Rule2022-24106
New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address
Primary source
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Published
December 14, 2022
Effective
December 14, 2022
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 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 87 Issue 239 (Wednesday, December 14, 2022)</title>
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[Federal Register Volume 87, Number 239 (Wednesday, December 14, 2022)]
[Rules and Regulations]
[Pages 76418-76425]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-24106]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 516, 520, 522, 528, and 558
[Docket No. FDA-2022-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications;
Change of Sponsor; Change of Sponsor Address
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is amending the
animal drug regulations to reflect application-related actions for new
animal drug applications (NADAs), abbreviated new animal drug
applications (ANADAs), and conditionally approved new animal drug
applications (cNADAs) during April, May, and June 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 December 14, 2022.
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#b6d1d3d9c4d1d398ded7dfd4d3daf6d0d2d798dedec598d1d9c0"><span class="__cf_email__" data-cfemail="8cebe9e3feebe9a2e4ede5eee9e0cceae8eda2e4e4ffa2ebe3fa">[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 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 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.
[[Page 76419]]
Table 1--Original and Supplemental NADAs, ANADAs, and cNADAs Approved During April, May, and June 2022 Requiring Evidence of Safety and/or Effectiveness
--------------------------------------------------------------------------------------------------------------------------------------------------------
21 CFR
Approval date File No. Sponsor Product name Effect of the action Public documents section
--------------------------------------------------------------------------------------------------------------------------------------------------------
April 28, 2022.................... 141-137 Pharmgate, Inc., 1800 PENNITRACIN MD Supplemental approval FOI Summary............ 558.76
Sir Tyler Dr., (bacitracin Type A for the prevention
Wilmington, NC 28405. medicated article). of mortality caused
by necrotic
enteritis associated
with Clostridium
perfringens in
broiler and
replacement chickens.
June 16, 2022..................... 141-556 Boehringer Ingelheim VETMEDIN-CA1 Conditional approval FOI Summary............ 516.1780
Animal Health USA, (pimobendan) for the delay of
Inc., 3239 Satellite Chewable Tablets. onset of congestive
Blvd., Duluth, GA heart failure in
30096. dogs with Stage B2
preclinical
myxomatous mitral
valve disease.
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 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 April, May, and June 2022 To Change the Marketing Status of
Antimicrobial Animal Drug Products From OTC to Rx
----------------------------------------------------------------------------------------------------------------
21 CFR
Approval date File No. Sponsor Product name section
----------------------------------------------------------------------------------------------------------------
May 31, 2022....................... 008-769 Zoetis Inc., 333 TERRAMYCIN (oxytetracycline 522.1662a
Portage St., hydrochloride) Injectable
Kalamazoo, MI 49007. Solution; LIQUAMYCIN
(oxytetracycline
hydrochloride) Injectable
Solution.
June 7, 2022....................... 007-981 Do.................... SOXISOL (sulfisoxazole) 520.2330
Tablets.
----------------------------------------------------------------------------------------------------------------
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 April, May, and June 2022
----------------------------------------------------------------------------------------------------------------
21 CFR
File No. Product name Transferring sponsor New sponsor section
----------------------------------------------------------------------------------------------------------------
119-688........................... CEFA-TABS Boehringer Ingelheim HQ Specialty Pharma 520.314
(cefadroxil) Animal Health USA, Corp., 120 Rte. 17
Tablets. Inc., 3239 North, Suite 130,
Satellite Blvd., Paramus, NJ 07652.
Duluth, GA 30096.
140-684........................... CEFA-DROPS Do.................. Do.................. 520.314
(cefadroxil) Powder
for Suspension.
141-217........................... ZEUTERIN (zinc Ark Sciences, Inc., Aiping 522.2690
gluconate) 1101 East 33rd St., Pharmaceutical,
Injectable Solution. Suite B304, Inc., 350 W
Baltimore, MD 21218. Wireless Blvd.,
Hauppauge, NY 11788.
141-551........................... ZENALPHA Vetcare Oy, P.O. Box Dechra, Ltd., 522.1338
(medetomidine 26 (Liedontie 45), Snaygill Industrial
hydrochloride and M[auml]nts[auml]l[a Estate, Keighley
vatinoxan uml], Uusimaa, Rd., Skipton, North
hydrochloride) 04601, Finland. Yorkshire, BD23
Injectable Solution. 2RW, United Kingdom.
----------------------------------------------------------------------------------------------------------------
Following these changes of sponsorship, Ark Sciences, Inc. and
Vetcare Oy are no longer the sponsor of an approved application.
Accordingly, the drug labeler codes for these firms will be removed
from Sec. 510.600 (21 CFR 510.600).
III. Change of Sponsor Address
Anivive Lifesciences, Inc., 3250 Airflite Way, Suite 400, Long
Beach, CA 90807 has informed FDA that it has changed its address to
3777 Worsham Ave. Long Beach, CA 90808. As provided in the regulatory
text, Sec. 510.600 is amended to reflect this change.
IV. Technical Amendments
FDA is making the following amendments to improve the accuracy of
the animal drug regulations:
<bullet> 21 CFR 510.600 is amended to remove Ark Sciences, Inc.,
and Vetcare Oy from the list of sponsors of approved applications and
to revise the address for Anivive Lifesciences, Inc. A punctuation
change is made in the codified name for Ve[aacute]toquinol USA, Inc.
<bullet> 21 CFR 520.563 is amended to reflect the correct section
title for diatrizoate oral solution.
<bullet> 21 CFR 520.2640 is amended to reflect sponsors' container
contents and the dosage in parts per million of tylosin tartrate
soluble powder for use in drinking water of turkeys and swine.
<bullet> 21 CFR 522.955 is amended to reflect drug labeler codes of
application sponsors and to revise a pathogen name for florfenicol
injectable solution in cattle.
<bullet> 21 CFR 522.2471 is amended to reflect a revised withdrawal
period and human food safety warnings for tilmicosin injectable
solution in sheep.
<bullet> The heading for Part 528 is revised to reflect a more
accurate title.
<bullet> 21 CFR 558.95 is amended to reflect revised classes of
cattle for use of bambermycins medicated feeds.
<bullet> 21 CFR 558.128 is amended to reflect approved
incorporation rates for
[[Page 76420]]
chlortetracycline medicated feeds for cattle.
<bullet> 21 CFR 558.342 is amended to reflect all sponsors of
approved applications for use of melengestrol medicated feeds in
heifers.
<bullet> 21 CFR 558.450 is amended to reflect revised residue
warnings for use of oxytetracycline medicated feeds in cattle.
<bullet> 21 CFR 558.455 is amended to reflect a revised indication
for use of oxytetracycline with neomycin in medicated cattle feeds and
an updated format.
<bullet> 21 CFR 558.575 is amended to reflect approved
incorporations rates for use of sulfadimethoxine and ormetoprim in
medicated feeds for salmonids and catfish.
V. 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 Part 516
Administrative practice and procedure, Animal drugs, Confidential
business information, Reporting and recordkeeping requirements.
21 CFR Parts 520, 522, 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, 516, 520, 522, 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), remove the entries for ``Ark
Sciences, Inc.'' and ``Vetcare Oy''; revise the entries for ``Anivive
Lifesciences, Inc.''; and ``Ve[aacute]toquinol USA, Inc.''; and add in
alphabetical order an entry for ``Aiping Pharmaceutical, Inc.''; and
0
b. In the table in paragraph (c)(2), add an entry for ``011788'';
revise the entries for ``017030'' and ``086121''; and remove the
entries for ``076175'' and ``086155''.
The revisions and additions read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Drug labeler
Firm name and address code
------------------------------------------------------------------------
* * * * * * *
Aiping Pharmaceutical, Inc., 350W Wireless Blvd., 011788
Hauppauge, NY 11788....................................
* * * * * * *
Anivive Lifesciences, Inc., 3777 Worsham Ave., Long 086121
Beach, CA 90808........................................
* * * * * * *
Vetoquinol USA, Inc., 4250 N Sylvania Ave., Fort Worth, 017030
TX 76137...............................................
* * * * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * * * *
011788.................. Aiping Pharmaceutical, Inc., 350W Wireless
Blvd., Hauppauge, NY 11788.
* * * * * * *
017030.................. Vetoquinol USA, Inc., 4250 N. Sylvania Ave.,
Fort Worth, TX 76137.
* * * * * * *
086121.................. Anivive Lifesciences, Inc., 3777 Worsham Ave.,
Long Beach, CA 90808.
* * * * * * *
------------------------------------------------------------------------
[[Page 76421]]
PART 516--NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
0
3. The authority citation for part 516 continues to read as follows:
Authority: 21 U.S.C. 360ccc-1, 360ccc-2, 371.
0
4. Add Sec. 516.1780 to subpart E to read as follows:
Sec. 516.1780 Pimobendan.
(a) Specifications. Each chewable tablet contains 1.25, 2.5, 5, or
10 milligrams (mg) pimobendan.
(b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. Administer orally at a total
daily dose of 0.23 mg per pound (0.5 mg per kilogram) body weight,
using a suitable combination of whole or half tablets. The total daily
dose should be divided into two portions administered approximately 12
hours apart.
(2) Indications for use in dogs. For the delay of onset of
congestive heart failure in dogs with Stage B2 preclinical myxomatous
mitral valve disease (2019 ACVIM Consensus Statement). Stage B2
preclinical myxomatous mitral valve disease (MMVD) refers to dogs with
asymptomatic MMVD that have a moderate or loud mitral murmur due to
mitral regurgitation and cardiomegaly.
(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
5. The authority citation for part 520 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 520.314 [Amended]
0
6. In Sec. 520.314, in paragraph (b), remove ``000010'' and in its
place add ``042791''.
0
7. In Sec. 520.563, revise the section heading to read as follows:
Sec. 520.563 Diatrizoate.
* * * * *
0
8. In Sec. 520.2330, amend paragraph (c)(3) by adding a sentence to
the end of the paragraph.
Sec. 520.2330 Sulfisoxazole tablets.
* * * * *
(c) * * *
(3) * * * Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
0
9. In Sec. 520.2640, revise paragraphs (a), (b), (e)(2)(i), and (3)(i)
to read as follows:
Sec. 520.2640 Tylosin.
(a) Specifications. Each container of soluble powder contains
tylosin tartrate equivalent to:
(1) 100 grams (g) tylosin base, or
(2) 256 g tylosin base.
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for
use as in paragraph (e) of this section:
(1) Nos. 016592 and 058198 for use of the 100-g container as in
paragraph (e) of this section
(2) No. 061133 for use of the 100-or 256-g container as in
paragraphs (e)(1)(i)(A), (e)(1)(ii), (e)(2), (e)(3), and (e)(4) of this
section.
* * * * *
(e) * * *
(2) * * *
(i) Amount. 2 grams per gallon (528 ppm) for 2 to 5 days as the
sole source of drinking water. Treated turkeys should consume enough
medicated drinking water to provide 60 mg tylosin per pound of body
weight per day.
* * * * *
(3) * * *
(i) Amount. 250 mg per gallon (66 ppm) as the only source of
drinking water for 3 to 10 days, depending on the severity of the
condition being treated.
* * * * *
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
10. The authority citation for part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
11. In Sec. 522.955, revise paragraphs (b)(3), (d)(1)(ii)(A)(2),
(d)(1)(ii)(B)(2), and (d)(1)(ii)(C) to read as follows:
Sec. 522.955 Florfenicol.
* * * * *
(b) * * *
(3) Nos. 058005 and 058198 for use of product described in
paragraph (a)(2) of this section as in paragraph (d)(1)(ii) of this
section.
* * * * *
(d) * * *
(1) * * *
(ii) * * *
(A) * * *
(2) Indications for use. For treatment of BRD associated with
Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni.
For treatment of bovine interdigital phlegmon (foot rot, acute
interdigital necrobacillosis, infectious pododermatitis) associated
with Fusobacterium necrophorum and Bacteroides melaninogenicus.
(B) * * *
(2) Indications for use. For control of respiratory disease in
cattle at high risk of developing BRD associated with Mannheimia
haemolytica, Pasteurella multocida, and Histophilus somni.
(C) Limitations. Animals intended for human consumption must not be
slaughtered within 28 days of the last intramuscular treatment. Nos.
000061, 058005, and 058198: Animals intended for human consumption must
not be slaughtered within 38 days of subcutaneous treatment. No.
055529: Animals intended for human consumption must not be slaughtered
within 33 days of subcutaneous treatment. This 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. A withdrawal period has not been
established in pre-ruminating 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.
* * * * *
Sec. 522.1338 [Amended]
0
12. In 522.1338, in paragraph (b), remove ``086155'' and in its place
add ``043264''.
0
13. In Sec. 522.1662a, revise paragraph (e)(1); add paragraphs
(e)(3)(i)(D), (e)(3)(ii)(C), and (e)(3)(iii)(D); and remove paragraphs
(e)(3)(iv) through (vii) to read as follows:
Sec. 522.1662a Oxytetracycline hydrochloride injection.
* * * * *
(e) * * *
(1) Specifications. Each milliliter of solution contains 50
milligrams (mg) oxytetracycline hydrochloride.
* * * * *
(3) * * *
(i) * * *
(D) Treatment must be discontinued at least 22 days prior to
slaughter. Not for use in lactating dairy animals. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.
(ii) * * *
(C) Treatment must be discontinued at least 22 days prior to
slaughter. Federal law restricts this drug to use by or on the order of
a licensed veterinarian.
(iii) * * *
(D) Do not administer to laying hens unless the eggs are used for
hatching only. Treatment must be discontinued at least 5 days prior to
slaughter. Federal law restricts this drug to use by or on the order of
a licensed veterinarian.
* * * * *
0
14. In Sec. 522.2471, revise paragraph (e)(2)(iii) to read as follows:
[[Page 76422]]
Sec. 522.2471 Tilmicosin.
* * * * *
(e) * * *
(2) * * *
(iii) Limitations. Animals intended for human consumption must not
be slaughtered within 42 days of the last treatment. Not for use in
lactating ewes producing milk for human consumption.
Sec. 522.2690 [Amended]
0
15. In 522.2690, in paragraph (b), remove ``076175'' and in its place
add ``011788''.
PART 528--INTENTIONAL GENOMIC ALTERATIONS IN ANIMALS
0
16. The authority citation for part 528 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
17. Revise the heading for part 528 to read as set forth above.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
18. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
0
19. In Sec. 558.95, revise paragraphs (e)(4)(i) and (ii) to read as
follows:
Sec. 558.95 Bambermycins.
* * * * *
(e) * * *
(4) * * *
----------------------------------------------------------------------------------------------------------------
Bambermycins in grams/ton Indications for use Limitations Sponsors
----------------------------------------------------------------------------------------------------------------
(i) 1 to 4............................... Growing beef steers and Feed continuously at a rate 016592
heifers fed in confinement of 10 to 20 milligrams per
for slaughter: For head per day.
increased rate of weight
gain and improved feed
efficiency.
(ii) 2 to 80............................. Growing beef steers and Feed continuously on a hand- 016592
heifers on pasture fed basis at a rate of 10
(stocker, feeder, and to 40 milligrams per head
slaughter), and replacement per day in 1 to 10 pounds
beef and dairy heifers on of supplemental Type C
pasture: For increased rate medicated feed.
of weight gain.
----------------------------------------------------------------------------------------------------------------
* * * * *
0
20. In Sec. 558.128, revise paragraphs (e)(4)(x), (xi), (xiii), (xxx),
and (xxxi) to read as follows:
Sec. 558.128 Chlortetracycline.
* * * * *
(e) * * *
(4) * * *
----------------------------------------------------------------------------------------------------------------
Chlortetracycline amount Combination in grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * * * *
(x) 500 to 2,000 g/ton to Laidlomycin, 5............ Cattle fed in Feed continuously 054771
provide 10 mg/lb of body weight confinement for at a rate of 30
daily. slaughter: For to 75 mg
treatment of laidlomycin
bacterial propionate
enteritis caused potassium per
by Escherichia head per day for
coli and bacterial not more than 5
pneumonia caused days. A
by Pasteurella withdrawal period
multocida has not been
organisms established for
susceptible to this product in
chlortetracycline; pre-ruminating
and for increased calves. Do not
rate of weight use in calves to
gain and improved be processed for
feed efficiency. veal. See Sec.
558.305(d) of
this chapter.
Laidlomycin as
provided by No.
054771 in Sec.
510.600(c) of
this chapter.
(xi) 500 to 4,000 g/ton to Laidlomycin, 5 to 10...... Cattle fed in Feed continuously 054771
provide 10 mg/lb of body weight confinement for at a rate of 30
daily. slaughter: For to 75 mg
treatment of laidlomycin
bacterial propionate
enteritis caused potassium per
by Escherichia head per day for
coli and bacterial not more than 5
pneumonia caused days. A
by Pasteurella withdrawal period
multocida has not been
organisms established for
susceptible to this product in
chlortetracycline; pre-ruminating
and for improved calves. Do not
feed efficiency. use in calves to
be processed for
veal. See Sec.
558.305(d) of
this chapter.
Laidlomycin as
provided by No.
054771 in Sec.
510.600(c) of
this chapter.
* * * * * * * * *
(xiii) 500 to 1,200 g/ton to Lasalocid, 25 to 30....... Cattle fed in Feed continuously 054771
provide 10 mg/lb of body weight confinement for in complete feed
daily. slaughter: For to provide 10 mg
treatment of chlortetracycline
bacterial per lb body
enteritis caused weight and not
by Escherichia less than 250 mg
coli and bacterial or more than 360
pneumonia caused mg lasalocid per
by Pasteurella head per day. Do
multocida not allow horses
organisms or other equines
susceptible to access to feeds
chlortetracycline; containing
and for increased lasalocid. A
rate of weight withdrawal period
gain and improved has not been
feed efficiency. established for
this product in
pre-ruminating
calves. Do not
use in calves to
be processed for
veal. See Sec.
558.311(d) of
this chapter.
Lasalocid as
provided by No.
054771 in Sec.
510.600(c) of
this chapter.
* * * * * * * * *
(xxx) 23.3 to 58.3 g/ton to Laidlomycin, 5............ Cattle fed in Feed continuously 054771
provide 350 mg/head/day. confinement for at a rate of 30
slaughter: For to 75 mg
control of laidlomycin
bacterial propionate
pneumonia potassium per
associated with head per day. A
shipping fever withdrawal period
complex caused by has not been
Pasteurella spp. established for
susceptible to this product in
chlortetracycline; pre-ruminating
and for increased calves. Do not
rate of weight use in calves to
gain and improved be processed for
feed efficiency. veal. See Sec.
558.305(d) of
this chapter.
Laidlomycin as
provided by No.
054771 in Sec.
510.600(c) of
this chapter.
[[Page 76423]]
(xxxi) 14.6 to 116.7 g/ton to Laidlomycin, 5 to 10...... Cattle fed in Feed continuously 054771
provide 350 mg/head/day. confinement for at a rate of 30
slaughter: For to 75 mg
control of laidlomycin
bacterial propionate
pneumonia potassium per
associated with head per day. A
shipping fever withdrawal period
complex caused by has not been
Pasteurella spp. established for
susceptible to this product in
chlortetracycline; pre-ruminating
and for improved calves. Do not
feed efficiency. use in calves to
be processed for
veal. See Sec.
558.305(d) of
this chapter.
Laidlomycin as
provided by No.
054771 in Sec.
510.600(c) of
this chapter.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
0
21. In Sec. 558.342, revise paragraph (e)(1)(ii) to read as follows:
Sec. 558.342 Melengestrol.
* * * * *
(e) * * *
(1) * * *
----------------------------------------------------------------------------------------------------------------
Melengestrol acetate in mg/
head/day Combination in grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * * * *
(ii) 0.5........................ .......................... Heifers intended Administer 0.5 to 016592
for breeding: For 2.0 lb/head/day 054771
suppression of of Type C feed 058198
estrus (heat). containing 0.25
to 1.0 mg
melengestrol
acetate/lb to
provide 0.5 mg
melengestrol
acetate/head/day.
Do not exceed 24
days of feeding.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
0
22. In Sec. 558.450:
0
a. Revise paragraph (e)(4)(i);
0
b. Redesignate paragraphs (e)(4)(ii) through (v) as paragraphs
(e)(4)(iii) through (vi);
0
c. Add new paragraph (e)(4)(ii); and
0
d. Revise newly redesignated paragraphs (e)(4)(iii) and (vi).
The addition and revisions read as follows:
Sec. 558.450 Oxytetracycline.
* * * * *
(e) * * *
(4) * * *
----------------------------------------------------------------------------------------------------------------
Oxytetracycline amount Combination in grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 10 mg/lb of body weight .......................... Calves and beef and Feed continuously 066104
daily. nonlactating dairy for 7 to 14 days. 069254
cattle: For This drug product
treatment of is not approved
bacterial for use in female
enteritis caused dairy cattle 20
by Escherichia months of age or
coli and bacterial older, including
pneumonia dry dairy cows.
(shipping fever Use in these
complex) caused by cattle may cause
Pasteurella drug residues in
multocida milk and/or in
susceptible to calves born to
oxytetracycline. these cows. For
No. 069254,
withdraw 5 days
before slaughter.
For No. 066104,
zero-day
withdrawal period.
(ii) 10 mg/lb of body weight .......................... Calves: For Feed continuously 066104
daily. treatment of for 7 to 14 days 069254
bacterial in milk replacer
enteritis caused or starter feed.
by E. coli This drug product
susceptible to is not approved
oxytetracycline. 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. For
No. 069254,
withdraw 5 days
before slaughter.
For No. 066104,
zero-day
withdrawal period.
(iii) 75 mg/head/day............ .......................... Growing cattle Feed continuously. 066104
(over 400 lb): For This drug product 069254
reduction of is not approved
incidence of liver for use in female
abscesses. 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.
* * * * * * * * * *
(vi) 0.5 to 2.0 g/head/day...... .......................... Cattle: For Feed 3 to 5 days 066104
prevention and before and after 069254
treatment of the arrival in
early stages of feedlots. This
shipping fever drug product is
complex. 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.
----------------------------------------------------------------------------------------------------------------
* * * * *
0
23. In Sec. 558.455:
0
a. Redesignate paragraphs (e)(1)(ii) through (iv) as paragraphs
(e)(1)(i) through (iii);
0
b. Redesignate paragraphs (e)(2)(ii) through (iv) as paragraphs
(e)(2)(i) through (iii);
0
c. Revise paragraphs (e)(3) and (4); and
0
d. Add paragraph (e)(5).
The revisions and addition read as follows:
[[Page 76424]]
Sec. 558.455 Oxytetracycline and neomycin.
* * * * *
(e) * * *
(3) Swine. It is used in feed as follows:
----------------------------------------------------------------------------------------------------------------
Oxytetracycline and neomycin sulfate
amount Limitations Sponsors
----------------------------------------------------------------------------------------------------------------
(i) To provide 10 mg/lb of body weight Swine: For treatment of Feed continuously for 7 to 14 066104
daily. bacterial enteritis caused by d; withdraw 5 d before 069254
E. coli and Salmonella slaughter.
choleraesuis and treatment of
bacterial pneumonia caused by
P. multocida susceptible to
oxytetracycline; treatment
and control of colibacillosis
(bacterial enteritis) caused
by E. coli susceptible to
neomycin.
(ii) To provide 10 mg/lb of body Breeding swine: For control Feed continuously for not 066104
weight daily. and treatment of more than 14 d; withdraw 5 d 069254
leptospirosis (reducing the before slaughter.
incidence of abortion and
shedding of leptospirae)
caused by Leptospira pomona
susceptible to
oxytetracycline.
----------------------------------------------------------------------------------------------------------------
(4) Cattle. It is used in feed as follows:
----------------------------------------------------------------------------------------------------------------
Oxytetracycline and neomycin sulfate
amount Indications for use Limitations Sponsors
----------------------------------------------------------------------------------------------------------------
(i) To provide 10 mg/lb of body weight Calves and beef and Feed continuously for 7 to 14 066104
daily. nonlactating dairy cattle: d; in feed or milk 069254
For treatment of bacterial replacers. Treatment should
enteritis caused by E. coli continue 24 to 48 hours
and bacterial pneumonia beyond remission of disease
(shipping fever complex) symptoms. A withdrawal
caused by P. multocida period has not been
susceptible to established for use in
oxytetracycline; treatment preruminating calves. Do not
and control of colibacillosis use in calves to be
(bacterial enteritis) caused processed for veal. A milk
by E. coli susceptible to discard time has not been
neomycin. established for use in
lactating dairy cattle. Do
not use in female dairy
cattle 20 months of age or
older. Withdraw 5 d before
slaughter.
(ii) To provide 10 mg/lb of body Calves (up to 250 lb): For Feed continuously for 7 to 14 066104
weight daily. treatment of bacterial d; in milk replacers or 069254
enteritis caused by E. coli starter feed. Treatment
susceptible to should continue 24 to 48
oxytetracycline; treatment hours beyond remission of
and control of colibacillosis disease symptoms. A
(bacterial enteritis) caused withdrawal period has not
by E. coli susceptible to been established for use in
neomycin. preruminating calves. Do not
use in calves to be
processed for veal. A milk
discard time has not been
established for use in
lactating dairy cattle. Do
not use in female dairy
cattle 20 months of age or
older. Withdraw 5 d before
slaughter.
(iii) To provide 75 mg/head/day....... Growing cattle (over 400 lb): Feed continuously............ 066104
For the reduction of the 069254
incidence of liver abscesses.
(iv) To provide 0.5 to 2.0 g/head/ day Cattle: For prevention and Feed 3 to 5 d before and 066104
treatment of the early stages after arrival in feedlots. A 069254
of shipping fever complex. withdrawal period has not
been established for use in
preruminating calves. Do not
use in calves to be
processed for veal. A milk
discard time has not been
established for use in
lactating dairy cattle. Do
not use in female dairy
cattle 20 months of age or
older.
----------------------------------------------------------------------------------------------------------------
(5) S. It is used in feed as follows:
----------------------------------------------------------------------------------------------------------------
Oxytetracycline and neomycin sulfate
amount Indications for use Limitations Sponsors
----------------------------------------------------------------------------------------------------------------
(i) To provide 10 mg/lb of body weight Sheep: For treatment of Feed continuously for 7 to 14 66104,
daily. bacterial enteritis caused by d. If symptoms persist after 069254
E. coli and bacterial using for 2 or 3 days,
pneumonia caused by P. consult a veterinarian.
multocida susceptible to Treatment should continue 24
oxytetracycline; treatment to 48 hours beyond remission
and control of colibacillosis of disease symptoms.
(bacterial enteritis) caused Withdraw 5 d before
by E. coli susceptible to slaughter.
neomycin.
(ii) [Reserved].......................
----------------------------------------------------------------------------------------------------------------
0
24. In Sec. 558.575, revise paragraphs (e)(3)(iv) and (v) to read as
follows:
Sec. 558.575 Sulfadimethoxine and ormetoprim.
* * * * *
(e) * * *
(3) * * *
----------------------------------------------------------------------------------------------------------------
Sulfadimethoxine and ormetoprim amount Indications for use Limitations Sponsors
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(iv) 630 to 3780 g/ton sulfadimethoxine Salmonids: For the control Administer for 5 consecutive 015331
and 126 to 756 g/ton ormetoprim to of furunculosis in days. Withdraw 42 days
provide 50 milligrams (mg) of active salmonids (trout and before release as stocker
ingredients per kilogram of body per day. salmon) caused by Aeromonas fish or slaughter.
salmonicida strains
susceptible to
sulfadimethoxine and
ormetoprim combination.
(v) 630 to 3780 g/ton sulfadimethoxine Catfish: For control of Administer for 5 consecutive 015331
and 126 to 756 g/ton ormetoprim to enteric septicemia of days. Withdraw 3 days
provide 50 mg of active ingredients per catfish caused by before slaughter or release
kilogram of body per day. Edwardsiella ictaluri as stocker fish.
strains susceptible to
sulfadimethoxine and
ormetoprim combination.
----------------------------------------------------------------------------------------------------------------
[[Page 76425]]
Dated: November 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-24106 Filed 12-13-22; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on December 14, 2022.
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