New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor, 16543-16550 [2023-05465]
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Federal Register / Vol. 88, No. 53 / Monday, March 20, 2023 / Rules and Regulations
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relevant facts concerning the issue,
including copies of all pertinent
documents. Except in unusual
circumstances, such official
interpretations will not be issued
separately but will be incorporated in
the official commentary to this part,
which will be amended periodically. No
official interpretations will be issued
approving financial institutions’ forms
or statements. This restriction does not
apply to forms or statements whose use
is required or sanctioned by a
government agency.
3. Unofficial oral interpretations.
Unofficial oral interpretations may be
provided at the discretion of Bureau
staff. Written requests for such
interpretations should be sent to the
address set forth for official
interpretations. Unofficial oral
interpretations provide no protection
under section 19(b) of RESPA.
Ordinarily, staff will not issue unofficial
oral interpretations on matters
adequately covered by this part or the
official Bureau interpretations.
4. Rules of construction. (a) Lists that
appear in the commentary may be
exhaustive or illustrative; the
appropriate construction should be clear
from the context. In most cases,
illustrative lists are introduced by
phrases such as ‘‘including, but not
limited to,’’ ‘‘among other things,’’ ‘‘for
example,’’ or ‘‘such as.’’
(b) Throughout the commentary,
reference to ‘‘this section’’ or ‘‘this
paragraph’’ means the section or
paragraph in the regulation that is the
subject of the comment.
5. Comment designations. Each
comment in the commentary is
identified by a number and the
regulatory section or paragraph that the
comment interprets. The comments are
designated with as much specificity as
possible according to the particular
regulatory provision addressed. For
example, some of the comments to
§ 1024.37(c)(1) are further divided by
subparagraph, such as comment
37(c)(1)(i)–1. In other cases, comments
have more general application and are
designated, for example, as comment
40(a)–1. This introduction may be cited
as comments I–1 through I–5.
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PART 1026—TRUTH IN LENDING
(REGULATION Z)
18. The authority citation for part
1026 continues to read as follows:
■
Authority: 12 U.S.C. 2601, 2603–2605,
2607, 2609, 2617, 3353, 5511, 5512, 5532,
5581; 15 U.S.C. 1601 et seq.
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Appendix A to Part 1026 [Amended]
■ 19. Appendix A to part 1026 is
amended in the first sentence of the first
paragraph immediately after the
subheading Request for Determination
by removing ‘‘20006’’ and adding
‘‘20552’’ in its place.
Appendix B to Part 1026 [Amended]
20. Appendix B to part 1026 is
amended in the ‘‘Application’’ section
in the second sentence by removing
‘‘20006’’ and adding ‘‘20552’’ in its
place.
■
Appendix C to Part 1026 [Amended]
21. Appendix C to part 1026 is
amended under ‘‘Requests for Issuance
of Official Interpretations’’ by:
■ a. Removing ‘‘Division of Research,
Markets, and Regulations’’ and adding
‘‘Division of Research, Monitoring, and
Regulations’’ in its place; and
■ b. Removing ‘‘20006’’ and adding
‘‘20552’’ in its place.
■ 22. Supplement I is amended by
revising paragraphs 1 and 2 under
‘‘Appendix J—Annual Percentage Rate
Computations for Closed-End Credit
Transactions’’ to read as follows:
■
Supplement I to Part 1026—Official
Interpretations
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Appendix J—Annual Percentage Rate
Computations for Closed-End Credit
Transactions
1. Use of appendix J. Appendix J sets
forth the actuarial equations and
instructions for calculating the annual
percentage rate in closed-end credit
transactions. While the formulas
contained in this appendix may be
directly applied to calculate the annual
percentage rate for an individual
transaction, they may also be utilized to
program calculators and computers to
perform the calculations.
2. Relation to Bureau tables. The
Bureau’s Annual Percentage Rate Tables
also provide creditors with a calculation
tool that applies the technical
information in appendix J. An annual
percentage rate computed in accordance
with the instructions in the tables is
deemed to comply with the regulation.
Volume I of the tables may be used for
credit transactions involving equal
payment amounts and periods, as well
as for transactions involving any of the
following irregularities: odd first period,
odd first payment and odd last payment.
Volume II of the tables may be used for
transactions that involve any type of
irregularities. These tables may be
obtained from the Bureau, 1700 G Street
NW, Washington, DC 20552, upon
request. The tables are also available on
PO 00000
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16543
the Bureau’s website at: https://
www.consumerfinance.gov//resources/
applicable-requirements/annualpercentage-rate-tables/.
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PART 1030—TRUTH IN SAVINGS
(REGULATION DD)
23. The authority citation for part
1030 continues to read as follows:
■
Authority: 12 U.S.C. 4302–4304, 4308,
5512, 5581.
Appendix C to Part 1030 [Amended]
24. Appendix C to part 1030 is
amended in the second sentence of
paragraph (b) by removing ‘‘20006’’ and
adding ‘‘20552’’ in its place.
■
Rohit Chopra,
Director, Consumer Financial Protection
Bureau.
[FR Doc. 2023–05216 Filed 3–17–23; 8:45 am]
BILLING CODE 4810–AM–C
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 516, 520, 522, 524,
526, 529, 556, and 558
[Docket No. FDA–2022–N–0002]
New Animal Drugs; Approval of New
Animal Drug Applications; Change of
Sponsor
AGENCY:
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
October, November, and December
2022. 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 the accuracy and
readability of the regulations.
DATES: This rule is effective March 20,
2023.
FOR FURTHER INFORMATION CONTACT:
George K. Haibel, Center for Veterinary
Medicine (HFV–6), Food and Drug
Administration, 7500 Standish Pl.,
SUMMARY:
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Federal Register / Vol. 88, No. 53 / Monday, March 20, 2023 / Rules and Regulations
Rockville, MD 20855, 240–402–5689,
George.Haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Approvals
FDA is amending the animal drug
regulations to reflect approval actions
for NADAs, ANADAs, and cNADAs
during October, November, and
December 2022, 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.
FDA has verified the website
addresses as of the date this document
publishes in the Federal Register, but
websites are subject to change over time.
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS, ANADAS, AND CNADAS APPROVED DURING OCTOBER, NOVEMBER,
AND DECEMBER 2022 REQUIRING EVIDENCE OF SAFETY AND/OR EFFECTIVENESS
Approval
date
File No.
Sponsor
Effect of the action
Public documents
Original approval for the treatment
of bovine respiratory disease,
infectious bovine
keratoconjunctivitis, and bovine
foot rot as a generic copy of
NADA 141–244.
Conditional approval for management of clinical signs associated
with acute onset of pancreatitis
in dogs.
Supplemental approval for control
of American foulbrood in honey
bees as a generic copy of
NADA 111–636.
Original approval for the prevention of mortality caused by necrotic enteritis and coccidiosis in
broiler chickens.
Original approval to improve glycemic control in otherwise
healthy cats with diabetes
mellitus not previously treated
with insulin.
Original approval for the control of
mortality caused by necrotic enteritis associated with Clostridium perfringens in broiler
chickens as a generic copy of
NADA 013–076.
Original approval for the control of
clinical signs associated with
osteoarthritis in horses.
Supplemental approval for control
of pyrexia associated with acute
bovine mastitis, for addition of
lactating dairy cows for all approved indications, and of a
milk discard time.
FOI Summary
522.2630
FOI Summary
516.1012
FOI Summary
520.1263b
FOI Summary
558.364
FOI Summary
520.170
FOI Summary
520.2640
FOI Summary
522.1704
FOI Summary
524.970
November 4,
2022.
200–730
Parnell Technologies Pty. Ltd.,
Unit 4, 476 Gardeners Rd., Alexandria, New South Wales
2015, Australia.
RESPIRMYCIN (tulathromycin injection) Injectable Solution.
November
14, 2022.
141–567
Ishihara Sangyo Kaisha, Ltd., 3–
15, Edobori 1-chome, Nishi-ku,
Osaka 550–0002, Japan.
PANOQUELL–CA1 (fuzapladib
sodium for injection) Powder for
injection.
December 2,
2022.
200–377
Bimeda Animal Health Ltd., 1B
LINXMED (lincomycin hydroThe Herbert Building, The Park,
chloride) Soluble Powder.
Carrickmines, Dublin 18, Ireland.
December 2,
2022.
141–529
Pharmgate, Inc., 1800 Sir Tyler
Dr., Wilmington, NC 28405.
December 8,
2022.
141–566
Increvet, Inc., 200 Portland St.,
Floor 3, Boston, MA 02114.
December
15, 2022.
200–455
Bimeda Animal Health Ltd., 1B
BILOVET (tylosin tartrate) Soluble
The Herbert Building, The Park,
Powder.
Carrickmines, Dublin 18, Ireland.
December
20, 2022.
141–559
December
23, 2022.
141–450
Anzac Animal Health, LLC, 218
Millwell Dr., Suite B, Maryland
Heights, MO 63043.
Intervet, Inc., 2 Giralda Farms,
Maison, NJ 07940.
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).
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Product name
PENNITRACIN (bacitracin
methylenedisalicylate) and
MAXIBAN (narasin and
nicarbazin).
BEXACAT (bexagliflozin tablets)
Tablets.
ZYCOSAN (pentosan polysulfate
sodium injection) Injectable Solution.
BANAMINE Transdermal (flunixin
transdermal solution)
Transdermal Solution.
These applications were submitted in
voluntary compliance with the goals of
the FDA Center for Veterinary
Medicine’s (CVM’s) Judicious Use
Initiative as identified by guidance for
industry #263, ‘‘Recommendations for
Sponsors of Medically Important
21 CFR
section
Antimicrobial Drugs Approved for Use
in Animals to Voluntarily Bring Under
Veterinary Oversight All Products That
Continue to be Available Over-theCounter,’’ June 11, 2021 (https://
www.fda.gov/media/130610/download).
TABLE 2—SUPPLEMENTAL APPLICATIONS APPROVED DURING OCTOBER, NOVEMBER, AND DECEMBER 2022 TO CHANGE
THE MARKETING STATUS OF ANTIMICROBIAL ANIMAL DRUG PRODUCTS FROM OTC TO Rx
Approval
date
October 11,
2022.
VerDate Sep<11>2014
File No.
097–222
Sponsor
Product name
Boehringer Ingelheim Animal Health USA, Inc., 3239
Satellite Blvd., Duluth, GA 30096.
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TODAY (cephapirin sodium)
Intramammary Infusion.
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21 CFR
section
526.365
Federal Register / Vol. 88, No. 53 / Monday, March 20, 2023 / Rules and Regulations
16545
TABLE 2—SUPPLEMENTAL APPLICATIONS APPROVED DURING OCTOBER, NOVEMBER, AND DECEMBER 2022 TO CHANGE
THE MARKETING STATUS OF ANTIMICROBIAL ANIMAL DRUG PRODUCTS FROM OTC TO Rx—Continued
Approval
date
File No.
Product name
Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov
Str., 1113 Sofia, Bulgaria.
Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 ....
Chlortetracycline Calf Oblets, 500 mg ....
520.443
LINCOMIX (lincomycin hydrochloride)
Injectable Solution.
PEN BP–48 (penicillin G benzathine and
penicillin G procaine) Injectable Suspension.
TOMORROW (cephapirin benzathine)
Intramammary Infusion.
NOROCILLIN (penicillin G procaine)
Injectable Suspension.
522.1260
October 18,
2022.
October 31,
2022.
November 2,
2022.
055–039
065–498
Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov
Str., 1113 Sofia, Bulgaria.
November 9,
2022.
November
15, 2022.
108–114
November
16, 2022.
140–582
Boehringer Ingelheim Animal Health USA, Inc., 3239
Satellite Blvd., Duluth, GA 30096.
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.
November
18, 2022.
141–143
November
30, 2022.
November
30, 2022.
November
30, 2022.
December 2,
2022.
December 7,
2022.
December 9,
2022.
December 9,
2022.
December
12, 2022.
December
15, 2022.
December
16, 2022.
December
22, 2022.
031–715
034–025
065–010
122–271
Norbrook Laboratories Ltd., Carnbane Industrial Estate, Newry, County Down, BT35 6QQ, United
Kingdom.
Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 ....
200–038
Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov
Str., 1113 Sofia, Bulgaria.
Do .................................................................................
101–862
Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940 ....
065–174
Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 ....
113–232
Do .................................................................................
200–523
Bimeda Animal Health Ltd., 1B The Herbert Building,
The Park, Carrickmines, Dublin 18, Ireland.
Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940 ....
103–037
200–508
138–955
092–523
Bimeda Animal Health Ltd., 1B The Herbert Building,
The Park, Carrickmines, Dublin 18, Ireland.
Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov
Str., 1113 Sofia, Bulgaria.
Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940 ....
II. Changes of Sponsorship
Increvet, Inc., 200 Portland St., Floor
3, Boston, MA 02114 has informed FDA
that it has transferred ownership of, and
all rights and interest in, NADA 141–
566 for BEXACAT (bexagliflozin tablets)
Tablets, approved December 8, 2022, to
Elanco US Inc., 2500 Innovation Way,
Greenfield, IN 46140. The regulatory
text for the original approval of this
application reflects this change of
sponsorship.
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III. Technical Amendments
FDA is making the following
amendments to improve the accuracy of
the animal drug regulations:
• 21 CFR 516.498 is removed from
subpart C of part 516 and is added to
subpart E.
• 21 CFR 520.370, 520.522, 522.246,
522.304, 522.2470, 524.1044c,
524.1044f, and 524.1484g are amended
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21 CFR
section
Sponsor
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BIOCYL–50 (oxytetracycline hydrochloride) Injectable Solution; BIOCYL–
100 (oxytetracycline hydrochloride)
Injectable Solution.
NOROMYCIN 300 LA (oxytetracycline)
Injectable Solution.
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526.363
522.1696b
522.1662
522.1660b
ALBON (sulfadimethoxine) Boluses .......
520.2220d
SULMET (sulfamethazine) Oblets ..........
520.2260a
DI–METHOX (sulfadimethoxine)
Injectable Solution.
GARASOL (gentamicin sulfate) Injection
522.2220
CRYSTICILLIN 300 A.S. (penicillin G
procaine) Injectable Suspension.
LIQUAMYCIN LA-200 (oxytetracycline)
Injectable Solution.
SULFAMED (sulfadimethoxine)
Injectable Solution.
GARACIN (gentamicin) Injectable Solution.
BILOVET (tylosin) Injectable Solution ....
522.1696b
TYLOVET (tylosin) Injectable Solution ...
522.2640
GARASOL (gentamicin sulfate) Solution
529.1044b
to reflect a sponsor’s current drug
labeler code.
• 21 CFR 520.441 is amended to
revise the sponsor listings for uses of
chlortetracycline in drinking water of
various food-producing animals.
• 21 CFR 520.443 is amended to
revise the sponsor listings for uses of
chlortetracycline tablets and boluses in
calves.
• 21 CFR 520.1196 is amended to
revise the indication for uses of
ivermectin and pyrantel tablets in dogs.
• 21 CFR 522. 1660a is amended to
reflect the correct drug labeler code for
a sponsor of an oxytetracycline
injectable solution.
• 21 CFR 522.2471 is amended to add
human food safety warnings for use of
tilmicosin injectable solution in cattle
and sheep.
• 21 CFR 524.1448 is amended to
revise the indication for use of
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522.1696a
522.1044
522.1660a
522.2220
522.1044
522.2640
mirtazapine transdermal ointment in
cats.
• 21 CFR 556.222 is amended to
reflect a revised tolerance for residues of
doramectin in liver of cattle.
• 21 CFR 556.500 is amended to
reflect revised numbering of sections for
oxytetracycline uses in food-producing
animals.
• 21 CFR 558.76 is amended to add
conditions of use previously approved
under NADA 141–137 for use of
bacitracin methylenedisalicylate in the
manufacture of Type C medicated feeds
for broiler and replacement chickens (87
FR 76418, December 14, 2022).
• 21 CFR 558.355 is amended to
revise a caution statement on labeling of
monensin Type A medicated articles for
use in broiler breeder replacement
chickens.
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IV. 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
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR parts 510,
516, 520, 522, 524, 526, 529, 556, and
558 are amended as follows:
PART 510—NEW ANIMAL DRUGS
21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
1. The authority citation for part 510
continues to read as follows:
■
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.
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
2. In § 510.600, in the table in
paragraph (c)(1), add entries in
alphabetical order for ‘‘Ishihara Sangyo
Kaisha, Ltd.’’ and ‘‘ZyVet Animal
Health, Inc.’’ and in the table in
paragraph (c)(2), add entries in
numerical order for ‘‘064642’’ and
‘‘086117’’ to read as follows:
■
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
*
*
(c) * * *
(1) * * *
*
*
Drug labeler
code
Firm name and address
*
*
*
*
*
*
Ishihara Sangyo Kaisha, Ltd., 3–15, Edobori 1-chome, Nishi-ku, Osaka 550–0002, Japan ..............................................................
*
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*
*
*
*
*
ZyVet Animal Health, Inc., 73 Route 31N, Pennington, NJ 08534 .....................................................................................................
*
064642
086117
(2) * * *
Drug labeler
code
Firm name and address
*
064642 ............
*
*
*
*
Ishihara Sangyo Kaisha, Ltd., 3–15, Edobori 1-chome, Nishi-ku, Osaka 550–0002, Japan.
*
*
*
086117 ............
*
*
*
ZyVet Animal Health, Inc., 73 Route 31N, Pennington, NJ 08534.
*
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*
*
*
*
*
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*
PART 516—NEW ANIMAL DRUGS FOR
MINOR USE AND MINOR SPECIES
3. The authority citation for part 516
continues to read as follows:
■
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Authority: 21 U.S.C. 360ccc–1, 360ccc–2,
371.
§ 516.498
[Transferred to Subpart E]
4. Transfer § 516.498 from subpart C
to subpart E.
■
■
5. Add § 516.1012 to read as follows:
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§ 516.1012
Fuzapladib.
(a) Specifications. The drug is
provided as a powder for injection that
is reconstituted with 3.5 milliliter (mL)
of provided diluent to a final
concentration of 4 milligrams (mg)
fuzapladib sodium per mL.
(b) Sponsor. See No. 064642 in
§ 510.600(c) of this chapter.
(c) Conditions of use—(1) Amount.
Administer at a dosage of 0.4 mg (0.1
mL) per kilogram of body weight once
daily for 3 consecutive days by
PO 00000
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intravenous (IV) injection over 15
seconds to 1 minute.
(2) Indications for use in dogs. For the
management of clinical signs associated
with acute onset of pancreatitis in dogs.
(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.
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PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
6. The authority citation for part 520
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
■
7. Add § 520.170 to read as follows:
§ 520.170
Bexagliflozin.
(a) Specifications. Each tablet
contains 15 milligrams bexagliflozin.
(b) Sponsor. See No. 058198 in
§ 510.600(c) of this chapter.
(c) Conditions of use—(1) Amount.
Administer one tablet by mouth to cats
6.6 lb (3.0 kg) or greater once daily, at
approximately the same time each day,
with or without food, and regardless of
blood glucose level.
(2) Indications for use. To improve
glycemic control in otherwise healthy
cats with diabetes mellitus not
previously treated with insulin.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
§ 520.370
[Amended]
9. In § 520.441, revise paragraphs
(b)(1) and (3) and (d)(4)(iii)(C) to read as
follows:
Chlortetracycline powder.
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*
*
*
*
(b) * * *
(1) No. 069254 for use as in paragraph
(d) of this section.
*
*
*
*
*
(3) Nos. 069043 and 076475 for use as
in paragraphs (d)(4)(i)(A), (d)(4)(i)(B),
and (d)(4)(ii) and (iii) of this section.
*
*
*
*
*
(d) * * *
(4) * * *
(iii) * * *.
(C) Limitations. Prepare fresh solution
daily as the sole source of
chlortetracycline. Do not use for more
than 5 days. For Nos. 066104, 069043,
069254, and 076475: Do not slaughter
animals for food within 5 days of
treatment. For No. 069254: Do not
slaughter animals for food within 24
hours of treatment. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
*
*
*
*
*
■ 10. In § 520.443, revise paragraphs (a),
(b), and (d)(3)(ii) to read as follows:
§ 520.443 Chlortetracycline hydrochloride
tablets and boluses.
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[Amended]
12. In § 520.1196, in paragraph
(c)(1)(ii), remove ‘‘ascarids’’ and add in
its place ‘‘roundworms’’.
13. In § 520.1263b, revise paragraphs
(b)(1) and (2) to read as follows:
■
§ 520.1263b
*
VerDate Sep<11>2014
[Amended]
11. In § 520.522, in paragraph (b)(2),
remove ‘‘026637’’ and add in its place
‘‘017033’’.
■
■
■
(a) Specifications. Each tablet
contains 25 milligrams (mg)
chlortetracycline hydrochloride; each
§ 520.522
§ 520.1196
8. In § 520.370, in paragraph (b)(1),
remove ‘‘026637’’ and add in its place
‘‘017033’’.
■
§ 520.441
bolus contains 250 or 500 mg
chlortetracycline hydrochloride.
(b) Sponsors. See sponsors in
§ 510.600(c) of this chapter for use as in
paragraph (d) of this section.
(1) No. 069043 for use of a 250-mg
bolus as in paragraph (d)(1) of this
section.
(2) No. 016592 for use of a 25-mg
tablet as in paragraph (d)(2) of this
section.
(3) No. 016592 for use of a 500-mg
bolus as in paragraph (d)(3) of this
section.
*
*
*
*
*
(d) * * *
(3) * * *
(ii) Limitations. 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.
Lincomycin powder.
*
*
*
*
*
(b) * * *
(1) Nos. 054771 and 061133 for use as
in paragraph (d) of this section.
(2) Nos. 016592, 054925, and 076475
for use as in paragraphs (d)(1) and (d)(2)
of this section.
*
*
*
*
*
■ 14. In § 520.2220d, revise paragraph
(d)(3) to read as follows:
§ 520.2220d
Sulfadimethoxine bolus.
*
*
*
*
*
(d) * * *
(3) Limitations. Do not administer
within 7 days of slaughter. Milk that has
been taken from animals during
treatment and 60 hours (five milkings)
after the latest treatment must not be
used for food. 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.
■ 15. In § 520.2260a, revise paragraph
(d)(1)(iii) to read as follows:
§ 520.2260a
boluses.
*
*
*
(d) * * *
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Sulfamethazine oblets and
*
Fmt 4700
*
Sfmt 4700
16547
(1) * * *
(iii) Limitations. Do not administer for
more than 5 consecutive days. Do not
treat cattle within 10 days of slaughter.
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. A withdrawal
period has not been established for this
product in preruminating calves. Do not
use in calves to be processed for veal.
Do not use in horses intended for
human consumption. Federal law
restricts this drug to use by or on the
order of a licensed veterinarian.
*
*
*
*
*
■ 16. In § 520.2640, add paragraph (b)(3)
to read as follows:
§ 520.2640
Tylosin.
*
*
*
*
*
(b) * * *
(3) No. 061133 for use of a 100-g
container as in paragraphs (e)(1)(i)(B)
and (e)(1)(ii) of this section.
*
*
*
*
*
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
17. The authority citation for part 522
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
18. In § 522.246, revise paragraph
(b)(3) to read as follows:
■
§ 522.246
Butorphanol.
*
*
*
*
*
(b) * * *
(3) Nos. 000061, 017033, 043264, and
059399 for use of the product described
in paragraph (a)(3) of this section as in
paragraph (d)(3) of this section.
*
*
*
*
*
§ 522.304
[Amended]
19. In § 522.304, in paragraph (b),
remove ‘‘026637’’ and add in its place
‘‘017033’’.
■
20. In § 522.1044, revise paragraphs
(d)(2)(i) through (iii), (d)(3)(i) though
(iii), and (d)(4)(i) through (iii) to read as
follows:
■
§ 522.1044
Gentamicin.
*
*
*
*
*
(d) * * *
(2) * * *
(i) Amount. Administer
subcutaneously in the neck 1 mg of
gentamicin per 0.2 mL dose, using the
50- or 100-mg/mL product diluted with
sterile saline to a concentration of 5 mg/
mL.
(ii) Indications for use. As an aid in
the prevention of early mortality in 1- to
3-day old turkey poults due to Arizona
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paracolon infections susceptible to
gentamicin.
(iii) Limitations. Injected poults must
not be slaughtered for food for at least
9 weeks after treatment. Federal law
restricts this drug to use by or on the
order of a licensed veterinarian.
(3) * * *
(i) Amount. Administer
subcutaneously in the neck 0.2 mg of
gentamicin per 0.2 mL dose, using the
50- or 100-mg/mL product diluted with
sterile saline to a concentration of 1.0
mg/mL.
(ii) Indications for use. For prevention
of early mortality in day-old chickens
caused by Escherichia coli, Salmonella
typhimurium, and Pseudomonas
aeruginosa susceptible to gentamicin.
(iii) Limitations. Injected chicks must
not be slaughtered for food for at least
5 weeks after treatment. Federal law
restricts this drug to use by or on the
order of a licensed veterinarian.
(4) * * *
(i) Amount. Administer 5 mg of
gentamicin as a single intramuscular
dose using the 5 mg/mL solution.
(ii) Indications for use. For treatment
of porcine colibacillosis in piglets up to
3 days old caused by strains of
Escherichia coli sensitive to gentamicin.
(iii) Limitations. For single
intramuscular dose in pigs up to 3 days
of age only. Do not slaughter treated
animals for food for at least 40 days
following treatment. Federal law
restricts this drug to use by or on the
order of a licensed veterinarian.
*
*
*
*
*
■ 21. In § 522.1260, revise paragraph
(e)(2)(iii) to read as follows:
§ 522.1260
Lincomycin.
*
*
*
*
*
(e) * * *
(2) * * *
(iii) Limitations. Do not treat within
48 hours of slaughter. For No 054771:
Federal law restricts this drug to use by
or on the order of a licensed
veterinarian.
■ 22. In § 522.1660a, revise paragraph
(b) and add a sentence to the end of
paragraphs (e)(1)(ii) and (e)(2)(ii) to read
as follows:
§ 522.1660a Oxytetracycline solution, 200
milligrams/milliliter.
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*
*
*
*
*
(b) Sponsors. See Nos. 000010,
016592, 054771, 055529, 061133, and
069254 in § 510.600(c) of this chapter.
*
*
*
*
*
(e) * * *
(1) * * *
(ii) * * * For No. 054771: Federal law
restricts this drug to use by or on the
order of a licensed veterinarian.
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(2) * * *
(ii) * * * For No. 054771: Federal law
restricts this drug to use by or on the
order of a licensed veterinarian.
23. In § 522.1660b, add a sentence to
the end of paragraphs (e)(1)(ii) and
(e)(2)(ii) to read as follows:
■
§ 522.1660b Oxytetracycline solution, 300
milligrams/milliliter.
*
*
*
*
*
(e) * * *
(1) * * *
(ii) * * * For No. 055529: Federal law
restricts this drug to use by or on the
order of a licensed veterinarian.
(2) * * *
(ii) * * * For No. 055529: Federal law
restricts this drug to use by or on the
order of a licensed veterinarian.
24. In § 522.1662, revise paragraphs
(j)(3)(i) and (iii) to read as follows:
■
§ 522.1662
Oxytetracycline.
*
*
*
*
*
(j) * * *
(3) * * *
(i) Amount. Administer by
intravenous injection 3 to 5 milligrams
per pound of body weight daily.
Administer 5 milligrams per pound for
anaplasmosis, severe foot rot, and severe
forms of other diseases. Treatment
should be continued 24 to 48 hours
following remission of disease
symptoms, but not to exceed a total of
4 consecutive days.
*
*
*
*
*
(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.
■ 25. In § 522.1696a, revise paragraph
(d)(2)(iii) to read as follows:
§ 522.1696a Penicillin G benzathine and
penicillin G procaine suspension.
*
*
*
*
*
(d) * * *
(2) * * *
(iii) Limitations. Not for use within 30
days of slaughter. For No. 016592: A
withdrawal period has not been
established for this product in preruminating calves. Do not use in calves
to be processed for veal. For No. 016592:
Federal law restricts this drug to use by
or on the order of a licensed
veterinarian.
26. In § 522.1696b, revise paragraph
(d)(2)(iii)(C) to read as follows:
■
§ 522.1696b Penicillin G procaine aqueous
suspension.
*
*
*
(d) * * *
(2) * * *
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*
Fmt 4700
*
Sfmt 4700
(iii) * * *
(C) For Nos. 054771 and 055529:
Federal law restricts this drug to use by
or on the order of a licensed
veterinarian.
■
27. Add § 522.1704 to read as follows:
§ 522.1704
Pentosan polysulfate sodium.
(a) Specifications. Each milliliter of
solution contains 250 milligrams (mg) of
pentosan polysulfate sodium.
(b) Sponsor. See No. 086073 in
§ 510.600(c) of this chapter.
(c) Conditions of use—(1) Amount.
Administer 3 mg per kilogram of body
weight (1.4 mg per pound) by
intramuscular injection once weekly for
4 weeks for a total of four doses.
(2) Indications for use. For the control
of clinical signs associated with
osteoarthritis in horses.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
28. In § 522.2470, revise paragraphs
(b) introductory text and (b)(1) to read
as follows:
■
§ 522.2470
injection.
Tiletamine and zolazepam for
*
*
*
*
*
(b) Sponsors. See sponsors in
§ 510.600(c) of this chapter.
(1) Nos. 017033 and 054771 for use as
in paragraph (c) of this section.
*
*
*
*
*
■ 29. In § 522.2471, remove paragraph
(d), redesignate paragraph (e) as
paragraph (d), and revise newly
redesignated paragraphs (d)(1)(iii) and
(d)(2)(iii).
The revisions read as follows:
§ 522.2471
Tilmicosin.
*
*
*
*
*
(d) * * *
(1) * * *
(iii) Limitations. Animals intended for
human consumption must not be
slaughtered within 42 days of last
treatment. Do not use in lactating dairy
cattle 20 months of age or older. Use of
tilmicosin in this class of cattle may
cause milk residues. Federal law
restricts this drug to use by or on the
order of a licensed veterinarian.
(2) * * *
(iii) Limitations. Not for use in
lactating ewes producing milk for
human consumption. Animals intended
for human consumption must not be
slaughtered within 42 days of last
treatment. Federal law restricts this drug
to use by or on the order of a licensed
veterinarian.
■ 30. In 522.2630, revise paragraph
(b)(1) to read as follows:
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§ 522.2630
Tulathromycin.
*
*
*
*
(b) * * *
(1) Nos. 000061, 013744, 051311,
054771, 055529, 058198, 061133, and
068504 for use of product described in
paragraph (a)(1) as in paragraphs
(d)(1)(i), (d)(1)(ii), (d)(1)(iii)(A), and
(d)(2) of this section.
*
*
*
*
*
§ 522.2640
PART 529—CERTAIN OTHER DOSAGE
FORM NEW ANIMAL DRUGS
§ 524.1044f Gentamicin and
betamethasone spray.
■
*
31. In § 522.2640, in paragraph (b)(2),
remove ‘‘000010’’ and add in its place
‘‘016592’’ and in paragraphs (e)(1)(iii)
and (e)(2)(iii), in the last sentence of
each paragraph, remove ‘‘For No.
058198:’’.
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
32. The authority citation for part 524
continues to read as follows:
■
41. The authority citation for part 529
continues to read as follows:
*
*
*
*
(b) Sponsors. See Nos. 000061,
017033, 054925, 058005, and 058829 in
§ 510.600(c) of this chapter.
*
*
*
*
*
■
36. In § 524.1448, revise paragraph
(c)(2) to read as follows:
§ 529.1044b Gentamicin solution for
dipping eggs.
■
[Amended]
■
§ 524.1448
ointment.
Mirtazapine transdermal
*
*
*
*
*
(c) * * *
(2) Indications for use. For body
weight gain in cats with a history of
weight loss.
*
*
*
*
*
§ 524.1484g
[Amended]
Authority: 21 U.S.C. 360b.
42. In § 529.1044b, add a sentence to
the end of paragraph (c)(3) to read as
follows:
*
*
*
*
*
(c) * * *
(3) * * * For No. 000061: 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
43. The authority citation for part 556
continues to read as follows:
■
■
37. In § 524.1484g, in paragraph (b),
remove ‘‘026637’’ and add in its place
‘‘017033’’.
■
§ 524.970
PART 526—INTRAMAMMARY DOSAGE
FORM NEW ANIMAL DRUGS
§ 556.222
Authority 21 U.S.C. 360b.
33. In § 524.970, revise paragraphs
(d)(2) and (3) to read as follows:
Flunixin.
*
*
*
*
*
(d) * * *
(2) Indications for use. For the control
of pyrexia associated with bovine
respiratory disease and acute bovine
mastitis, and the control of pain
associated with foot rot in beef cattle 2
months of age and older and dairy
cattle.
(3) Limitations. Not for use in beef
and dairy bulls intended for breeding
over 1 year of age. Milk that has been
taken during treatment and for 48 hours
after treatment must not be used for
human consumption. Cattle must not be
slaughtered for human consumption
within 8 days of treatment. Not for use
in replacement dairy heifers 20 months
of age or older or dry dairy cows; use
in these cattle may cause drug residues
in calves born to these cows or heifers.
Not for use in beef calves less than 2
months of age, dairy calves, and veal
calves. A withdrawal period has not
been established for this product in preruminating calves. Approved only as a
single topical dose in cattle. Repeated
treatments may result in violative
residues in milk or in edible tissues.
Federal law restricts this drug to use by
or on the order of a licensed
veterinarian.
lotter on DSK11XQN23PROD with RULES1
35. In § 524.1044f, revise paragraph
(b) to read as follows:
■
*
§ 524.1044c
[Amended]
34. In § 524.1044c, in paragraph (b),
remove ‘‘026637’’ and add in its place
‘‘017033’’.
■
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■
38. The authority citation for part 526
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
39. In § 526.363, revise paragraph
(d)(3) to read as follows:
■
§ 526.363
Cephapirin benzathine.
*
*
*
*
*
(d) * * *
(3) Limitations. For use in dry cows
only. Not to be used within 30 days of
calving. Milk from treated cows must
not be used for food during the first 72
hours after calving. Animals infused
with this product must not be
slaughtered for food until 42 days after
the latest infusion. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
40. In § 526.365, revise paragraph
(d)(3) to read as follows:
■
§ 526.365
Cephapirin sodium.
*
*
*
*
*
(d) * * *
(3) Limitations. Milk that has been
taken from animals during treatment
and for 96 hours after the last treatment
must not be used for food. Treated
animals must not be slaughtered for
food until 4 days after the last treatment.
Federal law restricts this drug to use by
or on the order of a licensed
veterinarian.
PO 00000
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Fmt 4700
Sfmt 4700
Authority: 21 U.S.C. 342, 360b, 371.
44. In § 556.222, revise paragraphs
(b)(1)(i) and (c) to read as follows:
Doramectin.
*
*
*
*
*
(b) * * *
(1) * * *
(i) Liver (target tissue): 300 ppb.
*
*
*
*
*
(c) Related conditions of use. See
§§ 522.770, 522.772, and 524.770 of this
chapter.
■ 45. In § 556.500, revise paragraph (c)
to read as follows:
§ 556.500
Oxytetracycline.
*
*
*
*
*
(c) Related conditions of use. See
§§ 520.1660a, 520.1660c, 520.1660d,
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
46. The authority citation for part 558
continues to read as follows:
■
Authority: 21 U.S.C. 354, 360b, 360ccc,
360ccc–1, 371.
47. In § 558.76, redesignate paragraph
(d)(1)(iv) as paragraph (d)(1)(v) and add
new paragraph (d)(1)(iv) to read as
follows:
■
§ 558.76
*
Bacitracin methylenedisalicylate.
*
*
(d) * * *
(1) * * *
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*
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Bacitracin in
grams per ton
Indications for use
*
(iv) 50 ................
*
*
*
*
*
*
48. In § 558.355, revise paragraph
(d)(8)(vi) to read as follows:
■
§ 558.355
*
Monensin.
*
*
(d) * * *
(8) * * *
Sponsor
*
*
*
*
*
Broiler and replacement chickens: For the prevention Feed as the sole ration for 28 to 35 days, starting
of mortality caused by necrotic enteritis associated
from the time chicks are placed for brooding.
with Clostridium perfringens.
*
*
Limitations
*
Narasin and
nicarbazin
grams/ton
*
*
*
(vi) Not for broiler breeder
replacement chickens.
*
*
*
*
*
■ 49. In § 558.364:
■ a. Revise paragraphs (d)(1)(ii) and (iii);
■ b. Redesignate paragraphs (d)(1)(iv)
and (v) as paragraphs (d)(1)(vi) and (vii);
and
*
c. Add new paragraphs (d)(1)(iv) and
(v).
The revisions and additions read as
follows:
■
§ 558.364
*
Narasin and nicarbazin.
*
*
(d) * * *
(1) * * *
*
Limitations
*
*
Bacitracin
methylenedisalicylate,
4 to 50.
*
*
Broiler chickens: For the prevention of coccidiosis
caused by Eimeria necatrix, E. tenella, E.
acervulina, E. brunetti, E. mivati, and E. maxima, and for increased rate of weight gain and
improved feed efficiency.
(iii) 27 to 45 of
each drug.
Bacitracin
methylenedisalicylate,
4 to 50.
Broiler chickens: For the prevention of coccidiosis
caused by Eimeria necatrix, E. tenella, E.
acervulina, E. brunetti, E. mivati, and E. maxima, and for increased rate of weight gain and
improved feed efficiency.
(iv) 27 to 45 of
each drug.
Bacitracin
methylenedisalicylate,
50.
Broiler chickens: For the prevention of coccidiosis
caused by Eimeria tenella, E. necatrix, E.
acervulina, E. maxima, E. brunetti, and E.
mivati, and as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to
bacitracin.
(v) 27 to 45 of
each drug.
Bacitracin
methylenedisalicylate,
50.
Broiler chickens: For the prevention of coccidiosis
caused by Eimeria necatrix, E. tenella, E.
acervulina, E. brunetti, E. mivati, and E. maxima, and for the prevention of mortality caused
by necrotic enteritis associated with Clostridium
perfringens.
*
*
*
Feed continuously as the sole ration. Do not feed
to laying hens. Do not allow adult turkeys,
horses, or other equines access to formulations
containing narasin. Ingestion of narasin by
these species has been fatal. Withdraw 5 days
before slaughter. Bacitracin
methylenedisalicylate as provided by No.
054771 in § 510.600(c) of this chapter.
Feed as the sole ration throughout the feeding period. For broiler chickens only. Do not feed to
laying hens. Do not allow adult turkeys, horses,
or other equines access to formulations containing narasin. Ingestion of narasin by these
species has been fatal. Bacitracin
methylenedisalicylate as provided by No.
069254 in § 510.600(c) of this chapter.
Feed continuously as the sole ration. Do not feed
to laying hens. Do not allow adult turkeys,
horses, or other equines access to formulations
containing narasin. Ingestion of narasin by
these species has been fatal. Withdraw 5 days
before slaughter. Bacitracin
methylenedisalicylate as provided by No.
054771 in § 510.600(c) of this chapter.
Feed as the sole ration for 28 to 35 days, starting
from the time chicks are placed for brooding.
For broiler chickens only. Do not feed to laying
hens. Do not allow adult turkeys, horses, or
other equines access to formulations containing
narasin. Ingestion of narasin by these species
has been fatal. Bacitracin methylenedisalicylate
as provided by No. 069254 in § 510.600(c) of
this chapter.
*
*
*
*
*
*
*
*
*
Dated: March 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
*
[FR Doc. 2023–05465 Filed 3–17–23; 8:45 am]
BILLING CODE 4164–01–P
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*
Indications for use
*
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069254
*
Combination in
grams/ton
(ii) 27 to 45 of
each drug.
*
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*
058198
069254
054771
069254
]]>Agencies
[Federal Register Volume 88, Number 53 (Monday, March 20, 2023)]
[Rules and Regulations]
[Pages 16543-16550]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-05465]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 516, 520, 522, 524, 526, 529, 556, and 558
[Docket No. FDA-2022-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications;
Change of Sponsor
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendments.
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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 October, November, and December 2022. 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 the
accuracy and readability of the regulations.
DATES: This rule is effective March 20, 2023.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7500
Standish Pl.,
[[Page 16544]]
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 October, November, and
December 2022, 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.
FDA has verified the website addresses as of the date this document
publishes in the Federal Register, but websites are subject to change
over time.
Table 1--Original and Supplemental NADAs, ANADAs, and cNADAs Approved During October, November, and December 2022 Requiring Evidence of Safety and/or
Effectiveness
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21 CFR
Approval date File No. Sponsor Product name Effect of the action Public documents section
--------------------------------------------------------------------------------------------------------------------------------------------------------
November 4, 2022................... 200-730 Parnell Technologies RESPIRMYCIN Original approval for FOI Summary 522.2630
Pty. Ltd., Unit 4, (tulathromycin the treatment of
476 Gardeners Rd., injection) Injectable bovine respiratory
Alexandria, New South Solution. disease, infectious
Wales 2015, Australia. bovine
keratoconjunctivitis,
and bovine foot rot
as a generic copy of
NADA 141-244.
November 14, 2022.................. 141-567 Ishihara Sangyo PANOQUELL-CA1 Conditional approval FOI Summary 516.1012
Kaisha, Ltd., 3-15, (fuzapladib sodium for management of
Edobori 1-chome, for injection) Powder clinical signs
Nishi-ku, Osaka 550- for injection. associated with acute
0002, Japan. onset of pancreatitis
in dogs.
December 2, 2022................... 200-377 Bimeda Animal Health LINXMED (lincomycin Supplemental approval FOI Summary 520.1263b
Ltd., 1B The Herbert hydrochloride) for control of
Building, The Park, Soluble Powder. American foulbrood in
Carrickmines, Dublin honey bees as a
18, Ireland. generic copy of NADA
111-636.
December 2, 2022................... 141-529 Pharmgate, Inc., 1800 PENNITRACIN Original approval for FOI Summary 558.364
Sir Tyler Dr., (bacitracin the prevention of
Wilmington, NC 28405. methylenedisalicylate mortality caused by
) and MAXIBAN necrotic enteritis
(narasin and and coccidiosis in
nicarbazin). broiler chickens.
December 8, 2022................... 141-566 Increvet, Inc., 200 BEXACAT (bexagliflozin Original approval to FOI Summary 520.170
Portland St., Floor tablets) Tablets. improve glycemic
3, Boston, MA 02114. control in otherwise
healthy cats with
diabetes mellitus not
previously treated
with insulin.
December 15, 2022.................. 200-455 Bimeda Animal Health BILOVET (tylosin Original approval for FOI Summary 520.2640
Ltd., 1B The Herbert tartrate) Soluble the control of
Building, The Park, Powder. mortality caused by
Carrickmines, Dublin necrotic enteritis
18, Ireland. associated with
Clostridium
perfringens in
broiler chickens as a
generic copy of NADA
013-076.
December 20, 2022.................. 141-559 Anzac Animal Health, ZYCOSAN (pentosan Original approval for FOI Summary 522.1704
LLC, 218 Millwell polysulfate sodium the control of
Dr., Suite B, injection) Injectable clinical signs
Maryland Heights, MO Solution. associated with
63043. osteoarthritis in
horses.
December 23, 2022.................. 141-450 Intervet, Inc., 2 BANAMINE Transdermal Supplemental approval FOI Summary 524.970
Giralda Farms, (flunixin transdermal for control of
Maison, NJ 07940. solution) Transdermal pyrexia associated
Solution. with acute bovine
mastitis, for
addition of lactating
dairy cows for all
approved indications,
and of a milk discard
time.
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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 (CVM'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 October, November, and December 2022 To Change the Marketing
Status of Antimicrobial Animal Drug Products From OTC to Rx
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Approval date File No. Sponsor Product name 21 CFR section
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October 11, 2022.................. 097-222 Boehringer Ingelheim TODAY (cephapirin 526.365
Animal Health USA, Inc., sodium)
3239 Satellite Blvd., Intramammary
Duluth, GA 30096. Infusion.
[[Page 16545]]
October 18, 2022.................. 055-039 Huvepharma EOOD, 5th Chlortetracycline 520.443
Floor, 3A Nikolay Haytov Calf Oblets, 500 mg.
Str., 1113 Sofia,
Bulgaria.
October 31, 2022.................. 034-025 Zoetis Inc., 333 Portage LINCOMIX (lincomycin 522.1260
St., Kalamazoo, MI 49007. hydrochloride)
Injectable Solution.
November 2, 2022.................. 065-498 Huvepharma EOOD, 5th PEN BP-48 522.1696a
Floor, 3A Nikolay Haytov (penicillin G
Str., 1113 Sofia, benzathine and
Bulgaria. penicillin G
procaine)
Injectable
Suspension.
November 9, 2022.................. 108-114 Boehringer Ingelheim TOMORROW (cephapirin 526.363
Animal Health USA, Inc., benzathine)
3239 Satellite Blvd., Intramammary
Duluth, GA 30096. Infusion.
November 15, 2022................. 065-010 Norbrook Laboratories NOROCILLIN 522.1696b
Ltd., Carnbane (penicillin G
Industrial Estate, procaine)
Newry, County Down, BT35 Injectable
6QQ, United Kingdom. Suspension.
November 16, 2022................. 140-582 Bimeda Animal Health BIOCYL-50 522.1662
Ltd., 1B The Herbert (oxytetracycline
Building, The Park, hydrochloride)
Carrickmines, Dublin 18, Injectable
Ireland. Solution; BIOCYL-
100
(oxytetracycline
hydrochloride)
Injectable Solution.
November 18, 2022................. 141-143 Norbrook Laboratories NOROMYCIN 300 LA 522.1660b
Ltd., Carnbane (oxytetracycline)
Industrial Estate, Injectable Solution.
Newry, County Down, BT35
6QQ, United Kingdom.
November 30, 2022................. 031-715 Zoetis Inc., 333 Portage ALBON 520.2220d
St., Kalamazoo, MI 49007. (sulfadimethoxine)
Boluses.
November 30, 2022................. 122-271 Huvepharma EOOD, 5th SULMET 520.2260a
Floor, 3A Nikolay Haytov (sulfamethazine)
Str., 1113 Sofia, Oblets.
Bulgaria.
November 30, 2022................. 200-038 Do....................... DI-METHOX 522.2220
(sulfadimethoxine)
Injectable Solution.
December 2, 2022.................. 101-862 Intervet, Inc., 2 Giralda GARASOL (gentamicin 522.1044
Farms, Madison, NJ 07940. sulfate) Injection.
December 7, 2022.................. 065-174 Zoetis Inc., 333 Portage CRYSTICILLIN 300 522.1696b
St., Kalamazoo, MI 49007. A.S. (penicillin G
procaine)
Injectable
Suspension.
December 9, 2022.................. 113-232 Do....................... LIQUAMYCIN 522.1660a
LA[dash]200
(oxytetracycline)
Injectable Solution.
December 9, 2022.................. 200-523 Bimeda Animal Health SULFAMED 522.2220
Ltd., 1B The Herbert (sulfadimethoxine)
Building, The Park, Injectable Solution.
Carrickmines, Dublin 18,
Ireland.
December 12, 2022................. 103-037 Intervet, Inc., 2 Giralda GARACIN (gentamicin) 522.1044
Farms, Madison, NJ 07940. Injectable Solution.
December 15, 2022................. 200-508 Bimeda Animal Health BILOVET (tylosin) 522.2640
Ltd., 1B The Herbert Injectable Solution.
Building, The Park,
Carrickmines, Dublin 18,
Ireland.
December 16, 2022................. 138-955 Huvepharma EOOD, 5th TYLOVET (tylosin) 522.2640
Floor, 3A Nikolay Haytov Injectable Solution.
Str., 1113 Sofia,
Bulgaria.
December 22, 2022................. 092-523 Intervet, Inc., 2 Giralda GARASOL (gentamicin 529.1044b
Farms, Madison, NJ 07940. sulfate) Solution.
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II. Changes of Sponsorship
Increvet, Inc., 200 Portland St., Floor 3, Boston, MA 02114 has
informed FDA that it has transferred ownership of, and all rights and
interest in, NADA 141-566 for BEXACAT (bexagliflozin tablets) Tablets,
approved December 8, 2022, to Elanco US Inc., 2500 Innovation Way,
Greenfield, IN 46140. The regulatory text for the original approval of
this application reflects this change of sponsorship.
III. Technical Amendments
FDA is making the following amendments to improve the accuracy of
the animal drug regulations:
21 CFR 516.498 is removed from subpart C of part 516 and
is added to subpart E.
21 CFR 520.370, 520.522, 522.246, 522.304, 522.2470,
524.1044c, 524.1044f, and 524.1484g are amended to reflect a sponsor's
current drug labeler code.
21 CFR 520.441 is amended to revise the sponsor listings
for uses of chlortetracycline in drinking water of various food-
producing animals.
21 CFR 520.443 is amended to revise the sponsor listings
for uses of chlortetracycline tablets and boluses in calves.
21 CFR 520.1196 is amended to revise the indication for
uses of ivermectin and pyrantel tablets in dogs.
21 CFR 522. 1660a is amended to reflect the correct drug
labeler code for a sponsor of an oxytetracycline injectable solution.
21 CFR 522.2471 is amended to add human food safety
warnings for use of tilmicosin injectable solution in cattle and sheep.
21 CFR 524.1448 is amended to revise the indication for
use of mirtazapine transdermal ointment in cats.
21 CFR 556.222 is amended to reflect a revised tolerance
for residues of doramectin in liver of cattle.
21 CFR 556.500 is amended to reflect revised numbering of
sections for oxytetracycline uses in food-producing animals.
21 CFR 558.76 is amended to add conditions of use
previously approved under NADA 141-137 for use of bacitracin
methylenedisalicylate in the manufacture of Type C medicated feeds for
broiler and replacement chickens (87 FR 76418, December 14, 2022).
21 CFR 558.355 is amended to revise a caution statement on
labeling of monensin Type A medicated articles for use in broiler
breeder replacement chickens.
[[Page 16546]]
IV. 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 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
510, 516, 520, 522, 524, 526, 529, 556, and 558 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for part 510 continues to read as follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
0
2. In Sec. 510.600, in the table in paragraph (c)(1), add entries in
alphabetical order for ``Ishihara Sangyo Kaisha, Ltd.'' and ``ZyVet
Animal Health, Inc.'' and in the table in paragraph (c)(2), add entries
in numerical order for ``064642'' and ``086117'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Drug labeler
Firm name and address code
------------------------------------------------------------------------
* * * * * * *
Ishihara Sangyo Kaisha, Ltd., 3-15, Edobori 1-chome, 064642
Nishi-ku, Osaka 550-0002, Japan........................
* * * * * * *
ZyVet Animal Health, Inc., 73 Route 31N, Pennington, NJ 086117
08534..................................................
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * * * *
064642....................... Ishihara Sangyo Kaisha, Ltd., 3-15,
Edobori 1-chome, Nishi-ku, Osaka 550-
0002, Japan.
* * * * * * *
086117....................... ZyVet Animal Health, Inc., 73 Route 31N,
Pennington, NJ 08534.
* * * * * * *
------------------------------------------------------------------------
PART 516--NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
0
3. The authority citation for part 516 continues to read as follows:
Authority: 21 U.S.C. 360ccc-1, 360ccc-2, 371.
Sec. 516.498 [Transferred to Subpart E]
0
4. Transfer Sec. 516.498 from subpart C to subpart E.
0
5. Add Sec. 516.1012 to read as follows:
Sec. 516.1012 Fuzapladib.
(a) Specifications. The drug is provided as a powder for injection
that is reconstituted with 3.5 milliliter (mL) of provided diluent to a
final concentration of 4 milligrams (mg) fuzapladib sodium per mL.
(b) Sponsor. See No. 064642 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. Administer at a dosage of 0.4 mg
(0.1 mL) per kilogram of body weight once daily for 3 consecutive days
by intravenous (IV) injection over 15 seconds to 1 minute.
(2) Indications for use in dogs. For the management of clinical
signs associated with acute onset of pancreatitis in dogs.
(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.
[[Page 16547]]
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
6. The authority citation for part 520 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
7. Add Sec. 520.170 to read as follows:
Sec. 520.170 Bexagliflozin.
(a) Specifications. Each tablet contains 15 milligrams
bexagliflozin.
(b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. Administer one tablet by mouth
to cats 6.6 lb (3.0 kg) or greater once daily, at approximately the
same time each day, with or without food, and regardless of blood
glucose level.
(2) Indications for use. To improve glycemic control in otherwise
healthy cats with diabetes mellitus not previously treated with
insulin.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Sec. 520.370 [Amended]
0
8. In Sec. 520.370, in paragraph (b)(1), remove ``026637'' and add in
its place ``017033''.
0
9. In Sec. 520.441, revise paragraphs (b)(1) and (3) and
(d)(4)(iii)(C) to read as follows:
Sec. 520.441 Chlortetracycline powder.
* * * * *
(b) * * *
(1) No. 069254 for use as in paragraph (d) of this section.
* * * * *
(3) Nos. 069043 and 076475 for use as in paragraphs (d)(4)(i)(A),
(d)(4)(i)(B), and (d)(4)(ii) and (iii) of this section.
* * * * *
(d) * * *
(4) * * *
(iii) * * *.
(C) Limitations. Prepare fresh solution daily as the sole source of
chlortetracycline. Do not use for more than 5 days. For Nos. 066104,
069043, 069254, and 076475: Do not slaughter animals for food within 5
days of treatment. For No. 069254: Do not slaughter animals for food
within 24 hours of treatment. Federal law restricts this drug to use by
or on the order of a licensed veterinarian.
* * * * *
0
10. In Sec. 520.443, revise paragraphs (a), (b), and (d)(3)(ii) to
read as follows:
Sec. 520.443 Chlortetracycline hydrochloride tablets and boluses.
(a) Specifications. Each tablet contains 25 milligrams (mg)
chlortetracycline hydrochloride; each bolus contains 250 or 500 mg
chlortetracycline hydrochloride.
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for
use as in paragraph (d) of this section.
(1) No. 069043 for use of a 250-mg bolus as in paragraph (d)(1) of
this section.
(2) No. 016592 for use of a 25-mg tablet as in paragraph (d)(2) of
this section.
(3) No. 016592 for use of a 500-mg bolus as in paragraph (d)(3) of
this section.
* * * * *
(d) * * *
(3) * * *
(ii) Limitations. 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. 520.522 [Amended]
0
11. In Sec. 520.522, in paragraph (b)(2), remove ``026637'' and add in
its place ``017033''.
Sec. 520.1196 [Amended]
0
12. In Sec. 520.1196, in paragraph (c)(1)(ii), remove ``ascarids'' and
add in its place ``roundworms''.
0
13. In Sec. 520.1263b, revise paragraphs (b)(1) and (2) to read as
follows:
Sec. 520.1263b Lincomycin powder.
* * * * *
(b) * * *
(1) Nos. 054771 and 061133 for use as in paragraph (d) of this
section.
(2) Nos. 016592, 054925, and 076475 for use as in paragraphs (d)(1)
and (d)(2) of this section.
* * * * *
0
14. In Sec. 520.2220d, revise paragraph (d)(3) to read as follows:
Sec. 520.2220d Sulfadimethoxine bolus.
* * * * *
(d) * * *
(3) Limitations. Do not administer within 7 days of slaughter. Milk
that has been taken from animals during treatment and 60 hours (five
milkings) after the latest treatment must not be used for food. 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
15. In Sec. 520.2260a, revise paragraph (d)(1)(iii) to read as
follows:
Sec. 520.2260a Sulfamethazine oblets and boluses.
* * * * *
(d) * * *
(1) * * *
(iii) Limitations. Do not administer for more than 5 consecutive
days. Do not treat cattle within 10 days of slaughter. 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. A withdrawal period has
not been established for this product in preruminating calves. Do not
use in calves to be processed for veal. Do not use in horses intended
for human consumption. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
* * * * *
0
16. In Sec. 520.2640, add paragraph (b)(3) to read as follows:
Sec. 520.2640 Tylosin.
* * * * *
(b) * * *
(3) No. 061133 for use of a 100-g container as in paragraphs
(e)(1)(i)(B) and (e)(1)(ii) of this section.
* * * * *
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
17. The authority citation for part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
18. In Sec. 522.246, revise paragraph (b)(3) to read as follows:
Sec. 522.246 Butorphanol.
* * * * *
(b) * * *
(3) Nos. 000061, 017033, 043264, and 059399 for use of the product
described in paragraph (a)(3) of this section as in paragraph (d)(3) of
this section.
* * * * *
Sec. 522.304 [Amended]
0
19. In Sec. 522.304, in paragraph (b), remove ``026637'' and add in
its place ``017033''.
0
20. In Sec. 522.1044, revise paragraphs (d)(2)(i) through (iii),
(d)(3)(i) though (iii), and (d)(4)(i) through (iii) to read as follows:
Sec. 522.1044 Gentamicin.
* * * * *
(d) * * *
(2) * * *
(i) Amount. Administer subcutaneously in the neck 1 mg of
gentamicin per 0.2 mL dose, using the 50- or 100-mg/mL product diluted
with sterile saline to a concentration of 5 mg/mL.
(ii) Indications for use. As an aid in the prevention of early
mortality in 1- to 3-day old turkey poults due to Arizona
[[Page 16548]]
paracolon infections susceptible to gentamicin.
(iii) Limitations. Injected poults must not be slaughtered for food
for at least 9 weeks after treatment. Federal law restricts this drug
to use by or on the order of a licensed veterinarian.
(3) * * *
(i) Amount. Administer subcutaneously in the neck 0.2 mg of
gentamicin per 0.2 mL dose, using the 50- or 100-mg/mL product diluted
with sterile saline to a concentration of 1.0 mg/mL.
(ii) Indications for use. For prevention of early mortality in day-
old chickens caused by Escherichia coli, Salmonella typhimurium, and
Pseudomonas aeruginosa susceptible to gentamicin.
(iii) Limitations. Injected chicks must not be slaughtered for food
for at least 5 weeks after treatment. Federal law restricts this drug
to use by or on the order of a licensed veterinarian.
(4) * * *
(i) Amount. Administer 5 mg of gentamicin as a single intramuscular
dose using the 5 mg/mL solution.
(ii) Indications for use. For treatment of porcine colibacillosis
in piglets up to 3 days old caused by strains of Escherichia coli
sensitive to gentamicin.
(iii) Limitations. For single intramuscular dose in pigs up to 3
days of age only. Do not slaughter treated animals for food for at
least 40 days following treatment. Federal law restricts this drug to
use by or on the order of a licensed veterinarian.
* * * * *
0
21. In Sec. 522.1260, revise paragraph (e)(2)(iii) to read as follows:
Sec. 522.1260 Lincomycin.
* * * * *
(e) * * *
(2) * * *
(iii) Limitations. Do not treat within 48 hours of slaughter. For
No 054771: Federal law restricts this drug to use by or on the order of
a licensed veterinarian.
0
22. In Sec. 522.1660a, revise paragraph (b) and add a sentence to the
end of paragraphs (e)(1)(ii) and (e)(2)(ii) to read as follows:
Sec. 522.1660a Oxytetracycline solution, 200 milligrams/milliliter.
* * * * *
(b) Sponsors. See Nos. 000010, 016592, 054771, 055529, 061133, and
069254 in Sec. 510.600(c) of this chapter.
* * * * *
(e) * * *
(1) * * *
(ii) * * * For No. 054771: Federal law restricts this drug to use
by or on the order of a licensed veterinarian.
(2) * * *
(ii) * * * For No. 054771: Federal law restricts this drug to use
by or on the order of a licensed veterinarian.
0
23. In Sec. 522.1660b, add a sentence to the end of paragraphs
(e)(1)(ii) and (e)(2)(ii) to read as follows:
Sec. 522.1660b Oxytetracycline solution, 300 milligrams/milliliter.
* * * * *
(e) * * *
(1) * * *
(ii) * * * For No. 055529: Federal law restricts this drug to use
by or on the order of a licensed veterinarian.
(2) * * *
(ii) * * * For No. 055529: Federal law restricts this drug to use
by or on the order of a licensed veterinarian.
0
24. In Sec. 522.1662, revise paragraphs (j)(3)(i) and (iii) to read as
follows:
Sec. 522.1662 Oxytetracycline.
* * * * *
(j) * * *
(3) * * *
(i) Amount. Administer by intravenous injection 3 to 5 milligrams
per pound of body weight daily. Administer 5 milligrams per pound for
anaplasmosis, severe foot rot, and severe forms of other diseases.
Treatment should be continued 24 to 48 hours following remission of
disease symptoms, but not to exceed a total of 4 consecutive days.
* * * * *
(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
25. In Sec. 522.1696a, revise paragraph (d)(2)(iii) to read as
follows:
Sec. 522.1696a Penicillin G benzathine and penicillin G procaine
suspension.
* * * * *
(d) * * *
(2) * * *
(iii) Limitations. Not for use within 30 days of slaughter. For No.
016592: A withdrawal period has not been established for this product
in pre-ruminating calves. Do not use in calves to be processed for
veal. For No. 016592: Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
26. In Sec. 522.1696b, revise paragraph (d)(2)(iii)(C) to read as
follows:
Sec. 522.1696b Penicillin G procaine aqueous suspension.
* * * * *
(d) * * *
(2) * * *
(iii) * * *
(C) For Nos. 054771 and 055529: Federal law restricts this drug to
use by or on the order of a licensed veterinarian.
0
27. Add Sec. 522.1704 to read as follows:
Sec. 522.1704 Pentosan polysulfate sodium.
(a) Specifications. Each milliliter of solution contains 250
milligrams (mg) of pentosan polysulfate sodium.
(b) Sponsor. See No. 086073 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. Administer 3 mg per kilogram of
body weight (1.4 mg per pound) by intramuscular injection once weekly
for 4 weeks for a total of four doses.
(2) Indications for use. For the control of clinical signs
associated with osteoarthritis in horses.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
28. In Sec. 522.2470, revise paragraphs (b) introductory text and
(b)(1) to read as follows:
Sec. 522.2470 Tiletamine and zolazepam for injection.
* * * * *
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter.
(1) Nos. 017033 and 054771 for use as in paragraph (c) of this
section.
* * * * *
0
29. In Sec. 522.2471, remove paragraph (d), redesignate paragraph (e)
as paragraph (d), and revise newly redesignated paragraphs (d)(1)(iii)
and (d)(2)(iii).
The revisions read as follows:
Sec. 522.2471 Tilmicosin.
* * * * *
(d) * * *
(1) * * *
(iii) Limitations. Animals intended for human consumption must not
be slaughtered within 42 days of last treatment. Do not use in
lactating dairy cattle 20 months of age or older. Use of tilmicosin in
this class of cattle may cause milk residues. Federal law restricts
this drug to use by or on the order of a licensed veterinarian.
(2) * * *
(iii) Limitations. Not for use in lactating ewes producing milk for
human consumption. Animals intended for human consumption must not be
slaughtered within 42 days of last treatment. Federal law restricts
this drug to use by or on the order of a licensed veterinarian.
0
30. In 522.2630, revise paragraph (b)(1) to read as follows:
[[Page 16549]]
Sec. 522.2630 Tulathromycin.
* * * * *
(b) * * *
(1) Nos. 000061, 013744, 051311, 054771, 055529, 058198, 061133,
and 068504 for use of product described in paragraph (a)(1) as in
paragraphs (d)(1)(i), (d)(1)(ii), (d)(1)(iii)(A), and (d)(2) of this
section.
* * * * *
Sec. 522.2640 [Amended]
0
31. In Sec. 522.2640, in paragraph (b)(2), remove ``000010'' and add
in its place ``016592'' and in paragraphs (e)(1)(iii) and (e)(2)(iii),
in the last sentence of each paragraph, remove ``For No. 058198:''.
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. In Sec. 524.970, revise paragraphs (d)(2) and (3) to read as
follows:
Sec. 524.970 Flunixin.
* * * * *
(d) * * *
(2) Indications for use. For the control of pyrexia associated with
bovine respiratory disease and acute bovine mastitis, and the control
of pain associated with foot rot in beef cattle 2 months of age and
older and dairy cattle.
(3) Limitations. Not for use in beef and dairy bulls intended for
breeding over 1 year of age. Milk that has been taken during treatment
and for 48 hours after treatment must not be used for human
consumption. Cattle must not be slaughtered for human consumption
within 8 days of treatment. Not for use in replacement dairy heifers 20
months of age or older or dry dairy cows; use in these cattle may cause
drug residues in calves born to these cows or heifers. Not for use in
beef calves less than 2 months of age, dairy calves, and veal calves. A
withdrawal period has not been established for this product in pre-
ruminating calves. Approved only as a single topical dose in cattle.
Repeated treatments may result in violative residues in milk or in
edible tissues. Federal law restricts this drug to use by or on the
order of a licensed veterinarian.
Sec. 524.1044c [Amended]
0
34. In Sec. 524.1044c, in paragraph (b), remove ``026637'' and add in
its place ``017033''.
0
35. In Sec. 524.1044f, revise paragraph (b) to read as follows:
Sec. 524.1044f Gentamicin and betamethasone spray.
* * * * *
(b) Sponsors. See Nos. 000061, 017033, 054925, 058005, and 058829
in Sec. 510.600(c) of this chapter.
* * * * *
0
36. In Sec. 524.1448, revise paragraph (c)(2) to read as follows:
Sec. 524.1448 Mirtazapine transdermal ointment.
* * * * *
(c) * * *
(2) Indications for use. For body weight gain in cats with a
history of weight loss.
* * * * *
Sec. 524.1484g [Amended]
0
37. In Sec. 524.1484g, in paragraph (b), remove ``026637'' and add in
its place ``017033''.
PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS
0
38. The authority citation for part 526 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
39. In Sec. 526.363, revise paragraph (d)(3) to read as follows:
Sec. 526.363 Cephapirin benzathine.
* * * * *
(d) * * *
(3) Limitations. For use in dry cows only. Not to be used within 30
days of calving. Milk from treated cows must not be used for food
during the first 72 hours after calving. Animals infused with this
product must not be slaughtered for food until 42 days after the latest
infusion. Federal law restricts this drug to use by or on the order of
a licensed veterinarian.
0
40. In Sec. 526.365, revise paragraph (d)(3) to read as follows:
Sec. 526.365 Cephapirin sodium.
* * * * *
(d) * * *
(3) Limitations. Milk that has been taken from animals during
treatment and for 96 hours after the last treatment must not be used
for food. Treated animals must not be slaughtered for food until 4 days
after the last treatment. 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
41. The authority citation for part 529 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
42. In Sec. 529.1044b, add a sentence to the end of paragraph (c)(3)
to read as follows:
Sec. 529.1044b Gentamicin solution for dipping eggs.
* * * * *
(c) * * *
(3) * * * For No. 000061: 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
43. The authority citation for part 556 continues to read as follows:
Authority: 21 U.S.C. 342, 360b, 371.
0
44. In Sec. 556.222, revise paragraphs (b)(1)(i) and (c) to read as
follows:
Sec. 556.222 Doramectin.
* * * * *
(b) * * *
(1) * * *
(i) Liver (target tissue): 300 ppb.
* * * * *
(c) Related conditions of use. See Sec. Sec. 522.770, 522.772, and
524.770 of this chapter.
0
45. In Sec. 556.500, revise paragraph (c) to read as follows:
Sec. 556.500 Oxytetracycline.
* * * * *
(c) Related conditions of use. See Sec. Sec. 520.1660a, 520.1660c,
520.1660d, 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
46. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
0
47. In Sec. 558.76, redesignate paragraph (d)(1)(iv) as paragraph
(d)(1)(v) and add new paragraph (d)(1)(iv) to read as follows:
Sec. 558.76 Bacitracin methylenedisalicylate.
* * * * *
(d) * * *
(1) * * *
[[Page 16550]]
----------------------------------------------------------------------------------------------------------------
Bacitracin in grams per ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(iv) 50........................ Broiler and replacement Feed as the sole ration for 28 069254
chickens: For the prevention to 35 days, starting from the
of mortality caused by time chicks are placed for
necrotic enteritis associated brooding.
with Clostridium perfringens.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
0
48. In Sec. 558.355, revise paragraph (d)(8)(vi) to read as follows:
Sec. 558.355 Monensin.
* * * * *
(d) * * *
(8) * * *
(vi) Not for broiler breeder replacement chickens.
* * * * *
0
49. In Sec. 558.364:
0
a. Revise paragraphs (d)(1)(ii) and (iii);
0
b. Redesignate paragraphs (d)(1)(iv) and (v) as paragraphs (d)(1)(vi)
and (vii); and
0
c. Add new paragraphs (d)(1)(iv) and (v).
The revisions and additions read as follows:
Sec. 558.364 Narasin and nicarbazin.
* * * * *
(d) * * *
(1) * * *
----------------------------------------------------------------------------------------------------------------
Narasin and nicarbazin grams/ Combination in
ton grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(ii) 27 to 45 of each drug.... Bacitracin Broiler chickens: For Feed continuously as 058198
methylenedisalic the prevention of the sole ration. Do
ylate, 4 to 50. coccidiosis caused by not feed to laying
Eimeria necatrix, E. hens. Do not allow
tenella, E. adult turkeys,
acervulina, E. horses, or other
brunetti, E. mivati, equines access to
and E. maxima, and formulations
for increased rate of containing narasin.
weight gain and Ingestion of narasin
improved feed by these species has
efficiency. been fatal. Withdraw
5 days before
slaughter.
Bacitracin
methylenedisalicylat
e as provided by No.
054771 in Sec.
510.600(c) of this
chapter.
(iii) 27 to 45 of each drug... Bacitracin Broiler chickens: For Feed as the sole 069254
methylenedisalic the prevention of ration throughout
ylate, 4 to 50. coccidiosis caused by the feeding period.
Eimeria necatrix, E. For broiler chickens
tenella, E. only. Do not feed to
acervulina, E. laying hens. Do not
brunetti, E. mivati, allow adult turkeys,
and E. maxima, and horses, or other
for increased rate of equines access to
weight gain and formulations
improved feed containing narasin.
efficiency. Ingestion of narasin
by these species has
been fatal.
Bacitracin
methylenedisalicylat
e as provided by No.
069254 in Sec.
510.600(c) of this
chapter.
(iv) 27 to 45 of each drug.... Bacitracin Broiler chickens: For Feed continuously as 054771
methylenedisalic the prevention of the sole ration. Do
ylate, 50. coccidiosis caused by not feed to laying
Eimeria tenella, E. hens. Do not allow
necatrix, E. adult turkeys,
acervulina, E. horses, or other
maxima, E. brunetti, equines access to
and E. mivati, and as formulations
an aid in the containing narasin.
prevention of Ingestion of narasin
necrotic enteritis by these species has
caused or complicated been fatal. Withdraw
by Clostridium spp. 5 days before
or other organisms slaughter.
susceptible to Bacitracin
bacitracin. methylenedisalicylat
e as provided by No.
054771 in Sec.
510.600(c) of this
chapter.
(v) 27 to 45 of each drug..... Bacitracin Broiler chickens: For Feed as the sole 069254
methylenedisalic the prevention of ration for 28 to 35
ylate, 50. coccidiosis caused by days, starting from
Eimeria necatrix, E. the time chicks are
tenella, E. placed for brooding.
acervulina, E. For broiler chickens
brunetti, E. mivati, only. Do not feed to
and E. maxima, and laying hens. Do not
for the prevention of allow adult turkeys,
mortality caused by horses, or other
necrotic enteritis equines access to
associated with formulations
Clostridium containing narasin.
perfringens. Ingestion of narasin
by these species has
been fatal.
Bacitracin
methylenedisalicylat
e as provided by No.
069254 in Sec.
510.600(c) of this
chapter.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
Dated: March 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-05465 Filed 3-17-23; 8:45 am]
BILLING CODE 4164-01-P
