Document ID: FDA-2022-N-0002-0017
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address
Posted Date: 2022-12-14T05:00Z

[Federal Register Volume 87, Number 239 (Wednesday, December 14, 2022)]
[Rules and Regulations]
[Pages 76418-76425]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-24106]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 516, 520, 522, 528, and 558

[Docket No. FDA-2022-N-0002]

New Animal Drugs; Approval of New Animal Drug Applications; 
Change of Sponsor; Change of Sponsor Address

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

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

SUMMARY: The Food and Drug Administration (FDA or we) is amending the 
animal drug regulations to reflect application-related actions for new 
animal drug applications (NADAs), abbreviated new animal drug 
applications (ANADAs), and conditionally approved new animal drug 
applications (cNADAs) during April, May, and June 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 December 14, 2022.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine (HFV-6), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-402-5689, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Approvals

    FDA is amending the animal drug regulations to reflect approval 
actions for NADAs, ANADAs, and cNADAs during April, May, and June 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.

[[Page 76419]]

Table 1--Original and Supplemental NADAs, ANADAs, and cNADAs Approved During April, May, and June 2022 Requiring Evidence of Safety and/or Effectiveness
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                                21 CFR
           Approval date             File No.          Sponsor              Product name       Effect of the action     Public  documents       section
--------------------------------------------------------------------------------------------------------------------------------------------------------
April 28, 2022....................     141-137  Pharmgate, Inc., 1800  PENNITRACIN MD         Supplemental approval  FOI Summary............      558.76
                                                 Sir Tyler Dr.,         (bacitracin Type A     for the prevention
                                                 Wilmington, NC 28405.  medicated article).    of mortality caused
                                                                                               by necrotic
                                                                                               enteritis associated
                                                                                               with Clostridium
                                                                                               perfringens in
                                                                                               broiler and
                                                                                               replacement chickens.
June 16, 2022.....................     141-556  Boehringer Ingelheim   VETMEDIN-CA1           Conditional approval   FOI Summary............    516.1780
                                                 Animal Health USA,     (pimobendan)           for the delay of
                                                 Inc., 3239 Satellite   Chewable Tablets.      onset of congestive
                                                 Blvd., Duluth, GA                             heart failure in
                                                 30096.                                        dogs with Stage B2
                                                                                               preclinical
                                                                                               myxomatous mitral
                                                                                               valve disease.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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 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 April, May, and June 2022 To Change the Marketing Status of
                                Antimicrobial Animal Drug Products From OTC to Rx
----------------------------------------------------------------------------------------------------------------
                                                                                                        21 CFR
           Approval date              File No.           Sponsor                 Product name           section
----------------------------------------------------------------------------------------------------------------
May 31, 2022.......................     008-769  Zoetis Inc., 333        TERRAMYCIN (oxytetracycline   522.1662a
                                                  Portage St.,            hydrochloride) Injectable
                                                  Kalamazoo, MI 49007.    Solution; LIQUAMYCIN
                                                                          (oxytetracycline
                                                                          hydrochloride) Injectable
                                                                          Solution.
June 7, 2022.......................     007-981  Do....................  SOXISOL (sulfisoxazole)        520.2330
                                                                          Tablets.
----------------------------------------------------------------------------------------------------------------

II. Changes of Sponsorship

    The sponsors of the following approved applications have informed 
FDA that they have transferred ownership of, and all rights and 
interest in, the applications to another sponsor, as listed in table 3.

                        Table 3--Changes of Sponsorship During April, May, and June 2022
----------------------------------------------------------------------------------------------------------------
                                                                                                        21 CFR
             File No.                   Product name      Transferring sponsor       New sponsor        section
----------------------------------------------------------------------------------------------------------------
119-688...........................  CEFA-TABS             Boehringer Ingelheim  HQ Specialty Pharma      520.314
                                     (cefadroxil)          Animal Health USA,    Corp., 120 Rte. 17
                                     Tablets.              Inc., 3239            North, Suite 130,
                                                           Satellite Blvd.,      Paramus, NJ 07652.
                                                           Duluth, GA 30096.
140-684...........................  CEFA-DROPS            Do..................  Do..................     520.314
                                     (cefadroxil) Powder
                                     for Suspension.
141-217...........................  ZEUTERIN (zinc        Ark Sciences, Inc.,   Aiping                  522.2690
                                     gluconate)            1101 East 33rd St.,   Pharmaceutical,
                                     Injectable Solution.  Suite B304,           Inc., 350 W
                                                           Baltimore, MD 21218.  Wireless Blvd.,
                                                                                 Hauppauge, NY 11788.
141-551...........................  ZENALPHA              Vetcare Oy, P.O. Box  Dechra, Ltd.,           522.1338
                                     (medetomidine         26 (Liedontie 45),    Snaygill Industrial
                                     hydrochloride and     M[auml]nts[auml]l[a   Estate, Keighley
                                     vatinoxan             uml], Uusimaa,        Rd., Skipton, North
                                     hydrochloride)        04601, Finland.       Yorkshire, BD23
                                     Injectable Solution.                        2RW, United Kingdom.
----------------------------------------------------------------------------------------------------------------

    Following these changes of sponsorship, Ark Sciences, Inc. and 
Vetcare Oy are no longer the sponsor of an approved application. 
Accordingly, the drug labeler codes for these firms will be removed 
from Sec.  510.600 (21 CFR 510.600).

III. Change of Sponsor Address

    Anivive Lifesciences, Inc., 3250 Airflite Way, Suite 400, Long 
Beach, CA 90807 has informed FDA that it has changed its address to 
3777 Worsham Ave. Long Beach, CA 90808. As provided in the regulatory 
text, Sec.  510.600 is amended to reflect this change.

IV. Technical Amendments

    FDA is making the following amendments to improve the accuracy of 
the animal drug regulations:
     21 CFR 510.600 is amended to remove Ark Sciences, Inc., 
and Vetcare Oy from the list of sponsors of approved applications and 
to revise the address for Anivive Lifesciences, Inc. A punctuation 
change is made in the codified name for Ve[aacute]toquinol USA, Inc.
     21 CFR 520.563 is amended to reflect the correct section 
title for diatrizoate oral solution.
     21 CFR 520.2640 is amended to reflect sponsors' container 
contents and the dosage in parts per million of tylosin tartrate 
soluble powder for use in drinking water of turkeys and swine.
     21 CFR 522.955 is amended to reflect drug labeler codes of 
application sponsors and to revise a pathogen name for florfenicol 
injectable solution in cattle.
     21 CFR 522.2471 is amended to reflect a revised withdrawal 
period and human food safety warnings for tilmicosin injectable 
solution in sheep.
     The heading for Part 528 is revised to reflect a more 
accurate title.
     21 CFR 558.95 is amended to reflect revised classes of 
cattle for use of bambermycins medicated feeds.
     21 CFR 558.128 is amended to reflect approved 
incorporation rates for

[[Page 76420]]

chlortetracycline medicated feeds for cattle.
     21 CFR 558.342 is amended to reflect all sponsors of 
approved applications for use of melengestrol medicated feeds in 
heifers.
     21 CFR 558.450 is amended to reflect revised residue 
warnings for use of oxytetracycline medicated feeds in cattle.
     21 CFR 558.455 is amended to reflect a revised indication 
for use of oxytetracycline with neomycin in medicated cattle feeds and 
an updated format.
     21 CFR 558.575 is amended to reflect approved 
incorporations rates for use of sulfadimethoxine and ormetoprim in 
medicated feeds for salmonids and catfish.

V. Legal Authority

    This final rule is issued under section 512(i) of the Federal Food, 
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b(i)), 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, and 528

    Animal drugs.

21 CFR Part 558

    Animal drugs, Animal feeds.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
510, 516, 520, 522, 528, 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:
0
a. In the table in paragraph (c)(1), remove the entries for ``Ark 
Sciences, Inc.'' and ``Vetcare Oy''; revise the entries for ``Anivive 
Lifesciences, Inc.''; and ``Ve[aacute]toquinol USA, Inc.''; and add in 
alphabetical order an entry for ``Aiping Pharmaceutical, Inc.''; and
0
b. In the table in paragraph (c)(2), add an entry for ``011788''; 
revise the entries for ``017030'' and ``086121''; and remove the 
entries for ``076175'' and ``086155''.
    The revisions and additions 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
------------------------------------------------------------------------
 
                              * * * * * * *
Aiping Pharmaceutical, Inc., 350W Wireless Blvd.,                 011788
 Hauppauge, NY 11788....................................
 
                              * * * * * * *
Anivive Lifesciences, Inc., 3777 Worsham Ave., Long               086121
 Beach, CA 90808........................................
 
                              * * * * * * *
Vetoquinol USA, Inc., 4250 N Sylvania Ave., Fort Worth,           017030
 TX 76137...............................................
 
                              * * * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
    Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                              * * * * * * *
011788..................  Aiping Pharmaceutical, Inc., 350W Wireless
                           Blvd., Hauppauge, NY 11788.
 
                              * * * * * * *
017030..................  Vetoquinol USA, Inc., 4250 N. Sylvania Ave.,
                           Fort Worth, TX 76137.
 
                              * * * * * * *
086121..................  Anivive Lifesciences, Inc., 3777 Worsham Ave.,
                           Long Beach, CA 90808.
 
                              * * * * * * *
------------------------------------------------------------------------

[[Page 76421]]

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.

0
4. Add Sec.  516.1780 to subpart E to read as follows:

Sec.  516.1780  Pimobendan.

    (a) Specifications. Each chewable tablet contains 1.25, 2.5, 5, or 
10 milligrams (mg) pimobendan.
    (b) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer orally at a total 
daily dose of 0.23 mg per pound (0.5 mg per kilogram) body weight, 
using a suitable combination of whole or half tablets. The total daily 
dose should be divided into two portions administered approximately 12 
hours apart.
    (2) Indications for use in dogs. For the delay of onset of 
congestive heart failure in dogs with Stage B2 preclinical myxomatous 
mitral valve disease (2019 ACVIM Consensus Statement). Stage B2 
preclinical myxomatous mitral valve disease (MMVD) refers to dogs with 
asymptomatic MMVD that have a moderate or loud mitral murmur due to 
mitral regurgitation and cardiomegaly.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian. It is a violation of Federal law 
to use this product other than as directed in the labeling.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
5. The authority citation for part 520 continues to read as follows:

    Authority: 21 U.S.C. 360b.

Sec.  520.314  [Amended]

0
6. In Sec.  520.314, in paragraph (b), remove ``000010'' and in its 
place add ``042791''.

0
7. In Sec.  520.563, revise the section heading to read as follows:

Sec.  520.563   Diatrizoate.

* * * * *

0
8. In Sec.  520.2330, amend paragraph (c)(3) by adding a sentence to 
the end of the paragraph.

Sec.  520.2330  Sulfisoxazole tablets.

* * * * *
    (c) * * *
    (3) * * * Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

0
9. In Sec.  520.2640, revise paragraphs (a), (b), (e)(2)(i), and (3)(i) 
to read as follows:

Sec.  520.2640  Tylosin.

    (a) Specifications. Each container of soluble powder contains 
tylosin tartrate equivalent to:
    (1) 100 grams (g) tylosin base, or
    (2) 256 g tylosin base.
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for 
use as in paragraph (e) of this section:
    (1) Nos. 016592 and 058198 for use of the 100-g container as in 
paragraph (e) of this section
    (2) No. 061133 for use of the 100-or 256-g container as in 
paragraphs (e)(1)(i)(A), (e)(1)(ii), (e)(2), (e)(3), and (e)(4) of this 
section.
* * * * *
    (e) * * *
    (2) * * *
    (i) Amount. 2 grams per gallon (528 ppm) for 2 to 5 days as the 
sole source of drinking water. Treated turkeys should consume enough 
medicated drinking water to provide 60 mg tylosin per pound of body 
weight per day.
* * * * *
    (3) * * *
    (i) Amount. 250 mg per gallon (66 ppm) as the only source of 
drinking water for 3 to 10 days, depending on the severity of the 
condition being treated.
* * * * *

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
10. The authority citation for part 522 continues to read as follows:

    Authority: 21 U.S.C. 360b.

0
11. In Sec.  522.955, revise paragraphs (b)(3), (d)(1)(ii)(A)(2), 
(d)(1)(ii)(B)(2), and (d)(1)(ii)(C) to read as follows:

Sec.  522.955  Florfenicol.

* * * * *
    (b) * * *
    (3) Nos. 058005 and 058198 for use of product described in 
paragraph (a)(2) of this section as in paragraph (d)(1)(ii) of this 
section.
* * * * *
    (d) * * *
    (1) * * *
    (ii) * * *
    (A) * * *
    (2) Indications for use. For treatment of BRD associated with 
Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni. 
For treatment of bovine interdigital phlegmon (foot rot, acute 
interdigital necrobacillosis, infectious pododermatitis) associated 
with Fusobacterium necrophorum and Bacteroides melaninogenicus.
    (B) * * *
    (2) Indications for use. For control of respiratory disease in 
cattle at high risk of developing BRD associated with Mannheimia 
haemolytica, Pasteurella multocida, and Histophilus somni.
    (C) Limitations. Animals intended for human consumption must not be 
slaughtered within 28 days of the last intramuscular treatment. Nos. 
000061, 058005, and 058198: Animals intended for human consumption must 
not be slaughtered within 38 days of subcutaneous treatment. No. 
055529: Animals intended for human consumption must not be slaughtered 
within 33 days of subcutaneous treatment. This product is not approved 
for use in female dairy cattle 20 months of age or older, including dry 
dairy cows. Use in these cattle may cause drug residues in milk and/or 
in calves born to these cows. A withdrawal period has not been 
established in pre-ruminating 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.
* * * * *

Sec.  522.1338  [Amended]

0
12. In 522.1338, in paragraph (b), remove ``086155'' and in its place 
add ``043264''.

0
13. In Sec.  522.1662a, revise paragraph (e)(1); add paragraphs 
(e)(3)(i)(D), (e)(3)(ii)(C), and (e)(3)(iii)(D); and remove paragraphs 
(e)(3)(iv) through (vii) to read as follows:

Sec.  522.1662a  Oxytetracycline hydrochloride injection.

* * * * *
    (e) * * *
    (1) Specifications. Each milliliter of solution contains 50 
milligrams (mg) oxytetracycline hydrochloride.
* * * * *
    (3) * * *
    (i) * * *
    (D) Treatment must be discontinued at least 22 days prior to 
slaughter. Not for use in lactating dairy animals. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.
    (ii) * * *
    (C) Treatment must be discontinued at least 22 days prior to 
slaughter. Federal law restricts this drug to use by or on the order of 
a licensed veterinarian.
    (iii) * * *
    (D) Do not administer to laying hens unless the eggs are used for 
hatching only. Treatment must be discontinued at least 5 days prior to 
slaughter. Federal law restricts this drug to use by or on the order of 
a licensed veterinarian.
* * * * *

0
14. In Sec.  522.2471, revise paragraph (e)(2)(iii) to read as follows:

[[Page 76422]]

Sec.  522.2471  Tilmicosin.

* * * * *
    (e) * * *
    (2) * * *
    (iii) Limitations. Animals intended for human consumption must not 
be slaughtered within 42 days of the last treatment. Not for use in 
lactating ewes producing milk for human consumption.

Sec.  522.2690  [Amended]

0
15. In 522.2690, in paragraph (b), remove ``076175'' and in its place 
add ``011788''.

PART 528--INTENTIONAL GENOMIC ALTERATIONS IN ANIMALS

0
16. The authority citation for part 528 continues to read as follows:

    Authority: 21 U.S.C. 360b.

0
17. Revise the heading for part 528 to read as set forth above.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
18. The authority citation for part 558 continues to read as follows:

    Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.

0
19. In Sec.  558.95, revise paragraphs (e)(4)(i) and (ii) to read as 
follows:

Sec.  558.95  Bambermycins.

* * * * *
    (e) * * *
    (4) * * *

----------------------------------------------------------------------------------------------------------------
        Bambermycins in grams/ton               Indications for use               Limitations           Sponsors
----------------------------------------------------------------------------------------------------------------
(i) 1 to 4...............................  Growing beef steers and       Feed continuously at a rate      016592
                                            heifers fed in confinement    of 10 to 20 milligrams per
                                            for slaughter: For            head per day.
                                            increased rate of weight
                                            gain and improved feed
                                            efficiency.
(ii) 2 to 80.............................  Growing beef steers and       Feed continuously on a hand-     016592
                                            heifers on pasture            fed basis at a rate of 10
                                            (stocker, feeder, and         to 40 milligrams per head
                                            slaughter), and replacement   per day in 1 to 10 pounds
                                            beef and dairy heifers on     of supplemental Type C
                                            pasture: For increased rate   medicated feed.
                                            of weight gain.
----------------------------------------------------------------------------------------------------------------

* * * * *

0
20. In Sec.  558.128, revise paragraphs (e)(4)(x), (xi), (xiii), (xxx), 
and (xxxi) to read as follows:

Sec.  558.128  Chlortetracycline.

* * * * *
    (e) * * *
    (4) * * *

----------------------------------------------------------------------------------------------------------------
    Chlortetracycline amount       Combination in grams/ton   Indications for use      Limitations      Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                * * * * * * * * *
(x) 500 to 2,000 g/ton to         Laidlomycin, 5............  Cattle fed in        Feed continuously      054771
 provide 10 mg/lb of body weight                               confinement for      at a rate of 30
 daily.                                                        slaughter: For       to 75 mg
                                                               treatment of         laidlomycin
                                                               bacterial            propionate
                                                               enteritis caused     potassium per
                                                               by Escherichia       head per day for
                                                               coli and bacterial   not more than 5
                                                               pneumonia caused     days. A
                                                               by Pasteurella       withdrawal period
                                                               multocida            has not been
                                                               organisms            established for
                                                               susceptible to       this product in
                                                               chlortetracycline;   pre-ruminating
                                                               and for increased    calves. Do not
                                                               rate of weight       use in calves to
                                                               gain and improved    be processed for
                                                               feed efficiency.     veal. See Sec.
                                                                                    558.305(d) of
                                                                                    this chapter.
                                                                                    Laidlomycin as
                                                                                    provided by No.
                                                                                    054771 in Sec.
                                                                                    510.600(c) of
                                                                                    this chapter.
(xi) 500 to 4,000 g/ton to        Laidlomycin, 5 to 10......  Cattle fed in        Feed continuously      054771
 provide 10 mg/lb of body weight                               confinement for      at a rate of 30
 daily.                                                        slaughter: For       to 75 mg
                                                               treatment of         laidlomycin
                                                               bacterial            propionate
                                                               enteritis caused     potassium per
                                                               by Escherichia       head per day for
                                                               coli and bacterial   not more than 5
                                                               pneumonia caused     days. A
                                                               by Pasteurella       withdrawal period
                                                               multocida            has not been
                                                               organisms            established for
                                                               susceptible to       this product in
                                                               chlortetracycline;   pre-ruminating
                                                               and for improved     calves. Do not
                                                               feed efficiency.     use in calves to
                                                                                    be processed for
                                                                                    veal. See Sec.
                                                                                    558.305(d) of
                                                                                    this chapter.
                                                                                    Laidlomycin as
                                                                                    provided by No.
                                                                                    054771 in Sec.
                                                                                    510.600(c) of
                                                                                    this chapter.
 
                                                * * * * * * * * *
(xiii) 500 to 1,200 g/ton to      Lasalocid, 25 to 30.......  Cattle fed in        Feed continuously      054771
 provide 10 mg/lb of body weight                               confinement for      in complete feed
 daily.                                                        slaughter: For       to provide 10 mg
                                                               treatment of         chlortetracycline
                                                               bacterial            per lb body
                                                               enteritis caused     weight and not
                                                               by Escherichia       less than 250 mg
                                                               coli and bacterial   or more than 360
                                                               pneumonia caused     mg lasalocid per
                                                               by Pasteurella       head per day. Do
                                                               multocida            not allow horses
                                                               organisms            or other equines
                                                               susceptible to       access to feeds
                                                               chlortetracycline;   containing
                                                               and for increased    lasalocid. A
                                                               rate of weight       withdrawal period
                                                               gain and improved    has not been
                                                               feed efficiency.     established for
                                                                                    this product in
                                                                                    pre-ruminating
                                                                                    calves. Do not
                                                                                    use in calves to
                                                                                    be processed for
                                                                                    veal. See Sec.
                                                                                    558.311(d) of
                                                                                    this chapter.
                                                                                    Lasalocid as
                                                                                    provided by No.
                                                                                    054771 in Sec.
                                                                                    510.600(c) of
                                                                                    this chapter.
 
                                                * * * * * * * * *
(xxx) 23.3 to 58.3 g/ton to       Laidlomycin, 5............  Cattle fed in        Feed continuously      054771
 provide 350 mg/head/day.                                      confinement for      at a rate of 30
                                                               slaughter: For       to 75 mg
                                                               control of           laidlomycin
                                                               bacterial            propionate
                                                               pneumonia            potassium per
                                                               associated with      head per day. A
                                                               shipping fever       withdrawal period
                                                               complex caused by    has not been
                                                               Pasteurella spp.     established for
                                                               susceptible to       this product in
                                                               chlortetracycline;   pre-ruminating
                                                               and for increased    calves. Do not
                                                               rate of weight       use in calves to
                                                               gain and improved    be processed for
                                                               feed efficiency.     veal. See Sec.
                                                                                    558.305(d) of
                                                                                    this chapter.
                                                                                    Laidlomycin as
                                                                                    provided by No.
                                                                                    054771 in Sec.
                                                                                    510.600(c) of
                                                                                    this chapter.

[[Page 76423]]

 
(xxxi) 14.6 to 116.7 g/ton to     Laidlomycin, 5 to 10......  Cattle fed in        Feed continuously      054771
 provide 350 mg/head/day.                                      confinement for      at a rate of 30
                                                               slaughter: For       to 75 mg
                                                               control of           laidlomycin
                                                               bacterial            propionate
                                                               pneumonia            potassium per
                                                               associated with      head per day. A
                                                               shipping fever       withdrawal period
                                                               complex caused by    has not been
                                                               Pasteurella spp.     established for
                                                               susceptible to       this product in
                                                               chlortetracycline;   pre-ruminating
                                                               and for improved     calves. Do not
                                                               feed efficiency.     use in calves to
                                                                                    be processed for
                                                                                    veal. See Sec.
                                                                                    558.305(d) of
                                                                                    this chapter.
                                                                                    Laidlomycin as
                                                                                    provided by No.
                                                                                    054771 in Sec.
                                                                                    510.600(c) of
                                                                                    this chapter.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

0
21. In Sec.  558.342, revise paragraph (e)(1)(ii) to read as follows:

Sec.  558.342  Melengestrol.

* * * * *
    (e) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
  Melengestrol  acetate in  mg/
            head/day               Combination  in grams/ton  Indications for use      Limitations      Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                * * * * * * * * *
(ii) 0.5........................  ..........................  Heifers intended     Administer 0.5 to      016592
                                                               for breeding: For    2.0 lb/head/day       054771
                                                               suppression of       of Type C feed        058198
                                                               estrus (heat).       containing 0.25
                                                                                    to 1.0 mg
                                                                                    melengestrol
                                                                                    acetate/lb to
                                                                                    provide 0.5 mg
                                                                                    melengestrol
                                                                                    acetate/head/day.
                                                                                    Do not exceed 24
                                                                                    days of feeding.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

0
22. In Sec.  558.450:
0
a. Revise paragraph (e)(4)(i);
0
b. Redesignate paragraphs (e)(4)(ii) through (v) as paragraphs 
(e)(4)(iii) through (vi);
0
c. Add new paragraph (e)(4)(ii); and
0
d. Revise newly redesignated paragraphs (e)(4)(iii) and (vi).
    The addition and revisions read as follows:

Sec.  558.450  Oxytetracycline.

* * * * *
    (e) * * *
    (4) * * *

----------------------------------------------------------------------------------------------------------------
     Oxytetracycline amount        Combination in grams/ton   Indications for use      Limitations      Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 10 mg/lb of body weight       ..........................  Calves and beef and  Feed continuously      066104
 daily.                                                        nonlactating dairy   for 7 to 14 days.     069254
                                                               cattle: For          This drug product
                                                               treatment of         is not approved
                                                               bacterial            for use in female
                                                               enteritis caused     dairy cattle 20
                                                               by Escherichia       months of age or
                                                               coli and bacterial   older, including
                                                               pneumonia            dry dairy cows.
                                                               (shipping fever      Use in these
                                                               complex) caused by   cattle may cause
                                                               Pasteurella          drug residues in
                                                               multocida            milk and/or in
                                                               susceptible to       calves born to
                                                               oxytetracycline.     these cows. For
                                                                                    No. 069254,
                                                                                    withdraw 5 days
                                                                                    before slaughter.
                                                                                    For No. 066104,
                                                                                    zero-day
                                                                                    withdrawal period.
(ii) 10 mg/lb of body weight      ..........................  Calves: For          Feed continuously      066104
 daily.                                                        treatment of         for 7 to 14 days      069254
                                                               bacterial            in milk replacer
                                                               enteritis caused     or starter feed.
                                                               by E. coli           This drug product
                                                               susceptible to       is not approved
                                                               oxytetracycline.     for use in female
                                                                                    dairy cattle 20
                                                                                    months of age or
                                                                                    older, including
                                                                                    dry dairy cows.
                                                                                    Use in these
                                                                                    cattle may cause
                                                                                    drug residues in
                                                                                    milk and/or in
                                                                                    calves born to
                                                                                    these cows. For
                                                                                    No. 069254,
                                                                                    withdraw 5 days
                                                                                    before slaughter.
                                                                                    For No. 066104,
                                                                                    zero-day
                                                                                    withdrawal period.
(iii) 75 mg/head/day............  ..........................  Growing cattle       Feed continuously.     066104
                                                               (over 400 lb): For   This drug product     069254
                                                               reduction of         is not approved
                                                               incidence of liver   for use in female
                                                               abscesses.           dairy cattle 20
                                                                                    months of age or
                                                                                    older, including
                                                                                    dry dairy cows.
                                                                                    Use in these
                                                                                    cattle may cause
                                                                                    drug residues in
                                                                                    milk and/or in
                                                                                    calves born to
                                                                                    these cows.
 
                                               * * * * * * * * * *
(vi) 0.5 to 2.0 g/head/day......  ..........................  Cattle: For          Feed 3 to 5 days       066104
                                                               prevention and       before and after      069254
                                                               treatment of the     arrival in
                                                               early stages of      feedlots. This
                                                               shipping fever       drug product is
                                                               complex.             not approved for
                                                                                    use in female
                                                                                    dairy cattle 20
                                                                                    months of age or
                                                                                    older, including
                                                                                    dry dairy cows.
                                                                                    Use in these
                                                                                    cattle may cause
                                                                                    drug residues in
                                                                                    milk and/or in
                                                                                    calves born to
                                                                                    these cows.
----------------------------------------------------------------------------------------------------------------

* * * * *

0
23. In Sec.  558.455:
0
a. Redesignate paragraphs (e)(1)(ii) through (iv) as paragraphs 
(e)(1)(i) through (iii);
0
b. Redesignate paragraphs (e)(2)(ii) through (iv) as paragraphs 
(e)(2)(i) through (iii);
0
c. Revise paragraphs (e)(3) and (4); and
0
d. Add paragraph (e)(5).
    The revisions and addition read as follows:

[[Page 76424]]

Sec.  558.455  Oxytetracycline and neomycin.

* * * * *
    (e) * * *
    (3) Swine. It is used in feed as follows:

----------------------------------------------------------------------------------------------------------------
 Oxytetracycline and neomycin sulfate
                amount                                                           Limitations            Sponsors
----------------------------------------------------------------------------------------------------------------
(i) To provide 10 mg/lb of body weight  Swine: For treatment of         Feed continuously for 7 to 14     066104
 daily.                                  bacterial enteritis caused by   d; withdraw 5 d before           069254
                                         E. coli and Salmonella          slaughter.
                                         choleraesuis and treatment of
                                         bacterial pneumonia caused by
                                         P. multocida susceptible to
                                         oxytetracycline; treatment
                                         and control of colibacillosis
                                         (bacterial enteritis) caused
                                         by E. coli susceptible to
                                         neomycin.
(ii) To provide 10 mg/lb of body        Breeding swine: For control     Feed continuously for not         066104
 weight daily.                           and treatment of                more than 14 d; withdraw 5 d     069254
                                         leptospirosis (reducing the     before slaughter.
                                         incidence of abortion and
                                         shedding of leptospirae)
                                         caused by Leptospira pomona
                                         susceptible to
                                         oxytetracycline.
----------------------------------------------------------------------------------------------------------------

    (4) Cattle. It is used in feed as follows:

----------------------------------------------------------------------------------------------------------------
 Oxytetracycline and neomycin sulfate
                amount                        Indications for use                Limitations            Sponsors
----------------------------------------------------------------------------------------------------------------
(i) To provide 10 mg/lb of body weight  Calves and beef and             Feed continuously for 7 to 14     066104
 daily.                                  nonlactating dairy cattle:      d; in feed or milk               069254
                                         For treatment of bacterial      replacers. Treatment should
                                         enteritis caused by E. coli     continue 24 to 48 hours
                                         and bacterial pneumonia         beyond remission of disease
                                         (shipping fever complex)        symptoms. A withdrawal
                                         caused by P. multocida          period has not been
                                         susceptible to                  established for use in
                                         oxytetracycline; treatment      preruminating calves. Do not
                                         and control of colibacillosis   use in calves to be
                                         (bacterial enteritis) caused    processed for veal. A milk
                                         by E. coli susceptible to       discard time has not been
                                         neomycin.                       established for use in
                                                                         lactating dairy cattle. Do
                                                                         not use in female dairy
                                                                         cattle 20 months of age or
                                                                         older. Withdraw 5 d before
                                                                         slaughter.
(ii) To provide 10 mg/lb of body        Calves (up to 250 lb): For      Feed continuously for 7 to 14     066104
 weight daily.                           treatment of bacterial          d; in milk replacers or          069254
                                         enteritis caused by E. coli     starter feed. Treatment
                                         susceptible to                  should continue 24 to 48
                                         oxytetracycline; treatment      hours beyond remission of
                                         and control of colibacillosis   disease symptoms. A
                                         (bacterial enteritis) caused    withdrawal period has not
                                         by E. coli susceptible to       been established for use in
                                         neomycin.                       preruminating calves. Do not
                                                                         use in calves to be
                                                                         processed for veal. A milk
                                                                         discard time has not been
                                                                         established for use in
                                                                         lactating dairy cattle. Do
                                                                         not use in female dairy
                                                                         cattle 20 months of age or
                                                                         older. Withdraw 5 d before
                                                                         slaughter.
(iii) To provide 75 mg/head/day.......  Growing cattle (over 400 lb):   Feed continuously............     066104
                                         For the reduction of the                                         069254
                                         incidence of liver abscesses.
(iv) To provide 0.5 to 2.0 g/head/ day  Cattle: For prevention and      Feed 3 to 5 d before and          066104
                                         treatment of the early stages   after arrival in feedlots. A     069254
                                         of shipping fever complex.      withdrawal period has not
                                                                         been established for use in
                                                                         preruminating calves. Do not
                                                                         use in calves to be
                                                                         processed for veal. A milk
                                                                         discard time has not been
                                                                         established for use in
                                                                         lactating dairy cattle. Do
                                                                         not use in female dairy
                                                                         cattle 20 months of age or
                                                                         older.
----------------------------------------------------------------------------------------------------------------

    (5) S. It is used in feed as follows:

----------------------------------------------------------------------------------------------------------------
 Oxytetracycline and neomycin sulfate
                amount                        Indications for use                Limitations            Sponsors
----------------------------------------------------------------------------------------------------------------
(i) To provide 10 mg/lb of body weight  Sheep: For treatment of         Feed continuously for 7 to 14     66104,
 daily.                                  bacterial enteritis caused by   d. If symptoms persist after     069254
                                         E. coli and bacterial           using for 2 or 3 days,
                                         pneumonia caused by P.          consult a veterinarian.
                                         multocida susceptible to        Treatment should continue 24
                                         oxytetracycline; treatment      to 48 hours beyond remission
                                         and control of colibacillosis   of disease symptoms.
                                         (bacterial enteritis) caused    Withdraw 5 d before
                                         by E. coli susceptible to       slaughter.
                                         neomycin.
(ii) [Reserved].......................
----------------------------------------------------------------------------------------------------------------

0
24. In Sec.  558.575, revise paragraphs (e)(3)(iv) and (v) to read as 
follows:

Sec.  558.575  Sulfadimethoxine and ormetoprim.

* * * * *
    (e) * * *
    (3) * * *

----------------------------------------------------------------------------------------------------------------
  Sulfadimethoxine and ormetoprim amount        Indications for use               Limitations           Sponsors
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(iv) 630 to 3780 g/ton sulfadimethoxine    Salmonids: For the control    Administer for 5 consecutive     015331
 and 126 to 756 g/ton ormetoprim to         of furunculosis in            days. Withdraw 42 days
 provide 50 milligrams (mg) of active       salmonids (trout and          before release as stocker
 ingredients per kilogram of body per day.  salmon) caused by Aeromonas   fish or slaughter.
                                            salmonicida strains
                                            susceptible to
                                            sulfadimethoxine and
                                            ormetoprim combination.
(v) 630 to 3780 g/ton sulfadimethoxine     Catfish: For control of       Administer for 5 consecutive     015331
 and 126 to 756 g/ton ormetoprim to         enteric septicemia of         days. Withdraw 3 days
 provide 50 mg of active ingredients per    catfish caused by             before slaughter or release
 kilogram of body per day.                  Edwardsiella ictaluri         as stocker fish.
                                            strains susceptible to
                                            sulfadimethoxine and
                                            ormetoprim combination.
----------------------------------------------------------------------------------------------------------------

[[Page 76425]]

    Dated: November 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
 [FR Doc. 2022-24106 Filed 12-13-22; 8:45 am]
 BILLING CODE 4164-01-P