Rule2024-03765
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
February 27, 2024
Effective
February 27, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during October, November, and December 2023. The animal drug regulations are also being amended to improve their accuracy and readability.
Full Text
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<title>Federal Register, Volume 89 Issue 39 (Tuesday, February 27, 2024)</title>
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[Federal Register Volume 89, Number 39 (Tuesday, February 27, 2024)]
[Rules and Regulations]
[Pages 14407-14412]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-03765]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, 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.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is amending the
animal drug regulations to reflect application-related actions for new
animal drug applications (NADAs) and abbreviated new animal drug
applications (ANADAs) during October, November, and December 2023. The
animal drug regulations are also being amended to improve their
accuracy and readability.
DATES: This rule is effective February 27, 2024.
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#0166646e7366642f69606863646d416765602f6969722f666e77"><span class="__cf_email__" data-cfemail="aec9cbc1dcc9cb80c6cfc7cccbc2eec8cacf80c6c6dd80c9c1d8">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Approvals
FDA is amending the animal drug regulations to reflect approval
actions for NADAs and ANADAs during October, November, and December
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 (FOIA Summaries) under the Freedom of
Information Act (FOIA). These documents, along with marketing
exclusivity and patent information, may be obtained at Animal Drugs
@FDA: <a href="https://animaldrugsatfda.fda.gov/adafda/views/#/search">https://animaldrugsatfda.fda.gov/adafda/views/#/search</a>.
Table 1--Original and Supplemental NADAs and ANADAs Approved During October, November, and December 2023
Requiring Evidence of Safety and/or Effectiveness
----------------------------------------------------------------------------------------------------------------
Sponsor (drug Effect of the 21 CFR
Date of approval File No. labeler code) Product name action section
----------------------------------------------------------------------------------------------------------------
October 11, 2023.............. 141-572 Virbac AH, Inc., AYRADIA Original approval 520.1425
P.O. Box 162059, (metronidazole) for the treatment
Fort Worth, TX oral solution. of Giardia
76161 (051311). duodenalis
infection in dogs.
October 13, 2023.............. 141-336 ECO LLC, 344 AIVLOSIN Supplemental 520.2645
Nassau St., (tylvalosin approval adding
Princeton, NJ tartrate) Water females intended
08540 (066916). Soluble Granules. for breeding to
approved classes
of swine.
October 20, 2023.............. 141-564 Pharmgate Inc., PENNCHLOR Original approval 558.128
1800 Sir Tyler (chlortetracyclin for treatment of
Rd., Wilmington, e Type A bacterial
NC 28405 (069254). medicated enteritis and
article) and pneumonia; and
RUMENSIN for increased
(monensin Type A rate of weight
medicated gain or
article). prevention and
control of
coccidiosis in
replacement beef
and dairy heifers.
November 8, 2023.............. 200-758 Felix Enrofloxacin Original approval 522.812
Pharmaceuticals Injectable for treatment and
Pvt. Ltd., 25-28 Solution. control of bovine
North Wall Quay, respiratory
Dublin 1, Ireland disease (BRD) in
(086101). beef cattle and
non-lactating
dairy cattle and
swine respiratory
disease (SRD) and
control of
colibacillosis in
groups or pens of
weaned pigs, as a
generic copy of
NADA 141-068.
[[Page 14408]]
November 17, 2023............. 141-580 Orion Corp., BONQAT Original approval 520.1892
Orionintie 1, (pregabalin) Oral for alleviation
02200 Espoo, Solution. of acute anxiety
Finland (052483). and fear
associated with
transportation
and veterinary
visits in cats.
December 14, 2023............. 141-502 Zoetis Inc., 333 REVOLUTION PLUS Supplemental 524.2099
Portage St., (selamectin and approval for the
Kalamazoo, MI sarolaner topical treatment and
49007 (054771). solution). control of tick
infestations with
Amblyomma
americanum (lone
star tick) in
cats and kittens
8 weeks of age
and older, and
weighing 2.8
pounds or greater.
December 21, 2023............. 200-760 Cronus Pharma FLORFENIJECT Original approval 522.955
Specialties India (florfenicol) for treatment of
Private Ltd., Sy Injectable bovine
No-99/1, M/s GMR Solution. respiratory
Hyderabad disease (BRD) and
Aviation SEZ bovine
Ltd., Mamidipalli interdigital
Village, phlegmon; and for
Shamshabad the control of
Mandal, Ranga respiratory
Reddy, Hyderabad, disease in cattle
Telangana, at high risk of
501218, India developing BRD,
(069043). as a generic copy
of NADA 141-063.
December 22, 2023............. 200-762 Do................ CAROFENVET Original approval 522.304
(carprofen) for the relief of
Injectable pain and
Solution. inflammation
associated with
osteoarthritis
and for the
control of
postoperative
pain associated
with soft tissue
and orthopedic
surgeries, as a
generic copy of
NADA 141-199.
December 22, 2023............. 200-764 Do................ ENROPRO 22.7 Original approval 522.812
(enrofloxacin) for the
Injectable management of
Solution. diseases in dogs
associated with
bacteria
susceptible to
enrofloxacin, as
a generic copy of
NADA 140-913.
December 22, 2023............. 200-765 Do................ ENROPRO 100 Original approval 522.812
(enrofloxacin) for treatment and
Injectable control of bovine
Solution. respiratory
disease (BRD) in
beef cattle and
non-lactating
dairy cattle and
swine respiratory
disease (SRD) and
control of
colibacillosis in
groups or pens of
weaned pigs, as a
generic copy of
NADA 141-068.
----------------------------------------------------------------------------------------------------------------
II. Withdrawals of Approval
ADM Animal Nutrition, Inc., 1000 North 30th St., Quincy, IL 62305-
3115 (drug labeler code 012286) requested that FDA withdraw approval of
the four NADAs listed in table 2 because the products are no longer
manufactured or marketed. As provided in the regulatory text of this
document, the animal drug regulations are amended to reflect these
actions.
Table 2--Applications for Which Approval Was Voluntarily Withdrawn
During October, November, and December 2023
------------------------------------------------------------------------
Date of withdrawal of 21 CFR
approval File No. New animal drug section
------------------------------------------------------------------------
November 14, 2023.......... 030-578 E-Z-EX Wormer Pellets n/a
(thiabendazole).
Do......................... 042-910 E-Z-EX WORMER 558.600
MINTRATE Block
(thiabendazole)
Mineral Protein
Block.
Do......................... 118-877 BAN-A-WORM (pyrantel n/a
tartrate) Ton Pack.
Do......................... 132-448 FLAVOMYCIN 558.95
(bambermycins) Type
A Medicated Article.
------------------------------------------------------------------------
III. Change of Sponsor
The sponsors of the approved applications listed in table 3 have
informed FDA that they have transferred ownership of, and all rights
and interest in, these applications to another sponsor. The regulations
cited in table 3 are amended to reflect these actions.
Table 3--Applications for Which Ownership Was Transferred to Another Sponsor During October, November, and
December 2023
----------------------------------------------------------------------------------------------------------------
Transferring sponsor New sponsor (drug
File No. Product name (drug labeler code) labeler code) 21 CFR section
----------------------------------------------------------------------------------------------------------------
200-237............. Isoflurane, U.S.P....... Piramal Pharma Ltd., Piramal Critical Care, 529.1186
Ground Floor, Piramal Inc., 3850 Schelden
Ananta, Agastya Circle, Bethlehem, PA
Corporate Park, 18017 (066794).
Mumbai, Maharashtra,
400070, India (065085).
[[Page 14409]]
200-576............. Gentamicin Sulfate Akorn Operating Co. Domes Pharma S.A., ZAC 524.1044a
Ophthalmic Solution. LLC, 5605 Centerpoint de Champ Lamet, 3 rue
Ct., Suite A, Gurnee, Andre Citroen, Pont-du-
IL 60031 (059399). Chateau, Auvergne-
Rh[ocirc]ne-Alpes,
63430, France (086189).
200-670............. SENERGY (selamectin) Chanelle Virbac AH, Inc., P.O. 524.2098
Topical Solution. Pharmaceuticals Box 162059, Fort
Manufacturing Ltd., Worth, TX 76161
Loughrea, County (051311).
Galway, Ireland
(061651).
200-700............. PARASEDGE Multi for Dogs Do..................... Do..................... 524.1146
(Imidacloprid and
moxidectin).
200-701............. PARASEDGE Multi for Cats Do..................... Do..................... 524.1146
(Imidacloprid and
moxidectin).
----------------------------------------------------------------------------------------------------------------
IV. Change of Sponsor Address
Accord Healthcare, Inc. 1009 Slater Rd., Suite 210-B, Durham, NC
27703 (drug labeler code 016729 in 21 CFR 510.600(c)) has informed FDA
that it has changed its address to 126 E Lincoln Ave., Rahway, NJ
07065. The entries in Sec. 510.600(c) are amended to reflect this
action.
V. Technical Amendments
FDA is making the following amendments to improve the accuracy of
the animal drug regulations.
<bullet> 21 CFR 520.1408 is revised to reflect all approved
strengths of methylprednisolone tablets for dogs and cats.
<bullet> 21 CFR 556.730 is removed because there are no approved
products containing thiabendazole for use in food-producing animals.
<bullet> 21 CFR 558.4(d) is being revised in the Category II table
by removing the row entry for ``Thiabendazole'' because there are no
longer any approved feed products for use in food-producing animals.
<bullet> 21 CFR 558.128 is revised to reflect withdrawal periods
for different applications approved for use of chlortetracycline in
cattle 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)). Although deemed
a rule pursuant to the FD&C Act, this document does not meet the
definition of ``rule'' in 5 U.S.C. 804(3)(A) because it is a ``rule of
particular applicability'' and is not subject to the congressional
review requirements in 5 U.S.C. 801-808. Likewise, this is not a rule
subject to Executive Order 12866.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Parts 520, 522, 524, and 529
Animal drugs.
21 CFR Part 556
Animal drugs, Food.
21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
510, 520, 522, 524, 529, 556, 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, in the table in paragraph (c)(1), revise the entry
for ``Accord Healthcare, Inc.''; and in the table in paragraph (c)(2),
revise the entry for ``016729'' to 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
------------------------------------------------------------------------
* * * * * * *
Accord Healthcare, Inc., 126 E Lincoln Ave., Rahway, NJ 016729
07065..................................................
* * * * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * * * *
016729..................... Accord Healthcare, Inc., 126 E Lincoln
Ave., Rahway, NJ 07065.
* * * * * * *
------------------------------------------------------------------------
[[Page 14410]]
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for part 520 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
4. In Sec. 520.1408, revise paragraph (b) to read as follows:
Sec. 520.1408 Methylprednisolone.
* * * * *
(b) Sponsors. See Nos. 054771 and 069043 in Sec. 510.600(c) of
this chapter.
* * * * *
0
5. Add Sec. 520.1425 to read as follows:
Sec. 520.1425 Metronidazole.
(a) Specifications. Each milliliter of suspension contains 125
milligrams (mg) metronidazole.
(b) Sponsor. See No. 051311 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. Administer 25 mg per kilogram
(11.3 mg per pound) of body weight twice daily for 5 consecutive days.
(2) Indications for use. For the treatment of Giardia duodenalis
infection in dogs.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
6. Add Sec. 520.1892 to read as follows:
Sec. 520.1892 Pregabalin.
(a) Specifications. Each milliliter (mL) of solution contains 50
milligrams (mg) pregabalin.
(b) Sponsor. See No. 052483 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. Administer orally as a single
dose of 5 mg/kg (0.1 mL/kg) approximately 1.5 hours before the start of
the transportation or veterinary visit.
(2) Indications for use. For alleviation of acute anxiety and fear
associated with transportation and veterinary visits.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
7. In Sec. 520.2645, revise paragraph (d)(2) to read as follows:
Sec. 520.2645 Tylvalosin.
* * * * *
(d) * * *
(2) Indications for use. For control of porcine proliferative
enteropathy (PPE) associated with Lawsonia intracellularis infection in
groups of swine intended for slaughter and female swine intended for
breeding in buildings experiencing an outbreak of PPE; and for control
of swine respiratory disease (SRD) associated with Bordetella
bronchiseptica, Glaesserella (Haemophilus) parasuis, Pasteurella
multocida, Streptococcus suis, and Mycoplasma hyopneumoniae in groups
of swine intended for slaughter and female swine intended for breeding
in buildings experiencing an outbreak of SRD.
* * * * *
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
8. The authority citation for part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
9. In Sec. 522.304, revise paragraph (b) to read as follows:
Sec. 522.304 Carprofen.
* * * * *
(b) Sponsors. See Nos. 016729, 017033, 054771, 055529, and 069043
in Sec. 510.600(c) of this chapter.
* * * * *
0
10. In Sec. 522.812, revise paragraphs (b)(1) and (2) to read as
follows:
Sec. 522.812 Enrofloxacin.
* * * * *
(b) * * *
(1) Nos. 016729, 017033, 055529, 058198, 069043, and 086101 for use
of product described in paragraph (a)(1) as in paragraph (e)(1) of this
section; and
(2) Nos. 051311, 055529, 058005, 058198, 061133, 069043, and 086101
for use of product described in paragraph (a)(2) as in paragraphs
(e)(2) and (3) of this section.
* * * * *
0
11. In Sec. 522.955, revise paragraph (b)(3) and the second sentence
in paragraph (d)(1)(ii)(C) to read as follows:
Sec. 522.955 Florfenicol.
* * * * *
(b) * * *
(3) Nos. 058005, 058198, and 069043 for use of product described in
paragraph (a)(2) of this section as in paragraph (d)(1)(ii) of this
section.
* * * * *
(d) * * *
(1) * * *
(ii) * * *
(C) Limitations. * * * Nos. 000061, 058005, 058198, and 069043:
Animals intended for human consumption must not be slaughtered within
38 days of subcutaneous treatment. * * *
* * * * *
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
12. The authority citation for part 524 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
13. In 524.1044a, revise paragraph (b) to read as follows:
Sec. 524.1044a Gentamicin ophthalmic solution.
* * * * *
(b) Sponsors. See Nos. 000061 and 086189 in Sec. 510.600(c) of
this chapter.
* * * * *
0
14. In 524.1146, revise paragraphs (b)(1) and (2) to read as follows:
Sec. 524.1146 Imidacloprid and moxidectin.
* * * * *
(b) * * *
(1) Nos. 017030, 051072, 051311, 055529, and 058198 for use of
product described in paragraph (a)(1) of this section as in paragraph
(d)(1) of this section.
(2) Nos. 017030, 051072, 051311, 055529, and 058198 for use of
product described in paragraph (a)(2) of this section as in paragraph
(d)(2) of this section.
* * * * *
0
15. In 524.2098, revise paragraph (b) to read as follows:
Sec. 524.2098 Selamectin.
* * * * *
(b) Sponsors. See Nos. 051072, 051311, 054771, 055529, and 061133
in Sec. 510.600(c) of this chapter.
* * * * *
0
16. In 524.2099, revise paragraph (c)(2) to read as follows:
Sec. 524.2099 Selamectin and sarolaner.
* * * * *
(c) * * *
(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 tick infestations with
Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast
tick), Dermacentor variabilis (American dog tick), and Ixodes
scapularis (black-legged tick), the treatment and control of ear mite
(Otodectes cynotis) infestations; and the treatment and control of
roundworm (Toxocara cati) and intestinal hookworm (Ancylostoma
tubaeforme) infections in cats and kittens 8 weeks of age and older,
and weighing 2.8 pounds or greater.
* * * * *
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
0
17. The authority citation for part 529 continues to read as follows:
[[Page 14411]]
Authority: 21 U.S.C. 360b.
0
18. In Sec. 529.1186, revise paragraph (b) to read as follows:
Sec. 529.1186 Isoflurane.
* * * * *
(b) Sponsors. See Nos. 017033, 054771, and 066794 in Sec.
510.600(c) of this chapter.
* * * * *
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
0
19. The authority citation for part 556 continues to read as follows:
Authority: 21 U.S.C. 342, 360b, 371.
Sec. 556.730 [Removed]
0
20. Remove Sec. 556.730.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
21. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
Sec. 558.4 [Amended]
0
22. Amend Sec. 558.4, by removing the entry for ``Thiabendazole'' in
the Category II'' table in paragraph (d).
0
23. In Sec. 558.95, revise paragraphs (b), (e)(2)(i) and (ii), and
(e)(3)(i) and (ii) to read as follows:
Sec. 558.95 Bambermycins.
* * * * *
(b) Sponsor. See No. 016592 in Sec. 510.600(c) of this chapter.
* * * * *
(e) * * *
(2) * * *
------------------------------------------------------------------------
Bambermycins
in grams/ton Indications for use Limitations Sponsor
------------------------------------------------------------------------
(i) 1 to 2.... Growing turkeys: For Feed continuously as 016592
improved feed the sole ration.
efficiency.
(ii) 2........ Growing turkeys: For Feed continuously as 016592
increased rate of the sole ration.
weight gain and
improved feed
efficiency.
------------------------------------------------------------------------
(3) * * *
------------------------------------------------------------------------
Bambermycins
in grams/ton Indications for use Limitations Sponsor
------------------------------------------------------------------------
(i) 2......... Growing-finishing Feed continuously as 016592
swine: For increased the sole ration.
rate of weight gain
and improved feed
efficiency.
(ii) 2 to 4... Growing-finishing Feed continuously as 016592
swine: For improved the sole ration.
feed efficiency.
------------------------------------------------------------------------
* * * * *
0
24. In Sec. 558.128:
0
a. Revise paragraphs (e)(4)(xvi) and (xvii);
0
b. Redesignate paragraphs (e)(4)(xxi) through (lviii) as paragraphs
(e)(4)(xxiii) through (lx); and
0
c. Add new paragraphs (e)(4)(xxi) and (xxii).
The revision and additions read as follows:
Sec. 558.128 Chlortetracycline.
* * * * *
(e) * * *
(4) * * *
----------------------------------------------------------------------------------------------------------------
Combination in grams/
Chlortetracycline amount ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(xvi) to provide 10 mg/lb of body .................... Calves, beef and Feed approximately 054771
weight daily. nonlactating dairy 400 g/ton, varying 066104
cattle: For with body weight 069254
treatment of and feed
bacterial enteritis consumption to
caused by provide 10 mg/lb
Escherichia coli and per day. Treat for
bacterial pneumonia not more than 5
caused by days. To sponsor
Pasteurella No. 054771 (NADAs
multocida organisms 048-761 and 046-
susceptible to 699) and to sponsor
chlortetracycline. No. 069254 (ANADA
200-510): May be
mixed in the
cattle's daily
ration or
administered as a
top-dress. In feed
including milk
replacers withdraw
10 days prior to
slaughter. To
sponsor No. 054771
under NADA 046-699:
24-hour withdrawal
period. To sponsor
No. 054771 under
NADA 048-761 and
No. 069254 under
ANADA 200-510: Zero
withdrawal period.
See paragraph
(d)(3) of this
section.
(xvii) to provide 10 mg/lb of body .................... Calves (up to 250 A withdrawal period 066104
weight daily. lb): For the has not been
treatment of established for
bacterial enteritis this product in pre-
caused by ruminating calves.
Escherichia coli Do not use in
susceptible to calves to be
chlortetracycline. processed for veal.
[[Page 14412]]
* * * * * * *
(xxi) 400 to 2,000 g/ton.......... Monensin, 15 to 84.. Replacement beef and For replacement beef 069254
dairy heifers: For and dairy heifers
treatment of not currently being
bacterial enteritis fed monensin: Feed
caused by as the sole ration
Escherichia coli and for not more than 5
bacterial pneumonia days to provide 10
caused by mg
Pasteurella chlortetracycline
multocida per pound of body
susceptible to weight per day and
chlortetracycline; 0.14 to 0.42 mg
and for the monensin per pound
prevention and of body weight per
control of day, depending upon
coccidiosis caused severity of
by Eimeria bovis and challenge, to
Eimeria zuernii. provide 50 to 100
mg monensin per
head per day in a
minimum of 1 pound
of Type C medicated
feed. After 5 days,
continue to feed
monensin Type C
medicated feed
alone to provide 50
to 200 mg monensin
per head per day in
a minimum of 1
pound of Type C
medicated feed.
For replacement beef
and dairy heifers
currently being fed
monensin: Feed as
the sole ration for
not more than 5
days to provide 10
mg
chlortetracycline
per pound of body
weight per day and
0.14 to 0.42 mg
monensin per pound
of body weight per
day, depending upon
severity of
challenge, to
provide 50 to 200
mg monensin per
head per day in a
minimum of 1 pound
of Type C medicated
feed. After 5 days,
continue to feed
monensin Type C
medicated feed
alone.
This drug 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 for
this product in pre-
ruminating calves.
Do not use in
calves to be
processed for veal.
Monensin as provided
by No. 058198,
chlortetracycline
by No. 069254 in
Sec. 510.600(c)
of this chapter.
(xxii) 400 to 2,000 g/ton......... Monensin, 15 to 400. Replacement beef and For replacement beef 069254
dairy heifers: For and dairy heifers
treatment of not currently being
bacterial enteritis fed monensin: Feed
caused by as the sole ration
Escherichia coli and for not more than 5
bacterial pneumonia days to provide 10
caused by mg
Pasteurella chlortetracycline
multocida per pound of body
susceptible to weight per day and
chlortetracycline; 50 to 100 mg
and for increased monensin per head
rate of weight gain. per day in a
minimum of 1 pound
of Type C medicated
feed. After 5 days,
continue to feed
monensin Type C
medicated feed
alone to provide 50
to 200 mg monensin
per head per day in
a minimum of 1
pound of Type C
medicated feed.
For replacement beef
and dairy heifers
currently being fed
monensin: Feed as
the sole ration for
not more than 5
days to provide 10
mg
chlortetracycline
per pound of body
weight per day and
50 to 200 mg
monensin per head
per day in a
minimum of 1 pound
of Type C medicated
feed. After 5 days,
continue to feed
monensin Type C
medicated feed
alone.
This drug 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 for
this product in pre-
ruminating calves.
Do not use in
calves to be
processed for veal.
Monensin as provided
by No. 058198,
chlortetracycline
by No. 069254 in
Sec. 510.600(c)
of this chapter.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
Sec. 558.600 [Removed]
0
25. Remove Sec. 558.600.
Dated: February 20, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-03765 Filed 2-26-24; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on February 27, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.