Rule2024-10586
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications, Change of Sponsor, Change of Sponsor Address
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 15, 2024
Effective
May 15, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) 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.
Full Text
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<title>Federal Register, Volume 89 Issue 95 (Wednesday, May 15, 2024)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-10586]
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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, <a href="/cdn-cgi/l/email-protection#95d2f0fae7f2f0bbddf4fcf7f0f9d5f3f1f4bbfdfde6bbf2fae3"><span class="__cf_email__" data-cfemail="ca8dafa5b8adafe482aba3a8afa68aacaeabe4a2a2b9e4ada5bc">[email protected]</span></a>.
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: <a href="https://animaldrugsatfda.fda.gov/adafda/views/#/search">https://animaldrugsatfda.fda.gov/adafda/views/#/search</a>.
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.
<bullet> 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.
<bullet> 21 CFR 522.840 is amended to reflect revisions to approved
labeling for cattle implants containing estradiol.
<bullet> 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.
<bullet> 21 CFR 522.2343 is amended to reflect revisions to
approved labeling for cattle implants containing testosterone
propionate and estradiol benzoate.
<bullet> 21 CFR 522.2477 is amended to reflect revisions to
approved labeling for cattle implants containing trenbolone acetate and
estradiol.
<bullet> 21 CFR 524.1193 is amended to reflect periods of
persistent activity for an approved generic ivermectin topical solution
used in cattle.
<bullet> 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
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</html>Indexed from Federal Register on May 15, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.