Rule2024-28061
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor
Primary source
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Published
December 2, 2024
Effective
December 2, 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 July, August, and September 2024. The animal drug regulations are also being amended to improve their accuracy and readability.
Full Text
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<title>Federal Register, Volume 89 Issue 231 (Monday, December 2, 2024)</title>
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[Federal Register Volume 89, Number 231 (Monday, December 2, 2024)]
[Rules and Regulations]
[Pages 95101-95108]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-28061]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, and 558
[Docket No. FDA-2024-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications;
Withdrawal of Approval of New Animal Drug Applications; Change of
Sponsor
AGENCY: Food and Drug Administration, HHS.
[[Page 95102]]
ACTION: Final rule; technical amendments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is amending the
animal drug regulations to reflect application-related actions for new
animal drug applications (NADAs) and abbreviated new animal drug
applications (ANADAs) during July, August, and September 2024. The
animal drug regulations are also being amended to improve their
accuracy and readability.
DATES: This rule is effective December 2, 2024.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240-402-5689, <a href="/cdn-cgi/l/email-protection#cf88aaa0bda8aae187aea6adaaa38fa9abaee1a7a7bce1a8a0b9"><span class="__cf_email__" data-cfemail="6e290b011c090b40260f070c0b022e080a0f4006061d40090118">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Approvals
FDA is amending the animal drug regulations to reflect approval
actions for NADAs and ANADAs during July, August, and September 2024,
as listed in table 1. In addition, FDA is informing the public of the
availability, where applicable, of documentation of environmental
review required under the National Environmental Policy Act and, for
actions requiring review of safety or effectiveness data, summaries of
the basis of approval under the Freedom of Information Act. 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 July, August, and September 2024 Requiring
Evidence of Safety and/or Effectiveness
----------------------------------------------------------------------------------------------------------------
Sponsor (drug Effect of the 21 CFR
Date of approval File No. labeler code \1\) Product name action section
----------------------------------------------------------------------------------------------------------------
July 2, 2024............... 200-788 Bimeda Animal MOXISOLV Injection Original approval 522.1450
Health Ltd. (moxidectin). as a generic copy
(061133). of NADA 141-220.
July 8, 2024............... 200-771 Norbrook FELANORM Original approval 520.1372
Laboratories, Ltd. (methimazole) Oral as a generic copy
(055529). Solution. of NADA 141-292.
August 15, 2024............ 200-770 Pharmgate Inc. DERACIN Original approval 558.128
(069254). (chlortetracycline as a generic copy
) and MGA of NADA 141-530.
(melengestrol
acetate) Type C
medicated feeds.
August 26, 2024............ 200-783 Huvepharma EOOD COXIDIN 90 Original approval 558.355
(016592). (monensin) Type C as a generic copy
medicated feeds. of NADA 038-878
and NADA 130-736.
September 5, 2024.......... 200-795 Felix CARPROFEN Soft Original approval 520.304
Pharmaceuticals Chewable Tablets as a generic copy
Pvt. Ltd. (086101). (carprofen). of NADA 141-111.
September 5, 2024.......... 200-773 Cronus Pharma TULAJECT 100 Original approval 522.2630
Specialties India (tulathromycin as a generic copy
Private Ltd. injection) of NADA 141-224.
(069043). Injectable
Solution.
September 10, 2024......... 200-774 Do................. TULAJECT 25 Original approval Do.
(tulathromycin as a generic copy
injection) of NADA 141-349.
Injectable
Solution.
September 19, 2024......... 141-585 Elanco US Inc. ZENRELIA Original approval 520.1136
(058198). (ilunocitinib for control of
tablet). pruritus
associated with
allergic
dermatitis and
control of atopic
dermatitis in dogs.
September 23, 2024......... 200-776 Pharmgate Inc. DERACIN Original approval 558.128
(069254. (chlortetracycline as a generic copy
), BOVATEC of NADA 141-531.
(lasalocid), and
MGA (melengestrol
acetate) Type C
medicated feeds.
----------------------------------------------------------------------------------------------------------------
\1\ See 21 CFR 510.600(c) for sponsor addresses.
II. Withdrawals of Approval
Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA 91767-1861
(drug labeler code 054925) requested that FDA withdraw approval of the
two 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 July, August, and September 2024
------------------------------------------------------------------------
Date of withdrawal of 21 CFR
approval File No. Product name section
------------------------------------------------------------------------
August 8, 2024............. 130-872 Nitrofurazone 524.1580c
Anesthetic Dressing
(nitrofurazone and
butacaine sulfate).
Do......................... 140-881 Nitrofurazone 524.1580a
Soluble Dressing
(nitrofurazone).
------------------------------------------------------------------------
III. Change of Sponsor
Cephazone Pharma, LLC, 250 East Bonita Ave., Pomona, CA 91767 has
informed FDA that it has transferred ownership of, and all rights and
interest in, ANADA 200-420 for Ceftiofur Sodium Sterile Powder to
Dechra Veterinary Products LLC, 7015 College Blvd., Suite 525, Overland
Park, KS 66211. As provided in the regulatory text, the animal drug
regulations are amended to reflect this action.
IV. Technical Amendments
FDA is making the following amendments to improve the accuracy and
readability of the animal drug regulations:
<bullet> 21 CFR 510.600(c) is amended to remove Cephazone Pharma,
LLC and Provetica LLC from the lists of sponsors of approved
applications as these firms are no longer the sponsor of an approved
application.
<bullet> 21 CFR 520.522 is amended to reflect a 2023 change of
sponsorship for cyclosporine oral solution.
<bullet> 21 CFR 520.2090 is amended to revise the description of a
tablet containing sarolaner, moxidectin, and pyrantel.
[[Page 95103]]
<bullet> 21 CFR 522.2470 is being amended to reflect previous
approval of additional indications for use of tiletamine and zolazepam.
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)). 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, and 524
Animal drugs.
21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
510, 520, 522, 524, 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.
Sec. 510.600 [Amended]
0
2. In Sec. 510.600, in the table in paragraph (c)(1), remove the
entries for ``Cephazone Pharma, LLC'' and ``Provetica LLC''; and in the
table in paragraph (c)(2), remove the entries for ``068330'' and
``086097''.
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.
Sec. 520.304 [Amended]
0
4. In Sec. 520.304, in paragraph (b)(2), add in numerical order the
text ``086101''.
Sec. 520.522 [Amended]
0
5. In Sec. 520.522 in paragraph (b)(4), remove the text ``086097'' and
add in its place the text ``013744''.
0
6. Add Sec. 520.1136 to read as follows:
Sec. 520.1136 Ilunocitinib.
(a) Specifications. Each tablet contains 4.8, 6.4, 8.5, and 15
milligrams (mg) ilunocitinib.
(b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. Administer orally 0.27 to 0.36
mg ilunocitinib/lb (0.6 to 0.8 mg ilunocitinib/kg) body weight, once
daily, with or without food.
(2) Indications for use. For the control of pruritus associated
with allergic dermatitis and control of atopic dermatitis in dogs at
least 12 months of age.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Sec. 520.1372 [Redesignated as Sec. 520.1375]
0
7. Redesignate Sec. 520.1372 as Sec. 520.1375 and revise the section
heading to read as follows:
Sec. 520.1375 Methimazole tablets.
* * * * *
0
8. Add Sec. 520.1376 to read as follows:
Sec. 520.1376 Methimazole solution.
(a) Specifications. Each milliliter of solution contains 5
milligrams (mg) methimazole.
(b) Sponsor. See No. 055529 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in cats--(1) Amount. Administer a starting
dose of 2.5 mg every 12 hours. Following 3 weeks of treatment, the dose
should be titrated to effect based on individual serum total T4 (TT4)
levels and clinical response. Dose adjustments should be made in 2.5 mg
increments with a maximum dosage of 20 mg per day divided, not to
exceed 10 mg as a single dose.
(2) Indications for use. For the treatment of hyperthyroidism.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
9. In Sec. 520.2090, revise paragraph (a)(1) to read as follows:
Sec. 520.2090 Sarolaner, moxidectin, and pyrantel.
(a) * * *
(1) 3.0 milligrams (mg) sarolaner, 0.06 mg moxidectin, and 12.5 mg
pyrantel (as pamoate salt);
* * * * *
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. 522.313c, revise paragraph (b) to read as follows:
Sec. 522.313c Ceftiofur sodium.
* * * * *
(b) Sponsors. See Nos. 017033 and 054771 in Sec. 510.600(c) of
this chapter.
* * * * *
0
12. In Sec. 522.1450, revise paragraph (b) to read as follows:
Sec. 522.1450 Moxidectin solution.
* * * * *
(b) Sponsors. See Nos. 055529, 058198, and 061133 in Sec.
510.600(c) of this chapter.
* * * * *
0
13. In Sec. 522.2470, revise the section heading and paragraph (b) to
read as follows:
Sec. 522.2470 Tiletamine and zolazepam.
* * * * *
(b) Sponsors. See Nos. 017033, 051311, and 054771 in Sec.
510.600(c) of this chapter.
* * * * *
Sec. 522.2630 [Amended]
0
14. In Sec. 522.2630, in paragraphs (b)(1) and (2), add in numerical
order the text ``069043''.
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
15. The authority citation for part 524 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 524.1580a [Amended]
0
16. Amend Sec. 524.1580a in paragraph (b)(1) by removing the text
``054925''.
Sec. 524.1580c [Removed]
0
17. Remove Sec. 524.1580c.
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. 558.128, revise paragraphs (e)(4)(ii), (vi), (viii),
(xxviii), (xxxi), (xxxii), (xxxv), (xxxvi), (xxxix), (xli), (xlii),
(l), (lii), (liv), (lvi), (lvii), (lix), and (lx) to read as follows:
Sec. 558.128 Chlortetracycline.
* * * * *
(e) * * *
(4) * * *
[[Page 95104]]
----------------------------------------------------------------------------------------------------------------
Combination in Indications for
Chlortetracycline amount grams/ton use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(ii) 5.83 to 14 g/ton to Melengestrol Growing beef Melengestrol acetate Type C 054771
provide 70 mg/head/day. acetate, 0.25 to heifers fed in top-dress medicated feed 069254
2 g/ton to confinement for must be top dressed or
provide 0.25 to slaughter (over mixed at feeding with the
0.5 mg 400 lb): For Type C medicated feed
melengestrol reduction of the containing 5.83 to 14 g/ton
acetate per head incidence of chlortetracycline.
per day. liver abscesses, Chlortetracycline as
increased rate of provided by Nos. 054771 or
weight gain, 069254; melengestrol as
improved feed provided by No. 054771 in
efficiency, and Sec. 510.600(c) of this
suppression of chapter.
estrus (heat).
* * * * * * *
(vi) 33.33 to 50 g/ton to Melengestrol Replacement beef Melengestrol acetate Type C 054771
provide 0.5 mg/lb of body acetate, 0.5 to 2 heifers over 700 top-dress medicated feed 069254
weight per day. g/ton to provide lb: For control must be top dressed or
0.5 mg of active mixed at feeding with the
melengestrol infection of Type C medicated feed
acetate per head anaplasmosis containing 33.33 to 50 g/
per day. caused by ton chlortetracycline.
Anaplasma Feeding a Type C top-dress
marginale medicated feed containing
susceptible to melengestrol acetate shall
chlortetracycline not exceed 24 days.
and for Chlortetracycline as
suppression of provided by Nos. 054771 or
estrus (heat). 069254; melengestrol as
provided by No. 054771 in
Sec. 510.600(c) of this
chapter.
* * * * * * *
(viii) 25 to 1,100 g/ton to Lasalocid, 30 to Replacement beef The melengestrol acetate 054771
provide 0.5 mg/lb of body 600; melengestrol heifers on Type C top-dress medicated 069254
weight daily. acetate, 0.5 to 2 pasture over 700 feed must be top dressed
g/ton to provide pounds: For onto or mixed at feeding
0.5 mg/head/day control of active with a Type C medicated
melengestrol infection of feed containing 25 to 1,100
acetate. anaplasmosis g/ton of chlortetracycline
caused by and 30 to 600 g/ton
Anaplasma lasalocid to provide 0.5 mg
marginale chlortetracycline per lb
susceptible to body weight per day and not
chlortetracycline less than 60 mg or more
, increased rate than 300 mg lasalocid per
of weight gain, head per day in at least 1
and suppression pound of feed. Do not
of estrus (heat). exceed 24 days of feeding.
See Sec. 558.311(d) of
this chapter.
Chlortetracycline as
provided by Nos. 054771 or
069254; lasalocid and
melengestrol as provided by
No. 054771 in Sec.
510.600(c) of this chapter.
* * * * * * *
(xxviii) 500 to 4,000 g/ton to Lasalocid, 30 to Replacement dairy The melengestrol acetate 054771
provide 10 mg/lb of body 600: Melengestrol heifers on Type C top-dress medicated 069254
weight daily. acetate, 0.5 to 2 pasture less than feed must be top dressed
g/ton to provide 20 months of age onto or mixed at feeding
0.5 mg/head/day and replacement with a Type C medicated
melengestrol beef heifers on feed containing 500 to
acetate. pasture: For 4,000 g/ton of
treatment of chlortetracycline and 30 to
bacterial 600 g/ton lasalocid to
enteritis caused provide 10 mg
by Escherichia chlortetracycline per lb
coli and body weight per day and not
bacterial less than 60 mg or more
pneumonia caused than 300 mg lasalocid per
by Pasteurella head per day in at least 1
multocida pound of feed for not more
organisms than 5 days. After
susceptible to completing feeding of this
chlortetracycline combination, continue
, increased rate feeding a Type C top-dress
of weight gain, medicated feed containing
and suppression melengestrol acetate alone
of estrus (heat). for a total time not
exceeding 24 days of
feeding. See Sec.
558.311(d) of this chapter.
Chlortetracycline as
provided by Nos. 054771 or
069254, lasalocid and
melengestrol as provided by
No. 054771 in Sec.
510.600(c) of this chapter.
* * * * * * *
(xxxi) 500 to 4,000 g/ton to Melengestrol Growing beef Melengestrol acetate Type C 054771
provide 10 mg/lb of body acetate, 0.25 to heifers fed in top-dress medicated feed 069254
weight daily. 2 g/ton to confinement for must be top dressed onto or
provide 0.25 to slaughter: For mixed at feeding with a
0.5 mg the treatment of Type C medicated feed
melengestrol bacterial containing 500 to 4,000 g/
acetate per head enteritis caused ton chlortetracycline for
per day. by Escherichia not more than 5 days. After
coli and completing feeding of this
bacterial combination, continue
pneumonia caused feeding a Type C top-dress
by Pasteurella medicated feed containing
multocida melengestrol acetate alone.
organisms Chlortetracycline as
susceptible to provided by Nos. 054771 or
chlortetracycline 069254; melengestrol as
, increased rate provided by No. 054771 in
of weight gain, Sec. 510.600(c) of this
improved feed chapter.
efficiency, and
suppression of
estrus (heat).
[[Page 95105]]
(xxxii) 500 to 4,000 g/ton to Melengestrol Replacement dairy Melengestrol acetate Type C 054771
provide 10 mg/lb of body acetate, 0.5 to 2 heifers less than top-dress medicated feed 069254
weight daily. g/ton to provide 20 months of age must be top dressed or
0.5 mg and replacement mixed at feeding with a
melengestrol beef heifers: For Type C medicated feed
acetate per head the treatment of containing 500 to 4,000 g/
per day. bacterial ton chlortetracycline for
enteritis caused not more than 5 days. After
by Escherichia completing feeding of this
coli and combination, continue
bacterial feeding a Type C top-dress
pneumonia caused medicated feed containing
by Pasteurella melengestrol acetate alone
multocida for a total time not
organisms exceeding 24 days. Use in
susceptible to dairy heifers less than 20
chlortetracycline months of age may cause
, and for drug residues in milk and/
suppression of or in calves born to these
estrus (heat). 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.
Chlortetracycline as
provided by Nos. 054771 or
069254; melengestrol as
provided by No. 054771 in
Sec. 510.600(c) of this
chapter.
* * * * * * *
(xxxv) 4,000 to 20,000 g/ton to Melengestrol Growing beef Top dress 0.5 to 2 pounds of 054771
provide 10 mg/lb of body acetate, 0.25 to heifers fed in this medicated feed 069254
weight per day. 2 g/ton to confinement for containing both drugs onto
provide 0.25 to slaughter: For or mix at feeding with a
0.5 mg the treatment of non-medicated feed for not
melengestrol bacterial more than 5 days to provide
acetate per head enteritis caused 10 mg chlortetracycline per
per day. by Escherichia pound of body weight per
coli and day. After completing
bacterial feeding of this
pneumonia caused combination, continue
by Pasteurella feeding a Type C top-dress
multocida medicated feed containing
organisms melengestrol acetate alone.
susceptible to A withdrawal period has not
chlortetracycline been established for this
, and for product in pre-ruminating
increased rate of calves. Do not use in
weight gain, calves to be processed for
improved feed veal. Chlortetracycline as
efficiency, and provided by Nos. 054771 or
suppression of 069254; melengestrol as
estrus (heat). provided by No. 054771 in
Sec. 510.600(c) of this
chapter.
(xxxvi) 4,000 to 20,000 g/ton Melengestrol Replacement dairy Top dress 0.5 to 2 pounds of 054771
to provide 10 mg/lb of body acetate, 0.5 to 2 heifers less than this medicated feed 069254
weight per day. g/ton to provide 20 months of age containing both drugs onto
0.5 mg and replacement or mix at feeding with a
melengestrol beef heifers: For non-medicated feed for not
acetate per head the treatment of more than 5 days to provide
per day. bacterial 10 mg chlortetracycline per
enteritis caused pound of body weight per
by Escherichia day. After completing
coli and feeding of this
bacterial combination, continue
pneumonia caused feeding a Type C top-dress
by Pasteurella medicated feed containing
multocida melengestrol acetate alone
organisms for a total time not
susceptible to exceeding 24 days. Use in
chlortetracycline dairy heifers less than 20
, and for months of age may cause
suppression of drug residues in milk and/
estrus (heat). 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.
Chlortetracycline as
provided by Nos. 054771 or
069254; melengestrol as
provided by No. 054771 in
Sec. 510.600(c) of this
chapter.
* * * * * * *
(xxxix) 50 to 350 g/ton to Melengestrol Replacement beef Melengestrol acetate Type C 054771
provide 350 mg/head/day. acetate, 0.5 to 2 heifers under 700 top-dress medicated feed 069254
g/ton to provide lb: For control must be top dressed or
0.5 mg of active mixed at feeding with the
melengestrol infection of Type C medicated feed
acetate per head anaplasmosis containing 50 to 350 g/ton
per day. caused by chlortetracycline for up to
Anaplasma 24 days of feeding.
marginale Chlortetracycline as
susceptible to provided by Nos. 054771 or
chlortetracycline 069254; melengestrol as
and for provided by No. 054771 in
suppression of Sec. 510.600(c) of this
estrus (heat). chapter.
* * * * * * *
(xli) 20 to 350 g/ton to Melengestrol Growing beef Melengestrol acetate Type C 054771
provide 350 mg/head/day. acetate, 0.25 to heifers fed in top-dress medicated feed 069254
2 g/ton to confinement for must be top dressed onto or
provide 0.25 to slaughter: For mixed at feeding with the
0.5 mg control of Type C medicated feed
melengestrol bacterial containing 20 to 350 g/ton
acetate per head pneumonia chlortetracycline.
per day. associated with Chlortetracycline as
shipping fever provided by Nos. 054771 or
complex caused by 069254; melengestrol as
Pasteurella spp. provided by No. 054771 in
susceptible to Sec. 510.600(c) of this
chlortetracycline chapter.
, increased rate
of weight gain,
improved feed
efficiency, and
suppression of
estrus (heat).
[[Page 95106]]
(xlii) 20 to 350 g/ton to Melengestrol Replacement dairy Melengestrol acetate Type C 054771
provide 350 mg/head/day. acetate, 0.5 to 2 heifers less than top-dress medicated feed 069254
g/ton to provide 20 months of age must be top dressed or
0.5 mg and replacement mixed at feeding with the
melengestrol beef heifers: For Type C medicated feed
acetate per head control of containing 20 to 350 g/ton
per day. bacterial chlortetracycline. Feeding
pneumonia a Type C top-dress
associated with medicated feed containing
shipping fever melengestrol acetate shall
complex caused by not exceed 24 days of
Pasteurella spp. feeding. Use in dairy
susceptible to heifers less than 20 months
chlortetracycline of age may cause drug
and suppression residues in milk and/or in
of estrus (heat). 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. Chlortetracycline as
provided by Nos. 054771 or
069254; melengestrol as
provided by No. 054771 in
Sec. 510.600(c) of this
chapter.
* * * * * * *
(l) 25 to 700 g/ton to provide Lasalocid, 30 to Replacement beef The melengestrol acetate 054771
350 mg/head/day. 600; melengestrol heifers on Type C top-dress medicated 069254
acetate, 0.5 to 2 pasture: For feed must be top dressed
g/ton to provide control of onto or mixed at feeding
0.5 mg/head/day bacterial with a Type C medicated
melengestrol pneumonia feed containing 25 to 700 g/
acetate. associated with ton of chlortetracycline
shipping fever and 30 to 600 g/ton
complex caused by lasalocid to provide 350 mg
Pasteurella spp. chlortetracycline per head
susceptible to daily and not less than 60
chlortetracycline mg or more than 300 mg
, increased rate lasalocid per head daily in
of weight gain, at least 1 pound of feed.
and suppression Do not exceed 24 days of
of estrus (heat). feeding. See Sec.
558.311(d) of this chapter.
Chlortetracycline as
provided by Nos. 054771 or
069254; lasalocid and
melengestrol as provided by
No. 054771 in Sec.
510.600(c) of this chapter.
* * * * * * *
(lii) 25 to 700 g/ton to Lasalocid, 30 to Replacement beef The melengestrol acetate 054771
provide 350 mg/head/day. 600; melengestrol heifers on Type C top-dress medicated 069254
acetate, 0.5 to 2 pasture under 700 feed must be top dressed
g/ton to provide pounds: For onto or mixed at feeding
0.5 mg/head/day control of active with a Type C medicated
melengestrol infection of feed containing 25 to 700 g/
acetate. anaplasmosis ton of chlortetracycline
caused by and 30 to 600 g/ton
Anaplasma lasalocid to provide 350 mg
marginale chlortetracycline per head
susceptible to daily and not less than 60
chlortetracycline mg or more than 300 mg
, increased rate lasalocid per head daily in
of weight gain, at least 1 pound of feed.
and suppression Do not exceed 24 days of
of estrus (heat). feeding. See Sec.
558.311(d) of this chapter.
Chlortetracycline as
provided by Nos. 054771 or
069254; lasalocid and
melengestrol as provided by
No. 054771 in Sec.
510.600(c) of this chapter.
* * * * * * *
(liv) 25 to 2,800 g/ton to Lasalocid, 30 to Growing beef The melengestrol acetate 054771
provide 350 mg/head/day. 181.8; heifers fed in Type C top-dress medicated 069254
melengestrol confinement for feed must be top dressed
acetate, 0.25 to slaughter under onto or mixed at feeding
2 g/ton to 700 pounds: For with a Type C medicated
provide 0.25 to control of active feed containing 25 to 2,800
0.5 mg/head/day infection of g/ton of chlortetracycline
melengestrol anaplasmosis and 30 to 181.8 g/ton
acetate. caused by lasalocid to provide 350 mg
Anaplasma chlortetracycline per head
marginale per day and 1 mg lasalocid
susceptible to per 2.2 lb. of body weight
chlortetracycline daily with a maximum of 360
, control of mg lasalocid per head per
coccidiosis day. See Sec. 558.311(d)
caused by Eimeria of this chapter.
bovis and E. Chlortetracycline as
zuernii, provided by Nos. 054771 or
increased rate of 069254; lasalocid and
weight gain, melengestrol as provided by
improved feed No. 054771 in Sec.
efficiency, and 510.600(c) of this chapter.
suppression of
estrus (heat).
* * * * * * *
(lvi) 25 to 2,800 g/ton to Lasalocid, 30 to Growing beef The melengestrol acetate 054771
provide 350 mg/head/day. 181.8; heifers fed in Type C top-dress medicated 069254
melengestrol confinement for feed must be top dressed
acetate, 0.25 to slaughter up to onto or mixed at feeding
2 g/ton to 800 pounds: For with a Type C medicated
provide 0.25 to control of feed containing 25 to 2,800
0.5 mg/head/day bacterial g/ton of chlortetracycline
melengestrol pneumonia and 30 to 181.8 g/ton
acetate. associated with lasalocid to provide 350 mg
shipping fever chlortetracycline per head
complex caused by daily and 1 mg lasalocid
Pasteurella spp. per 2.2 lb. of body weight
susceptible to daily with a maximum of 360
chlortetracycline mg lasalocid per head per
, control of day. SeeSec. 558.311(d)
coccidiosis of this chapter.
caused by Eimeria Chlortetracycline as
bovis and E. provided by Nos. 054771 or
zuernii, 069254; lasalocid and
increased rate of melengestrol as provided by
weight gain, No. 054771 in Sec.
improved feed 510.600(c) of this chapter.
efficiency, and
suppression of
estrus (heat).
[[Page 95107]]
(lvii) 25 to 2,800 g/ton to Lasalocid, 30 to Replacement beef The melengestrol acetate 054771
provide 350 mg/head/day. 181.8; heifers up to 800 Type C top-dress medicated 069254
melengestrol pounds: For feed must be top dressed
acetate, 0.5 to 2 control of onto or mixed at feeding
g/ton to provide bacterial with a Type C medicated
0.5 mg/head/day pneumonia feed containing 25 to 2,800
melengestrol associated with g/ton of chlortetracycline
acetate. shipping fever and 30 to 181.8 g/ton
complex caused by lasalocid to provide 350 mg
Pasteurella spp. chlortetracycline per head
susceptible to daily and 1 mg lasalocid
chlortetracycline per 2.2 lb. of body weight
, control of daily with a maximum of 360
coccidiosis mg lasalocid per head per
caused by Eimeria day. Do not exceed 24 days
bovis and E. of feeding. See Sec.
zuernii, and 558.311(d) of this chapter.
suppression of Chlortetracycline as
estrus (heat). provided by Nos. 054771 or
069254; lasalocid and
melengestrol as provided by
No. 054771 in Sec.
510.600(c) of this chapter.
* * * * * * *
(lix) 500 to 4,000 g/ton to Lasalocid, 30 to Growing beef The melengestrol acetate 054771
provide 10 mg/lb of body 181.8; heifers fed in Type C top-dress medicated 069254
weight daily. melengestrol confinement for feed must be top dressed
acetate, 0.25 to slaughter up to onto or mixed at feeding
2 g/ton to 800 pounds: For with a Type C medicated
provide 0.25 to the treatment of feed containing 500 to
0.5 mg/head/day bacterial 4,000 g/ton of
melengestrol enteritis caused chlortetracycline and 30 to
acetate. by Escherichia 181.8 g/ton lasalocid to
coli and provide 10 mg
bacterial chlortetracycline per lb of
pneumonia caused body weight per day and 1
by Pasteurella mg lasalocid per 2.2 lb of
multocida body weight per day with a
organisms maximum of 360 mg lasalocid
susceptible to per head per day for not
chlortetracycline more than 5 days of
, control of feeding. After completing
coccidiosis feeding of this
caused by Eimeria combination, continue
bovis and E. feeding a Type C top-dress
zuernii, medicated feed containing
increased rate of melengestrol acetate alone.
weight gain, See Sec. 558.311(d) of
improved feed this chapter.
efficiency, and Chlortetracycline as
suppression of provided by Nos. 054771 or
estrus (heat). 069254; lasalocid and
melengestrol as provided by
No. 054771 in Sec.
510.600(c) of this chapter.
(lx) 500 to 4,000 g/ton to Lasalocid, 30 to Replacement dairy The melengestrol acetate 054771
provide 10 mg/lb of body 181.8; heifers up to 800 Type C top-dress medicated 069254
weight daily. melengestrol pounds and less feed must be top dressed
acetate, 0.5 to 2 than 20 months of onto or mixed at feeding
g/ton to provide age and with a Type C medicated
0.5 mg/head/day replacement beef feed containing 500 to
melengestrol heifers up to 800 4,000 g/ton of
acetate. pounds: For the chlortetracycline and 30 to
treatment of 181.8 g/ton lasalocid to
bacterial provide 10 mg
enteritis caused chlortetracycline per lb of
by Escherichia body weight per day and 1
coli and mg lasalocid per 2.2 lb of
bacterial body weight per day with a
pneumonia caused maximum of 360 mg lasalocid
by Pasteurella per head per day for not
multocida more than 5 days. After
organisms completing feeding of this
susceptible to combination, continue
chlortetracycline feeding a Type C top-dress
, control of medicated feed containing
coccidiosis melengestrol acetate alone.
caused by Eimeria See Sec. 558.311(d) of
bovis and E. this chapter.
zuernii, and Chlortetracycline as
suppression of provided by Nos. 054771 or
estrus (heat). 069254; lasalocid and
melengestrol as provided by
No. 054771 in Sec.
510.600(c) of this chapter.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
0
20. In Sec. 558.355:
0
a. Revise paragraphs (b)(1) and (2);
0
b. Revise the headings for paragraphs (d)(9)(i) and (ii) and (d)(10)(i)
and (ii);
0
c. Redesignate paragraph (f) as paragraph (e);
0
d. Revise newly redesignated paragraphs (e)(1)(i) and (ii), (e)(2)(i),
and (e)(5);
0
e. Remove newly redesignated paragraph (e)(6); and
0
f. Redesignate newly redesignated paragraph (e)(7) as paragraph (e)(6).
The revisions read as follows:
Sec. 558.355 Monensin.
* * * * *
(b) * * *
(1) No. 058198 for use as in paragraph (e) of this section.
(2) No. 016592 for use of a Type A medicated article containing
90.7 grams monensin, USP, per pound as in paragraphs (e)(1)(i),
(e)(1)(ii), (e)(2)(i), (e)(3), (e)(4)(v), and (e)(5) of this section.
* * * * *
(d) * * *
(9) * * *
(i) Cattle (as described in paragraphs (e)(3)(i) through (iii),
(vi), and (vii); and (e)(4)(i) through (vi) of this section). * * *
(ii) Dairy cows (as described in paragraphs (e)(3)(iv) and (v) of
this section).* * *
(10) * * *
(i) Cattle (as described in paragraphs (e)(3)(i) through (iii),
(vi), and (vii); and (e)(4)(i) through (vi) of this section). * * *
(ii) Dairy cows (as described in paragraphs (e)(3)(iv) and (v) of
this section).* * *
* * * * *
(e) * * *
(1) * * *
[[Page 95108]]
----------------------------------------------------------------------------------------------------------------
Monensin in grams/ton Combination in grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 90 to 110........... ........................ Broiler chickens: Feed continuously as the 016592
As an aid in the sole ration. Not for 058198
prevention of broiler breeder replacement
coccidiosis caused chickens. Do not feed to
by E. necatrix, E. chickens over 16 weeks of
tenella, E. age. Do not feed to laying
acervulina, E. chickens. In the absence of
brunetti, E. coccidiosis in broiler
mivati, and E. chickens the use of
maxima. monensin with no withdrawal
period may limit feed
intake resulting in reduced
weight gain. Do not allow
horses, other equines,
mature turkeys, or guinea
fowl access to feed
containing monensin.
Ingestion of monensin by
horses and guinea fowl has
been fatal.
(ii) 90 to 110.......... ........................ Laying hen Feed continuously as the 016592
replacement sole ration. Not for 058198
chickens and layer broiler breeder replacement
breeder chickens. Do not feed to
replacement chickens over 16 weeks of
chickens: As an age. Do not feed to laying
aid in the chickens. In the absence of
prevention of coccidiosis in broiler
coccidiosis caused chickens the use of
by E. necatrix, E. monensin with no withdrawal
tenella, E. period may limit feed
acervulina, E. intake resulting in reduced
brunetti, E. weight gain. Do not allow
mivati, and E. horses, other equines,
maxima. mature turkeys, or guinea
fowl access to feed
containing monensin.
Ingestion of monensin by
horses and guinea fowl has
been fatal.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
(2) * * *
----------------------------------------------------------------------------------------------------------------
Monensin in grams/ton Combination in grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 54 to 90............ ........................ Growing turkeys: For growing turkeys only. 016592
For the prevention Feed continuously as sole 058198
of coccidiosis ration. Some strains of
caused by E. turkey coccidia may be
adenoeides, E. monensin tolerant or
meleagrimitis, and resistant. Not for broiler
E.gallopavonis. breeder replacement
chickens. Do not feed to
laying hens. Do not feed to
chickens over 16 weeks of
age. Monensin may interfere
with development of
immunity to turkey
coccidiosis. Do not allow
horses, other equines,
mature turkeys, or guinea
fowl access to feed
containing monensin.
Ingestion of monensin by
horses and guinea fowl has
been fatal.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
(5) Minor species--
----------------------------------------------------------------------------------------------------------------
Monensin in grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 73........................... Growing bobwhite quail: For Feed continuously as sole ration. Not 016592
the prevention of for broiler breeder replacement 058198
coccidiosis caused by chickens. Do not feed to laying
Eimeria dispersa and E. hens. Do not feed to chickens over
lettyae. 16 weeks of age. Do not allow
horses, other equines, mature
turkeys, or guinea fowl access to
feed containing monensin. Ingestion
of monensin by horses and guinea
fowl has been fatal.
(ii) 20.......................... Goats maintained in Feed continuously. Do not feed to 016592
confinement: For the lactating goats. See paragraph 058198
prevention of coccidiosis (d)(11) of this section for
caused by Eimeria provisions for monensin liquid Type
crandallis, E. C goat feeds.
christenseni, and E.
ninakohlyakimovae.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
Dated: November 20, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-28061 Filed 11-29-24; 8:45 am]
BILLING CODE 4164-01-P
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