New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address, 84696-84704 [2023-26545]
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84696
Federal Register / Vol. 88, No. 233 / Wednesday, December 6, 2023 / Rules and Regulations
Using Agency. U.S. Marine Corps,
Commanding Officer, Marine Corps Air
Station Yuma, Yuma, AZ.
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Issued in Washington, DC, on November
30, 2023.
Karen Chiodini,
Acting Manager, Rules and Regulations
Group.
[FR Doc. 2023–26706 Filed 12–5–23; 8:45 am]
BILLING CODE 4910–13–P
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.
Final rule; technical
amendments.
ACTION:
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,
George.Haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
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: https://
animaldrugsatfda.fda.gov/adafda/
views/#/search.
I. Approvals
FDA is amending the animal drug
regulations to reflect approval actions
for NADAs, ANADAs, and CNADAs
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS, ANADAS, AND CNADAS APPROVED DURING JULY, AUGUST, AND
SEPTEMBER 2023 REQUIRING EVIDENCE OF SAFETY AND/OR EFFECTIVENESS
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Approval date
File No.
July 6, 2023 ................
200–752
July 11, 2023 ..............
200–753
July 19, 2023 ..............
141–554
August 3, 2023 ...........
200–755
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Sponsor
Product name
Cronus Pharma Specialties India Private
Ltd., Sy No-99/1, M/
s GMR Hyderabad
Aviation SEZ Ltd.,
Mamidipalli Village,
Shamshabad
Mandal, Ranga
Reddy, Hyderabad,
Telangana, 501218,
India.
Do ...............................
Boehringer Ingelheim
Animal Health USA,
Inc., 3239 Satellite
Blvd., Duluth,
GA30096.
Felix Pharmaceuticals
Pvt. Ltd., 25–28
North Wall Quay,
Dublin 1, Ireland.
PO 00000
Frm 00012
Effect of the action
21 CFR
section
DEXMEDVET
(dexmedetomidine
hydrochloride)
Injectable Solution.
Original approval as a sedative,
analgesic, and preanesthetic in
dogs and cats as a generic
copy of NADA 141–267.
522.558
CROPAMEZOLE
(atipamezole hydrochloride) Injectable
Solution.
NEXGARD PLUS
(afoxolaner,
moxidectin, and
pyrantel chewable
tablets).
Firocoxib Chewable
Tablets.
Original approval for reversal of
sedation and analgesia in dogs
as a generic copy of NADA
141–033.
Original approval for the prevention, treatment, and control of
internal and external parasites
in dogs.
522.147
Original approval for the control of
pain and inflammation associated 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.
520.928
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Federal Register / Vol. 88, No. 233 / Wednesday, December 6, 2023 / Rules and Regulations
84697
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS, ANADAS, AND CNADAS APPROVED DURING JULY, AUGUST, AND
SEPTEMBER 2023 REQUIRING EVIDENCE OF SAFETY AND/OR EFFECTIVENESS—Continued
Approval date
File No.
Sponsor
Product name
Effect of the action
August 3, 2023 ...........
200–756
Ceva Sante Animale,
10 Avenue de la
Ballastie`re, 33500
Libourne, France.
FIRODYL (firocoxib)
Chewable Tablets.
August 10, 2023 .........
141–568
SENVELGO
(velagliflozin oral solution).
August 31, 2023 .........
200–757
Boehringer Ingelheim
Animal Health USA,
Inc., 3239 Satellite
Blvd., Duluth,
GA30096.
ZyVet Animal Health,
Inc., 73 Route 31N,
Pennington, NJ
08534.
September 6, 2023 .....
141–578
FIDOQUEL–CA1 (phenobarbital tablets).
September 20, 2023 ...
200–310
Genus Lifesciences
Inc., 700 N Fenwick
St., Allentown, PA
18109.
Parnell Technologies
Pty. Ltd., Unit 4, 476
Gardeners Rd., Alexandria, New
South Wales 2015,
Australia.
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
Acepromazine Maleate
Tablets
(acepromazine maleate tablets).
ESTROPLAN
(cloprostenol injection) Injectable Solution.
Original approval for the control of
pain and inflammation associated 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.
Original approval to improve glycemic control in otherwise
healthy cats with diabetes
mellitus not previously treated
with insulin.
Original approval as an aid in
tranquilization and as a
preanesthetic agent in dogs as
a generic copy of NADA 117–
532.
Conditional approval for the control of seizures associated with
idiopathic epilepsy in dogs.
Supplemental approval for use
with gonadorelin to synchronize
estrous cycles to allow for fixed
time artificial insemination
(FTAI) in lactating dairy cows
as a generic copy of NADA
113–645.
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
21 CFR
section
520.928
520.2654
520.23
516.1760
522.460
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.
200–190
200–241
200–245
200–275
200–289
200–292
200–299
200–456
New animal drug
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GENTORAL (gentamicin sulfate) Concentrate Solution ..........................................................
LINCOSOL (lincomycin hydrochloride) Soluble Powder ..........................................................
DERMA–VET (neomycin sulfate, nystatin, thiostrepton, triamcinolone acetonide) Cream .....
MEDALONE (triamcinolone acetonide) Cream ........................................................................
NEOSOL–ORAL (neomycin sulfate) Concentrate Solution .....................................................
IVERSOL (ivermectin) Liquid for Horses .................................................................................
IVER–ON (ivermectin) Topical Solution ...................................................................................
Dexamethasone Solution .........................................................................................................
III. Change of Sponsor
The sponsors of the approved
applications listed in table 3 have
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21 CFR section
informed FDA that they have transferred
ownership of, and all rights and interest
in, these applications to another
sponsor. As provided in the regulatory
520.1044a
520.1263b
524.1600a
524.2483
520.1484
520.1195
524.1193
522.540
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.
141–342 .......
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Product name
Transferring sponsor
ALFAXAN Multidose (alfaxalone)
injectable solution.
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New sponsor
Jurox Pty. Ltd., 85 Gardiner St.,
Rutherford, NSW 2320, Australia.
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Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007.
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21 CFR section
522.52
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Federal Register / Vol. 88, No. 233 / Wednesday, December 6, 2023 / Rules and Regulations
TABLE 3—APPLICATIONS FOR WHICH OWNERSHIP WAS TRANSFERRED TO ANOTHER SPONSOR DURING JULY, AUGUST,
AND SEPTEMBER 2023—Continued
File No.
Product name
Transferring sponsor
200–699 .......
Dexmedetomidine hydrochloride
injection.
Akorn Operating Co. LLC, 5605
Centerpoint Ct., Suite A,
Gurnee, IL 60031.
200–614 .......
Pentobarbital sodium and phenytoin sodium injectable solution.
Pentosan polysulfate sodium
injectable solution.
Do .................................................
Bacitracin, neomycin, polymyxin B
ophthalmic ointment.
Akorn Operating Co. LLC, 5605
Centerpoint Ct., Suite A,
Gurnee, IL 60031.
141–559 .......
200–553 .......
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
§ 510.600(c) are amended to reflect this
action.
V. Technical Amendments
FDA is making the following
amendments to improve the accuracy of
the animal drug regulations.
• 21 CFR 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.
• 21 CFR 520.23 is amended to reflect
approved strengths of acepromazine
maleate tablets for dogs and cats.
• 21 CFR 522.460 is amended to
reflect current labeling for cloprostenol
injectable solution for use in cattle.
• 21 CFR 522.2640 is amended to
reflect the approved strengths of generic
tylosin injectable solutions.
• 21 CFR 558.330 is amended to
reflect the sponsors of drugs approved
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New sponsor
Anzac Animal Health, LLC, 218
Millwell Dr., Suite B, Maryland
Heights, MO 63043.
21 CFR section
Parnell Technologies Pty. Ltd.,
Unit 4, 476 Gardeners Rd., Alexandria, New South Wales
2015, Australia.
Noble Pharma, LLC, 4602 Domain Dr., Menomonie, WI
54751.
Dechra, Ltd., Snaygill Industrial
Estate, Keighley Rd., Skipton,
North Yorkshire, BD23 2RW,
United Kingdom.
Domes Pharma S.A., ZAC de
Champ Lamet, 3 rue Andre
Citroen, Pont-du-Chateau, Auvergne-Rhoˆne-Alpes, 63430,
FRANCE.
for use in combination medicated feeds
containing lubebegron and monensin.
• 21 CFR 558.355 is amended to
reflect the classes of pasture cattle
approved for use of a monensin freechoice block.
• 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.
522.558
522.1700
522.1704
524.154
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
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.
2. In § 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’’.
■ 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:
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§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
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(c) * * *
(1) * * *
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Firm name and address
Drug
labeler code
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Domes Pharma S.A., ZAC de Champ Lamet, 3 rue Andre Citroen, Pont-du-Chateau, Auvergne-Rhoˆne-Alpes, 63430,
FRANCE .....................................................................................................................................................................................
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Firm name and address
Drug
labeler code
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Genus Lifesciences Inc., 700 N Fenwick St., Allentown, PA 18109 ............................................................................................
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Heska Corp., 3760 Rocky Mountain Ave., Loveland, CO 80538–7084 .......................................................................................
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Noble Pharma, LLC, 4602 Domain Dr., Menomonie, WI 54751 ...................................................................................................
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064950
063604
086119
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(2) * * *
Drug
labeler code
Firm name and address
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063604 .............
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Heska Corp., 3760 Rocky Mountain Ave., Loveland, CO 80538–7084.
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064950 .............
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Genus Lifesciences Inc., 700 N Fenwick St., Allentown, PA 18109.
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086119 .............
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Noble Pharma, LLC, 4602 Domain Dr., Menomonie, WI 54751.
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086189 .............
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Domes Pharma S.A., ZAC de Champ Lamet, 3 rue Andre Citroen, Pont-du-Chateau, Auvergne-Rhoˆne-Alpes, 63430,
FRANCE.
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PART 516—NEW ANIMAL DRUGS FOR
MINOR USE AND MINOR SPECIES
3. The authority citation for part 516
continues to read as follows:
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a licensed veterinarian. It is a violation
of Federal law to use this product other
than as directed in the labeling.
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Authority: 21 U.S.C. 360ccc–1, 360ccc–2,
371.
§ 516.1684
[Removed]
4. Remove § 516.1684.
5. Add § 516.1760 to subchapter E to
read as follows:
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
6. The authority citation for part 520
continues to read as follows:
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Authority: 21 U.S.C. 360b.
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§ 516.1760
7. In § 520.23, revise paragraphs (a)
and (b) to read as follows:
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Phenobarbital.
(a) Specifications. Each tablet
contains 16.2, 32.4, 64.8, or 97.2
milligrams (mg) phenobarbital.
(b) Sponsor. See No. 064950 in
§ 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
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§ 520.23
Acepromazine.
(a) Specifications. Each tablet
contains 10 or 25 milligrams (mg)
acepromazine maleate.
(b) Sponsors. See Nos. 000010 and
086117 in § 510.600(c) of this chapter.
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■ 8. Add § 520.35 to read as follows:
§ 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;
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or 150 mg afoxolaner, 720 mcg
moxidectin, and 300 mg pyrantel.
(b) Sponsor. See No. 000010 in
§ 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.
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(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
§ 520.928
[Amended]
9. In § 520.928, in paragraph (b)(1),
remove ‘‘Nos. 000010, 055246, and
055529’’ and in its place add ‘‘Nos.
000010, 013744, 055246, 055529, and
086101’’.
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§ 520.1044a
[Amended]
10. In § 520.1044a, in paragraph (b),
remove ‘‘Nos. 000061 and 054925’’ and
in its place add ‘‘No. 000061’’.
■ 11. In § 520.1195, revise paragraph
(b)(1) to read as follows:
■
§ 520.1195
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(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.
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■ 12. In § 520.1263b, revise paragraphs
(b)(2) and (d)(1)(iii) to read as follows:
Lincomycin powder.
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(b) * * *
(2) Nos. 016592 and 076475 for use as
in paragraphs (d)(1) and (2) of this
section.
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(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.
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§ 520.1484
[Amended]
13. In § 520.1484, in paragraph (b)(1),
remove ‘‘Nos. 054771 and 054925’’ and
in its place add ‘‘No. 054771’’; and
remove paragraph (b)(4).
■ 14. Add § 520.2654 to read as follows:
■
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§ 520.2654
Velagliflozin.
(a) Specifications. Each milliliter of
solution contains 15 milligrams (mg)
velagliflozin.
(b) Sponsor. See No. 000010 in
§ 510.600(c) of this chapter.
(c) Conditions of use—(1) Amount.
Administer orally 0.45 mg per pound of
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PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
15. The authority citation for part 522
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
§ 522.52
Ivermectin liquid.
*
§ 520.1263b
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.
Jkt 262001
[Amended]
16. In § 522.52, in paragraph (b),
remove ‘‘049480’’ and in its place add
‘‘054771’’.
■ 17. In § 522.147, revise paragraphs (b),
(c)(1), and (2) to read as follows:
■
§ 522.147
Atipamezole.
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(b) Sponsors. See Nos. 015914,
052483, and 069043 in § 510.600(c) of
this chapter.
(c) * * *
(1) Amount. Administer 3,750 mcg/m2
intramuscularly for the reversal of
intravenous dexmedetomidine
hydrochloride or medetomidine
hydrochloride and 5,000 mcg/m2
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.
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■ 18. In § 522.460, revise paragraphs (b)
and (c) to read as follows:
§ 522.460
Cloprostenol.
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(b) Sponsors. See sponsors in
§ 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 mg by
intramuscular injection to induce
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abortion in pregnant feedlot heifers from
1 week after mating until 41⁄2 months of
gestation.
(ii) Administer 500 mg by
intramuscular injection for unobserved
or non-detected estrus in beef cows,
lactating dairy cows, and replacement
beef and dairy heifers.
(iii) Administer 500 mg 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 mg by
intramuscular injection for treatment of
mummified fetus in beef cows, lactating
dairy cows, and replacement beef and
dairy heifers.
(v) Administer 500 mg by
intramuscular injection for treatment of
luteal cysts in beef cows, lactating dairy
cows, and replacement beef and dairy
heifers.
(vi) Administer 500 mg 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 mg 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 mg
gonadorelin by intramuscular injection,
followed 6 to 8 days later by 500 mg
cloprostenol by intramuscular injection,
followed 30 to 72 hours later by 86 mg
gonadorelin by intramuscular injection.
Gonadorelin acetate as provided in
§ 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 mg
cloprostenol by intramuscular injection,
followed 30 to 72 hours later by
gonadorelin by intramuscular injection.
Gonadorelin as provided in
§ 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.
§ 522.540
[Amended]
19. In § 522.540, in paragraph
(a)(2)(ii), remove ‘‘Sponsors. See Nos.
■
E:\FR\FM\06DER1.SGM
06DER1
Federal Register / Vol. 88, No. 233 / Wednesday, December 6, 2023 / Rules and Regulations
054925 and 058005’’ and in its place
add ‘‘No. 058005’’.
§ 522.558
(2) No. 061133 for use of a 200-mg/mL
solution as in paragraphs (e)(1) and (2)
of this section.
*
*
*
*
*
[Amended]
20. In § 522.558, in paragraph (b)(1),
remove ‘‘Nos. 017033, 059399, and
086117’’ and in its place add ‘‘Nos.
017033, 068504, 069043, and 086117’’.
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
§ 522.1700
■
■
24. The authority citation for part 524
continues to read as follows:
[Amended]
21. In § 522.1700, in paragraph (b),
remove ‘‘059399’’ and in its place add
‘‘086119’’.
§ 524.154
§ 522.1704
■
■
Authority: 21 U.S.C. 360b.
[Amended]
22. In § 522.1704, in paragraph (b),
remove ‘‘086073’’ and in its place add
‘‘043264’’.
■ 23. In § 522.2640, revise paragraphs
(b)(1) and (2) to read as follows:
■
§ 522.2640
*
*
*
*
(b) * * *
(1) Nos. 016592 and 058198 for use of
50- or 200-mg/mL solutions as in
paragraph (e) of this section.
Lubabegron
fumarate in
grams/ton
lotter on DSK11XQN23PROD with RULES1
*
(ii) 1.25 to 4.54 ......
VerDate Sep<11>2014
Combination
in grams/ton
*
Monensin, 5 to 40
16:08 Dec 05, 2023
Jkt 262001
(b) Sponsors. See sponsors in
§ 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.
*
*
*
*
*
§ 524.2483
■
[Removed]
28. Remove § 524.2483.
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
[Amended]
25. In § 524.154, in paragraph (b)(2),
remove ‘‘059399’’ and in its place add
‘‘086189’’.
■
§ 524.1193
Authority: 21 U.S.C. 354, 360b, 360ccc,
360ccc–1, 371.
[Amended]
26. In § 524.1193, in paragraph (b)(2),
remove ‘‘Nos. 016592 and 054925’’ and
in its place add ‘‘No. 016592’’.
■ 27. In § 524.1600a, revise paragraph
(b) to read as follows:
■
Tylosin.
*
84701
§ 524.1600a Nystatin, neomycin,
thiostrepton, and triamcinolone ointment.
*
*
*
*
29. The authority citation for part 558
continues to read as follows:
30. In § 558.330, revise paragraphs
(d)(1)(ii) and (iii) and (d)(2)(i) and (ii) to
read as follows:
■
§ 558.330
*
*
Lubabegron.
*
*
(d) * * *
(1) * * *
*
*
Indications for use
Limitations
*
Beef steers and
heifers fed in
confinement for
slaughter: for reduction of ammonia gas emissions per pound
of live weight
and hot carcass
weight and for
improved feed
efficiency during
the last 14 to 91
days on feed.
*
*
*
Feed continuously as the sole ration to provide 13 to 90
mg lubabegron/head/day and 50 to 480 mg monensin/
head/day during the last 14 to 91 days on feed. No additional improvement in feed efficiency has been shown
from feeding monensin at levels greater than 30 g/ton
(360 mg monensin/head/day). A decrease in dry matter
intake may be 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
§ 558.355(d) of this chapter. Lubabegron fumarate as
provided by No. 058198, monensin as provided by No.
016592 or 058198 in § 510.600(c) of this chapter.
PO 00000
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Sponsor
06DER1
*
016592, 058198
84702
Federal Register / Vol. 88, No. 233 / Wednesday, December 6, 2023 / Rules and Regulations
Lubabegron
fumarate in
grams/ton
Combination
in grams/ton
Indications for use
Limitations
(iii) 1.25 to 4.54 .....
Monensin, 10 to 40
Beef steers and
heifers fed in
confinement for
slaughter: for reduction of ammonia gas emissions per pound
of live weight
and hot carcass
weight; and for
prevention and
control of coccidiosis due to
Eimeria bovis
and E. zuernii
during the last
14 to 91 days on
feed.
Feed continuously as the sole ration to provide 13 to 90
mg lubabegron/head/day and 0.14 to 0.42 mg
monensin/lb body weight per day, depending upon severity of coccidiosis challenge, during the last 14 to 91
days on feed. A decrease in dry matter intake may be
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 § 558.355(d) of this chapter.
Lubabegron fumarate as provided by No. 058198,
monensin as provided by No. 016592 or 058198 in
§ 510.600(c) of this chapter.
(2) * * *
(i) Monensin as in § 558.355.
(ii) Tylosin in § 558.625.
§ 558.355
31. In § 558.355, revise paragraph
(f)(4)(iv) to read as follows:
■
*
*
*
Indications for use
Limitations
*
*
(iv) 400 mg per pound of block
*
Growing beef steers and heifers on pasture (stocker,
feeder, and slaughter) and
beef replacement heifers):
for increased rate of weight
gain.
*
*
*
Provide 50 to 200 mg of monensin (2 to 8 ounces of block)
per head per day, in at least one block per five head of
cattle. Feed blocks continuously. Do not feed 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..
*
*
*
*
VerDate Sep<11>2014
*
*
*
16:08 Dec 05, 2023
*
32. In § 558.625, revise paragraphs
(e)(2)(vii) and (viii) to read as follows:
Jkt 262001
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Sponsor
*
■
Sfmt 4700
*
§ 558.625
*
06DER1
*
086113
*
Tylosin.
*
*
(e) * * *
(2) * * *
E:\FR\FM\06DER1.SGM
016592, 058198
Monensin.
*
*
(f) * * *
(4) * * *
Monensin amount
*
lotter on DSK11XQN23PROD with RULES1
Sponsor
*
*
84703
lotter on DSK11XQN23PROD with RULES1
Federal Register / Vol. 88, No. 233 / Wednesday, December 6, 2023 / Rules and Regulations
Tylosin grams/ton
Combination in
grams/ton
Indications for use
Limitations
*
(vii) 8 to 10 ............
*
Monensin, 5 to 40
plus lubabegron
fumarate, 1.25 to
4.54.
*
Beef steers and
heifers fed in
confinement for
slaughter: for reduction of ammonia gas emissions per pound
of live weight
and hot carcass
weight; for reduction of incidence of liver
abscesses associated with
Fusobacterium
necrophorum
and
Arcanobacterium
pyogenes and
for improved
feed efficiency
during the last
14 to 91 days on
feed.
(viii) 8 to 10 ...........
Monensin, 10 to 40
plus lubabegron
fumarate, 1.25 to
4.54.
Beef steers and
heifers fed in
confinement for
slaughter: for reduction of ammonia gas emissions per pound
of live weight
and hot carcass
weight, for reduction of incidence of liver
abscesses associated with
Fusobacterium
necrophorum
and
Arcanobacterium
pyogenes and
for prevention
and control of
coccidiosis due
to Eimeria bovis
and E. zuernii
during the last
14 to 91 days on
feed.
*
*
*
Feed continuously as sole ration to provide 13 to 90 mg
lubabegron/head/day, 50 to 480 mg monensin/head/
day, and 60 to 90 mg tylosin/head/day during the last
14 to 91 days on feed. No additional improvement in
feed efficiency has been shown from feeding monensin
at levels greater than 30 g/ton (360 mg monensin/head/
day). A decrease in dry matter intake may be 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 § 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
§ 510.600(c) of this chapter.
Feed continuously as sole ration to provide 13 to 90 mg
lubabegron/head/day, 0.14 to 0.42 mg monensin/lb
body weight per day, depending upon severity of coccidiosis challenge, up to 480 mg/head/day, and 60 to 90
mg tylosin/head/day during the last 14 to 91 days on
feed. A decrease in dry matter intake may be 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 § 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
§ 510.600(c) of this chapter.
*
VerDate Sep<11>2014
*
16:08 Dec 05, 2023
*
Jkt 262001
PO 00000
*
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*
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E:\FR\FM\06DER1.SGM
*
06DER1
*
016592, 058198
016592, 058198
*
84704
Federal Register / Vol. 88, No. 233 / Wednesday, December 6, 2023 / Rules and Regulations
*
*
*
*
*
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
DEPARTMENT OF AGRICULTURE
Forest Service
36 CFR Parts 212, 214, and 251
RIN 0596–AD54
Travel Management; Administration of
the Forest Transportation System;
Postdecisional Administrative Review
Process for Occupancy or Use of
National Forest System Lands and
Resources; Land Uses; Special Uses
Forest Service, USDA.
Final rule.
AGENCY:
ACTION:
lotter on DSK11XQN23PROD with RULES1
36 CFR Part 212, Subpart A
The United States Department
of Agriculture, Forest Service (Forest
Service or Agency) is making purely
technical, clarifying revisions to its
existing regulations governing
administration of the forest
transportation system, administrative
appeal of certain written decisions
pertaining to written authorizations for
occupancy or use of National Forest
System (NFS) lands and resources, and
issuance and administration of special
use authorizations for use and
occupancy of NFS lands. The purely
technical, clarifying revisions update
citations and enhance consistency of the
existing regulations with governing
statutes.
DATES: This rule is effective December 6,
2023.
ADDRESSES: Information on this final
rule may be obtained via written request
addressed to the Director, Lands,
Minerals, and Geology Management,
USDA Forest Service, 201 14th Street
NW, Washington, DC 20250–1124 or by
email to SM.FS.WO_LandStaff@
usda.gov.
FOR FURTHER INFORMATION CONTACT:
Mark Chandler, Realty Specialist, (202)
205–1117 or mark.chandler@usda.gov.
Individuals who use telecommunication
devices for the hearing impaired may
call the Federal Relay Service at (800)
877–8339 between 8:00 a.m. and 5:00
p.m., Eastern Time, Monday through
Friday.
SUPPLEMENTARY INFORMATION: This final
rule makes purely technical, clarifying
revisions to the Agency’s existing
regulations at 36 CFR 212.8, 214.4,
251.50, 251.51, 251.53, 251.54, 251.55,
SUMMARY:
VerDate Sep<11>2014
16:08 Dec 05, 2023
Jkt 262001
251.57, 251.58, 251.59, 251.60, 251.64,
and 251.124 governing administration of
the forest transportation system,
administrative appeal of certain written
decisions pertaining to written
authorizations for occupancy or use of
NFS lands and resources, and issuance
and administration of special use
authorizations for use and occupancy of
NFS lands. The purely technical,
clarifying revisions update citations and
enhance consistency of the existing
regulations with governing statutes.
These purely technical, clarifying
revisions do not formulate standards,
criteria, or guidelines applicable to
Forest Service programs and therefore
do not require public notice and
opportunity to comment under section
14(a) of the Forest and Rangeland
Renewable Resources Planning Act of
1974 (16 U.S.C. 1612(a)).
The Department is revising text in
§ 212.8(d)(5)(i) to track revisions being
made to § 251.60(a)(2)(i) and to provide
that a formal adjudicatory hearing is
required for revocation for nonuse of an
easement issued under the National
Forest Roads and Trails Act (FRTA).
36 CFR Part 214
The Department is revising
§ 214.4(c)(1)(i) to provide that
suspension or revocation of permits as
well as easements issued under the
Mineral Leasing Act (MLA) and
revocation for nonuse of an easement
issued under FRTA are not subject to
administrative appeal under 36 CFR
part 214. In contrast to the Federal Land
Policy and Management Act (FLPMA)
addressed in 36 CFR 251.53(l), the MLA
addressed in 36 CFR 251.53(e) requires
a formal adjudicatory proceeding for
suspension or revocation of permits as
well as easements (30 U.S.C.
185(o)(1)(C)). Therefore, suspension or
revocation of permits as well as
easements issued under the MLA must
be exempt from the informal
administrative appeal process under 36
CFR part 214. FRTA provides for a
formal hearing for revocation of an
easement for nonuse (16 U.S.C. 534).
36 CFR Part 251, Subpart B
§ 251.50
The Department is removing
paragraph (c)(3) of § 251.50, which
requires a special use authorization for
a noncommercial recreational activity if
required by an order issued under 36
CFR part 261, subpart B, or by a
regulation issued under 36 CFR part
261, subpart C. There is no basis for
issuance of such an order under 36 CFR
PO 00000
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Fmt 4700
Sfmt 4700
part 261, subpart B. Moreover, there is
no need for issuance of such an order
or regulation because the Forest Service
has the authority to require a
noncommercial special recreation
permit under the Federal Lands
Recreation Enhancement Act and its
implementing directives in Forest
Service Handbook (FSH) 2309.13,
Chapter 30.
§ 251.51
The Department is revising the
definitions for ‘‘outfitting’’ and
‘‘guiding’’ by replacing the phrase
‘‘pecuniary remuneration’’ with the
word ‘‘monetary.’’ The revised language
is more contemporary and easier to
understand.
§ 251.53
The Department is revising § 251.53(a)
by changing the phrase ‘‘group events’’
to ‘‘noncommercial group use’’ and
deleting the phrase ‘‘and distribution of
noncommercial printed materials’’ for
authorizations issued under the Organic
Administration Act (16 U.S.C. 551). The
term of art per the definitions for special
uses in 36 CFR 251.51 is
‘‘noncommercial group use.’’ The
distribution of noncommercial printed
materials does not require a special use
authorization under 36 CFR 251.50(c).
The Department is adding paragraph
(o) to § 251.53 to include the Forest
Service’s authority under section 111 of
the National Historic Preservation Act of
1966 (54 U.S.C. 306121) to issue leases
for Federally owned historic properties
on NFS lands.
§ 251.54
The Department is revising
§ 251.54(d) through (g) to use
appropriate terminology when referring
to a proponent or a proposal and to
enhance clarity.
The Department is revising
§ 251.54(e)(1)(iv), which precludes
consideration of proposals for a
permanent use and occupancy of NFS
lands, to add an exception for
permanent easements issued under
FRTA (16 U.S.C. 533).
The Department is revising
§ 251.54(f)(1)(i) regarding who may
apply for an oil or gas pipeline right-ofway authorization for greater
consistency with the MLA (30 U.S.C.
181).
The Department is revising
§ 251.54(g)(3)(iii) to replace the citation
to 36 CFR part 215 with a citation to 36
CFR part 218. The postdecisional
administrative appeal process in 36 CFR
part 215 has been replaced with the
predecisional objection process in 36
CFR part 218.
E:\FR\FM\06DER1.SGM
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]]>Agencies
[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 [www.gpo.gov]
[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,
[email protected].
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: https://animaldrugsatfda.fda.gov/adafda/views/#/search.
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.
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.
21 CFR 520.23 is amended to reflect approved strengths of
acepromazine maleate tablets for dogs and cats.
21 CFR 522.460 is amended to reflect current labeling for
cloprostenol injectable solution for use in cattle.
21 CFR 522.2640 is amended to reflect the approved
strengths of generic tylosin injectable solutions.
21 CFR 558.330 is amended to reflect the sponsors of drugs
approved for use in combination medicated feeds containing lubebegron
and monensin.
21 CFR 558.355 is amended to reflect the classes of
pasture cattle approved for use of a monensin free-choice block.
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..
* * * * * * *
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* * * * *
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]]
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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.
* * * * * * *
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[[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
