Document ID: FDA-2022-N-0002-0050
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
Posted Date: 2023-03-20T04:00Z

[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.

-----------------------------------------------------------------------

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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                                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.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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
----------------------------------------------------------------------------------------------------------------
           Approval date              File No.            Sponsor               Product name      21 CFR section
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------

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