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Rule2023-03649

New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Name and Address

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Published

March 10, 2023

Effective

March 10, 2023

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July, August, and September 2022. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to improve the accuracy and readability of the regulations.

Full Text

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<title>Federal Register, Volume 88 Issue 47 (Friday, March 10, 2023)</title>
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[Federal Register Volume 88, Number 47 (Friday, March 10, 2023)]
[Rules and Regulations]
[Pages 14893-14908]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-03649]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 524, 526, 528, and 558

[Docket No. FDA-2022-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 Name and 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 July, August, and September 2022. FDA is
informing the public of the availability of summaries of the basis of
approval and of environmental review documents, where applicable. The
animal drug regulations are also being amended to improve the accuracy
and readability of the regulations.

DATES: This rule is effective March 10, 2023.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-402-5689,
<a href="/cdn-cgi/l/email-protection#2146444e5346440f49404843444d614745400f4949520f464e57"><span class="__cf_email__" data-cfemail="6c0b09031e0b0942040d050e09002c0a080d4204041f420b031a">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Approvals

FDA is amending the animal drug regulations to reflect approval
actions for NADAs and ANADAs during July, August, and September 2022,
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 (FOI Summaries) under the Freedom of
Information Act (FOIA). These public documents may be seen in the
office of the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500. Persons
with access to the internet may obtain these documents at the CVM

[[Page 14894]]

FOIA Electronic Reading Room: <a href="https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room">https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room</a>. Marketing
exclusivity and patent information may be accessed in FDA's
publication, Approved Animal Drug Products Online (Green Book) at:
<a href="https://www.fda.gov/animal-veterinary/products/approved-animal-drug-products-green-book">https://www.fda.gov/animal-veterinary/products/approved-animal-drug-products-green-book</a>.
FDA has verified the website addresses as of the date this document
publishes in the Federal Register, but websites are subject to change
over time.

Table 1--Original and Supplemental NADAs and ANADAs Approved During July, August, and September 2022 Requiring Evidence of Safety and/or Effectiveness
--------------------------------------------------------------------------------------------------------------------------------------------------------
21 CFR
Approval date File No. Sponsor Product name Effect of the action Public documents section
--------------------------------------------------------------------------------------------------------------------------------------------------------
July 18, 2022.................. 141-043 Zoetis Inc., 333 SYNOVEX Choice and Supplemental approval FOI Summary, EA, FONSI.... 522.2478
Portage St., SYNOVEX Plus of a reimplantation
Kalamazoo, MI 49007. (trenbolone acetate program for growing
and estradiol beef steers and
benzoate implants) heifers fed in
Implants. confinement for
slaughter for
increased rate of
weight gain for up
to 200 days.
July 18, 2022.................. 141-348 Zoetis Inc., 333 SYNOVEX ONE Feedlot Supplemental approval FOI Summary, EA, FONSI.... 522.2478
Portage St., (trenbolone acetate of a reimplantation
Kalamazoo, MI 49007. and estradiol program for growing
benzoate extended- beef steers and
release implants) heifers fed in
Implants. confinement for
slaughter for
increased rate of
weight gain for up
to 200 days.
July 19, 2022.................. 200-724 Huvepharma EOOD, 5th Lubabegron, monensin, Original approval for FOI Summary............... 558.625
Floor, 3A Nikolay and tylosin Type C use of EXPERIOR
Haytov Str., 1113 medicated feeds. (lubabegron Type A
Sofia, Bulgaria. medicated article)
with MONOVET
(monensin Type A
medicated article)
and TYLOVET (tylosin
phosphate Type A
medicated article)
in the manufacture
of Type C medicated
cattle feeds as a
generic copy of NADA
141-512.
July 19, 2022.................. 200-725 Huvepharma EOOD, 5th Lubabegron and Original approval for FOI Summary............... 558.330
Floor, 3A Nikolay monensin Type C use of EXPERIOR
Haytov Str., 1113 medicated feeds. (lubabegron Type A
Sofia, Bulgaria. medicated article)
with MONOVET
(monensin Type A
medicated article)
in the manufacture
of Type C medicated
cattle feeds as a
generic copy of NADA
141-514.
July 28, 2022.................. 141-564 Pharmgate, Inc., 1800 Chlortetracycline and Original approval for FOI Summary............... 558.128
Sir Tyler Dr., monensin Type C use of PENNCHLOR
Wilmington, NC 28405. medicated feeds. (chlortetracycline
Type A medicated
article) and
RUMENSIN (monensin
Type A medicated
article) in the
manufacture of Type
C medicated cattle
feeds.
July 29, 2022.................. 200-726 Pegasus Laboratories, Firocoxib Tablets for Original approval for FOI Summary............... 520.928
Inc., 8809 Ely Rd., Horses (firocoxib the control of pain
Pensacola, FL 32514. tablets). and inflammation
associated with
osteoarthritis in
horses as a generic
copy of NADA 141-458.
July 29, 2022.................. 200-727 Felix Pharmaceuticals Meloxicam 5 mg/mL Original approval for FOI Summary............... 522.1367
Pvt. Ltd., 25-28 Solution for the control of pain
North Wall Quay, Injection. and inflammation in
Dublin, 1, Ireland. dogs and cats as a
generic copy of NADA
141-219.
August 9, 2022................. 141-459 Intervet, Inc., 2 BRAVECTO (fluralaner Supplemental approval FOI Summary............... 524.998
Giralda Farms, topical solution) for for the treatment
Madison, NJ 07940. Cats. and control of Asian
longhorned tick
infestations for 12
weeks in cats and
kittens.
August 9, 2022................. 141-518 Intervet, Inc., 2 BRAVECTO PLUS Supplemental approval FOI Summary............... 524.1001
Giralda Farms, (fluralaner and for the treatment
Madison, NJ 07940. moxidectin topical and control of Asian
solution) for Cats. longhorned tick
infestations for 2
months in cats and
kittens.
August 11, 2022................ 141-565 Pharmgate, Inc., 1800 Bacitracin and Original approval of FOI Summary............... 558.355
Sir Tyler Dr., monensin Type C PENNITRACIN MD
Wilmington, NC 28405. medicated feeds. (bacitracin Type A
medicated article)
and COBAN (monensin
Type A medicated
article) to be used
in the manufacture
of Type C medicated
feeds for the
prevention of
mortality caused by
necrotic enteritis,
or for increased
rate of weight gain
and improved feed
efficiency, and as
an aid in the
prevention of
coccidiosis in
broiler chickens,
laying hen
replacement
chickens, and layer
breeder replacement
chickens.
September 6, 2022.............. 141-462 Phibro Animal Health Virginiamycin and Original approval of FOI Summary............... 558.635
Corp., GlenPointe narasin Type C STAFAC
Centre East, 3d medicated feeds. (virginiamycin Type
Floor, 300 Frank W A medicated article)
Burr Blvd., Suite 21, and MONTEBAN
Teaneck, NJ 07666. (narasin Type A
medicated article)
to be used in the
manufacture of Type
C medicated feeds
for the prevention
of necrotic
enteritis and
coccidiosis in
broiler chickens.

[[Page 14895]]

September 6, 2022.............. 141-429 Phibro Animal Health Virginiamycin, Original approval of FOI Summary............... 558.635
Corp., GlenPointe narasin, and STAFAC
Centre East, 3d nicarbazin Type C (virginiamycin Type
Floor, 300 Frank W medicated feeds. A medicated article)
Burr Blvd., Suite 21, and MAXIBAN (narasin
Teaneck, NJ 07666. and nicarbazin Type
A medicated article)
to be used in the
manufacture of Type
C medicated feeds
for the prevention
of necrotic
enteritis and
coccidiosis in
broiler chickens.
September 9, 2022.............. 141-553 Zoetis Inc, 333 VALCOR (doramectin and Original approval for FOI Summary............... 522.772
Portage St., levamisole injection) the treatment and
Kalamazoo, MI 49007. Injectable Solution. control of certain
gastrointestinal
roundworms,
lungworms, eyeworms,
grubs, sucking lice,
and mange mites in
cattle; and for
revising the
tolerance for
residues of
doramectin in the
target tissue,
cattle liver.
September 28, 2022............. 200-719 Vetoquinol USA, Inc., SIMPLERA (florfenicol, Original approval for FOI Summary............... 524.957
4250 N Sylvania Ave., terbinafine, the treatment of
Fort Worth, TX 76137. mometasone furoate) otitis externa in
Otic Solution. dogs as a generic
copy of NADA 141-440.
September 29, 2022............. 200-694 Bimeda Animal Health SPECTOGARD Original approval for FOI Summary............... 522.2121
Ltd., 1B The Herbert (spectinomycin the treatment of
Building, The Park, sulfate) Injectable bovine respiratory
Carrickmines, Dublin Solution. disease as a generic
18, Ireland. copy of NADA 141-077.
--------------------------------------------------------------------------------------------------------------------------------------------------------

Also, FDA is amending the animal drug regulations to reflect
approval of supplemental applications, as listed in table 2, to change
the marketing status of dosage form antimicrobial animal drug products
from over-the-counter (OTC) to by veterinary prescription (Rx). These
applications were submitted in voluntary compliance with the goals of
the FDA Center for Veterinary Medicine's (CVM's) Judicious Use
Initiative as identified by guidance for industry #263,
``Recommendations for Sponsors of Medically Important Antimicrobial
Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary
Oversight All Products That Continue to be Available Over-the-
Counter,'' June 11, 2021 (<a href="https://www.fda.gov/media/130610/download">https://www.fda.gov/media/130610/download</a>).

Table 2--Supplemental Applications Approved During July, August, and September 2022, To Change the Marketing
Status of Antimicrobial Animal Drug Products From OTC to Rx
----------------------------------------------------------------------------------------------------------------
Approval date File No. Sponsor Product name 21 CFR section
----------------------------------------------------------------------------------------------------------------
July 7, 2022.................. 041-629 Zoetis Inc., 333 SPECTOGARD 520.2123c.
Portage St., (spectinomycin)
Kalamazoo, MI 49007. Solution.
July 7, 2022.................. 055-072 Do.................. ALBACILLIN 526.1698.
(penicillin G
procaine and
novobiocin sodium)
Intramammary
Infusion.
July 19, 2022................. 041-245 Do.................. ALBON 522.2220.
(sulfadimethoxine)
Injection 40%.
July 29, 2022................. 055-098 Do.................. ALBADRY PLUS 526.1698.
(penicillin G
procaine and
novobiocin sodium)
Intramammary
Infusion.
July 29, 2022................. 012-965 Elanco US Inc., 2500 TYLAN 50 (tylosin) 522.2640.
Innovation Way, Injection and TYLAN
Greenfield, IN 200 (tylosin)
46140. Injection.
July 29, 2022................. 011-060 Zoetis Inc., 333 TERRAMYCIN 520.1660c.
Portage St., (oxytetracycline
Kalamazoo, MI 49007. HCl) Tablets.
July 29, 2022................. 140-909 Do.................. SULKA-S 520.2260a.
(sulfamethazine)
Bolus.
July 29, 2022................. 094-114 Do.................. TERRAMYCIN 100 522.1662a.
(oxytetracycline
HCl) Injectable
Solution; and
LIQUAMYCIN 100
(oxytetracycline
HCl) Injectable
Solution.
August 3, 2022................ 037-586 Do.................. ERYTHROMAST 36 526.820.
(erythromycin)
Intramammary
Infusion.
August 5, 2022................ 065-124 Do.................. Tetracycline Not codified.
Intramuscular Vet
(tetracycline)
Injection.
August 11, 2022............... 031-944 Do.................. DYNAMXYIN 522.2340.
(sulfomyxin)
Injectable.
August 16, 2022............... 065-130 Do.................. CRYSTALLINE PRO 522.1696b.
PENICILLIN G
(penicillin G
procaine)
Injectable
Suspension.
August 30, 2022............... 099-402 Do.................. OXYVET and AQUACHEL 522.1662a.
(oxytetracycline
hydrochloride)
Injectable Solution.
September 22, 2022............ 008-763 Do.................. TERRAMYCIN 524.1662b.
(oxytetracycline
hydrochloride and
polymyxin B
sulfate) Ophthalmic
Ointment.
September 23, 2022............ 091-127 Do.................. OXYVET Injection 522.1662a.
(oxytetracycline
hydrochloride)
Injectable Solution.
September 23, 2022............ 048-287 Huvepharma EEOD, 5th Oxytetracycline 50 522.1662a.
Floor, 3A Nikolay (oxytetracycline
Haytov Str., 1113 hydrochloride)
Sofia, Bulgaria. Injectable Solution.
----------------------------------------------------------------------------------------------------------------

[[Page 14896]]

II. Changes of Sponsorship

The sponsors of the following approved applications have informed
FDA that they have transferred ownership of, and all rights and
interest in, the applications to another sponsor, as listed in table 3.

Table 3--Changes of Sponsorship During July, August, and September 2022
----------------------------------------------------------------------------------------------------------------
21 CFR
File No. Product name Transferring sponsor New sponsor section
----------------------------------------------------------------------------------------------------------------
039-583........................ GRANULEX V (balsam Mylan Institutional, Cronus Pharma 524.2620.
Peru oil, castor oil, Inc., 12720 Dairy Specialities India
trypsin). Ashford Rd., Sugar Private Ltd., Sy No-
Land, TX 77478. 99/1, M/s GMR
Hyderabad Aviation
SEZ Ltd.,
Mamidipalli Village,
Shamshabad Mandal,
Ranga Reddy,
Hyderabad,
Telangana, 501218,
India.
141-513........................ ZIMETA (dipyrone) Kindred Biosciences, Dechra, Ltd., 522.728.
Injectable Solution. Inc., 1555 Bayshore Snaygill Industrial
Hwy., Suite 200, Estate, Keighley
Burlingame, CA 94010. Rd., Skipton, North
Yorkshire, BD23 2RW,
United Kingdom.
----------------------------------------------------------------------------------------------------------------

Following these changes of sponsorship, Kindred Biosciences, Inc.
is no longer the sponsor of an approved application. Accordingly, the
drug labeler code for this firm will be removed from Sec. 510.600(c)
(21 CFR 510.600(c)).

III. Withdrawals of Approval

LFB USA, Inc., 175 Crossing Blvd., Framingham, MA 01702 has
requested that FDA withdraw approval of NADA 141-294 for a Bc6 rDNA
construct in GTC 155-92 Goats because the product is no longer
manufactured or marketed. As provided in the regulatory text of this
document, the animal drug regulations in 21 CFR 528.1070 are amended to
reflect this action and in Sec. 510.600(c) to reflect that LFB USA,
Inc. is no longer the sponsor of an approved application.

IV. Change of Sponsor Name and Address

Akorn Animal Health, Inc., 1925 West Field Ct., Suite 300, Lake
Forest, IL 60045 has informed FDA that it has changed its name and
address to Akorn Operating Co. LLC, 5605 Centerpoint Ct., Suite A,
Gurnee, IL 60031. As provided in the regulatory text, Sec. 510.600(c)
is amended to reflect this change.

V. Technical Amendments

FDA is making the following amendments to improve the accuracy of
the animal drug regulations:
<bullet> 21 CFR 510.600(c) is amended to revise the names and
addresses of Akorn Animal Health, Inc.; Mylan Institutional, Inc.; and
Mylan Institutional LLC in the list of sponsors of approved
applications and to remove Kindred Biosciences, Inc.
<bullet> 21 CFR 520.154a is amended to add instructions for
administration of bacitracin methylenedisalicylate soluble powder in
drinking water of chickens, turkeys, and swine.
<bullet> 21 CFR 522.840 is amended to reflect revised conditions of
use for estradiol sustained-release implants in beef steers and
heifers.
<bullet> 21 CFR 522.1372 is amended to reflect the correct volume
of mepivacaine solution for nerve blocks used in horses.
<bullet> 21 CFR 522.1702 is redesignated to list it in a correct
alphabetical sequence.
<bullet> 21 CFR 558.128 is amended to reflect the correct
terminology for chlortetracycline Type C free-choice cattle feeds used
for control of anaplasmosis.
<bullet> 21 CFR 558.258 is amended to reflect approved conditions
of use for free-choice fenbendazole protein and mineral blocks in beef
cattle.
<bullet> 21 CFR 558.330 is amended to add a previously uncodified
concentration of lubabegron Type A medicated article for use in the
manufacture of Type C feeds for beef steers and heifers fed in
confinement for slaughter.
<bullet> 21 CFR 558.366 is amended to correctly describe the target
class for nicarbazin medicated chicken feeds.
<bullet> 21 CFR 558.450 is amended to revise the instructions for
use of oxytetracycline medicated feeds in breeding swine.

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)), which requires
Federal Register publication of ``notice[s] . . . effective as a
regulation,'' of the conditions of use of approved new animal drugs.
This rule sets forth technical amendments to the regulations to codify
recent actions on approved new animal drug applications and corrections
to improve the accuracy of the regulations, and as such does not impose
any burden on regulated entities.
Although denominated 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.'' Therefore, it 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, which
defines a rule as ``an agency statement of general applicability and
future effect, which the agency intends to have the force and effect of
law, that is designed to implement, interpret, or prescribe law or
policy or to describe the procedure or practice requirements of an
agency.''

List of Subjects

21 CFR Part 510

Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.

21 CFR Parts 520, 522, 524, 526, and 528

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, 526, 528, 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), revise the entry for ``Akorn
Animal Health, Inc.'', remove the entries for ``Kindred Biosciences,
Inc.'' and ``LFB USA, Inc.'', and revise the entries for ``Mylan
Institutional, Inc.'' and ``Mylan Institutional LLC''; and
0
b. In the table in paragraph (c)(2), revise the entries for ``051079'',
``059399'', and ``063286'' and remove the entries for ``086047'' and
``086078''.
The revisions read as follows:

[[Page 14897]]

Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.

* * * * *
(c) * * *
(1) * * *

------------------------------------------------------------------------
Drug labeler
Firm name and address code
------------------------------------------------------------------------

* * * * * * *
Akorn Operating Co. LLC, 5605 Centerpoint Ct., Suite A, 059399
Gurnee, IL 60031.......................................

* * * * * * *
Mylan Institutional, Inc., 12720 Dairy Ashford Rd., 051079
Sugar Land, TX 77478...................................
Mylan Institutional LLC, a Viatris Company, 3711 Collins 063286
Ferry Rd., Morgantown, WV 26505........................

* * * * * * *
------------------------------------------------------------------------

(2) * * *

------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------

* * * * * * *
051079....................... Mylan Institutional, Inc., 12720 Dairy
Ashford Rd., Sugar Land, TX 77478.

* * * * * * *
059399....................... Akorn Operating Co. LLC, 5605 Centerpoint
Ct., Suite A, Gurnee, IL 60031.

* * * * * * *
063286....................... Mylan Institutional LLC, a Viatris
Company, 3711 Collins Ferry Rd.,
Morgantown, WV 26505

* * * * * * *
------------------------------------------------------------------------

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. 520.154a:
0
a. Redesignate paragraphs (d)(1) and (2) as paragraphs (d)(2) and (1),
respectively;
0
b. In newly redesignated paragraphs (d)(1)(i)(B), (d)(1)(ii)(B), and
(d)(2)(iii), add a sentence to the end of the paragraph; and
0
c. Revise paragraph (d)(3)(iii).
The additions and revision read as follows:

Sec. 520.154a Bacitracin methylenedisalicylate.

* * * * *
(d) * * *
(1) * * *
(i) * * *
(B) * * * Use as the sole source of drinking water.
(ii) * * *
(B) * * * Use as the sole source of drinking water.
(2) * * *
(iii) * * * Use as the sole source of drinking water.
(3) * * *
(iii) Limitations. Prepare a fresh solution daily. Use as the sole
source of drinking water. Treatment not to exceed 14 days. Not to be
given to swine that weigh more than 250 pounds.
* * * * *

Sec. 520.928 [Amended]

0
5. In Sec. 520.928, in paragraph (b)(2), remove ``No. 000010'' and in
its place add ``Nos. 000010 and 055246''.

0
6. In Sec. 520.1660c, revise the section heading and paragraph (d)(3)
to read as follows:

Sec. 520.1660c Oxytetracycline hydrochloride tablets and boluses.

* * * * *
(d) * * *
(3) Limitations--(i) For No. 000010: Dosage should continue until
the animal returns to normal and for 24 hours to 48 hours after
symptoms have subsided. Treatment should not exceed 4 consecutive days.
Do not exceed 500 milligrams per 100 pounds of body weight every 12
hours (10 milligrams per pound daily).
(ii) For No. 054771: Discontinue treatment 7 days prior to
slaughter. Not for use in lactating dairy cattle. A withdrawal period
has not been established for this product in preruminating calves. Do
not use in calves to be processed for veal. Federal law restricts this
drug to use by or on the order of a licensed veterinarian.

0
7. In Sec. 520.2123c, revise paragraph (d)(3) to read as follows:

Sec. 520.2123c Spectinomycin solution.

* * * * *
(d) * * *
(3) Limitations. Do not administer to pigs over 15 lb body weight
or over 4 weeks of age. Do not administer within 21 days of slaughter.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.

0
8. In Sec. 520.2260a, revise paragraph (d)(2)(iii) to read as follows:

Sec. 520.2260a Sulfamethazine oblets and boluses.

* * * * *
(d) * * *
(2) * * *
(iii) Limitations. Do not administer for more than 5 consecutive
days. Do not treat calves within 11 days of slaughter. Do not use in
calves to be slaughtered under 1 month of age or in calves being fed an
all milk diet. Do not use in female dairy cattle 20 months of age or
older; such use may cause drug residues in milk. Federal law restricts
this drug to use by or on the order of a licensed veterinarian.

[[Page 14898]]

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
9. The authority citation for part 522 continues to read as follows:

Authority: 21 U.S.C. 360b.

Sec. 522.728 [Amended]

0
10. In 522.728, in paragraph (b), remove ``086078'' and in its place
add ``043264''.

0
11. Add Sec. 522.772 to read as follows:

Sec. 522.772 Doramectin and levamisole.

(a) Specifications. Each milliliter of solution contains 5
milligrams (mg) of doramectin and 150 mg levamisole hydrochloride.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. Sec. 556.222 and 556.350 of this
chapter.
(d) Conditions of use--(1) Cattle--(i) Amount. Inject
subcutaneously in the neck as a single dose at a dosage of 0.2 mg
doramectin (0.91 mg/lb) and 6 mg of levamisole hydrochloride per kg
(2.72 mg/lb) of body weight.
(ii) Indications for use. For treatment and control of
gastrointestinal roundworms (adults and fourth stage larvae):
Ostertagia ostertagi (including inhibited larvae), O. lyrata,
Haemonchus placei, Trichostrongylus axei, T. colubriformis, T.
longispicularis, Cooperia oncophora, C. pectinata, C. punctata, C.
surnabada, Bunostomum phlebotomum (adults only), Strongyloides
papillosus (adults only), Oesophagostomum radiatum, Trichuris spp.
(adults only) and Nematodirus helvetianus (adults only); lungworms
(adults and fourth stage larvae): Dictyocaulus viviparus; eyeworms
(adults): Thelazia spp.; grubs (parasitic stages): Hypoderma bovis and
H. lineatum; sucking lice: Haematopinus eurysternus, Linognathus
vituli, and Solenopotes capillatus; mange mites: Psoroptes bovis and
Sarcoptes scabiei in beef cattle 2 months of age and older and
replacement dairy heifers less than 20 months of age. Not for use in
beef bulls intended for breeding over 1 year of age, dairy calves, and
veal calves.
(iii) Limitations. Cattle must not be slaughtered for human
consumption within 15 days following last treatment with this drug
product. Not for use in female dairy cattle 20 months of age or older,
including dry dairy cows; use in these cattle may cause drug residues
in milk and/or in calves born to these cows or heifers. Not for use in
beef calves less than 2 months of age, dairy calves, and veal calves. A
withdrawal period has not been established for this product in pre-
ruminating calves.
(2) [Reserved]

0
12. In Sec. 522.840, revise paragraphs (d)(1) and (2) and remove
paragraph (d)(3).
The revisions read as follows:

Sec. 522.840 Estradiol.

* * * * *
(d) * * *
(1) Amounts and indications for use--(i) 25.7-mg extended-release
implant. Insert one implant for increased rate of weight gain for up to
200 days in beef steer calves 2 months of age and older; for increased
rate of weight gain for up to 200 days in growing beef steers and
heifers on pasture (stocker, feeder, and slaughter); and for increased
rate of weight gain and improved feed efficiency for up to 200 days in
growing beef steers and heifers fed in confinement for slaughter.
(ii) 43.9-mg extended-release implant. Insert one implant for
increased rate of weight gain for up to 400 days in beef steer calves 2
months of age and older; for increased rate of weight gain for up to
400 days in growing beef steers and heifers on pasture (stocker,
feeder, and slaughter); and for increased rate of weight gain and
improved feed efficiency for up to 400 days in growing beef steers and
heifers fed in confinement for slaughter.
(2) Limitations. For subcutaneous ear implantation only. Not
approved for repeated implantation (reimplantation) with this or any
other cattle ear implant within each separate production phase (beef
steer calves 2 months of age and older, growing beef steers on pasture
(stocker, feeder, and slaughter), 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.

0
13. In Sec. 522.1367, revise paragraph (b) to read as follows:

Sec. 522.1367 Meloxicam.

* * * * *
(b) Sponsors. See Nos. 000010, 016729, 017033, 055529, and 086101
in Sec. 510.600(c) of this chapter.
* * * * *

Sec. 522.1372 [Amended]

0
14. In Sec. 522.1372, in paragraph (c)(1), remove ``3 to 5 mL'' and in
its place add ``3 to 15 mL''.

Sec. Sec. 522.1662a and 522.1662b [Redesignated as Sec. 522.1662 and
Sec. 522.1663]

0
15. Redesignate Sec. Sec. 522.1662a and 522.1662b as Sec. Sec.
522.1662 and 522.1663, respectively.

0
16. In newly redesignated Sec. 522.1662:
0
a. Revise the section heading;
0
b. Add headings to paragraphs (b)(3)(i) through (iii);
0
c. Remove paragraph (b)(3)(iv); and
0
d. Revise paragraphs (d), (e), (f), and (i)(1) through (3).
The revisions and additions read as follows:

Sec. 522.1662 Oxytetracycline.

* * * * *
(b) * * *
(3) * * *
(i) Amount. * * *
(ii) Indications for use. * * *
(iii) Limitations. * * *
* * * * *
(d)(1) Specifications. Each milliliter of solution contains 100 mg
of oxytetracycline hydrochloride.
(2) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(3) Conditions of use in beef cattle and nonlactating dairy
cattle--(i) Amount. Administer 3 to 5 mg of oxytetracycline per pound
of body weight per day by intramuscular injection, not to exceed a
total of 4 consecutive days. Administer 5 mg/lb of body weight per day
for treatment of anaplasmosis, severe foot-rot, or severe cases of
other indicated diseases, not to exceed a total of 4 consecutive days.
(ii) Indications for use. For treatment of diseases due to
oxytetracycline-susceptible organisms as follows: Pneumonia and
shipping fever complex associated with Pasteurella spp. and Haemophilus
spp., foot-rot and diphtheria caused by Fusobacterium necrophorum,
bacterial enteritis (scours) caused by Escherichia coli, wooden tongue
caused by Actinobacillus lignieresii, leptospirosis caused by
Leptospira pomona, and wound infections and acute metritis caused by
Staphylococcus spp. and Streptococcus spp. For treatment of
anaplasmosis caused by Anaplasma marginale and anthrax caused by
Bacillus anthracis.
(iii) Limitations. This drug product is not approved for use in
female dairy cattle 20 months of age or older, including dry dairy
cows. Use in these cattle may cause drug residues in milk and/or in
calves born to these cows. Discontinue treatment at least 15 days

[[Page 14899]]

prior to slaughter. Federal law restricts this drug to use by or on the
order of a licensed veterinarian.
(e)(1) Specifications. Each milliliter of solution contains 50 mg
of oxytetracycline hydrochloride.
(2) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(3) Conditions of use in beef cattle and nonlactating dairy cattle.
It is used as follows:
(i) Amount. Administer by intravenous or intramuscular injection at
3 to 5 mg/lb of body weight per day, not exceed a total of 4
consecutive days.
(ii) Indications for use. For treatment of pneumonia and shipping
fever complex associated with Pasteurella spp. and Haemophilus spp.;
foot-rot and diphtheria caused by Spherophorus necrophorus; bacterial
enteritis (scours) caused by Escherichia coli; wooden tongue caused by
Actinobacillus lignieresii; leptospirosis caused by Leptospira pomona;
wound infections and acute metritis caused by staphylococcal and
streptococcal organisms; and treatment of anaplasmosis caused by
Anaplasma marginale and anthrax caused by Bacillus anthracis.
(iii) Limitations. This drug product is not approved for use in
female dairy cattle 20 months of age or older, including dry dairy
cows. Use in these cattle may cause drug residues in milk and/or in
calves born to these cows. Discontinue treatment at least 22 days prior
to slaughter. Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
(4) Conditions of use in swine. It is used in swine as follows:
(i) Amount. Administer by intramuscular injection at 3 to 5 mg/lb
of body weight per day to swine, not to exceed a total of 4 consecutive
days. Administered to sows at 3 mg/lb of body weight approximately 8
hours before farrowing or immediately after farrowing.
(ii) Indications for use. It is used for the treatment of bacterial
enteritis (scours, colibacillosis) caused by Escherichia coli;
pneumonia caused by Pasteurella multocida; and leptospirosis caused by
Leptospira pomona. Administered to sows as an aid in the control of
infectious enteritis (baby pig scours, colibacillosis) in suckling pigs
caused by Escherichia coli.
(iii) Limitations. Discontinue treatment at least 22 days prior to
slaughter. Federal law restricts this drug to use by or on the order of
a licensed veterinarian.
(5) Poultry (broilers, turkeys, and breeding chickens). It is used
as follows:
(i) Amount. Administer subcutaneously to chickens and turkeys
according to age as directed on labeling.
(ii) Indications for use. For the treatment of air sacculitis (air-
sac disease, chronic respiratory disease) caused by Mycoplasma
gallisepticum and Escherichia coli; fowl cholera caused by Pasteurella
multocida; infectious sinusitis caused by Mycoplasma gallisepticum; and
infectious synovitis caused by Mycoplasma synoviae.
(iii) Limitations. Do not administer to laying hens unless the eggs
are used for hatching only. Discontinue treatment at least 5 days prior
to slaughter. Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
(f)(1) Specifications. Each milliliter of solution contains 100 mg
of oxytetracycline hydrochloride.
(2) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(3) Conditions of use in beef cattle and nonlactating dairy
cattle--(i) Amount. Administer 3 to 5 mg of oxytetracycline per pound
of body weight per day by intramuscular injection, not to exceed a
total of 4 consecutive days. Administer 5 mg/lb of body weight per day
for treatment of anaplasmosis, severe foot-rot, or severe cases of
other indicated diseases, not to exceed a total of 4 consecutive days.
(ii) Indications for use. For treatment of diseases due to
oxytetracycline-susceptible organisms as follows: Pneumonia and
shipping fever complex associated with Pasteurella spp. and Haemophilus
spp., foot-rot and diphtheria caused by Fusobacterium necrophorum,
bacterial enteritis (scours) caused by Escherichia coli, wooden tongue
caused by Actinobacillus lignieresii, leptospirosis caused by
Leptospira pomona, and wound infections and acute metritis caused by
Staphylococcus spp. and Streptococcus spp. For treatment of
anaplasmosis caused by Anaplasma marginale and anthrax caused by
Bacillus anthracis.
(iii) Limitations. This drug product is not approved for use in
female dairy cattle 20 months of age or older, including dry dairy
cows. Use in these cattle may cause drug residues in milk and/or in
calves born to these cows. Discontinue treatment at least 15 days prior
to slaughter. Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
* * * * *
(i) * * *
(1) Specifications. Each milliliter of solution contains 50
milligrams (mg) of oxytetracycline hydrochloride.
(2) Sponsor. See No. 016592 in Sec. 510.600(c) of this chapter.
(3) Conditions of use in beef cattle, beef calves, nonlactating
dairy cattle, and dairy calves--(i) Amount. Administer 3 to 5 mg/lb
body weight per day by intramuscular injection not to exceed a total of
4 consecutive days.
(ii) Indications for use. For treatment of bacterial pneumonia and
shipping fever complex associated with Pasteurella spp.; foot-rot and
diphtheria caused by Spherophorus necrophorus; bacterial enteritis
(scours) caused by Escherichia coli; wooden tongue caused by
Actinobacillus lignieresii; wound infections and acute metritis caused
by staphylococcal and streptococcal organisms susceptible to
oxytetracycline.
(iii) Limitations. This drug product is not approved for use in
female dairy cattle 20 months of age or older, including dry dairy
cows. Use in these cattle may cause drug residues in milk and/or in
calves born to these cows. Discontinue treatment at least 18 days
before slaughter. Federal law restricts this drug to use by or on the
order of a licensed veterinarian.
* * * * *

0
17. In Sec. 522.1696b, revise paragraphs (b)(2), (d)(1)(i), and
(d)(2)(iii)(B) and add paragraph (d)(2)(iii)(C) to read as follows:

Sec. 522.1696b Penicillin G procaine aqueous suspension.

* * * * *
(b) * * *
(2) Nos. 055529 and 061133 for use as in paragraph (d)(2) of this
section.
* * * * *
(d) * * *
(1) * * *
(i) Amount. 10,000 units per pound body weight daily by
intramuscular injection.
* * * * *
(2) * * *
(iii) * * *
(B) For Nos. 016592 and 055529: Treatment should not exceed 4
consecutive days. A withdrawal period has not been established for this
product in pre-ruminating calves. Discontinue treatment for the
following number of days before slaughter: Cattle--10; sheep--9; and
swine--7.
(C) For No. 054771: Federal law restricts this drug to use by or on
the order of a licensed veterinarian.

Sec. 522.1702 [Redesignated as Sec. 522.1698]

0
18. Redesignate Sec. 522.1702 as Sec. 522.1698.

Sec. 522.2121 [Amended]

0
19. In Sec. 522.2121, in paragraph (b), remove ``No. 054771'' and in
its place add ``Nos. 054771 and 061133''.

[[Page 14900]]

0
20. In Sec. 522.2220, revise paragraph (d)(4)(iii) to read as follows:

Sec. 522.2220 Sulfadimethoxine.

* * * * *
(d) * * *
(4) * * *
(iii) Limitations. Milk taken from animals during treatment and for
60 hours (5 milkings) after the latest treatment must not be used for
food. Do not administer within 5 days of slaughter. A withdrawal period
has not been established for this product in preruminating calves. Do
not use in calves to be processed for veal. Federal law restricts this
drug to use by or on the order of a licensed veterinarian.

0
21. In Sec. 522.2340, revise paragraph (e)(4) to read as follows:

Sec. 522.2340 Sulfomyxin.

* * * * *
(e) * * *
(4) Not for use in laying hens; do not treat chickens within 5 days
of slaughter. Do not treat turkeys within 7 days of slaughter. Federal
law restricts this drug to use by or on the order of a licensed
veterinarian.

0
22. Revise Sec. 522.2478 to read as follows:

Sec. 522.2478 Trenbolone acetate and estradiol benzoate.

(a) Specifications. (1) Each implant consists of:
(i) 100 milligrams (mg) trenbolone acetate and 14 mg estradiol
benzoate (one implant consisting of four pellets, each pellet
containing 25 mg trenbolone acetate and 3.5 mg estradiol benzoate) per
implant dose.
(ii) 200 mg trenbolone acetate and 28 mg estradiol benzoate (one
implant consisting of eight pellets, each pellet containing 25 mg
trenbolone acetate and 3.5 mg estradiol benzoate) per implant dose.
(2) Each extended-release implant consists of:
(i) 150 mg trenbolone acetate and 21 mg estradiol benzoate (one
implant consisting of six pellets with a porous polymer film coating,
each pellet containing 25 mg trenbolone acetate and 3.5 mg estradiol
benzoate) per implant dose.
(ii) 200 mg trenbolone acetate and 28 mg estradiol benzoate (one
implant consisting of eight pellets with a porous polymer film coating,
each pellet containing 25 mg trenbolone acetate and 3.5 mg estradiol
benzoate) per implant dose.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. Sec. 556.240 and 556.739 of this
chapter.
(d) Conditions of use--(1) Growing beef steers and heifers fed in
confinement for slaughter--(i) Amounts and indications for use--(A) An
implant containing 100 mg trenbolone acetate and 14 mg estradiol
benzoate as described in paragraph (a)(1)(i) of this section for
increased rate of weight gain in growing beef steers fed in confinement
for slaughter and for increased rate of weight gain and improved feed
efficiency in growing beef heifers fed in confinement for slaughter.
For increased rate of weight gain for up to 200 days in a
reimplantation program where an implant as described in paragraph
(a)(1)(i) of this section is the first implant and an implant as
described in paragraph (a)(1)(i) or (ii) or (a)(2)(ii) of this section
is administered 60 to 120 days later.
(B) An implant containing 200 mg trenbolone acetate and 28 mg
estradiol benzoate as described in paragraph (a)(1)(ii) of this section
for increased rate of weight gain and improved feed efficiency in
growing beef steers fed in confinement for slaughter and for increased
rate of weight gain in growing beef heifers fed in confinement for
slaughter. For increased rate of weight gain for up to 200 days in a
reimplantation program where an implant as described in paragraph
(a)(1)(i) of this section is the first implant and an implant as
described in paragraph (a)(1)(ii) of this section is administered 60 to
120 days later.
(C) An extended-release implant containing 150 mg trenbolone
acetate and 21 mg estradiol benzoate as described in paragraph
(a)(2)(i) of this section for increased rate of weight gain for up to
200 days.
(D) An extended-release implant containing 200 mg trenbolone
acetate and 28 mg estradiol benzoate as described in paragraph
(a)(2)(ii) of this section for increased rate of weight gain and
improved feed efficiency for up to 200 days. For increased rate of
weight gain for up to 200 days in a reimplantation program where an
implant as described in paragraph (a)(1)(i) of this section is the
first implant and an implant as described in paragraph (a)(2)(ii) of
this section is administered 60 to 120 days later.
(ii) Limitations. Implant pellets subcutaneously in ear only. Other
than as described on the labeling, this implant 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 established. A
withdrawal period has not been established for this product in pre-
ruminating calves. Do not use in dairy cows or in animals intended for
subsequent breeding. Use in these cattle may cause drug residues in
milk and/or in calves born to these cows. The extended-release implant
described in paragraph (a)(2)(i) of this section, used as described in
paragraph (d)(1)(i)(C) of this section, is not approved for repeated
implantation (reimplantation) with this or any other cattle ear
implant.
(2) Growing beef steers and heifers on pasture (stocker, feeder,
and slaughter)--(i) Amounts and indications for use. An extended-
release implant containing 150 mg trenbolone acetate and 21 mg
estradiol benzoate as described in paragraph (a)(2)(i) of this section
for increased rate of weight gain for up to 200 days.
(ii) Limitations. Implant pellets subcutaneously in ear only. Not
approved for repeated implantation (reimplantation) with this or any
other cattle ear implant. Safety and effectiveness following
reimplantation have not been evaluated. Do not use in beef calves less
than 2 months of age, dairy calves, and veal calves because
effectiveness and safety have not been established. A withdrawal period
has not been established for this product in pre-ruminating calves. Do
not use in dairy cows or in animals intended for subsequent breeding.
Use in these cattle may cause drug residues in milk and/or in calves
born to these cows.

0
23. In Sec. 522.2640, revise paragraphs (b)(1), (e)(1)(iii), and
(e)(2)(iii) to read as follows:

Sec. 522.2640 Tylosin.

* * * * *
(b) * * *
(1) No. 058198 for use of 50- or 200-mg/mL solutions as in
paragraph (e) of this section.
* * * * *
(e) * * *
(1) * * *
(iii) Limitations. Cattle intended for human consumption must not
be slaughtered within 21 days of the last use of this drug product.
This drug product is not approved for use in female dairy cattle 20
months of age or older, including dry dairy cows. Use in these cattle
may cause drug residues in milk and/or in calves born to these cows.
This product is not approved for use in calves intended to be processed
for veal. A withdrawal period has not been established in preruminating
calves. For No. 058198: Federal law

[[Page 14901]]

restricts this drug to use by or on the order of a licensed
veterinarian.
(2) * * *
(iii) Limitations. Swine intended for human consumption must not be
slaughtered within 14 days of the last use of this drug product. For
No. 058198: Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
* * * * *

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

0
24. The authority citation for part 524 continues to read as follows:

Authority: 21 U.S.C. 360b.

Sec. 524.957 [Amended]

0
25. In Sec. 524.957, in paragraph (b), remove ``No. 058198'' and in
its place add ``Nos. 017030 and 058198''.

0
26. In Sec. 524.998, revise paragraph (c)(2)(ii) to read as follows:

Sec. 524.998 Fluralaner.

* * * * *
(c) * * *
(2) * * *
(ii) Indications for use. Kills adult fleas; for the treatment and
prevention of flea infestations (C. felis) and the treatment and
control of I. scapularis (black-legged tick) and Haemaphysalis
longicornis (Asian longhorned tick) infestations for 12 weeks in cats
and kittens 6 months of age and older, and weighing 2.6 lb or greater;
for the treatment and control of D. variabilis (American dog tick)
infestations for 8 weeks in cats and kittens 6 months of age and older,
and weighing 2.6 lb or greater.
* * * * *

0
27. In Sec. 524.1001, revise paragraph (c)(2) to read as follows:

Sec. 524.1001 Fluralaner and moxidectin.

* * * * *
(c) * * *
(2) Indications for use. For the prevention of heartworm disease
caused by Dirofilaria immitis and for the treatment of infections with
intestinal roundworm (Toxocara cati, fourth-stage larvae, immature
adults, and adults) and hookworm (Ancylostoma tubaeforme, fourth-stage
larvae, immature adults, and adults); kills adult fleas and is
indicated for the treatment and prevention of flea infestations
(Ctenocephalides felis) and the treatment and control of tick
infestations (Ixodes scapularis (black-legged tick), Dermacentor
variabilis (American dog tick), and Haemaphysalis longicornis (Asian
longhorned tick)) for 2 months in cats and kittens 6 months of age and
older and weighing 2.6 lb or greater.
* * * * *

0
28. In Sec. 524.1662b, revise paragraph (c)(3) to read as follows:

Sec. 524.1662b Oxytetracycline and polymyxin B ophthalmic ointment.

* * * * *
(c) * * *
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.

Sec. 524.2620 [Amended]

0
29. In Sec. 524.2620, in paragraph (b)(1), remove ``051079'' and in
its place add ``069043''.

PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS

0
30. The authority citation for part 526 continues to read as follows:

Authority: 21 U.S.C. 360b.

0
31. In Sec. 526.820, revise paragraphs (d)(3) and (e)(3) to read as
follows:

Sec. 526.820 Erythromycin.

* * * * *
(d) * * *
(3) Limitations. Milk taken from animals during treatment and for
36 hours (3 milkings) after the latest treatment must not be used for
food. Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
(e) * * *
(3) Limitations. For use in dry cows only. Federal law restricts
this drug to use by or on the order of a licensed veterinarian.

0
32. In Sec. 526.1698, revise paragraphs (d)(3) and (e)(3) to read as
follows:

Sec. 526.1698 Penicillin G procaine and novobiocin.

* * * * *
(d) * * *
(3) Limitations. For udder instillation in lactating cows only. Do
not milk for at least 6 hours after treatment; thereafter, milk at
regular intervals. Milk taken from treated animals within 72 hours (6
milkings) after the latest treatment must not be used for food. Treated
animals must not be slaughtered for food for 15 days following the
latest treatment. Federal law restricts this drug to use by or on the
order of a licensed veterinarian.
(e) * * *
(3) Limitations. For udder instillation in dry cows only. Do not
use less than 30 days prior to calving. Milk from treated cows must not
be used for food during the first 72 hours after calving. Treated
animals must not be slaughtered for food for 30 days following udder
infusion. Federal law restricts this drug to use by or on the order of
a licensed veterinarian.

PART 528--INTENTIONAL GENOMIC ALTERATIONS IN ANIMALS

0
33. The authority citation for part 528 continues to read as follows:

Authority: 21 U.S.C. 360b.

Sec. 528.1070 [Removed]

0
34. Remove Sec. 528.1070.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
35. The authority citation for part 558 continues to read as follows:

Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.

0
36. In Sec. 558.128:
0
a. Redesignate paragraphs (e)(4)(x) through (xlvii) as paragraphs
(e)(4)(xxi) through (lviii);
0
b. Redesignate paragraphs (e)(4)(vii) through (ix) as paragraphs
(e)(4)(xv) through (xvii);
0
c. Redesignate paragraphs (e)(4)(iii) through (vi) as paragraphs
(e)(4)(v) through (viii);
0
d. Revise newly redesignated paragraph (e)(4)(xv); and
0
e. Add new paragraphs (e)(4)(iii) and (iv), (ix) through (xiv), and
(xviii) through (xx).
The revision and additions read as follows:

Sec. 558.128 Chlortetracycline.

* * * * *
(e) * * *
(4) * * *

[[Page 14902]]

* * * * * * *
(iii) 7 to 17.5 g/ton............ Monensin, 5 to 40.......... Growing beef steers and Feed as the sole ration to provide 70 mg 069254
heifers fed in chlortetracycline per head per day and 50 to 480 mg
confinement for monensin per head per day. No additional
slaughter over 400 lb: improvement in feed efficiency has been shown from
For reduction of the feeding monensin at levels greater than 30 grams
incidence of liver per ton (360 mg monensin per head per day). For use
abscesses and for in dry feeds only. Not for use in liquid feed
improved feed supplements. Do not allow horses or other equines
efficiency. access to feed containing monensin. Ingestion of
monensin by horses has been fatal. Monensin
medicated cattle and goat feeds are safe for use in
cattle and goats only. Consumption by unapproved
species may result in toxic reactions. Do not
exceed the levels of monensin recommended in the
feeding directions, as reduced average daily gains
may result. If feed refusals containing monensin
are fed to other groups of cattle, the
concentration of monensin in the refusals and
amount of refusals fed should be taken into
consideration to prevent monensin overdosing. A
withdrawal period has not been established for this
product in pre-ruminating calves. Do not use in
calves to be processed for veal. Monensin as
provided by No. 058198, chlortetracycline by No.
069254 in Sec. 510.600(c) of this chapter.
(iv) 7 to 17.5 g/ton............. Monensin, 10 to 40......... Growing beef steers and Feed as the sole ration to provide 70 mg 069254
heifers fed in chlortetracycline per head per day and 0.14 to 0.42
confinement for mg monensin per lb. body weight per day to provide,
slaughter over 400 lb: depending upon severity of coccidiosis challenge,
For reduction of the up to 480 mg monensin per head per day. For use in
incidence of liver dry feeds only. Not for use in liquid feed
abscesses and for supplements. Do not allow horses or other equines
prevention and control access to feed containing monensin. Ingestion of
of coccidiosis due to monensin by horses has been fatal. Monensin
Eimeria bovis and medicated cattle and goat feeds are safe for use in
Eimeria zuernii. cattle and goats only. Consumption by unapproved
species may result in toxic reactions. Do not
exceed the levels of monensin recommended in the
feeding directions, as reduced average daily gains
may result. If feed refusals containing monensin
are fed to other groups of cattle, the
concentration of monensin in the refusals and
amount of refusals fed should be taken into
consideration to prevent monensin overdosing. A
withdrawal period has not been established for this
product in pre-ruminating calves. Do not use in
calves to be processed for veal. Monensin as
provided by No. 058198, chlortetracycline by No.
069254 in Sec. 510.600(c) of this chapter.

* * * * * * *
(ix) 33.33 to 66.67 g/ton........ Monensin, 5 to 40.......... Growing beef steers and Feed as the sole ration to provide 0.5 mg 069254
heifers fed in chlortetracycline per lb. body weight per day and
confinement for 50 to 480 mg monensin per head per day. No
slaughter over 700 lb: additional improvement in feed efficiency has been
For control of active shown from feeding monensin at levels greater than
infection of 30 grams per ton (360 mg monensin per head per
anaplasmosis caused by day). For use in dry feeds only. Not for use in
Anaplasma marginale liquid feed supplements. Do not allow horses or
susceptible to other equines access to feed containing monensin.
chlortetracycline and Ingestion of monensin by horses has been fatal.
for improved feed Monensin medicated cattle and goat feeds are safe
efficiency. for use in cattle and goats only. Consumption by
unapproved species may result in toxic reactions.
Do not exceed the levels of monensin recommended in
the feeding directions, as reduced average daily
gains may result. If feed refusals containing
monensin are fed to other groups of cattle, the
concentration of monensin in the refusals and
amount of refusals fed should be taken into
consideration to prevent monensin overdosing. A
withdrawal period has not been established for this
product in pre-ruminating calves. Do not use in
calves to be processed for veal. Monensin as
provided by No. 058198, chlortetracycline by No.
069254 in Sec. 510.600(c) of this chapter.
(x) 33.33 to 66.67 g/ton......... Monensin, 10 to 40......... Growing beef steers and Feed as the sole ration to provide 0.5 mg 069254
heifers fed in chlortetracycline per lb. body weight per day and
confinement for 0.14 to 0.42 mg monensin per lb. body weight per
slaughter over 700 lb: day to provide, depending upon severity of
For control of active coccidiosis challenge, up to 480 mg monensin per
infection of head per day. For use in dry feeds only. Not for
anaplasmosis caused by use in liquid feed supplements. Do not allow horses
Anaplasma marginale or other equines access to feed containing
susceptible to monensin. Ingestion of monensin by horses has been
chlortetracycline and fatal. Monensin medicated cattle and goat feeds are
for the prevention and safe for use in cattle and goats only. Consumption
control of coccidiosis by unapproved species may result in toxic
due to Eimeria bovis reactions. Do not exceed the levels of monensin
and Eimeria zuernii. recommended in the feeding directions, as reduced
average daily gains may result. If feed refusals
containing monensin are fed to other groups of
cattle, the concentration of monensin in the
refusals and amount of refusals fed should be taken
into consideration to prevent monensin overdosing.
A withdrawal period has not been established for
this product in pre-ruminating calves. Do not use
in calves to be processed for veal. Monensin as
provided by No. 058198, chlortetracycline by No.
069254 in Sec. 510.600(c) of this chapter.

[[Page 14903]]

(xi) 50 to 117 g/ton............. Monensin, 7.14 to 40....... Growing beef steers and Feed as the sole ration to provide 350 mg 069254
heifers fed in chlortetracycline per head per day and 50 to 480 mg
confinement for monensin per head per day. No additional
slaughter under 700 lb: improvement in feed efficiency has been shown from
For control of active feeding monensin at levels greater than 30 grams
infection of per ton (360 mg monensin per head per day). For use
anaplasmosis caused by in dry feeds only. Not for use in liquid feed
Anaplasma marginale supplements. Do not allow horses or other equines
susceptible to access to feed containing monensin. Ingestion of
chlortetracycline and monensin by horses has been fatal. Monensin
for improved feed medicated cattle and goat feeds are safe for use in
efficiency. cattle and goats only. Consumption by unapproved
species may result in toxic reactions. Do not
exceed the levels of monensin recommended in the
feeding directions, as reduced average daily gains
may result. If feed refusals containing monensin
are fed to other groups of cattle, the
concentration of monensin in the refusals and
amount of refusals fed should be taken into
consideration to prevent monensin overdosing. A
withdrawal period has not been established for this
product in pre-ruminating calves. Do not use in
calves to be processed for veal. Monensin as
provided by No. 058198, chlortetracycline by No.
069254 in Sec. 510.600(c) of this chapter.
(xii) 50 to 117 g/ton............ Monensin, 10 to 40......... Growing beef steers and Feed as the sole ration to provide 350 mg 069254
heifers fed in chlortetracycline per head per day and 0.14 to 0.42
confinement for mg monensin per lb. body weight per day to provide,
slaughter under 700 lb: depending upon severity of coccidiosis challenge,
For control of active up to 480 mg monensin per head per day. For use in
infection of dry feeds only. Not for use in liquid feed
anaplasmosis caused by supplements. Do not allow horses or other equines
Anaplasma marginale access to feed containing monensin. Ingestion of
susceptible to monensin by horses has been fatal. Monensin
chlortetracycline and medicated cattle and goat feeds are safe for use in
for the prevention and cattle and goats only. Consumption by unapproved
control of coccidiosis species may result in toxic reactions. Do not
due to Eimeria bovis exceed the levels of monensin recommended in the
and Eimeria zuernii. feeding directions, as reduced average daily gains
may result. If feed refusals containing monensin
are fed to other groups of cattle, the
concentration of monensin in the refusals and
amount of refusals fed should be taken into
consideration to prevent monensin overdosing. A
withdrawal period has not been established for this
product in pre-ruminating calves. Do not use in
calves to be processed for veal. Monensin as
provided by No. 058198, chlortetracycline by No.
069254 in Sec. 510.600(c) of this chapter.
(xiii) 50 to 117 g/ton........... Monensin, 7.14 to 40....... Growing beef steers and Feed as the sole ration to provide 350 mg 069254
heifers fed in chlortetracycline per head per day and 50 to 480 mg
confinement for monensin per head per day. No additional
slaughter: For the improvement in feed efficiency has been shown from
control of bacterial feeding monensin at levels greater than 30 grams
pneumonia associated per ton (360 mg monensin per head per day). For use
with shipping fever in dry feeds only. Not for use in liquid feed
complex caused by supplements. Do not allow horses or other equines
Pasteurella spp. access to feed containing monensin. Ingestion of
susceptible to monensin by horses has been fatal. Monensin
chlortetracycline and medicated cattle and goat feeds are safe for use in
for improved feed cattle and goats only. Consumption by unapproved
efficiency. species may result in toxic reactions. Do not
exceed the levels of monensin recommended in the
feeding directions, as reduced average daily gains
may result. If feed refusals containing monensin
are fed to other groups of cattle, the
concentration of monensin in the refusals and
amount of refusals fed should be taken into
consideration to prevent monensin overdosing. A
withdrawal period has not been established for this
product in pre-ruminating calves. Do not use in
calves to be processed for veal. Monensin as
provided by No. 058198, chlortetracycline by No.
069254 in Sec. 510.600(c) of this chapter.
(xiv) 50 to 117 g/ton............ Monensin, 10 to 40......... Growing beef steers and Feed as the sole ration to provide 350 mg 069254
heifers fed in chlortetracycline per head per day and 0.14 to 0.42
confinement for mg monensin per lb. body weight per day to provide,
slaughter: For the depending upon severity of coccidiosis challenge,
control of bacterial up to 480 mg monensin per head per day. For use in
pneumonia associated dry feeds only. Not for use in liquid feed
with shipping fever supplements. Do not allow horses or other equines
complex caused by access to feed containing monensin. Ingestion of
Pasteurella spp. monensin by horses has been fatal. Monensin
susceptible to medicated cattle and goat feeds are safe for use in
chlortetracycline and cattle and goats only. Consumption by unapproved
for the prevention and species may result in toxic reactions. Do not
control of coccidiosis exceed the levels of monensin recommended in the
due to Eimeria bovis feeding directions, as reduced average daily gains
and Eimeria zuernii. may result. If feed refusals containing monensin
are fed to other groups of cattle, the
concentration of monensin in the refusals and
amount of refusals fed should be taken into
consideration to prevent monensin overdosing. A
withdrawal period has not been established for this
product in pre-ruminating calves. Do not use in
calves to be processed for veal. Monensin as
provided by No. 058198, chlortetracycline by No.
069254 in Sec. 510.600(c) of this chapter.
(xv) to provide 0.5 to 2.0 mg/lb ........................... Beef cattle and In Type C free-choice cattle feeds such as feed 054771
of body weight daily. nonlactating dairy blocks or salt-mineral mixes manufactured from 069254
cattle: As an aid in approved Type A articles. See paragraph (d)(4) of
the control of active this section.
infection of
anaplasmosis caused by
Anaplasma marginale
susceptible to
chlortetracycline.

[[Page 14904]]

* * * * * * *
(xviii) 400 to 2,000 g/ton....... Monensin, 5 to 40.......... Growing beef steers and Feed as the sole ration to provide 10 mg 069254
heifers fed in chlortetracycline per lb. body weight per day.
confinement for Treat for not more than 5 days, then continue
slaughter: For feeding monensin Type C medicated feed alone. No
treatment of bacterial additional improvement in feed efficiency has been
enteritis caused by shown from feeding monensin at levels greater than
Escherichia coli and 30 grams per ton (360 mg monensin per head per
bacterial pneumonia day). For use in dry feeds only. Not for use in
caused by Pasteurella liquid feed supplements. Do not allow horses or
multocida susceptible other equines access to feed containing monensin.
to chlortetracycline; Ingestion of monensin by horses has been fatal.
for improved feed Monensin medicated cattle and goat feeds are safe
efficiency. for use in cattle and goats only. Consumption by
unapproved species may result in toxic reactions.
Do not exceed the levels of monensin recommended in
the feeding directions, as reduced average daily
gains may result. If feed refusals containing
monensin are fed to other groups of cattle, the
concentration of monensin in the refusals and
amount of refusals fed should be taken into
consideration to prevent monensin overdosing. A
withdrawal period has not been established for this
product in pre-ruminating calves. Do not use in
calves to be processed for veal. Monensin as
provided by No. 058198, chlortetracycline by No.
069254 in Sec. 510.600(c) of this chapter.
(xix) 400 to 2,000 g/ton......... Monensin, 5 to 40.......... Growing beef steers and Feed as the sole ration to provide 10 mg 069254
heifers: For treatment chlortetracycline per lb. body weight per day and
of bacterial enteritis 0.14 to 0.42 mg monensin per lb. body weight per
caused by Escherichia day to provide, depending upon severity of the
coli and bacterial coccidiosis challenge, up to 480 mg monensin per
pneumonia caused by head per day. Treat for not more than 5 days, then
Pasteurella multocida continue feeding monensin Type C medicated feed
susceptible to alone. For use in dry feeds only. Not for use in
chlortetracycline; and liquid feed supplements. Do not allow horses or
for the prevention and other equines access to feed containing monensin.
control of coccidiosis Ingestion of monensin by horses has been fatal.
due to Eimeria bovis Monensin medicated cattle and goat feeds are safe
and Eimeria zuernii. for use in cattle and goats only. Consumption by
unapproved species may result in toxic reactions.
Do not exceed the levels of monensin recommended in
the feeding directions, as reduced average daily
gains may result. If feed refusals containing
monensin are fed to other groups of cattle, the
concentration of monensin in the refusals and
amount of refusals fed should be taken into
consideration to prevent monensin overdosing. A
withdrawal period has not been established for this
product in pre-ruminating calves. Do not use in
calves to be processed for veal. Monensin as
provided by No. 058198, chlortetracycline by No.
069254 in Sec. 510.600(c) of this chapter.
(xx) 400 to 2,000 g/ton.......... Monensin, 10 to 200........ Beef calves 2 months of Feed as the sole ration to provide 10 mg 069254
age and older: For chlortetracycline per lb. body weight per day and
treatment of bacterial 0.14 to 1.00 mg monensin per lb. body weight per
enteritis caused by day to provide, depending upon severity of
Escherichia coli and coccidiosis challenge, up to 200 mg of monensin per
bacterial pneumonia head per day. Feed for not more than 5 days, then
caused by Pasteurella continue to feed monensin Type C medicated feed
multocida susceptible alone. For use in dry feeds only. Not for use in
to chlortetracycline; liquid feed supplements. Do not allow horses or
and for the prevention other equines access to feed containing monensin.
and control of Ingestion of monensin by horses has been fatal.
coccidiosis due to Monensin medicated cattle and goat feeds are safe
Eimeria bovis and for use in cattle and goats only. Consumption by
Eimeria zuernii. unapproved species may result in toxic reactions.
Do not exceed the levels of monensin recommended in
the feeding directions, as reduced average daily
gains may result. If feed refusals containing
monensin are fed to other groups of cattle, the
concentration of monensin in the refusals and
amount of refusals fed should be taken into
consideration to prevent monensin overdosing. A
withdrawal period has not been established for this
product in pre-ruminating calves. Do not use in
calves to be processed for veal. Monensin as
provided by No. 058198, chlortetracycline by No.
069254 in Sec. 510.600(c) of this chapter.

* * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *

0
37. In Sec. 558.258, add paragraphs (e)(3)(iv)(A)(3) and (4) to read
as follows:

Sec. 558.258 Fenbendazole.

(e) * * *
(3) * * *
(iv) * * *
(A) * * *

[[Page 14905]]

----------------------------------------------------------------------------------------------------------------
Fenbendazole concentration Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------

* * * * * * *
(3) 750 mg/lb of protein Beef cattle: For the Feed free choice at a rate of 0.1 pound of 000061
block (to provide 5 mg/kg treatment and control of: block per 100 pounds of body weight per
body weight (2.27 mg/lb)). Lungworms: adult day for 3 days to deliver a total of 2.27
(Dictyocaulus viviparus); mg fenbendazole per pound of body weight.
Stomach worms: adult Cattle must not be slaughtered for human
brown stomach worms consumption within 16 days following last
(Ostertagia ostertagi), treatment with this drug product. Not for
adult and fourth-stage use in female dairy cattle 20 months of
larvae barberpole worms age or older, including dry dairy cows.
(Haemonchus contortus), Use in these cattle may cause drug
fourth-stage larvae residues in milk and/or in calves born to
barberpole worms (H. these cows or heifers. Not for use in beef
placei), and adult and calves less than 2 months of age, dairy
fourth-stage larvae small calves, and veal calves. A withdrawal
stomach worms period has not been established for this
(Trichostrongylus axei); product in pre-ruminating calves.
Intestinal worms (adult
and fourth-stage larvae):
hookworms (Bunostomum
phlebotomum), thread-
necked intestinal worms
(Nematodirus
helvetianus), small
intestinal worms
(Cooperia punctata and C.
oncophora), bankrupt
worms (Trichostrongylus
colubriformis), and
nodular worms
(Oesophagostomum
radiatum).
(4) 750 mg/lb of molasses Beef cattle: For the Feed free choice at a rate of 0.1 pound of 000061
block (to provide 5 mg/kg treatment and control of: block per 100 pounds of body weight per
body weight (2.27 mg/lb)). Lungworms: adult day for 3 days to deliver a total of 2.27
(Dictyocaulus viviparus); mg fenbendazole per pound of body weight.
Stomach worms: adult Cattle must not be slaughtered for human
brown stomach worms consumption within 11 days following last
(Ostertagia ostertagi), treatment with this drug product. Not for
adult and fourth-stage use in female dairy cattle 20 months of
larvae barberpole worms age or older, including dry dairy cows.
(Haemonchus contortus), Use in these cattle may cause drug
fourth-stage larvae residues in milk and/or in calves born to
barberpole worms (H. these cows or heifers. Not for use in beef
placei), and adult and calves less than 2 months of age, dairy
fourth-stage larvae small calves, and veal calves. A withdrawal
stomach worms period has not been established for this
(Trichostrongylus axei); product in pre-ruminating calves.
Intestinal worms (adult
and fourth-stage larvae):
hookworms (Bunostomum
phlebotomum), thread-
necked intestinal worms
(Nematodirus
helvetianus), small
intestinal worms
(Cooperia punctata and C.
oncophora), bankrupt
worms (Trichostrongylus
colubriformis), and
nodular worms
(Oesophagostomum
radiatum).
----------------------------------------------------------------------------------------------------------------

* * * * *

0
38. In Sec. 558.330, revise paragraphs (a) and (d)(1)(ii) and (iii) to
read as follows:

Sec. 558.330 Lubabegron.

(a) Specifications. Each pound of Type A medicated article contains
4.54 grams (10 grams per kilogram) or 22.7 grams (50 grams per
kilogram) of lubabegron as lubabegron fumarate.
* * * * *
(d) * * *
(1) * * *

* * * * * * *
(ii) 1.25 to 4.54................ Monensin, 5 to 40.......... Beef steers and heifers Feed continuously as the sole ration to provide 13 016592
fed in confinement for to 90 mg lubabegron/head/day and 50 to 480 mg 058198
slaughter: For monensin/head/day during the last 14 to 91 days on
reduction of ammonia feed. No additional improvement in feed efficiency
gas emissions per pound has been shown from feeding monensin at levels
of live weight and hot greater than 30 g/ton (360 mg monensin/head/day). A
carcass weight and for decrease in dry matter intake may be noticed in
improved feed some animals receiving lubabegron. Lubabegron has
efficiency during the not been approved for use in breeding animals
last 14 to 91 days on because safety and effectiveness have not been
feed. evaluated in these animals. Do not allow horses or
other equines access to feed containing lubabegron
and monensin. Ingestion of monensin by horses has
been fatal. Monensin medicated cattle and goat
feeds are safe for use in cattle and goats only.
Consumption by unapproved species may result in
toxic reactions. Feeding undiluted or mixing errors
resulting in high concentrations of monensin has
been fatal to cattle and could be fatal to goats.
Must be thoroughly mixed in feeds before use. Do
not exceed the levels of monensin recommended in
the feeding directions, as reduced average daily
gains may result. If feed refusals containing
monensin are fed to other groups of cattle, the
concentration of monensin in the refusals and
amount of refusals fed should be taken into
consideration to prevent monensin overdosing. A
withdrawal period has not been established for this
product for preruminating calves. Do not use in
calves to be processed for veal.

[[Page 14906]]

(iii) 1.25 to 4.54............... Monensin, 10 to 40......... Beef steers and heifers Feed continuously as the sole ration to provide 13 016592
fed in confinement for to 90 mg lubabegron/head/day and 0.14 to 0.42 mg 058198
slaughter: For monensin/lb body weight per day, depending upon
reduction of ammonia severity of coccidiosis challenge, during the last
gas emissions per pound 14 to 91 days on feed. A decrease in dry matter
of live weight and hot intake may be noticed in some animals receiving
carcass weight; and for lubabegron. Lubabegron has not been approved for
prevention and control use in breeding animals because safety and
of coccidiosis due to effectiveness have not been evaluated in these
Eimeria bovis and E. animals. Do not allow horses or other equines
zuernii during the last access to feed containing lubabegron and monensin.
14 to 91 days on feed. Ingestion of monensin by horses has been fatal.
Monensin medicated cattle and goat feeds are safe
for use in cattle and goats only. Consumption by
unapproved species may result in toxic reactions.
Feeding undiluted or mixing errors resulting in
high concentrations of monensin has been fatal to
cattle and could be fatal to goats. Must be
thoroughly mixed in feeds before use. Do not exceed
the levels of monensin recommended in the feeding
directions, as reduced average daily gains may
result. If feed refusals containing monensin are
fed to other groups of cattle, the concentration of
monensin in the refusals and amount of refusals fed
should be taken into consideration to prevent
monensin overdosing. A withdrawal period has not
been established for this product for preruminating
calves. Do not use in calves to be processed for
veal.

* * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------

0
39. In Sec. 558.355, redesignate paragraphs (f)(1)(iv), (v), and (vi)
through (x) as paragraphs (f)(1)(vi), (vii), and (x) through (xiv),
respectively, and add new paragraphs (f)(1)(iv), (v), (viii), and (ix)
to read as follows:

Sec. 558.355 Monensin.

* * * * *
(f) * * *
(1) * * *

* * * * * * *
(iv) 90 to 110................... Bacitracin Broiler chickens: As an Feed as the sole ration throughout the feeding 069254
methylenedisalicylate, 4 aid in the prevention period. Do not feed to laying chickens. Do not feed
to 50. of coccidiosis caused to chickens over 16 weeks of age. Do not allow
by Eimeria necatrix, E. horses, other equines, mature turkeys, or guinea
tenella, E. acervulina, fowl access to feed containing monensin. Ingestion
E. brunetti, E. mivati, of monensin by horses and guinea fowl has been
and E. maxima, and for fatal. In the absence of coccidiosis in broiler
increased rate of chickens, the use of monensin with no withdrawal
weight gain and period may limit feed intake resulting in reduced
improved feed weight gain. Not for broiler breeder replacement
efficiency. chickens. Monensin provided by No. 058198,
bacitracin methylenedisalicylate provided by No.
069254 in Sec. 510.600(c) of this chapter.
(v) 90 to 110.................... Bacitracin Laying hen replacement Feed as the sole ration throughout the feeding 069254
methylenedisalicylate, 4 chickens and layer period. Do not feed to laying chickens. Do not feed
to 50. breeder replacement to chickens over 16 weeks of age. Do not allow
chickens: As an aid in horses, other equines, mature turkeys, or guinea
the prevention of fowl access to feed containing monensin. Ingestion
coccidiosis caused by of monensin by horses and guinea fowl has been
Eimeria necatrix, E. fatal. Not for broiler breeder replacement
tenella, E. acervulina, chickens. Monensin provided by No. 058198,
E. brunetti, E. mivati, bacitracin methylenedisalicylate provided by No.
and E. maxima, and for 069254 in Sec. 510.600(c) of this chapter.
increased rate of
weight gain and
improved feed
efficiency.

* * * * * * *
(viii) 90 to 110................. Bacitracin Broiler chickens: As an Feed as the sole ration for 28 to 35 days, starting 069254
methylenedisalicylate, 50. aid in the prevention from the time chicks are placed for brooding. Do
of coccidiosis caused not feed to laying chickens. Do not feed to
by Eimeria necatrix, E. chickens over 16 weeks of age. Do not allow horses,
tenella, E. acervulina, other equines, mature turkeys, or guinea fowl
E. brunetti, E. mivati, access to feed containing monensin. Ingestion of
and E. maxima, and for monensin by horses and guinea fowl has been fatal.
the prevention of In the absence of coccidiosis in broiler chickens,
mortality caused by the use of monensin with no withdrawal period may
necrotic enteritis limit feed intake resulting in reduced weight gain.
associated with Not for broiler breeder replacement chickens.
Clostridium perfringens. Monensin provided by No. 058198, bacitracin
methylenedisalicylate provided by No. 069254 in
Sec. 510.600(c) of this chapter.
(ix) 90 to 110................... Bacitracin Laying hen replacement Feed as the sole ration for 28 to 35 days, starting 069254
methylenedisalicylate, 50. chickens and layer from the time chicks are placed for brooding. Do
breeder replacement not feed to laying chickens. Do not feed to
chickens: As an aid in chickens over 16 weeks of age. Do not allow horses,
the prevention of other equines, mature turkeys, or guinea fowl
coccidiosis caused by access to feed containing monensin. Ingestion of
Eimeria necatrix, E. monensin by horses and guinea fowl has been fatal.
tenella, E. acervulina, Not for broiler breeder replacement chickens.
E. brunetti, E. mivati, Monensin provided by No. 058198, bacitracin
and E. maxima, and for methylenedisalicylate provided by No. 069254 in
the prevention of Sec. 510.600(c) of this chapter.
mortality caused by
necrotic enteritis
associated with
Clostridium perfringens.

[[Page 14907]]

* * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *

0
40. In Sec. 558.364, add paragraph (d)(2)(ii) to read as follows:

Sec. 558.364 Naracin and nicarbazin.

* * * * *
(d) * * *
(2) * * *
(ii) Virginiamycin as in Sec. 558.635.

0
41. In Sec. 558.366, revise paragraph (d)(1)(i) and add paragraph
(d)(2) to read as follows:

Sec. 558.366 Nicarbazin.

* * * * *
(d) * * *
(1) * * *

--------------------------------------------------------------------------------------------------------------------------------------------------------
Nicarbazin in grams per ton Combination in grams/ton Indications for use Limitations Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
(i) 90.8 to 181.6................ ........................... Chickens: As an aid in Feed continuously as sole ration from time chicks 066104
preventing outbreaks of are placed on litter until past the time when
cecal (Eimeria tenella) coccidiosis is ordinarily a hazard. Do not use as a
and intestinal (E. treatment for outbreaks of coccidiosis. Do not use
acervulina, E. maxima, in flushing mashes. Do not feed to laying hens.
E. necatrix, and E. Withdraw 4 days before slaughter for use levels at
brunetti) coccidiosis. or below 113.5 g/ton. Withdraw 5 days before
slaughter for use levels above 113.5 g/ton.

* * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------

(2) Nicarbazin single-ingredient Type A medicated articles may also
be used in combination with:
(i) [Reserved]
(ii) Virginiamycin as in Sec. 558.635.

0
42. In Sec. 558.450:
0
a. Revise paragraph (e)(3)(i);
0
b. Redesignate paragraph (e)(3)(ii) as paragraph (e)(3)(iii); and
0
c. Add new paragraph (e)(3)(ii).
The revision and addition read as follows:

Sec. 558.450 Oxytetracycline.

* * * * *
(e) * * *
(3) * * *

----------------------------------------------------------------------------------------------------------------
Combination in grams/
Oxytetracycline amount ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 10 mg/lb of body weight ..................... Swine: For treatment of Feed continuously 066104
daily. bacterial enteritis caused for 7 to 14 days. 069254
by E. coli and Salmonella
choleraesuis susceptible to
oxytetracycline and
treatment of bacterial
pneumonia caused by
Pasteurella multocida
susceptible to
oxytetracycline.
(ii) 10 mg/lb of body weight ..................... Breeding swine: For control Feed continuously 066104
daily. and treatment of for not more than 069254
leptospirosis (reducing the 14 days.
incidence of abortion and
shedding of leptospirae)
caused by Leptospira pomona
susceptible to
oxytetracycline.

* * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

0
43. In Sec. 558.625, revise paragraphs (e)(2)(vii) and (viii) to read
as follows:

Sec. 558.625 Tylosin.

* * * * *
(e) * * *
(2) * * *

* * * * * * *
(vii) 8 to 10................... Monensin, 5 to 40 plus Beef steers and Feed continuously as sole ration to provide 13 to 016592
lubabegron fumarate, 1.25 to heifers fed in 90 mg lubabegron/head/day, 50 to 480 mg monensin/ 058198
4.54. confinement for head/day, and 60 to 90 mg tylosin/head/day during
slaughter: For the last 14 to 91 days on feed. No additional
reduction of ammonia improvement in feed efficiency has been shown
gas emissions per from feeding monensin at levels greater than 30 g/
pound of live weight ton (360 mg monensin/head/day). A decrease in dry
and hot carcass matter intake may be noticed in some animals
weight; for reduction receiving lubabegron. Lubabegron has not been
of incidence of liver approved for use in breeding animals because
abscesses associated safety and effectiveness have not been evaluated
with Fusobacterium in these animals. Do not allow horses or other
necrophorum and equines access to feed containing lubabegron and
Arcanobacterium monensin. Ingestion of monensin by horses has
pyogenes, and for been fatal. Monensin medicated cattle and goat
improved feed feeds are safe for use in cattle and goats only.
efficiency during the Consumption by unapproved species may result in
last 14 to 91 days on toxic reactions. Feeding undiluted or mixing
feed. errors resulting in high concentrations of
monensin has been fatal to cattle and could be
fatal to goats. Must be thoroughly mixed in feeds
before use. Do not exceed the levels of monensin
recommended in the feeding directions, as reduced
average daily gains may result. If feed refusals
containing monensin are fed to other groups of
cattle, the concentration of monensin in the
refusals and amount of refusals fed should be
taken into consideration to prevent monensin
overdosing. A withdrawal period has not been
established for this product for preruminating
calves. Do not use in calves to be processed for
veal.

[[Page 14908]]

(viii) 8 to 10.................. Monensin, 10 to 40 plus Beef steers and Feed continuously as sole ration to provide 13 to 016592
lubabegron fumarate, 1.25 to heifers fed in 90 mg lubabegron/head/day, 0.14 to 0.42 mg 058198
4.54. confinement for monensin/lb body weight per day, depending upon
slaughter: For severity of coccidiosis challenge, up to 480 mg/
reduction of ammonia head/day, and 60 to 90 mg tylosin/head/day during
gas emissions per the last 14 to 91 days on feed. A decrease in dry
pound of live weight matter intake may be noticed in some animals
and hot carcass receiving lubabegron. Lubabegron has not been
weight, for reduction approved for use in breeding animals because
of incidence of liver safety and effectiveness have not been evaluated
abscesses associated in these animals. Do not allow horses or other
with Fusobacterium equines access to feed containing lubabegron and
necrophorum and monensin. Ingestion of monensin by horses has
Arcanobacterium been fatal. Monensin medicated cattle and goat
pyogenes, and for feeds are safe for use in cattle and goats only.
prevention and Consumption by unapproved species may result in
control of toxic reactions. Feeding undiluted or mixing
coccidiosis due to errors resulting in high concentrations of
Eimeria bovis and E. monensin has been fatal to cattle and could be
zuernii during the fatal to goats. Must be thoroughly mixed in feeds
last 14 to 91 days on before use. Do not exceed the levels of monensin
feed. recommended in the feeding directions, as reduced
average daily gains may result. If feed refusals
containing monensin are fed to other groups of
cattle, the concentration of monensin in the
refusals and amount of refusals fed should be
taken into consideration to prevent monensin
overdosing. A withdrawal period has not been
established for this product for preruminating
calves. Do not use in calves to be processed for
veal.

* * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------

0
44. In Sec. 558.635, redesignate paragraphs (e)(1)(vii) through (ix)
as paragraphs (e)(1)(ix) through (xi), respectively, and add new
paragraphs (e)(1)(vii) and (viii) to read as follows:

Sec. 558.635 Virginiamycin.

* * * * *
(e) * * *
(1) * * *

----------------------------------------------------------------------------------------------------------------
Virginiamycin grams/ton Combination in grams/ton Indications for use Limitations Sponsors
----------------------------------------------------------------------------------------------------------------

* * * * * * *
(vii) 20..................... Narasin, 54 to 90........... Broiler chickens: Feed as the sole 066104
For prevention of ration for broiler
necrotic enteritis chickens. Do not
caused by feed to chickens
Clostridium producing eggs for
perfringens human consumption.
susceptible to Do not allow adult
virginiamycin and turkeys, horses,
for the prevention or other equines
of coccidiosis access to narasin
caused by Eimeria formulations.
necatrix, E. Ingestion of
tenella, E. narasin by these
acervulina, E. species has been
brunetti, E. fatal. Naracin as
mivati, and E. provided by No.
maxima. 066104 in Sec.
510.600(c) of this
chapter.
(viii) 20.................... Narasin, 27 to 54 plus Broiler chickens: Feed as the sole 066104
nicarbazin, 27 to 54. For prevention of ration for broiler
necrotic enteritis chickens. Do not
caused by feed to chickens
Clostridium producing eggs for
perfringens human consumption.
susceptible to Nicarbazin
virginiamycin and medicated broilers
for the prevention may show reduced
of coccidiosis heat tolerance if
caused by Eimeria exposed to high
necatrix, E. temperature and
tenella, E. high humidity.
acervulina, E. Provide adequate
brunetti, E. drinking water and
mivati, and E. ventilation during
maxima. these periods. Do
not allow adult
turkeys, horses,
or other equines
access to narasin
formulations.
Ingestion of
narasin by these
species has been
fatal. Naracin as
provided by No.
066104 in Sec.
510.600(c) of this
chapter.

* * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

Dated: February 15, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-03649 Filed 3-9-23; 8:45 am]
BILLING CODE 4164-01-P

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