New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications, Change of Sponsor, Change of Sponsor Address, 14407-14412 [2024-03765]
Download as PDF
<![CDATA[
Federal Register / Vol. 89, No. 39 / Tuesday, February 27, 2024 / Rules and Regulations
Country
License
requirement
Entity
*
*
*
*
UNITED ARAB
EMIRATES.
*
*
*
*
*
*
The Food and Drug
Administration (FDA or we) is
amending the animal drug regulations to
reflect application-related actions for
new animal drug applications (NADAs)
and abbreviated new animal drug
applications (ANADAs) during October,
November, and December 2023. The
animal drug regulations are also being
amended to improve their accuracy and
readability.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, 529,
556, and 558
This rule is effective February
27, 2024.
DATES:
[Docket No. FDA–2023–N–0002]
New Animal Drugs; Approval of New
Animal Drug Applications; Withdrawal
of Approval of New Animal Drug
Applications, Change of Sponsor,
Change of Sponsor Address
AGENCY:
Food and Drug Administration,
HHS.
89 FR [INSERT FR PAGE
NUMBER February 27,
2024.
*
*
*
I. Approvals
SUMMARY:
BILLING CODE 3510–33–P
*
*
*
Final rule; technical
amendments.
[FR Doc. 2024–03674 Filed 2–26–24; 8:45 am]
*
*
ACTION:
Thea D. Rozman Kendler,
Assistant Secretary for Export
Administration.
*
Presumption of denial ............
*
*
*
*
*
For all items subject to the
EAR (See § 744.11 of the
EAR).
Federal Register citation
*
*
*
*
*
*
*
Sandvine Incorporated, a.k.a., the following
one alias:
—Sandvine Inc.
Business Central Tower, A BLOCK, 28th
floor, Office No. 2805/06/07/08, Dubai
Media City, United Arab Emirates. (See alternate addresses under Canada, India,
Japan, and Malaysia.)
*
*
*
*
*
*
License
review policy
14407
FOR FURTHER INFORMATION CONTACT:
George K. Haibel, Center for Veterinary
Medicine (HFV–6), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–5689,
george.haibel@fda.hhs.gov.
FDA is amending the animal drug
regulations to reflect approval actions
for NADAs and ANADAs during
October, November, and December
2023, as listed in table 1. In addition,
FDA is informing the public of the
availability, where applicable, of
documentation of environmental review
required under the National
Environmental Policy Act (NEPA) and,
for actions requiring review of safety or
effectiveness data, summaries of the
basis of approval (FOIA Summaries)
under the Freedom of Information Act
(FOIA). These documents, along with
marketing exclusivity and patent
information, may be obtained at Animal
Drugs @FDA: https://animaldrugsatfda.
fda.gov/adafda/views/#/search.
SUPPLEMENTARY INFORMATION:
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING OCTOBER, NOVEMBER, AND
DECEMBER 2023 REQUIRING EVIDENCE OF SAFETY AND/OR EFFECTIVENESS
lotter on DSK11XQN23PROD with RULES1
Date of approval
Sponsor
(drug labeler code)
File No.
Product name
Effect of the
action
21 CFR
section
Original approval for the treatment
of Giardia duodenalis infection in
dogs.
Supplemental approval adding females intended for breeding to
approved classes of swine.
Original approval for treatment of
bacterial enteritis and pneumonia;
and for increased rate of weight
gain or prevention and control of
coccidiosis in replacement beef
and dairy heifers.
Original approval for treatment and
control of bovine respiratory disease (BRD) in beef cattle and
non-lactating dairy cattle and
swine respiratory disease (SRD)
and control of colibacillosis in
groups or pens of weaned pigs,
as a generic copy of NADA 141–
068.
520.1425
October 11, 2023 ............
141–572
Virbac AH, Inc., P.O. Box 162059,
Fort Worth, TX 76161 (051311).
AYRADIA (metronidazole) oral solution.
October 13, 2023 ............
141–336
ECO LLC, 344 Nassau St., Princeton, NJ 08540 (066916).
AIVLOSIN (tylvalosin tartrate) Water
Soluble Granules.
October 20, 2023 ............
141–564
Pharmgate Inc., 1800 Sir Tyler Rd.,
Wilmington, NC 28405 (069254).
PENNCHLOR (chlortetracycline
Type A medicated article) and
RUMENSIN (monensin Type A
medicated article).
November 8, 2023 ..........
200–758
Felix Pharmaceuticals Pvt. Ltd., 25–
28 North Wall Quay, Dublin 1,
Ireland (086101).
Enrofloxacin Injectable Solution ......
VerDate Sep<11>2014
15:59 Feb 26, 2024
Jkt 262001
PO 00000
Frm 00039
Fmt 4700
Sfmt 4700
E:\FR\FM\27FER1.SGM
27FER1
520.2645
558.128
522.812
14408
Federal Register / Vol. 89, No. 39 / Tuesday, February 27, 2024 / Rules and Regulations
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING OCTOBER, NOVEMBER, AND
DECEMBER 2023 REQUIRING EVIDENCE OF SAFETY AND/OR EFFECTIVENESS—Continued
Date of approval
Sponsor
(drug labeler code)
File No.
Product name
Effect of the
action
21 CFR
section
Original approval for alleviation of
acute anxiety and fear associated
with transportation and veterinary
visits in cats.
Supplemental approval for the treatment and control of tick infestations with Amblyomma
americanum (lone star tick) in
cats and kittens 8 weeks of age
and older, and weighing 2.8
pounds or greater.
Original approval for treatment of
bovine respiratory disease (BRD)
and bovine interdigital phlegmon;
and for the control of respiratory
disease in cattle at high risk of
developing BRD, as a generic
copy of NADA 141–063.
Original approval for the relief of
pain and inflammation associated
with osteoarthritis and for the
control of postoperative pain associated with soft tissue and orthopedic surgeries, as a generic
copy of NADA 141–199.
Original approval for the management of diseases in dogs associated with bacteria susceptible to
enrofloxacin, as a generic copy of
NADA 140–913.
Original approval for treatment and
control of bovine respiratory disease (BRD) in beef cattle and
non-lactating dairy cattle and
swine respiratory disease (SRD)
and control of colibacillosis in
groups or pens of weaned pigs,
as a generic copy of NADA 141–
068.
520.1892
November 17, 2023 ........
141–580
Orion Corp., Orionintie 1, 02200
Espoo, Finland (052483).
BONQAT (pregabalin) Oral Solution
December 14, 2023 ........
141–502
Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 (054771).
REVOLUTION PLUS (selamectin
and sarolaner topical solution).
December 21, 2023 ........
200–760
FLORFENIJECT (florfenicol)
Injectable Solution.
December 22, 2023 ........
200–762
Cronus Pharma Specialties India
Private Ltd., Sy No-99/1, M/s
GMR Hyderabad Aviation SEZ
Ltd., Mamidipalli Village,
Shamshabad Mandal, Ranga
Reddy, Hyderabad, Telangana,
501218, India (069043).
Do ....................................................
December 22, 2023 ........
200–764
Do ....................................................
ENROPRO 22.7 (enrofloxacin)
Injectable Solution.
December 22, 2023 ........
200–765
Do ....................................................
ENROPRO 100 (enrofloxacin)
Injectable Solution.
II. Withdrawals of Approval
ADM Animal Nutrition, Inc., 1000
North 30th St., Quincy, IL 62305–3115
CAROFENVET (carprofen)
Injectable Solution.
(drug labeler code 012286) requested
that FDA withdraw approval of the four
NADAs listed in table 2 because the
products are no longer manufactured or
524.2099
522.955
522.304
522.812
522.812
marketed. As provided in the regulatory
text of this document, the animal drug
regulations are amended to reflect these
actions.
TABLE 2—APPLICATIONS FOR WHICH APPROVAL WAS VOLUNTARILY WITHDRAWN DURING OCTOBER, NOVEMBER, AND
DECEMBER 2023
Date of withdrawal
of approval
File No.
November 14, 2023 ........
Do ....................................
Do ....................................
Do ....................................
21 CFR
section
New animal drug
030–578
042–910
118–877
132–448
E–Z–EX Wormer Pellets (thiabendazole) ...................................................................................................................
E–Z–EX WORMER MINTRATE Block (thiabendazole) Mineral Protein Block ..........................................................
BAN–A–WORM (pyrantel tartrate) Ton Pack .............................................................................................................
FLAVOMYCIN (bambermycins) Type A Medicated Article ........................................................................................
III. Change of Sponsor
The sponsors of the approved
applications listed in table 3 have
informed FDA that they have transferred
ownership of, and all rights and interest
in, these applications to another
n/a
558.600
n/a
558.95
sponsor. The regulations cited in table
3 are amended to reflect these actions.
lotter on DSK11XQN23PROD with RULES1
TABLE 3—APPLICATIONS FOR WHICH OWNERSHIP WAS TRANSFERRED TO ANOTHER SPONSOR DURING OCTOBER,
NOVEMBER, AND DECEMBER 2023
Transferring sponsor
(drug labeler code)
File No.
Product name
200–237 ...
Isoflurane, U.S.P .........................................
VerDate Sep<11>2014
15:59 Feb 26, 2024
Jkt 262001
PO 00000
New sponsor
(drug labeler code)
Piramal Pharma Ltd., Ground Floor,
Piramal Ananta, Agastya Corporate
Park, Mumbai, Maharashtra, 400070,
India (065085).
Frm 00040
Fmt 4700
Sfmt 4700
Piramal Critical Care, Inc., 3850 Schelden
Circle, Bethlehem, PA 18017 (066794).
E:\FR\FM\27FER1.SGM
27FER1
21 CFR
section
529.1186
14409
Federal Register / Vol. 89, No. 39 / Tuesday, February 27, 2024 / Rules and Regulations
TABLE 3—APPLICATIONS FOR WHICH OWNERSHIP WAS TRANSFERRED TO ANOTHER SPONSOR DURING OCTOBER,
NOVEMBER, AND DECEMBER 2023—Continued
Transferring sponsor
(drug labeler code)
New sponsor
(drug labeler code)
File No.
Product name
200–576 ...
Gentamicin Sulfate Ophthalmic Solution ....
Akorn Operating Co. LLC, 5605
Centerpoint Ct., Suite A, Gurnee, IL
60031 (059399).
200–670 ...
SENERGY (selamectin) Topical Solution ...
200–700 ...
PARASEDGE Multi for Dogs (Imidacloprid
and moxidectin).
PARASEDGE Multi for Cats (Imidacloprid
and moxidectin).
200–701 ...
IV. Change of Sponsor Address
Accord Healthcare, Inc. 1009 Slater
Rd., Suite 210–B, Durham, NC 27703
(drug labeler code 016729 in 21 CFR
510.600(c)) has informed FDA that it has
changed its address to 126 E Lincoln
Ave., Rahway, NJ 07065. The entries in
§ 510.600(c) are amended to reflect this
action.
V. Technical Amendments
FDA is making the following
amendments to improve the accuracy of
the animal drug regulations.
• 21 CFR 520.1408 is revised to
reflect all approved strengths of
methylprednisolone tablets for dogs and
cats.
• 21 CFR 556.730 is removed because
there are no approved products
containing thiabendazole for use in
food-producing animals.
• 21 CFR 558.4(d) is being revised in
the Category II table by removing the
row entry for ‘‘Thiabendazole’’ because
there are no longer any approved feed
products for use in food-producing
animals.
• 21 CFR 558.128 is revised to reflect
withdrawal periods for different
21 CFR
section
524.1044a
Chanelle Pharmaceuticals Manufacturing
Ltd., Loughrea, County Galway, Ireland
(061651).
Do ................................................................
Domes Pharma S.A., ZAC de Champ
Lamet, 3 rue Andre Citroen, Pont-duChateau, Auvergne-Rhoˆne-Alpes, 63430,
France (086189).
Virbac AH, Inc., P.O. Box 162059, Fort
Worth, TX 76161 (051311).
Do ................................................................
524.1146
Do ................................................................
Do ................................................................
524.1146
applications approved for use of
chlortetracycline in cattle feed.
21 CFR Part 558
Animal drugs, Animal feeds.
VI. Legal Authority
This final rule is issued under section
512(i) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
360b(i)). Although deemed a rule
pursuant to the FD&C Act, this
document does not meet the definition
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
it is a ‘‘rule of particular applicability’’
and is not subject to the congressional
review requirements in 5 U.S.C. 801–
808. Likewise, this is not a rule subject
to Executive Order 12866.
List of Subjects
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR parts 510,
520, 522, 524, 529, 556, and 558 are
amended as follows:
PART 510—NEW ANIMAL DRUGS
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.
2. In § 510.600, in the table in
paragraph (c)(1), revise the entry for
‘‘Accord Healthcare, Inc.’’; and in the
table in paragraph (c)(2), revise the entry
for ‘‘016729’’ to read as follows:
■
21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
21 CFR Parts 520, 522, 524, and 529
Animal drugs.
*
21 CFR Part 556
Animal drugs, Food.
*
*
(c) * * *
(1) * * *
*
*
Drug labeler
code
Firm name and address
*
*
*
*
*
*
Accord Healthcare, Inc., 126 E Lincoln Ave., Rahway, NJ 07065 ......................................................................................................
*
*
*
524.2098
*
*
*
016729
*
*
*
*
*
*
*
*
(2) * * *
lotter on DSK11XQN23PROD with RULES1
Drug labeler code
*
016729 ...................
*
VerDate Sep<11>2014
Firm name and address
*
*
*
Accord Healthcare, Inc., 126 E Lincoln Ave., Rahway, NJ 07065.
*
15:59 Feb 26, 2024
*
Jkt 262001
PO 00000
*
Frm 00041
Fmt 4700
Sfmt 4700
E:\FR\FM\27FER1.SGM
27FER1
14410
Federal Register / Vol. 89, No. 39 / Tuesday, February 27, 2024 / Rules and Regulations
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
3. The authority citation for part 520
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
4. In § 520.1408, revise paragraph (b)
to read as follows:
■
§ 520.1408
Methylprednisolone.
*
*
*
*
*
(b) Sponsors. See Nos. 054771 and
069043 in § 510.600(c) of this chapter.
*
*
*
*
*
■ 5. Add § 520.1425 to read as follows:
§ 520.1425
8. The authority citation for part 522
continues to read as follows:
Authority: 21 U.S.C. 360b.
9. In § 522.304, revise paragraph (b) to
read as follows:
Pregabalin.
Tylvalosin.
lotter on DSK11XQN23PROD with RULES1
*
*
*
*
*
(d) * * *
(2) Indications for use. For control of
porcine proliferative enteropathy (PPE)
associated with Lawsonia intracellularis
infection in groups of swine intended
for slaughter and female swine intended
for breeding in buildings experiencing
an outbreak of PPE; and for control of
swine respiratory disease (SRD)
associated with Bordetella
bronchiseptica, Glaesserella
(Haemophilus) parasuis, Pasteurella
VerDate Sep<11>2014
15:59 Feb 26, 2024
Jkt 262001
§ 522.304
Carprofen.
*
*
*
*
*
(b) Sponsors. See Nos. 016729,
017033, 054771, 055529, and 069043 in
§ 510.600(c) of this chapter.
*
*
*
*
*
■ 10. In § 522.812, revise paragraphs
(b)(1) and (2) to read as follows:
§ 522.812
Enrofloxacin.
*
*
*
*
*
(b) * * *
(1) Nos. 016729, 017033, 055529,
058198, 069043, and 086101 for use of
product described in paragraph (a)(1) as
in paragraph (e)(1) of this section; and
(2) Nos. 051311, 055529, 058005,
058198, 061133, 069043, and 086101 for
use of product described in paragraph
(a)(2) as in paragraphs (e)(2) and (3) of
this section.
*
*
*
*
*
■ 11. In § 522.955, revise paragraph
(b)(3) and the second sentence in
paragraph (d)(1)(ii)(C) to read as follows:
§ 522.955
Florfenicol.
*
*
*
*
*
(b) * * *
(3) Nos. 058005, 058198, and 069043
for use of product described in
paragraph (a)(2) of this section as in
paragraph (d)(1)(ii) of this section.
*
*
*
*
*
(d) * * *
(1) * * *
(ii) * * *
(C) Limitations. * * * Nos. 000061,
058005, 058198, and 069043: Animals
intended for human consumption must
not be slaughtered within 38 days of
subcutaneous treatment. * * *
*
*
*
*
*
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
12. The authority citation for part 524
continues to read as follows:
■
PO 00000
Frm 00042
Fmt 4700
Sfmt 4700
Authority: 21 U.S.C. 360b.
13. In 524.1044a, revise paragraph (b)
to read as follows:
■
§ 524.1044a
solution.
Gentamicin ophthalmic
*
*
*
*
*
(b) Sponsors. See Nos. 000061 and
086189 in § 510.600(c) of this chapter.
*
*
*
*
*
■ 14. In 524.1146, revise paragraphs
(b)(1) and (2) to read as follows:
§ 524.1146
Imidacloprid and moxidectin.
*
■
Metronidazole.
(a) Specifications. Each milliliter (mL)
of solution contains 50 milligrams (mg)
pregabalin.
(b) Sponsor. See No. 052483 in
§ 510.600(c) of this chapter.
(c) Conditions of use—(1) Amount.
Administer orally as a single dose of 5
mg/kg (0.1 mL/kg) approximately 1.5
hours before the start of the
transportation or veterinary visit.
(2) Indications for use. For alleviation
of acute anxiety and fear associated with
transportation and veterinary visits.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
■ 7. In § 520.2645, revise paragraph
(d)(2) to read as follows:
§ 520.2645
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
■
(a) Specifications. Each milliliter of
suspension contains 125 milligrams
(mg) metronidazole.
(b) Sponsor. See No. 051311 in
§ 510.600(c) of this chapter.
(c) Conditions of use—(1) Amount.
Administer 25 mg per kilogram (11.3 mg
per pound) of body weight twice daily
for 5 consecutive days.
(2) Indications for use. For the
treatment of Giardia duodenalis
infection in dogs.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
■ 6. Add § 520.1892 to read as follows:
§ 520.1892
multocida, Streptococcus suis, and
Mycoplasma hyopneumoniae in groups
of swine intended for slaughter and
female swine intended for breeding in
buildings experiencing an outbreak of
SRD.
*
*
*
*
*
*
*
*
*
(b) * * *
(1) Nos. 017030, 051072, 051311,
055529, and 058198 for use of product
described in paragraph (a)(1) of this
section as in paragraph (d)(1) of this
section.
(2) Nos. 017030, 051072, 051311,
055529, and 058198 for use of product
described in paragraph (a)(2) of this
section as in paragraph (d)(2) of this
section.
*
*
*
*
*
■ 15. In 524.2098, revise paragraph (b)
to read as follows:
§ 524.2098
Selamectin.
*
*
*
*
*
(b) Sponsors. See Nos. 051072,
051311, 054771, 055529, and 061133 in
§ 510.600(c) of this chapter.
*
*
*
*
*
■ 16. In 524.2099, revise paragraph
(c)(2) to read as follows:
§ 524.2099
Selamectin and sarolaner.
*
*
*
*
*
(c) * * *
(2) Indications for use. For the
prevention of heartworm disease caused
by Dirofilaria immitis. Kills adult fleas
(Ctenocephalides felis) and is indicated
for the treatment and prevention of flea
infestations; the treatment and control
of tick infestations with Amblyomma
americanum (lone star tick),
Amblyomma maculatum (Gulf Coast
tick), Dermacentor variabilis (American
dog tick), and Ixodes scapularis (blacklegged tick), the treatment and control of
ear mite (Otodectes cynotis) infestations;
and the treatment and control of
roundworm (Toxocara cati) and
intestinal hookworm (Ancylostoma
tubaeforme) infections in cats and
kittens 8 weeks of age and older, and
weighing 2.8 pounds or greater.
*
*
*
*
*
PART 529—CERTAIN OTHER DOSAGE
FORM NEW ANIMAL DRUGS
17. The authority citation for part 529
continues to read as follows:
■
E:\FR\FM\27FER1.SGM
27FER1
14411
Federal Register / Vol. 89, No. 39 / Tuesday, February 27, 2024 / Rules and Regulations
Authority: 21 U.S.C. 360b.
Authority: 21 U.S.C. 342, 360b, 371.
18. In § 529.1186, revise paragraph (b)
to read as follows:
■
§ 529.1186
§ 556.730
■
[Removed]
20. Remove § 556.730.
23. In § 558.95, revise paragraphs (b),
(e)(2)(i) and (ii), and (e)(3)(i) and (ii) to
read as follows:
■
§ 558.95
Isoflurane.
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
*
*
*
*
*
(b) Sponsors. See Nos. 017033,
054771, and 066794 in § 510.600(c) of
this chapter.
*
*
*
*
*
21. The authority citation for part 558
continues to read as follows:
■
Authority: 21 U.S.C. 354, 360b, 360ccc,
360ccc–1, 371.
PART 556—TOLERANCES FOR
RESIDUES OF NEW ANIMAL DRUGS
IN FOOD
§ 558.4
Bambermycins.
*
*
*
*
*
(b) Sponsor. See No. 016592 in
§ 510.600(c) of this chapter.
*
*
*
*
*
(e) * * *
(2) * * *
[Amended]
22. Amend § 558.4, by removing the
entry for ‘‘Thiabendazole’’ in the
Category II’’ table in paragraph (d).
■
19. The authority citation for part 556
continues to read as follows:
■
Bambermycins
in grams/ton
Indications for use
Limitations
(i) 1 to 2 ..........
(ii) 2 ................
Growing turkeys: For improved feed efficiency ...............
Growing turkeys: For increased rate of weight gain and
improved feed efficiency.
Feed continuously as the sole ration ...............................
Feed continuously as the sole ration ...............................
Bambermycins
in grams/ton
Indications for use
Limitations
(i) 2 .................
Growing-finishing swine: For increased rate of weight
gain and improved feed efficiency.
Growing-finishing swine: For improved feed efficiency ...
Feed continuously as the sole ration ...............................
016592
Feed continuously as the sole ration ...............................
016592
Sponsor
016592
016592
(3) * * *
(ii) 2 to 4 .........
*
*
*
*
*
b. Redesignate paragraphs (e)(4)(xxi)
through (lviii) as paragraphs (e)(4)(xxiii)
through (lx); and
■ c. Add new paragraphs (e)(4)(xxi) and
(xxii).
The revision and additions read as
follows:
■
24. In § 558.128:
■ a. Revise paragraphs (e)(4)(xvi) and
(xvii);
■
*
Chlortetracycline.
*
*
(e) * * *
(4) * * *
*
*
Combination
in grams/ton
Indications for use
Limitations
*
(xvi) to provide 10 mg/lb of body
weight daily.
*
......................
*
*
Calves, beef and nonlactating dairy
cattle: For treatment of bacterial
enteritis caused by Escherichia coli
and bacterial pneumonia caused
by Pasteurella multocida organisms susceptible to chlortetracycline.
(xvii) to provide 10 mg/lb of body
weight daily.
......................
*
*
*
Feed approximately 400 g/ton, varying with body weight
and feed consumption to provide 10 mg/lb per day.
Treat for not more than 5 days. To sponsor No.
054771 (NADAs 048–761 and 046–699) and to sponsor No. 069254 (ANADA 200–510): May be mixed in
the cattle’s daily ration or administered as a topdress. In feed including milk replacers withdraw 10
days prior to slaughter. To sponsor No. 054771 under
NADA 046–699: 24-hour withdrawal period. To sponsor No. 054771 under NADA 048–761 and No.
069254 under ANADA 200–510: Zero withdrawal period. See paragraph (d)(3) of this section.
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 amount
lotter on DSK11XQN23PROD with RULES1
§ 558.128
Sponsor
VerDate Sep<11>2014
15:59 Feb 26, 2024
Jkt 262001
Calves (up to 250 lb): For the treatment of bacterial enteritis caused
by Escherichia coli susceptible to
chlortetracycline.
PO 00000
Frm 00043
Fmt 4700
Sfmt 4700
E:\FR\FM\27FER1.SGM
27FER1
Sponsor
054771
066104
069254
066104
14412
Federal Register / Vol. 89, No. 39 / Tuesday, February 27, 2024 / Rules and Regulations
Combination
in grams/ton
Chlortetracycline amount
Indications for use
*
*
(xxi) 400 to 2,000 g/ton ....................... Monensin, 15
to 84.
*
*
Replacement beef and dairy heifers:
For treatment of bacterial enteritis
caused by Escherichia coli and
bacterial pneumonia caused by
Pasteurella multocida susceptible
to chlortetracycline; and for the
prevention and control of coccidiosis caused by Eimeria bovis and
Eimeria zuernii.
(xxii) 400 to 2,000 g/ton ......................
Replacement beef and dairy heifers:
For treatment of bacterial enteritis
caused by Escherichia coli and
bacterial pneumonia caused by
Pasteurella multocida susceptible
to chlortetracycline; and for increased rate of weight gain.
*
§ 558.600
■
Monensin, 15
to 400.
*
[Removed]
*
Limitations
*
*
*
For replacement beef and dairy heifers not currently
being fed monensin: Feed as the sole ration for not
more than 5 days to provide 10 mg chlortetracycline
per pound of body weight per day and 0.14 to 0.42
mg monensin per pound of body weight per day, depending upon severity of challenge, to provide 50 to
100 mg monensin per head per day in a minimum of
1 pound of Type C medicated feed. After 5 days, continue to feed monensin Type C medicated feed alone
to provide 50 to 200 mg monensin per head per day
in a minimum of 1 pound of Type C medicated feed.
For replacement beef and dairy heifers currently being
fed monensin: Feed as the sole ration for not more
than 5 days to provide 10 mg chlortetracycline per
pound of body weight per day and 0.14 to 0.42 mg
monensin per pound of body weight per day, depending upon severity of challenge, to provide 50 to 200
mg monensin per head per day in a minimum of 1
pound of Type C medicated feed. After 5 days, continue to feed monensin Type C medicated feed alone.
This drug is not approved for use in female dairy cattle
20 months of age or older, including dry dairy cows.
Use in these cattle may cause drug residues in milk
and/or in calves born to these cows. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.
Monensin as provided by No. 058198, chlortetracycline
by No. 069254 in § 510.600(c) of this chapter.
For replacement beef and dairy heifers not currently
being fed monensin: Feed as the sole ration for not
more than 5 days to provide 10 mg chlortetracycline
per pound of body weight per day and 50 to 100 mg
monensin per head per day in a minimum of 1 pound
of Type C medicated feed. After 5 days, continue to
feed monensin Type C medicated feed alone to provide 50 to 200 mg monensin per head per day in a
minimum of 1 pound of Type C medicated feed.
For replacement beef and dairy heifers currently being
fed monensin: Feed as the sole ration for not more
than 5 days to provide 10 mg chlortetracycline per
pound of body weight per day and 50 to 200 mg
monensin per head per day in a minimum of 1 pound
of Type C medicated feed. After 5 days, continue to
feed monensin Type C medicated feed alone.
This drug is not approved for use in female dairy cattle
20 months of age or older, including dry dairy cows.
Use in these cattle may cause drug residues in milk
and/or in calves born to these cows. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.
Monensin as provided by No. 058198, chlortetracycline
by No. 069254 in § 510.600(c) of this chapter.
*
*
ENVIRONMENTAL PROTECTION
AGENCY
25. Remove § 558.600.
Dated: February 20, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
40 CFR Part 52
[EPA–R09–OAR–2022–0604; FRL–10574–
02–R9]
[FR Doc. 2024–03765 Filed 2–26–24; 8:45 am]
Air Plan Approval; CA; San Joaquin
Valley Air Pollution Control District
BILLING CODE 4164–01–P
Environmental Protection
Agency (EPA).
ACTION: Final rule.
lotter on DSK11XQN23PROD with RULES1
AGENCY:
The Environmental Protection
Agency (EPA) is taking final action to
approve revisions to the San Joaquin
Valley Air Pollution Control District
SUMMARY:
VerDate Sep<11>2014
15:59 Feb 26, 2024
Jkt 262001
PO 00000
Frm 00044
Fmt 4700
Sfmt 4700
Sponsor
*
069254
069254
*
(SJVAPCD) portion of the California
State Implementation Plan (SIP). The
revisions were submitted by the
California Air Resources Board (CARB),
on behalf of SJVAPCD, in response to
the EPA’s May 22, 2015 finding of
substantial inadequacy and SIP call for
certain provisions in the SIP related to
exemptions and affirmative defenses
applicable to excess emissions during
startup, shutdown, and malfunction
(SSM) events. The EPA is finalizing
approval of the SIP revisions because
the Agency has determined that they are
in accordance with the requirements for
SIP provisions under the Clean Air Act
(CAA or the Act) and correct
E:\FR\FM\27FER1.SGM
27FER1
]]>Agencies
[Federal Register Volume 89, Number 39 (Tuesday, February 27, 2024)]
[Rules and Regulations]
[Pages 14407-14412]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-03765]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, 529, 556, and 558
[Docket No. FDA-2023-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications;
Withdrawal of Approval of New Animal Drug Applications, Change of
Sponsor, Change of Sponsor Address
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is amending the
animal drug regulations to reflect application-related actions for new
animal drug applications (NADAs) and abbreviated new animal drug
applications (ANADAs) during October, November, and December 2023. The
animal drug regulations are also being amended to improve their
accuracy and readability.
DATES: This rule is effective February 27, 2024.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-402-5689,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Approvals
FDA is amending the animal drug regulations to reflect approval
actions for NADAs and ANADAs during October, November, and December
2023, as listed in table 1. In addition, FDA is informing the public of
the availability, where applicable, of documentation of environmental
review required under the National Environmental Policy Act (NEPA) and,
for actions requiring review of safety or effectiveness data, summaries
of the basis of approval (FOIA Summaries) under the Freedom of
Information Act (FOIA). These documents, along with marketing
exclusivity and patent information, may be obtained at Animal Drugs
@FDA: https://animaldrugsatfda.fda.gov/adafda/views/#/search.
Table 1--Original and Supplemental NADAs and ANADAs Approved During October, November, and December 2023
Requiring Evidence of Safety and/or Effectiveness
----------------------------------------------------------------------------------------------------------------
Sponsor (drug Effect of the 21 CFR
Date of approval File No. labeler code) Product name action section
----------------------------------------------------------------------------------------------------------------
October 11, 2023.............. 141-572 Virbac AH, Inc., AYRADIA Original approval 520.1425
P.O. Box 162059, (metronidazole) for the treatment
Fort Worth, TX oral solution. of Giardia
76161 (051311). duodenalis
infection in dogs.
October 13, 2023.............. 141-336 ECO LLC, 344 AIVLOSIN Supplemental 520.2645
Nassau St., (tylvalosin approval adding
Princeton, NJ tartrate) Water females intended
08540 (066916). Soluble Granules. for breeding to
approved classes
of swine.
October 20, 2023.............. 141-564 Pharmgate Inc., PENNCHLOR Original approval 558.128
1800 Sir Tyler (chlortetracyclin for treatment of
Rd., Wilmington, e Type A bacterial
NC 28405 (069254). medicated enteritis and
article) and pneumonia; and
RUMENSIN for increased
(monensin Type A rate of weight
medicated gain or
article). prevention and
control of
coccidiosis in
replacement beef
and dairy heifers.
November 8, 2023.............. 200-758 Felix Enrofloxacin Original approval 522.812
Pharmaceuticals Injectable for treatment and
Pvt. Ltd., 25-28 Solution. control of bovine
North Wall Quay, respiratory
Dublin 1, Ireland disease (BRD) in
(086101). beef cattle and
non-lactating
dairy cattle and
swine respiratory
disease (SRD) and
control of
colibacillosis in
groups or pens of
weaned pigs, as a
generic copy of
NADA 141-068.
[[Page 14408]]
November 17, 2023............. 141-580 Orion Corp., BONQAT Original approval 520.1892
Orionintie 1, (pregabalin) Oral for alleviation
02200 Espoo, Solution. of acute anxiety
Finland (052483). and fear
associated with
transportation
and veterinary
visits in cats.
December 14, 2023............. 141-502 Zoetis Inc., 333 REVOLUTION PLUS Supplemental 524.2099
Portage St., (selamectin and approval for the
Kalamazoo, MI sarolaner topical treatment and
49007 (054771). solution). control of tick
infestations with
Amblyomma
americanum (lone
star tick) in
cats and kittens
8 weeks of age
and older, and
weighing 2.8
pounds or greater.
December 21, 2023............. 200-760 Cronus Pharma FLORFENIJECT Original approval 522.955
Specialties India (florfenicol) for treatment of
Private Ltd., Sy Injectable bovine
No-99/1, M/s GMR Solution. respiratory
Hyderabad disease (BRD) and
Aviation SEZ bovine
Ltd., Mamidipalli interdigital
Village, phlegmon; and for
Shamshabad the control of
Mandal, Ranga respiratory
Reddy, Hyderabad, disease in cattle
Telangana, at high risk of
501218, India developing BRD,
(069043). as a generic copy
of NADA 141-063.
December 22, 2023............. 200-762 Do................ CAROFENVET Original approval 522.304
(carprofen) for the relief of
Injectable pain and
Solution. inflammation
associated with
osteoarthritis
and for the
control of
postoperative
pain associated
with soft tissue
and orthopedic
surgeries, as a
generic copy of
NADA 141-199.
December 22, 2023............. 200-764 Do................ ENROPRO 22.7 Original approval 522.812
(enrofloxacin) for the
Injectable management of
Solution. diseases in dogs
associated with
bacteria
susceptible to
enrofloxacin, as
a generic copy of
NADA 140-913.
December 22, 2023............. 200-765 Do................ ENROPRO 100 Original approval 522.812
(enrofloxacin) for treatment and
Injectable control of bovine
Solution. respiratory
disease (BRD) in
beef cattle and
non-lactating
dairy cattle and
swine respiratory
disease (SRD) and
control of
colibacillosis in
groups or pens of
weaned pigs, as a
generic copy of
NADA 141-068.
----------------------------------------------------------------------------------------------------------------
II. Withdrawals of Approval
ADM Animal Nutrition, Inc., 1000 North 30th St., Quincy, IL 62305-
3115 (drug labeler code 012286) requested that FDA withdraw approval of
the four NADAs listed in table 2 because the products are no longer
manufactured or marketed. As provided in the regulatory text of this
document, the animal drug regulations are amended to reflect these
actions.
Table 2--Applications for Which Approval Was Voluntarily Withdrawn
During October, November, and December 2023
------------------------------------------------------------------------
Date of withdrawal of 21 CFR
approval File No. New animal drug section
------------------------------------------------------------------------
November 14, 2023.......... 030-578 E-Z-EX Wormer Pellets n/a
(thiabendazole).
Do......................... 042-910 E-Z-EX WORMER 558.600
MINTRATE Block
(thiabendazole)
Mineral Protein
Block.
Do......................... 118-877 BAN-A-WORM (pyrantel n/a
tartrate) Ton Pack.
Do......................... 132-448 FLAVOMYCIN 558.95
(bambermycins) Type
A Medicated Article.
------------------------------------------------------------------------
III. Change of Sponsor
The sponsors of the approved applications listed in table 3 have
informed FDA that they have transferred ownership of, and all rights
and interest in, these applications to another sponsor. The regulations
cited in table 3 are amended to reflect these actions.
Table 3--Applications for Which Ownership Was Transferred to Another Sponsor During October, November, and
December 2023
----------------------------------------------------------------------------------------------------------------
Transferring sponsor New sponsor (drug
File No. Product name (drug labeler code) labeler code) 21 CFR section
----------------------------------------------------------------------------------------------------------------
200-237............. Isoflurane, U.S.P....... Piramal Pharma Ltd., Piramal Critical Care, 529.1186
Ground Floor, Piramal Inc., 3850 Schelden
Ananta, Agastya Circle, Bethlehem, PA
Corporate Park, 18017 (066794).
Mumbai, Maharashtra,
400070, India (065085).
[[Page 14409]]
200-576............. Gentamicin Sulfate Akorn Operating Co. Domes Pharma S.A., ZAC 524.1044a
Ophthalmic Solution. LLC, 5605 Centerpoint de Champ Lamet, 3 rue
Ct., Suite A, Gurnee, Andre Citroen, Pont-du-
IL 60031 (059399). Chateau, Auvergne-
Rh[ocirc]ne-Alpes,
63430, France (086189).
200-670............. SENERGY (selamectin) Chanelle Virbac AH, Inc., P.O. 524.2098
Topical Solution. Pharmaceuticals Box 162059, Fort
Manufacturing Ltd., Worth, TX 76161
Loughrea, County (051311).
Galway, Ireland
(061651).
200-700............. PARASEDGE Multi for Dogs Do..................... Do..................... 524.1146
(Imidacloprid and
moxidectin).
200-701............. PARASEDGE Multi for Cats Do..................... Do..................... 524.1146
(Imidacloprid and
moxidectin).
----------------------------------------------------------------------------------------------------------------
IV. Change of Sponsor Address
Accord Healthcare, Inc. 1009 Slater Rd., Suite 210-B, Durham, NC
27703 (drug labeler code 016729 in 21 CFR 510.600(c)) has informed FDA
that it has changed its address to 126 E Lincoln Ave., Rahway, NJ
07065. The entries in Sec. 510.600(c) are amended to reflect this
action.
V. Technical Amendments
FDA is making the following amendments to improve the accuracy of
the animal drug regulations.
21 CFR 520.1408 is revised to reflect all approved
strengths of methylprednisolone tablets for dogs and cats.
21 CFR 556.730 is removed because there are no approved
products containing thiabendazole for use in food-producing animals.
21 CFR 558.4(d) is being revised in the Category II table
by removing the row entry for ``Thiabendazole'' because there are no
longer any approved feed products for use in food-producing animals.
21 CFR 558.128 is revised to reflect withdrawal periods
for different applications approved for use of chlortetracycline in
cattle feed.
VI. Legal Authority
This final rule is issued under section 512(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b(i)). Although deemed
a rule pursuant to the FD&C Act, this document does not meet the
definition of ``rule'' in 5 U.S.C. 804(3)(A) because it is a ``rule of
particular applicability'' and is not subject to the congressional
review requirements in 5 U.S.C. 801-808. Likewise, this is not a rule
subject to Executive Order 12866.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Parts 520, 522, 524, and 529
Animal drugs.
21 CFR Part 556
Animal drugs, Food.
21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
510, 520, 522, 524, 529, 556, and 558 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for part 510 continues to read as follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
0
2. In Sec. 510.600, in the table in paragraph (c)(1), revise the entry
for ``Accord Healthcare, Inc.''; and in the table in paragraph (c)(2),
revise the entry for ``016729'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Drug labeler
Firm name and address code
------------------------------------------------------------------------
* * * * * * *
Accord Healthcare, Inc., 126 E Lincoln Ave., Rahway, NJ 016729
07065..................................................
* * * * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * * * *
016729..................... Accord Healthcare, Inc., 126 E Lincoln
Ave., Rahway, NJ 07065.
* * * * * * *
------------------------------------------------------------------------
[[Page 14410]]
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for part 520 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
4. In Sec. 520.1408, revise paragraph (b) to read as follows:
Sec. 520.1408 Methylprednisolone.
* * * * *
(b) Sponsors. See Nos. 054771 and 069043 in Sec. 510.600(c) of
this chapter.
* * * * *
0
5. Add Sec. 520.1425 to read as follows:
Sec. 520.1425 Metronidazole.
(a) Specifications. Each milliliter of suspension contains 125
milligrams (mg) metronidazole.
(b) Sponsor. See No. 051311 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. Administer 25 mg per kilogram
(11.3 mg per pound) of body weight twice daily for 5 consecutive days.
(2) Indications for use. For the treatment of Giardia duodenalis
infection in dogs.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
6. Add Sec. 520.1892 to read as follows:
Sec. 520.1892 Pregabalin.
(a) Specifications. Each milliliter (mL) of solution contains 50
milligrams (mg) pregabalin.
(b) Sponsor. See No. 052483 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. Administer orally as a single
dose of 5 mg/kg (0.1 mL/kg) approximately 1.5 hours before the start of
the transportation or veterinary visit.
(2) Indications for use. For alleviation of acute anxiety and fear
associated with transportation and veterinary visits.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
7. In Sec. 520.2645, revise paragraph (d)(2) to read as follows:
Sec. 520.2645 Tylvalosin.
* * * * *
(d) * * *
(2) Indications for use. For control of porcine proliferative
enteropathy (PPE) associated with Lawsonia intracellularis infection in
groups of swine intended for slaughter and female swine intended for
breeding in buildings experiencing an outbreak of PPE; and for control
of swine respiratory disease (SRD) associated with Bordetella
bronchiseptica, Glaesserella (Haemophilus) parasuis, Pasteurella
multocida, Streptococcus suis, and Mycoplasma hyopneumoniae in groups
of swine intended for slaughter and female swine intended for breeding
in buildings experiencing an outbreak of SRD.
* * * * *
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
8. The authority citation for part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
9. In Sec. 522.304, revise paragraph (b) to read as follows:
Sec. 522.304 Carprofen.
* * * * *
(b) Sponsors. See Nos. 016729, 017033, 054771, 055529, and 069043
in Sec. 510.600(c) of this chapter.
* * * * *
0
10. In Sec. 522.812, revise paragraphs (b)(1) and (2) to read as
follows:
Sec. 522.812 Enrofloxacin.
* * * * *
(b) * * *
(1) Nos. 016729, 017033, 055529, 058198, 069043, and 086101 for use
of product described in paragraph (a)(1) as in paragraph (e)(1) of this
section; and
(2) Nos. 051311, 055529, 058005, 058198, 061133, 069043, and 086101
for use of product described in paragraph (a)(2) as in paragraphs
(e)(2) and (3) of this section.
* * * * *
0
11. In Sec. 522.955, revise paragraph (b)(3) and the second sentence
in paragraph (d)(1)(ii)(C) to read as follows:
Sec. 522.955 Florfenicol.
* * * * *
(b) * * *
(3) Nos. 058005, 058198, and 069043 for use of product described in
paragraph (a)(2) of this section as in paragraph (d)(1)(ii) of this
section.
* * * * *
(d) * * *
(1) * * *
(ii) * * *
(C) Limitations. * * * Nos. 000061, 058005, 058198, and 069043:
Animals intended for human consumption must not be slaughtered within
38 days of subcutaneous treatment. * * *
* * * * *
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
12. The authority citation for part 524 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
13. In 524.1044a, revise paragraph (b) to read as follows:
Sec. 524.1044a Gentamicin ophthalmic solution.
* * * * *
(b) Sponsors. See Nos. 000061 and 086189 in Sec. 510.600(c) of
this chapter.
* * * * *
0
14. In 524.1146, revise paragraphs (b)(1) and (2) to read as follows:
Sec. 524.1146 Imidacloprid and moxidectin.
* * * * *
(b) * * *
(1) Nos. 017030, 051072, 051311, 055529, and 058198 for use of
product described in paragraph (a)(1) of this section as in paragraph
(d)(1) of this section.
(2) Nos. 017030, 051072, 051311, 055529, and 058198 for use of
product described in paragraph (a)(2) of this section as in paragraph
(d)(2) of this section.
* * * * *
0
15. In 524.2098, revise paragraph (b) to read as follows:
Sec. 524.2098 Selamectin.
* * * * *
(b) Sponsors. See Nos. 051072, 051311, 054771, 055529, and 061133
in Sec. 510.600(c) of this chapter.
* * * * *
0
16. In 524.2099, revise paragraph (c)(2) to read as follows:
Sec. 524.2099 Selamectin and sarolaner.
* * * * *
(c) * * *
(2) Indications for use. For the prevention of heartworm disease
caused by Dirofilaria immitis. Kills adult fleas (Ctenocephalides
felis) and is indicated for the treatment and prevention of flea
infestations; the treatment and control of tick infestations with
Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast
tick), Dermacentor variabilis (American dog tick), and Ixodes
scapularis (black-legged tick), the treatment and control of ear mite
(Otodectes cynotis) infestations; and the treatment and control of
roundworm (Toxocara cati) and intestinal hookworm (Ancylostoma
tubaeforme) infections in cats and kittens 8 weeks of age and older,
and weighing 2.8 pounds or greater.
* * * * *
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
0
17. The authority citation for part 529 continues to read as follows:
[[Page 14411]]
Authority: 21 U.S.C. 360b.
0
18. In Sec. 529.1186, revise paragraph (b) to read as follows:
Sec. 529.1186 Isoflurane.
* * * * *
(b) Sponsors. See Nos. 017033, 054771, and 066794 in Sec.
510.600(c) of this chapter.
* * * * *
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
0
19. The authority citation for part 556 continues to read as follows:
Authority: 21 U.S.C. 342, 360b, 371.
Sec. 556.730 [Removed]
0
20. Remove Sec. 556.730.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
21. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
Sec. 558.4 [Amended]
0
22. Amend Sec. 558.4, by removing the entry for ``Thiabendazole'' in
the Category II'' table in paragraph (d).
0
23. In Sec. 558.95, revise paragraphs (b), (e)(2)(i) and (ii), and
(e)(3)(i) and (ii) to read as follows:
Sec. 558.95 Bambermycins.
* * * * *
(b) Sponsor. See No. 016592 in Sec. 510.600(c) of this chapter.
* * * * *
(e) * * *
(2) * * *
------------------------------------------------------------------------
Bambermycins
in grams/ton Indications for use Limitations Sponsor
------------------------------------------------------------------------
(i) 1 to 2.... Growing turkeys: For Feed continuously as 016592
improved feed the sole ration.
efficiency.
(ii) 2........ Growing turkeys: For Feed continuously as 016592
increased rate of the sole ration.
weight gain and
improved feed
efficiency.
------------------------------------------------------------------------
(3) * * *
------------------------------------------------------------------------
Bambermycins
in grams/ton Indications for use Limitations Sponsor
------------------------------------------------------------------------
(i) 2......... Growing-finishing Feed continuously as 016592
swine: For increased the sole ration.
rate of weight gain
and improved feed
efficiency.
(ii) 2 to 4... Growing-finishing Feed continuously as 016592
swine: For improved the sole ration.
feed efficiency.
------------------------------------------------------------------------
* * * * *
0
24. In Sec. 558.128:
0
a. Revise paragraphs (e)(4)(xvi) and (xvii);
0
b. Redesignate paragraphs (e)(4)(xxi) through (lviii) as paragraphs
(e)(4)(xxiii) through (lx); and
0
c. Add new paragraphs (e)(4)(xxi) and (xxii).
The revision and additions read as follows:
Sec. 558.128 Chlortetracycline.
* * * * *
(e) * * *
(4) * * *
----------------------------------------------------------------------------------------------------------------
Combination in grams/
Chlortetracycline amount ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(xvi) to provide 10 mg/lb of body .................... Calves, beef and Feed approximately 054771
weight daily. nonlactating dairy 400 g/ton, varying 066104
cattle: For with body weight 069254
treatment of and feed
bacterial enteritis consumption to
caused by provide 10 mg/lb
Escherichia coli and per day. Treat for
bacterial pneumonia not more than 5
caused by days. To sponsor
Pasteurella No. 054771 (NADAs
multocida organisms 048-761 and 046-
susceptible to 699) and to sponsor
chlortetracycline. No. 069254 (ANADA
200-510): May be
mixed in the
cattle's daily
ration or
administered as a
top-dress. In feed
including milk
replacers withdraw
10 days prior to
slaughter. To
sponsor No. 054771
under NADA 046-699:
24-hour withdrawal
period. To sponsor
No. 054771 under
NADA 048-761 and
No. 069254 under
ANADA 200-510: Zero
withdrawal period.
See paragraph
(d)(3) of this
section.
(xvii) to provide 10 mg/lb of body .................... Calves (up to 250 A withdrawal period 066104
weight daily. lb): For the has not been
treatment of established for
bacterial enteritis this product in pre-
caused by ruminating calves.
Escherichia coli Do not use in
susceptible to calves to be
chlortetracycline. processed for veal.
[[Page 14412]]
* * * * * * *
(xxi) 400 to 2,000 g/ton.......... Monensin, 15 to 84.. Replacement beef and For replacement beef 069254
dairy heifers: For and dairy heifers
treatment of not currently being
bacterial enteritis fed monensin: Feed
caused by as the sole ration
Escherichia coli and for not more than 5
bacterial pneumonia days to provide 10
caused by mg
Pasteurella chlortetracycline
multocida per pound of body
susceptible to weight per day and
chlortetracycline; 0.14 to 0.42 mg
and for the monensin per pound
prevention and of body weight per
control of day, depending upon
coccidiosis caused severity of
by Eimeria bovis and challenge, to
Eimeria zuernii. provide 50 to 100
mg monensin per
head per day in a
minimum of 1 pound
of Type C medicated
feed. After 5 days,
continue to feed
monensin Type C
medicated feed
alone to provide 50
to 200 mg monensin
per head per day in
a minimum of 1
pound of Type C
medicated feed.
For replacement beef
and dairy heifers
currently being fed
monensin: Feed as
the sole ration for
not more than 5
days to provide 10
mg
chlortetracycline
per pound of body
weight per day and
0.14 to 0.42 mg
monensin per pound
of body weight per
day, depending upon
severity of
challenge, to
provide 50 to 200
mg monensin per
head per day in a
minimum of 1 pound
of Type C medicated
feed. After 5 days,
continue to feed
monensin Type C
medicated feed
alone.
This drug is not
approved for use in
female dairy cattle
20 months of age or
older, including
dry dairy cows. Use
in these cattle may
cause drug residues
in milk and/or in
calves born to
these cows. A
withdrawal period
has not been
established for
this product in pre-
ruminating calves.
Do not use in
calves to be
processed for veal.
Monensin as provided
by No. 058198,
chlortetracycline
by No. 069254 in
Sec. 510.600(c)
of this chapter.
(xxii) 400 to 2,000 g/ton......... Monensin, 15 to 400. Replacement beef and For replacement beef 069254
dairy heifers: For and dairy heifers
treatment of not currently being
bacterial enteritis fed monensin: Feed
caused by as the sole ration
Escherichia coli and for not more than 5
bacterial pneumonia days to provide 10
caused by mg
Pasteurella chlortetracycline
multocida per pound of body
susceptible to weight per day and
chlortetracycline; 50 to 100 mg
and for increased monensin per head
rate of weight gain. per day in a
minimum of 1 pound
of Type C medicated
feed. After 5 days,
continue to feed
monensin Type C
medicated feed
alone to provide 50
to 200 mg monensin
per head per day in
a minimum of 1
pound of Type C
medicated feed.
For replacement beef
and dairy heifers
currently being fed
monensin: Feed as
the sole ration for
not more than 5
days to provide 10
mg
chlortetracycline
per pound of body
weight per day and
50 to 200 mg
monensin per head
per day in a
minimum of 1 pound
of Type C medicated
feed. After 5 days,
continue to feed
monensin Type C
medicated feed
alone.
This drug is not
approved for use in
female dairy cattle
20 months of age or
older, including
dry dairy cows. Use
in these cattle may
cause drug residues
in milk and/or in
calves born to
these cows. A
withdrawal period
has not been
established for
this product in pre-
ruminating calves.
Do not use in
calves to be
processed for veal.
Monensin as provided
by No. 058198,
chlortetracycline
by No. 069254 in
Sec. 510.600(c)
of this chapter.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
Sec. 558.600 [Removed]
0
25. Remove Sec. 558.600.
Dated: February 20, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-03765 Filed 2-26-24; 8:45 am]
BILLING CODE 4164-01-P
