New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications, Change of Sponsor, Change of Sponsor Address, 42354-42361 [2024-10586]
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Federal Register / Vol. 89, No. 95 / Wednesday, May 15, 2024 / Rules and Regulations
will thereafter be continuously published in
the Chart Supplement.
DEPARTMENT OF COMMERCE
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International Trade Administration
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Paragraph 6002 Class E Airspace Areas
Designated as Surface Areas.
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ASW TX E2
[Amended]
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[Docket No. 240226–0059]
RIN 0625–AB24
Beaumont/Port Arthur, TX
Jack Brooks Regional Airport, TX
(Lat. 29°57′03″ N, long. 94°01′15″ W)
Within a 5-mile radius of Jack Brooks
Regional Airport. This Class E airspace area
is effective during the specific dates and
times established in advance by a Notice to
Air Missions. The effective dates and times
will thereafter be continuously published in
the Chart Supplement.
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Paragraph 6005 Class E Airspace Areas
Extending Upward From 700 Feet or More
Above the Surface of the Earth.
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ASW TX E5
[Amended]
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Beaumont/Port Arthur, TX
Jack Brooks Regional Airport, TX
(Lat. 29°57′03″ N, long. 94°01′15″ W)
Beaumont Municipal Airport, TX
(Lat. 30°04′13″ N, long. 94°12′54″ W)
Orange County Airport, TX
(Lat. 30°04′06″ N, long. 93°48′14″ W)
That airspace extending upward from 700
feet above the surface within a 7.5-mile
radius of Jack Brooks Regional Airport; and
within a 6.4-mile radius of Beaumont
Municipal Airport; and within a 6.5-mile
radius of Orange County Airport.
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The U.S. and Foreign Commercial
Service Pilot Fellowship Program;
Correction
International Trade
Administration, Department of
Commerce.
ACTION: Final rule; correction.
AGENCY:
The International Trade
Administration is correcting a final rule
published in the Federal Register on
May 7, 2024, regarding The U.S. and
Foreign Commercial Service Pilot
Fellowship Program. This correction
applies to the effective date of final rule.
DATES: Effective May 15, 2024.
FOR FURTHER INFORMATION CONTACT:
Wendy Thompson at wendy.thompson@
trade.gov or 202–754–4075.
SUPPLEMENTARY INFORMATION: In FR Doc.
2024–09863, on page 37972 in the
Federal Register of Tuesday, May 7,
2024, in the second column, correct the
DATES caption by adding ‘‘, 2024’’ after
‘‘May 6’’.
SUMMARY:
Dated: May 8, 2024
Kimberly White-Bacon,
Program Manager.
[FR Doc. 2024–10561 Filed 5–14–24; 8:45 am]
BILLING CODE 3510–FP–P
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Issued in Fort Worth, Texas, on May 1,
2024.
Steven T. Phillips,
Acting Manager, Operations Support Group,
ATO Central Service Center.
[FR Doc. 2024–09872 Filed 5–14–24; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, 529,
and 558
BILLING CODE 4910–13–P
The Food and Drug
Administration (FDA or we) is
amending the animal drug regulations to
reflect application-related actions for
new animal drug applications (NADAs)
and abbreviated new animal drug
applications (ANADAs) during January,
February, and March 2024. The animal
drug regulations are also being amended
to improve their accuracy and
readability.
SUMMARY:
15 CFR Part 326
*
Final rule; technical
amendments.
ACTION:
DATES:
This rule is effective May 15,
2024.
FOR FURTHER INFORMATION CONTACT:
George K. Haibel, Center for Veterinary
Medicine, Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–5689,
George.Haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Approvals
FDA is amending the animal drug
regulations to reflect approval actions
for NADAs and ANADAs during
January, February, and March 2024, as
listed in table 1. In addition, FDA is
informing the public of the availability,
where applicable, of documentation of
environmental review required under
the National Environmental Policy Act
(NEPA) and, for actions requiring
review of safety or effectiveness data,
summaries of the basis of approval
(FOIA Summaries) under the Freedom
of Information Act (FOIA). These
documents, along with marketing
exclusivity and patent information, may
be obtained at Animal Drugs @FDA:
https://animaldrugsatfda.fda.gov/
adafda/views/#/search.
[Docket No. FDA–2024–N–0002]
New Animal Drugs; Approval of New
Animal Drug Applications; Withdrawal
of Approval of New Animal Drug
Applications, Change of Sponsor,
Change of Sponsor Address
AGENCY:
Food and Drug Administration,
HHS.
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TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING JANUARY, FEBRUARY, AND MARCH
2024 REQUIRING EVIDENCE OF SAFETY AND/OR EFFECTIVENESS
Date of approval
January 11, 2024 ........
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File No.
200–766
15:57 May 14, 2024
Sponsor
(drug labeler code)
Product name
Aurora Pharmaceutical, Inc., 1196
Highway 3 South, Northfield, MN
55057–3009 (051072).
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EQUICOXIB (firocoxib) Oral Solution.
Fmt 4700
Sfmt 4700
Effect of the action
Original approval as a generic copy
of NADA 141–253.
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21 CFR
section
520.929
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TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING JANUARY, FEBRUARY, AND MARCH
2024 REQUIRING EVIDENCE OF SAFETY AND/OR EFFECTIVENESS—Continued
Date of approval
Sponsor
(drug labeler code)
Product name
Effect of the action
Huvepharma EOOD, 5th Floor, 3A
Nikolay Haytov Str., 1113 Sofia,
Bulgaria (016592).
Felix Pharmaceuticals Pvt. Ltd., 25–
28 North Wall Quay, Dublin 1,
Ireland (086101).
ZyVet Animal Health, Inc., 73 Route
31N, Pennington, NJ 08534
(086117).
Boehringer Ingelheim Animal Health
USA, Inc., 3239 Satellite Blvd.,
Duluth, GA 30096 (000010).
RAVANTAGE 9 and RAVANTAGE
45 (ractopamine hydrochloride)
Type A Medicated Articles.
Carprofen Tablets ............................
Original approval as a generic copy
of NADA 140–863.
558.500
Original approval as a generic copy
of NADA 141–053.
520.304
SELAMECTIN Topical Solution .......
Original approval as a generic copy
of NADA 141–152.
524.2098
VETMEDIN (pimobendan oral solution) Solution.
520.1782
Ceva Sante Animale, 10 Avenue de
la Ballastière, 33500 Libourne,
France (013744).
Parnell Technologies Pty. Ltd., unit
4, 476 Gardeners Rd., Alexandria, New South Wales 2015,
Australia (068504).
Dechra Ltd. Snaygill Industrial Estate, Keighley Road, Skipton,
North Yorkshire, BD23 2RW,
United Kingdom (043264).
KESIUM (amoxicillin and
clavulanate potassium tablets)
Chewable Tablets.
CONTRASED (atipamezole hydrochloride) Injectable Solution.
Original approval for management
of the signs of mild, moderate, or
severe congestive heart failure in
dogs.
Original approval as a generic copy
of NADA 055–099.
Original approval as a generic copy
of NADA 141–033.
522.147
Original approval for treatment of
otitis externa in dogs, associated
with susceptible strains of yeast
(Malassezia pachydermatis).
524.2338
File No.
January 12, 2024 ........
200–768
January 12, 2024 ........
200–767
January 30, 2024 ........
200–769
February 13, 2024 ......
141–575
February 22, 2024 ......
200–749
March 1, 2024 .............
200–772
March 15, 2024 ...........
141–579
II. Withdrawals of Approval
Boehringer Ingelheim Animal Health
USA, Inc., 3239 Satellite Blvd., Duluth,
DUOTIC (terbinafine and
betamethasone acetate otic gel)
Otic Gel.
GA 30096 (drug labeler code 000010)
requested that FDA withdraw approval
of the five NADAs listed in table 2
because the products are no longer
21 CFR
section
520.88g
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 JANUARY, FEBRUARY, AND
MARCH 2024
Date of withdrawal
of approval
March 4, 2024 ........
Do ...........................
Do ...........................
Do ...........................
Do ...........................
File No.
21 CFR
section
Product name
141–015
141–096
141–108
141–274
141–421
ENACARD (enalapril maleate) Tablets ...........................................................................................
DICURAL (difloxacin hydrochloride) Tablets ..................................................................................
ETOGESIC (etodolac) Tablets ........................................................................................................
ETOGESIC (etodolac) Injectable Solution ......................................................................................
DUOCARE (ivermectin and praziquantel) Paste ............................................................................
III. Changes of Sponsor
informed FDA that they have transferred
ownership of, and all rights and interest
in, these applications to another
The sponsors of the approved
applications listed in table 3 have
520.804
520.645
520.870
522.870
520.1198
sponsor. The regulations cited in table
3 are amended to reflect these actions.
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TABLE 3—APPLICATIONS FOR WHICH OWNERSHIP WAS TRANSFERRED TO ANOTHER SPONSOR DURING JANUARY,
FEBRUARY, AND MARCH 2024
Transferring sponsor
(drug labeler code)
File No.
Product name
200–141 .......................
ATTANE (isoflurane) ..............................
Piramal Critical Care, Inc., 3850
Schelden Circle, Bethlehem, PA
18017 (066794).
200–237 .......................
200–338 .......................
Isoflurane, USP ......................................
TRI–HEART (ivermectin and pyrantel
pamoate) Tablets.
200–438 .......................
PETREM (sevoflurane) ...........................
Do ...........................................................
Heska Corp., 3760 Rocky Mountain
Ave., Loveland, CO 80538–7084
(063604).
Piramal Critical Care, Inc., 3850
Schelden Circle, Bethlehem, PA
18017 (066794).
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New sponsor
(drug labeler code)
Piramal Pharma Ltd., Ground floor,
Piramal Ananta, Agastya Corporate
Park, Mumbai, Maharashtra—400070,
India (065085).
Do ...........................................................
Diamond Animal Health, Inc., 2538 SE
43rd St., Des Moines, IA 50327
(053701).
Piramal Pharma Ltd., Ground floor,
Piramal Ananta, Agastya Corporate
Park, Mumbai, Maharashtra—400070,
India (065085).
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21 CFR
section
529.1186
Do.
510.600
520.1196
529.2110
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Federal Register / Vol. 89, No. 95 / Wednesday, May 15, 2024 / Rules and Regulations
IV. Change of Sponsor Address
ECO LLC, 344 Nassau St., Princeton,
NJ 08540 (drug labeler code 066916 in
21 CFR 510.600(c)) has informed FDA
that it has changed its address to 11224
Aurora Ave., Urbandale, IA 50322. 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
and readability of the animal drug
regulations.
• 21 CFR 510.600 is amended to
remove entries for Heska Corp. and
Piramal Critical Care, Inc. from the lists
of sponsors of approved applications, to
revise the entries for Cronus Pharma
Specialities India Private Ltd. and ECO
LLC; and to add entries for Diamond
Animal Health, Inc.
• 21 CFR 522.840 is amended to
reflect revisions to approved labeling for
cattle implants containing estradiol.
• 21 CFR 522.1940 is amended to
reflect the current format for regulations
and revisions to approved labeling for
cattle implants containing progesterone
and estradiol benzoate.
• 21 CFR 522.2343 is amended to
reflect revisions to approved labeling for
cattle implants containing testosterone
propionate and estradiol benzoate.
• 21 CFR 522.2477 is amended to
reflect revisions to approved labeling for
cattle implants containing trenbolone
acetate and estradiol.
• 21 CFR 524.1193 is amended to
reflect periods of persistent activity for
an approved generic ivermectin topical
solution used in cattle.
• 21 CFR 558.485 is amended to
reflect an inclusion rate for pyrantel
tartrate in medicated horse feeds.
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.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR parts 510,
520, 522, 524, 529, 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:
a. In the table in paragraph (c)(1):
i. Add in alphabetical order an entry
for ‘‘Diamond Animal Health, Inc.’’;
■ ii. Revise the entries for ‘‘Cronus
Pharma Specialities India Private Ltd.’’;
and ‘‘ECO LLC’’; and
■ iii. Remove the entries for ‘‘Heska
Corp.’’ and ‘‘Piramal Critical Care, Inc.’’;
■ b. In the table in paragraph (c)(2), add
an entry for ‘‘053701’’; remove the
entries for ‘‘063604’’ and ‘‘066794’’; and
revise the entries for ‘‘066916’’ and
‘‘069043’’.
The revisions and additions read as
follows:
■
■
■
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
21 CFR Parts 520, 522, 524, and 529
Animal drugs.
*
21 CFR Part 558
Animal drugs, Animal feeds.
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*
(c) * * *
(1) * * *
*
Firm name and address
*
Drug labeler code
*
*
*
*
*
*
Cronus Pharma Specialities India Private Ltd., Plot No.9(B), Survey No. 99/1, GMR Hyderabad Aviation SEZ Ltd.,
Mamidipalle Village, Balapur Mandal, Shamshabad, Rangareddy, Hyderabad, Telangana, 500108, India ......................
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Diamond Animal Health, Inc., 2538 SE 43rd St., Des Moines, IA 50327 ...............................................................................
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ECO LLC, 11224 Aurora Ave., Urbandale, IA 50322 .............................................................................................................
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*
069043
053701
066916
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(2) * * *
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Drug labeler code
Firm name and address
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053701 .......................
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Diamond Animal Health, Inc., 2538 SE 43rd St., Des Moines, IA 50327.
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066916 .......................
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ECO LLC, 11224 Aurora Ave., Urbandale, IA 50322.
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069043 .......................
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Cronus Pharma Specialities India Private Ltd., Plot No.9(B), Survey No. 99/1, GMR Hyderabad Aviation SEZ Ltd.,
Mamidipalle Village, Balapur Mandal, Shamshabad, Rangareddy, Hyderabad, Telangana, 500108, India.
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Federal Register / Vol. 89, No. 95 / Wednesday, May 15, 2024 / Rules and Regulations
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
3. The authority citation for part 520
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
4. In § 520.88g, revise the section
heading and paragraph (a), and add
paragraph (b)(3) to read as follows:
■
§ 520.88g Amoxicillin and clavulanate
potassium tablets.
(a) Specifications. Each tablet or
chewable tablet contains amoxicillin
and clavulanate potassium equivalent to
50 milligrams (mg) amoxicillin and 12.5
mg clavulanic acid, 100 mg amoxicillin
and 25 mg clavulanic acid, 200 mg
amoxicillin and 50 mg clavulanic acid,
or 300 mg amoxicillin and 75 mg
clavulanic acid.
(b) * * *
(3) No. 013744 for use of chewable
tablets as in paragraph (c) of this
section.
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*
■ 5. In § 520.304:
■ i. Add paragraph (a)(4);
■ ii. Revise paragraph (b)(1); and
■ iii. Add paragraph (b)(4).
The additions and revision read as
follows:
§ 520.304
§ 520.1196
Ivermectin and pyrantel tablets.
*
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*
*
(b) Sponsors. See Nos. 000010,
051311, and 053701 in § 510.600(c) of
this chapter.
*
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§ 520.1198
[Amended]
12. In § 520.1198, remove paragraphs
(a)(3) and (b)(3).
■ 13. Amend § 520.1780 by revising the
section heading to read as follows:
■
§ 520.1780
■
Pimobendan tablets.
14. Add § 520.1782 to read as follows:
§ 520.1782
Carprofen.
Pimobendan solution.
■
(a) Specifications. Each milliliter of
solution contains 1.5 milligrams (mg)
pimobendan.
(b) Sponsor. See No. 000010 in
§ 510.600(c) of this chapter.
(c) Conditions of use in dogs—(1)
Amount. Administer orally at a total
daily dose of 0.23 mg/lb (0.5 mg/kg)
body weight. The total daily dose
should be divided into two equal
portions administered approximately 12
hours apart (i.e., morning and evening).
(2) Indications for use. For the
management of the signs of mild,
moderate, or severe congestive heart
failure in dogs due to clinical
myxomatous mitral valve disease
(MMVD) or dilated cardiomyopathy
(DCM); for use with concurrent therapy
for congestive heart failure (e.g.,
furosemide, etc.) as appropriate on a
case-by-case basis.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
§ 520.928
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
(a) * * *
(4) Each flavored tablet contains 25,
75, or 100 mg carprofen.
(b) * * *
(1) Nos. 017033, 054771, 055529, and
062250 for use of products described in
paragraphs (a)(1) and (a)(2) of this
section as in paragraph (c) of this
section.
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*
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*
*
(4) No. 086101 for use of product
described in paragraphs (a)(1), (a)(2),
and (a)(4) of this section as in paragraph
(c) of this section.
*
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*
*
§ 520.645
■
■
[Removed]
6. Remove § 520.645.
§ 520.804
[Removed]
7. Remove § 520.804.
§ 520.870
[Removed]
8. Remove § 520.870.
■ 9. Amend § 520.928 by revising the
section heading to read as follows:
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(b) Sponsors. See No. 051072 in
§ 510.600(c) of this chapter.
(c) Conditions of use in horses—(1)
Amount. Administer 0.1 mg per
kilogram (0.045 mg per pound) of body
weight once daily for up to 14 days.
(2) Indications for use. For the control
of pain and inflammation associated
with osteoarthritis.
(3) Limitations. Do not use in horses
intended for human consumption.
Federal law restricts this drug to use by
or on the order of a licensed
veterinarian.
■ 11. In § 520.1196, revise paragraph (b)
to read as follows:
■
Firocoxib tablets.
10. Add § 520.929 to read as follows:
§ 520.929
Firocoxib solution.
(a) Specifications. Each milliliter of
solution contains 9 milligram (mg)
firocoxib.
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15. The authority citation for part 522
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
16. In § 522.147, revise paragraph (b)
to read as follows:
■
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42357
Atipamezole.
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(b) Sponsors. See Nos. 015914,
052483, 068504, and 069043 in
§ 510.600(c) of this chapter.
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■ 17. In § 522.840, revise paragraph (d)
to read as follows:
§ 522.840
Estradiol.
*
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*
(d) Conditions of use—(1) Beef steer
calves 2 months of age and older—(i)
Amount and indications for use. (A) An
extended-release implant containing
25.7 mg estradiol for increased rate of
weight gain for up to 200 days.
(B) An extended-release implant
containing 43.9 mg estradiol for
increased rate of weight gain for up to
400 days.
(ii) Limitations. For subcutaneous ear
implantation only. Not approved for
repeated implantation (reimplantation)
with this or any other cattle ear implant
in beef steer calves 2 months of age and
older. Safety and effectiveness following
reimplantation have not been evaluated.
Do not use in beef calves less than 2
months of age, dairy calves, and veal
calves. A withdrawal period has not
been established for this product in preruminating calves. Do not use in dairy
cows or in animals intended for
subsequent breeding. Use in these cattle
may cause drug residues in milk and/or
in calves born to these cows.
(2) Growing beef steers and heifers on
pasture (stocker, feeder, and
slaughter)—(i) Amount and indications
for use. (A) An extended-release implant
containing 25.7 mg estradiol for
increased rate of weight gain for up to
200 days.
(B) An extended-release implant
containing 43.9 mg estradiol for
increased rate of weight gain for up to
400 days.
(ii) Limitations. For subcutaneous ear
implantation only. Not approved for
repeated implantation (reimplantation)
with this or any other cattle ear implant
in growing beef steers and heifers on
pasture (stocker, feeder, and slaughter).
Safety and effectiveness following
reimplantation have not been evaluated.
Do not use in beef calves less than 2
months of age, dairy calves, and veal
calves. A withdrawal period has not
been established for this product in preruminating calves. Do not use in dairy
cows or in animals intended for
subsequent breeding. Use in these cattle
may cause drug residues in milk and/or
in calves born to these cows.
(3) Growing beef steers and heifers fed
in confinement for slaughter—(i)
Amount and indications for use. (A) An
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(2) No. 058198 for use as in
paragraphs (e)(1)(i)(A), (e)(1)(i)(B),
(e)(1)(ii), and (e)(3) of this section.
(c) Related tolerances. See §§ 556.240
and 556.540 of this chapter.
(d) Special considerations. Labeling of
implants described in paragraphs
(a)(2)(i) and (a)(2)(ii) for use in
paragraphs (e)(1)(i)(B), (e)(1)(ii), (e)(3)(i),
and (e)(3)(ii) of this section shall bear
the following: ‘‘Federal law restricts this
drug to use by or on the order of a
licensed veterinarian.’’
(e) Conditions of use—(1) Beef calves
45 days of age and older and weighing
up to 400 lbs—(i) Amounts and
indications for use. (A) An implant
containing 100 mg progesterone and 10
mg estradiol benzoate as described in
paragraph (a)(1)(i) of this section for
increased rate of weight gain.
(B) An implant containing 100 mg
progesterone, 10 mg estradiol benzoate,
and 29 mg tylosin tartrate as described
in paragraph (a)(2)(i) of this section for
increased rate of weight gain.
(ii) Limitations. Implant pellets
subcutaneously in ear only. Other than
§ 522.870 [Removed]
when used as described in (e)(2)(i)(B) of
■ 18. Remove § 522.870.
this section, the implant as described in
■ 19. Revise § 522.1940 to read as
paragraph (a)(1)(i) of this section is not
follows:
approved for repeated implantation
(reimplantation). The implant as
§ 522.1940 Progesterone and estradiol
benzoate.
described in paragraph (a)(2)(i) of this
section is not approved for repeated
(a) Specifications—(1) Each implant
implantation (reimplantation) with this
consists of progesterone and estradiol
or any other cattle ear implant. Do not
benzoate. (i) 100 mg progesterone and
use in beef calves less than 45 days of
10 mg estradiol benzoate (one implant
age, dairy calves, and veal calves
consisting of four pellets, each
because effectiveness and safety have
containing 25 mg progesterone and 2.5
not been evaluated. Do not use in dairy
mg estradiol benzoate).
cows or in animals intended for
(ii) 200 mg progesterone and 20 mg
subsequent breeding. Use in these cattle
estradiol benzoate (one implant
may cause drug residues in milk and/or
consisting of eight pellets, each
calves born to these cows.
containing 25 mg progesterone and 2.5
(2) Growing beef steers fed in
mg estradiol benzoate).
confinement for slaughter—(i) Amounts
(2) Each implant consists of
progesterone and estradiol benzoate and and indications for use. (A) An implant
tylosin tartrate. (i) 100 mg progesterone, containing 200 mg progesterone and 20
mg estradiol benzoate as described in
10 mg estradiol benzoate, and 29 mg
paragraph (a)(1)(ii) of this section for
tylosin tartrate (one implant consisting
increased rate of weight gain and
of four pellets, each containing 25 mg
improved feed efficiency.
progesterone and 2.5 mg estradiol
(B) An implant containing 200 mg
benzoate, and one pellet containing 29
progesterone and 20 mg estradiol
mg tylosin tartrate).
benzoate as described in paragraph
(ii) 200 mg progesterone, 20 mg
(a)(1)(ii) of this section for increased rate
estradiol benzoate, and 29 mg tylosin
of weight gain in a reimplantation
tartrate (one implant consisting of eight
program where an implant as described
pellets, each containing 25 mg
in paragraph (a)(1)(i) of this section is
progesterone and 2.5 mg estradiol
the first implant and an implant as
benzoate, and one pellet containing 29
described in paragraph (a)(1)(ii) of this
mg tylosin tartrate).
(b) Sponsors. See sponsors in
section is administered approximately
§ 510.600(c) of this chapter for use as in 70 days later.
(C) An implant containing 200 mg
paragraph (c) of this section:
progesterone and 20 mg estradiol
(1) No. 054771 for use as in
benzoate as described in paragraph
paragraphs (e)(1)(i)(A), (e)(1)(ii),
(a)(1)(ii) of this section for increased rate
(e)(2)(i)(A), (B), (C), and (e)(2)(ii) of this
of weight gain in a reimplantation
section.
lotter on DSK11XQN23PROD with RULES1
extended-release implant containing
25.7 mg estradiol for increased rate of
weight gain and improved feed
efficiency for up to 200 days.
(B) An extended-release implant
containing 43.9 mg estradiol for
increased rate of weight gain and
improved feed efficiency for up to 400
days.
(ii) Limitations. For subcutaneous ear
implantation only. Not approved for
repeated implantation (reimplantation)
with this or any other cattle ear implant
in growing beef steers and heifers fed in
confinement for slaughter. Safety and
effectiveness following reimplantation
have not been evaluated. Do not use in
beef calves less than 2 months of age,
dairy calves, and veal calves. A
withdrawal period has not been
established for this product in preruminating calves. Do not use in dairy
cows or in animals intended for
subsequent breeding. Use in these cattle
may cause drug residues in milk and/or
in calves born to these cows.
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15:57 May 14, 2024
Jkt 262001
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Frm 00018
Fmt 4700
Sfmt 4700
program where an implant as described
in paragraph (a)(1)(ii) of this section is
the first implant and an implant as
described in paragraph (a)(1)(ii) of this
section is administered approximately
70 days later.
(ii) Limitations. Implant pellets
subcutaneously in ear only. Other than
when used as described in paragraphs
(e)(2)(i)(B) or (C) of this section, the
implant described in paragraph (a)(1)(ii)
of this section is not approved for
repeated implantation (reimplantation)
with any other cattle ear implant in
growing beef steers and heifers fed in
confinement for slaughter as safety and
effectiveness have not been evaluated.
Do not use in beef calves less than 2
months of age, dairy calves, and veal
calves because effectiveness and safety
have not been evaluated. Do not use in
dairy cows or in animals intended for
subsequent breeding. Use in these cattle
may cause drug residues in milk and/or
calves born to these cows.
(3) Growing beef steers weighing 400
lbs or more—(i) Amounts and
indications for use. An implant
containing 200 mg progesterone, 20 mg
estradiol benzoate, and 29 mg tylosin
tartrate as described in paragraph
(a)(2)(ii) of this section for increased rate
of weight gain and improved feed
efficiency.
(ii) Limitations. The implant as
described in paragraph (a)(2)(ii) of this
section is not approved for repeated
implantation (reimplantation) with this
or any other cattle ear implant. Do not
use in beef calves less than 2 months of
age, dairy calves, and veal calves
because effectiveness and safety have
not been evaluated. Do not use in dairy
cows or in animals intended for
subsequent breeding. Use in these cattle
may cause drug residues in milk and/or
calves born to these cows.
■ 20. Revise § 522.2343 to read as
follows:
§ 522.2343 Testosterone propionate and
estradiol benzoate.
(a) Sponsors. See sponsors in
§ 510.600(c) of this chapter for use as in
paragraph (d) of this section.
(1) No. 054771 for use as in paragraph
(d)(1) of this section.
(2) No. 058198 for use as in paragraph
(d)(2) of this section.
(b) Related tolerances. See §§ 556.240
and 556.710 of this chapter.
(c) Special considerations. Labeling of
the implants described in paragraph
(d)(2) of this section shall bear the
following: ‘‘Federal law restricts this
drug to use by or on the order of a
licensed veterinarian.’’
(d) Conditions of use—(1) Growing
beef heifers fed in confinement for
E:\FR\FM\15MYR1.SGM
15MYR1
Federal Register / Vol. 89, No. 95 / Wednesday, May 15, 2024 / Rules and Regulations
slaughter—(i) Amounts and indications
for use. An implant containing 200 mg
testosterone propionate and 20 mg
estradiol benzoate (one implant
consisting of eight pellets, each
containing 25 mg testosterone
propionate and 2.5 mg estradiol
benzoate) for increased rate of weight
gain and improved feed efficiency.
(ii) Limitations. Implant pellets
subcutaneously in ear only. Not
approved for repeated implantation
(reimplantation) with this or any other
cattle ear implant. Do not use in beef
calves less than 2 months of age, dairy
calves, and veal calves because safety
and effectiveness have not been
evaluated. Do not use in dairy cows or
in animals intended for subsequent
breeding. Use in these cattle may cause
drug residues in milk and/or in calves
born to these cows.
(2) Growing beef heifers weighing 400
lbs or more—(i) Amounts and
indications for use. An implant
containing 200 mg testosterone
propionate, 20 mg estradiol benzoate,
and 29 mg tylosin tartrate (one implant
consisting of eight pellets, each
containing 25 mg testosterone
propionate and 2.5 mg estradiol
benzoate, and one pellet containing 29
mg tylosin tartrate) for increased rate of
weight gain and improved feed
efficiency.
(ii) Limitations. Implant pellets
subcutaneously in ear only. Not
approved for repeated implantation
(reimplantation) with this or any other
cattle ear implant. Do not use in beef
calves less than 2 months of age, dairy
calves, and veal calves because safety
and effectiveness have not been
evaluated. Do not use in dairy cows or
in animals intended for subsequent
breeding. Use in these cattle may cause
drug residues in milk and/or in calves
born to these cows.
21. Revise § 522.2477 to read as
follows:
■
lotter on DSK11XQN23PROD with RULES1
§ 522.2477
estradiol.
Trenbolone acetate and
(a) Sponsors. See sponsors in
§ 510.600(c) of this chapter for uses as
in paragraph (d) of this section.
(1) No. 058198 for use in paragraphs
(d)(1)(i)(B), (d)(1)(ii), (d)(2)(i)(B),
(d)(2)(i)(D), (d)(2)(ii), (d)(3)(i)(B),
(d)(3)(i)(D), (d)(3)(ii), (d)(4)(i)(A),
(d)(4)(i)(B), and (d)(4)(ii) of this section.
(2) No. 000061 for use in paragraphs
(d)(1)(i)(A), (d)(1)(i)(C), (d)(1)(ii),
(d)(2)(i)(A), (d)(2)(i)(C), (d)(2)(i)(E),
(d)(2)(ii), (d)(3)(i)(A), (d)(3)(i)(C),
(d)(3)(i)(E), (d)(3)(ii), (d)(4)(i)(A), and
(d)(4)(ii) of this section.
VerDate Sep<11>2014
15:57 May 14, 2024
Jkt 262001
(3) No. 054771 for use in paragraphs
(d)(2)(i)(A), (C), (d)(2)(ii), (d)(4)(i)(A),
and (d)(4)(ii) of this section.
(b) Related tolerances. See §§ 556.240
and 556.739 of this chapter.
(c) Special considerations. Labeling of
implants described in paragraphs
(d)(1)(i)(B), (d)(2)(i)(B), (d)(2)(i)(D),
(d)(3)(i)(B), (d)(3)(i)(D), and (d)(4)(i)(B)
of this section shall bear the following:
‘‘Federal law restricts this drug to use by
or on the order of a licensed
veterinarian.’’
(d) Conditions of use—(1) Growing
beef steers and heifers fed in
confinement for slaughter—(i) Amounts
and indications. (A) An implant
containing 200 mg trenbolone acetate
and 20 mg estradiol (one implant
consisting of 10 pellets each containing
20 mg trenbolone acetate and 2 mg
estradiol) for increased rate of weight
gain and improved feed efficiency.
(B) An implant containing 200 mg
trenbolone acetate, 20 mg estradiol, and
29 mg tylosin tartrate (one implant
consisting of 10 pellets, each containing
20 mg trenbolone acetate and 2 mg
estradiol, and 1 pellet containing 29 mg
tylosin tartrate) for increased rate of
weight gain and improved feed
efficiency.
(C) An extended- and delayed-release
implant containing 200 mg trenbolone
acetate and 20 mg estradiol (1 implant
consisting of 10 coated pellets, each
containing 20 mg trenbolone acetate and
2 mg estradiol) for increased rate of
weight gain and improved feed
efficiency during 70 to 200 days after
implantation.
(ii) Limitations. Implant pellets
subcutaneously in ear only. Not
approved for repeated implantation
(reimplantation) with this or any other
cattle ear implant in growing beef steers
and heifers fed in confinement for
slaughter. Do not use in beef calves less
than 2 months of age, dairy calves, and
veal calves because safety and
effectiveness have not been evaluated.
Do not use in dairy cows or in animals
intended for subsequent breeding. Use
in these cattle may cause drug residues
in milk and/or calves born to these
cows.
(2) Growing beef steers fed in
confinement for slaughter—(i) Amounts
and indications. (A) An implant
containing 80 mg trenbolone acetate and
16 mg estradiol (one implant consisting
of four pellets, each containing 20 mg
trenbolone acetate and 4 mg estradiol)
for increased rate of weight gain and
improved feed efficiency.
(B) An implant containing 80 mg
trenbolone acetate, 16 mg estradiol, and
29 mg tylosin tartrate (one implant
consisting of four pellets, each
PO 00000
Frm 00019
Fmt 4700
Sfmt 4700
42359
containing 20 mg trenbolone acetate and
4 mg estradiol, and one pellet
containing 29 mg tylosin tartrate) for
increased rate of weight gain and
improved feed efficiency.
(C) An implant containing 120 mg
trenbolone acetate and 24 mg estradiol
(one implant consisting of six pellets,
each containing 20 mg trenbolone
acetate and 4 mg estradiol) for increased
rate of weight gain and improved feed
efficiency.
(D) An implant containing 120 mg
trenbolone acetate, 24 mg estradiol, and
29 mg tylosin tartrate (one implant
consisting of six pellets, each containing
20 mg trenbolone acetate and 4 mg
estradiol, and one pellet containing 29
mg tylosin tartrate) for increased rate of
weight gain and improved feed
efficiency.
(E) An extended-release implant
containing 200 mg trenbolone acetate
and 40 mg estradiol (one implant
consisting of six coated pellets and four
uncoated pellets, each containing 20 mg
trenbolone acetate and 4 mg estradiol)
for increased rate of weight gain and
improved feed efficiency for up to 200
days after implantation.
(ii) Limitations. Implant pellets
subcutaneously in ear only. Not
approved for repeated implantation
(reimplantation) with this or any other
cattle ear implant in growing beef steers
fed in confinement for slaughter. Do not
use in beef calves less than 2 months of
age, dairy calves, and veal calves
because safety and effectiveness have
not been evaluated. Do not use in dairy
cows or in animals intended for
subsequent breeding. Use in these cattle
may cause drug residues in milk and/or
calves born to these cows.
(3) Growing beef heifers fed in
confinement for slaughter—(i) Amounts
and indications. (A) An implant
containing 80 mg trenbolone acetate and
8 mg estradiol (one implant consisting
of four pellets, each containing 20 mg
trenbolone acetate and 2 mg estradiol)
for increased rate of weight gain.
(B) An implant containing 80 mg
trenbolone acetate, 8 mg estradiol, and
29 mg tylosin tartrate (one implant
consisting of four pellets, each
containing 20 mg trenbolone acetate and
2 mg estradiol, and one pellet
containing 29 mg tylosin tartrate) for
increased rate of weight gain and
improved feed efficiency.
(C) An implant containing 140 mg
trenbolone acetate and 14 mg estradiol
(one implant consisting of seven pellets,
each containing 20 mg trenbolone
acetate and 2 mg estradiol) for increased
rate of weight gain and improved feed
efficiency.
E:\FR\FM\15MYR1.SGM
15MYR1
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(D) An implant containing 140 mg
trenbolone acetate, 14 mg estradiol, and
29 mg tylosin tartrate (one implant
consisting of seven pellets, each
containing 20 mg trenbolone acetate and
2 mg estradiol, and one pellet
containing 29 mg tylosin tartrate) for
increased rate of weight gain and
improved feed efficiency.
(E) An extended-release implant
containing 200 mg trenbolone acetate
and 20 mg estradiol (one implant
consisting of six coated pellets and four
uncoated pellets, each containing 20 mg
trenbolone acetate and 2 mg estradiol)
for increased rate of weight gain and
improved feed efficiency for up to 200
days after implantation.
(ii) Limitations. Implant pellets
subcutaneously in ear only. Not
approved for repeated implantation
(reimplantation) with this or any other
cattle ear implant in growing beef
heifers fed in confinement for slaughter.
Do not use in beef calves less than 2
months of age, dairy calves, and veal
calves because safety and effectiveness
have not been evaluated. Do not use in
dairy cows or in animals intended for
subsequent breeding. Use in these cattle
may cause drug residues in milk and/or
calves born to these cows.
(4) Growing beef steers and heifers on
pasture (stocker, feeder, and
slaughter)—(i) Amounts and indications
for use. (A) An implant containing 40
mg trenbolone acetate and 8 mg
estradiol (one implant consisting of two
pellets, each containing 20 mg
trenbolone acetate and 4 mg estradiol)
for increased rate of weight gain.
(B) An implant containing 40 mg
trenbolone acetate, 8 mg estradiol, and
29 mg tylosin tartrate (one implant
consisting of two pellets, each
containing 20 mg trenbolone acetate and
4 mg estradiol, and one pellet
containing 29 mg tylosin tartrate) for
increased rate of weight gain.
(ii) Limitations. Implant pellets
subcutaneously in ear only. Not
approved for repeated implantation
(reimplantation) with this or any other
cattle ear implant in growing beef steers
and heifers on pasture (stocker, feeder,
and slaughter). Do not use in beef calves
less than 2 months of age, dairy calves,
and veal calves because safety and
effectiveness have not been evaluated.
Do not use in dairy cows or in animals
intended for subsequent breeding. Use
in these cattle may cause drug residues
in milk and/or calves born to these
cows.
VerDate Sep<11>2014
15:57 May 14, 2024
Jkt 262001
25. Add § 524.2338 to read as follows:
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
■
22. The authority citation for part 524
continues to read as follows:
(a) Specifications. Each milliliter of
gel contains 10 milligrams (mg)
terbinafine and 1 mg betamethasone
acetate.
(b) Sponsor. See No. 043264 in
§ 510.600(c) of this chapter.
(c) Conditions of use in dogs—(1)
Amount. Administer one dose (1 tube)
per affected ear(s) and repeat
administration in 7 days.
(2) Indications for use. For the
treatment of otitis externa in dogs,
associated with susceptible strains of
yeast (Malassezia pachydermatis).
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
■
Authority: 21 U.S.C. 360b.
23. In § 524.1193:
a. Revise paragraph (b);
b. Remove paragraph (d);
c. Redesignate paragraph (e) as
paragraph (d) and revise newly
redesignated paragraphs (d)(2) and
(d)(3).
The revisions read as follows:
■
■
■
■
§ 524.1193
Ivermectin topical solution.
*
*
*
*
*
(b) Sponsors. See Nos. 000010,
016592, 055529, 058829, and 061133 in
§ 510.600(c) of this chapter for use as in
paragraph (d) of this section.
*
*
*
*
*
(d) * * *
(2) Indications for use. It is used for
the treatment and control of:
Gastrointestinal roundworms (adults
and fourth-stage larvae) Ostertagia
ostertagi (including inhibited stage),
Haemonchus placei, Trichostrongylus
axei, T. colubriformis, Cooperia
oncophora, C. punctata, C. surnabada,
Oesophagostomum radiatum (adults);
Strongyloides papillosus, Trichuris spp.;
lungworms (adults and fourth-stage
larvae) Dictyocaulus viviparus; cattle
grubs (parasitic stages) Hypoderma
bovis, H. lineatum; mites Sarcoptes
scabiei var. bovis; lice Linognathus
vituli, Haematopinus eurysternus,
Damalinia bovis, Solenoptes capillatus;
and horn flies Haematobia irritans. It
controls infections and prevents
reinfection with O. radiatum and D.
viviparus for 28 days after treatment, C.
punctata and T. axei for 21 days after
treatment, O. ostertagi, H. placei, C.
oncophora, and C. surnabada for 14
days after treatment, and D. bovis for 56
days after treatment.
(3) Limitations. Do not treat cattle
within 48 days of slaughter. Do not use
on female dairy cattle of breeding age or
on calves to be processed for veal.
Consult your veterinarian for assistance
in the diagnosis, treatment, and control
of parasitism.
■ 24. In § 524.2098, revise paragraph (b)
to read as follows:
§ 524.2098
Selamectin.
*
*
*
*
*
(b) Sponsors. See Nos. 051072,
051311, 054771, 055529, 061133, and
086117 of this chapter.
*
*
*
*
*
PO 00000
Frm 00020
Fmt 4700
Sfmt 4700
§ 524.2338
acetate.
Terbinafine and betamethasone
PART 529—CERTAIN OTHER DOSAGE
FORM NEW ANIMAL DRUGS
26. The authority citation for part 529
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
27. In § 529.1186, revise paragraph (b)
to read as follows:
■
§ 529.1186
Isoflurane.
*
*
*
*
*
(b) Sponsors. See Nos. 017033,
054771, and 065085 in § 510.600(c) of
this chapter.
*
*
*
*
*
28. In § 529.2110, revise paragraph (b)
to read as follows:
■
§ 529.2110
Sevoflurane.
*
*
*
*
*
(b) Sponsors. See Nos. 017033,
054771, and 065085 in § 510.600(c) of
this chapter.
*
*
*
*
*
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
29. The authority citation for part 558
continues to read as follows:
■
Authority: 21 U.S.C. 354, 360b, 360ccc,
360ccc–1, 371.
30. In § 558.485, revise (e)(2) to read
as follows:
■
§ 558.485
*
Pyrantel.
*
*
(e) * * *
(2) Horses—
E:\FR\FM\15MYR1.SGM
15MYR1
*
*
Federal Register / Vol. 89, No. 95 / Wednesday, May 15, 2024 / Rules and Regulations
Pyrantel tartrate
g/ton
Indications for use
Limitation
(i) 120 to 1,200 to provide
1.2 mg/lb body weight.
For prevention of Strongylus vulgaris larval infections; control
of adult large strongyles (S. vulgaris, and S. edentatus),
adult and 4th stage larvae small strongyles
(Cyathostomum spp., Cylicocyclus spp., Cylicostephanus
spp., Cylicodontophorus spp., Poteriostomum spp., and
Triodontophorus spp.), adult and 4th stage larvae
pinworms (Oxyuris equi), and adult and 4th stage larvae
ascarids (Parascaris equorum).
Feed continuously as the horse’s daily grain ration during the
time that the animal is at risk of exposure to internal
parasites. Do not use in horses intended for human consumption. Consult your veterinarian before using in severely debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism.
(ii) Top dress medicated feed—(A)
Proprietary Formulas. The following
feed can be manufactured only per an
Indications for use
(1) 9.6 g/lb to provide 1.2
mg/lb body weight.
Prevention of Strongylus vulgaris larval infections; control of
adult large strongyles (S. vulgaris, and S. edentatus), adult
and 4th stage larvae small strongyles (Cyathostomum
spp., Cylicocyclus spp., Cylicostephanus spp.,
Cylicodontophorus spp., Poteriostomum spp., and
Triodontophorus spp.), adult and 4th stage larvae
pinworms (Oxyuris equi), and adult and 4th stage larvae
ascarids (Parascaris equorum).
..................................................................................................
(B) [Reserved]
*
*
*
*
§ 558.500
31. In § 558.500, revise (b)(1), (b)(2),
and (e)(1)(i) to read as follows:
..................................................................................................
Ractopamine.
Combination in grams/ton
Indications for use
(i) 4.5 to 9.0 ..........................
...............................................
For increased rate of weight gain, improved feed efficiency, and increased carcass leanness in finishing
swine, weighing not less than 150 lb, fed a complete ration containing at least 16% crude protein for the last 45
to 90 lb of gain prior to slaughter.
*
*
*
*
*
*
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 516
DATES:
[Docket No. FDA–2006–N–0239]
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
ACTION:
This rule is effective May 15,
2024.
Index of Legally Marketed Unapproved
New Animal Drugs for Minor Species
15:57 May 14, 2024
*
The Food and Drug
Administration (FDA, the Agency, or
we) is amending the animal drug
regulations for labeling of new animal
drugs included on FDA’s Index of
Legally Marketed Unapproved New
Animal Drugs for Minor Species
(indexed products) to reflect the 2018
statutory changes to the Federal Food,
Drug, and Cosmetic Act (FD&C Act).
This amendment is intended to ensure
accuracy and clarity in the Agency’s
regulations. This amendment is
nonsubstantive.
[FR Doc. 2024–10586 Filed 5–14–24; 8:45 am]
VerDate Sep<11>2014
Limitations
SUMMARY:
Dated: May 9, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
AGENCY:
*
FOR FURTHER INFORMATION CONTACT:
Lucy Lee, Center for Veterinary
Medicine (HFV–50), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–0563,
lucy.lee@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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017135
054771
................
(2) Nos. 051311 and 054771: Type A
medicated articles containing 45.4 g/lb
ractopamine hydrochloride.
*
*
*
*
*
(e) * * *
(1) * * *
Ractopamine in grams/ton
*
017135
054771
Sponsor
Feed continuously as a top dress during the time that the
animal is at risk of exposure to internal parasites. Do not
use in horses intended for human consumption. Consult
your veterinarian before using in severely debilitated animals and for assistance in the diagnosis, treatment, and
control of parasitism.
*
*
*
*
(b) * * *
(1) Nos. 016592 and 058198: Type A
medicated articles containing 9 or 45.4
grams per pound (g/lb) ractopamine
hydrochloride.
■
lotter on DSK11XQN23PROD with RULES1
Limitations
*
*
*
Sponsor
approved proprietary formula and
specifications:
Pyrantel tartrate amount
(2) [Reserved].
42361
Sponsors
Feed continuously as sole
ration.
*
016592
054771
058198
*
I. Background
The Minor Use and Minor Species
Animal Health Act of 2004 (MUMS Act
of 2004) (Pub. L. 108–282) amended the
FD&C Act to establish regulatory
procedures that provide incentives
intended to make more drugs legally
available to veterinarians and animal
owners for the treatment of minor
animal species and uncommon diseases
in major animal species.
In 2007, FDA issued final regulations
(72 FR 69108, December 6, 2007) to
implement section 572 of the MUMS
Act entitled ‘‘Index of Legally Marketed
Unapproved New Animal Drugs for
Minor Species.’’ These regulations
establish administrative procedures and
criteria for index listing a new animal
drug that provide a basis for legally
marketing an unapproved new animal
drug for use in a minor species.
The MUMS Act and the 2007
regulations derived from it required
indexed products to state their
E:\FR\FM\15MYR1.SGM
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Agencies
[Federal Register Volume 89, Number 95 (Wednesday, May 15, 2024)]
[Rules and Regulations]
[Pages 42354-42361]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-10586]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, 529, and 558
[Docket No. FDA-2024-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications;
Withdrawal of Approval of New Animal Drug Applications, Change of
Sponsor, 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) and abbreviated new animal drug
applications (ANADAs) during January, February, and March 2024. The
animal drug regulations are also being amended to improve their
accuracy and readability.
DATES: This rule is effective May 15, 2024.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240-402-5689, [email protected].
SUPPLEMENTARY INFORMATION:
I. Approvals
FDA is amending the animal drug regulations to reflect approval
actions for NADAs and ANADAs during January, February, and March 2024,
as listed in table 1. In addition, FDA is informing the public of the
availability, where applicable, of documentation of environmental
review required under the National Environmental Policy Act (NEPA) and,
for actions requiring review of safety or effectiveness data, summaries
of the basis of approval (FOIA Summaries) under the Freedom of
Information Act (FOIA). These documents, along with marketing
exclusivity and patent information, may be obtained at Animal Drugs
@FDA: https://animaldrugsatfda.fda.gov/adafda/views/#/search.
Table 1--Original and Supplemental NADAs and ANADAs Approved During January, February, and March 2024 Requiring
Evidence of Safety and/or Effectiveness
----------------------------------------------------------------------------------------------------------------
Sponsor (drug Effect of the 21 CFR
Date of approval File No. labeler code) Product name action section
----------------------------------------------------------------------------------------------------------------
January 11, 2024............ 200-766 Aurora EQUICOXIB Original approval 520.929
Pharmaceutical, (firocoxib) Oral as a generic copy
Inc., 1196 Solution. of NADA 141-253.
Highway 3 South,
Northfield, MN
55057-3009
(051072).
[[Page 42355]]
January 12, 2024............ 200-768 Huvepharma EOOD, RAVANTAGE 9 and Original approval 558.500
5th Floor, 3A RAVANTAGE 45 as a generic copy
Nikolay Haytov (ractopamine of NADA 140-863.
Str., 1113 Sofia, hydrochloride)
Bulgaria (016592). Type A Medicated
Articles.
January 12, 2024............ 200-767 Felix Carprofen Tablets. Original approval 520.304
Pharmaceuticals as a generic copy
Pvt. Ltd., 25-28 of NADA 141-053.
North Wall Quay,
Dublin 1, Ireland
(086101).
January 30, 2024............ 200-769 ZyVet Animal SELAMECTIN Topical Original approval 524.2098
Health, Inc., 73 Solution. as a generic copy
Route 31N, of NADA 141-152.
Pennington, NJ
08534 (086117).
February 13, 2024........... 141-575 Boehringer VETMEDIN Original approval 520.1782
Ingelheim Animal (pimobendan oral for management of
Health USA, Inc., solution) the signs of
3239 Satellite Solution. mild, moderate,
Blvd., Duluth, GA or severe
30096 (000010). congestive heart
failure in dogs.
February 22, 2024........... 200-749 Ceva Sante KESIUM Original approval 520.88g
Animale, 10 (amoxicillin and as a generic copy
Avenue de la clavulanate of NADA 055-099.
Ballasti[egrave]r potassium
e, 33500 tablets) Chewable
Libourne, France Tablets.
(013744).
March 1, 2024............... 200-772 Parnell CONTRASED Original approval 522.147
Technologies Pty. (atipamezole as a generic copy
Ltd., unit 4, 476 hydrochloride) of NADA 141-033.
Gardeners Rd., Injectable
Alexandria, New Solution.
South Wales 2015,
Australia
(068504).
March 15, 2024.............. 141-579 Dechra Ltd. DUOTIC Original approval 524.2338
Snaygill (terbinafine and for treatment of
Industrial betamethasone otitis externa in
Estate, Keighley acetate otic gel) dogs, associated
Road, Skipton, Otic Gel. with susceptible
North Yorkshire, strains of yeast
BD23 2RW, United (Malassezia
Kingdom (043264). pachydermatis).
----------------------------------------------------------------------------------------------------------------
II. Withdrawals of Approval
Boehringer Ingelheim Animal Health USA, Inc., 3239 Satellite Blvd.,
Duluth, GA 30096 (drug labeler code 000010) requested that FDA withdraw
approval of the five NADAs listed in table 2 because the products are
no longer manufactured or marketed. As provided in the regulatory text
of this document, the animal drug regulations are amended to reflect
these actions.
Table 2--Applications for Which Approval Was Voluntarily Withdrawn
During January, February, and March 2024
------------------------------------------------------------------------
Date of withdrawal of 21 CFR
approval File No. Product name section
------------------------------------------------------------------------
March 4, 2024............... 141-015 ENACARD (enalapril 520.804
maleate) Tablets.
Do.......................... 141-096 DICURAL 520.645
(difloxacin
hydrochloride)
Tablets.
Do.......................... 141-108 ETOGESIC 520.870
(etodolac)
Tablets.
Do.......................... 141-274 ETOGESIC 522.870
(etodolac)
Injectable
Solution.
Do.......................... 141-421 DUOCARE 520.1198
(ivermectin and
praziquantel)
Paste.
------------------------------------------------------------------------
III. Changes 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. The regulations
cited in table 3 are amended to reflect these actions.
Table 3--Applications for Which Ownership Was Transferred to Another Sponsor During January, February, and March
2024
----------------------------------------------------------------------------------------------------------------
Transferring sponsor New sponsor (drug 21 CFR
File No. Product name (drug labeler code) labeler code) section
----------------------------------------------------------------------------------------------------------------
200-141........................ ATTANE (isoflurane).. Piramal Critical Piramal Pharma Ltd., 529.1186
Care, Inc., 3850 Ground floor,
Schelden Circle, Piramal Ananta,
Bethlehem, PA 18017 Agastya Corporate
(066794). Park, Mumbai,
Maharashtra--400070,
India (065085).
200-237........................ Isoflurane, USP...... Do................... Do................... Do.
200-338........................ TRI-HEART (ivermectin Heska Corp., 3760 Diamond Animal 510.600
and pyrantel Rocky Mountain Ave., Health, Inc., 2538 520.1196
pamoate) Tablets. Loveland, CO 80538- SE 43rd St., Des
7084 (063604). Moines, IA 50327
(053701).
200-438........................ PETREM (sevoflurane). Piramal Critical Piramal Pharma Ltd., 529.2110
Care, Inc., 3850 Ground floor,
Schelden Circle, Piramal Ananta,
Bethlehem, PA 18017 Agastya Corporate
(066794). Park, Mumbai,
Maharashtra--400070,
India (065085).
----------------------------------------------------------------------------------------------------------------
[[Page 42356]]
IV. Change of Sponsor Address
ECO LLC, 344 Nassau St., Princeton, NJ 08540 (drug labeler code
066916 in 21 CFR 510.600(c)) has informed FDA that it has changed its
address to 11224 Aurora Ave., Urbandale, IA 50322. 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 and
readability of the animal drug regulations.
21 CFR 510.600 is amended to remove entries for Heska
Corp. and Piramal Critical Care, Inc. from the lists of sponsors of
approved applications, to revise the entries for Cronus Pharma
Specialities India Private Ltd. and ECO LLC; and to add entries for
Diamond Animal Health, Inc.
21 CFR 522.840 is amended to reflect revisions to approved
labeling for cattle implants containing estradiol.
21 CFR 522.1940 is amended to reflect the current format
for regulations and revisions to approved labeling for cattle implants
containing progesterone and estradiol benzoate.
21 CFR 522.2343 is amended to reflect revisions to
approved labeling for cattle implants containing testosterone
propionate and estradiol benzoate.
21 CFR 522.2477 is amended to reflect revisions to
approved labeling for cattle implants containing trenbolone acetate and
estradiol.
21 CFR 524.1193 is amended to reflect periods of
persistent activity for an approved generic ivermectin topical solution
used in cattle.
21 CFR 558.485 is amended to reflect an inclusion rate for
pyrantel tartrate in medicated horse feeds.
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 Parts 520, 522, 524, and 529
Animal drugs.
21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
510, 520, 522, 524, 529, 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:
0
a. In the table in paragraph (c)(1):
0
i. Add in alphabetical order an entry for ``Diamond Animal Health,
Inc.'';
0
ii. Revise the entries for ``Cronus Pharma Specialities India Private
Ltd.''; and ``ECO LLC''; and
0
iii. Remove the entries for ``Heska Corp.'' and ``Piramal Critical
Care, Inc.'';
0
b. In the table in paragraph (c)(2), add an entry for ``053701'';
remove the entries for ``063604'' and ``066794''; and revise the
entries for ``066916'' and ``069043''.
The revisions and additions 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
------------------------------------------------------------------------
* * * * * * *
Cronus Pharma Specialities India Private Ltd., 069043
Plot No.9(B), Survey No. 99/1, GMR Hyderabad
Aviation SEZ Ltd., Mamidipalle Village, Balapur
Mandal, Shamshabad, Rangareddy, Hyderabad,
Telangana, 500108, India.........................
* * * * * * *
Diamond Animal Health, Inc., 2538 SE 43rd St., Des 053701
Moines, IA 50327.................................
* * * * * * *
ECO LLC, 11224 Aurora Ave., Urbandale, IA 50322... 066916
* * * * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * * * *
053701...................... Diamond Animal Health, Inc., 2538 SE 43rd
St., Des Moines, IA 50327.
* * * * * * *
066916...................... ECO LLC, 11224 Aurora Ave., Urbandale, IA
50322.
* * * * * * *
069043...................... Cronus Pharma Specialities India Private
Ltd., Plot No.9(B), Survey No. 99/1, GMR
Hyderabad Aviation SEZ Ltd., Mamidipalle
Village, Balapur Mandal, Shamshabad,
Rangareddy, Hyderabad, Telangana, 500108,
India.
* * * * * * *
------------------------------------------------------------------------
[[Page 42357]]
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for part 520 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
4. In Sec. 520.88g, revise the section heading and paragraph (a), and
add paragraph (b)(3) to read as follows:
Sec. 520.88g Amoxicillin and clavulanate potassium tablets.
(a) Specifications. Each tablet or chewable tablet contains
amoxicillin and clavulanate potassium equivalent to 50 milligrams (mg)
amoxicillin and 12.5 mg clavulanic acid, 100 mg amoxicillin and 25 mg
clavulanic acid, 200 mg amoxicillin and 50 mg clavulanic acid, or 300
mg amoxicillin and 75 mg clavulanic acid.
(b) * * *
(3) No. 013744 for use of chewable tablets as in paragraph (c) of
this section.
* * * * *
0
5. In Sec. 520.304:
0
i. Add paragraph (a)(4);
0
ii. Revise paragraph (b)(1); and
0
iii. Add paragraph (b)(4).
The additions and revision read as follows:
Sec. 520.304 Carprofen.
(a) * * *
(4) Each flavored tablet contains 25, 75, or 100 mg carprofen.
(b) * * *
(1) Nos. 017033, 054771, 055529, and 062250 for use of products
described in paragraphs (a)(1) and (a)(2) of this section as in
paragraph (c) of this section.
* * * * *
(4) No. 086101 for use of product described in paragraphs (a)(1),
(a)(2), and (a)(4) of this section as in paragraph (c) of this section.
* * * * *
Sec. 520.645 [Removed]
0
6. Remove Sec. 520.645.
Sec. 520.804 [Removed]
0
7. Remove Sec. 520.804.
Sec. 520.870 [Removed]
0
8. Remove Sec. 520.870.
0
9. Amend Sec. 520.928 by revising the section heading to read as
follows:
Sec. 520.928 Firocoxib tablets.
0
10. Add Sec. 520.929 to read as follows:
Sec. 520.929 Firocoxib solution.
(a) Specifications. Each milliliter of solution contains 9
milligram (mg) firocoxib.
(b) Sponsors. See No. 051072 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in horses--(1) Amount. Administer 0.1 mg per
kilogram (0.045 mg per pound) of body weight once daily for up to 14
days.
(2) Indications for use. For the control of pain and inflammation
associated with osteoarthritis.
(3) Limitations. Do not use in horses intended for human
consumption. Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
0
11. In Sec. 520.1196, revise paragraph (b) to read as follows:
Sec. 520.1196 Ivermectin and pyrantel tablets.
* * * * *
(b) Sponsors. See Nos. 000010, 051311, and 053701 in Sec.
510.600(c) of this chapter.
* * * * *
Sec. 520.1198 [Amended]
0
12. In Sec. 520.1198, remove paragraphs (a)(3) and (b)(3).
0
13. Amend Sec. 520.1780 by revising the section heading to read as
follows:
Sec. 520.1780 Pimobendan tablets.
0
14. Add Sec. 520.1782 to read as follows:
Sec. 520.1782 Pimobendan solution.
(a) Specifications. Each milliliter of solution contains 1.5
milligrams (mg) pimobendan.
(b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. Administer orally at a
total daily dose of 0.23 mg/lb (0.5 mg/kg) body weight. The total daily
dose should be divided into two equal portions administered
approximately 12 hours apart (i.e., morning and evening).
(2) Indications for use. For the management of the signs of mild,
moderate, or severe congestive heart failure in dogs due to clinical
myxomatous mitral valve disease (MMVD) or dilated cardiomyopathy (DCM);
for use with concurrent therapy for congestive heart failure (e.g.,
furosemide, etc.) as appropriate on a case-by-case basis.
(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.
0
16. In Sec. 522.147, revise paragraph (b) to read as follows:
Sec. 522.147 Atipamezole.
* * * * *
(b) Sponsors. See Nos. 015914, 052483, 068504, and 069043 in Sec.
510.600(c) of this chapter.
* * * * *
0
17. In Sec. 522.840, revise paragraph (d) to read as follows:
Sec. 522.840 Estradiol.
* * * * *
(d) Conditions of use--(1) Beef steer calves 2 months of age and
older--(i) Amount and indications for use. (A) An extended-release
implant containing 25.7 mg estradiol for increased rate of weight gain
for up to 200 days.
(B) An extended-release implant containing 43.9 mg estradiol for
increased rate of weight gain for up to 400 days.
(ii) Limitations. For subcutaneous ear implantation only. Not
approved for repeated implantation (reimplantation) with this or any
other cattle ear implant in beef steer calves 2 months of age and
older. Safety and effectiveness following reimplantation have not been
evaluated. Do not use in beef calves less than 2 months of age, dairy
calves, and veal calves. A withdrawal period has not been established
for this product in pre-ruminating calves. Do not use in dairy cows or
in animals intended for subsequent breeding. Use in these cattle may
cause drug residues in milk and/or in calves born to these cows.
(2) Growing beef steers and heifers on pasture (stocker, feeder,
and slaughter)--(i) Amount and indications for use. (A) An extended-
release implant containing 25.7 mg estradiol for increased rate of
weight gain for up to 200 days.
(B) An extended-release implant containing 43.9 mg estradiol for
increased rate of weight gain for up to 400 days.
(ii) Limitations. For subcutaneous ear implantation only. Not
approved for repeated implantation (reimplantation) with this or any
other cattle ear implant in growing beef steers and heifers on pasture
(stocker, feeder, and slaughter). Safety and effectiveness following
reimplantation have not been evaluated. Do not use in beef calves less
than 2 months of age, dairy calves, and veal calves. A withdrawal
period has not been established for this product in pre-ruminating
calves. Do not use in dairy cows or in animals intended for subsequent
breeding. Use in these cattle may cause drug residues in milk and/or in
calves born to these cows.
(3) Growing beef steers and heifers fed in confinement for
slaughter--(i) Amount and indications for use. (A) An
[[Page 42358]]
extended-release implant containing 25.7 mg estradiol for increased
rate of weight gain and improved feed efficiency for up to 200 days.
(B) An extended-release implant containing 43.9 mg estradiol for
increased rate of weight gain and improved feed efficiency for up to
400 days.
(ii) Limitations. For subcutaneous ear implantation only. Not
approved for repeated implantation (reimplantation) with this or any
other cattle ear implant in growing beef steers and heifers fed in
confinement for slaughter. Safety and effectiveness following
reimplantation have not been evaluated. Do not use in beef calves less
than 2 months of age, dairy calves, and veal calves. A withdrawal
period has not been established for this product in pre-ruminating
calves. Do not use in dairy cows or in animals intended for subsequent
breeding. Use in these cattle may cause drug residues in milk and/or in
calves born to these cows.
Sec. 522.870 [Removed]
0
18. Remove Sec. 522.870.
0
19. Revise Sec. 522.1940 to read as follows:
Sec. 522.1940 Progesterone and estradiol benzoate.
(a) Specifications--(1) Each implant consists of progesterone and
estradiol benzoate. (i) 100 mg progesterone and 10 mg estradiol
benzoate (one implant consisting of four pellets, each containing 25 mg
progesterone and 2.5 mg estradiol benzoate).
(ii) 200 mg progesterone and 20 mg estradiol benzoate (one implant
consisting of eight pellets, each containing 25 mg progesterone and 2.5
mg estradiol benzoate).
(2) Each implant consists of progesterone and estradiol benzoate
and tylosin tartrate. (i) 100 mg progesterone, 10 mg estradiol
benzoate, and 29 mg tylosin tartrate (one implant consisting of four
pellets, each containing 25 mg progesterone and 2.5 mg estradiol
benzoate, and one pellet containing 29 mg tylosin tartrate).
(ii) 200 mg progesterone, 20 mg estradiol benzoate, and 29 mg
tylosin tartrate (one implant consisting of eight pellets, each
containing 25 mg progesterone and 2.5 mg estradiol benzoate, and one
pellet containing 29 mg tylosin tartrate).
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for
use as in paragraph (c) of this section:
(1) No. 054771 for use as in paragraphs (e)(1)(i)(A), (e)(1)(ii),
(e)(2)(i)(A), (B), (C), and (e)(2)(ii) of this section.
(2) No. 058198 for use as in paragraphs (e)(1)(i)(A), (e)(1)(i)(B),
(e)(1)(ii), and (e)(3) of this section.
(c) Related tolerances. See Sec. Sec. 556.240 and 556.540 of this
chapter.
(d) Special considerations. Labeling of implants described in
paragraphs (a)(2)(i) and (a)(2)(ii) for use in paragraphs (e)(1)(i)(B),
(e)(1)(ii), (e)(3)(i), and (e)(3)(ii) of this section shall bear the
following: ``Federal law restricts this drug to use by or on the order
of a licensed veterinarian.''
(e) Conditions of use--(1) Beef calves 45 days of age and older and
weighing up to 400 lbs--(i) Amounts and indications for use. (A) An
implant containing 100 mg progesterone and 10 mg estradiol benzoate as
described in paragraph (a)(1)(i) of this section for increased rate of
weight gain.
(B) An implant containing 100 mg progesterone, 10 mg estradiol
benzoate, and 29 mg tylosin tartrate as described in paragraph
(a)(2)(i) of this section for increased rate of weight gain.
(ii) Limitations. Implant pellets subcutaneously in ear only. Other
than when used as described in (e)(2)(i)(B) of this section, the
implant as described in paragraph (a)(1)(i) of this section is not
approved for repeated implantation (reimplantation). The implant as
described in paragraph (a)(2)(i) of this section is not approved for
repeated implantation (reimplantation) with this or any other cattle
ear implant. Do not use in beef calves less than 45 days of age, dairy
calves, and veal calves because effectiveness and safety have not been
evaluated. Do not use in dairy cows or in animals intended for
subsequent breeding. Use in these cattle may cause drug residues in
milk and/or calves born to these cows.
(2) Growing beef steers fed in confinement for slaughter--(i)
Amounts and indications for use. (A) An implant containing 200 mg
progesterone and 20 mg estradiol benzoate as described in paragraph
(a)(1)(ii) of this section for increased rate of weight gain and
improved feed efficiency.
(B) An implant containing 200 mg progesterone and 20 mg estradiol
benzoate as described in paragraph (a)(1)(ii) of this section for
increased rate of weight gain in a reimplantation program where an
implant as described in paragraph (a)(1)(i) of this section is the
first implant and an implant as described in paragraph (a)(1)(ii) of
this section is administered approximately 70 days later.
(C) An implant containing 200 mg progesterone and 20 mg estradiol
benzoate as described in paragraph (a)(1)(ii) of this section for
increased rate of weight gain in a reimplantation program where an
implant as described in paragraph (a)(1)(ii) of this section is the
first implant and an implant as described in paragraph (a)(1)(ii) of
this section is administered approximately 70 days later.
(ii) Limitations. Implant pellets subcutaneously in ear only. Other
than when used as described in paragraphs (e)(2)(i)(B) or (C) of this
section, the implant described in paragraph (a)(1)(ii) of this section
is not approved for repeated implantation (reimplantation) with any
other cattle ear implant in growing beef steers and heifers fed in
confinement for slaughter as safety and effectiveness have not been
evaluated. Do not use in beef calves less than 2 months of age, dairy
calves, and veal calves because effectiveness and safety have not been
evaluated. Do not use in dairy cows or in animals intended for
subsequent breeding. Use in these cattle may cause drug residues in
milk and/or calves born to these cows.
(3) Growing beef steers weighing 400 lbs or more--(i) Amounts and
indications for use. An implant containing 200 mg progesterone, 20 mg
estradiol benzoate, and 29 mg tylosin tartrate as described in
paragraph (a)(2)(ii) of this section for increased rate of weight gain
and improved feed efficiency.
(ii) Limitations. The implant as described in paragraph (a)(2)(ii)
of this section is not approved for repeated implantation
(reimplantation) with this or any other cattle ear implant. Do not use
in beef calves less than 2 months of age, dairy calves, and veal calves
because effectiveness and safety have not been evaluated. Do not use in
dairy cows or in animals intended for subsequent breeding. Use in these
cattle may cause drug residues in milk and/or calves born to these
cows.
0
20. Revise Sec. 522.2343 to read as follows:
Sec. 522.2343 Testosterone propionate and estradiol benzoate.
(a) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for
use as in paragraph (d) of this section.
(1) No. 054771 for use as in paragraph (d)(1) of this section.
(2) No. 058198 for use as in paragraph (d)(2) of this section.
(b) Related tolerances. See Sec. Sec. 556.240 and 556.710 of this
chapter.
(c) Special considerations. Labeling of the implants described in
paragraph (d)(2) of this section shall bear the following: ``Federal
law restricts this drug to use by or on the order of a licensed
veterinarian.''
(d) Conditions of use--(1) Growing beef heifers fed in confinement
for
[[Page 42359]]
slaughter--(i) Amounts and indications for use. An implant containing
200 mg testosterone propionate and 20 mg estradiol benzoate (one
implant consisting of eight pellets, each containing 25 mg testosterone
propionate and 2.5 mg estradiol benzoate) for increased rate of weight
gain and improved feed efficiency.
(ii) Limitations. Implant pellets subcutaneously in ear only. Not
approved for repeated implantation (reimplantation) with this or any
other cattle ear implant. Do not use in beef calves less than 2 months
of age, dairy calves, and veal calves because safety and effectiveness
have not been evaluated. Do not use in dairy cows or in animals
intended for subsequent breeding. Use in these cattle may cause drug
residues in milk and/or in calves born to these cows.
(2) Growing beef heifers weighing 400 lbs or more--(i) Amounts and
indications for use. An implant containing 200 mg testosterone
propionate, 20 mg estradiol benzoate, and 29 mg tylosin tartrate (one
implant consisting of eight pellets, each containing 25 mg testosterone
propionate and 2.5 mg estradiol benzoate, and one pellet containing 29
mg tylosin tartrate) for increased rate of weight gain and improved
feed efficiency.
(ii) Limitations. Implant pellets subcutaneously in ear only. Not
approved for repeated implantation (reimplantation) with this or any
other cattle ear implant. Do not use in beef calves less than 2 months
of age, dairy calves, and veal calves because safety and effectiveness
have not been evaluated. Do not use in dairy cows or in animals
intended for subsequent breeding. Use in these cattle may cause drug
residues in milk and/or in calves born to these cows.
0
21. Revise Sec. 522.2477 to read as follows:
Sec. 522.2477 Trenbolone acetate and estradiol.
(a) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for
uses as in paragraph (d) of this section.
(1) No. 058198 for use in paragraphs (d)(1)(i)(B), (d)(1)(ii),
(d)(2)(i)(B), (d)(2)(i)(D), (d)(2)(ii), (d)(3)(i)(B), (d)(3)(i)(D),
(d)(3)(ii), (d)(4)(i)(A), (d)(4)(i)(B), and (d)(4)(ii) of this section.
(2) No. 000061 for use in paragraphs (d)(1)(i)(A), (d)(1)(i)(C),
(d)(1)(ii), (d)(2)(i)(A), (d)(2)(i)(C), (d)(2)(i)(E), (d)(2)(ii),
(d)(3)(i)(A), (d)(3)(i)(C), (d)(3)(i)(E), (d)(3)(ii), (d)(4)(i)(A), and
(d)(4)(ii) of this section.
(3) No. 054771 for use in paragraphs (d)(2)(i)(A), (C), (d)(2)(ii),
(d)(4)(i)(A), and (d)(4)(ii) of this section.
(b) Related tolerances. See Sec. Sec. 556.240 and 556.739 of this
chapter.
(c) Special considerations. Labeling of implants described in
paragraphs (d)(1)(i)(B), (d)(2)(i)(B), (d)(2)(i)(D), (d)(3)(i)(B),
(d)(3)(i)(D), and (d)(4)(i)(B) of this section shall bear the
following: ``Federal law restricts this drug to use by or on the order
of a licensed veterinarian.''
(d) Conditions of use--(1) Growing beef steers and heifers fed in
confinement for slaughter--(i) Amounts and indications. (A) An implant
containing 200 mg trenbolone acetate and 20 mg estradiol (one implant
consisting of 10 pellets each containing 20 mg trenbolone acetate and 2
mg estradiol) for increased rate of weight gain and improved feed
efficiency.
(B) An implant containing 200 mg trenbolone acetate, 20 mg
estradiol, and 29 mg tylosin tartrate (one implant consisting of 10
pellets, each containing 20 mg trenbolone acetate and 2 mg estradiol,
and 1 pellet containing 29 mg tylosin tartrate) for increased rate of
weight gain and improved feed efficiency.
(C) An extended- and delayed-release implant containing 200 mg
trenbolone acetate and 20 mg estradiol (1 implant consisting of 10
coated pellets, each containing 20 mg trenbolone acetate and 2 mg
estradiol) for increased rate of weight gain and improved feed
efficiency during 70 to 200 days after implantation.
(ii) Limitations. Implant pellets subcutaneously in ear only. Not
approved for repeated implantation (reimplantation) with this or any
other cattle ear implant in growing beef steers and heifers fed in
confinement for slaughter. Do not use in beef calves less than 2 months
of age, dairy calves, and veal calves because safety and effectiveness
have not been evaluated. Do not use in dairy cows or in animals
intended for subsequent breeding. Use in these cattle may cause drug
residues in milk and/or calves born to these cows.
(2) Growing beef steers fed in confinement for slaughter--(i)
Amounts and indications. (A) An implant containing 80 mg trenbolone
acetate and 16 mg estradiol (one implant consisting of four pellets,
each containing 20 mg trenbolone acetate and 4 mg estradiol) for
increased rate of weight gain and improved feed efficiency.
(B) An implant containing 80 mg trenbolone acetate, 16 mg
estradiol, and 29 mg tylosin tartrate (one implant consisting of four
pellets, each containing 20 mg trenbolone acetate and 4 mg estradiol,
and one pellet containing 29 mg tylosin tartrate) for increased rate of
weight gain and improved feed efficiency.
(C) An implant containing 120 mg trenbolone acetate and 24 mg
estradiol (one implant consisting of six pellets, each containing 20 mg
trenbolone acetate and 4 mg estradiol) for increased rate of weight
gain and improved feed efficiency.
(D) An implant containing 120 mg trenbolone acetate, 24 mg
estradiol, and 29 mg tylosin tartrate (one implant consisting of six
pellets, each containing 20 mg trenbolone acetate and 4 mg estradiol,
and one pellet containing 29 mg tylosin tartrate) for increased rate of
weight gain and improved feed efficiency.
(E) An extended-release implant containing 200 mg trenbolone
acetate and 40 mg estradiol (one implant consisting of six coated
pellets and four uncoated pellets, each containing 20 mg trenbolone
acetate and 4 mg estradiol) for increased rate of weight gain and
improved feed efficiency for up to 200 days after implantation.
(ii) Limitations. Implant pellets subcutaneously in ear only. Not
approved for repeated implantation (reimplantation) with this or any
other cattle ear implant in growing beef steers fed in confinement for
slaughter. Do not use in beef calves less than 2 months of age, dairy
calves, and veal calves because safety and effectiveness have not been
evaluated. Do not use in dairy cows or in animals intended for
subsequent breeding. Use in these cattle may cause drug residues in
milk and/or calves born to these cows.
(3) Growing beef heifers fed in confinement for slaughter--(i)
Amounts and indications. (A) An implant containing 80 mg trenbolone
acetate and 8 mg estradiol (one implant consisting of four pellets,
each containing 20 mg trenbolone acetate and 2 mg estradiol) for
increased rate of weight gain.
(B) An implant containing 80 mg trenbolone acetate, 8 mg estradiol,
and 29 mg tylosin tartrate (one implant consisting of four pellets,
each containing 20 mg trenbolone acetate and 2 mg estradiol, and one
pellet containing 29 mg tylosin tartrate) for increased rate of weight
gain and improved feed efficiency.
(C) An implant containing 140 mg trenbolone acetate and 14 mg
estradiol (one implant consisting of seven pellets, each containing 20
mg trenbolone acetate and 2 mg estradiol) for increased rate of weight
gain and improved feed efficiency.
[[Page 42360]]
(D) An implant containing 140 mg trenbolone acetate, 14 mg
estradiol, and 29 mg tylosin tartrate (one implant consisting of seven
pellets, each containing 20 mg trenbolone acetate and 2 mg estradiol,
and one pellet containing 29 mg tylosin tartrate) for increased rate of
weight gain and improved feed efficiency.
(E) An extended-release implant containing 200 mg trenbolone
acetate and 20 mg estradiol (one implant consisting of six coated
pellets and four uncoated pellets, each containing 20 mg trenbolone
acetate and 2 mg estradiol) for increased rate of weight gain and
improved feed efficiency for up to 200 days after implantation.
(ii) Limitations. Implant pellets subcutaneously in ear only. Not
approved for repeated implantation (reimplantation) with this or any
other cattle ear implant in growing beef heifers fed in confinement for
slaughter. Do not use in beef calves less than 2 months of age, dairy
calves, and veal calves because safety and effectiveness have not been
evaluated. Do not use in dairy cows or in animals intended for
subsequent breeding. Use in these cattle may cause drug residues in
milk and/or calves born to these cows.
(4) Growing beef steers and heifers on pasture (stocker, feeder,
and slaughter)--(i) Amounts and indications for use. (A) An implant
containing 40 mg trenbolone acetate and 8 mg estradiol (one implant
consisting of two pellets, each containing 20 mg trenbolone acetate and
4 mg estradiol) for increased rate of weight gain.
(B) An implant containing 40 mg trenbolone acetate, 8 mg estradiol,
and 29 mg tylosin tartrate (one implant consisting of two pellets, each
containing 20 mg trenbolone acetate and 4 mg estradiol, and one pellet
containing 29 mg tylosin tartrate) for increased rate of weight gain.
(ii) Limitations. Implant pellets subcutaneously in ear only. Not
approved for repeated implantation (reimplantation) with this or any
other cattle ear implant in growing beef steers and heifers on pasture
(stocker, feeder, and slaughter). Do not use in beef calves less than 2
months of age, dairy calves, and veal calves because safety and
effectiveness have not been evaluated. Do not use in dairy cows or in
animals intended for subsequent breeding. Use in these cattle may cause
drug residues in milk and/or calves born to these cows.
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
22. The authority citation for part 524 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
23. In Sec. 524.1193:
0
a. Revise paragraph (b);
0
b. Remove paragraph (d);
0
c. Redesignate paragraph (e) as paragraph (d) and revise newly
redesignated paragraphs (d)(2) and (d)(3).
The revisions read as follows:
Sec. 524.1193 Ivermectin topical solution.
* * * * *
(b) Sponsors. See Nos. 000010, 016592, 055529, 058829, and 061133
in Sec. 510.600(c) of this chapter for use as in paragraph (d) of this
section.
* * * * *
(d) * * *
(2) Indications for use. It is used for the treatment and control
of: Gastrointestinal roundworms (adults and fourth-stage larvae)
Ostertagia ostertagi (including inhibited stage), Haemonchus placei,
Trichostrongylus axei, T. colubriformis, Cooperia oncophora, C.
punctata, C. surnabada, Oesophagostomum radiatum (adults);
Strongyloides papillosus, Trichuris spp.; lungworms (adults and fourth-
stage larvae) Dictyocaulus viviparus; cattle grubs (parasitic stages)
Hypoderma bovis, H. lineatum; mites Sarcoptes scabiei var. bovis; lice
Linognathus vituli, Haematopinus eurysternus, Damalinia bovis,
Solenoptes capillatus; and horn flies Haematobia irritans. It controls
infections and prevents reinfection with O. radiatum and D. viviparus
for 28 days after treatment, C. punctata and T. axei for 21 days after
treatment, O. ostertagi, H. placei, C. oncophora, and C. surnabada for
14 days after treatment, and D. bovis for 56 days after treatment.
(3) Limitations. Do not treat cattle within 48 days of slaughter.
Do not use on female dairy cattle of breeding age or on calves to be
processed for veal. Consult your veterinarian for assistance in the
diagnosis, treatment, and control of parasitism.
0
24. In Sec. 524.2098, revise paragraph (b) to read as follows:
Sec. 524.2098 Selamectin.
* * * * *
(b) Sponsors. See Nos. 051072, 051311, 054771, 055529, 061133, and
086117 of this chapter.
* * * * *
0
25. Add Sec. 524.2338 to read as follows:
Sec. 524.2338 Terbinafine and betamethasone acetate.
(a) Specifications. Each milliliter of gel contains 10 milligrams
(mg) terbinafine and 1 mg betamethasone acetate.
(b) Sponsor. See No. 043264 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. Administer one dose (1
tube) per affected ear(s) and repeat administration in 7 days.
(2) Indications for use. For the treatment of otitis externa in
dogs, associated with susceptible strains of yeast (Malassezia
pachydermatis).
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
0
26. The authority citation for part 529 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
27. In Sec. 529.1186, revise paragraph (b) to read as follows:
Sec. 529.1186 Isoflurane.
* * * * *
(b) Sponsors. See Nos. 017033, 054771, and 065085 in Sec.
510.600(c) of this chapter.
* * * * *
0
28. In Sec. 529.2110, revise paragraph (b) to read as follows:
Sec. 529.2110 Sevoflurane.
* * * * *
(b) Sponsors. See Nos. 017033, 054771, and 065085 in Sec.
510.600(c) of this chapter.
* * * * *
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. 558.485, revise (e)(2) to read as follows:
Sec. 558.485 Pyrantel.
* * * * *
(e) * * *
(2) Horses--
[[Page 42361]]
------------------------------------------------------------------------
Indications for
Pyrantel tartrate g/ton use Limitation Sponsor
------------------------------------------------------------------------
(i) 120 to 1,200 to provide For prevention Feed 017135
1.2 mg/lb body weight. of Strongylus continuously 054771
vulgaris as the horse's
larval daily grain
infections; ration during
control of the time that
adult large the animal is
strongyles (S. at risk of
vulgaris, and exposure to
S. edentatus), internal
adult and 4th parasites. Do
stage larvae not use in
small horses
strongyles intended for
(Cyathostomum human
spp., consumption.
Cylicocyclus Consult your
spp., veterinarian
Cylicostephanu before using
s spp., in severely
Cylicodontopho debilitated
rus spp., animals and
Poteriostomum for assistance
spp., and in the
Triodontophoru diagnosis,
s spp.), adult treatment, and
and 4th stage control of
larvae parasitism.
pinworms
(Oxyuris
equi), and
adult and 4th
stage larvae
ascarids
(Parascaris
equorum).
------------------------------------------------------------------------
(ii) Top dress medicated feed--(A) Proprietary Formulas. The
following feed can be manufactured only per an approved proprietary
formula and specifications:
------------------------------------------------------------------------
Indications for
Pyrantel tartrate amount use Limitations Sponsor
------------------------------------------------------------------------
(1) 9.6 g/lb to provide 1.2 Prevention of Feed 017135
mg/lb body weight. Strongylus continuously 054771
vulgaris as a top dress
larval during the
infections; time that the
control of animal is at
adult large risk of
strongyles (S. exposure to
vulgaris, and internal
S. edentatus), parasites. Do
adult and 4th not use in
stage larvae horses
small intended for
strongyles human
(Cyathostomum consumption.
spp., Consult your
Cylicocyclus veterinarian
spp., before using
Cylicostephanu in severely
s spp., debilitated
Cylicodontopho animals and
rus spp., for assistance
Poteriostomum in the
spp., and diagnosis,
Triodontophoru treatment, and
s spp.), adult control of
and 4th stage parasitism.
larvae
pinworms
(Oxyuris
equi), and
adult and 4th
stage larvae
ascarids
(Parascaris
equorum).
(2) [Reserved]. ............... ............... .........
------------------------------------------------------------------------
(B) [Reserved]
* * * * *
0
31. In Sec. 558.500, revise (b)(1), (b)(2), and (e)(1)(i) to read as
follows:
Sec. 558.500 Ractopamine.
* * * * *
(b) * * *
(1) Nos. 016592 and 058198: Type A medicated articles containing 9
or 45.4 grams per pound (g/lb) ractopamine hydrochloride.
(2) Nos. 051311 and 054771: Type A medicated articles containing
45.4 g/lb ractopamine hydrochloride.
* * * * *
(e) * * *
(1) * * *
----------------------------------------------------------------------------------------------------------------
Combination in
Ractopamine in grams/ton grams/ton Indications for use Limitations Sponsors
----------------------------------------------------------------------------------------------------------------
(i) 4.5 to 9.0................... ................... For increased rate of Feed continuously 016592
weight gain, improved as sole ration. 054771
feed efficiency, and 058198
increased carcass
leanness in finishing
swine, weighing not
less than 150 lb, fed a
complete ration
containing at least 16%
crude protein for the
last 45 to 90 lb of
gain prior to slaughter.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
Dated: May 9, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-10586 Filed 5-14-24; 8:45 am]
BILLING CODE 4164-01-P