New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor, 95101-95108 [2024-28061]
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Federal Register / Vol. 89, No. 231 / Monday, December 2, 2024 / Rules and Regulations
approach fix (FAF), and to contain the
departure procedure starting at
JODRO—given that arrivals are visual
flight rules (VFR) after the FAF, and
departures are VFR until reaching
JODRO.
In addition, the Chenega, AK, Class E
airspace extending upward from 700
feet above the surface of the earth is
extended to the north of the airport to
contain arriving IFR operations below
1,500 feet above the surface until
reaching the FAF.
Finally, the FAA is modifying the
airport’s associated legal description to
update the city name within the text
header from ‘‘Chenega Bay, AK’’ to
‘‘Chenega, AK.’’
Regulatory Notices and Analyses
The FAA has determined that this
regulation only involves an established
body of technical regulations for which
frequent and routine amendments are
necessary to keep them operationally
current. It, therefore: (1) is not a
‘‘significant regulatory action’’ under
Executive Order 12866; (2) is not a
‘‘significant rule’’ under DOT
Regulatory Policies and Procedures (44
FR 11034; February 26, 1979); and (3)
does not warrant preparation of a
regulatory evaluation as the anticipated
impact is so minimal. Since this is a
routine matter that only affects air traffic
procedures and air navigation, it is
certified that this rule, when
promulgated, does not have a significant
economic impact on a substantial
number of small entities under the
criteria of the Regulatory Flexibility Act.
PART 71—DESIGNATION OF CLASS A,
B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND
REPORTING POINTS
1. The authority citation for 14 CFR
part 71 continues to read as follows:
■
Authority: 49 U.S.C. 106(f), 106(g), 40103,
40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR,
1959–1963 Comp., p. 389.
§ 71.1
[Amended]
2. The incorporation by reference in
14 CFR part 71.1 of FAA Order JO
7400.11J, Airspace Designations and
Reporting Points, dated July 31, 2024,
and effective September 15, 2024, is
amended as follows:
■
Paragraph 6005 Class E Airspace Areas
Extending Upward From 700 Feet or More
Above the Surface of the Earth.
*
*
*
*
*
AAL AK E5 Chenega, AK [Amended]
Chenega Bay Airport, AK
(Lat. 60°04′43″ N, long. 147°59′41″ W)
That airspace extending upward from 700
feet above the surface within an area
bounded by a line beginning at lat. 60°11′28″
N, long. 148°4′30″ W; to lat. 60°18′43″ N,
long. 147°59′37″ W; to lat. 60°18′23″ N, long
147°55′19″ W; to lat. 60°14′30″ N, long.
147°56′37″ W; to lat. 60°5′57″ N, long.
147°37′29″ W; to lat. 60°3′26″ N, long.
147°42′48″ W; thence to the point of
beginning.
*
*
*
*
*
Issued in Des Moines, Washington, on
November 25, 2024.
B.G. Chew,
Group Manager, Operations Support Group,
Western Service Center.
[FR Doc. 2024–28135 Filed 11–29–24; 8:45 am]
BILLING CODE 4910–13–P
Environmental Review
The FAA has determined that this
action qualifies for categorical exclusion
under the National Environmental
Policy Act in accordance with FAA
Order 1050.1F, ‘‘Environmental
Impacts: Policies and Procedures,’’
paragraph 5–6.5.a. This airspace action
is not expected to cause any potentially
significant environmental impacts, and
no extraordinary circumstances exist
that warrant preparation of an
environmental assessment.
ddrumheller on DSK120RN23PROD with RULES1
Airspace, Incorporation by reference,
Navigation (air).
The Amendment
In consideration of the foregoing, the
Federal Aviation Administration
amends 14 CFR part 71 as follows:
16:22 Nov 29, 2024
Jkt 265001
providing notice that the final rule
published on October 16, 2024, to
designate Chumash Heritage National
Marine Sanctuary (CHNMS), is effective
on November 30, 2024.
DATES: The final rule to designate
CHNMS, which was published in the
Federal Register (89 FR 83554) on
October 16, 2024, is effective November
30, 2024.
FOR FURTHER INFORMATION CONTACT:
Laura Ingulsrud, West Coast Regional
Policy Analyst, 99 Pacific Street, Suite
100F, Monterey, CA 93940, 831–647–
6450, laura.ingulsrud@noaa.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to Section 304(b) of the National Marine
Sanctuaries Act (NMSA) (16 U.S.C.
1434(b)), NOAA published in the
Federal Register notification of the
designation of CHNMS and final
regulations to implement the
designation on October 16, 2024 (89 FR
83554). As required by the NMSA, the
designation and regulations would
become effective following the close of
a review period of 45 days of
continuous session of Congress
beginning on the date of publication (16
U.S.C. 1434(b)(1)). The regulations are
effective as of November 30, 2024.
List of Subjects in 15 CFR Part 922
Administrative practice and
procedure, Coastal zone, Cultural
resources, Historic preservation, Marine
protected areas, Marine resources,
National marine sanctuaries, Recreation
and recreation areas, Reporting and
recordkeeping requirements,
Shipwrecks.
John Armor,
Director, Office of National Marine
Sanctuaries, National Ocean Service,
National Oceanic and Atmospheric
Administration.
[FR Doc. 2024–27387 Filed 11–29–24; 8:45 am]
National Oceanic and Atmospheric
Administration
BILLING CODE 3510–NK–P
15 CFR Part 922
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. 240829–0230]
RIN 0648–BL31
Food and Drug Administration
Chumash Heritage National Marine
Sanctuary
Office of National Marine
Sanctuaries, National Ocean Service,
National Oceanic and Atmospheric
Administration, Department of
Commerce.
ACTION: Notification of effective date of
final rule.
AGENCY:
List of Subjects in 14 CFR Part 71
VerDate Sep<11>2014
DEPARTMENT OF COMMERCE
95101
The National Oceanic and
Atmospheric Administration (NOAA) is
SUMMARY:
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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.
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Federal Register / Vol. 89, No. 231 / Monday, December 2, 2024 / Rules and Regulations
Final rule; technical
amendments.
ACTION:
DATES:
This rule is effective December 2,
2024.
FOR FURTHER INFORMATION CONTACT:
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.
SUMMARY:
George K. Haibel, Center for Veterinary
Medicine, Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–5689,
George.Haibel@fda.hhs.gov.
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:
https://animaldrugsatfda.fda.gov/
adafda/views/#/search.
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING JULY, AUGUST, AND SEPTEMBER
2024 REQUIRING EVIDENCE OF SAFETY AND/OR EFFECTIVENESS
Date of approval
File No.
Sponsor
(drug labeler code 1)
Product name
Effect of the action
July 2, 2024 ................
200–788
Bimeda Animal Health Ltd. (061133)
MOXISOLV Injection (moxidectin) ....
July 8, 2024 ................
200–771
Norbrook Laboratories, Ltd. (055529)
August 15, 2024 .........
200–770
Pharmgate Inc. (069254) ..................
August 26, 2024 .........
200–783
Huvepharma EOOD (016592) ..........
FELANORM (methimazole) Oral Solution.
DERACIN (chlortetracycline) and
MGA (melengestrol acetate) Type
C medicated feeds.
COXIDIN 90 (monensin) Type C
medicated feeds.
September 5, 2024 .....
200–795
September 5, 2024 .....
200–773
September 10, 2024 ...
200–774
Felix Pharmaceuticals Pvt. Ltd.
(086101).
Cronus Pharma Specialties India Private Ltd. (069043).
Do ......................................................
September 19, 2024 ...
141–585
Elanco US Inc. (058198) ..................
September 23, 2024 ...
200–776
Pharmgate Inc. (069254 ...................
1 See
CARPROFEN Soft Chewable Tablets (carprofen).
TULAJECT 100 (tulathromycin injection) Injectable Solution.
TULAJECT 25 (tulathromycin injection) Injectable Solution.
ZENRELIA (ilunocitinib tablet) ..........
DERACIN (chlortetracycline),
BOVATEC (lasalocid), and MGA
(melengestrol acetate) Type C
medicated feeds.
Original approval as a generic copy
of NADA 141–220.
Original approval as a generic copy
of NADA 141–292.
Original approval as a generic copy
of NADA 141–530.
Original approval as a generic copy
of NADA 038–878 and NADA
130–736.
Original approval as a generic copy
of NADA 141–111.
Original approval as a generic copy
of NADA 141–224.
Original approval as a generic copy
of NADA 141–349.
Original approval for control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs.
Original approval as a generic copy
of NADA 141–531.
21 CFR
section
522.1450
520.1372
558.128
558.355
520.304
522.2630
Do.
520.1136
558.128
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 approval
Product name
21 CFR
section
Nitrofurazone Anesthetic Dressing (nitrofurazone and butacaine sulfate) ...............................................................
Nitrofurazone Soluble Dressing (nitrofurazone) ........................................................................................................
524.1580c
524.1580a
File No.
August 8, 2024 ................
Do ....................................
130–872
140–881
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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
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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:
• 21 CFR 510.600(c) is amended to
remove Cephazone Pharma, LLC and
Provetica LLC from the lists of sponsors
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of approved applications as these firms
are no longer the sponsor of an
approved application.
• 21 CFR 520.522 is amended to
reflect a 2023 change of sponsorship for
cyclosporine oral solution.
• 21 CFR 520.2090 is amended to
revise the description of a tablet
containing sarolaner, moxidectin, and
pyrantel.
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Federal Register / Vol. 89, No. 231 / Monday, December 2, 2024 / Rules and Regulations
• 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.
PART 510—NEW ANIMAL DRUGS
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.
[Amended]
2. In § 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
3. The authority citation for part 520
continues to read as follows:
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[Amended]
4. In § 520.304, in paragraph (b)(2),
add in numerical order the text
‘‘086101’’.
■
[Amended]
5. In § 520.522 in paragraph (b)(4),
remove the text ‘‘086097’’ and add in its
place the text ‘‘013744’’.
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§ 520.1376
Methimazole solution.
(a) Specifications. Each milliliter of
solution contains 5 milligrams (mg)
methimazole.
(b) Sponsor. See No. 055529 in
§ 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.
■ 9. In § 520.2090, revise paragraph
(a)(1) to read as follows:
Sarolaner, moxidectin, and
(a) * * *
(1) 3.0 milligrams (mg) sarolaner, 0.06
mg moxidectin, and 12.5 mg pyrantel
(as pamoate salt);
*
*
*
*
*
Authority: 21 U.S.C. 360b.
■
■
Methimazole tablets.
*
*
*
*
8. Add § 520.1376 to read as follows:
§ 520.2090
pyrantel.
■
§ 520.522
[Redesignated as § 520.1375]
7. Redesignate § 520.1372 as
§ 520.1375 and revise the section
heading to read as follows:
§ 520.1375
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
10. The authority citation for part 522
continues to read as follows:
■
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11. In § 522.313c, revise paragraph (b)
to read as follows:
■
Ilunocitinib.
(a) Specifications. Each tablet
contains 4.8, 6.4, 8.5, and 15 milligrams
(mg) ilunocitinib.
(b) Sponsor. See No. 058198 in
§ 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.
■
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:
§ 520.304
§ 520.1136
*
Authority: 21 U.S.C. 360b.
6. Add § 520.1136 to read as follows:
§ 520.1372
21 CFR Parts 520, 522, and 524
Animal drugs.
§ 510.600
■
95103
§ 522.313c
Ceftiofur sodium.
*
*
*
*
*
(b) Sponsors. See Nos. 017033 and
054771 in § 510.600(c) of this chapter.
*
*
*
*
*
■ 12. In § 522.1450, revise paragraph (b)
to read as follows:
§ 522.1450
Moxidectin solution.
*
*
*
*
*
(b) Sponsors. See Nos. 055529,
058198, and 061133 in § 510.600(c) of
this chapter.
*
*
*
*
*
■ 13. In § 522.2470, revise the section
heading and paragraph (b) to read as
follows:
§ 522.2470
Tiletamine and zolazepam.
*
*
*
*
*
(b) Sponsors. See Nos. 017033,
051311, and 054771 in § 510.600(c) of
this chapter.
*
*
*
*
*
§ 522.2630
[Amended]
14. In § 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
15. The authority citation for part 524
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
§ 524.1580a
[Amended]
16. Amend § 524.1580a in paragraph
(b)(1) by removing the text ‘‘054925’’.
■
§ 524.1580c
■
[Removed]
17. Remove § 524.1580c.
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
18. The authority citation for part 558
continues to read as follows:
■
Authority: 21 U.S.C. 354, 360b, 360ccc,
360ccc–1, 371.
19. In § 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:
■
§ 558.128
*
Chlortetracycline.
*
*
(e) * * *
(4) * * *
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Federal Register / Vol. 89, No. 231 / Monday, December 2, 2024 / Rules and Regulations
ddrumheller on DSK120RN23PROD with RULES1
Chlortetracycline amount
Combination in grams/ton
Indications for use
Limitations
*
(ii) 5.83 to 14 g/ton to provide 70
mg/head/day.
*
*
Melengestrol acetate, 0.25 to 2
g/ton to provide 0.25 to 0.5
mg melengestrol acetate per
head per day.
*
*
*
*
Growing beef heifers fed in con- Melengestrol acetate Type C top-dress medifinement for slaughter (over
cated feed must be top dressed or mixed at
400 lb): For reduction of the
feeding with the Type C medicated feed conincidence of liver abscesses,
taining 5.83 to 14 g/ton chlortetracycline.
increased rate of weight gain,
Chlortetracycline as provided by Nos. 054771
improved feed efficiency, and
or 069254; melengestrol as provided by No.
suppression of estrus (heat).
054771 in § 510.600(c) of this chapter.
*
(vi) 33.33 to 50 g/ton to provide
0.5 mg/lb of body weight per
day.
*
*
Melengestrol acetate, 0.5 to 2 g/
ton to provide 0.5 mg
melengestrol acetate per
head per day.
*
*
*
*
Replacement beef heifers over
Melengestrol acetate Type C top-dress medi700 lb: For control of active
cated feed must be top dressed or mixed at
infection of anaplasmosis
feeding with the Type C medicated feed concaused by Anaplasma
taining 33.33 to 50 g/ton chlortetracycline.
marginale susceptible to
Feeding a Type C top-dress medicated feed
chlortetracycline and for supcontaining melengestrol acetate shall not expression of estrus (heat).
ceed 24 days. Chlortetracycline as provided
by Nos. 054771 or 069254; melengestrol as
provided by No. 054771 in § 510.600(c) of this
chapter.
*
(viii) 25 to 1,100 g/ton to provide
0.5 mg/lb of body weight daily.
*
*
Lasalocid, 30 to 600;
melengestrol acetate, 0.5 to 2
g/ton to provide 0.5 mg/head/
day melengestrol acetate.
*
*
*
*
Replacement beef heifers on
The melengestrol acetate Type C top-dress
pasture over 700 pounds: For
medicated feed must be top dressed onto or
control of active infection of
mixed at feeding with a Type C medicated
anaplasmosis caused by
feed containing 25 to 1,100 g/ton of chlortetraAnaplasma marginale suscepcycline and 30 to 600 g/ton lasalocid to protible to chlortetracycline, invide 0.5 mg chlortetracycline per lb body
creased rate of weight gain,
weight per day and not less than 60 mg or
and suppression of estrus
more than 300 mg lasalocid per head per day
(heat).
in at least 1 pound of feed. Do not exceed 24
days of feeding. See § 558.311(d) of this
chapter. Chlortetracycline as provided by Nos.
054771 or 069254; lasalocid and melengestrol
as provided by No. 054771 in § 510.600(c) of
this chapter.
*
(xxviii) 500 to 4,000 g/ton to provide 10 mg/lb of body weight
daily.
*
*
Lasalocid, 30 to 600:
Melengestrol acetate, 0.5 to 2
g/ton to provide 0.5 mg/head/
day melengestrol acetate.
*
*
*
*
Replacement dairy heifers on
The melengestrol acetate Type C top-dress
pasture less than 20 months
medicated feed must be top dressed onto or
of age and replacement beef
mixed at feeding with a Type C medicated
heifers on pasture: For treatfeed containing 500 to 4,000 g/ton of chlorment of bacterial enteritis
tetracycline and 30 to 600 g/ton lasalocid to
caused by Escherichia coli
provide 10 mg chlortetracycline per lb body
and bacterial pneumonia
weight per day and not less than 60 mg or
caused by Pasteurella
more than 300 mg lasalocid per head per day
multocida organisms suscepin at least 1 pound of feed for not more than 5
tible to chlortetracycline, indays. After completing feeding of this comcreased rate of weight gain,
bination, continue feeding a Type C top-dress
and suppression of estrus
medicated feed containing melengestrol ace(heat).
tate alone for a total time not exceeding 24
days of feeding. See § 558.311(d) of this
chapter. Chlortetracycline as provided by Nos.
054771 or 069254, lasalocid and melengestrol
as provided by No. 054771 in § 510.600(c) of
this chapter.
*
(xxxi) 500 to 4,000 g/ton to provide 10 mg/lb of body weight
daily.
*
*
Melengestrol acetate, 0.25 to 2
g/ton to provide 0.25 to 0.5
mg melengestrol acetate per
head per day.
*
*
*
*
Growing beef heifers fed in con- Melengestrol acetate Type C top-dress medifinement for slaughter: For
cated feed must be top dressed onto or mixed
the treatment of bacterial enat feeding with a Type C medicated feed conteritis caused by Escherichia
taining 500 to 4,000 g/ton chlortetracycline for
coli and bacterial pneumonia
not more than 5 days. After completing feedcaused by Pasteurella
ing of this combination, continue feeding a
multocida organisms suscepType C top-dress medicated feed containing
tible to chlortetracycline, inmelengestrol acetate alone. Chlortetracycline
creased rate of weight gain,
as provided by Nos. 054771 or 069254;
improved feed efficiency, and
melengestrol as provided by No. 054771 in
suppression of estrus (heat).
§ 510.600(c) of this chapter.
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Sponsor
054771
069254
054771
069254
054771
069254
054771
069254
054771
069254
ddrumheller on DSK120RN23PROD with RULES1
Federal Register / Vol. 89, No. 231 / Monday, December 2, 2024 / Rules and Regulations
Chlortetracycline amount
Combination in grams/ton
Indications for use
Limitations
(xxxii) 500 to 4,000 g/ton to provide 10 mg/lb of body weight
daily.
Melengestrol acetate, 0.5 to 2 g/
ton to provide 0.5 mg
melengestrol acetate per
head per day.
Replacement dairy heifers less
than 20 months of age and
replacement beef heifers: For
the treatment of bacterial enteritis caused by Escherichia
coli and bacterial pneumonia
caused by Pasteurella
multocida organisms susceptible to chlortetracycline, and
for suppression of estrus
(heat).
Melengestrol acetate Type C top-dress medicated feed must be top dressed or mixed at
feeding with a Type C medicated feed containing 500 to 4,000 g/ton chlortetracycline for
not more than 5 days. After completing feeding of this combination, continue feeding a
Type C top-dress medicated feed containing
melengestrol acetate alone for a total time not
exceeding 24 days. Use in dairy heifers less
than 20 months of age 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. Chlortetracycline as provided by Nos.
054771 or 069254; melengestrol as provided
by No. 054771 in § 510.600(c) of this chapter.
*
(xxxv) 4,000 to 20,000 g/ton to
provide 10 mg/lb of body
weight per day.
*
*
Melengestrol acetate, 0.25 to 2
g/ton to provide 0.25 to 0.5
mg melengestrol acetate per
head per day.
(xxxvi) 4,000 to 20,000 g/ton to
provide 10 mg/lb of body
weight per day.
Melengestrol acetate, 0.5 to 2 g/
ton to provide 0.5 mg
melengestrol acetate per
head per day.
*
*
*
*
Growing beef heifers fed in con- Top dress 0.5 to 2 pounds of this medicated
finement for slaughter: For
feed containing both drugs onto or mix at
the treatment of bacterial enfeeding with a non-medicated feed for not
teritis caused by Escherichia
more than 5 days to provide 10 mg chlortetracoli and bacterial pneumonia
cycline per pound of body weight per day.
caused by Pasteurella
After completing feeding of this combination,
multocida organisms suscepcontinue feeding a Type C top-dress meditible to chlortetracycline, and
cated feed containing melengestrol acetate
for increased rate of weight
alone. A withdrawal period has not been esgain, improved feed effitablished for this product in pre-ruminating
ciency, and suppression of
calves. Do not use in calves to be processed
estrus (heat).
for veal. Chlortetracycline as provided by Nos.
054771 or 069254; melengestrol as provided
by No. 054771 in § 510.600(c) of this chapter.
Replacement dairy heifers less
Top dress 0.5 to 2 pounds of this medicated
than 20 months of age and
feed containing both drugs onto or mix at
replacement beef heifers: For
feeding with a non-medicated feed for not
the treatment of bacterial enmore than 5 days to provide 10 mg chlortetrateritis caused by Escherichia
cycline per pound of body weight per day.
coli and bacterial pneumonia
After completing feeding of this combination,
caused by Pasteurella
continue feeding a Type C top-dress medimultocida organisms suscepcated feed containing melengestrol acetate
tible to chlortetracycline, and
alone for a total time not exceeding 24 days.
for suppression of estrus
Use in dairy heifers less than 20 months of
(heat).
age 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. Chlortetracycline as
provided by Nos. 054771 or 069254;
melengestrol as provided by No. 054771 in
§ 510.600(c) of this chapter.
*
(xxxix) 50 to 350 g/ton to provide 350 mg/head/day.
*
*
Melengestrol acetate, 0.5 to 2 g/
ton to provide 0.5 mg
melengestrol acetate per
head per day.
*
*
*
*
Replacement beef heifers under Melengestrol acetate Type C top-dress medi700 lb: For control of active
cated feed must be top dressed or mixed at
infection of anaplasmosis
feeding with the Type C medicated feed concaused by Anaplasma
taining 50 to 350 g/ton chlortetracycline for up
marginale susceptible to
to 24 days of feeding. Chlortetracycline as
chlortetracycline and for supprovided by Nos. 054771 or 069254;
pression of estrus (heat).
melengestrol as provided by No. 054771 in
§ 510.600(c) of this chapter.
*
(xli) 20 to 350 g/ton to provide
350 mg/head/day.
*
*
Melengestrol acetate, 0.25 to 2
g/ton to provide 0.25 to 0.5
mg melengestrol acetate per
head per day.
*
*
*
*
Growing beef heifers fed in con- Melengestrol acetate Type C top-dress medifinement for slaughter: For
cated feed must be top dressed onto or mixed
control of bacterial pneumonia
at feeding with the Type C medicated feed
associated with shipping fever
containing 20 to 350 g/ton chlortetracycline.
complex caused by
Chlortetracycline as provided by Nos. 054771
Pasteurella spp. susceptible
or 069254; melengestrol as provided by No.
to chlortetracycline, increased
054771 in § 510.600(c) of this chapter.
rate of weight gain, improved
feed efficiency, and suppression of estrus (heat).
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054771
069254
054771
069254
054771
069254
054771
069254
95106
Federal Register / Vol. 89, No. 231 / Monday, December 2, 2024 / Rules and Regulations
ddrumheller on DSK120RN23PROD with RULES1
Chlortetracycline amount
Combination in grams/ton
Indications for use
Limitations
(xlii) 20 to 350 g/ton to provide
350 mg/head/day.
Melengestrol acetate, 0.5 to 2 g/
ton to provide 0.5 mg
melengestrol acetate per
head per day.
Replacement dairy heifers less
than 20 months of age and
replacement beef heifers: For
control of bacterial pneumonia
associated with shipping fever
complex caused by
Pasteurella spp. susceptible
to chlortetracycline and suppression of estrus (heat).
Melengestrol acetate Type C top-dress medicated feed must be top dressed or mixed at
feeding with the Type C medicated feed containing 20 to 350 g/ton chlortetracycline. Feeding a Type C top-dress medicated feed containing melengestrol acetate shall not exceed
24 days of feeding. Use in dairy heifers less
than 20 months of age 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. Chlortetracycline as provided by Nos.
054771 or 069254; melengestrol as provided
by No. 054771 in § 510.600(c) of this chapter.
*
(l) 25 to 700 g/ton to provide
350 mg/head/day.
*
*
Lasalocid, 30 to 600;
melengestrol acetate, 0.5 to 2
g/ton to provide 0.5 mg/head/
day melengestrol acetate.
*
*
*
*
Replacement beef heifers on
The melengestrol acetate Type C top-dress
pasture: For control of bacmedicated feed must be top dressed onto or
terial pneumonia associated
mixed at feeding with a Type C medicated
with shipping fever complex
feed containing 25 to 700 g/ton of chlortetracaused by Pasteurella spp.
cycline and 30 to 600 g/ton lasalocid to prosusceptible to chlortetravide 350 mg chlortetracycline per head daily
cycline, increased rate of
and not less than 60 mg or more than 300 mg
weight gain, and suppression
lasalocid per head daily in at least 1 pound of
of estrus (heat).
feed. Do not exceed 24 days of feeding. See
§ 558.311(d) of this chapter. Chlortetracycline
as provided by Nos. 054771 or 069254;
lasalocid and melengestrol as provided by No.
054771 in § 510.600(c) of this chapter.
*
(lii) 25 to 700 g/ton to provide
350 mg/head/day.
*
*
Lasalocid, 30 to 600;
melengestrol acetate, 0.5 to 2
g/ton to provide 0.5 mg/head/
day melengestrol acetate.
*
*
*
*
Replacement beef heifers on
The melengestrol acetate Type C top-dress
pasture under 700 pounds:
medicated feed must be top dressed onto or
For control of active infection
mixed at feeding with a Type C medicated
of anaplasmosis caused by
feed containing 25 to 700 g/ton of chlortetraAnaplasma marginale suscepcycline and 30 to 600 g/ton lasalocid to protible to chlortetracycline, invide 350 mg chlortetracycline per head daily
creased rate of weight gain,
and not less than 60 mg or more than 300 mg
and suppression of estrus
lasalocid per head daily in at least 1 pound of
(heat).
feed. Do not exceed 24 days of feeding. See
§ 558.311(d) of this chapter. Chlortetracycline
as provided by Nos. 054771 or 069254;
lasalocid and melengestrol as provided by No.
054771 in § 510.600(c) of this chapter.
*
(liv) 25 to 2,800 g/ton to provide
350 mg/head/day.
*
*
Lasalocid, 30 to 181.8;
melengestrol acetate, 0.25 to
2 g/ton to provide 0.25 to 0.5
mg/head/day melengestrol acetate.
*
*
*
*
Growing beef heifers fed in con- The melengestrol acetate Type C top-dress
finement for slaughter under
medicated feed must be top dressed onto or
700 pounds: For control of acmixed at feeding with a Type C medicated
tive infection of anaplasmosis
feed containing 25 to 2,800 g/ton of chlortetracaused by Anaplasma
cycline and 30 to 181.8 g/ton lasalocid to promarginale susceptible to
vide 350 mg chlortetracycline per head per
chlortetracycline, control of
day and 1 mg lasalocid per 2.2 lb. of body
coccidiosis caused by Eimeria
weight daily with a maximum of 360 mg
bovis and E. zuernii, inlasalocid per head per day. See § 558.311(d)
creased rate of weight gain,
of this chapter. Chlortetracycline as provided
improved feed efficiency, and
by Nos. 054771 or 069254; lasalocid and
suppression of estrus (heat).
melengestrol as provided by No. 054771 in
§ 510.600(c) of this chapter.
*
(lvi) 25 to 2,800 g/ton to provide
350 mg/head/day.
*
*
Lasalocid, 30 to 181.8;
melengestrol acetate, 0.25 to
2 g/ton to provide 0.25 to 0.5
mg/head/day melengestrol acetate.
*
*
*
*
Growing beef heifers fed in con- The melengestrol acetate Type C top-dress
finement for slaughter up to
medicated feed must be top dressed onto or
800 pounds: For control of
mixed at feeding with a Type C medicated
bacterial pneumonia associfeed containing 25 to 2,800 g/ton of chlortetraated with shipping fever comcycline and 30 to 181.8 g/ton lasalocid to proplex caused by Pasteurella
vide 350 mg chlortetracycline per head daily
spp. susceptible to chlortetraand 1 mg lasalocid per 2.2 lb. of body weight
cycline, control of coccidiosis
daily with a maximum of 360 mg lasalocid per
caused by Eimeria bovis and
head per day. See§ 558.311(d) of this chapter.
E. zuernii, increased rate of
Chlortetracycline as provided by Nos. 054771
weight gain, improved feed
or 069254; lasalocid and melengestrol as proefficiency, and suppression of
vided by No. 054771 in § 510.600(c) of this
estrus (heat).
chapter.
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069254
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069254
054771
069254
054771
069254
Federal Register / Vol. 89, No. 231 / Monday, December 2, 2024 / Rules and Regulations
Chlortetracycline amount
Combination in grams/ton
Indications for use
Limitations
(lvii) 25 to 2,800 g/ton to provide
350 mg/head/day.
Lasalocid, 30 to 181.8;
melengestrol acetate, 0.5 to 2
g/ton to provide 0.5 mg/head/
day melengestrol acetate.
Replacement beef heifers up to
800 pounds: For control of
bacterial pneumonia associated with shipping fever complex caused by Pasteurella
spp. susceptible to chlortetracycline, control of coccidiosis
caused by Eimeria bovis and
E. zuernii, and suppression of
estrus (heat).
The melengestrol acetate Type C top-dress
medicated feed must be top dressed onto or
mixed at feeding with a Type C medicated
feed containing 25 to 2,800 g/ton of chlortetracycline and 30 to 181.8 g/ton lasalocid to provide 350 mg chlortetracycline per head daily
and 1 mg lasalocid per 2.2 lb. of body weight
daily with a maximum of 360 mg lasalocid per
head per day. Do not exceed 24 days of feeding. See § 558.311(d) of this chapter. Chlortetracycline as provided by Nos. 054771 or
069254; lasalocid and melengestrol as provided by No. 054771 in § 510.600(c) of this
chapter.
*
(lix) 500 to 4,000 g/ton to provide 10 mg/lb of body weight
daily.
*
*
Lasalocid, 30 to 181.8;
melengestrol acetate, 0.25 to
2 g/ton to provide 0.25 to 0.5
mg/head/day melengestrol acetate.
(lx) 500 to 4,000 g/ton to provide
10 mg/lb of body weight daily.
Lasalocid, 30 to 181.8;
melengestrol acetate, 0.5 to 2
g/ton to provide 0.5 mg/head/
day melengestrol acetate.
*
*
*
*
Growing beef heifers fed in con- The melengestrol acetate Type C top-dress
finement for slaughter up to
medicated feed must be top dressed onto or
800 pounds: For the treatmixed at feeding with a Type C medicated
ment of bacterial enteritis
feed containing 500 to 4,000 g/ton of chlorcaused by Escherichia coli
tetracycline and 30 to 181.8 g/ton lasalocid to
and bacterial pneumonia
provide 10 mg chlortetracycline per lb of body
caused by Pasteurella
weight per day and 1 mg lasalocid per 2.2 lb
multocida organisms suscepof body weight per day with a maximum of
tible to chlortetracycline, con360 mg lasalocid per head per day for not
trol of coccidiosis caused by
more than 5 days of feeding. After completing
Eimeria bovis and E. zuernii,
feeding of this combination, continue feeding
increased rate of weight gain,
a Type C top-dress medicated feed containing
improved feed efficiency, and
melengestrol acetate alone. See § 558.311(d)
suppression of estrus (heat).
of this chapter. Chlortetracycline as provided
by Nos. 054771 or 069254; lasalocid and
melengestrol as provided by No. 054771 in
§ 510.600(c) of this chapter.
Replacement dairy heifers up to The melengestrol acetate Type C top-dress
800 pounds and less than 20
medicated feed must be top dressed onto or
months of age and replacemixed at feeding with a Type C medicated
ment beef heifers up to 800
feed containing 500 to 4,000 g/ton of chlorpounds: For the treatment of
tetracycline and 30 to 181.8 g/ton lasalocid to
bacterial enteritis caused by
provide 10 mg chlortetracycline per lb of body
Escherichia coli and bacterial
weight per day and 1 mg lasalocid per 2.2 lb
pneumonia caused by
of body weight per day with a maximum of
Pasteurella multocida orga360 mg lasalocid per head per day for not
nisms susceptible to chlormore than 5 days. After completing feeding of
tetracycline, control of coccidithis combination, continue feeding a Type C
osis caused by Eimeria bovis
top-dress medicated feed containing
and E. zuernii, and suppresmelengestrol acetate alone. See § 558.311(d)
sion of estrus (heat).
of this chapter. Chlortetracycline as provided
by Nos. 054771 or 069254; lasalocid and
melengestrol as provided by No. 054771 in
§ 510.600(c) of this chapter.
*
*
ddrumheller on DSK120RN23PROD with RULES1
*
*
*
*
*
*
■ 20. In § 558.355:
■ a. Revise paragraphs (b)(1) and (2);
■ b. Revise the headings for paragraphs
(d)(9)(i) and (ii) and (d)(10)(i) and (ii);
■ c. Redesignate paragraph (f) as
paragraph (e);
■ d. Revise newly redesignated
paragraphs (e)(1)(i) and (ii), (e)(2)(i), and
(e)(5);
■ e. Remove newly redesignated
paragraph (e)(6); and
■ f. Redesignate newly redesignated
paragraph (e)(7) as paragraph (e)(6).
The revisions read as follows:
VerDate Sep<11>2014
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§ 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
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*
95107
Sponsor
054771
069254
054771
069254
054771
069254
*
(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) * * *
E:\FR\FM\02DER1.SGM
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Federal Register / Vol. 89, No. 231 / Monday, December 2, 2024 / Rules and Regulations
Monensin in
grams/ton
Combination
in grams/ton
Indications for use
Limitations
(i) 90 to 110 ..........
..............................
Broiler chickens: As an aid in the prevention of coccidiosis caused by E. necatrix,
E. tenella, E. acervulina, E. brunetti, E.
mivati, and E. maxima.
(ii) 90 to 110 .........
..............................
Laying hen replacement chickens and
layer breeder replacement chickens: As
an aid in the prevention of coccidiosis
caused by E. necatrix, E. tenella, E.
acervulina, E. brunetti, E. mivati, and E.
maxima.
Feed continuously as the sole ration. Not for broiler breeder replacement chickens. Do not feed to chickens over 16 weeks of
age. Do not feed to laying chickens. In the absence of coccidiosis in broiler chickens the use of 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.
Feed continuously as the sole ration. Not for broiler breeder replacement chickens. Do not feed to chickens over 16 weeks of
age. Do not feed to laying chickens. In the absence of coccidiosis in broiler chickens the use of 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.
*
*
*
*
*
*
Sponsor
016592
058198
016592
058198
*
(2) * * *
Monensin in
grams/ton
Combination
in grams/ton
Indications for use
Limitations
(i) 54 to 90 ............
..............................
Growing turkeys: For the prevention of
coccidiosis caused by E. adenoeides, E.
meleagrimitis, and E.gallopavonis.
For growing turkeys only. Feed continuously as sole ration.
Some strains of turkey coccidia may be monensin tolerant or
resistant. Not for broiler 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.
*
*
*
*
*
*
Sponsor
016592
058198
*
(5) Minor species—
Monensin in
grams/ton
Indications for use
Limitations
(i) 73 .....................
Growing bobwhite quail: For the prevention of coccidiosis caused by Eimeria dispersa and E.
lettyae.
(ii) 20 ....................
Goats maintained in confinement: For the prevention of coccidiosis caused by Eimeria crandallis,
E. christenseni, and E. ninakohlyakimovae.
Feed continuously as sole ration. Not for broiler breeder replacement chickens. Do not feed to laying hens. Do not feed to chickens over 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.
Feed continuously. Do not feed to lactating goats. See paragraph (d)(11) of
this section for provisions for monensin liquid Type C goat feeds.
*
*
*
*
*
*
*
*
*
*
DEPARTMENT OF THE TREASURY
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
Internal Revenue Service
26 CFR Part 1
[TD 10014]
RIN 1545–BL21
ddrumheller on DSK120RN23PROD with RULES1
Recourse Partnership Liabilities and
Related Party Rules
Internal Revenue Service (IRS),
Treasury.
ACTION: Final rule.
AGENCY:
This document contains final
regulations relating to recourse
liabilities of a partnership and special
rules for related persons. These
SUMMARY:
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Sponsor
*
016592
058198
016592
058198
*
regulations affect partnerships and their
partners.
DATES:
Effective date: These regulations are
effective on December 2, 2024.
Applicability dates: For dates of
applicability, see §§ 1.704–2(l)(1)(vi),
1.752–2(l)(4), and 1.752–5(a).
FOR FURTHER INFORMATION CONTACT:
Concerning these final regulations,
contact Caroline Hay of the Office of
Associate Chief Counsel (Passthroughs
and Special Industries), (202) 317–6850
(not a toll-free number).
SUPPLEMENTARY INFORMATION:
Authority
This document amends the Income
Tax Regulations (26 CFR part 1) under
E:\FR\FM\02DER1.SGM
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]]>Agencies
[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 [www.gpo.gov]
[FR Doc No: 2024-28061]
=======================================================================
-----------------------------------------------------------------------
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, [email protected].
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: https://animaldrugsatfda.fda.gov/adafda/views/#/search.
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:
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.
21 CFR 520.522 is amended to reflect a 2023 change of
sponsorship for cyclosporine oral solution.
21 CFR 520.2090 is amended to revise the description of a
tablet containing sarolaner, moxidectin, and pyrantel.
[[Page 95103]]
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
