approval as a
India Private ne sedative,
Ltd., Sy No-99/ hydrochloride) analgesic, and
1, M/s GMR Injectable preanesthetic
Hyderabad Solution. in dogs and
Aviation SEZ cats as a
Ltd., generic copy
Mamidipalli of NADA 141-
Village, 267.
Shamshabad
Mandal, Ranga
Reddy,
Hyderabad,
Telangana,
501218, India.
July 11, 2023................ 200-753 Do............. CROPAMEZOLE Original 522.147
(atipamezole approval for
hydrochloride) reversal of
Injectable sedation and
Solution. analgesia in
dogs as a
generic copy
of NADA 141-
033.
July 19, 2023................ 141-554 Boehringer NEXGARD PLUS Original 520.35
Ingelheim (afoxolaner, approval for
Animal Health moxidectin, the
USA, Inc., and pyrantel prevention,
3239 Satellite chewable treatment, and
Blvd., Duluth, tablets). control of
GA30096. internal and
external
parasites in
dogs.
August 3, 2023............... 200-755 Felix Firocoxib Original 520.928
Pharmaceutical Chewable approval for
s Pvt. Ltd., Tablets. the control of
25-28 North pain and
Wall Quay, inflammation
Dublin 1, associated
Ireland. with
osteoarthritis
and for the
control of
postoperative
pain and
inflammation
associated
with soft-
tissue and
orthopedic
surgery as a
generic copy
of NADA 141-
230.
[[Page 84697]]
August 3, 2023............... 200-756 Ceva Sante FIRODYL Original 520.928
Animale, 10 (firocoxib) approval for
Avenue de la Chewable the control of
Ballasti[egrav Tablets. pain and
e]re, 33500 inflammation
Libourne, associated
France. with
osteoarthritis
and for the
control of
postoperative
pain and
inflammation
associated
with soft-
tissue and
orthopedic
surgery as a
generic copy
of NADA 141-
230.
August 10, 2023.............. 141-568 Boehringer SENVELGO Original 520.2654
Ingelheim (velagliflozin approval to
Animal Health oral solution). improve
USA, Inc., glycemic
3239 Satellite control in
Blvd., Duluth, otherwise
GA30096. healthy cats
with diabetes
mellitus not
previously
treated with
insulin.
August 31, 2023.............. 200-757 ZyVet Animal Acepromazine Original 520.23
Health, Inc., Maleate approval as an
73 Route 31N, Tablets aid in
Pennington, NJ (acepromazine tranquilizatio
08534. maleate n and as a
tablets). preanesthetic
agent in dogs
as a generic
copy of NADA
117-532.
September 6, 2023............ 141-578 Genus FIDOQUEL-CA1 Conditional 516.1760
Lifesciences (phenobarbital approval for
Inc., 700 N tablets). the control of
Fenwick St., seizures
Allentown, PA associated
18109. with
idiopathic
epilepsy in
dogs.
September 20, 2023........... 200-310 Parnell ESTROPLAN Supplemental 522.460
Technologies (cloprostenol approval for
Pty. Ltd., injection) use with
Unit 4, 476 Injectable gonadorelin to
Gardeners Rd., Solution. synchronize
Alexandria, estrous cycles
New South to allow for
Wales 2015, fixed time
Australia. artificial
insemination
(FTAI) in
lactating
dairy cows as
a generic copy
of NADA 113-
645.
----------------------------------------------------------------------------------------------------------------
II. Withdrawals of Approval
Oasmia Pharmaceutical AB, Vallongatan 1, Uppsala, 75228 Sweden
requested that FDA withdraw conditional approval of CNADA 141-422 for
PACCAL VET-CA1 (paclitaxel for injection) because the product is no
longer manufactured or marketed. Also, Med-Pharmex, Inc., 2727 Thompson
Creek Rd., Pomona, CA 91767-1861 requested that FDA withdraw approval
of the eight abbreviated applications 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 2023
----------------------------------------------------------------------------------------------------------------
File No. New animal drug 21 CFR section
----------------------------------------------------------------------------------------------------------------
200-190...................................... GENTORAL (gentamicin sulfate) Concentrate 520.1044a
Solution.
200-241...................................... LINCOSOL (lincomycin hydrochloride) Soluble 520.1263b
Powder.
200-245...................................... DERMA-VET (neomycin sulfate, nystatin, 524.1600a
thiostrepton, triamcinolone acetonide) Cream.
200-275...................................... MEDALONE (triamcinolone acetonide) Cream...... 524.2483
200-289...................................... NEOSOL-ORAL (neomycin sulfate) Concentrate 520.1484
Solution.
200-292...................................... IVERSOL (ivermectin) Liquid for Horses........ 520.1195
200-299...................................... IVER-ON (ivermectin) Topical Solution......... 524.1193
200-456...................................... Dexamethasone Solution........................ 522.540
----------------------------------------------------------------------------------------------------------------
III. Change of Sponsor
The sponsors of the approved applications listed in table 3 have
informed FDA that they have transferred ownership of, and all rights
and interest in, these applications to another sponsor. As provided in
the regulatory text of this document, the animal drug regulations are
amended to reflect these actions.
Table 3--Applications for Which Ownership Was Transferred to Another Sponsor During July, August, and September
2023
----------------------------------------------------------------------------------------------------------------
File No. Product name Transferring sponsor New sponsor 21 CFR section
----------------------------------------------------------------------------------------------------------------
141-342................ ALFAXAN Multidose Jurox Pty. Ltd., 85 Zoetis Inc., 333 522.52
(alfaxalone) Gardiner St., Portage St.,
injectable solution. Rutherford, NSW Kalamazoo, MI 49007.
2320, Australia.
[[Page 84698]]
200-699................ Dexmedetomidine Akorn Operating Co. Parnell Technologies 522.558
hydrochloride LLC, 5605 Pty. Ltd., Unit 4,
injection. Centerpoint Ct., 476 Gardeners Rd.,
Suite A, Gurnee, IL Alexandria, New
60031. South Wales 2015,
Australia.
200-614................ Pentobarbital sodium Do................... Noble Pharma, LLC, 522.1700
and phenytoin sodium 4602 Domain Dr.,
injectable solution. Menomonie, WI 54751.
141-559................ Pentosan polysulfate Anzac Animal Health, Dechra, Ltd., 522.1704
sodium injectable LLC, 218 Millwell Snaygill Industrial
solution. Dr., Suite B, Estate, Keighley
Maryland Heights, MO Rd., Skipton, North
63043. Yorkshire, BD23 2RW,
United Kingdom.
200-553................ Bacitracin, neomycin, Akorn Operating Co. Domes Pharma S.A., 524.154
polymyxin B LLC, 5605 ZAC de Champ Lamet,
ophthalmic ointment. Centerpoint Ct., 3 rue Andre Citroen,
Suite A, Gurnee, IL Pont-du-Chateau,
60031. Auvergne-Rh[ocirc]ne-
Alpes, 63430, FRANCE.
----------------------------------------------------------------------------------------------------------------
As provided in the regulatory text of this document, the animal
drug regulations cited in table 3 are amended to reflect these actions.
IV. Change of Sponsor Address
Heska Corp., 1825 Sharp Point Dr., Fort Collins, CO 80525 has
informed FDA that it has changed its address to 3760 Rocky Mountain
Ave., Loveland, CO 80538-7084. The entries in Sec. 510.600(c) are
amended to reflect this action.
V. Technical Amendments
FDA is making the following amendments to improve the accuracy of
the animal drug regulations.
<bullet> 21 CFR 510.600 is amended to reflect sponsors of approved
applications by adding entries for Domes Pharma S.A., Genus
Lifesciences, Inc., and Noble Pharma, LLC, by revising the entry for
Heska Corp., and by removing the entries for Jurox Pty. Ltd. and Oasmia
Pharmaceutical AB.
<bullet> 21 CFR 520.23 is amended to reflect approved strengths of
acepromazine maleate tablets for dogs and cats.
<bullet> 21 CFR 522.460 is amended to reflect current labeling for
cloprostenol injectable solution for use in cattle.
<bullet> 21 CFR 522.2640 is amended to reflect the approved
strengths of generic tylosin injectable solutions.
<bullet> 21 CFR 558.330 is amended to reflect the sponsors of drugs
approved for use in combination medicated feeds containing lubebegron
and monensin.
<bullet> 21 CFR 558.355 is amended to reflect the classes of
pasture cattle approved for use of a monensin free-choice block.
<bullet> 21 CFR 558.625 is amended to reflect the sponsors of drugs
approved for use in combination medicated feeds containing lubebegron,
monensin, and tylosin.
VI. Legal Authority
This final rule is issued under section 512(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b(i)). Although deemed
a rule pursuant to the FD&C Act, this document does not meet the
definition of ``rule'' in 5 U.S.C. 804(3)(A) because it is a ``rule of
particular applicability'' and is not subject to the congressional
review requirements in 5 U.S.C. 801-808. Likewise, this is not a rule
subject to Executive Order 12866.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Part 516
Administrative practice and procedure, Animal drugs, Confidential
business information, 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, 516, 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.
0
2. In Sec. 510.600, in the table in paragraph (c)(1), add entries for
``Domes Pharma S.A.'', ``Genus Lifesciences, Inc.'', and ``Noble
Pharma, LLC''; revise the entry for ``Heska Corp.''; and remove the
entries for ``Jurox Pty. Ltd.'' and ``Oasmia Pharmaceutical AB''.
0
3. In the table in paragraph (c)(2), remove the entries for ``049480''
and ``052818'', revise the entry for ``063604'', and add entries for
``064950'', ``086119'', and ``086189''.
The revisions read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Firm name and address Drug labeler code
------------------------------------------------------------------------
* * * * * * *
Domes Pharma S.A., ZAC de Champ Lamet, 3 rue Andre 086189
Citroen, Pont-du-Chateau, Auvergne-Rh[ocirc]ne-
Alpes, 63430, FRANCE................................
[[Page 84699]]
* * * * * * *
Genus Lifesciences Inc., 700 N Fenwick St., 064950
Allentown, PA 18109.................................
* * * * * * *
Heska Corp., 3760 Rocky Mountain Ave., Loveland, CO 063604
80538-7084..........................................
* * * * * * *
Noble Pharma, LLC, 4602 Domain Dr., Menomonie, WI 086119
54751...............................................
* * * * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * * * *
063604........................ Heska Corp., 3760 Rocky Mountain Ave.,
Loveland, CO 80538-7084.
* * * * * * *
064950........................ Genus Lifesciences Inc., 700 N Fenwick
St., Allentown, PA 18109.
* * * * * * *
086119........................ Noble Pharma, LLC, 4602 Domain Dr.,
Menomonie, WI 54751.
* * * * * * *
086189........................ Domes Pharma S.A., ZAC de Champ Lamet, 3
rue Andre Citroen, Pont-du-Chateau,
Auvergne-Rh[ocirc]ne-Alpes, 63430,
FRANCE.
* * * * * * *
------------------------------------------------------------------------
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.
Sec. 516.1684 [Removed]
0
4. Remove Sec. 516.1684.
0
5. Add Sec. 516.1760 to subchapter E to read as follows:
Sec. 516.1760 Phenobarbital.
(a) Specifications. Each tablet contains 16.2, 32.4, 64.8, or 97.2
milligrams (mg) phenobarbital.
(b) Sponsor. See No. 064950 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. Administer phenobarbital as
tablets given orally twice a day at the minimum dosage of 2.5 mg per
kilogram of body weight (mg/kg) and may be titrated to effect to a
maximum dosage of 5 mg/kg. The dosage of phenobarbital tablets should
be adjusted based on monitoring the clinical response of the individual
patient.
(2) Indications for use. For the control of seizures associated
with idiopathic epilepsy in dogs.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian. It is a violation of Federal law
to use this product other than as directed in the labeling.
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. 520.23, revise paragraphs (a) and (b) to read as follows:
Sec. 520.23 Acepromazine.
(a) Specifications. Each tablet contains 10 or 25 milligrams (mg)
acepromazine maleate.
(b) Sponsors. See Nos. 000010 and 086117 in Sec. 510.600(c) of
this chapter.
* * * * *
0
8. Add Sec. 520.35 to read as follows:
Sec. 520.35 Afoxolaner, moxidectin, and pyrantel.
(a) Specifications. Each chewable tablet contains 9.375 milligrams
(mg) afoxolaner, 45 micrograms (mcg) moxidectin, and 18.75 mg pyrantel;
18.75 mg afoxolaner, 90 mcg moxidectin, and 37.5 mg pyrantel; 37.5 mg
afoxolaner, 180 mcg moxidectin, and 75 mg pyrantel; 75 mg afoxolaner,
360 mcg moxidectin, and 150 mg pyrantel; or 150 mg afoxolaner, 720 mcg
moxidectin, and 300 mg pyrantel.
(b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. Administer orally once a month
at the minimum dose of 1.14 mg/lb (2.5 mg/kg) afoxolaner, 5.45 mcg/lb
(12 mcg/kg) moxidectin, and 2.27 mg/lb (5.0 mg/kg) pyrantel. For
heartworm disease prevention, give once monthly for at least 6 months
after last exposure to mosquitoes.
(2) Indications for use in dogs. For the prevention of heartworm
disease caused by Dirofilaria immitis and for the treatment and control
of adult hookworm (Ancylostoma caninum, Ancylostoma braziliense, and
Uncinaria stenocephala) and roundworm (Toxocara canis and Toxascaris
leonina) infections. Kills adult fleas and is indicated for the
treatment and prevention of flea infestations (Ctenocephalides felis)
and the treatment and control of Ixodes scapularis (black-legged tick),
Rhipicephalus sanguineus (brown dog tick), Dermacentor variabilis
(American dog tick), and Amblyomma americanum (lone star tick)
infestations for 1 month in dogs and puppies 8 weeks of age and older,
weighing 4 pounds of body weight or greater.
[[Page 84700]]
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Sec. 520.928 [Amended]
0
9. In Sec. 520.928, in paragraph (b)(1), remove ``Nos. 000010, 055246,
and 055529'' and in its place add ``Nos. 000010, 013744, 055246,
055529, and 086101''.
Sec. 520.1044a [Amended]
0
10. In Sec. 520.1044a, in paragraph (b), remove ``Nos. 000061 and
054925'' and in its place add ``No. 000061''.
0
11. In Sec. 520.1195, revise paragraph (b)(1) to read as follows:
Sec. 520.1195 Ivermectin liquid.
* * * * *
(b) * * *
(1) Nos. 058005 and 058198 for use of product described in
paragraph (a)(1) of this section as in paragraphs (e)(1)(i),
(e)(1)(ii)(A), and (e)(1)(iii) of this section.
* * * * *
0
12. In Sec. 520.1263b, revise paragraphs (b)(2) and (d)(1)(iii) to
read as follows:
Sec. 520.1263b Lincomycin powder.
* * * * *
(b) * * *
(2) Nos. 016592 and 076475 for use as in paragraphs (d)(1) and (2)
of this section.
* * * * *
(d) * * *
(1) * * *
(iii) Limitations. Discard medicated drinking water if not used
within 2 days. Prepare fresh stock solution daily. Do not use for more
than 10 days. If clinical signs of disease have not improved within 6
days, discontinue treatment and reevaluate diagnosis. The safety of
lincomycin has not been demonstrated in pregnant swine or swine
intended for breeding. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
* * * * *
Sec. 520.1484 [Amended]
0
13. In Sec. 520.1484, in paragraph (b)(1), remove ``Nos. 054771 and
054925'' and in its place add ``No. 054771''; and remove paragraph
(b)(4).
0
14. Add Sec. 520.2654 to read as follows:
Sec. 520.2654 Velagliflozin.
(a) Specifications. Each milliliter of solution contains 15
milligrams (mg) velagliflozin.
(b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. Administer orally 0.45 mg per
pound of body weight (1 mg per kilogram) velagliflozin once daily.
(2) Indications for use. To improve glycemic control in otherwise
healthy cats with diabetes mellitus not previously treated with
insulin.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
15. The authority citation for part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 522.52 [Amended]
0
16. In Sec. 522.52, in paragraph (b), remove ``049480'' and in its
place add ``054771''.
0
17. In Sec. 522.147, revise paragraphs (b), (c)(1), and (2) to read as
follows:
Sec. 522.147 Atipamezole.
* * * * *
(b) Sponsors. See Nos. 015914, 052483, and 069043 in Sec.
510.600(c) of this chapter.
(c) * * *
(1) Amount. Administer 3,750 mcg/m\2\ intramuscularly for the
reversal of intravenous dexmedetomidine hydrochloride or medetomidine
hydrochloride and 5,000 mcg/m\2\ intramuscularly for the reversal of
intramuscular dexmedetomidine hydrochloride or medetomidine
hydrochloride.
(2) Indications for use. For the reversal of the sedative and
analgesic effects of dexmedetomidine hydrochloride and medetomidine
hydrochloride.
* * * * *
0
18. In Sec. 522.460, revise paragraphs (b) and (c) to read as follows:
Sec. 522.460 Cloprostenol.
* * * * *
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter.
(1) No. 000061 for use of product described in paragraph (a)(1) of
this section as in paragraphs (c)(1)(i) and (c)(2) of this section.
(2) No. 000061 for use of product described in paragraph (a)(2) as
in paragraphs (c)(1)(ii) through (viii) and (c)(2) of this section.
(3) No. 068504 for use of product described in paragraph (a)(2) as
in paragraphs (c)(1)(ii) through (vii), (c)(1)(ix), and (c)(2) of this
section.
(c) Conditions of use in cattle--(1) Amount and indications for
use.
(i) Administer 375 [micro]g by intramuscular injection to induce
abortion in pregnant feedlot heifers from 1 week after mating until
4\1/2\ months of gestation.
(ii) Administer 500 [micro]g by intramuscular injection for
unobserved or non-detected estrus in beef cows, lactating dairy cows,
and replacement beef and dairy heifers.
(iii) Administer 500 [micro]g by intramuscular injection for
treatment of pyometra or chronic endometritis in beef cows, lactating
dairy cows, and replacement beef and dairy heifers.
(iv) Administer 500 [micro]g by intramuscular injection for
treatment of mummified fetus in beef cows, lactating dairy cows, and
replacement beef and dairy heifers.
(v) Administer 500 [micro]g by intramuscular injection for
treatment of luteal cysts in beef cows, lactating dairy cows, and
replacement beef and dairy heifers.
(vi) Administer 500 [micro]g by intramuscular injection for
abortion of beef cows, lactating dairy cows, and replacement beef and
dairy heifers from 1 week after mating until 5 months of gestation. Not
for use in heifers placed in feedlots.
(vii) Administer 500 [micro]g by intramuscular injection as a
single injection regimen or double injection regimen with a second
injection 11 days after the first injection, for estrus synchronization
in beef cows, lactating dairy cows, and replacement beef and dairy
heifers.
(viii) For use with gonadorelin acetate to synchronize estrous
cycles to allow for fixed time artificial insemination (FTAI) in
lactating dairy cows: administer to each cow 86 [micro]g gonadorelin by
intramuscular injection, followed 6 to 8 days later by 500 [micro]g
cloprostenol by intramuscular injection, followed 30 to 72 hours later
by 86 [micro]g gonadorelin by intramuscular injection. Gonadorelin
acetate as provided in Sec. 522.1077(a)(1) of this chapter.
(ix) For use with gonadorelin to synchronize estrous cycles to
allow for FTAI in lactating dairy cows: administer to each cow by
intramuscular injection, followed 6 to 8 days later by 500 [micro]g
cloprostenol by intramuscular injection, followed 30 to 72 hours later
by gonadorelin by intramuscular injection. Gonadorelin as provided in
Sec. 522.1077(a)(1) through (3) of this chapter.
(2) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Sec. 522.540 [Amended]
0
19. In Sec. 522.540, in paragraph (a)(2)(ii), remove ``Sponsors. See
Nos.
[[Page 84701]]
054925 and 058005'' and in its place add ``No. 058005''.
Sec. 522.558 [Amended]
0
20. In Sec. 522.558, in paragraph (b)(1), remove ``Nos. 017033,
059399, and 086117'' and in its place add ``Nos. 017033, 068504,
069043, and 086117''.
Sec. 522.1700 [Amended]
0
21. In Sec. 522.1700, in paragraph (b), remove ``059399'' and in its
place add ``086119''.
Sec. 522.1704 [Amended]
0
22. In Sec. 522.1704, in paragraph (b), remove ``086073'' and in its
place add ``043264''.
0
23. In Sec. 522.2640, revise paragraphs (b)(1) and (2) to read as
follows:
Sec. 522.2640 Tylosin.
* * * * *
(b) * * *
(1) Nos. 016592 and 058198 for use of 50- or 200-mg/mL solutions as
in paragraph (e) of this section.
(2) No. 061133 for use of a 200-mg/mL solution as in paragraphs
(e)(1) and (2) of this section.
* * * * *
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.
Sec. 524.154 [Amended]
0
25. In Sec. 524.154, in paragraph (b)(2), remove ``059399'' and in its
place add ``086189''.
Sec. 524.1193 [Amended]
0
26. In Sec. 524.1193, in paragraph (b)(2), remove ``Nos. 016592 and
054925'' and in its place add ``No. 016592''.
0
27. In Sec. 524.1600a, revise paragraph (b) to read as follows:
Sec. 524.1600a Nystatin, neomycin, thiostrepton, and triamcinolone
ointment.
* * * * *
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter:
(1) For petrolatum base ointments: Nos. 025463 and 054771; or
(2) For vanishing cream base ointments: Nos. 025463 and 054771.
* * * * *
Sec. 524.2483 [Removed]
0
28. Remove Sec. 524.2483.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
29. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
0
30. In Sec. 558.330, revise paragraphs (d)(1)(ii) and (iii) and
(d)(2)(i) and (ii) to read as follows:
Sec. 558.330 Lubabegron.
* * * * *
(d) * * *
(1) * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
Lubabegron fumarate in grams/ton Combination in grams/ton Indications for use Limitations Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * * * *
(ii) 1.25 to 4.54..................... Monensin, 5 to 40........ Beef steers and heifers Feed continuously as the sole ration to 016592, 058198
fed in confinement for provide 13 to 90 mg lubabegron/head/
slaughter: for reduction day and 50 to 480 mg monensin/head/day
of ammonia gas emissions during the last 14 to 91 days on feed.
per pound of live weight No additional improvement in feed
and hot carcass weight efficiency has been shown from feeding
and for improved feed monensin at levels greater than 30 g/
efficiency during the ton (360 mg monensin/head/day). A
last 14 to 91 days on decrease in dry matter intake may be
feed. noticed in some animals receiving
lubabegron. Lubabegron has not been
approved for use in breeding animals
because safety and effectiveness have
not been evaluated in these animals.
Do not allow horses or other equines
access to feed containing lubabegron
and monensin. Ingestion of monensin by
horses has been fatal. Monensin
medicated cattle and goat feeds are
safe for use in cattle and goats only.
Consumption by unapproved species may
result in toxic reactions. Feeding
undiluted or mixing errors resulting
in high concentrations of monensin has
been fatal to cattle and could be
fatal to goats. Must be thoroughly
mixed in feeds before use. Do not
exceed the levels of monensin
recommended in the feeding directions,
as reduced average daily gains may
result. If feed refusals containing
monensin are fed to other groups of
cattle, the concentration of monensin
in the refusals and amount of refusals
fed should be taken into consideration
to prevent monensin overdosing. A
withdrawal period has not been
established for this product for
preruminating calves. Do not use in
calves to be processed for veal. See
special labeling considerations in
Sec. 558.355(d) of this chapter.
Lubabegron fumarate as provided by No.
058198, monensin as provided by No.
016592 or 058198 in Sec. 510.600(c)
of this chapter.
[[Page 84702]]
(iii) 1.25 to 4.54.................... Monensin, 10 to 40....... Beef steers and heifers Feed continuously as the sole ration to 016592, 058198
fed in confinement for provide 13 to 90 mg lubabegron/head/
slaughter: for reduction day and 0.14 to 0.42 mg monensin/lb
of ammonia gas emissions body weight per day, depending upon
per pound of live weight severity of coccidiosis challenge,
and hot carcass weight; during the last 14 to 91 days on feed.
and for prevention and A decrease in dry matter intake may be
control of coccidiosis noticed in some animals receiving
due to Eimeria bovis and lubabegron. Lubabegron has not been
E. zuernii during the approved for use in breeding animals
last 14 to 91 days on because safety and effectiveness have
feed. not been evaluated in these animals.
Do not allow horses or other equines
access to feed containing lubabegron
and monensin. Ingestion of monensin by
horses has been fatal. Monensin
medicated cattle and goat feeds are
safe for use in cattle and goats only.
Consumption by unapproved species may
result in toxic reactions. Feeding
undiluted or mixing errors resulting
in high concentrations of monensin has
been fatal to cattle and could be
fatal to goats. Must be thoroughly
mixed in feeds before use. Do not
exceed the levels of monensin
recommended in the feeding directions,
as reduced average daily gains may
result. If feed refusals containing
monensin are fed to other groups of
cattle, the concentration of monensin
in the refusals and amount of refusals
fed should be taken into consideration
to prevent monensin overdosing. A
withdrawal period has not been
established for this product for
preruminating calves. Do not use in
calves to be processed for veal. See
special labeling considerations in
Sec. 558.355(d) of this chapter.
Lubabegron fumarate as provided by No.
058198, monensin as provided by No.
016592 or 058198 in Sec. 510.600(c)
of this chapter.
--------------------------------------------------------------------------------------------------------------------------------------------------------
(2) * * *
(i) Monensin as in Sec. 558.355.
(ii) Tylosin in Sec. 558.625.
0
31. In Sec. 558.355, revise paragraph (f)(4)(iv) to read as follows:
Sec. 558.355 Monensin.
* * * * *
(f) * * *
(4) * * *
----------------------------------------------------------------------------------------------------------------
Monensin amount Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(iv) 400 mg per pound of block........ Growing beef steers and Provide 50 to 200 mg of 086113
heifers on pasture monensin (2 to 8 ounces of
(stocker, feeder, and block) per head per day, in
slaughter) and beef at least one block per five
replacement heifers): head of cattle. Feed blocks
for increased rate of continuously. Do not feed
weight gain. salt of mineral supplements
in addition to this block.
Discontinue feeding if block
consumption falls below 2
ounces or rises above 8
ounces daily. See paragraph
(d)(10)(i) of this section..
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
0
32. In Sec. 558.625, revise paragraphs (e)(2)(vii) and (viii) to read
as follows:
Sec. 558.625 Tylosin.
* * * * *
(e) * * *
(2) * * *
[[Page 84703]]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tylosin grams/ton Combination in grams/ton Indications for use Limitations Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * * * *
(vii) 8 to 10......................... Monensin, 5 to 40 plus Beef steers and heifers Feed continuously as sole ration to 016592, 058198
lubabegron fumarate, fed in confinement for provide 13 to 90 mg lubabegron/head/
1.25 to 4.54. slaughter: for reduction day, 50 to 480 mg monensin/head/day,
of ammonia gas emissions and 60 to 90 mg tylosin/head/day
per pound of live weight during the last 14 to 91 days on feed.
and hot carcass weight; No additional improvement in feed
for reduction of efficiency has been shown from feeding
incidence of liver monensin at levels greater than 30 g/
abscesses associated ton (360 mg monensin/head/day). A
with Fusobacterium decrease in dry matter intake may be
necrophorum and noticed in some animals receiving
Arcanobacterium pyogenes lubabegron. Lubabegron has not been
and for improved feed approved for use in breeding animals
efficiency during the because safety and effectiveness have
last 14 to 91 days on not been evaluated in these animals.
feed. Do not allow horses or other equines
access to feed containing lubabegron
and monensin. Ingestion of monensin by
horses has been fatal. Monensin
medicated cattle and goat feeds are
safe for use in cattle and goats only.
Consumption by unapproved species may
result in toxic reactions. Feeding
undiluted or mixing errors resulting
in high concentrations of monensin has
been fatal to cattle and could be
fatal to goats. Must be thoroughly
mixed in feeds before use. Do not
exceed the levels of monensin
recommended in the feeding directions,
as reduced average daily gains may
result. If feed refusals containing
monensin are fed to other groups of
cattle, the concentration of monensin
in the refusals and amount of refusals
fed should be taken into consideration
to prevent monensin overdosing. A
withdrawal period has not been
established for this product for
preruminating calves. Do not use in
calves to be processed for veal. See
special labeling considerations in
Sec. 558.355(d) of this chapter.
Tylosin as provided by No. 016592 or
058198, monensin as provided by No.
016592 or 058198, lubabegron fumarate
as provided by No. 058198 in Sec.
510.600(c) of this chapter.
(viii) 8 to 10........................ Monensin, 10 to 40 plus Beef steers and heifers Feed continuously as sole ration to 016592, 058198
lubabegron fumarate, fed in confinement for provide 13 to 90 mg lubabegron/head/
1.25 to 4.54. slaughter: for reduction day, 0.14 to 0.42 mg monensin/lb body
of ammonia gas emissions weight per day, depending upon
per pound of live weight severity of coccidiosis challenge, up
and hot carcass weight, to 480 mg/head/day, and 60 to 90 mg
for reduction of tylosin/head/day during the last 14 to
incidence of liver 91 days on feed. A decrease in dry
abscesses associated matter intake may be noticed in some
with Fusobacterium animals receiving lubabegron.
necrophorum and Lubabegron has not been approved for
Arcanobacterium pyogenes use in breeding animals because safety
and for prevention and and effectiveness have not been
control of coccidiosis evaluated in these animals. Do not
due to Eimeria bovis and allow horses or other equines access
E. zuernii during the to feed containing lubabegron and
last 14 to 91 days on monensin. Ingestion of monensin by
feed. horses has been fatal. Monensin
medicated cattle and goat feeds are
safe for use in cattle and goats only.
Consumption by unapproved species may
result in toxic reactions. Feeding
undiluted or mixing errors resulting
in high concentrations of monensin has
been fatal to cattle and could be
fatal to goats. Must be thoroughly
mixed in feeds before use. Do not
exceed the levels of monensin
recommended in the feeding directions,
as reduced average daily gains may
result. If feed refusals containing
monensin are fed to other groups of
cattle, the concentration of monensin
in the refusals and amount of refusals
fed should be taken into consideration
to prevent monensin overdosing. A
withdrawal period has not been
established for this product for
preruminating calves. Do not use in
calves to be processed for veal. See
special labeling considerations in
Sec. 558.355(d) of this chapter.
Tylosin as provided by No. 016592 or
058198, monensin as provided by No.
016592 or 058198, lubabegron fumarate
as provided by No. 058198 in Sec.
510.600(c) of this chapter.
* * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 84704]]
* * * * *
Dated: November 29, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-26545 Filed 12-5-23; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on December 6, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.