Rule2023-17454
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
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Published
August 16, 2023
Effective
August 16, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and conditionally approved new animal drug applications (cNADAs) during April, May, and June 2023. 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 their accuracy and readability.
Full Text
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<title>Federal Register, Volume 88 Issue 157 (Wednesday, August 16, 2023)</title>
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[Federal Register Volume 88, Number 157 (Wednesday, August 16, 2023)]
[Rules and Regulations]
[Pages 55559-55571]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-17454]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 500, 510, 516, 520, 522, 524, 526, 529, 556 and 558
[Docket No. FDA-2023-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications;
Withdrawal of Approval of New Animal Drug Applications, Change of
Sponsor, Change of Sponsor Address
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendments.
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SUMMARY: The Food and Drug Administration (FDA or we) is amending the
animal drug regulations to reflect application-related actions for new
animal drug applications (NADAs), abbreviated new animal drug
applications (ANADAs), and conditionally approved new animal drug
applications (cNADAs) during April, May, and June 2023. 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 their
accuracy and readability.
DATES: This rule is effective August 16, 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#d7b0b2b8a5b0b2f9bfb6beb5b2bb97b1b3b6f9bfbfa4f9b0b8a1"><span class="__cf_email__" data-cfemail="5e393b312c393b70363f373c3b321e383a3f7036362d70393128">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Approvals
FDA is amending the animal drug regulations to reflect approval
actions for NADAs, ANADAs, and cNADAs during April, May, and June 2023,
as listed in table 1. In addition, FDA is informing the public of the
availability, where applicable, of documentation of environmental
review required under the National Environmental Policy Act (NEPA) and,
for actions requiring review of safety or effectiveness data, summaries
of the basis of approval (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 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>.
Table 1--Original and Supplemental NADAs, ANADAs, and cNADAs Approved During April, May, and June 2023 Requiring Evidence of Safety and/or Effectiveness
--------------------------------------------------------------------------------------------------------------------------------------------------------
21 CFR
Approval date File No. Sponsor Product name Effect of the action Public documents section
--------------------------------------------------------------------------------------------------------------------------------------------------------
April 5, 2023................... 200-612 Bimeda Animal Health BIMASONE Original approval for FOI Summary 522.960c
Ltd., 1B The Herbert (flumethasone) the treatment of
Building, The Park, Injectable Solution. various inflammatory
Carrickmines, Dublin conditions in horses,
18, Ireland. dogs, and cats as a
generic copy of NADA
030-414.
April 10, 2023.................. 038-439 Phibro Animal Health TERRAMYCIN for Fish Supplemental approval FOI Summary 558.450
Corp., GlenPointe (oxytetracycline) for the control of
Centre East, 3d Floor, Type A Medicated mortality due to
300 Frank W. Burr Article. columnaris disease in
Blvd., Suite 21, catfish and
Teaneck, NJ 07666. freshwater-reared
salmonids.
[[Page 55560]]
April 20, 2023.................. 141-570 Boehringer Ingelheim NEXGARD COMBO Original approval for FOI Summary 524.838
Animal Health USA, (esafoxolaner, prevention of
Inc., 3239 Satellite eprinomectin, and heartworm disease;
Blvd., Duluth, GA praziquantel) Topical for treatment and
30096. Solution. prevention of flea
infestations,
treatment and control
of tick infestations,
roundworms,
hookworms, and
tapeworms in cats and
kittens.
May 1, 2023..................... 141-571 Elanco US Inc., 2500 VARENZIN-CA1 Conditional approval FOI Summary 516.1449
Innovation Way, (molidustat oral for the control of
Greenfield, IN 46140. suspension). nonregenerative
anemia associated
with chronic kidney
disease (CKD) in cats.
May 5, 2023..................... 141-562 Zoetis Inc., 333 LIBRELA (bedinvetmab Original approval for FOI Summary 522.158
Portage St., injection) Injectable the control of pain
Kalamazoo, MI 49007. Solution. associated with
osteoarthritis in
dogs.
May 10, 2023.................... 200-748 Huvepharma EOOD, 5th PENNCHLOR Original approval for FOI Summary 558.128
Floor, 3A Nikolay (chlortetracycline multiple indications
Haytov Str., 1113 Type A medicated in beef calves 2
Sofia, Bulgaria. article) and MONOVET months of age and
(monensin Type A older and in growing
medicated article) to beef steers and
be used in the heifers fed in
manufacture of Type B confinement for
and Type C medicated slaughter as a
feeds. generic copy of NADA
141-564.
May 25, 2023.................... 200-750 Cronus Pharma DORAJECT (doramectin Original approval for FOI Summary 522.770
Specialities India injection) Injectable treatment and control
Private Ltd., Sy No-99/ Solution. of internal and
1, M/s GMR Hyderabad external parasites of
Aviation SEZ Ltd., cattle and swine as a
Mamidipalli Village, generic copy of NADA
Shamshabad Mandal, 141-061.
Ranga Reddy,
Hyderabad, Telangana,
501218, India.
June 9, 2023.................... 141-555 Zoetis Inc., 333 APOQUEL CHEWABLE Original approval for FOI Summary 520.1604
Portage St., (oclacitinib tablet) control of pruritus
Kalamazoo, MI 49007. Tablets. associated with
allergic dermatitis
and control of atopic
dermatitis in dogs at
least 12 months of
age.
June 21, 2023................... 141-406 Boehringer Ingelheim NEXGARD (afoxolaner) Supplemental approval FOI Summary 520.43
Animal Health USA, Chewable Tablet. for Asian longhorned
Inc., 3239 Satellite tick.
Blvd., Duluth, GA
30096.
June 22, 2023................... 200-751 Pegasus Laboratories, Firocoxib Chewable Original approval for FOI Summary 520.928
Inc., 8809 Ely Rd., Tablets for Dogs the control of pain
Pensacola, FL 32514. (firocoxib). and inflammation
associated with
osteoarthritis and
for the control of
postoperative pain
and inflammation
associated with soft-
tissue and orthopedic
surgery in dogs as a
generic copy of NADA
141-230.
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 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 April, May, and June 2023 To Change the Marketing Status of
Antimicrobial Animal Drug Products From OTC to Rx
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21 CFR
Approval date File No. Sponsor Product name section
----------------------------------------------------------------------------------------------------------------
April 14, 2023.................... 200-147 Huvepharma EOOD, 5th GENTAPOULT (gentamicin) 522.1044
Floor, 3A Nikolay Haytov Injectable Solution.
Str., 1113 Sofia,
Bulgaria.
April 24, 2023.................... 065-481 Cronus Pharma Chlortetracycline 520.443
Specialities India Pneumonia/Calf Scour
Private Ltd., Sy No-99/ Bolus.
1, M/s GMR Hyderabad
Aviation SEZ Ltd.,
Mamidipalli Village,
Shamshabad Mandal, Ranga
Reddy, Hyderabad,
Telangana, 501218, India.
April 24, 2023.................... 200-128 Huvepharma EOOD, 5th AGRIMYCIN 200 522.1660a
Floor, 3A Nikolay Haytov (oxytetracycline HCl)
Str., 1113 Sofia, Injectable Solution.
Bulgaria.
[[Page 55561]]
April 28, 2023.................... 108-963 Cronus Pharma MEDAMYCIN 100 522.1662
Specialities India (oxytetracycline HCl)
Private Ltd., Sy No-99/ Injectable Solution.
1, M/s GMR Hyderabad
Aviation SEZ Ltd.,
Mamidipalli Village,
Shamshabad Mandal, Ranga
Reddy, Hyderabad,
Telangana, 501218, India.
April 28, 2023.................... 097-452 Do....................... OXYJECT 100 522.1662
(oxytetracycline HCl)
Injectable Solution.
April 28, 2023.................... 047-278 Do....................... OXY-TET 50 522.1662
(oxytetracycline HCl)
Injectable Solution.
April 28, 2023.................... 045-143 Do....................... OXYJECT 50 522.1662
(oxytetracycline HCl)
Injectable Solution.
May 15, 2023...................... 140-270 Huvepharma EOOD, 5th SULFATECH SR 520.2260b
Floor, 3A Nikolay Haytov (sulfamethazine
Str., 1113 Sofia, sustained release bolus).
Bulgaria.
May 15, 2023...................... 200-306 Norbrook Laboratories Oxytetracycline Injection 522.1660a
Ltd., Carnbane 200.
Industrial Estate,
Newry, County Down, BT35
6QQ, United Kingdom.
May 16, 2023...................... 120-615 Bimeda Animal Health SUSTAIN III 520.2260b
Ltd., 1B The Herbert (sulfamethazine) Calf
Building, The Park, Bolus.
Carrickmines, Dublin 18,
Ireland.
May 17, 2023...................... 200-224 Elanco US Inc., 2500 COMPONENT T-S with TYLAN; 522.2476
Innovation Way, COMPONENT T-H with TYLAN
Greenfield, IN 46140. (trenbolone acetate and
tylosin tartrate)
Implants.
May 19, 2023...................... 200-364 Bimeda Animal Health SPECTOGARD Scour-Chek 520.2123c
Ltd., 1B The Herbert (spectinomycin
Building, The Park, dihydrochloride
Carrickmines, Dublin 18, pentahydrate) Oral
Ireland. Solution.
May 22, 2023...................... 035-455 Do....................... ERYTHRO-36 Dry 526.820
(erythromycin) IMM
Infusion.
May 22, 2023...................... 200-452 Norbrook Laboratories OXYTET 100 522.1662
Ltd., Carnbane (oxytetracycline HCl)
Industrial Estate, Injectable Solution.
Newry, County Down, BT35
6QQ, United Kingdom.
May 26, 2023...................... 200-068 Huvepharma EOOD, 5th Oxytetracycline 522.1662
Floor, 3A Nikolay Haytov Hydrochloride Injection,
Str., 1113 Sofia, 100 mg/mL.
Bulgaria.
May 30, 2023...................... 055-097 HQ Specialty Pharma DRY-MAST 526.1697
Corp., 120 Rte. 17 (dihydrostreptomycin
North, Suite 130, sulfate and penicillin G
Paramus, NJ 07652. procaine).
May 31, 2023...................... 200-008 Boehringer Ingelheim BIO-MYCIN 200 522.1660a
Animal Health USA, Inc., (oxytetracycline HCl)
3239 Satellite Blvd., Injectable Solution.
Duluth, GA 30096.
June 2, 2023...................... 065-383 Bimeda Animal Health FORMULA A-34; UNI BIOTIC 526.1696
Ltd., 1B The Herbert (penicillin G procaine)
Building, The Park, 4 DOSE.
Carrickmines, Dublin 18,
Ireland.
June 2, 2023...................... 200-537 Do....................... TETROXY-LA 522.1660a
(oxytetracycline HCl)
Injectable Solution.
June 7, 2023...................... 200-154 Pharmgate Inc., 1800 Sir PENNOX 200 522.1660a
Tyler Dr., Wilmington, (oxytetracycline HCl)
NC 28405. Injectable Solution.
June 8, 2023...................... 200-123 Huvepharma EOOD, 5th MAXIM-200 Injection 522.1660a
Floor, 3A Nikolay Haytov (oxytetracycline HCl).
Str., 1113 Sofia,
Bulgaria.
June 9, 2023...................... 200-117 Bimeda Animal Health OXYSHOT LA 522.1660a
Ltd., 1B The Herbert (oxytetracycline HCl)
Building, The Park, Injectable Solution.
Carrickmines, Dublin 18,
Ireland.
June 15, 2023..................... 135-906 Elanco US Inc., 2500 COMPONENT E-H with TYLAN 522.2343
Innovation Way, (testosterone propionate
Greenfield, IN 46140. and estradiol benzoate
with tylosin tartrate)
Implant.
June 22, 2023..................... 200-221 Do....................... COMPONENT TE-G with 522.2477
TYLAN; COMPONENT TE-ID
with TYLAN; COMPONENT TE-
IS with TYLAN; COMPONENT
TE-S with TYLAN
(trenbolone acetate,
estradiol, and tylosin
tartrate) Implants.
June 30, 2023..................... 200-346 Do....................... COMPONENT TE-200 with 522.2477
TYLAN; COMPONENT TE-H
with TYLAN; COMPONENT TE-
IH with TYLAN;
(trenbolone acetate,
estradiol, and tylosin
tartrate) Implants.
June 30, 2023..................... 110-315 Do....................... COMPONENT E-C with TYLAN; 522.1940
COMPONENT E-S with TYLAN
(progesterone, estradiol
benzoate, and tylosin
tartrate) Implants.
----------------------------------------------------------------------------------------------------------------
II. Withdrawals of Approval
The sponsors of the following files have requested that FDA
withdraw approval of the applications listed in table 3 because the
products are no longer manufactured or marketed. As provided in the
regulatory text of this document, the cited animal drug regulations are
amended to reflect these actions.
Table 3--Applications for Which Approval Was Voluntarily Withdrawn
During April, May, and June 2023
------------------------------------------------------------------------
21 CFR
File No. Sponsor Product name section
------------------------------------------------------------------------
140-954.................. Intervet, Inc., Type C 558.325
2 Giralda medicated
Farms, swine feed
Madison, NJ containing
07940. fenbendazole
and lincomycin.
141-002.................. Boehringer OXY 1000 520.1660c
Ingelheim (oxytetracycli
Animal Health ne HCl) Calf
USA, Inc., Bolus; OXY 500
3239 Satellite (oxytetracycli
Blvd., Duluth, ne HCl) Calf
GA 30096. Bolus.
200-191.................. Med-Pharmex, GENTASOL 529.1044b
Inc., 2727 (gentamicin
Thompson Creek sulfate
Rd., Pomona, solution).
CA 91767-1861.
------------------------------------------------------------------------
[[Page 55562]]
III. Change of Sponsor
Elanco US, Inc., 2500 Innovation Way, Greenfield, IN 46140 has
informed FDA that it has transferred ownership of, and all rights and
interest in, NADA 135-468 for CARBIGRAN 25 (nicarbazin) Type A
Medicated Article to Pharmgate Inc., 1800 Sir Tyler Dr., Wilmington, NC
28405. As provided in the regulatory text of this document, 21 CFR
558.366 is amended to reflect this action.
IV. Change of Sponsor Address
Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940 has informed FDA
that it has changed its address to 126 E. Lincoln Ave., Rahway, NJ
07065. As provided in the regulatory text of this document, the tabular
listings in 21 CFR 510.600(c) are amended to reflect this action.
V. Technical Amendments
FDA is making the following amendments to improve the accuracy of
the animal drug regulations.
<bullet> 21 CFR 500.1410 and 522.1660a are amended to reflect the
use of N-methyl-2-pyrrolidone as an excipient in a formulation of
oxytetracycline injectable solution.
<bullet> 21 CFR 520.1484 is being revised to include use of
neomycin administered in drinking water of turkeys.
<bullet> 21 CFR 520.1660a is being redesignated as 21 CFR 520.1664
to reflect the drug as a fixed-ratio combination of oxytetracycline and
carbomycin.
<bullet> 21 CFR 520.1660b is being revised to reflect the format
and content of a prescription drug.
<bullet> 21 CFR 520.2220b is amended to reflect revised conditions
of use for sulfadimethoxine oral suspension in dogs and cats.
<bullet> 21 CFR 520.2220c is amended to reflect revised conditions
of use for sulfadimethoxine tablets in dogs and cats.
<bullet> 21 CFR 520.2260b is amended to reflect current sponsors of
sulfamethazine sustained-release boluses for use in cattle.
<bullet> 21 CFR 522.2680 is amended to reflect revised conditions
of use for zeranol implants in beef cattle.
<bullet> 21 CFR 529.1044a is amended to reflect sponsors of
approved applications for use of gentamicin solution for uterine
infusion in mares.
<bullet> 21 CFR 556.110 and 556.500 are being revised to reflect
redesignation of a combination drug containing oxytetracycline and
carbomycin used in the drinking water of chickens.
<bullet> 21 CFR 558.68 is being revised to reflect approved feeding
instructions for avilamycin and monensin two-way, combination drug Type
C medicated chicken feed.
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 500
Animal drugs, Animal feeds, Cancer, Labeling, Packaging and
containers, Polychlorinated biphenyls (PCBs).
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Part 516
Administrative practice and procedure, Animal drugs, Confidential
business information, Reporting and recordkeeping requirements.
21 CFR Parts 520, 522, 524, 526, and 529
Animal drugs.
21 CFR Part 556
Animal drugs, Dairy products, Foods, Meat and meat products.
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
500, 510, 516, 520, 522, 524, 526, 529, 556, and 558 are amended as
follows:
PART 500--GENERAL
0
1. The authority citation for part 500 continues to read as follows:
Authority: 21 U.S.C. 321, 331, 342, 343, 348, 351, 352, 353,
360b, 371, 379e.
0
2. In Sec. 500.1410, revise paragraph (c) to read as follows:
Sec. 500.1410 N-methyl-2-pyrrolidone.
* * * * *
(c) Related conditions of use. See Sec. Sec. 522.814, 522.955, and
522.1660a of this chapter.
PART 510--NEW ANIMAL DRUGS
0
3. 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
4. In Sec. 510.600, in the table in paragraph (c)(1), revise the entry
for ``Intervet, Inc.'' and in the table in paragraph (c)(2), revise the
entry for ``000061'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
[[Page 55563]]
------------------------------------------------------------------------
Firm name and address Drug labeler code
------------------------------------------------------------------------
* * * * * * *
Intervet, Inc., 126 E Lincoln Ave., Rahway, NJ 000061
07065............................................
* * * * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * * * *
000061...................... Intervet, Inc., 126 E Lincoln Ave.,
Rahway, NJ 07065
* * * * * * *
------------------------------------------------------------------------
PART 516--NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
0
5. The authority citation for part 516 continues to read as follows:
Authority: 21 U.S.C. 360ccc-1, 360ccc-2, 371.
0
6. Add Sec. 516.1449 to read as follows:
Sec. 516.1449 Molidustat oral suspension.
(a) Specifications. Each milliliter (mL) of suspension contains 25
milligrams (mg) molidustat sodium.
(b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. Administer orally at a dosage of
5 mg/kg of body weight (2.3 mg/lb) daily for up to 28 consecutive days.
(2) Indications for use. For the control of nonregenerative anemia
associated with chronic kidney disease in cats.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian. It is a violation of Federal law
to use this product other than as directed in the labeling.
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
7. The authority citation for part 520 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
8. In Sec. 520.43, revise paragraphs (c)(1) and (2) to read as
follows:
Sec. 520.43 Afoxolaner.
* * * * *
(c) * * *
(1) Amount. Administer orally once a month at a minimum dosage of
1.14 mg/pound (2.5 mg/kilogram).
(2) Indications for use. Kills adult fleas and for the treatment
and prevention of flea infestations (Ctenocephalides felis); and the
treatment and control of Ixodes scapularis (black-legged tick),
Dermacentor variabilis (American dog tick), Amblyomma americanum (lone
star tick), Rhipicephalus sanguineus (brown dog tick), and
Haemaphysalis longicornis (longhorned tick) infestations in dogs and
puppies 8 weeks of age and older, weighing 4 pounds of body weight or
greater, for 1 month; and for the prevention of Borrelia burgdorferi
infections as a direct result of killing Ixodes scapularis vector
ticks.
* * * * *
0
9. In Sec. 520.443, revise paragraph (d)(1)(ii) to read as follows:
Sec. 520.443 Chlortetracycline tablets and boluses.
* * * * *
(d) * * *
(1) * * *
(ii) Limitations. Administer bolus directly by mouth or crush and
dissolve in milk or water for drenching or bucket feeding. Do not use
for more than 5 days. Do not administer within 24 hours of slaughter.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.
* * * * *
Sec. 520.928 [Amended]
0
10. In Sec. 520.928, in paragraph (b)(1), remove ``Nos. 000010 and
055529'' and add in its place ``Nos. 000010, 055246, and 055529''.
0
11. In Sec. 520.1484, revise paragraph (b)(3) and add paragraph (b)(4)
to read as follows:
Sec. 520.1484 Neomycin.
* * * * *
(b) * * *
(3) Nos. 016592, 054771, and 058005 for use of product described in
paragraph (a)(2) as in paragraph (e)(1) of this section.
(4) No. 054925 for use of product described in paragraph (a)(2) as
in paragraphs (e)(1) and (2) of this section.
* * * * *
Sec. 520.1604 [Amended]
0
12. In Sec. 520.1604, in paragraph (a), remove ``Each tablet
contains'' and add in its place ``Each tablet or chewable tablet
contains''.
Sec. 520.1660a [Redesignated as Sec. 520.1664]
0
13. Redesignate Sec. 520.1660a as Sec. 520.1664.
Sec. 520.1660a [Reserved]
0
14. Add reserved Sec. 520.1660a.
0
15. In Sec. 520.1660b, revise the section heading and paragraphs (a)
and (c) to read as follows:
Sec. 520.1660b Oxytetracycline capsules.
(a) Specifications. Each capsule contains 125 or 250 milligrams
(mg) oxytetracycline hydrochloride.
* * * * *
(c) Conditions of use in dogs and cats--(1) Amount. Administer
orally 25 to 50 mg per pound of body weight per day in divided doses at
12-hour intervals.
(2) Indications for use. For the treatment of bacterial pneumonia
caused by Brucella bronchiseptica, tonsilitis caused by Streptococcus
hemolyticus, bacterial enteritis caused by Escherichia coli, urinary
tract infections caused by Escherichia coli, and wound infections
caused by Staphylococcus aureus.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
16. In Sec. 520.1660c, revise the section heading and paragraphs (a),
(b), and (d) to read as follows:
[[Page 55564]]
Sec. 520.1660c Oxytetracycline tablets.
(a) Specifications. Each tablet contains 250 or 500 milligrams (mg)
oxytetracycline hydrochloride.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
* * * * *
(d) Conditions of use in beef and dairy cattle--(1) Amounts. 10 mg
per pound of body weight every 12 hours for treatment; 5 mg per pound
of body weight every 12 hours for control.
(2) Indications for use. For treatment and control of bacterial
enteritis caused by Salmonella typhimurium and Escherichia coli
(colibacillosis) and bacterial pneumonia (shipping fever complex,
pasteurellosis) caused by Pasteurella multocida.
(3) Limitations. 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
17. In Sec. 520.2220b, revise paragraphs (c)(1) and (2) to read as
follows:
Sec. 520.2220b Sulfadimethoxine suspension.
* * * * *
(c) * * *
(1) Amount. Administer orally 25 mg per pound of body weight,
followed by 12.5 mg per pound of body weight daily until the animal is
free of clinical signs for 48 hours.
(2) Indications for use. For the treatment of sulfadimethoxine-
susceptible bacterial infections in dogs and cats and enteritis
associated with coccidiosis in dogs.
* * * * *
0
18. In Sec. 520.2220c, revise paragraphs (d)(1) and (2) to read as
follows:
Sec. 520.2220c Sulfadimethoxine tablet.
* * * * *
(d) * * *
(1) Amount. Administer orally 25 mg per pound of body weight,
followed by 12.5 mg per pound of body weight daily until the animal is
free of clinical signs for 48 hours.
(2) Indications for use. For the treatment of sulfadimethoxine-
susceptible bacterial infections in dogs and cats and enteritis
associated with coccidiosis in dogs.
* * * * *
0
19. In Sec. 520.2260b, revise paragraphs (d)(2)(iii), (f)(2)(iii), and
(g)(2)(iii) and remove paragraph (h).
The revisions read as follows:
Sec. 520.2260b Sulfamethazine sustained-release boluses.
* * * * *
(d) * * *
(2) * * *
(iii) Limitations. Do not use in female dairy cattle 20 months of
age or older. Use of sulfamethazine in this class of cattle may cause
milk residues. Do not treat animals within 12 days of slaughter.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.
* * * * *
(f) * * *
(2) * * *
(iii) Limitations. For use in ruminating replacement calves only.
Do not slaughter animals for food for at least 12 days after the last
dose. Exceeding two consecutive doses may cause violative tissue
residue to remain beyond the withdrawal time. Do not use in calves
under 1 month of age or calves being fed an all milk diet. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.
(g) * * *
(2) * * *
(iii) Limitations. For use in beef cattle and nonlactating dairy
cattle only. Do not slaughter animals for food for at least 8 days
after the last dose. Do not use in lactating dairy cattle. Do not
administer more than two consecutive doses. 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
20. The authority citation for part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
21. Add Sec. 522.158 to read as follows:
Sec. 522.158 Bedinvetmab.
(a) Specifications. Each single-use vial contains 5, 10, 15, 20, or
30 milligrams (mg) bedinvetmab in an extractable volume of 1
milliliter.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. Administer 0.23 mg/pound (0.5
mg/kilogram) body weight monthly by subcutaneous injection.
(2) Indications for use. For the control of pain associated with
osteoarthritis in dogs.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
22. In Sec. 522.770, revise paragraphs (b), (d)(1)(iii), and
(d)(2)(iii) to read as follows:
Sec. 522.770 Doramectin.
* * * * *
(b) Sponsors. See Nos. 054771 and 069043 in Sec. 510.600(c) of
this chapter.
* * * * *
(d) * * *
(1) * * *
(iii) Limitations. Consult your veterinarian for assistance in the
diagnosis, treatment, and control of parasitism. Administer as a single
subcutaneous or intramuscular injection. Do not slaughter cattle for
human consumption within 35 days of treatment. Not for use in female
dairy cattle 20 months of age or older. A withdrawal period has not
been established for this product in preruminating calves. Do not use
in calves to be processed for veal.
(2) * * *
(iii) Limitations. Consult your veterinarian for assistance in the
diagnosis, treatment, and control of parasitism. Administer as a single
intramuscular injection. Do not slaughter swine for human consumption
within 24 days of treatment.
0
23. In Sec. 522.960c, revise paragraphs (b) and (c)(1)(iii) to read as
follows:
Sec. 522.960c Flumethasone solution.
* * * * *
(b) Sponsors. See Nos. 054771 and 061133 in Sec. 510.600(c) of
this chapter.
(c) * * *
(1) * * *
(iii) Limitations. Not for use in horses intended for human
consumption. Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
* * * * *
Sec. 522.1222 [Amended]
0
24. In Sec. 522.1222, in paragraph (b), remove ``063286,''.
0
25. In Sec. 522.1660a:
0
a. Revise paragraph (c);
0
b. Remove paragraph (d);
0
c. Redesignate paragraph (e) as paragraph (d); and
0
d. Revise newly redesignated paragraphs (d)(1)(ii) and (d)(2)(ii).
The revisions read as follows:
Sec. 522.1660a Oxytetracycline solution, 200 milligrams/milliliter.
* * * * *
(c) Related tolerances. See Sec. 556.500 of this chapter; and for
No. 061133, see also Sec. 500.1410 of this chapter.
(d) * * *
(1) * * *
(ii) Limitations. Discontinue treatment at least 28 days prior to
slaughter. Milk taken from animals during treatment and for 96 hours
after the last treatment
[[Page 55565]]
must not be used for food. Federal law restricts this drug to use by or
on the order of a licensed veterinarian.
(2) * * *
(ii) Limitations. Administer intramuscularly. Do not inject more
than 5 mL per site in adult swine. Discontinue treatment at least 28
days prior to slaughter. Federal law restricts this drug to use by or
on the order of a licensed veterinarian.
0
26. In Sec. 522.1662, revise paragraphs (b), (c), (g), (h), and (j) to
read as follows:
Sec. 522.1662 Oxytetracycline.
* * * * *
(b)(1) Specifications. Each milliliter (mL) of solution contains 50
milligrams (mg) oxytetracycline hydrochloride.
(2) Sponsor. See No. 069043 in Sec. 510.600(c) of this chapter.
(3) Conditions of use--(i) Amount. Administer 3 to 5 mg per pound
of body weight (mg/lb) per day by intramuscular injection.
Leptospirosis, severe foot-rot, and severe forms of the indicated
diseases should be treated with 5 mg/lb per day. Treatment should be
continued for 24 to 48 hours following remission of clinical signs of
disease, not to exceed 4 consecutive days. Not more than 10 mL should
be injected per injection site in adult cattle, and only 2 mL per
injection site in calves weighing 100 pounds or less.
(ii) Indications for use. Beef cattle, beef calves, nonlactating
dairy cattle, and dairy calves; for treatment of diseases due to
oxytetracycline-susceptible organisms as follows: Pneumonia and
shipping fever complex (Pasteurella spp., Haemophilus spp., Klebsiella
spp.), bacterial enteritis (scours) (Escherichia coli), foot-rot
(Spherophorus necrophorus), diphtheria (Spherophorus necrophorus),
wooden tongue (Actinobacillus lignieresii), leptospirosis (Leptospira
pomona), and wound infections and acute metritis caused by
Staphylococcus spp. and Streptococcus spp.
(iii) Limitations. Discontinue treatment at least 20 days prior to
slaughter. Federal law restricts this drug to use by or on the order of
a licensed veterinarian.
(c)(1) Specifications. Each milliliter (mL) of solution contains 50
or 100 milligrams (mg) oxytetracycline hydrochloride.
(2) Sponsor. See No. 069043 in Sec. 510.600(c) of this chapter.
(3) Conditions of use--(i) Beef cattle and nonlactating dairy
cattle--(A) Amount. Administer 3 to 5 mg per pound of body weight (mg/
lb) per day; 5 mg/lb per day for the treatment of anaplasmosis, severe
foot-rot, and severe cases of other indicated diseases. For 50-mg/mL
solution, administer intramuscularly or intravenously; for 100-mg/mL
solution, administer intramuscularly only. Treatment should be
continued for 24 to 48 hours following remission of clinical signs of
disease, not to exceed 4 consecutive days.
(B) Indications for use. For treatment of diseases due to
oxytetracycline-susceptible organisms as follows: Pneumonia and
shipping fever complex associated with Pasteurella spp., Haemophilus
spp., and Klebsiella 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, anaplasmosis caused by
Anaplasma marginale; and wound infections and acute metritis caused by
Staphylococcus spp. and Streptococcus spp.
(C) Limitations. Exceeding the highest recommended dose of 5 mg/lb,
administering at recommended levels for more than 4 consecutive days,
and/or exceeding 10 mL intramuscularly per injection site may result in
antibiotic residues beyond the withdrawal time. Discontinue treatment
at least 18 days prior to slaughter. Not for use in lactating dairy
cattle. Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
(ii) Swine--(A) Amount. Administer 3 to 5 mg/lb per day by
intramuscular injection. Sows: Administer 3 mg/lb by intramuscular
injection approximately 8 hours before farrowing or immediately after
completion of farrowing.
(B) Indications for use. For treatment of bacterial enteritis
(scours, colibacillosis) caused by Escherichia coli, pneumonia caused
by Pasteurella multocida, and leptospirosis caused by Leptospira
pomona. Sows: as an aid in control of infectious enteritis (baby pig
scours, colibacillosis) in suckling pigs caused by Escherichia coli.
(C) Limitations. Do not inject more than 5 mL per injection site.
Do not use for more than 4 consecutive days. Discontinue treatment at
least 26 days before slaughter. Federal law restricts this drug to use
by or on the order of a licensed veterinarian.
* * * * *
(g)(1) Specifications. Each milliliter (mL) of solution contains
100 milligrams (mg) oxytetracycline hydrochloride.
(2) Sponsor. See No. 069043 in Sec. 510.600(c) of this chapter.
(3) Conditions of use. For the treatment of diseases due to
oxytetracycline-susceptible organisms as follows:
(i) Beef cattle, beef calves, nonlactating dairy cattle, and dairy
calves--(A) Amount. Administer 3 to 5 mg/lb body weight per day by
intramuscular, intravenous, or subcutaneous injection. In severe forms
of the indicated diseases, administer 5 mg/lb body weight per day.
Continue treatment 24 to 48 hours following remission of clinical signs
of disease, not to exceed 4 consecutive days.
(B) Indications for use. For the treatment of pneumonia and
shipping fever complex associated with Pasteurella spp., Haemophilus
spp., or Klebsiella spp.
(C) Limitations. Do not inject more than 10 mL per intramuscular
injection site in adult cattle, and no more than 1 mL per site in
calves weighing 100 pounds or less. Do not slaughter cattle for 13 days
after intramuscular or intravenous treatment, or 2 days after
subcutaneous treatment. Exceeding the highest recommended dosage or
duration of treatment (not more than 4 consecutive days) may result in
residues beyond the withdrawal period. A withdrawal period has not been
established for use of 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.
(ii) Swine--(A) Amount. Administer 3 to 5 mg/lb body weight per day
by intramuscular injection. Sows: Administer 3 mg/lb body weight once,
by intramuscular injection, approximately 8 hours before farrowing or
immediately after completion of farrowing.
(B) Indications for use. For treatment of bacterial enteritis
(scours, colibacillosis) caused by Escherichia coli, pneumonia caused
by Pasteurella multocida, and leptospirosis caused by Leptospira
pomona. Sows: As an aid in control of infectious enteritis (baby pig
scours, colibacillosis) in suckling pigs caused by Escherichia coli.
(C) Limitations. Do not inject more than 5 mL per site. Discontinue
treatment at least 20 days prior to slaughter. Federal law restricts
this drug to use by or on the order of a licensed veterinarian.
(h)(1) Specifications. Each milliliter (mL) of solution contains 50
or 100 milligrams (mg) oxytetracycline hydrochloride.
(2) Sponsors. See No. 069043 in Sec. 510.600(c) of this chapter
for use of 50- and 100-mg/mL solution and Nos. 016592 and 055529 in
Sec. 510.600(c) of this chapter for use of 100-mg/mL solution.
(3) Conditions of use in beef cattle, beef calves, nonlactating
dairy cattle,
[[Page 55566]]
and dairy calves--(i) Amount. Administer 3 to 5 mg/lb body weight per
day by intramuscular injection; 5 mg/lb body weight per day for
treatment of severe forms of the indicated diseases.
(ii) Indications for use. For treatment of bacterial pneumonia and
shipping fever complex associated with Pasteurella spp., foot-rot and
calf diphtheria caused by Fusobacterium necrophorum, bacterial
enteritis (scours) caused by Escherichia coli, wooden tongue caused by
Actinobacillus lignieresii; and wound infections and acute metritis
caused by Staphylococcus spp. and Streptococcus spp.
(iii) Limitations. Do not inject more than 10 mL per site in adult
cattle. Reduce the volume administered per injection site according to
age and body size. In calves weighing 100 pounds or less, do not inject
more than 2 mL per site. Discontinue treatment at least 22 days before
slaughter. Not for use in lactating dairy animals. 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.
* * * * *
(j)(1) Specifications. Each milliliter (mL) of solution contains
either 50 or 100 milligrams (mg) of oxytetracycline hydrochloride.
(2) Sponsor. See No. 061133 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/lb body weight daily by
intravenous injection. Administer 5 mg/lb for anaplasmosis, severe foot
rot, and severe forms of other diseases. Treatment should be continued
24 to 48 hours following remission of clinical signs of disease, but
not to exceed 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, anaplasmosis caused by Anaplasma marginale and
anthrax caused by Bacillus anthracis; and acute metritis and wound
infections caused by staphylococcal and streptococcal organisms.
(iii) Limitations. Not for use in lactating dairy cattle.
Discontinue use at least 19 days prior to slaughter. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.
0
27. In Sec. 522.1940, revise paragraph (a), redesignate paragraph (c)
as paragraph (d), and add new paragraph (c).
The revision and addition read as follows:
Sec. 522.1940 Progesterone 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 paragraphs (d)(1)(i)(A), (d)(1)(ii)
and (iii), (d)(2)(i)(A), (d)(2)(ii) and (iii), and (d)(3) of this
section.
(2) No. 058198 for use as in paragraphs (d)(1) and (2) of this
section.
* * * * *
(c) Special considerations. Labeling of implants described in
paragraphs (d)(1)(i)(B) and (d)(2)(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.''.
* * * * *
0
28. In Sec. 522.2343, revise paragraph (a), redesignate paragraph (c)
as paragraph (d), and add new paragraph (c).
The revision and addition 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 paragraphs (d)(1)(i) and (d)(2) and
(3) of this section.
(2) No. 058198 for use as in paragraph (d) of this section.
* * * * *
(c) Special considerations. Labeling of implants described in
paragraph (d)(1)(ii) of this section shall bear the following:
``Federal law restricts this drug to use by or on the order of a
licensed veterinarian.''
* * * * *
0
29. In Sec. 522.2476, revise paragraph (a), redesignate paragraph (c)
as paragraph (d), and add new paragraph (c).
The revision and addition read as follows:
Sec. 522.2476 Trenbolone acetate.
(a) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for
use as in paragraph (d) of this section.
(1) No. 000061 for use as in paragraphs (d)(1)(i)(A), (d)(1)(ii)
and (iii), (d)(2)(i)(A), and (d)(2)(ii) and (iii) of this section.
(2) No. 058198 for use as in paragraph (d) of this section.
* * * * *
(c) Special considerations. Labeling of implants described in
paragraph (d)(1)(i)(B) and (d)(2)(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.''.
* * * * *
0
30. In Sec. 522.2477, redesignate paragraphs (b) and (c) as paragraphs
(a) and (b) and add new paragraph (c) to read as follows:
Sec. 522.2477 Trenbolone acetate and estradiol.
* * * * *
(c) Special considerations. Labeling of implants described in
paragraphs (d)(1)(i)(B), (E), and (F), (d)(2)(i)(B), (E), and (F), and
(d)(3)(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.''.
* * * * *
0
31. In Sec. 522.2680, revise paragraphs (d)(1)(ii)(A) and (B) and
(d)(1)(iii) to read as follows:
Sec. 522.2680 Zeranol.
* * * * *
(d) * * *
(1) * * *
(ii) * * *
(A) Weaned beef calves, growing beef cattle, feedlot steers, and
feedlot heifers: For increased rate of weight gain and improved feed
conversion.
(B) Suckling calves: For increased rate of weight gain.
(iii) Limitations. Implant pellets subcutaneously only. Not
approved for repeated implantation (reimplantation) with this or any
other cattle ear implant within a single production phase 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. A withdrawal period
has not been established for this product in preruminating calves. Do
not use in replacement beef heifers after weaning or in bulls, dairy
cows, or replacement dairy heifers.
* * * * *
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
32. The authority citation for part 524 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
33. Add Sec. 524.838 to read as follows:
Sec. 524.838 Esafoxolaner, eprinomectin, and praziquantel.
(a) Specifications. Each milliliter (mL) of topical solution
contains 12
[[Page 55567]]
milligrams (mg) esafoxolaner, 4 mg eprinomectin, and 83 mg
praziquantel.
(b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. Administer the entire contents
of a provided unit applicator topically once a month at a minimum dose
of 0.055 mL/lb (0.12 mL/kg), which delivers a minimum dose of 0.66 mg/
lb (1.45 mg/kg) esafoxolaner, 0.23 mg/lb (0.51 mg/kg) eprinomectin, and
4.55 mg/lb (10.0 mg/kg) praziquantel.
(2) Indications for use. For the prevention of heartworm disease
caused by Dirofilaria immitis. Kills adult fleas (Ctenocephalides
felis) and is indicated for the treatment and prevention of flea
infestations, the treatment and control of Ixodes scapularis (black-
legged tick) and Amblyomma americanum (lone star tick) infestations,
and the treatment and control of roundworms (fourth-stage larval and
adult Toxocara cati), hookworms (fourth-stage larval and adult
Ancylostoma tubaeforme; adult Ancylostoma braziliense), and tapeworms
(Dipylidium caninum) in cats and kittens 8 weeks of age and older, and
weighing 1.8 lbs or greater.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS
0
34. The authority citation for part 526 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 526.1696 [Amended]
0
35. In Sec. 526.1696, in paragraphs (d)(3) and (e)(3), in the last
sentence, remove ``For No. 042791:''.
0
36. In Sec. 526.1697, add a sentence to the end of paragraph (d)(3) to
read as follows:
Sec. 526.1697 Penicillin G procaine and dihydrostreptomycin.
(d) * * *
(3) * * * 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
37. The authority citation for part 529 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
38. In Sec. 529.1044a, revise paragraph (b) to read as follows:
Sec. 529.1044a Gentamicin solution for infusion.
* * * * *
(b) Sponsors. See Nos. 000061, 016592, 054771, 058005, 058198,
061133, and 069043 in Sec. 510.600(c) of this chapter.
* * * * *
0
39. In 529.1044b, revise paragraph (c)(3) to read as follows:
Sec. 529.1044b Gentamicin solution for dipping eggs.
* * * * *
(c) * * *
(3) Limitations. Eggs which have been dipped in the drug shall not
be used for food. Federal law restricts this drug to use by or on the
order of a licensed veterinarian.
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
0
40. The authority citation for part 556 continues to read as follows:
Authority: 21 U.S.C. 342, 360b, 371.
0
41. In Sec. 556.110, revise paragraph (c) to read as follows:
Sec. 556.110 Carbomycin.
* * * * *
(c) Related conditions of use. See Sec. 520.1664 of this chapter.
0
42. In Sec. 556.500, revise paragraph (c) to read as follows:
Sec. 556.500 Oxytetracycline.
* * * * *
(c) Related conditions of use. See Sec. Sec. 520.1660c, 520.1660d,
520.1664, 522.1660a, 522.1660b, 522.1662, 522.1664, 529.1660, 558.450,
and 558.455 of this chapter.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
43. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
0
44. In Sec. 558.68, revise paragraph (e)(1)(ii) to read as follows:
Sec. 558.68 Avilamycin.
* * * * *
(e) * * *
(1) * * *
----------------------------------------------------------------------------------------------------------------
Avilamycin in grams/ton Combination in grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(ii) 13.6 to 40.9............ Monensin, 90 to 110......... Broiler chickens: Feed this complete 058198
For the prevention Type C medicated
of mortality feed as the sole
caused by necrotic ration for 21
enteritis consecutive days.
associated with To assure
Clostridium responsible
perfringens; and antimicrobial drug
as an aid in the use in broiler
prevention of chickens,
coccidiosis caused treatment
by Eimeria administration
necatrix, E. must begin on or
tenella, E. before 18 days of
acervulina, E. age. See Sec.
brunetti, E. 558.355(d) of this
mivati, and E. chapter. Monensin
maxima. as provided by No.
058198 in Sec.
510.600(c) of this
chapter.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
0
45. In Sec. 558.128, revise paragraphs (e)(4)(iii) and (iv),
(e)(4)(ix) through (xiv), and (e)(4)(xviii) through (xx) to read as
follows:
Sec. 558.128 Chlortetracycline.
* * * * *
(e) * * *
(4) * * *
[[Page 55568]]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chlortetracycline amount Combination in grams/ton Indications for use Limitations Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * * * *
(iii) 7 to 17.5 g/ton............ Monensin, 5 to 40...................... Growing beef steers and Feed as the sole ration to provide 70 016592
heifers fed in mg chlortetracycline per head per day 069254
confinement for and 50 to 480 mg monensin per head per
slaughter over 400 lb: day. No additional improvement in feed
For reduction of the efficiency has been shown from feeding
incidence of liver monensin at levels greater than 30
abscesses and for grams per ton (360 mg monensin per
improved feed head per day). For use in dry feeds
efficiency. only. Not for use in liquid feed
supplements. Do not allow horses or
other equines 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
preruminating calves. Do not use in
calves to be processed for veal.
Monensin as provided by Nos. 016592
and 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 016592
heifers fed in mg chlortetracycline per head per day 069254
confinement for and 0.14 to 0.42 mg monensin per lb.
slaughter over 400 lb: body weight per day to provide,
For reduction of the depending upon severity of coccidiosis
incidence of liver challenge, up to 480 mg monensin per
abscesses and for head per day. For use in dry feeds
prevention and control only. Not for use in liquid feed
of coccidiosis due to supplements. Do not allow horses or
Eimeria bovis and other equines access to feed
Eimeria zuernii. 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
preruminating calves. Do not use in
calves to be processed for veal.
Monensin as provided by Nos. 016592
and 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 016592
heifers fed in mg chlortetracycline per lb. body 069254
confinement for weight per day and 50 to 480 mg
slaughter over 700 lbs: monensin per head per day. No
For control of active additional improvement in feed
infection of efficiency has been shown from feeding
anaplasmosis caused by monensin at levels greater than 30
Anaplasma marginale grams per ton (360 mg monensin per
susceptible to head per day). For use in dry feeds
chlortetracycline and only. Not for use in liquid feed
for improved feed supplements. Do not allow horses or
efficiency. other equines 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
preruminating calves. Do not use in
calves to be processed for veal.
Monensin as provided by Nos. 016592
and 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 016592
heifers fed in mg chlortetracycline per lb. body 069254
confinement for weight per day and 0.14 to 0.42 mg
slaughter over 700 lbs: monensin per lb. body weight per day
For control of active to provide, depending upon severity of
infection of coccidiosis challenge, up to 480 mg
anaplasmosis caused by monensin per head per day. For use in
Anaplasma marginale dry feeds only. Not for use in liquid
susceptible to feed supplements. Do not allow horses
chlortetracycline and or other equines access to feed
for the prevention and containing monensin. Ingestion of
control of coccidiosis monensin by horses has been fatal.
due to Eimeria bovis Monensin medicated cattle and goat
and Eimeria zuernii. 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
preruminating calves. Do not use in
calves to be processed for veal.
Monensin as provided by Nos. 016592
and 058198, chlortetracycline by No.
069254 in Sec. 510.600(c) of this
chapter.
[[Page 55569]]
(xi) 50 to 117 g/ton............. Monensin, 7.14 to 40................... Growing beef steers and Feed as the sole ration to provide 350 016592
heifers fed in mg chlortetracycline per head per day 069254
confinement for and 50 to 480 mg monensin per head per
slaughter under 700 day. No additional improvement in feed
lbs: For control of efficiency has been shown from feeding
active infection of monensin at levels greater than 30
anaplasmosis caused by grams per ton (360 mg monensin per
Anaplasma marginale head per day). For use in dry feeds
susceptible to only. Not for use in liquid feed
chlortetracycline and supplements. Do not allow horses or
for improved feed other equines access to feed
efficiency. 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
preruminating calves. Do not use in
calves to be processed for veal.
Monensin as provided by Nos. 016592
and 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 016592
heifers fed in mg chlortetracycline per head per day 069254
confinement for and 0.14 to 0.42 mg monensin per lb.
slaughter under 700 body weight per day to provide,
lbs: For control of depending upon severity of coccidiosis
active infection of challenge, up to 480 mg monensin per
anaplasmosis caused by head per day. For use in dry feeds
Anaplasma marginale only. Not for use in liquid feed
susceptible to supplements. Do not allow horses or
chlortetracycline and other equines access to feed
for the prevention and containing monensin. Ingestion of
control of coccidiosis monensin by horses has been fatal.
due to Eimeria bovis Monensin medicated cattle and goat
and Eimeria zuernii. 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
preruminating calves. Do not use in
calves to be processed for veal.
Monensin as provided by Nos. 016592
and 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 016592
heifers fed in mg chlortetracycline per head per day 069254
confinement for and 50 to 480 mg monensin per head per
slaughter: For the day. No additional improvement in feed
control of bacterial efficiency has been shown from feeding
pneumonia associated monensin at levels greater than 30
with shipping fever grams per ton (360 mg monensin per
complex caused by head per day). For use in dry feeds
Pasteurella spp. only. Not for use in liquid feed
susceptible to supplements. Do not allow horses or
chlortetracycline and other equines access to feed
for improved feed containing monensin. Ingestion of
efficiency. 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
preruminating calves. Do not use in
calves to be processed for veal.
Monensin as provided by Nos. 016592
and 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 016592
heifers fed in mg chlortetracycline per head per day 069254
confinement for and 0.14 to 0.42 mg monensin per lb.
slaughter: For the body weight per day to provide,
control of bacterial depending upon severity of coccidiosis
pneumonia associated challenge, up to 480 mg monensin per
with shipping fever head per day. For use in dry feeds
complex caused by only. Not for use in liquid feed
Pasteurella spp. supplements. Do not allow horses or
susceptible to other equines access to feed
chlortetracycline and containing monensin. Ingestion of
for the prevention and monensin by horses has been fatal.
control of coccidiosis Monensin medicated cattle and goat
due to Eimeria bovis feeds are safe for use in cattle and
and Eimeria zuernii. 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
preruminating calves. Do not use in
calves to be processed for veal.
Monensin as provided by Nos. 016592
and 058198, chlortetracycline by No.
069254 in Sec. 510.600(c) of this
chapter.
[[Page 55570]]
* * * * * * *
(xviii) 400 to 2,000 g/ton....... Monensin, 5 to 40...................... Growing beef steers and Feed as the sole ration to provide 10 016592
heifers fed in mg chlortetracycline per lb. body 069254
confinement for weight per day and 50 to 480 mg
slaughter: For monensin per head per day. Feed for
treatment of bacterial not more than 5 days, then continue
enteritis caused by feeding monensin Type C medicated feed
Escherichia coli and alone. No additional improvement in
bacterial pneumonia feed efficiency has been shown from
caused by Pasteurella feeding monensin at levels greater
multocida susceptible than 30 grams per ton (360 mg monensin
to chlortetracycline; per head per day). For use in dry
for improved feed feeds only. Not for use in liquid feed
efficiency. supplements. Do not allow horses or
other equines 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
preruminating calves. Do not use in
calves to be processed for veal.
Monensin as provided by Nos. 016592
and 058198, chlortetracycline by No.
069254 in Sec. 510.600(c) of this
chapter.
(xix) 400 to 2,000 g/ton......... Monensin, 10 to 40..................... Growing beef steers and Feed as the sole ration to provide 10 016592
heifers: For treatment mg chlortetracycline per lb. body 069254
of bacterial enteritis weight per day and 0.14 to 0.42 mg
caused by Escherichia monensin per lb. body weight per day
coli and bacterial to provide, depending upon severity of
pneumonia caused by the coccidiosis challenge, up to 480
Pasteurella multocida mg monensin per head per day. Feed for
susceptible to not more than 5 days, then continue
chlortetracycline; and feeding monensin Type C medicated feed
for the prevention and alone. For use in dry feeds only. Not
control of coccidiosis for use in liquid feed supplements. Do
due to Eimeria bovis not allow horses or other equines
and Eimeria zuernii. 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 preruminating calves. Do not use in
calves to be processed for veal.
Monensin as provided by Nos. 016592
and 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 016592
age and older: For mg chlortetracycline per lb. body 069254
treatment of bacterial weight per day and 0.14 to 1.00 mg
enteritis caused by monensin per lb. body weight per day
Escherichia coli and to provide, depending upon severity of
bacterial pneumonia coccidiosis challenge, up to 200 mg of
caused by Pasteurella monensin per head per day. Feed for
multocida susceptible not more than 5 days, then continue to
to chlortetracycline; feed monensin Type C medicated feed
and for the prevention alone. For use in dry feeds only. Not
and control of for use in liquid feed supplements. Do
coccidiosis due to not allow horses or other equines
Eimeria bovis and access to feed containing monensin.
Eimeria zuernii. 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 preruminating calves. Do not use in
calves to be processed for veal.
Monensin as provided by Nos. 016592
and 058198, chlortetracycline by No.
069254 in Sec. 510.600(c) of this
chapter.
* * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 558.325 [Amended]
0
46. In Sec. 558.325, remove and reserve paragraphs (e)(2)(ii), (viii),
and (xiii).
0
47. In Sec. 558.366, revise paragraphs (b) and (d)(1)(v) to read as
follows:
Sec. 558.366 Nicarbazin.
* * * * *
(b) Sponsors. See Nos. 060728, 066104, and 069254 in Sec.
510.600(c) of this chapter.
* * * * *
(d) * * *
(1) * * *
[[Page 55571]]
----------------------------------------------------------------------------------------------------------------
Combination in grams per
Nicarbazin in grams per ton ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(v) 113.5..................... ......................... Chickens: As an aid Feed continuously as 060728
in preventing sole ration from 069254
outbreaks of cecal time chicks are
(Eimeria tenella) placed on litter
and intestinal (E. until past the time
acervulina, E. when coccidiosis is
maxima, E. ordinarily a
necatrix, and E. hazard. Do not use
brunetti) as a treatment for
coccidiosis. coccidiosis. Do not
use in flushing
mashes. Do not feed
to laying hens.
Withdraw 4 days
before slaughter.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
0
48. In Sec. 558.450, revise paragraphs (e)(5)(iv) and (v) to read as
follows:
Sec. 558.450 Oxytetracycline.
* * * * *
(e) * * *
(5) * * *
------------------------------------------------------------------------
Indications for
Oxytetracycline amount use Limitations Sponsor
------------------------------------------------------------------------
* * * * * * *
(iv) 2.5 to 3.75 g/100 lb 1. Freshwater- Administer in 066104
of fish/day. reared mixed ration
salmonids: For for 10 days.
control of Do not
ulcer disease liberate fish
caused by or slaughter
Haemophilus fish for food
piscium, for 21 days
furunculosis following the
caused by last
Aeromonas administration
salmonicida, of medicated
bacterial feed.
hemorrhagic
septicemia
caused by A.
hydrophila,
and
pseudomonas
disease.
2. Catfish: For Administer in 066104
control of mixed ration
bacterial for 10 days.
hemorrhagic Do not
septicemia liberate fish
caused by A. or slaughter
hydrophila and fish for food
pseudomonas for 21 days
disease. following the
last
administration
of medicated
feed. Do not
administer
when water
temperature is
below 16.7
[deg]C (62 F).
(v) 3.75 g/100 lb of fish/ 1. Freshwater- Administer in 066104
day. reared mixed ration
salmonids: For for 10 days.
control of Do not
mortality due liberate fish
to coldwater or slaughter
disease fish for food
associated for 21 days
with following the
Flavobacterium last
psychrophilum administration
or for control of medicated
of mortality feed.
due to
columnaris
disease
associated
with
Flavobacterium
columnare.
2. Freshwater- Feed for 10 066104
reared days.
salmonids Immediate
weighing up to release is
55 grams: For permitted
marking the following last
skeletal feeding of
tissue. medicated feed.
3. Catfish: For Administer in 066104
control of mixed ration
mortality due for 10 days.
to columnaris Do not
disease liberate fish
associated or slaughter
with fish for food
Flavobacterium for 21 days
columnare. following the
last
administration
of medicated
feed. Do not
administer
when water
temperature is
below 16.7
[deg]C (62 F).
* * * * * * *
------------------------------------------------------------------------
Dated: August 9, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-17454 Filed 8-15-23; 8:45 am]
BILLING CODE 4164-01-P
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