New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications, Change of Sponsor, Change of Sponsor Address, 55559-55571 [2023-17454]
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Federal Register / Vol. 88, No. 157 / Wednesday, August 16, 2023 / Rules and Regulations
General, 5 U.S.C. 801(a)(1), and indicate
whether the rule is a ‘‘major rule’’ as
defined in 5 U.S.C. 804(2). The CRA
further states that the Office of
Information and Regulatory Affairs
(OIRA) determines whether a rule
qualifies as a ‘‘major rule.’’ OIRA has
determined that this rule is not a ‘‘major
rule’’ under the CRA. To comply with
the CRA, the Commission will submit
the required information to each House
of Congress and the Comptroller
General.
List of Subjects in 16 CFR Part 1310
Administrative practice and
procedure, Consumer protection, Infants
and children.
For the reasons stated in the preamble,
the Commission adds part 1310 to title
16 of the Code of Federal Regulations as
follows:
§ 1310.3
Banned Hazardous Product.
Any inclined sleeper for infants, as
defined in section 1310.2, regardless of
the date of manufacture, is a banned
hazardous product under section 8 of
the Consumer Product Safety Act (15
U.S.C. 2057).
§ 1310.4
Effective Date.
By statute, the effective date of this
ban is November 12, 2022. The effective
date of this rule is September 15, 2023.
Alberta E. Mills,
Secretary, Consumer Product Safety
Commission.
[FR Doc. 2023–17350 Filed 8–15–23; 8:45 am]
Sec.
1310.1
1310.2
1310.3
1310.4
New Animal Drugs; Approval of New
Animal Drug Applications; Withdrawal
of Approval of New Animal Drug
Applications, Change of Sponsor,
Change of Sponsor Address
Purpose and Scope.
The purpose of this rule is to prohibit
the sale, offer for sale, manufacture for
sale, distribution in commerce, or
importation into the United States, of
any inclined sleepers for infants, as
defined in part 1310.2 and as set forth
in the Safe Sleep for Babies Act of 2021
(15. U.S.C. 2057d).
§ 1310.2
Food and Drug Administration
[Docket No. FDA–2023–N–0002]
Authority: 15 U.S.C. 2057d.
§ 1310.1
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
21 CFR Parts 500, 510, 516, 520, 522,
524, 526, 529, 556 and 558
Purpose and Scope.
Definition.
Banned Hazardous Product.
Effective Date.
Definition.
Inclined sleeper for infants means a
product with an inclined sleep surface
greater than ten degrees that is intended,
marketed, or designed to provide
sleeping accommodations for an infant
up to 1 year old.
AGENCY:
of summaries of the basis of approval
and of environmental review
documents, where applicable. The
animal drug regulations are also being
amended to improve their accuracy and
readability.
DATES: This rule is effective August 16,
2023.
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.
SUPPLEMENTARY INFORMATION:
I. Approvals
BILLING CODE 6355–01–P
■
PART 1310—BAN OF INCLINED
SLEEPERS FOR INFANTS
55559
Food and Drug Administration,
HHS.
Final rule; technical
amendments.
ACTION:
The Food and Drug
Administration (FDA or we) is
amending the animal drug regulations to
reflect application-related actions for
new animal drug applications (NADAs),
abbreviated new animal drug
applications (ANADAs), and
conditionally approved new animal
drug applications (cNADAs) during
April, May, and June 2023. FDA is
informing the public of the availability
SUMMARY:
FDA is amending the animal drug
regulations to reflect approval actions
for NADAs, ANADAs, and cNADAs
during April, May, and June 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 (FOI
Summaries) under the Freedom of
Information Act (FOIA). These public
documents may be seen in the office of
the Dockets Management Staff (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852, between 9 a.m. and 4 p.m.,
Monday through Friday, 240–402–7500.
Persons with access to the internet may
obtain these documents at the CVM
FOIA Electronic Reading Room: https://
www.fda.gov/about-fda/centerveterinary-medicine/cvm-foiaelectronic-reading-room. Marketing
exclusivity and patent information may
be accessed in FDA’s publication,
Approved Animal Drug Products Online
(Green Book) at: https://www.fda.gov/
animal-veterinary/products/approvedanimal-drug-products-green-book.
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS, ANADAS, AND CNADAS APPROVED DURING APRIL, MAY, AND JUNE
2023 REQUIRING EVIDENCE OF SAFETY AND/OR EFFECTIVENESS
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Approval date
File No.
Sponsor
Product name
April 5, 2023 ...............
200–612
Bimeda Animal Health Ltd.,
1B The Herbert Building,
The Park, Carrickmines,
Dublin 18, Ireland.
BIMASONE (flumethasone)
Injectable Solution.
April 10, 2023 .............
038–439
Phibro Animal Health Corp.,
GlenPointe Centre East, 3d
Floor, 300 Frank W. Burr
Blvd., Suite 21, Teaneck,
NJ 07666.
TERRAMYCIN for Fish (oxytetracycline) Type A Medicated Article.
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Effect of the action
Public
documents
Original approval for the treatment of various inflammatory conditions in horses,
dogs, and cats as a generic
copy of NADA 030–414.
Supplemental approval for the
control of mortality due to
columnaris disease in catfish and freshwater-reared
salmonids.
FOI Summary
522.960c
FOI Summary
558.450
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TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS, ANADAS, AND CNADAS APPROVED DURING APRIL, MAY, AND JUNE
2023 REQUIRING EVIDENCE OF SAFETY AND/OR EFFECTIVENESS—Continued
Approval date
File No.
Sponsor
Product name
Effect of the action
Public
documents
Original approval for prevention of heartworm disease;
for treatment and prevention
of flea infestations, treatment and control of tick infestations, roundworms,
hookworms, and tapeworms
in cats and kittens.
Conditional approval for the
control of nonregenerative
anemia associated with
chronic kidney disease
(CKD) in cats.
Original approval for the control of pain associated with
osteoarthritis in dogs.
Original approval for multiple
indications in beef calves 2
months of age and older
and in growing beef steers
and heifers fed in confinement for slaughter as a generic copy of NADA 141–
564.
Original approval for treatment
and control of internal and
external parasites of cattle
and swine as a generic
copy of NADA 141–061.
FOI Summary
524.838
FOI Summary
516.1449
FOI Summary
522.158
FOI Summary
558.128
FOI Summary
522.770
Original approval for control of
pruritus associated with allergic dermatitis and control
of atopic dermatitis in dogs
at least 12 months of age.
Supplemental approval for
Asian longhorned tick.
FOI Summary
520.1604
FOI Summary
520.43
Original approval for the control of pain and inflammation
associated with osteoarthritis and for the control
of postoperative pain and
inflammation associated
with soft-tissue and orthopedic surgery in dogs as a
generic copy of NADA 141–
230.
FOI Summary
520.928
April 20, 2023 .............
141–570
Boehringer Ingelheim Animal
Health USA, Inc., 3239 Satellite Blvd., Duluth, GA
30096.
NEXGARD COMBO
(esafoxolaner, eprinomectin,
and praziquantel) Topical
Solution.
May 1, 2023 ................
141–571
Elanco US Inc., 2500 Innovation Way, Greenfield, IN
46140.
VARENZIN–CA1 (molidustat
oral suspension).
May 5, 2023 ................
141–562
Zoetis Inc., 333 Portage St.,
Kalamazoo, MI 49007.
LIBRELA (bedinvetmab injection) Injectable Solution.
May 10, 2023 ..............
200–748
Huvepharma EOOD, 5th
Floor, 3A Nikolay Haytov
Str., 1113 Sofia, Bulgaria.
May 25, 2023 ..............
200–750
June 9, 2023 ...............
141–555
Cronus Pharma Specialities
India Private Ltd., Sy No-99/
1, M/s GMR Hyderabad
Aviation SEZ Ltd.,
Mamidipalli Village,
Shamshabad Mandal,
Ranga Reddy, Hyderabad,
Telangana, 501218, India.
Zoetis Inc., 333 Portage St.,
Kalamazoo, MI 49007.
PENNCHLOR (chlortetracycline Type A medicated
article) and MONOVET
(monensin Type A medicated article) to be used in
the manufacture of Type B
and Type C medicated
feeds.
DORAJECT (doramectin injection) Injectable Solution.
June 21, 2023 .............
141–406
June 22, 2023 .............
200–751
Boehringer Ingelheim Animal
Health USA, Inc., 3239 Satellite Blvd., Duluth, GA
30096.
Pegasus Laboratories, Inc.,
8809 Ely Rd., Pensacola,
FL 32514.
Also, FDA is amending the animal
drug regulations to reflect approval of
supplemental applications, as listed in
table 2, to change the marketing status
of dosage form antimicrobial animal
drug products from over-the-counter
(OTC) to by veterinary prescription (Rx).
APOQUEL CHEWABLE
(oclacitinib tablet) Tablets.
NEXGARD (afoxolaner)
Chewable Tablet.
Firocoxib Chewable Tablets
for Dogs (firocoxib).
These applications were submitted in
voluntary compliance with the goals of
the FDA Center for Veterinary
Medicine’s Judicious Use Initiative as
identified by guidance for industry
#263, ‘‘Recommendations for Sponsors
of Medically Important Antimicrobial
21 CFR
section
Drugs Approved for Use in Animals to
Voluntarily Bring Under Veterinary
Oversight All Products That Continue to
be Available Over-the-Counter,’’ June
11, 2021 (https://www.fda.gov/media/
130610/download).
TABLE 2—SUPPLEMENTAL APPLICATIONS APPROVED DURING APRIL, MAY, AND JUNE 2023 TO CHANGE THE MARKETING
STATUS OF ANTIMICROBIAL ANIMAL DRUG PRODUCTS FROM OTC TO RX
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Approval date
File No.
April 14, 2023 ..............
200–147
April 24, 2023 ..............
065–481
April 24, 2023 ..............
200–128
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section
Sponsor
Product name
Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str.,
1113 Sofia, Bulgaria.
Cronus Pharma Specialities India Private Ltd., Sy No99/1, M/s GMR Hyderabad Aviation SEZ Ltd.,
Mamidipalli Village, Shamshabad Mandal, Ranga
Reddy, Hyderabad, Telangana, 501218, India.
Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str.,
1113 Sofia, Bulgaria.
GENTAPOULT (gentamicin) Injectable Solution ...........
522.1044
Chlortetracycline Pneumonia/Calf Scour Bolus .............
520.443
AGRIMYCIN 200 (oxytetracycline HCl) Injectable Solution.
522.1660a
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TABLE 2—SUPPLEMENTAL APPLICATIONS APPROVED DURING APRIL, MAY, AND JUNE 2023 TO CHANGE THE MARKETING
STATUS OF ANTIMICROBIAL ANIMAL DRUG PRODUCTS FROM OTC TO RX—Continued
Approval date
File No.
21 CFR
section
Sponsor
Product name
Cronus Pharma Specialities India Private Ltd., Sy No99/1, M/s GMR Hyderabad Aviation SEZ Ltd.,
Mamidipalli Village, Shamshabad Mandal, Ranga
Reddy, Hyderabad, Telangana, 501218, India.
Do ...................................................................................
Do ...................................................................................
Do ...................................................................................
Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str.,
1113 Sofia, Bulgaria.
Norbrook Laboratories Ltd., Carnbane Industrial Estate, Newry, County Down, BT35 6QQ, United Kingdom.
Bimeda Animal Health Ltd., 1B The Herbert Building,
The Park, Carrickmines, Dublin 18, Ireland.
Elanco US Inc., 2500 Innovation Way, Greenfield, IN
46140.
MEDAMYCIN 100 (oxytetracycline HCl) Injectable Solution.
522.1662
OXYJECT 100 (oxytetracycline HCl) Injectable Solution
OXY–TET 50 (oxytetracycline HCl) Injectable Solution
OXYJECT 50 (oxytetracycline HCl) Injectable Solution
SULFATECH SR (sulfamethazine sustained release
bolus).
Oxytetracycline Injection 200 .........................................
522.1662
522.1662
522.1662
520.2260b
522.1660a
SUSTAIN III (sulfamethazine) Calf Bolus ......................
520.2260b
COMPONENT T–S with TYLAN; COMPONENT T–H
with TYLAN (trenbolone acetate and tylosin tartrate)
Implants.
SPECTOGARD Scour-Chek (spectinomycin
dihydrochloride pentahydrate) Oral Solution.
ERYTHRO–36 Dry (erythromycin) IMM Infusion ...........
OXYTET 100 (oxytetracycline HCl) Injectable Solution
522.2476
520.2123c
Oxytetracycline Hydrochloride Injection, 100 mg/mL ....
522.1662
DRY–MAST (dihydrostreptomycin sulfate and penicillin
G procaine).
BIO–MYCIN 200 (oxytetracycline HCl) Injectable Solution.
FORMULA A–34; UNI BIOTIC (penicillin G procaine) 4
DOSE.
TETROXY–LA (oxytetracycline HCl) Injectable Solution
PENNOX 200 (oxytetracycline HCl) Injectable Solution
526.1697
522.1660a
522.1660a
MAXIM–200 Injection (oxytetracycline HCl) ..................
522.1660a
OXYSHOT LA (oxytetracycline HCl) Injectable Solution
522.1660a
COMPONENT E–H with TYLAN (testosterone propionate and estradiol benzoate with tylosin tartrate) Implant.
COMPONENT TE–G with TYLAN; COMPONENT TE–
ID with TYLAN; COMPONENT TE–IS with TYLAN;
COMPONENT TE–S with TYLAN (trenbolone acetate, estradiol, and tylosin tartrate) Implants.
COMPONENT TE–200 with TYLAN; COMPONENT
TE–H with TYLAN; COMPONENT TE–IH with
TYLAN; (trenbolone acetate, estradiol, and tylosin
tartrate) Implants.
COMPONENT E–C with TYLAN; COMPONENT E–S
with TYLAN (progesterone, estradiol benzoate, and
tylosin tartrate) Implants.
522.2343
April 28, 2023 ..............
108–963
April 28, 2023
April 28, 2023
April 28, 2023
May 15, 2023
..............
..............
..............
..............
097–452
047–278
045–143
140–270
May 15, 2023 ..............
200–306
May 16, 2023 ..............
120–615
May 17, 2023 ..............
200–224
May 19, 2023 ..............
200–364
May 22, 2023 ..............
May 22, 2023 ..............
035–455
200–452
May 26, 2023 ..............
200–068
May 30, 2023 ..............
055–097
May 31, 2023 ..............
200–008
June 2, 2023 ...............
065–383
June 2, 2023 ...............
June 7, 2023 ...............
200–537
200–154
June 8, 2023 ...............
200–123
June 9, 2023 ...............
200–117
June 15, 2023 .............
135–906
June 22, 2023 .............
200–221
Do ...................................................................................
June 30, 2023 .............
200–346
Do ...................................................................................
June 30, 2023 .............
110–315
Do ...................................................................................
Bimeda Animal Health Ltd., 1B The Herbert Building,
The Park, Carrickmines, Dublin 18, Ireland.
Do ...................................................................................
Norbrook Laboratories Ltd., Carnbane Industrial Estate, Newry, County Down, BT35 6QQ, United Kingdom.
Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str.,
1113 Sofia, Bulgaria.
HQ Specialty Pharma Corp., 120 Rte. 17 North, Suite
130, Paramus, NJ 07652.
Boehringer Ingelheim Animal Health USA, Inc., 3239
Satellite Blvd., Duluth, GA 30096.
Bimeda Animal Health Ltd., 1B The Herbert Building,
The Park, Carrickmines, Dublin 18, Ireland.
Do ...................................................................................
Pharmgate Inc., 1800 Sir Tyler Dr., Wilmington, NC
28405.
Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str.,
1113 Sofia, Bulgaria.
Bimeda Animal Health Ltd., 1B The Herbert Building,
The Park, Carrickmines, Dublin 18, Ireland.
Elanco US Inc., 2500 Innovation Way, Greenfield, IN
46140.
II. Withdrawals of Approval
The sponsors of the following files
have requested that FDA withdraw
approval of the applications listed in
table 3 because the products are no
longer manufactured or marketed. As
provided in the regulatory text of this
526.820
522.1662
522.1660a
526.1696
522.2477
522.2477
522.1940
document, the cited animal drug
regulations are amended to reflect these
actions.
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TABLE 3—APPLICATIONS FOR WHICH APPROVAL WAS VOLUNTARILY WITHDRAWN DURING APRIL, MAY, AND JUNE 2023
File No.
Sponsor
Product name
140–954 ......................
Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940 ................
141–002 ......................
Boehringer Ingelheim Animal Health USA, Inc., 3239 Satellite
Blvd., Duluth, GA 30096.
Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA
91767–1861.
Type C medicated swine feed containing fenbendazole and
lincomycin.
OXY 1000 (oxytetracycline HCl) Calf Bolus; OXY 500 (oxytetracycline HCl) Calf Bolus.
GENTASOL (gentamicin sulfate solution) ................................
200–191 ......................
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III. Change of Sponsor
Elanco US, Inc., 2500 Innovation
Way, Greenfield, IN 46140 has informed
FDA that it has transferred ownership
of, and all rights and interest in, NADA
135–468 for CARBIGRAN 25
(nicarbazin) Type A Medicated Article
to Pharmgate Inc., 1800 Sir Tyler Dr.,
Wilmington, NC 28405. As provided in
the regulatory text of this document, 21
CFR 558.366 is amended to reflect this
action.
IV. Change of Sponsor Address
Intervet, Inc., 2 Giralda Farms,
Madison, NJ 07940 has informed FDA
that it has changed its address to 126 E.
Lincoln Ave., Rahway, NJ 07065. As
provided in the regulatory text of this
document, the tabular listings in 21 CFR
510.600(c) are amended to reflect this
action.
V. Technical Amendments
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FDA is making the following
amendments to improve the accuracy of
the animal drug regulations.
• 21 CFR 500.1410 and 522.1660a are
amended to reflect the use of N-methyl2-pyrrolidone as an excipient in a
formulation of oxytetracycline injectable
solution.
• 21 CFR 520.1484 is being revised to
include use of neomycin administered
in drinking water of turkeys.
• 21 CFR 520.1660a is being
redesignated as 21 CFR 520.1664 to
reflect the drug as a fixed-ratio
combination of oxytetracycline and
carbomycin.
• 21 CFR 520.1660b is being revised
to reflect the format and content of a
prescription drug.
• 21 CFR 520.2220b is amended to
reflect revised conditions of use for
sulfadimethoxine oral suspension in
dogs and cats.
• 21 CFR 520.2220c is amended to
reflect revised conditions of use for
sulfadimethoxine tablets in dogs and
cats.
• 21 CFR 520.2260b is amended to
reflect current sponsors of
sulfamethazine sustained-release
boluses for use in cattle.
• 21 CFR 522.2680 is amended to
reflect revised conditions of use for
zeranol implants in beef cattle.
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• 21 CFR 529.1044a is amended to
reflect sponsors of approved
applications for use of gentamicin
solution for uterine infusion in mares.
• 21 CFR 556.110 and 556.500 are
being revised to reflect redesignation of
a combination drug containing
oxytetracycline and carbomycin used in
the drinking water of chickens.
• 21 CFR 558.68 is being revised to
reflect approved feeding instructions for
avilamycin and monensin two-way,
combination drug Type C medicated
chicken 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)), which requires Federal
Register publication of ‘‘notice[s] . . .
effective as a regulation,’’ of the
conditions of use of approved new
animal drugs. This rule sets forth
technical amendments to the regulations
to codify recent actions on approved
new animal drug applications and
corrections to improve the accuracy of
the regulations, and as such does not
impose any burden on regulated
entities.
Although denominated a rule
pursuant to the FD&C Act, this
document does not meet the definition
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
it is a ‘‘rule of particular applicability.’’
Therefore, it is not subject to the
congressional review requirements in 5
U.S.C. 801–808. Likewise, this is not a
rule subject to Executive Order 12866,
which defines a rule as ‘‘an agency
statement of general applicability and
future effect, which the agency intends
to have the force and effect of law, that
is designed to implement, interpret, or
prescribe law or policy or to describe
the procedure or practice requirements
of an agency.’’
List of Subjects
21 CFR Part 500
Animal drugs, Animal feeds, Cancer,
Labeling, Packaging and containers,
Polychlorinated biphenyls (PCBs).
21 CFR Part 510
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21 CFR Part 516
Administrative practice and
procedure, Animal drugs, Confidential
business information, Reporting and
recordkeeping requirements.
21 CFR Parts 520, 522, 524, 526, and
529
Animal drugs.
21 CFR Part 556
Animal drugs, Dairy products, Foods,
Meat and meat products.
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 500,
510, 516, 520, 522, 524, 526, 529, 556,
and 558 are amended as follows:
PART 500—GENERAL
1. The authority citation for part 500
continues to read as follows:
■
Authority: 21 U.S.C. 321, 331, 342, 343,
348, 351, 352, 353, 360b, 371, 379e.
2. In § 500.1410, revise paragraph (c)
to read as follows:
■
§ 500.1410
Sfmt 4700
N-methyl-2-pyrrolidone.
*
*
*
*
*
(c) Related conditions of use. See
§§ 522.814, 522.955, and 522.1660a of
this chapter.
PART 510—NEW ANIMAL DRUGS
3. The authority citation for part 510
continues to read as follows:
■
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
4. In § 510.600, in the table in
paragraph (c)(1), revise the entry for
‘‘Intervet, Inc.’’ and in the table in
paragraph (c)(2), revise the entry for
‘‘000061’’ to read as follows:
■
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
Administrative practice and
procedure, Animal drugs, Labeling,
PO 00000
Reporting and recordkeeping
requirements.
*
*
(c) * * *
(1) * * *
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Firm name and address
Drug labeler code
*
*
*
*
*
*
Intervet, Inc., 126 E Lincoln Ave., Rahway, NJ 07065 ...........................................................................................................
*
*
*
*
*
*
000061
*
*
*
*
*
*
*
*
(2) * * *
Drug labeler code
*
000061 .......................
Firm name and address
*
*
*
Intervet, Inc., 126 E Lincoln Ave., Rahway, NJ 07065
*
*
*
PART 516—NEW ANIMAL DRUGS FOR
MINOR USE AND MINOR SPECIES
5. The authority citation for part 516
continues to read as follows:
■
Authority: 21 U.S.C. 360ccc–1, 360ccc–2,
371.
■
6. Add § 516.1449 to read as follows:
§ 516.1449
Molidustat oral suspension.
(a) Specifications. Each milliliter (mL)
of suspension contains 25 milligrams
(mg) molidustat sodium.
(b) Sponsor. See No. 058198 in
§ 510.600(c) of this chapter.
(c) Conditions of use—(1) Amount.
Administer orally at a dosage of 5 mg/
kg of body weight (2.3 mg/lb) daily for
up to 28 consecutive days.
(2) Indications for use. For the control
of nonregenerative anemia associated
with chronic kidney disease in cats.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian. It is a violation
of Federal law to use this product other
than as directed in the labeling.
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
7. The authority citation for part 520
continues to read as follows:
■
Afoxolaner.
lotter on DSK11XQN23PROD with RULES1
*
*
*
*
*
(c) * * *
(1) Amount. Administer orally once a
month at a minimum dosage of 1.14 mg/
pound (2.5 mg/kilogram).
(2) Indications for use. Kills adult
fleas and for the treatment and
prevention of flea infestations
(Ctenocephalides felis); and the
treatment and control of Ixodes
scapularis (black-legged tick),
16:04 Aug 15, 2023
9. In § 520.443, revise paragraph
(d)(1)(ii) to read as follows:
■
§ 520.443
boluses.
Jkt 259001
*
*
*
*
(d) * * *
(1) * * *
(ii) Limitations. Administer bolus
directly by mouth or crush and dissolve
in milk or water for drenching or bucket
feeding. Do not use for more than 5
days. Do not administer within 24 hours
of slaughter. Federal law restricts this
drug to use by or on the order of a
licensed veterinarian.
*
*
*
*
*
[Amended]
10. In § 520.928, in paragraph (b)(1),
remove ‘‘Nos. 000010 and 055529’’ and
add in its place ‘‘Nos. 000010, 055246,
and 055529’’.
11. In § 520.1484, revise paragraph
(b)(3) and add paragraph (b)(4) to read
as follows:
■
Neomycin.
*
*
*
*
*
(b) * * *
(3) Nos. 016592, 054771, and 058005
for use of product described in
paragraph (a)(2) as in paragraph (e)(1) of
this section.
PO 00000
§ 520.1604
Frm 00013
Fmt 4700
Sfmt 4700
[Amended]
12. In § 520.1604, in paragraph (a),
remove ‘‘Each tablet contains’’ and add
in its place ‘‘Each tablet or chewable
tablet contains’’.
■
§ 520.1660a
[Redesignated as § 520.1664]
13. Redesignate § 520.1660a as
§ 520.1664.
■
§ 520.1660a
■
*
§ 520.1484
(4) No. 054925 for use of product
described in paragraph (a)(2) as in
paragraphs (e)(1) and (2) of this section.
*
*
*
*
*
Chlortetracycline tablets and
■
8. In § 520.43, revise paragraphs (c)(1)
and (2) to read as follows:
■
VerDate Sep<11>2014
Dermacentor variabilis (American dog
tick), Amblyomma americanum (lone
star tick), Rhipicephalus sanguineus
(brown dog tick), and Haemaphysalis
longicornis (longhorned tick)
infestations in dogs and puppies 8
weeks of age and older, weighing 4
pounds of body weight or greater, for 1
month; and for the prevention of
Borrelia burgdorferi infections as a
direct result of killing Ixodes scapularis
vector ticks.
*
*
*
*
*
§ 520.928
Authority: 21 U.S.C. 360b.
§ 520.43
*
[Reserved]
14. Add reserved § 520.1660a.
15. In § 520.1660b, revise the section
heading and paragraphs (a) and (c) to
read as follows:
■
§ 520.1660b
Oxytetracycline capsules.
(a) Specifications. Each capsule
contains 125 or 250 milligrams (mg)
oxytetracycline hydrochloride.
*
*
*
*
*
(c) Conditions of use in dogs and
cats—(1) Amount. Administer orally 25
to 50 mg per pound of body weight per
day in divided doses at 12-hour
intervals.
(2) Indications for use. For the
treatment of bacterial pneumonia
caused by Brucella bronchiseptica,
tonsilitis caused by Streptococcus
hemolyticus, bacterial enteritis caused
by Escherichia coli, urinary tract
infections caused by Escherichia coli,
and wound infections caused by
Staphylococcus aureus.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
16. In § 520.1660c, revise the section
heading and paragraphs (a), (b), and (d)
to read as follows:
■
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§ 520.1660c
Oxytetracycline tablets.
(a) Specifications. Each tablet
contains 250 or 500 milligrams (mg)
oxytetracycline hydrochloride.
(b) Sponsor. See No. 054771 in
§ 510.600(c) of this chapter.
*
*
*
*
*
(d) Conditions of use in beef and dairy
cattle—(1) Amounts. 10 mg per pound
of body weight every 12 hours for
treatment; 5 mg per pound of body
weight every 12 hours for control.
(2) Indications for use. For treatment
and control of bacterial enteritis caused
by Salmonella typhimurium and
Escherichia coli (colibacillosis) and
bacterial pneumonia (shipping fever
complex, pasteurellosis) caused by
Pasteurella multocida.
(3) Limitations. Discontinue treatment
7 days prior to slaughter. Not for use in
lactating dairy cattle. A withdrawal
period has not been established for this
product in preruminating calves. Do not
use in calves to be processed for veal.
Federal law restricts this drug to use by
or on the order of a licensed
veterinarian.
■ 17. In § 520.2220b, revise paragraphs
(c)(1) and (2) to read as follows:
§ 520.2220b
Sulfadimethoxine suspension.
*
*
*
*
*
(c) * * *
(1) Amount. Administer orally 25 mg
per pound of body weight, followed by
12.5 mg per pound of body weight daily
until the animal is free of clinical signs
for 48 hours.
(2) Indications for use. For the
treatment of sulfadimethoxinesusceptible bacterial infections in dogs
and cats and enteritis associated with
coccidiosis in dogs.
*
*
*
*
*
■ 18. In § 520.2220c, revise paragraphs
(d)(1) and (2) to read as follows:
§ 520.2220c
Sulfadimethoxine tablet.
lotter on DSK11XQN23PROD with RULES1
*
*
*
*
*
(d) * * *
(1) Amount. Administer orally 25 mg
per pound of body weight, followed by
12.5 mg per pound of body weight daily
until the animal is free of clinical signs
for 48 hours.
(2) Indications for use. For the
treatment of sulfadimethoxinesusceptible bacterial infections in dogs
and cats and enteritis associated with
coccidiosis in dogs.
*
*
*
*
*
■ 19. In § 520.2260b, revise paragraphs
(d)(2)(iii), (f)(2)(iii), and (g)(2)(iii) and
remove paragraph (h).
The revisions read as follows:
VerDate Sep<11>2014
16:04 Aug 15, 2023
Jkt 259001
§ 520.2260b Sulfamethazine sustainedrelease boluses.
*
*
*
*
*
(d) * * *
(2) * * *
(iii) Limitations. Do not use in female
dairy cattle 20 months of age or older.
Use of sulfamethazine in this class of
cattle may cause milk residues. Do not
treat animals within 12 days of
slaughter. Federal law restricts this drug
to use by or on the order of a licensed
veterinarian.
*
*
*
*
*
(f) * * *
(2) * * *
(iii) Limitations. For use in
ruminating replacement calves only. Do
not slaughter animals for food for at
least 12 days after the last dose.
Exceeding two consecutive doses may
cause violative tissue residue to remain
beyond the withdrawal time. Do not use
in calves under 1 month of age or calves
being fed an all milk diet. Federal law
restricts this drug to use by or on the
order of a licensed veterinarian.
(g) * * *
(2) * * *
(iii) Limitations. For use in beef cattle
and nonlactating dairy cattle only. Do
not slaughter animals for food for at
least 8 days after the last dose. Do not
use in lactating dairy cattle. Do not
administer more than two consecutive
doses. Federal law restricts this drug to
use by or on the order of a licensed
veterinarian.
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
20. The authority citation for part 522
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
■
Bedinvetmab.
(a) Specifications. Each single-use vial
contains 5, 10, 15, 20, or 30 milligrams
(mg) bedinvetmab in an extractable
volume of 1 milliliter.
(b) Sponsor. See No. 054771 in
§ 510.600(c) of this chapter.
(c) Conditions of use—(1) Amount.
Administer 0.23 mg/pound (0.5 mg/
kilogram) body weight monthly by
subcutaneous injection.
(2) Indications for use. For the control
of pain associated with osteoarthritis in
dogs.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
■ 22. In § 522.770, revise paragraphs (b),
(d)(1)(iii), and (d)(2)(iii) to read as
follows:
PO 00000
Frm 00014
Fmt 4700
Sfmt 4700
Doramectin.
*
*
*
*
*
(b) Sponsors. See Nos. 054771 and
069043 in § 510.600(c) of this chapter.
*
*
*
*
*
(d) * * *
(1) * * *
(iii) Limitations. Consult your
veterinarian for assistance in the
diagnosis, treatment, and control of
parasitism. Administer as a single
subcutaneous or intramuscular
injection. Do not slaughter cattle for
human consumption within 35 days of
treatment. Not for use in female dairy
cattle 20 months of age or older. A
withdrawal period has not been
established for this product in
preruminating calves. Do not use in
calves to be processed for veal.
(2) * * *
(iii) Limitations. Consult your
veterinarian for assistance in the
diagnosis, treatment, and control of
parasitism. Administer as a single
intramuscular injection. Do not
slaughter swine for human consumption
within 24 days of treatment.
■ 23. In § 522.960c, revise paragraphs
(b) and (c)(1)(iii) to read as follows:
§ 522.960c
Flumethasone solution.
*
*
*
*
*
(b) Sponsors. See Nos. 054771 and
061133 in § 510.600(c) of this chapter.
(c) * * *
(1) * * *
(iii) Limitations. Not for use in horses
intended for human consumption.
Federal law restricts this drug to use by
or on the order of a licensed
veterinarian.
*
*
*
*
*
§ 522.1222
[Amended]
24. In § 522.1222, in paragraph (b),
remove ‘‘063286,’’.
■ 25. In § 522.1660a:
■ a. Revise paragraph (c);
■ b. Remove paragraph (d);
■ c. Redesignate paragraph (e) as
paragraph (d); and
■ d. Revise newly redesignated
paragraphs (d)(1)(ii) and (d)(2)(ii).
The revisions read as follows:
■
21. Add § 522.158 to read as follows:
§ 522.158
§ 522.770
§ 522.1660a Oxytetracycline solution, 200
milligrams/milliliter.
*
*
*
*
*
(c) Related tolerances. See § 556.500
of this chapter; and for No. 061133, see
also § 500.1410 of this chapter.
(d) * * *
(1) * * *
(ii) Limitations. Discontinue treatment
at least 28 days prior to slaughter. Milk
taken from animals during treatment
and for 96 hours after the last treatment
E:\FR\FM\16AUR1.SGM
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Federal Register / Vol. 88, No. 157 / Wednesday, August 16, 2023 / Rules and Regulations
must not be used for food. Federal law
restricts this drug to use by or on the
order of a licensed veterinarian.
(2) * * *
(ii) Limitations. Administer
intramuscularly. Do not inject more
than 5 mL per site in adult swine.
Discontinue treatment at least 28 days
prior to slaughter. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
■ 26. In § 522.1662, revise paragraphs
(b), (c), (g), (h), and (j) to read as follows:
§ 522.1662
Oxytetracycline.
lotter on DSK11XQN23PROD with RULES1
*
*
*
*
*
(b)(1) Specifications. Each milliliter
(mL) of solution contains 50 milligrams
(mg) oxytetracycline hydrochloride.
(2) Sponsor. See No. 069043 in
§ 510.600(c) of this chapter.
(3) Conditions of use—(i) Amount.
Administer 3 to 5 mg per pound of body
weight (mg/lb) per day by intramuscular
injection. Leptospirosis, severe foot-rot,
and severe forms of the indicated
diseases should be treated with 5 mg/lb
per day. Treatment should be continued
for 24 to 48 hours following remission
of clinical signs of disease, not to exceed
4 consecutive days. Not more than 10
mL should be injected per injection site
in adult cattle, and only 2 mL per
injection site in calves weighing 100
pounds or less.
(ii) Indications for use. Beef cattle,
beef calves, nonlactating dairy cattle,
and dairy calves; for treatment of
diseases due to oxytetracyclinesusceptible organisms as follows:
Pneumonia and shipping fever complex
(Pasteurella spp., Haemophilus spp.,
Klebsiella spp.), bacterial enteritis
(scours) (Escherichia coli), foot-rot
(Spherophorus necrophorus), diphtheria
(Spherophorus necrophorus), wooden
tongue (Actinobacillus lignieresii),
leptospirosis (Leptospira pomona), and
wound infections and acute metritis
caused by Staphylococcus spp. and
Streptococcus spp.
(iii) Limitations. Discontinue
treatment at least 20 days prior to
slaughter. Federal law restricts this drug
to use by or on the order of a licensed
veterinarian.
(c)(1) Specifications. Each milliliter
(mL) of solution contains 50 or 100
milligrams (mg) oxytetracycline
hydrochloride.
(2) Sponsor. See No. 069043 in
§ 510.600(c) of this chapter.
(3) Conditions of use—(i) Beef cattle
and nonlactating dairy cattle—(A)
Amount. Administer 3 to 5 mg per
pound of body weight (mg/lb) per day;
5 mg/lb per day for the treatment of
anaplasmosis, severe foot-rot, and
severe cases of other indicated diseases.
VerDate Sep<11>2014
16:04 Aug 15, 2023
Jkt 259001
For 50-mg/mL solution, administer
intramuscularly or intravenously; for
100-mg/mL solution, administer
intramuscularly only. Treatment should
be continued for 24 to 48 hours
following remission of clinical signs of
disease, not to exceed 4 consecutive
days.
(B) Indications for use. For treatment
of diseases due to oxytetracyclinesusceptible organisms as follows:
Pneumonia and shipping fever complex
associated with Pasteurella spp.,
Haemophilus spp., and Klebsiella spp.,
foot-rot and diphtheria caused by
Spherophorus necrophorus, bacterial
enteritis (scours) caused by Escherichia
coli, wooden tongue caused by
Actinobacillus lignieresii, leptospirosis
caused by Leptospira pomona,
anaplasmosis caused by Anaplasma
marginale; and wound infections and
acute metritis caused by Staphylococcus
spp. and Streptococcus spp.
(C) Limitations. Exceeding the highest
recommended dose of 5 mg/lb,
administering at recommended levels
for more than 4 consecutive days, and/
or exceeding 10 mL intramuscularly per
injection site may result in antibiotic
residues beyond the withdrawal time.
Discontinue treatment at least 18 days
prior to slaughter. Not for use in
lactating dairy cattle. Federal law
restricts this drug to use by or on the
order of a licensed veterinarian.
(ii) Swine—(A) Amount. Administer 3
to 5 mg/lb per day by intramuscular
injection. Sows: Administer 3 mg/lb by
intramuscular injection approximately 8
hours before farrowing or immediately
after completion of farrowing.
(B) Indications for use. For treatment
of bacterial enteritis (scours,
colibacillosis) caused by Escherichia
coli, pneumonia caused by Pasteurella
multocida, and leptospirosis caused by
Leptospira pomona. Sows: as an aid in
control of infectious enteritis (baby pig
scours, colibacillosis) in suckling pigs
caused by Escherichia coli.
(C) Limitations. Do not inject more
than 5 mL per injection site. Do not use
for more than 4 consecutive days.
Discontinue treatment at least 26 days
before slaughter. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
*
*
*
*
*
(g)(1) Specifications. Each milliliter
(mL) of solution contains 100
milligrams (mg) oxytetracycline
hydrochloride.
(2) Sponsor. See No. 069043 in
§ 510.600(c) of this chapter.
(3) Conditions of use. For the
treatment of diseases due to
oxytetracycline-susceptible organisms
as follows:
PO 00000
Frm 00015
Fmt 4700
Sfmt 4700
55565
(i) Beef cattle, beef calves,
nonlactating dairy cattle, and dairy
calves—(A) Amount. Administer 3 to 5
mg/lb body weight per day by
intramuscular, intravenous, or
subcutaneous injection. In severe forms
of the indicated diseases, administer 5
mg/lb body weight per day. Continue
treatment 24 to 48 hours following
remission of clinical signs of disease,
not to exceed 4 consecutive days.
(B) Indications for use. For the
treatment of pneumonia and shipping
fever complex associated with
Pasteurella spp., Haemophilus spp., or
Klebsiella spp.
(C) Limitations. Do not inject more
than 10 mL per intramuscular injection
site in adult cattle, and no more than 1
mL per site in calves weighing 100
pounds or less. Do not slaughter cattle
for 13 days after intramuscular or
intravenous treatment, or 2 days after
subcutaneous treatment. Exceeding the
highest recommended dosage or
duration of treatment (not more than 4
consecutive days) may result in residues
beyond the withdrawal period. A
withdrawal period has not been
established for use of this product in
preruminating calves. Do not use in
calves to be processed for veal. Federal
law restricts this drug to use by or on
the order of a licensed veterinarian.
(ii) Swine—(A) Amount. Administer 3
to 5 mg/lb body weight per day by
intramuscular injection. Sows:
Administer 3 mg/lb body weight once,
by intramuscular injection,
approximately 8 hours before farrowing
or immediately after completion of
farrowing.
(B) Indications for use. For treatment
of bacterial enteritis (scours,
colibacillosis) caused by Escherichia
coli, pneumonia caused by Pasteurella
multocida, and leptospirosis caused by
Leptospira pomona. Sows: As an aid in
control of infectious enteritis (baby pig
scours, colibacillosis) in suckling pigs
caused by Escherichia coli.
(C) Limitations. Do not inject more
than 5 mL per site. Discontinue
treatment at least 20 days prior to
slaughter. Federal law restricts this drug
to use by or on the order of a licensed
veterinarian.
(h)(1) Specifications. Each milliliter
(mL) of solution contains 50 or 100
milligrams (mg) oxytetracycline
hydrochloride.
(2) Sponsors. See No. 069043 in
§ 510.600(c) of this chapter for use of 50and 100-mg/mL solution and Nos.
016592 and 055529 in § 510.600(c) of
this chapter for use of 100-mg/mL
solution.
(3) Conditions of use in beef cattle,
beef calves, nonlactating dairy cattle,
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Federal Register / Vol. 88, No. 157 / Wednesday, August 16, 2023 / Rules and Regulations
and dairy calves—(i) Amount.
Administer 3 to 5 mg/lb body weight
per day by intramuscular injection; 5
mg/lb body weight per day for treatment
of severe forms of the indicated
diseases.
(ii) Indications for use. For treatment
of bacterial pneumonia and shipping
fever complex associated with
Pasteurella spp., foot-rot and calf
diphtheria caused by Fusobacterium
necrophorum, bacterial enteritis (scours)
caused by Escherichia coli, wooden
tongue caused by Actinobacillus
lignieresii; and wound infections and
acute metritis caused by Staphylococcus
spp. and Streptococcus spp.
(iii) Limitations. Do not inject more
than 10 mL per site in adult cattle.
Reduce the volume administered per
injection site according to age and body
size. In calves weighing 100 pounds or
less, do not inject more than 2 mL per
site. Discontinue treatment at least 22
days before slaughter. Not for use in
lactating dairy animals. A withdrawal
period has not been established for this
product in preruminating calves. Do not
use in calves to be processed for veal.
Federal law restricts this drug to use by
or on the order of a licensed
veterinarian.
*
*
*
*
*
(j)(1) Specifications. Each milliliter
(mL) of solution contains either 50 or
100 milligrams (mg) of oxytetracycline
hydrochloride.
(2) Sponsor. See No. 061133 in
§ 510.600(c) of this chapter.
(3) Conditions of use in beef cattle
and nonlactating dairy cattle—(i)
Amount. Administer 3 to 5 mg/lb body
weight daily by intravenous injection.
Administer 5 mg/lb for anaplasmosis,
severe foot rot, and severe forms of other
diseases. Treatment should be
continued 24 to 48 hours following
remission of clinical signs of disease,
but not to exceed 4 consecutive days.
(ii) Indications for use. For treatment
of diseases due to oxytetracyclinesusceptible organisms as follows:
Pneumonia and shipping fever complex
associated with Pasteurella spp. and
Haemophilus spp., foot rot and
diphtheria caused by Fusobacterium
necrophorum, bacterial enteritis (scours)
caused by Escherichia coli, wooden
tongue caused by Actinobacillus
lignieresii, leptospirosis caused by
Leptospira pomona, anaplasmosis
caused by Anaplasma marginale and
anthrax caused by Bacillus anthracis;
and acute metritis and wound infections
caused by staphylococcal and
streptococcal organisms.
(iii) Limitations. Not for use in
lactating dairy cattle. Discontinue use at
VerDate Sep<11>2014
16:04 Aug 15, 2023
Jkt 259001
least 19 days prior to slaughter. Federal
law restricts this drug to use by or on
the order of a licensed veterinarian.
■ 27. In § 522.1940, revise paragraph (a),
redesignate paragraph (c) as paragraph
(d), and add new paragraph (c).
The revision and addition read as
follows:
§ 522.1940
benzoate.
Progesterone and estradiol
(a) Sponsors. See sponsors in
§ 510.600(c) of this chapter for use as in
paragraph (d) of this section.
(1) No. 054771 for use as in
paragraphs (d)(1)(i)(A), (d)(1)(ii) and
(iii), (d)(2)(i)(A), (d)(2)(ii) and (iii), and
(d)(3) of this section.
(2) No. 058198 for use as in
paragraphs (d)(1) and (2) of this section.
*
*
*
*
*
(c) Special considerations. Labeling of
implants described in paragraphs
(d)(1)(i)(B) and (d)(2)(i)(B) of this section
shall bear the following: ‘‘Federal law
restricts this drug to use by or on the
order of a licensed veterinarian.’’.
*
*
*
*
*
■ 28. In § 522.2343, revise paragraph (a),
redesignate paragraph (c) as paragraph
(d), and add new paragraph (c).
The revision and addition read as
follows:
§ 522.2343 Testosterone propionate and
estradiol benzoate.
(a) Sponsors. See sponsors in
§ 510.600(c) of this chapter for use as in
paragraph (d) of this section.
(1) No. 054771 for use as in
paragraphs (d)(1)(i) and (d)(2) and (3) of
this section.
(2) No. 058198 for use as in paragraph
(d) of this section.
*
*
*
*
*
(c) Special considerations. Labeling of
implants described in paragraph
(d)(1)(ii) of this section shall bear the
following: ‘‘Federal law restricts this
drug to use by or on the order of a
licensed veterinarian.’’
*
*
*
*
*
■ 29. In § 522.2476, revise paragraph (a),
redesignate paragraph (c) as paragraph
(d), and add new paragraph (c).
The revision and addition read as
follows:
§ 522.2476
Trenbolone acetate.
(a) Sponsors. See sponsors in
§ 510.600(c) of this chapter for use as in
paragraph (d) of this section.
(1) No. 000061 for use as in
paragraphs (d)(1)(i)(A), (d)(1)(ii) and
(iii), (d)(2)(i)(A), and (d)(2)(ii) and (iii) of
this section.
(2) No. 058198 for use as in paragraph
(d) of this section.
*
*
*
*
*
PO 00000
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Fmt 4700
Sfmt 4700
(c) Special considerations. Labeling of
implants described in paragraph
(d)(1)(i)(B) and (d)(2)(i)(B) of this section
shall bear the following: ‘‘Federal law
restricts this drug to use by or on the
order of a licensed veterinarian.’’.
*
*
*
*
*
■ 30. In § 522.2477, redesignate
paragraphs (b) and (c) as paragraphs (a)
and (b) and add new paragraph (c) to
read as follows:
§ 522.2477
estradiol.
Trenbolone acetate and
*
*
*
*
*
(c) Special considerations. Labeling of
implants described in paragraphs
(d)(1)(i)(B), (E), and (F), (d)(2)(i)(B), (E),
and (F), and (d)(3)(i)(B) of this section
shall bear the following: ‘‘Federal law
restricts this drug to use by or on the
order of a licensed veterinarian.’’.
*
*
*
*
*
■ 31. In § 522.2680, revise paragraphs
(d)(1)(ii)(A) and (B) and (d)(1)(iii) to
read as follows:
§ 522.2680
Zeranol.
*
*
*
*
*
(d) * * *
(1) * * *
(ii) * * *
(A) Weaned beef calves, growing beef
cattle, feedlot steers, and feedlot heifers:
For increased rate of weight gain and
improved feed conversion.
(B) Suckling calves: For increased rate
of weight gain.
(iii) Limitations. Implant pellets
subcutaneously only. Not approved for
repeated implantation (reimplantation)
with this or any other cattle ear implant
within a single production phase as
safety and effectiveness have not been
evaluated. Do not use in beef calves less
than 2 months of age, dairy calves, and
veal calves because effectiveness and
safety have not been evaluated. A
withdrawal period has not been
established for this product in
preruminating calves. Do not use in
replacement beef heifers after weaning
or in bulls, dairy cows, or replacement
dairy heifers.
*
*
*
*
*
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
32. The authority citation for part 524
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
■
33. Add § 524.838 to read as follows:
§ 524.838 Esafoxolaner, eprinomectin, and
praziquantel.
(a) Specifications. Each milliliter (mL)
of topical solution contains 12
E:\FR\FM\16AUR1.SGM
16AUR1
Federal Register / Vol. 88, No. 157 / Wednesday, August 16, 2023 / Rules and Regulations
milligrams (mg) esafoxolaner, 4 mg
eprinomectin, and 83 mg praziquantel.
(b) Sponsor. See No. 000010 in
§ 510.600(c) of this chapter.
(c) Conditions of use—(1) Amount.
Administer the entire contents of a
provided unit applicator topically once
a month at a minimum dose of 0.055
mL/lb (0.12 mL/kg), which delivers a
minimum dose of 0.66 mg/lb (1.45 mg/
kg) esafoxolaner, 0.23 mg/lb (0.51 mg/
kg) eprinomectin, and 4.55 mg/lb (10.0
mg/kg) praziquantel.
(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 Ixodes scapularis (black-legged tick)
and Amblyomma americanum (lone star
tick) infestations, and the treatment and
control of roundworms (fourth-stage
larval and adult Toxocara cati),
hookworms (fourth-stage larval and
adult Ancylostoma tubaeforme; adult
Ancylostoma braziliense), and
tapeworms (Dipylidium caninum) in
cats and kittens 8 weeks of age and
older, and weighing 1.8 lbs or greater.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
PART 526—INTRAMAMMARY DOSAGE
FORM NEW ANIMAL DRUGS
34. The authority citation for part 526
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
Avilamycin in
grams/ton
Combination in
grams/ton
*
(ii) 13.6 to 40.9 ...........
*
Monensin, 90 to 110 ..
*
*
*
*
*
*
45. In § 558.128, revise paragraphs
(e)(4)(iii) and (iv), (e)(4)(ix) through
35. In § 526.1696, in paragraphs (d)(3)
and (e)(3), in the last sentence, remove
‘‘For No. 042791:’’.
■ 36. In § 526.1697, add a sentence to
the end of paragraph (d)(3) to read as
follows:
§ 526.1697 Penicillin G procaine and
dihydrostreptomycin.
PART 529—CERTAIN OTHER DOSAGE
FORM NEW ANIMAL DRUGS
37. The authority citation for part 529
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
18:09 Aug 15, 2023
Jkt 259001
PART 556—TOLERANCES FOR
RESIDUES OF NEW ANIMAL DRUGS
IN FOOD
40. The authority citation for part 556
continues to read as follows:
■
41. In § 556.110, revise paragraph (c)
to read as follows:
■
§ 556.110
Carbomycin.
*
*
*
*
*
(c) Related conditions of use. See
§ 520.1664 of this chapter.
■ 42. In § 556.500, revise paragraph (c)
to read as follows:
§ 556.500
Oxytetracycline.
*
38. In § 529.1044a, revise paragraph
(b) to read as follows:
■
§ 529.1044a
infusion.
use by or on the order of a licensed
veterinarian.
Authority: 21 U.S.C. 342, 360b, 371.
(d) * * *
(3) * * * Federal law restricts this
drug to use by or on the order of a
licensed veterinarian.
*
*
*
*
*
Gentamicin solution for
*
*
*
*
*
(b) Sponsors. See Nos. 000061,
016592, 054771, 058005, 058198,
061133, and 069043 in § 510.600(c) of
this chapter.
*
*
*
*
*
■ 39. In 529.1044b, revise paragraph
(c)(3) to read as follows:
*
*
*
*
(c) Related conditions of use. See
§§ 520.1660c, 520.1660d, 520.1664,
522.1660a, 522.1660b, 522.1662,
522.1664, 529.1660, 558.450, and
558.455 of this chapter.
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
43. The authority citation for part 558
continues to read as follows:
■
Authority: 21 U.S.C. 354, 360b, 360ccc,
360ccc–1, 371.
44. In § 558.68, revise paragraph
(e)(1)(ii) to read as follows:
§ 529.1044b Gentamicin solution for
dipping eggs.
■
*
*
*
*
*
(c) * * *
(3) Limitations. Eggs which have been
dipped in the drug shall not be used for
food. Federal law restricts this drug to
§ 558.68
*
Avilamycin.
*
*
(e) * * *
(1) * * *
*
*
Indications for use
Limitations
*
*
Broiler chickens: For the prevention of mortality
caused by necrotic enteritis associated with
Clostridium perfringens; and as an aid in the
prevention of coccidiosis caused by Eimeria
necatrix, E. tenella, E. acervulina, E. brunetti, E.
mivati, and E. maxima.
*
*
*
Feed this complete Type C medicated feed as the
sole ration for 21 consecutive days. To assure
responsible antimicrobial drug use in broiler
chickens, treatment administration must begin
on or before 18 days of age. See § 558.355(d)
of this chapter. Monensin as provided by No.
058198 in § 510.600(c) of this chapter.
*
*
*
(xiv), and (e)(4)(xviii) through (xx) to
read as follows:
§ 558.128
*
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■
*
■
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§ 526.1696
PO 00000
*
*
(e) * * *
(4) * * *
Chlortetracycline.
*
Frm 00017
*
Fmt 4700
*
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Sponsor
*
058198
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55568
Federal Register / Vol. 88, No. 157 / Wednesday, August 16, 2023 / Rules and Regulations
Chlortetracycline
amount
Combination
in grams/ton
Indications for use
Limitations
*
(iii) 7 to 17.5 g/ton ......
*
Monensin, 5 to 40 ................
*
Growing beef steers
and heifers fed in
confinement for
slaughter over 400
lb: For reduction of
the incidence of liver
abscesses and for
improved feed efficiency.
(iv) 7 to 17.5 g/ton ......
Monensin, 10 to 40 ..............
Growing beef steers
and heifers fed in
confinement for
slaughter over 400
lb: For reduction of
the incidence of liver
abscesses and for
prevention and control of coccidiosis
due to Eimeria bovis
and Eimeria zuernii.
*
*
*
*
Feed as the sole ration to provide 70 mg chlortetracycline per head
per day and 50 to 480 mg monensin per head per day. No additional improvement in feed efficiency has been shown from feeding
monensin at levels greater than 30 grams per ton (360 mg
monensin per head per day). For use in dry feeds only. Not for use
in liquid feed supplements. Do not allow horses or other equines access to feed containing monensin. Ingestion of monensin by horses
has been fatal. Monensin medicated cattle and goat feeds are safe
for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Do not exceed the levels of
monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are
fed to other groups of cattle, the concentration of monensin in the
refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. 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
Nos. 016592 and 058198, chlortetracycline by No. 069254 in
§ 510.600(c) of this chapter.
Feed as the sole ration to provide 70 mg chlortetracycline per head
per day and 0.14 to 0.42 mg monensin per lb. body weight per day
to provide, depending upon severity of coccidiosis challenge, up to
480 mg monensin per head per day. For use in dry feeds only. Not
for use in liquid feed supplements. Do not allow horses or other
equines access to feed containing monensin. Ingestion of monensin
by horses has been fatal. Monensin medicated cattle and goat
feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Do not exceed the
levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing
monensin are fed to other groups of cattle, the concentration of
monensin in the refusals and amount of refusals fed should be
taken into consideration to prevent monensin overdosing. 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 Nos. 016592 and 058198, chlortetracycline by No. 069254 in § 510.600(c) of this chapter.
*
(ix) 33.33 to 66.67 g/
ton.
*
Monensin, 5 to 40 ................
(x) 33.33 to 66.67 g/
ton.
Monensin, 10 to 40 ..............
*
*
*
*
*
Growing beef steers
Feed as the sole ration to provide 0.5 mg chlortetracycline per lb.
and heifers fed in
body weight per day and 50 to 480 mg monensin per head per day.
confinement for
No additional improvement in feed efficiency has been shown from
slaughter over 700
feeding monensin at levels greater than 30 grams per ton (360 mg
lbs: For control of acmonensin per head per day). For use in dry feeds only. Not for use
tive infection of
in liquid feed supplements. Do not allow horses or other equines acanaplasmosis
cess to feed containing monensin. Ingestion of monensin by horses
caused by
has been fatal. Monensin medicated cattle and goat feeds are safe
Anaplasma
for use in cattle and goats only. Consumption by unapproved spemarginale suscepcies may result in toxic reactions. Do not exceed the levels of
tible to chlortetramonensin recommended in the feeding directions, as reduced avercycline and for image daily gains may result. If feed refusals containing monensin are
proved feed effifed to other groups of cattle, the concentration of monensin in the
ciency.
refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. 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
Nos. 016592 and 058198, chlortetracycline by No. 069254 in
§ 510.600(c) of this chapter.
Growing beef steers
Feed as the sole ration to provide 0.5 mg chlortetracycline per lb.
and heifers fed in
body weight per day and 0.14 to 0.42 mg monensin per lb. body
confinement for
weight per day to provide, depending upon severity of coccidiosis
slaughter over 700
challenge, up to 480 mg monensin per head per day. For use in dry
lbs: For control of acfeeds only. Not for use in liquid feed supplements. Do not allow
tive infection of
horses or other equines access to feed containing monensin. Ingesanaplasmosis
tion of monensin by horses has been fatal. Monensin medicated
caused by
cattle and goat feeds are safe for use in cattle and goats only. ConAnaplasma
sumption by unapproved species may result in toxic reactions. Do
marginale suscepnot exceed the levels of monensin recommended in the feeding ditible to chlortetrarections, as reduced average daily gains may result. If feed refusals
cycline and for the
containing monensin are fed to other groups of cattle, the conprevention and concentration of monensin in the refusals and amount of refusals fed
trol of coccidiosis
should be taken into consideration to prevent monensin overdosing.
due to Eimeria bovis
A withdrawal period has not been established for this product in
and Eimeria zuernii.
preruminating calves. Do not use in calves to be processed for veal.
Monensin as provided by Nos. 016592 and 058198, chlortetracycline by No. 069254 in § 510.600(c) of this chapter.
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016592
069254
016592
069254
016592
069254
016592
069254
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Federal Register / Vol. 88, No. 157 / Wednesday, August 16, 2023 / Rules and Regulations
Chlortetracycline
amount
Combination
in grams/ton
Indications for use
Limitations
(xi) 50 to 117 g/ton .....
Monensin, 7.14 to 40 ...........
Growing beef steers
and heifers fed in
confinement for
slaughter under 700
lbs: For control of active infection of
anaplasmosis
caused by
Anaplasma
marginale susceptible to chlortetracycline and for improved feed efficiency.
(xii) 50 to 117 g/ton ....
Monensin, 10 to 40 ..............
Growing beef steers
and heifers fed in
confinement for
slaughter under 700
lbs: For control of active infection of
anaplasmosis
caused by
Anaplasma
marginale susceptible to chlortetracycline and for the
prevention and control of coccidiosis
due to Eimeria bovis
and Eimeria zuernii.
(xiii) 50 to 117 g/ton ...
Monensin, 7.14 to 40 ...........
Growing beef steers
and heifers fed in
confinement for
slaughter: For the
control of bacterial
pneumonia associated with shipping
fever complex
caused by
Pasteurella spp. susceptible to chlortetracycline and for improved feed efficiency.
(xiv) 50 to 117 g/ton ...
Monensin, ≤10 to 40 .............
Growing beef steers
and heifers fed in
confinement for
slaughter: For the
control of bacterial
pneumonia associated with shipping
fever complex
caused by
Pasteurella spp. susceptible to chlortetracycline and for the
prevention and control of coccidiosis
due to Eimeria bovis
and Eimeria zuernii.
Feed as the sole ration to provide 350 mg chlortetracycline per head
per day and 50 to 480 mg monensin per head per day. No additional improvement in feed efficiency has been shown from feeding
monensin at levels greater than 30 grams per ton (360 mg
monensin per head per day). For use in dry feeds only. Not for use
in liquid feed supplements. Do not allow horses or other equines access to feed containing monensin. Ingestion of monensin by horses
has been fatal. Monensin medicated cattle and goat feeds are safe
for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Do not exceed the levels of
monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are
fed to other groups of cattle, the concentration of monensin in the
refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. 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
Nos. 016592 and 058198, chlortetracycline by No. 069254 in
§ 510.600(c) of this chapter.
Feed as the sole ration to provide 350 mg chlortetracycline per head
per day and 0.14 to 0.42 mg monensin per lb. body weight per day
to provide, depending upon severity of coccidiosis challenge, up to
480 mg monensin per head per day. For use in dry feeds only. Not
for use in liquid feed supplements. Do not allow horses or other
equines access to feed containing monensin. Ingestion of monensin
by horses has been fatal. Monensin medicated cattle and goat
feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Do not exceed the
levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing
monensin are fed to other groups of cattle, the concentration of
monensin in the refusals and amount of refusals fed should be
taken into consideration to prevent monensin overdosing. 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 Nos. 016592 and 058198, chlortetracycline by No. 069254 in § 510.600(c) of this chapter.
Feed as the sole ration to provide 350 mg chlortetracycline per head
per day and 50 to 480 mg monensin per head per day. No additional improvement in feed efficiency has been shown from feeding
monensin at levels greater than 30 grams per ton (360 mg
monensin per head per day). For use in dry feeds only. Not for use
in liquid feed supplements. Do not allow horses or other equines access to feed containing monensin. Ingestion of monensin by horses
has been fatal. Monensin medicated cattle and goat feeds are safe
for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Do not exceed the levels of
monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are
fed to other groups of cattle, the concentration of monensin in the
refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. 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
Nos. 016592 and 058198, chlortetracycline by No. 069254 in
§ 510.600(c) of this chapter.
Feed as the sole ration to provide 350 mg chlortetracycline per head
per day and 0.14 to 0.42 mg monensin per lb. body weight per day
to provide, depending upon severity of coccidiosis challenge, up to
480 mg monensin per head per day. For use in dry feeds only. Not
for use in liquid feed supplements. Do not allow horses or other
equines access to feed containing monensin. Ingestion of monensin
by horses has been fatal. Monensin medicated cattle and goat
feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Do not exceed the
levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing
monensin are fed to other groups of cattle, the concentration of
monensin in the refusals and amount of refusals fed should be
taken into consideration to prevent monensin overdosing. 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 Nos. 016592 and 058198, chlortetracycline by No. 069254 in § 510.600(c) of this chapter.
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Sponsor
016592
069254
016592
069254
016592
069254
016592
069254
55570
Federal Register / Vol. 88, No. 157 / Wednesday, August 16, 2023 / Rules and Regulations
Chlortetracycline
amount
Combination
in grams/ton
Indications for use
*
(xviii) 400 to 2,000 g/
ton.
*
Monensin, 5 to 40 ................
*
Growing beef steers
and heifers fed in
confinement for
slaughter: For treatment of bacterial enteritis caused by
Escherichia coli and
bacterial pneumonia
caused by
Pasteurella
multocida susceptible to chlortetracycline; for improved
feed efficiency.
(xix) 400 to 2,000 g/
ton.
Monensin, 10 to 40 ..............
(xx) 400 to 2,000 g/ton
Monensin, 10 to 200 ............
*
§ 558.325
*
§ 558.366
46. In § 558.325, remove and reserve
paragraphs (e)(2)(ii), (viii), and (xiii).
47. In § 558.366, revise paragraphs (b)
and (d)(1)(v) to read as follows:
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■
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Jkt 259001
*
*
Nicarbazin.
*
*
*
*
(b) Sponsors. See Nos. 060728,
066104, and 069254 in § 510.600(c) of
this chapter.
*
*
*
*
*
PO 00000
Frm 00020
Fmt 4700
*
(d) * * *
*
■
Sponsor
*
*
*
*
Feed as the sole ration to provide 10 mg chlortetracycline per lb. body
weight per day and 50 to 480 mg monensin per head per day. Feed
for not more than 5 days, then continue feeding monensin Type C
medicated feed alone. No additional improvement in feed efficiency
has been shown from feeding monensin at levels greater than 30
grams per ton (360 mg monensin per head per day). For use in dry
feeds only. Not for use in liquid feed supplements. Do not allow
horses or other equines access to feed containing monensin. Ingestion of monensin by horses has been fatal. Monensin medicated
cattle and goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Do
not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals
containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed
should be taken into consideration to prevent monensin overdosing.
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 Nos. 016592 and 058198, chlortetracycline by No. 069254 in § 510.600(c) of this chapter.
Growing beef steers
Feed as the sole ration to provide 10 mg chlortetracycline per lb. body
and heifers: For
weight per day and 0.14 to 0.42 mg monensin per lb. body weight
treatment of bacterial
per day to provide, depending upon severity of the coccidiosis chalenteritis caused by
lenge, up to 480 mg monensin per head per day. Feed for not more
Escherichia coli and
than 5 days, then continue feeding monensin Type C medicated
bacterial pneumonia
feed alone. For use in dry feeds only. Not for use in liquid feed supcaused by
plements. Do not allow horses or other equines access to feed conPasteurella
taining monensin. Ingestion of monensin by horses has been fatal.
multocida suscepMonensin medicated cattle and goat feeds are safe for use in cattle
tible to chlortetraand goats only. Consumption by unapproved species may result in
cycline; and for the
toxic reactions. Do not exceed the levels of monensin recprevention and conommended in the feeding directions, as reduced average daily gains
trol of coccidiosis
may result. If feed refusals containing monensin are fed to other
due to Eimeria bovis
groups of cattle, the concentration of monensin in the refusals and
and Eimeria zuernii.
amount of refusals fed should be taken into consideration to prevent
monensin overdosing. 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 Nos. 016592 and
058198, chlortetracycline by No. 069254 in § 510.600(c) of this
chapter.
Beef calves 2 months
Feed as the sole ration to provide 10 mg chlortetracycline per lb. body
of age and older: For
weight per day and 0.14 to 1.00 mg monensin per lb. body weight
treatment of bacterial
per day to provide, depending upon severity of coccidiosis chalenteritis caused by
lenge, up to 200 mg of monensin per head per day. Feed for not
Escherichia coli and
more than 5 days, then continue to feed monensin Type C medibacterial pneumonia
cated feed alone. For use in dry feeds only. Not for use in liquid
caused by
feed supplements. Do not allow horses or other equines access to
Pasteurella
feed containing monensin. Ingestion of monensin by horses has
multocida suscepbeen fatal. Monensin medicated cattle and goat feeds are safe for
tible to chlortetrause in cattle and goats only. Consumption by unapproved species
cycline; and for the
may result in toxic reactions. Do not exceed the levels of monensin
prevention and conrecommended in the feeding directions, as reduced average daily
trol of coccidiosis
gains may result. If feed refusals containing monensin are fed to
due to Eimeria bovis
other groups of cattle, the concentration of monensin in the refusals
and Eimeria zuernii.
and amount of refusals fed should be taken into consideration to
prevent monensin overdosing. 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 Nos.
016592 and 058198, chlortetracycline by No. 069254 in § 510.600(c)
of this chapter.
*
[Amended]
Limitations
Sfmt 4700
(1) * * *
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*
016592
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016592
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016592
069254
Federal Register / Vol. 88, No. 157 / Wednesday, August 16, 2023 / Rules and Regulations
Nicarbazin in grams
per ton
Combination
in grams per ton
*
(v) 113.5 .....................
*
..............................
*
Indications for use
*
*
Chickens: As an aid in preventing outbreaks of
cecal (Eimeria tenella) and intestinal (E.
acervulina, E. maxima, E. necatrix, and E.
brunetti) coccidiosis.
*
*
*
§ 558.450
■
*
*
*
*
*
48. In § 558.450, revise paragraphs
(e)(5)(iv) and (v) to read as follows:
Oxytetracycline amount
*
(iv) 2.5 to 3.75 g/100 lb
of fish/day.
(v) 3.75 g/100 lb of fish/
day.
*
*
*
Feed continuously as sole ration from time chicks
are placed on litter until past the time when coccidiosis is ordinarily a hazard. Do not use as a
treatment for coccidiosis. Do not use in flushing
mashes. Do not feed to laying hens. Withdraw 4
days before slaughter.
*
*
Oxytetracycline.
*
*
(e) * * *
*
(5) * * *
*
*
*
*
1. Freshwater-reared salmonids: For control of ulcer disease
caused by Haemophilus piscium, furunculosis caused by
Aeromonas salmonicida, bacterial hemorrhagic septicemia
caused by A. hydrophila, and pseudomonas disease.
2. Catfish: For control of bacterial hemorrhagic septicemia
caused by A. hydrophila and pseudomonas disease.
*
*
*
Administer in mixed ration for 10 days. Do not liberate fish or
slaughter fish for food for 21 days following the last administration of medicated feed.
1. Freshwater-reared salmonids: For control of mortality due
to coldwater disease associated with Flavobacterium
psychrophilum or for control of mortality due to columnaris
disease associated with Flavobacterium columnare.
2. Freshwater-reared salmonids weighing up to 55 grams:
For marking the skeletal tissue.
3. Catfish: For control of mortality due to columnaris disease
associated with Flavobacterium columnare.
*
*
[FR Doc. 2023–17454 Filed 8–15–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF THE INTERIOR
Office of Natural Resources Revenue
30 CFR Part 1217
[Docket No. ONRR–2022–0001; DS63644000
DRT000000.CH7000 223D1113RT]
RIN 1012–AA32
Electronic Provision of Records During
an Audit; Correction
Office of Natural Resources
Revenue (‘‘ONRR’’), Interior.
ACTION: Final rule; correction.
AGENCY:
On August 9, 2023, ONRR
published a final rule amending its
regulations to allow ONRR and other
authorized Department of the Interior
(‘‘Department’’) representatives the
option to require that an auditee use
SUMMARY:
18:09 Aug 15, 2023
Jkt 259001
Feed for 10 days. Immediate release is permitted following
last feeding of medicated feed.
Administer in mixed ration for 10 days. Do not liberate fish or
slaughter fish for food for 21 days following the last administration of medicated feed. Do not administer when water
temperature is below 16.7 °C (62 F).
066104
*
Fmt 4700
066104
066104
*
Federal Register Correction
Effective September 8, 2023, in rule
document 2023–17059 at 88 FR 53790
in the issue of August 9, 2023, on page
53793, in the first column, amendatory
Frm 00021
Sponsor
Administer in mixed ration for 10 days. Do not liberate fish or
slaughter fish for food for 21 days following the last administration of medicated feed. Do not administer when water
temperature is below 16.7 °C (62 F).
Administer in mixed ration for 10 days. Do not liberate fish or
slaughter fish for food for 21 days following the last administration of medicated feed.
electronic means to provide records
requested during an audit of an
auditee’s royalty reporting and payment.
The final rule used a subpart that was
designated reserved. This document
corrects the final regulations by adding
the subpart.
DATES: Effective on September 8, 2023.
FOR FURTHER INFORMATION CONTACT: For
questions concerning this final
rulemaking, contact Ginger Hensley,
Regulatory Specialist, by phone at 303–
231–3171, or by email at ONRR_
RegulationsMailbox@onrr.gov.
SUPPLEMENTARY INFORMATION: ONRR
published a final rule in the Federal
Register on August 9, 2023 (88 FR
53790). ONRR amended a reserved
subpart under part 1217, subpart A,
without including instructions to add
the subpart. Accordingly, the final rule
is corrected by making the following
correcting amendments.
PO 00000
060728
069254
*
Limitations
Dated: August 9, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
lotter on DSK11XQN23PROD with RULES1
*
Sponsor
Indications for use
*
VerDate Sep<11>2014
Limitations
55571
Sfmt 4700
*
066104
066104
*
instruction 8 and the accompanying
regulatory text are corrected to read as
follows:
§ 1217.10
[Corrected]
8. Add subpart A, consisting of
§ 1217.10, to read as follows:
■
Subpart A—General Provisions
§ 1217.10
audit.
Providing records during an
(a) ONRR or an authorized State or
Tribe may specify the method an
auditee must use to provide records for
all audits conducted under this chapter,
statute, or agreement. The methods may
include one or more of the following:
(1) Inspect records at an auditee’s
place of business during normal
business hours;
(2) Send records using secure
electronic means. When requesting that
records be provided electronically,
ONRR or the authorized State or Tribe
will specify the format in which the
records shall be produced, directions for
electronic transmission, and
instructions to ensure secure
transmission; or
E:\FR\FM\16AUR1.SGM
16AUR1
]]>Agencies
[Federal Register Volume 88, Number 157 (Wednesday, August 16, 2023)]
[Rules and Regulations]
[Pages 55559-55571]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17454]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 500, 510, 516, 520, 522, 524, 526, 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), abbreviated new animal drug
applications (ANADAs), and conditionally approved new animal drug
applications (cNADAs) during April, May, and June 2023. FDA is
informing the public of the availability of summaries of the basis of
approval and of environmental review documents, where applicable. The
animal drug regulations are also being amended to improve their
accuracy and readability.
DATES: This rule is effective August 16, 2023.
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, ANADAs, and cNADAs during April, May, and June 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 (FOI Summaries) under the Freedom of
Information Act (FOIA). These public documents may be seen in the
office of the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500. Persons
with access to the internet may obtain these documents at the CVM FOIA
Electronic Reading Room: https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room. Marketing
exclusivity and patent information may be accessed in FDA's
publication, Approved Animal Drug Products Online (Green Book) at:
https://www.fda.gov/animal-veterinary/products/approved-animal-drug-products-green-book.
Table 1--Original and Supplemental NADAs, ANADAs, and cNADAs Approved During April, May, and June 2023 Requiring Evidence of Safety and/or Effectiveness
--------------------------------------------------------------------------------------------------------------------------------------------------------
21 CFR
Approval date File No. Sponsor Product name Effect of the action Public documents section
--------------------------------------------------------------------------------------------------------------------------------------------------------
April 5, 2023................... 200-612 Bimeda Animal Health BIMASONE Original approval for FOI Summary 522.960c
Ltd., 1B The Herbert (flumethasone) the treatment of
Building, The Park, Injectable Solution. various inflammatory
Carrickmines, Dublin conditions in horses,
18, Ireland. dogs, and cats as a
generic copy of NADA
030-414.
April 10, 2023.................. 038-439 Phibro Animal Health TERRAMYCIN for Fish Supplemental approval FOI Summary 558.450
Corp., GlenPointe (oxytetracycline) for the control of
Centre East, 3d Floor, Type A Medicated mortality due to
300 Frank W. Burr Article. columnaris disease in
Blvd., Suite 21, catfish and
Teaneck, NJ 07666. freshwater-reared
salmonids.
[[Page 55560]]
April 20, 2023.................. 141-570 Boehringer Ingelheim NEXGARD COMBO Original approval for FOI Summary 524.838
Animal Health USA, (esafoxolaner, prevention of
Inc., 3239 Satellite eprinomectin, and heartworm disease;
Blvd., Duluth, GA praziquantel) Topical for treatment and
30096. Solution. prevention of flea
infestations,
treatment and control
of tick infestations,
roundworms,
hookworms, and
tapeworms in cats and
kittens.
May 1, 2023..................... 141-571 Elanco US Inc., 2500 VARENZIN-CA1 Conditional approval FOI Summary 516.1449
Innovation Way, (molidustat oral for the control of
Greenfield, IN 46140. suspension). nonregenerative
anemia associated
with chronic kidney
disease (CKD) in cats.
May 5, 2023..................... 141-562 Zoetis Inc., 333 LIBRELA (bedinvetmab Original approval for FOI Summary 522.158
Portage St., injection) Injectable the control of pain
Kalamazoo, MI 49007. Solution. associated with
osteoarthritis in
dogs.
May 10, 2023.................... 200-748 Huvepharma EOOD, 5th PENNCHLOR Original approval for FOI Summary 558.128
Floor, 3A Nikolay (chlortetracycline multiple indications
Haytov Str., 1113 Type A medicated in beef calves 2
Sofia, Bulgaria. article) and MONOVET months of age and
(monensin Type A older and in growing
medicated article) to beef steers and
be used in the heifers fed in
manufacture of Type B confinement for
and Type C medicated slaughter as a
feeds. generic copy of NADA
141-564.
May 25, 2023.................... 200-750 Cronus Pharma DORAJECT (doramectin Original approval for FOI Summary 522.770
Specialities India injection) Injectable treatment and control
Private Ltd., Sy No-99/ Solution. of internal and
1, M/s GMR Hyderabad external parasites of
Aviation SEZ Ltd., cattle and swine as a
Mamidipalli Village, generic copy of NADA
Shamshabad Mandal, 141-061.
Ranga Reddy,
Hyderabad, Telangana,
501218, India.
June 9, 2023.................... 141-555 Zoetis Inc., 333 APOQUEL CHEWABLE Original approval for FOI Summary 520.1604
Portage St., (oclacitinib tablet) control of pruritus
Kalamazoo, MI 49007. Tablets. associated with
allergic dermatitis
and control of atopic
dermatitis in dogs at
least 12 months of
age.
June 21, 2023................... 141-406 Boehringer Ingelheim NEXGARD (afoxolaner) Supplemental approval FOI Summary 520.43
Animal Health USA, Chewable Tablet. for Asian longhorned
Inc., 3239 Satellite tick.
Blvd., Duluth, GA
30096.
June 22, 2023................... 200-751 Pegasus Laboratories, Firocoxib Chewable Original approval for FOI Summary 520.928
Inc., 8809 Ely Rd., Tablets for Dogs the control of pain
Pensacola, FL 32514. (firocoxib). and inflammation
associated with
osteoarthritis and
for the control of
postoperative pain
and inflammation
associated with soft-
tissue and orthopedic
surgery in dogs as a
generic copy of NADA
141-230.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Also, FDA is amending the animal drug regulations to reflect
approval of supplemental applications, as listed in table 2, to change
the marketing status of dosage form antimicrobial animal drug products
from over-the-counter (OTC) to by veterinary prescription (Rx). These
applications were submitted in voluntary compliance with the goals of
the FDA Center for Veterinary Medicine's Judicious Use Initiative as
identified by guidance for industry #263, ``Recommendations for
Sponsors of Medically Important Antimicrobial Drugs Approved for Use in
Animals to Voluntarily Bring Under Veterinary Oversight All Products
That Continue to be Available Over-the-Counter,'' June 11, 2021
(https://www.fda.gov/media/130610/download).
Table 2--Supplemental Applications Approved During April, May, and June 2023 To Change the Marketing Status of
Antimicrobial Animal Drug Products From OTC to Rx
----------------------------------------------------------------------------------------------------------------
21 CFR
Approval date File No. Sponsor Product name section
----------------------------------------------------------------------------------------------------------------
April 14, 2023.................... 200-147 Huvepharma EOOD, 5th GENTAPOULT (gentamicin) 522.1044
Floor, 3A Nikolay Haytov Injectable Solution.
Str., 1113 Sofia,
Bulgaria.
April 24, 2023.................... 065-481 Cronus Pharma Chlortetracycline 520.443
Specialities India Pneumonia/Calf Scour
Private Ltd., Sy No-99/ Bolus.
1, M/s GMR Hyderabad
Aviation SEZ Ltd.,
Mamidipalli Village,
Shamshabad Mandal, Ranga
Reddy, Hyderabad,
Telangana, 501218, India.
April 24, 2023.................... 200-128 Huvepharma EOOD, 5th AGRIMYCIN 200 522.1660a
Floor, 3A Nikolay Haytov (oxytetracycline HCl)
Str., 1113 Sofia, Injectable Solution.
Bulgaria.
[[Page 55561]]
April 28, 2023.................... 108-963 Cronus Pharma MEDAMYCIN 100 522.1662
Specialities India (oxytetracycline HCl)
Private Ltd., Sy No-99/ Injectable Solution.
1, M/s GMR Hyderabad
Aviation SEZ Ltd.,
Mamidipalli Village,
Shamshabad Mandal, Ranga
Reddy, Hyderabad,
Telangana, 501218, India.
April 28, 2023.................... 097-452 Do....................... OXYJECT 100 522.1662
(oxytetracycline HCl)
Injectable Solution.
April 28, 2023.................... 047-278 Do....................... OXY-TET 50 522.1662
(oxytetracycline HCl)
Injectable Solution.
April 28, 2023.................... 045-143 Do....................... OXYJECT 50 522.1662
(oxytetracycline HCl)
Injectable Solution.
May 15, 2023...................... 140-270 Huvepharma EOOD, 5th SULFATECH SR 520.2260b
Floor, 3A Nikolay Haytov (sulfamethazine
Str., 1113 Sofia, sustained release bolus).
Bulgaria.
May 15, 2023...................... 200-306 Norbrook Laboratories Oxytetracycline Injection 522.1660a
Ltd., Carnbane 200.
Industrial Estate,
Newry, County Down, BT35
6QQ, United Kingdom.
May 16, 2023...................... 120-615 Bimeda Animal Health SUSTAIN III 520.2260b
Ltd., 1B The Herbert (sulfamethazine) Calf
Building, The Park, Bolus.
Carrickmines, Dublin 18,
Ireland.
May 17, 2023...................... 200-224 Elanco US Inc., 2500 COMPONENT T-S with TYLAN; 522.2476
Innovation Way, COMPONENT T-H with TYLAN
Greenfield, IN 46140. (trenbolone acetate and
tylosin tartrate)
Implants.
May 19, 2023...................... 200-364 Bimeda Animal Health SPECTOGARD Scour-Chek 520.2123c
Ltd., 1B The Herbert (spectinomycin
Building, The Park, dihydrochloride
Carrickmines, Dublin 18, pentahydrate) Oral
Ireland. Solution.
May 22, 2023...................... 035-455 Do....................... ERYTHRO-36 Dry 526.820
(erythromycin) IMM
Infusion.
May 22, 2023...................... 200-452 Norbrook Laboratories OXYTET 100 522.1662
Ltd., Carnbane (oxytetracycline HCl)
Industrial Estate, Injectable Solution.
Newry, County Down, BT35
6QQ, United Kingdom.
May 26, 2023...................... 200-068 Huvepharma EOOD, 5th Oxytetracycline 522.1662
Floor, 3A Nikolay Haytov Hydrochloride Injection,
Str., 1113 Sofia, 100 mg/mL.
Bulgaria.
May 30, 2023...................... 055-097 HQ Specialty Pharma DRY-MAST 526.1697
Corp., 120 Rte. 17 (dihydrostreptomycin
North, Suite 130, sulfate and penicillin G
Paramus, NJ 07652. procaine).
May 31, 2023...................... 200-008 Boehringer Ingelheim BIO-MYCIN 200 522.1660a
Animal Health USA, Inc., (oxytetracycline HCl)
3239 Satellite Blvd., Injectable Solution.
Duluth, GA 30096.
June 2, 2023...................... 065-383 Bimeda Animal Health FORMULA A-34; UNI BIOTIC 526.1696
Ltd., 1B The Herbert (penicillin G procaine)
Building, The Park, 4 DOSE.
Carrickmines, Dublin 18,
Ireland.
June 2, 2023...................... 200-537 Do....................... TETROXY-LA 522.1660a
(oxytetracycline HCl)
Injectable Solution.
June 7, 2023...................... 200-154 Pharmgate Inc., 1800 Sir PENNOX 200 522.1660a
Tyler Dr., Wilmington, (oxytetracycline HCl)
NC 28405. Injectable Solution.
June 8, 2023...................... 200-123 Huvepharma EOOD, 5th MAXIM-200 Injection 522.1660a
Floor, 3A Nikolay Haytov (oxytetracycline HCl).
Str., 1113 Sofia,
Bulgaria.
June 9, 2023...................... 200-117 Bimeda Animal Health OXYSHOT LA 522.1660a
Ltd., 1B The Herbert (oxytetracycline HCl)
Building, The Park, Injectable Solution.
Carrickmines, Dublin 18,
Ireland.
June 15, 2023..................... 135-906 Elanco US Inc., 2500 COMPONENT E-H with TYLAN 522.2343
Innovation Way, (testosterone propionate
Greenfield, IN 46140. and estradiol benzoate
with tylosin tartrate)
Implant.
June 22, 2023..................... 200-221 Do....................... COMPONENT TE-G with 522.2477
TYLAN; COMPONENT TE-ID
with TYLAN; COMPONENT TE-
IS with TYLAN; COMPONENT
TE-S with TYLAN
(trenbolone acetate,
estradiol, and tylosin
tartrate) Implants.
June 30, 2023..................... 200-346 Do....................... COMPONENT TE-200 with 522.2477
TYLAN; COMPONENT TE-H
with TYLAN; COMPONENT TE-
IH with TYLAN;
(trenbolone acetate,
estradiol, and tylosin
tartrate) Implants.
June 30, 2023..................... 110-315 Do....................... COMPONENT E-C with TYLAN; 522.1940
COMPONENT E-S with TYLAN
(progesterone, estradiol
benzoate, and tylosin
tartrate) Implants.
----------------------------------------------------------------------------------------------------------------
II. Withdrawals of Approval
The sponsors of the following files have requested that FDA
withdraw approval of the applications listed in table 3 because the
products are no longer manufactured or marketed. As provided in the
regulatory text of this document, the cited animal drug regulations are
amended to reflect these actions.
Table 3--Applications for Which Approval Was Voluntarily Withdrawn
During April, May, and June 2023
------------------------------------------------------------------------
21 CFR
File No. Sponsor Product name section
------------------------------------------------------------------------
140-954.................. Intervet, Inc., Type C 558.325
2 Giralda medicated
Farms, swine feed
Madison, NJ containing
07940. fenbendazole
and lincomycin.
141-002.................. Boehringer OXY 1000 520.1660c
Ingelheim (oxytetracycli
Animal Health ne HCl) Calf
USA, Inc., Bolus; OXY 500
3239 Satellite (oxytetracycli
Blvd., Duluth, ne HCl) Calf
GA 30096. Bolus.
200-191.................. Med-Pharmex, GENTASOL 529.1044b
Inc., 2727 (gentamicin
Thompson Creek sulfate
Rd., Pomona, solution).
CA 91767-1861.
------------------------------------------------------------------------
[[Page 55562]]
III. Change of Sponsor
Elanco US, Inc., 2500 Innovation Way, Greenfield, IN 46140 has
informed FDA that it has transferred ownership of, and all rights and
interest in, NADA 135-468 for CARBIGRAN 25 (nicarbazin) Type A
Medicated Article to Pharmgate Inc., 1800 Sir Tyler Dr., Wilmington, NC
28405. As provided in the regulatory text of this document, 21 CFR
558.366 is amended to reflect this action.
IV. Change of Sponsor Address
Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940 has informed FDA
that it has changed its address to 126 E. Lincoln Ave., Rahway, NJ
07065. As provided in the regulatory text of this document, the tabular
listings in 21 CFR 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 500.1410 and 522.1660a are amended to reflect the
use of N-methyl-2-pyrrolidone as an excipient in a formulation of
oxytetracycline injectable solution.
21 CFR 520.1484 is being revised to include use of
neomycin administered in drinking water of turkeys.
21 CFR 520.1660a is being redesignated as 21 CFR 520.1664
to reflect the drug as a fixed-ratio combination of oxytetracycline and
carbomycin.
21 CFR 520.1660b is being revised to reflect the format
and content of a prescription drug.
21 CFR 520.2220b is amended to reflect revised conditions
of use for sulfadimethoxine oral suspension in dogs and cats.
21 CFR 520.2220c is amended to reflect revised conditions
of use for sulfadimethoxine tablets in dogs and cats.
21 CFR 520.2260b is amended to reflect current sponsors of
sulfamethazine sustained-release boluses for use in cattle.
21 CFR 522.2680 is amended to reflect revised conditions
of use for zeranol implants in beef cattle.
21 CFR 529.1044a is amended to reflect sponsors of
approved applications for use of gentamicin solution for uterine
infusion in mares.
21 CFR 556.110 and 556.500 are being revised to reflect
redesignation of a combination drug containing oxytetracycline and
carbomycin used in the drinking water of chickens.
21 CFR 558.68 is being revised to reflect approved feeding
instructions for avilamycin and monensin two-way, combination drug Type
C medicated chicken 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)), which requires
Federal Register publication of ``notice[s] . . . effective as a
regulation,'' of the conditions of use of approved new animal drugs.
This rule sets forth technical amendments to the regulations to codify
recent actions on approved new animal drug applications and corrections
to improve the accuracy of the regulations, and as such does not impose
any burden on regulated entities.
Although denominated a rule pursuant to the FD&C Act, this document
does not meet the definition of ``rule'' in 5 U.S.C. 804(3)(A) because
it is a ``rule of particular applicability.'' Therefore, it is not
subject to the congressional review requirements in 5 U.S.C. 801-808.
Likewise, this is not a rule subject to Executive Order 12866, which
defines a rule as ``an agency statement of general applicability and
future effect, which the agency intends to have the force and effect of
law, that is designed to implement, interpret, or prescribe law or
policy or to describe the procedure or practice requirements of an
agency.''
List of Subjects
21 CFR Part 500
Animal drugs, Animal feeds, Cancer, Labeling, Packaging and
containers, Polychlorinated biphenyls (PCBs).
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Part 516
Administrative practice and procedure, Animal drugs, Confidential
business information, Reporting and recordkeeping requirements.
21 CFR Parts 520, 522, 524, 526, and 529
Animal drugs.
21 CFR Part 556
Animal drugs, Dairy products, Foods, Meat and meat products.
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
500, 510, 516, 520, 522, 524, 526, 529, 556, and 558 are amended as
follows:
PART 500--GENERAL
0
1. The authority citation for part 500 continues to read as follows:
Authority: 21 U.S.C. 321, 331, 342, 343, 348, 351, 352, 353,
360b, 371, 379e.
0
2. In Sec. 500.1410, revise paragraph (c) to read as follows:
Sec. 500.1410 N-methyl-2-pyrrolidone.
* * * * *
(c) Related conditions of use. See Sec. Sec. 522.814, 522.955, and
522.1660a of this chapter.
PART 510--NEW ANIMAL DRUGS
0
3. 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
4. In Sec. 510.600, in the table in paragraph (c)(1), revise the entry
for ``Intervet, Inc.'' and in the table in paragraph (c)(2), revise the
entry for ``000061'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
[[Page 55563]]
------------------------------------------------------------------------
Firm name and address Drug labeler code
------------------------------------------------------------------------
* * * * * * *
Intervet, Inc., 126 E Lincoln Ave., Rahway, NJ 000061
07065............................................
* * * * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * * * *
000061...................... Intervet, Inc., 126 E Lincoln Ave.,
Rahway, NJ 07065
* * * * * * *
------------------------------------------------------------------------
PART 516--NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
0
5. The authority citation for part 516 continues to read as follows:
Authority: 21 U.S.C. 360ccc-1, 360ccc-2, 371.
0
6. Add Sec. 516.1449 to read as follows:
Sec. 516.1449 Molidustat oral suspension.
(a) Specifications. Each milliliter (mL) of suspension contains 25
milligrams (mg) molidustat sodium.
(b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. Administer orally at a dosage of
5 mg/kg of body weight (2.3 mg/lb) daily for up to 28 consecutive days.
(2) Indications for use. For the control of nonregenerative anemia
associated with chronic kidney disease in cats.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian. It is a violation of Federal law
to use this product other than as directed in the labeling.
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
7. The authority citation for part 520 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
8. In Sec. 520.43, revise paragraphs (c)(1) and (2) to read as
follows:
Sec. 520.43 Afoxolaner.
* * * * *
(c) * * *
(1) Amount. Administer orally once a month at a minimum dosage of
1.14 mg/pound (2.5 mg/kilogram).
(2) Indications for use. Kills adult fleas and for the treatment
and prevention of flea infestations (Ctenocephalides felis); and the
treatment and control of Ixodes scapularis (black-legged tick),
Dermacentor variabilis (American dog tick), Amblyomma americanum (lone
star tick), Rhipicephalus sanguineus (brown dog tick), and
Haemaphysalis longicornis (longhorned tick) infestations in dogs and
puppies 8 weeks of age and older, weighing 4 pounds of body weight or
greater, for 1 month; and for the prevention of Borrelia burgdorferi
infections as a direct result of killing Ixodes scapularis vector
ticks.
* * * * *
0
9. In Sec. 520.443, revise paragraph (d)(1)(ii) to read as follows:
Sec. 520.443 Chlortetracycline tablets and boluses.
* * * * *
(d) * * *
(1) * * *
(ii) Limitations. Administer bolus directly by mouth or crush and
dissolve in milk or water for drenching or bucket feeding. Do not use
for more than 5 days. Do not administer within 24 hours of slaughter.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.
* * * * *
Sec. 520.928 [Amended]
0
10. In Sec. 520.928, in paragraph (b)(1), remove ``Nos. 000010 and
055529'' and add in its place ``Nos. 000010, 055246, and 055529''.
0
11. In Sec. 520.1484, revise paragraph (b)(3) and add paragraph (b)(4)
to read as follows:
Sec. 520.1484 Neomycin.
* * * * *
(b) * * *
(3) Nos. 016592, 054771, and 058005 for use of product described in
paragraph (a)(2) as in paragraph (e)(1) of this section.
(4) No. 054925 for use of product described in paragraph (a)(2) as
in paragraphs (e)(1) and (2) of this section.
* * * * *
Sec. 520.1604 [Amended]
0
12. In Sec. 520.1604, in paragraph (a), remove ``Each tablet
contains'' and add in its place ``Each tablet or chewable tablet
contains''.
Sec. 520.1660a [Redesignated as Sec. 520.1664]
0
13. Redesignate Sec. 520.1660a as Sec. 520.1664.
Sec. 520.1660a [Reserved]
0
14. Add reserved Sec. 520.1660a.
0
15. In Sec. 520.1660b, revise the section heading and paragraphs (a)
and (c) to read as follows:
Sec. 520.1660b Oxytetracycline capsules.
(a) Specifications. Each capsule contains 125 or 250 milligrams
(mg) oxytetracycline hydrochloride.
* * * * *
(c) Conditions of use in dogs and cats--(1) Amount. Administer
orally 25 to 50 mg per pound of body weight per day in divided doses at
12-hour intervals.
(2) Indications for use. For the treatment of bacterial pneumonia
caused by Brucella bronchiseptica, tonsilitis caused by Streptococcus
hemolyticus, bacterial enteritis caused by Escherichia coli, urinary
tract infections caused by Escherichia coli, and wound infections
caused by Staphylococcus aureus.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
16. In Sec. 520.1660c, revise the section heading and paragraphs (a),
(b), and (d) to read as follows:
[[Page 55564]]
Sec. 520.1660c Oxytetracycline tablets.
(a) Specifications. Each tablet contains 250 or 500 milligrams (mg)
oxytetracycline hydrochloride.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
* * * * *
(d) Conditions of use in beef and dairy cattle--(1) Amounts. 10 mg
per pound of body weight every 12 hours for treatment; 5 mg per pound
of body weight every 12 hours for control.
(2) Indications for use. For treatment and control of bacterial
enteritis caused by Salmonella typhimurium and Escherichia coli
(colibacillosis) and bacterial pneumonia (shipping fever complex,
pasteurellosis) caused by Pasteurella multocida.
(3) Limitations. Discontinue treatment 7 days prior to slaughter.
Not for use in lactating dairy cattle. A withdrawal period has not been
established for this product in preruminating calves. Do not use in
calves to be processed for veal. Federal law restricts this drug to use
by or on the order of a licensed veterinarian.
0
17. In Sec. 520.2220b, revise paragraphs (c)(1) and (2) to read as
follows:
Sec. 520.2220b Sulfadimethoxine suspension.
* * * * *
(c) * * *
(1) Amount. Administer orally 25 mg per pound of body weight,
followed by 12.5 mg per pound of body weight daily until the animal is
free of clinical signs for 48 hours.
(2) Indications for use. For the treatment of sulfadimethoxine-
susceptible bacterial infections in dogs and cats and enteritis
associated with coccidiosis in dogs.
* * * * *
0
18. In Sec. 520.2220c, revise paragraphs (d)(1) and (2) to read as
follows:
Sec. 520.2220c Sulfadimethoxine tablet.
* * * * *
(d) * * *
(1) Amount. Administer orally 25 mg per pound of body weight,
followed by 12.5 mg per pound of body weight daily until the animal is
free of clinical signs for 48 hours.
(2) Indications for use. For the treatment of sulfadimethoxine-
susceptible bacterial infections in dogs and cats and enteritis
associated with coccidiosis in dogs.
* * * * *
0
19. In Sec. 520.2260b, revise paragraphs (d)(2)(iii), (f)(2)(iii), and
(g)(2)(iii) and remove paragraph (h).
The revisions read as follows:
Sec. 520.2260b Sulfamethazine sustained-release boluses.
* * * * *
(d) * * *
(2) * * *
(iii) Limitations. Do not use in female dairy cattle 20 months of
age or older. Use of sulfamethazine in this class of cattle may cause
milk residues. Do not treat animals within 12 days of slaughter.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.
* * * * *
(f) * * *
(2) * * *
(iii) Limitations. For use in ruminating replacement calves only.
Do not slaughter animals for food for at least 12 days after the last
dose. Exceeding two consecutive doses may cause violative tissue
residue to remain beyond the withdrawal time. Do not use in calves
under 1 month of age or calves being fed an all milk diet. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.
(g) * * *
(2) * * *
(iii) Limitations. For use in beef cattle and nonlactating dairy
cattle only. Do not slaughter animals for food for at least 8 days
after the last dose. Do not use in lactating dairy cattle. Do not
administer more than two consecutive doses. Federal law restricts this
drug to use by or on the order of a licensed veterinarian.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
20. The authority citation for part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
21. Add Sec. 522.158 to read as follows:
Sec. 522.158 Bedinvetmab.
(a) Specifications. Each single-use vial contains 5, 10, 15, 20, or
30 milligrams (mg) bedinvetmab in an extractable volume of 1
milliliter.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. Administer 0.23 mg/pound (0.5
mg/kilogram) body weight monthly by subcutaneous injection.
(2) Indications for use. For the control of pain associated with
osteoarthritis in dogs.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
22. In Sec. 522.770, revise paragraphs (b), (d)(1)(iii), and
(d)(2)(iii) to read as follows:
Sec. 522.770 Doramectin.
* * * * *
(b) Sponsors. See Nos. 054771 and 069043 in Sec. 510.600(c) of
this chapter.
* * * * *
(d) * * *
(1) * * *
(iii) Limitations. Consult your veterinarian for assistance in the
diagnosis, treatment, and control of parasitism. Administer as a single
subcutaneous or intramuscular injection. Do not slaughter cattle for
human consumption within 35 days of treatment. Not for use in female
dairy cattle 20 months of age or older. A withdrawal period has not
been established for this product in preruminating calves. Do not use
in calves to be processed for veal.
(2) * * *
(iii) Limitations. Consult your veterinarian for assistance in the
diagnosis, treatment, and control of parasitism. Administer as a single
intramuscular injection. Do not slaughter swine for human consumption
within 24 days of treatment.
0
23. In Sec. 522.960c, revise paragraphs (b) and (c)(1)(iii) to read as
follows:
Sec. 522.960c Flumethasone solution.
* * * * *
(b) Sponsors. See Nos. 054771 and 061133 in Sec. 510.600(c) of
this chapter.
(c) * * *
(1) * * *
(iii) Limitations. Not for use in horses intended for human
consumption. Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
* * * * *
Sec. 522.1222 [Amended]
0
24. In Sec. 522.1222, in paragraph (b), remove ``063286,''.
0
25. In Sec. 522.1660a:
0
a. Revise paragraph (c);
0
b. Remove paragraph (d);
0
c. Redesignate paragraph (e) as paragraph (d); and
0
d. Revise newly redesignated paragraphs (d)(1)(ii) and (d)(2)(ii).
The revisions read as follows:
Sec. 522.1660a Oxytetracycline solution, 200 milligrams/milliliter.
* * * * *
(c) Related tolerances. See Sec. 556.500 of this chapter; and for
No. 061133, see also Sec. 500.1410 of this chapter.
(d) * * *
(1) * * *
(ii) Limitations. Discontinue treatment at least 28 days prior to
slaughter. Milk taken from animals during treatment and for 96 hours
after the last treatment
[[Page 55565]]
must not be used for food. Federal law restricts this drug to use by or
on the order of a licensed veterinarian.
(2) * * *
(ii) Limitations. Administer intramuscularly. Do not inject more
than 5 mL per site in adult swine. Discontinue treatment at least 28
days prior to slaughter. Federal law restricts this drug to use by or
on the order of a licensed veterinarian.
0
26. In Sec. 522.1662, revise paragraphs (b), (c), (g), (h), and (j) to
read as follows:
Sec. 522.1662 Oxytetracycline.
* * * * *
(b)(1) Specifications. Each milliliter (mL) of solution contains 50
milligrams (mg) oxytetracycline hydrochloride.
(2) Sponsor. See No. 069043 in Sec. 510.600(c) of this chapter.
(3) Conditions of use--(i) Amount. Administer 3 to 5 mg per pound
of body weight (mg/lb) per day by intramuscular injection.
Leptospirosis, severe foot-rot, and severe forms of the indicated
diseases should be treated with 5 mg/lb per day. Treatment should be
continued for 24 to 48 hours following remission of clinical signs of
disease, not to exceed 4 consecutive days. Not more than 10 mL should
be injected per injection site in adult cattle, and only 2 mL per
injection site in calves weighing 100 pounds or less.
(ii) Indications for use. Beef cattle, beef calves, nonlactating
dairy cattle, and dairy calves; for treatment of diseases due to
oxytetracycline-susceptible organisms as follows: Pneumonia and
shipping fever complex (Pasteurella spp., Haemophilus spp., Klebsiella
spp.), bacterial enteritis (scours) (Escherichia coli), foot-rot
(Spherophorus necrophorus), diphtheria (Spherophorus necrophorus),
wooden tongue (Actinobacillus lignieresii), leptospirosis (Leptospira
pomona), and wound infections and acute metritis caused by
Staphylococcus spp. and Streptococcus spp.
(iii) Limitations. Discontinue treatment at least 20 days prior to
slaughter. Federal law restricts this drug to use by or on the order of
a licensed veterinarian.
(c)(1) Specifications. Each milliliter (mL) of solution contains 50
or 100 milligrams (mg) oxytetracycline hydrochloride.
(2) Sponsor. See No. 069043 in Sec. 510.600(c) of this chapter.
(3) Conditions of use--(i) Beef cattle and nonlactating dairy
cattle--(A) Amount. Administer 3 to 5 mg per pound of body weight (mg/
lb) per day; 5 mg/lb per day for the treatment of anaplasmosis, severe
foot-rot, and severe cases of other indicated diseases. For 50-mg/mL
solution, administer intramuscularly or intravenously; for 100-mg/mL
solution, administer intramuscularly only. Treatment should be
continued for 24 to 48 hours following remission of clinical signs of
disease, not to exceed 4 consecutive days.
(B) Indications for use. For treatment of diseases due to
oxytetracycline-susceptible organisms as follows: Pneumonia and
shipping fever complex associated with Pasteurella spp., Haemophilus
spp., and Klebsiella spp., foot-rot and diphtheria caused by
Spherophorus necrophorus, bacterial enteritis (scours) caused by
Escherichia coli, wooden tongue caused by Actinobacillus lignieresii,
leptospirosis caused by Leptospira pomona, anaplasmosis caused by
Anaplasma marginale; and wound infections and acute metritis caused by
Staphylococcus spp. and Streptococcus spp.
(C) Limitations. Exceeding the highest recommended dose of 5 mg/lb,
administering at recommended levels for more than 4 consecutive days,
and/or exceeding 10 mL intramuscularly per injection site may result in
antibiotic residues beyond the withdrawal time. Discontinue treatment
at least 18 days prior to slaughter. Not for use in lactating dairy
cattle. Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
(ii) Swine--(A) Amount. Administer 3 to 5 mg/lb per day by
intramuscular injection. Sows: Administer 3 mg/lb by intramuscular
injection approximately 8 hours before farrowing or immediately after
completion of farrowing.
(B) Indications for use. For treatment of bacterial enteritis
(scours, colibacillosis) caused by Escherichia coli, pneumonia caused
by Pasteurella multocida, and leptospirosis caused by Leptospira
pomona. Sows: as an aid in control of infectious enteritis (baby pig
scours, colibacillosis) in suckling pigs caused by Escherichia coli.
(C) Limitations. Do not inject more than 5 mL per injection site.
Do not use for more than 4 consecutive days. Discontinue treatment at
least 26 days before slaughter. Federal law restricts this drug to use
by or on the order of a licensed veterinarian.
* * * * *
(g)(1) Specifications. Each milliliter (mL) of solution contains
100 milligrams (mg) oxytetracycline hydrochloride.
(2) Sponsor. See No. 069043 in Sec. 510.600(c) of this chapter.
(3) Conditions of use. For the treatment of diseases due to
oxytetracycline-susceptible organisms as follows:
(i) Beef cattle, beef calves, nonlactating dairy cattle, and dairy
calves--(A) Amount. Administer 3 to 5 mg/lb body weight per day by
intramuscular, intravenous, or subcutaneous injection. In severe forms
of the indicated diseases, administer 5 mg/lb body weight per day.
Continue treatment 24 to 48 hours following remission of clinical signs
of disease, not to exceed 4 consecutive days.
(B) Indications for use. For the treatment of pneumonia and
shipping fever complex associated with Pasteurella spp., Haemophilus
spp., or Klebsiella spp.
(C) Limitations. Do not inject more than 10 mL per intramuscular
injection site in adult cattle, and no more than 1 mL per site in
calves weighing 100 pounds or less. Do not slaughter cattle for 13 days
after intramuscular or intravenous treatment, or 2 days after
subcutaneous treatment. Exceeding the highest recommended dosage or
duration of treatment (not more than 4 consecutive days) may result in
residues beyond the withdrawal period. A withdrawal period has not been
established for use of this product in preruminating calves. Do not use
in calves to be processed for veal. Federal law restricts this drug to
use by or on the order of a licensed veterinarian.
(ii) Swine--(A) Amount. Administer 3 to 5 mg/lb body weight per day
by intramuscular injection. Sows: Administer 3 mg/lb body weight once,
by intramuscular injection, approximately 8 hours before farrowing or
immediately after completion of farrowing.
(B) Indications for use. For treatment of bacterial enteritis
(scours, colibacillosis) caused by Escherichia coli, pneumonia caused
by Pasteurella multocida, and leptospirosis caused by Leptospira
pomona. Sows: As an aid in control of infectious enteritis (baby pig
scours, colibacillosis) in suckling pigs caused by Escherichia coli.
(C) Limitations. Do not inject more than 5 mL per site. Discontinue
treatment at least 20 days prior to slaughter. Federal law restricts
this drug to use by or on the order of a licensed veterinarian.
(h)(1) Specifications. Each milliliter (mL) of solution contains 50
or 100 milligrams (mg) oxytetracycline hydrochloride.
(2) Sponsors. See No. 069043 in Sec. 510.600(c) of this chapter
for use of 50- and 100-mg/mL solution and Nos. 016592 and 055529 in
Sec. 510.600(c) of this chapter for use of 100-mg/mL solution.
(3) Conditions of use in beef cattle, beef calves, nonlactating
dairy cattle,
[[Page 55566]]
and dairy calves--(i) Amount. Administer 3 to 5 mg/lb body weight per
day by intramuscular injection; 5 mg/lb body weight per day for
treatment of severe forms of the indicated diseases.
(ii) Indications for use. For treatment of bacterial pneumonia and
shipping fever complex associated with Pasteurella spp., foot-rot and
calf diphtheria caused by Fusobacterium necrophorum, bacterial
enteritis (scours) caused by Escherichia coli, wooden tongue caused by
Actinobacillus lignieresii; and wound infections and acute metritis
caused by Staphylococcus spp. and Streptococcus spp.
(iii) Limitations. Do not inject more than 10 mL per site in adult
cattle. Reduce the volume administered per injection site according to
age and body size. In calves weighing 100 pounds or less, do not inject
more than 2 mL per site. Discontinue treatment at least 22 days before
slaughter. Not for use in lactating dairy animals. A withdrawal period
has not been established for this product in preruminating calves. Do
not use in calves to be processed for veal. Federal law restricts this
drug to use by or on the order of a licensed veterinarian.
* * * * *
(j)(1) Specifications. Each milliliter (mL) of solution contains
either 50 or 100 milligrams (mg) of oxytetracycline hydrochloride.
(2) Sponsor. See No. 061133 in Sec. 510.600(c) of this chapter.
(3) Conditions of use in beef cattle and nonlactating dairy
cattle--(i) Amount. Administer 3 to 5 mg/lb body weight daily by
intravenous injection. Administer 5 mg/lb for anaplasmosis, severe foot
rot, and severe forms of other diseases. Treatment should be continued
24 to 48 hours following remission of clinical signs of disease, but
not to exceed 4 consecutive days.
(ii) Indications for use. For treatment of diseases due to
oxytetracycline-susceptible organisms as follows: Pneumonia and
shipping fever complex associated with Pasteurella spp. and Haemophilus
spp., foot rot and diphtheria caused by Fusobacterium necrophorum,
bacterial enteritis (scours) caused by Escherichia coli, wooden tongue
caused by Actinobacillus lignieresii, leptospirosis caused by
Leptospira pomona, anaplasmosis caused by Anaplasma marginale and
anthrax caused by Bacillus anthracis; and acute metritis and wound
infections caused by staphylococcal and streptococcal organisms.
(iii) Limitations. Not for use in lactating dairy cattle.
Discontinue use at least 19 days prior to slaughter. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.
0
27. In Sec. 522.1940, revise paragraph (a), redesignate paragraph (c)
as paragraph (d), and add new paragraph (c).
The revision and addition read as follows:
Sec. 522.1940 Progesterone and estradiol benzoate.
(a) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for
use as in paragraph (d) of this section.
(1) No. 054771 for use as in paragraphs (d)(1)(i)(A), (d)(1)(ii)
and (iii), (d)(2)(i)(A), (d)(2)(ii) and (iii), and (d)(3) of this
section.
(2) No. 058198 for use as in paragraphs (d)(1) and (2) of this
section.
* * * * *
(c) Special considerations. Labeling of implants described in
paragraphs (d)(1)(i)(B) and (d)(2)(i)(B) of this section shall bear the
following: ``Federal law restricts this drug to use by or on the order
of a licensed veterinarian.''.
* * * * *
0
28. In Sec. 522.2343, revise paragraph (a), redesignate paragraph (c)
as paragraph (d), and add new paragraph (c).
The revision and addition read as follows:
Sec. 522.2343 Testosterone propionate and estradiol benzoate.
(a) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for
use as in paragraph (d) of this section.
(1) No. 054771 for use as in paragraphs (d)(1)(i) and (d)(2) and
(3) of this section.
(2) No. 058198 for use as in paragraph (d) of this section.
* * * * *
(c) Special considerations. Labeling of implants described in
paragraph (d)(1)(ii) of this section shall bear the following:
``Federal law restricts this drug to use by or on the order of a
licensed veterinarian.''
* * * * *
0
29. In Sec. 522.2476, revise paragraph (a), redesignate paragraph (c)
as paragraph (d), and add new paragraph (c).
The revision and addition read as follows:
Sec. 522.2476 Trenbolone acetate.
(a) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for
use as in paragraph (d) of this section.
(1) No. 000061 for use as in paragraphs (d)(1)(i)(A), (d)(1)(ii)
and (iii), (d)(2)(i)(A), and (d)(2)(ii) and (iii) of this section.
(2) No. 058198 for use as in paragraph (d) of this section.
* * * * *
(c) Special considerations. Labeling of implants described in
paragraph (d)(1)(i)(B) and (d)(2)(i)(B) of this section shall bear the
following: ``Federal law restricts this drug to use by or on the order
of a licensed veterinarian.''.
* * * * *
0
30. In Sec. 522.2477, redesignate paragraphs (b) and (c) as paragraphs
(a) and (b) and add new paragraph (c) to read as follows:
Sec. 522.2477 Trenbolone acetate and estradiol.
* * * * *
(c) Special considerations. Labeling of implants described in
paragraphs (d)(1)(i)(B), (E), and (F), (d)(2)(i)(B), (E), and (F), and
(d)(3)(i)(B) of this section shall bear the following: ``Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.''.
* * * * *
0
31. In Sec. 522.2680, revise paragraphs (d)(1)(ii)(A) and (B) and
(d)(1)(iii) to read as follows:
Sec. 522.2680 Zeranol.
* * * * *
(d) * * *
(1) * * *
(ii) * * *
(A) Weaned beef calves, growing beef cattle, feedlot steers, and
feedlot heifers: For increased rate of weight gain and improved feed
conversion.
(B) Suckling calves: For increased rate of weight gain.
(iii) Limitations. Implant pellets subcutaneously only. Not
approved for repeated implantation (reimplantation) with this or any
other cattle ear implant within a single production phase as safety and
effectiveness have not been evaluated. Do not use in beef calves less
than 2 months of age, dairy calves, and veal calves because
effectiveness and safety have not been evaluated. A withdrawal period
has not been established for this product in preruminating calves. Do
not use in replacement beef heifers after weaning or in bulls, dairy
cows, or replacement dairy heifers.
* * * * *
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
32. The authority citation for part 524 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
33. Add Sec. 524.838 to read as follows:
Sec. 524.838 Esafoxolaner, eprinomectin, and praziquantel.
(a) Specifications. Each milliliter (mL) of topical solution
contains 12
[[Page 55567]]
milligrams (mg) esafoxolaner, 4 mg eprinomectin, and 83 mg
praziquantel.
(b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. Administer the entire contents
of a provided unit applicator topically once a month at a minimum dose
of 0.055 mL/lb (0.12 mL/kg), which delivers a minimum dose of 0.66 mg/
lb (1.45 mg/kg) esafoxolaner, 0.23 mg/lb (0.51 mg/kg) eprinomectin, and
4.55 mg/lb (10.0 mg/kg) praziquantel.
(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 Ixodes scapularis (black-
legged tick) and Amblyomma americanum (lone star tick) infestations,
and the treatment and control of roundworms (fourth-stage larval and
adult Toxocara cati), hookworms (fourth-stage larval and adult
Ancylostoma tubaeforme; adult Ancylostoma braziliense), and tapeworms
(Dipylidium caninum) in cats and kittens 8 weeks of age and older, and
weighing 1.8 lbs or greater.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS
0
34. The authority citation for part 526 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 526.1696 [Amended]
0
35. In Sec. 526.1696, in paragraphs (d)(3) and (e)(3), in the last
sentence, remove ``For No. 042791:''.
0
36. In Sec. 526.1697, add a sentence to the end of paragraph (d)(3) to
read as follows:
Sec. 526.1697 Penicillin G procaine and dihydrostreptomycin.
(d) * * *
(3) * * * Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
* * * * *
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
0
37. The authority citation for part 529 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
38. In Sec. 529.1044a, revise paragraph (b) to read as follows:
Sec. 529.1044a Gentamicin solution for infusion.
* * * * *
(b) Sponsors. See Nos. 000061, 016592, 054771, 058005, 058198,
061133, and 069043 in Sec. 510.600(c) of this chapter.
* * * * *
0
39. In 529.1044b, revise paragraph (c)(3) to read as follows:
Sec. 529.1044b Gentamicin solution for dipping eggs.
* * * * *
(c) * * *
(3) Limitations. Eggs which have been dipped in the drug shall not
be used for food. Federal law restricts this drug to use by or on the
order of a licensed veterinarian.
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
0
40. The authority citation for part 556 continues to read as follows:
Authority: 21 U.S.C. 342, 360b, 371.
0
41. In Sec. 556.110, revise paragraph (c) to read as follows:
Sec. 556.110 Carbomycin.
* * * * *
(c) Related conditions of use. See Sec. 520.1664 of this chapter.
0
42. In Sec. 556.500, revise paragraph (c) to read as follows:
Sec. 556.500 Oxytetracycline.
* * * * *
(c) Related conditions of use. See Sec. Sec. 520.1660c, 520.1660d,
520.1664, 522.1660a, 522.1660b, 522.1662, 522.1664, 529.1660, 558.450,
and 558.455 of this chapter.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
43. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
0
44. In Sec. 558.68, revise paragraph (e)(1)(ii) to read as follows:
Sec. 558.68 Avilamycin.
* * * * *
(e) * * *
(1) * * *
----------------------------------------------------------------------------------------------------------------
Avilamycin in grams/ton Combination in grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(ii) 13.6 to 40.9............ Monensin, 90 to 110......... Broiler chickens: Feed this complete 058198
For the prevention Type C medicated
of mortality feed as the sole
caused by necrotic ration for 21
enteritis consecutive days.
associated with To assure
Clostridium responsible
perfringens; and antimicrobial drug
as an aid in the use in broiler
prevention of chickens,
coccidiosis caused treatment
by Eimeria administration
necatrix, E. must begin on or
tenella, E. before 18 days of
acervulina, E. age. See Sec.
brunetti, E. 558.355(d) of this
mivati, and E. chapter. Monensin
maxima. as provided by No.
058198 in Sec.
510.600(c) of this
chapter.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
0
45. In Sec. 558.128, revise paragraphs (e)(4)(iii) and (iv),
(e)(4)(ix) through (xiv), and (e)(4)(xviii) through (xx) to read as
follows:
Sec. 558.128 Chlortetracycline.
* * * * *
(e) * * *
(4) * * *
[[Page 55568]]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chlortetracycline amount Combination in grams/ton Indications for use Limitations Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * * * *
(iii) 7 to 17.5 g/ton............ Monensin, 5 to 40...................... Growing beef steers and Feed as the sole ration to provide 70 016592
heifers fed in mg chlortetracycline per head per day 069254
confinement for and 50 to 480 mg monensin per head per
slaughter over 400 lb: day. No additional improvement in feed
For reduction of the efficiency has been shown from feeding
incidence of liver monensin at levels greater than 30
abscesses and for grams per ton (360 mg monensin per
improved feed head per day). For use in dry feeds
efficiency. only. Not for use in liquid feed
supplements. Do not allow horses or
other equines access to feed
containing monensin. Ingestion of
monensin by horses has been fatal.
Monensin medicated cattle and goat
feeds are safe for use in cattle and
goats only. Consumption by unapproved
species may result in toxic reactions.
Do not exceed the levels of monensin
recommended in the feeding directions,
as reduced average daily gains may
result. If feed refusals containing
monensin are fed to other groups of
cattle, the concentration of monensin
in the refusals and amount of refusals
fed should be taken into consideration
to prevent monensin overdosing. 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 Nos. 016592
and 058198, chlortetracycline by No.
069254 in Sec. 510.600(c) of this
chapter.
(iv) 7 to 17.5 g/ton............. Monensin, 10 to 40..................... Growing beef steers and Feed as the sole ration to provide 70 016592
heifers fed in mg chlortetracycline per head per day 069254
confinement for and 0.14 to 0.42 mg monensin per lb.
slaughter over 400 lb: body weight per day to provide,
For reduction of the depending upon severity of coccidiosis
incidence of liver challenge, up to 480 mg monensin per
abscesses and for head per day. For use in dry feeds
prevention and control only. Not for use in liquid feed
of coccidiosis due to supplements. Do not allow horses or
Eimeria bovis and other equines access to feed
Eimeria zuernii. containing monensin. Ingestion of
monensin by horses has been fatal.
Monensin medicated cattle and goat
feeds are safe for use in cattle and
goats only. Consumption by unapproved
species may result in toxic reactions.
Do not exceed the levels of monensin
recommended in the feeding directions,
as reduced average daily gains may
result. If feed refusals containing
monensin are fed to other groups of
cattle, the concentration of monensin
in the refusals and amount of refusals
fed should be taken into consideration
to prevent monensin overdosing. 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 Nos. 016592
and 058198, chlortetracycline by No.
069254 in Sec. 510.600(c) of this
chapter.
* * * * * * *
(ix) 33.33 to 66.67 g/ton........ Monensin, 5 to 40...................... Growing beef steers and Feed as the sole ration to provide 0.5 016592
heifers fed in mg chlortetracycline per lb. body 069254
confinement for weight per day and 50 to 480 mg
slaughter over 700 lbs: monensin per head per day. No
For control of active additional improvement in feed
infection of efficiency has been shown from feeding
anaplasmosis caused by monensin at levels greater than 30
Anaplasma marginale grams per ton (360 mg monensin per
susceptible to head per day). For use in dry feeds
chlortetracycline and only. Not for use in liquid feed
for improved feed supplements. Do not allow horses or
efficiency. other equines access to feed
containing monensin. Ingestion of
monensin by horses has been fatal.
Monensin medicated cattle and goat
feeds are safe for use in cattle and
goats only. Consumption by unapproved
species may result in toxic reactions.
Do not exceed the levels of monensin
recommended in the feeding directions,
as reduced average daily gains may
result. If feed refusals containing
monensin are fed to other groups of
cattle, the concentration of monensin
in the refusals and amount of refusals
fed should be taken into consideration
to prevent monensin overdosing. 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 Nos. 016592
and 058198, chlortetracycline by No.
069254 in Sec. 510.600(c) of this
chapter.
(x) 33.33 to 66.67 g/ton......... Monensin, 10 to 40..................... Growing beef steers and Feed as the sole ration to provide 0.5 016592
heifers fed in mg chlortetracycline per lb. body 069254
confinement for weight per day and 0.14 to 0.42 mg
slaughter over 700 lbs: monensin per lb. body weight per day
For control of active to provide, depending upon severity of
infection of coccidiosis challenge, up to 480 mg
anaplasmosis caused by monensin per head per day. For use in
Anaplasma marginale dry feeds only. Not for use in liquid
susceptible to feed supplements. Do not allow horses
chlortetracycline and or other equines access to feed
for the prevention and containing monensin. Ingestion of
control of coccidiosis monensin by horses has been fatal.
due to Eimeria bovis Monensin medicated cattle and goat
and Eimeria zuernii. feeds are safe for use in cattle and
goats only. Consumption by unapproved
species may result in toxic reactions.
Do not exceed the levels of monensin
recommended in the feeding directions,
as reduced average daily gains may
result. If feed refusals containing
monensin are fed to other groups of
cattle, the concentration of monensin
in the refusals and amount of refusals
fed should be taken into consideration
to prevent monensin overdosing. 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 Nos. 016592
and 058198, chlortetracycline by No.
069254 in Sec. 510.600(c) of this
chapter.
[[Page 55569]]
(xi) 50 to 117 g/ton............. Monensin, 7.14 to 40................... Growing beef steers and Feed as the sole ration to provide 350 016592
heifers fed in mg chlortetracycline per head per day 069254
confinement for and 50 to 480 mg monensin per head per
slaughter under 700 day. No additional improvement in feed
lbs: For control of efficiency has been shown from feeding
active infection of monensin at levels greater than 30
anaplasmosis caused by grams per ton (360 mg monensin per
Anaplasma marginale head per day). For use in dry feeds
susceptible to only. Not for use in liquid feed
chlortetracycline and supplements. Do not allow horses or
for improved feed other equines access to feed
efficiency. containing monensin. Ingestion of
monensin by horses has been fatal.
Monensin medicated cattle and goat
feeds are safe for use in cattle and
goats only. Consumption by unapproved
species may result in toxic reactions.
Do not exceed the levels of monensin
recommended in the feeding directions,
as reduced average daily gains may
result. If feed refusals containing
monensin are fed to other groups of
cattle, the concentration of monensin
in the refusals and amount of refusals
fed should be taken into consideration
to prevent monensin overdosing. 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 Nos. 016592
and 058198, chlortetracycline by No.
069254 in Sec. 510.600(c) of this
chapter.
(xii) 50 to 117 g/ton............ Monensin, 10 to 40..................... Growing beef steers and Feed as the sole ration to provide 350 016592
heifers fed in mg chlortetracycline per head per day 069254
confinement for and 0.14 to 0.42 mg monensin per lb.
slaughter under 700 body weight per day to provide,
lbs: For control of depending upon severity of coccidiosis
active infection of challenge, up to 480 mg monensin per
anaplasmosis caused by head per day. For use in dry feeds
Anaplasma marginale only. Not for use in liquid feed
susceptible to supplements. Do not allow horses or
chlortetracycline and other equines access to feed
for the prevention and containing monensin. Ingestion of
control of coccidiosis monensin by horses has been fatal.
due to Eimeria bovis Monensin medicated cattle and goat
and Eimeria zuernii. feeds are safe for use in cattle and
goats only. Consumption by unapproved
species may result in toxic reactions.
Do not exceed the levels of monensin
recommended in the feeding directions,
as reduced average daily gains may
result. If feed refusals containing
monensin are fed to other groups of
cattle, the concentration of monensin
in the refusals and amount of refusals
fed should be taken into consideration
to prevent monensin overdosing. 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 Nos. 016592
and 058198, chlortetracycline by No.
069254 in Sec. 510.600(c) of this
chapter.
(xiii) 50 to 117 g/ton........... Monensin, 7.14 to 40................... Growing beef steers and Feed as the sole ration to provide 350 016592
heifers fed in mg chlortetracycline per head per day 069254
confinement for and 50 to 480 mg monensin per head per
slaughter: For the day. No additional improvement in feed
control of bacterial efficiency has been shown from feeding
pneumonia associated monensin at levels greater than 30
with shipping fever grams per ton (360 mg monensin per
complex caused by head per day). For use in dry feeds
Pasteurella spp. only. Not for use in liquid feed
susceptible to supplements. Do not allow horses or
chlortetracycline and other equines access to feed
for improved feed containing monensin. Ingestion of
efficiency. monensin by horses has been fatal.
Monensin medicated cattle and goat
feeds are safe for use in cattle and
goats only. Consumption by unapproved
species may result in toxic reactions.
Do not exceed the levels of monensin
recommended in the feeding directions,
as reduced average daily gains may
result. If feed refusals containing
monensin are fed to other groups of
cattle, the concentration of monensin
in the refusals and amount of refusals
fed should be taken into consideration
to prevent monensin overdosing. 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 Nos. 016592
and 058198, chlortetracycline by No.
069254 in Sec. 510.600(c) of this
chapter.
(xiv) 50 to 117 g/ton............ Monensin, >10 to 40.................... Growing beef steers and Feed as the sole ration to provide 350 016592
heifers fed in mg chlortetracycline per head per day 069254
confinement for and 0.14 to 0.42 mg monensin per lb.
slaughter: For the body weight per day to provide,
control of bacterial depending upon severity of coccidiosis
pneumonia associated challenge, up to 480 mg monensin per
with shipping fever head per day. For use in dry feeds
complex caused by only. Not for use in liquid feed
Pasteurella spp. supplements. Do not allow horses or
susceptible to other equines access to feed
chlortetracycline and containing monensin. Ingestion of
for the prevention and monensin by horses has been fatal.
control of coccidiosis Monensin medicated cattle and goat
due to Eimeria bovis feeds are safe for use in cattle and
and Eimeria zuernii. goats only. Consumption by unapproved
species may result in toxic reactions.
Do not exceed the levels of monensin
recommended in the feeding directions,
as reduced average daily gains may
result. If feed refusals containing
monensin are fed to other groups of
cattle, the concentration of monensin
in the refusals and amount of refusals
fed should be taken into consideration
to prevent monensin overdosing. 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 Nos. 016592
and 058198, chlortetracycline by No.
069254 in Sec. 510.600(c) of this
chapter.
[[Page 55570]]
* * * * * * *
(xviii) 400 to 2,000 g/ton....... Monensin, 5 to 40...................... Growing beef steers and Feed as the sole ration to provide 10 016592
heifers fed in mg chlortetracycline per lb. body 069254
confinement for weight per day and 50 to 480 mg
slaughter: For monensin per head per day. Feed for
treatment of bacterial not more than 5 days, then continue
enteritis caused by feeding monensin Type C medicated feed
Escherichia coli and alone. No additional improvement in
bacterial pneumonia feed efficiency has been shown from
caused by Pasteurella feeding monensin at levels greater
multocida susceptible than 30 grams per ton (360 mg monensin
to chlortetracycline; per head per day). For use in dry
for improved feed feeds only. Not for use in liquid feed
efficiency. supplements. Do not allow horses or
other equines access to feed
containing monensin. Ingestion of
monensin by horses has been fatal.
Monensin medicated cattle and goat
feeds are safe for use in cattle and
goats only. Consumption by unapproved
species may result in toxic reactions.
Do not exceed the levels of monensin
recommended in the feeding directions,
as reduced average daily gains may
result. If feed refusals containing
monensin are fed to other groups of
cattle, the concentration of monensin
in the refusals and amount of refusals
fed should be taken into consideration
to prevent monensin overdosing. 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 Nos. 016592
and 058198, chlortetracycline by No.
069254 in Sec. 510.600(c) of this
chapter.
(xix) 400 to 2,000 g/ton......... Monensin, 10 to 40..................... Growing beef steers and Feed as the sole ration to provide 10 016592
heifers: For treatment mg chlortetracycline per lb. body 069254
of bacterial enteritis weight per day and 0.14 to 0.42 mg
caused by Escherichia monensin per lb. body weight per day
coli and bacterial to provide, depending upon severity of
pneumonia caused by the coccidiosis challenge, up to 480
Pasteurella multocida mg monensin per head per day. Feed for
susceptible to not more than 5 days, then continue
chlortetracycline; and feeding monensin Type C medicated feed
for the prevention and alone. For use in dry feeds only. Not
control of coccidiosis for use in liquid feed supplements. Do
due to Eimeria bovis not allow horses or other equines
and Eimeria zuernii. access to feed containing monensin.
Ingestion of monensin by horses has
been fatal. Monensin medicated cattle
and goat feeds are safe for use in
cattle and goats only. Consumption by
unapproved species may result in toxic
reactions. Do not exceed the levels of
monensin recommended in the feeding
directions, as reduced average daily
gains may result. If feed refusals
containing monensin are fed to other
groups of cattle, the concentration of
monensin in the refusals and amount of
refusals fed should be taken into
consideration to prevent monensin
overdosing. 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 Nos. 016592
and 058198, chlortetracycline by No.
069254 in Sec. 510.600(c) of this
chapter.
(xx) 400 to 2,000 g/ton.......... Monensin, 10 to 200.................... Beef calves 2 months of Feed as the sole ration to provide 10 016592
age and older: For mg chlortetracycline per lb. body 069254
treatment of bacterial weight per day and 0.14 to 1.00 mg
enteritis caused by monensin per lb. body weight per day
Escherichia coli and to provide, depending upon severity of
bacterial pneumonia coccidiosis challenge, up to 200 mg of
caused by Pasteurella monensin per head per day. Feed for
multocida susceptible not more than 5 days, then continue to
to chlortetracycline; feed monensin Type C medicated feed
and for the prevention alone. For use in dry feeds only. Not
and control of for use in liquid feed supplements. Do
coccidiosis due to not allow horses or other equines
Eimeria bovis and access to feed containing monensin.
Eimeria zuernii. Ingestion of monensin by horses has
been fatal. Monensin medicated cattle
and goat feeds are safe for use in
cattle and goats only. Consumption by
unapproved species may result in toxic
reactions. Do not exceed the levels of
monensin recommended in the feeding
directions, as reduced average daily
gains may result. If feed refusals
containing monensin are fed to other
groups of cattle, the concentration of
monensin in the refusals and amount of
refusals fed should be taken into
consideration to prevent monensin
overdosing. 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 Nos. 016592
and 058198, chlortetracycline by No.
069254 in Sec. 510.600(c) of this
chapter.
* * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 558.325 [Amended]
0
46. In Sec. 558.325, remove and reserve paragraphs (e)(2)(ii), (viii),
and (xiii).
0
47. In Sec. 558.366, revise paragraphs (b) and (d)(1)(v) to read as
follows:
Sec. 558.366 Nicarbazin.
* * * * *
(b) Sponsors. See Nos. 060728, 066104, and 069254 in Sec.
510.600(c) of this chapter.
* * * * *
(d) * * *
(1) * * *
[[Page 55571]]
----------------------------------------------------------------------------------------------------------------
Combination in grams per
Nicarbazin in grams per ton ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(v) 113.5..................... ......................... Chickens: As an aid Feed continuously as 060728
in preventing sole ration from 069254
outbreaks of cecal time chicks are
(Eimeria tenella) placed on litter
and intestinal (E. until past the time
acervulina, E. when coccidiosis is
maxima, E. ordinarily a
necatrix, and E. hazard. Do not use
brunetti) as a treatment for
coccidiosis. coccidiosis. Do not
use in flushing
mashes. Do not feed
to laying hens.
Withdraw 4 days
before slaughter.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
0
48. In Sec. 558.450, revise paragraphs (e)(5)(iv) and (v) to read as
follows:
Sec. 558.450 Oxytetracycline.
* * * * *
(e) * * *
(5) * * *
------------------------------------------------------------------------
Indications for
Oxytetracycline amount use Limitations Sponsor
------------------------------------------------------------------------
* * * * * * *
(iv) 2.5 to 3.75 g/100 lb 1. Freshwater- Administer in 066104
of fish/day. reared mixed ration
salmonids: For for 10 days.
control of Do not
ulcer disease liberate fish
caused by or slaughter
Haemophilus fish for food
piscium, for 21 days
furunculosis following the
caused by last
Aeromonas administration
salmonicida, of medicated
bacterial feed.
hemorrhagic
septicemia
caused by A.
hydrophila,
and
pseudomonas
disease.
2. Catfish: For Administer in 066104
control of mixed ration
bacterial for 10 days.
hemorrhagic Do not
septicemia liberate fish
caused by A. or slaughter
hydrophila and fish for food
pseudomonas for 21 days
disease. following the
last
administration
of medicated
feed. Do not
administer
when water
temperature is
below 16.7
[deg]C (62 F).
(v) 3.75 g/100 lb of fish/ 1. Freshwater- Administer in 066104
day. reared mixed ration
salmonids: For for 10 days.
control of Do not
mortality due liberate fish
to coldwater or slaughter
disease fish for food
associated for 21 days
with following the
Flavobacterium last
psychrophilum administration
or for control of medicated
of mortality feed.
due to
columnaris
disease
associated
with
Flavobacterium
columnare.
2. Freshwater- Feed for 10 066104
reared days.
salmonids Immediate
weighing up to release is
55 grams: For permitted
marking the following last
skeletal feeding of
tissue. medicated feed.
3. Catfish: For Administer in 066104
control of mixed ration
mortality due for 10 days.
to columnaris Do not
disease liberate fish
associated or slaughter
with fish for food
Flavobacterium for 21 days
columnare. following the
last
administration
of medicated
feed. Do not
administer
when water
temperature is
below 16.7
[deg]C (62 F).
* * * * * * *
------------------------------------------------------------------------
Dated: August 9, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-17454 Filed 8-15-23; 8:45 am]
BILLING CODE 4164-01-P
