[Federal Register Volume 87, Number 39 (Monday, February 28, 2022)]
[Rules and Regulations]
[Pages 10964-10973]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-03538]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 500, 510, 516, 520, 522, 524, 529, 556, and 558

[Docket No. FDA-2021-N-0002]


New Animal Drugs; Approval of New Animal Drug Applications; 
Withdrawal of Approval of a New Animal Drug Application; 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 a conditionally approved new animal drug 
application (cNADA) during July, August, and September 2021. 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 
of the regulations.

DATES: This rule is effective February 28, 2022. The incorporation by 
reference of certain material listed in this rule is approved by the 
Director of the Federal Register as February 28, 2022. The 
incorporation by reference of other material listed in this rule was 
approved by the Director of the Federal Register as of November 25, 
2011.

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

SUPPLEMENTARY INFORMATION: 

I. Approvals

    FDA is amending the animal drug regulations to reflect approval 
actions for NADAs and ANADAs during July, August, and September 2021, 
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 10965]]



                          Table 1--Original and Supplemental NADAs and ANADAs Approved During July, August, and September 2021
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                  Effect of the
       Approval date           File No.           Sponsor            Product name             Species                action          Public  documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
July 7, 2021..............         200-703  Dechra Veterinary    Carprofen Tablets..  Dogs...................  Original approval   FOI Summary.
                                             Products LLC, 7015                                                 as a generic copy
                                             College Blvd.,                                                     of NADA 141-053.
                                             Suite 525,
                                             Overland Park, KS
                                             66211.
July 15, 2021.............         141-545  VetDC, Inc., 320 E   TANOVEA              Dogs...................  Full approval of    FOI Summary.
                                             Vine Dr., Suite      (rabacfosadine for                            conditionally
                                             218, Fort Collins,   injection) Powder                             approved cNADA
                                             CO 80524.            for Injection.                                141-475 for the
                                                                                                                treatment of
                                                                                                                lymphoma.
August 2, 2021............         200-708  Felix                Enrofloxacin         Dogs...................  Original approval   FOI Summary.
                                             Pharmaceuticals      Antibacterial                                 as a generic copy
                                             PVT Ltd., 25-288     Injectable                                    of NADA 140-913.
                                             North Wall Quay,     Solution 2.27%.
                                             Dublin, 1, Ireland.
August 16, 2021...........         200-618  Virbac AH, Inc., PO  ZOLETIL (tiletamine  Dogs and cats..........  Original approval   FOI Summary.
                                             Box 162059, Fort     and zolazepam for                             as a generic copy
                                             Worth, TX 76161.     Injection).                                   of NADA 106-111.
August 18, 2021...........         200-709  Cronus Pharma        Amoxicillin and      Dogs and cats..........  Original approval   FOI Summary.
                                             Specialties India    Clavulanate                                   as a generic copy
                                             Private Ltd., Sy     Potassium for Oral                            of NADA 055-101.
                                             No-99/1, M/s GMR     Suspension.
                                             Hyderabad Aviation
                                             SEZ Ltd.,
                                             Mamidipalli
                                             Village,
                                             Shamshabad Mandal,
                                             Ranga Reddy,
                                             Hyderabad,
                                             Telangana, 501218,
                                             India.
August 19, 2021...........         141-063  Intervet, Inc., 2    NUFLOR-S             Swine..................  Supplemental        FOI Summary.
                                             Giralda Farms,       (florfenicol)                                 approval for the
                                             Madison, NJ 07940.   Injectable                                    treatment of
                                                                  Solution.                                     swine respiratory
                                                                                                                disease.
--------------------------------------------------------------------------------------------------------------------------------------------------------

II. Withdrawal of Approval

    Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140, has 
requested that FDA withdraw approval of NADA 093-329 for use of a 
sustained-release bolus containing sulfamethazine in cattle because the 
product is no longer manufactured or marketed. As provided in the 
regulatory text of this document, the animal drug regulations are 
amended to reflect this action. Elsewhere in this issue of the Federal 
Register, FDA gave notice that approval of NADA 093-329, and all 
supplements and amendments thereto, is withdrawn.

III. Change of Sponsor

    VetDC, Inc., 320 E Vine Dr., Suite 218, Fort Collins, CO 80524, has 
informed FDA that it has transferred ownership of, and all rights and 
interest in, newly approved NADA 141-545 for TANOVEA (rabacfosadine) 
for Injection to Elanco US Inc., 2500 Innovation Way, Greenfield, IN 
46140. The codification of this application in new 21 CFR 522.2065 will 
reflect this change of sponsorship.

IV. Technical Amendments

    FDA is making the following amendments to improve the accuracy of 
the animal drug regulations:
     21 CFR 500.1410 is amended to add uncooked edible tissues 
of swine to the standard for residues of n-methyl-2-pyrrolidone.
     21 CFR 510.600 is amended to have sponsor addresses 
conform to the current style.
     21 CFR 520.905c is amended to reflect the current label 
indications for use of fenbendazole paste in horses.
     21 CFR 520.1044c is amended to reflect a current swine 
pathogen name for gentamicin soluble powder.
     21 CFR 520.1660d is amended to revise conditions of use of 
oxytetracycline in drinking water of swine to reflect approved 
applications.
     21 CFR 520.1780 is amended to revise the indications for 
use of pimobendan tablets in dogs.
     21 CFR 520.2130 is amended to remove the 90-milligram 
strength for spinosad chewable tablets.
     21 CFR 520.2220a is amended to add human food safety 
warnings for use of sulfadimethoxine concentrate solution and soluble 
powder.
     21 CFR 520.2260b is amended to reflect the voluntary 
withdrawal of approval of an application for sustained-release boluses 
containing sulfamethazine and to correct the spelling of a disease 
condition.
     21 CFR 520.2604 is amended to revise indications for use 
of tablets in dogs containing trimeprazine with prednisolone.
     21 CFR 522.558 is amended to reflect the drug labeler code 
for the current sponsor of a dexmedetomidine injectable solution.
     21 CFR 522.840 is amended to reflect the current classes 
of cattle approved for use of estradiol ear implants.
     21 CFR 522.842 for testosterone propionate and estradiol 
benzoate implants is renamed to list the drug with the higher 
concentration first and redesignated to be listed in alphabetical 
order.
     21 CFR 522.955 is amended to reflect the current 
scientific name of a bovine pathogen and the withdrawal

[[Page 10966]]

periods for different formulations of florfenicol injectable solution.
     21 CFR 522.1156 is amended to add subcutaneous 
administration to the approved conditions of use of imidocarb 
dipropionate solution in dogs.
     21 CFR 522.2477 is amended to reorganize an approved use 
of trenbolone acetate and estradiol implants in steers.
     21 CFR 524.770 is amended to reflect current label dosage 
information and human food safety warnings.
     21 CFR 529.1030 is redesignated as Sec.  529.1004 in 
conformity with an announced FDA numbering system (40 FR 13802, March 
27, 1975).
     21 CFR 529.1940 is amended to add limitations to the use 
of progesterone intravaginal inserts in cows.
     21 CFR 558.59 is amended to reference apramycin's status 
as a veterinary feed directive (VFD) drug and to add current 
limitations on VFD refills for apramycin medicated feeds.
     21 CFR 558.205 is amended to reflect a current egg food 
safety warning for broiler chickens and growing turkeys fed Type C 
medicated feeds containing diclazuril.
     21 CFR 558.254 is amended to remove an erroneous table 
title.
     21 CFR 558.261 is amended to correct the upper inclusion 
rate for florfenicol in Type C medicated feed for freshwater-reared 
salmonids.
     21 CFR 558.311 is being amended to codify free-choice Type 
C medicated cattle feeds containing lasalocid.
     21 CFR 558.450 is amended to add conditions of use in 
honey bees for a Type C extender patty containing oxytetracycline.
     21 CFR 558.633 is amended to add manufacturing limitations 
for use of Type C medicated swine feeds containing tylvalosin.
     21 CFR 558.635 is amended to reflect a current egg food 
safety warning for broiler chickens fed Type C medicated feeds 
containing virginiamycin and diclazuril.

V. Incorporation by Reference

    FDA is incorporating by reference an analytical method approved by 
the Office of the Federal Register in accordance with 5 U.S.C. 552(a) 
and 1 CFR part 51. To obtain a copy of the analytical method, go to: 
https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room. You may inspect a copy at the office of the 
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 
a.m. and 4 p.m., Monday through Friday.
    This standard adds a method of detection for total for residues of 
the carcinogenic excipient n-methyl-2-pyrrolidone in uncooked edible 
swine tissues to a section established for a method for residues of n-
methyl-2-pyrrolidone in uncooked edible cattle tissues.

VI. Legal Authority

    This final rule is issued under section 512(i) of the Federal Food, 
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.360b(i)), which requires 
Federal Register publication of ``notice[s] . . . effective as a 
regulation,'' of the conditions of use of approved new animal drugs. 
This rule sets forth technical amendments to the regulations to codify 
recent actions on approved new animal drug applications and corrections 
to improve the accuracy of the regulations, and as such does not impose 
any burden on regulated entities.
    Although denominated a rule pursuant to the FD&C Act, this document 
does not meet the definition of ``rule'' in 5 U.S.C. 804(3)(A) because 
it is a ``rule of particular applicability.'' Therefore, it is not 
subject to the congressional review requirements in 5 U.S.C. 801-808. 
Likewise, this is not a rule subject to Executive Order 12866, which 
defines a rule as ``an agency statement of general applicability and 
future effect, which the agency intends to have the force and effect of 
law, that is designed to implement, interpret, or prescribe law or 
policy or to describe the procedure or practice requirements of an 
agency.''

List of Subjects

21 CFR Part 500

    Animal drugs, Animal feeds, Cancer, Incorporation by reference, 
Labeling, Packaging and containers, Polychlorinated biphenyls (PCBs).

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Part 516

    Administrative practice and procedure, Animal drugs, Confidential 
business information, Reporting and recordkeeping requirements.

21 CFR Parts 520, 522, 524, and 529

    Animal drugs.

21 CFR Part 556

    Animal drugs, Food.

21 CFR Part 558

    Animal drugs, Animal feeds.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
500, 510, 516, 520, 522, 524, 529, 556, and 558 are amended as follows:

PART 500--GENERAL

0
1. The authority citation for part 500 continues to read as follows:

    Authority: 21 U.S.C. 321, 331, 342, 343, 348, 351, 352, 353, 
360b, 371, 379e.


0
2. Revise Sec.  500.1410 to read as follows:


Sec.  500.1410   N-methyl-2-pyrrolidone.

    (a) Standard for residues. No residues of n-methyl-2-pyrrolidone 
may be found in the uncooked edible tissues of cattle and swine as 
determined by methods in paragraph (b) of this section.
    (b) Incorporation by reference. The standards required in this 
section are incorporated by reference into this section with the 
approval of the Director of the Federal Register under 5 U.S.C. 552(a) 
and 1 CFR part 51. All approved material is available for inspection at 
the Food and Drug Administration's Dockets Management Staff (HFA-305), 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 
9 a.m. and 4 p.m., Monday through Friday. It may be obtained from the 
sources indicated elsewhere in paragraph (b) of this section and at: 
https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room. It is also available for inspection at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, email 
[email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.
    (1) Food and Drug Administration, Center for Veterinary Medicine, 
7500 Standish Pl., Rockville, MD 20855, 240-402-7002.
    (i) ``Method of Analysis: N-methyl-2-pyrrolidone,'' September 26, 
2011; the method of analysis for uncooked edible tissues of cattle.
    (ii) [Reserved]
    (2) Merck Animal Health, 29160 Intervet Lane, Millsboro, DE 19966, 
1-800-211-3573.
    (i) ``Determinative and Confirmatory Procedures for the Analysis of 
N-Methyl-2-pyrrolidone (NMP) in Swine Liver Tissue using LC-MS/MS,'' 
July 20, 2017; the method of analysis for uncooked edible tissues of 
swine.
    (ii) [Reserved]

[[Page 10967]]

    (c) Related conditions of use. See Sec. Sec.  522.814 and 522.955 
of this chapter.

PART 510--NEW ANIMAL DRUGS

0
3. The authority citation for part 510 continues to read as follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.


Sec.  510.600   [Amended]

0
4. In Sec.  510.600:
0
a. In the table in paragraph (c)(1), revise the entries for ``Anzac 
Animal Health, LLC'', ``AquaBounty Technologies, Inc.'', ``Dechra 
Veterinary Products LLC'', ``Halocarbon Products Corp.'', ``Kindred 
Biosciences, Inc.'', ``Mizner Bioscience LLC'', ``QBiotics Group 
Ltd.'', ``Revivicor, Inc.'', and ``Ridley USA, Inc.'', remove ``Suite'' 
and in its place add ``suite''; and
0
b. In the table in paragraph (c)(2), revise the entries for ``012164'', 
``017033'', ``067949'', ``086039'', ``086053'', ``086073'', ``086078'', 
``086132'', and ``086134''.
    The revisions read as follows:
    (c) * * *

                  (1) Alphabetical Listing of Sponsors
------------------------------------------------------------------------
                                                           Drug labeler
                  Firm name and address                        code
------------------------------------------------------------------------
 
                              * * * * * * *
Anivive Lifesciences, Inc., 3250 Airflite Way, Suite              086121
 400, Long Beach, CA 90807..............................
Anzac Animal Health, LLC, 218 Millwell Dr., suite B,              086073
 Maryland Heights, MO 63043.............................
AquaBounty Technologies, Inc., 2 Mill and Main Pl.,               086053
 Suite 395, Maynard, MA 01754...........................
 
                              * * * * * * *
Dechra Veterinary Products LLC, 7015 College Blvd.,               017033
 Suite 525, Overland Park, KS 66211.....................
 
                              * * * * * * *
Halocarbon Products Corp., 6525 The Corners Pkwy., Suite          012164
 200, Peachtree Corners, GA 30092.......................
 
                              * * * * * * *
Kindred Biosciences, Inc., 1555 Bayshore Hwy., Suite              086078
 200, Burlingame, CA 94010..............................
 
                              * * * * * * *
Mizner Bioscience LLC, 225 NE Mizner Blvd., Suite 760,            086039
 Boca Raton, FL 33432...................................
 
                              * * * * * * *
QBiotics Group Ltd., Suite 3A, Level 1, 165 Moggill Rd.,          086132
 Taringa, Queensland 4068, Australia....................
 
                              * * * * * * *
Revivicor, Inc., a wholly owned subsidiary of United              086134
 Therapeutics Corp., 1700 Kraft Dr., Suite 2400,
 Blacksburg, VA 24060...................................
Ridley USA, Inc., 111 W Cherry St., Suite 500, Mankato,           067949
 MN 56001...............................................
 
                              * * * * * * *
------------------------------------------------------------------------


                    (2) Numerical Listing of Sponsors
------------------------------------------------------------------------
    Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                              * * * * * * *
012164..................  Halocarbon Products Corp., 6525 The Corners
                           Pkwy., Suite 200, Peachtree Corners, GA
                           30092.
 
                              * * * * * * *
017033..................  Dechra Veterinary Products LLC, 7015 College
                           Blvd., Suite 525, Overland Park, KS 66211.
 
                              * * * * * * *
067949..................  Ridley USA, Inc., 111 W Cherry St., Suite 500,
                           Mankato, MN 56001.
 
                              * * * * * * *
086039..................  Mizner Bioscience LLC, 225 NE Mizner Blvd.,
                           Suite 760, Boca Raton, FL 33432.
 
                              * * * * * * *
086053..................  AquaBounty Technologies, Inc., 2 Mill and Main
                           Pl., Suite 395, Maynard, MA 01754.
 
                              * * * * * * *
086073..................  Anzac Animal Health, LLC, 218 Millwell Dr.,
                           Suite B, Maryland Heights, MO 63043.
086078..................  Kindred Biosciences, Inc., 1555 Bayshore Hwy.,
                           Suite 200, Burlingame, CA 94010.
 
                              * * * * * * *
086121..................  Anivive Lifesciences, Inc., 3250 Airflite Way,
                           Suite 400, Long Beach, CA 90807.
086132..................  QBiotics Group Ltd., Suite 3A, Level 1, 165
                           Moggill Rd., Taringa, Queensland 4068,
                           Australia.
086134..................  Revivicor, Inc., a wholly owned subsidiary of
                           United Therapeutics Corp., 1700 Kraft Dr.,
                           Suite 2400, Blacksburg, VA 24060
 
                              * * * * * * *
------------------------------------------------------------------------


[[Page 10968]]

PART 516--NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES

0
5. The authority citation for part 516 continues to read as follows:

    Authority: 21 U.S.C. 360ccc, 360ccc-2, 371.


Sec.  516.2065   [Removed]

0
6. Remove Sec.  516.2065.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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

0
8. Revise Sec.  520.88h to read as follows:


Sec.  520.88h   Amoxicillin trihydrate and clavulanate potassium for 
oral suspension.

    (a) Specifications. When constituted, each milliliter (mL) of 
suspension contains amoxicillin trihydrate equivalent to 50 milligrams 
(mg) amoxicillin and clavulanate potassium equivalent to 12.5 mg 
clavulanic acid.
    (b) Sponsors. See Nos. 054771 and 069043 in Sec.  510.600(c) of 
this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. 6.25 mg/lb (1 mL/10 lb 
of body weight) twice a day. Skin and soft tissue infections such as 
abscesses, cellulitis, wounds, superficial/juvenile pyoderma, and 
periodontal infections should be treated for 5 to 7 days or for 48 
hours after all signs have subsided. If no response is seen after 5 
days of treatment, therapy should be discontinued and the case 
reevaluated. Deep pyoderma may require treatment for 21 days; the 
maximum duration of treatment should not exceed 30 days.
    (ii) Indications for use. Treatment of skin and soft tissue 
infections such as wounds, abscesses, cellulitis, superficial/juvenile 
and deep pyoderma due to susceptible strains of the following 
organisms: beta-lactamase-producing Staphylococcus aureus, non-beta-
lactamase-producing Staphylococcus aureus, Staphylococcus spp., 
Streptococcus spp., and Escherichia coli. Treatment of periodontal 
infections due to susceptible strains of both aerobic and anaerobic 
bacteria.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Cats--(i) Amount. 62.5 mg (1 mL) twice daily. Skin and soft 
tissue infections such as abscesses and cellulitis/dermatitis should be 
treated for 5 to 7 days or 48 hours after all symptoms have subsided, 
not to exceed 30 days. If no response is seen after 3 days of 
treatment, therapy should be discontinued and the case reevaluated. 
Urinary tract infections may require treatment for 10 to 14 days or 
longer. The maximum duration of treatment should not exceed 30 days.
    (ii) Indications for use. Treatment of skin and soft tissue 
infections, such as wounds, abscesses, and cellulitis/dermatitis due to 
susceptible strains of the following organisms: beta-lactamase-
producing Staphylococcus aureus, non-beta-lactamase-producing 
Staphylococcus aureus, Staphylococcus spp., Streptococcus spp., 
Escherichia coli, Pasteurella multocida, and Pasteurella spp. Urinary 
tract infections (cystitis) due to susceptible strains of E. coli.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
9. In Sec.  520.905c, revise paragraphs (e)(1)(i) to read as follows:


Sec.  520.905c  Fenbendazole paste.

* * * * *
    (e) * * *
    (1) * * *
    (i) Indications for use and amounts. (A) For the treatment and 
control of large strongyles (Strongylus edentatus, S. equinus, S. 
vulgaris), small strongyles, and pinworms (Oxyuris equi). For large 
strongyles, small strongyles, and pinworms, the recommended dose is 5 
mg/kg (2.3 mg/lb).
    (B) For treatment and control of ascarids (Parascaris equorum). For 
ascarids, the recommended dose is 10 mg/kg (4.6 mg/lb).
    (C) For treatment and control of hypobiotic (encysted early third-
stage), late third-stage, and fourth-stage cyathostome larvae, as well 
as fourth-stage Strongylus vulgaris larvae, the recommended dose is 10 
mg/kg (4.6 mg/lb) daily for 5 consecutive days.
    (D) For the control of arteritis caused by fourth-stage larvae of 
Strongylus vulgaris in horses.
    (E) Fenbendazole paste 10 percent may be used concomitantly with 
approved forms of trichlorfon for the indications provided in paragraph 
(e)(1)(i)(A) of this section and for treating infections of stomach 
bots as provided in Sec.  520.2520.
* * * * *

0
10. In Sec.  520.1044c, revise paragraph (d)(2) to read as follows:


Sec.  520.1044c   Gentamicin sulfate powder.

* * * * *
    (d) * * *
    (2) Indications for use. For control and treatment of 
colibacillosis in weanling swine caused by strains of Escherichia coli 
sensitive to gentamicin, and for control and treatment of swine 
dysentery associated with Brachyspira hyodysenteriae.
* * * * *

0
11. In Sec.  520.1660d, revise paragraphs (d)(1)(iii)(A) and (C) to 
read as follows:


Sec.  520.1660d   Oxytetracycline powder.

* * * * *
    (d) * * *
    (1) * * *
    (iii) * * *
    (A) Amount. Administer 10 milligrams per pound of body weight daily 
in drinking water. Administer up to 14 days; do not use for more than 
14 consecutive days those products sponsored by Nos. 054771, 061133, 
and 069254. Administer up to 5 days; do not use for more than 5 
consecutive days those products sponsored by Nos. 016592 and 061133.
* * * * *
    (C) Limitations. Withdraw zero days prior to slaughter. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.
* * * * *

0
12. In Sec.  520.1780, revise paragraph (c)(2) to read as follows:


Sec.  520.1780   Pimobendan.

* * * * *
    (c) * * *
    (2) Indications for use. For the management of the signs of mild, 
moderate, or severe congestive heart failure in dogs due to clinical 
myxomatous mitral valve disease (MMVD) or dilated cardiomyopathy (DCM); 
for use with concurrent therapy for congestive heart failure (e.g., 
furosemide, etc.) as appropriate on a case-by-case basis.
* * * * *

0
13. In Sec.  520.2130, revise paragraph (a) to read as follows:


Sec.  520.2130   Spinosad.

    (a) Specifications. Each chewable tablet contains 140, 270, 560, 
810, or 1620 milligrams (mg) spinosad.
* * * * *

0
14. In Sec.  520.2220a, revise paragraphs (d)(1)(iii) and (d)(2)(iii) 
to read as follows:


Sec.  520.2220a   Sulfadimethoxine oral solution and soluble powder.

* * * * *
    (d) * * *
    (1) * * *
    (iii) Limitations. Withdraw 5 days before slaughter. Do not 
administer to chickens over 16 weeks (112 days) of age. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.

[[Page 10969]]

    (2) * * *
    (iii) Limitations. Withdraw 5 days before slaughter. Do not 
administer to turkeys over 24 weeks (168 days) of age. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.
* * * * *


Sec.  520.2260b   [Amended]

0
15. In Sec.  520.2260b, remove and reserve paragraphs (b) and (e); and 
in paragraph (f)(2)(ii) remove ``diptheria'' and in its place add 
``diphtheria''.

0
16. In Sec.  520.2604, revise paragraph (c)(2) to read as follows:


Sec.  520.2604   Trimeprazine with prednisolone tablets.

* * * * *
    (c) * * *
    (2) Indications for use. For the relief of itching regardless of 
cause; and for reduction of inflammation commonly associated with most 
skin disorders of dogs such as eczema, caused by internal disorders, 
otitis, and dermatitis, allergic, parasitic, pustular, and nonspecific 
origins. As adjunctive therapy in various cough conditions including 
treatment of ``kennel cough'' or tracheobronchitis, bronchitis 
including allergic bronchitis, infections, and coughs of nonspecific 
origin.
* * * * *

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.


Sec.  522.558   [Amended]

0
18. In Sec.  522.558, in paragraph (b)(1), remove ``026637'' and in its 
place add ``017033''.

0
19. In Sec.  522.812, revise paragraph (b)(1) to read as follows:


Sec.  522.812  Enrofloxacin.

* * * * *
    (b) * * *
    (1) Nos. 016729, 017033, 055529, 058198, and 086101 for use of 
product described in paragraph (a)(1) as in paragraph (e)(1) of this 
section; and
* * * * *


Sec.  522.840  [Amended]

0
20. In Sec.  522.840, in paragraph (d)(2), in the first sentence, 
remove ``confined steers and heifers'' and in its place add ``steers 
and heifers fed in confinement for slaughter''.


Sec.  522.842  [Redesignated as Sec.  522.2343]

0
21. Redesignate Sec.  522.842 as Sec.  522.2343.

0
22. In Sec.  522.955:
0
a. Revise paragraph (b)(2);
0
b. Redesignate paragraph (b)(3) as paragraph (b)(4) and add new 
paragraph (b)(3);
0
c. In paragraphs (d)(1)(ii)(A)(2) and (d)(1)(ii)(B)(2), remove 
``Haemophilus somnus'' and in its place add ``Histophilus somni'';
0
d. Revise paragraph (d)(1)(ii)(C); and
0
e. Add paragraph (d)(2).
    The revisions and additions read as follows:


Sec.  522.955  Florfenicol.

* * * * *
    (b) * * *
    (2) No. 000061 for use of product described in paragraph (a)(2) of 
this section as in paragraphs (d)(1)(ii) and (d)(2) of this section.
    (3) No. 086050 for use of product described in paragraph (a)(2) of 
this section as in paragraph (d)(1)(ii) of this section.
* * * * *
    (d) * * *
    (1) * * *
    (ii) * * *
    (C) Limitations. Animals intended for human consumption must not be 
slaughtered within 28 days of the last intramuscular treatment. No. 
000061: 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.
    (2) Swine--(i) 300 mg/mL florfenicol in the inactive vehicles n-
methyl-2-pyrrolidone, propylene glycol, and polyethylene glycol:
    (A) Amount. 15 mg/kg of body weight as an intramuscular injection. 
A second dose should be administered 48 hours later.
    (B) Indications for use. For the treatment of swine respiratory 
disease associated with Actinobacillus pleuropneumoniae, Pasteurella 
multocida, Salmonella Choleraesuis, Streptococcus suis, Bordetella 
bronchiseptica, and Glaesserella (Haemophilus) parasuis in swine except 
for nursing piglets and swine of reproductive age intended for 
breeding.
    (C) Limitations. Swine intended for human consumption must not be 
slaughtered within 11 days of the last intramuscular treatment. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.
    (ii) [Reserved]

0
23. In Sec.  522.1156, revise paragraph (c)(1) to read as follows:


Sec.  522.1156  Imidocarb solution.

* * * * *
    (c) * * *
    (1) Amount. Administer 6.6 mg per kilogram (3 mg per pound) of body 
weight by intramuscular or subcutaneous injection. Repeat the dose 
after 2 weeks for a total of two treatments.
* * * * *

0
24. Add Sec.  522.2065 to read as follows:


Sec.  522.2065  Rabacfosadine.

    (a) Specifications. Each vial of powder contains 16.4 milligrams 
(mg) rabacfosadine. Each milliliter of constituted solution contains 
8.2 mg rabacfosadine.
    (b) Sponsor. See No. 058198 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer rabacfosadine 
at 1 mg/kilogram body weight as a 30-minute intravenous infusion, once 
every 3 weeks, for up to 5 doses.
    (2) Indications for use. For the treatment of lymphoma in dogs.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
25. Revise the section heading of newly designated Sec.  522.2343 to 
read as follows:


Sec.  522.2343  Testosterone propionate and estradiol benzoate.

0
26. In Sec.  522.2470, revise paragraph (b) introductory text to read 
as follows:


Sec.  522.2470  Tiletamine and zolazepam for injection.

* * * * *
    (b) Sponsors. See Nos. 026637, 051311, and 054771 in Sec.  
510.600(c) of this chapter.
* * * * *

0
27. In Sec.  522.2477, revise paragraph (b)(2), remove paragraph 
(d)(1)(i)(G), and add paragraph (d)(6) to read as follows:


Sec.  522.2477  Trenbolone acetate and estradiol.

* * * * *
    (b) * * *

[[Page 10970]]

    (2) No. 000061 for use as in paragraphs (d)(1)(i)(A), (d)(1)(i)(C), 
(d)(1)(i)(D), (d)(1)(ii), (d)(1)(iii), (d)(2)(i)(A), (d)(2)(i)(C), 
(d)(2)(i)(D), (d)(2)(ii), (d)(2)(iii), (d)(3)(i)(A), (d)(3)(ii), 
(d)(3)(iii), (d)(4), (d)(5), and (d)(6) of this section.
* * * * *
    (d) * * *
    (6) Steers fed in confinement for slaughter--(i) Amount. Each 
extended-release implant contains 200 mg trenbolone acetate and 40 mg 
estradiol (one implant consisting of 6 coated and 4 uncoated pellets, 
each containing 20 mg trenbolone acetate and 4 mg estradiol).
    (ii) Indications for use. For increased rate of weight gain and 
improved feed efficiency for up to 200 days after implantation.
    (iii) Limitations. Administer implant subcutaneously in the ear 
only. Do not use in lactating dairy cows or in animals intended for 
subsequent breeding. Use in these cattle may cause drug residues in 
milk and/or in calves born to these cows. A withdrawal period has not 
been established for this product in pre-ruminating calves. Do not use 
in calves to be processed for veal. Effectiveness and animal safety in 
veal calves have not been established. Not approved for repeated 
implantation (reimplantation) with this or any other cattle ear implant 
during the production phase(s) identified on labeling (steers fed in 
confinement for slaughter) unless otherwise indicated on labeling 
because safety and effectiveness have not been evaluated.

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

0
28. The authority citation for part 524 continues to read as follows:

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

0
29. In Sec.  524.770, revise paragraphs (e)(1) and (e)(3) to read as 
follows:


Sec.  524.770  Doramectin.

* * * * *
    (e) * * *
    (1) Amount. Administer topically 1 mL (5 mg doramectin) per 22 lb 
(10 kg) of body weight.
* * * * *
    (3) Limitations. Cattle must not be slaughtered for human 
consumption within 45 days of treatment. Not for use in female dairy 
cattle 20 months of age or older. A withdrawal period has not been 
established for this product in pre-ruminating calves. Do not use in 
calves to be processed for veal.

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

0
30. The authority citation for part 529 continues to read as follows:

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


Sec.  529.1030  [Redesignated as Sec.  529.1004]

0
31. Redesignate Sec.  529.1030 as Sec.  529.1004.

0
32. In Sec.  529.1940, revise paragraph (e)(1)(iii) to read as follows:


Sec.  529.1940  Progesterone intravaginal inserts.

* * * * *
    (e) * * *
    (1) * * *
    (iii) Limitations. Do not use in beef or dairy heifers of 
insufficient size or age for breeding or in animals with abnormal, 
immature, or infected genital tracts. Do not use in anestrous lactating 
dairy cows less than 42 days or greater than 78 days postpartum. Do not 
use in lactating dairy cows less than 40 days postpartum. Do not use in 
beef cows that are less than 20 days postpartum. Do not use an insert 
more than once. To prevent the potential transmission of venereal and 
bloodborne diseases, the inserts should be disposed after a single use. 
Administration of vaginal inserts for periods greater than 7 days may 
result in reduced fertility. Dinoprost injection for use in paragraphs 
(e)(1)(ii)(A) and (e)(1)(ii)(B) of this section as in Sec.  522.690 of 
this chapter, as provided by No. 054771 in Sec.  510.600(c) of this 
chapter.
* * * * *

PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

0
33. The authority citation for part 556 continues to read as follows:

    Authority:  21 U.S.C. 342, 360b, 371.

0
34. In Sec.  556.710, revise paragraph (c) to read as follows:


Sec.  556.710  Testosterone.

* * * * *
    (c) Related conditions of use. See Sec.  522.2343 of this chapter.

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

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

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

0
36. In Sec.  558.59, redesignate paragraph (d) as paragraph (e) and add 
new paragraph (d) to read as follows:


Sec.  558.59  Apramycin.

* * * * *
    (d) Special considerations. (1) Federal law restricts medicated 
feed containing this veterinary feed directive (VFD) drug to use by or 
on the order of a licensed veterinarian. See Sec.  558.6 for additional 
requirements.
    (2) The expiration date of VFDs for apramycin medicated feeds must 
not exceed 6 months from the date of issuance. VFDs for apramycin shall 
not be refilled.
* * * * *

0
37. In Sec.  558.205, revise paragraphs (d)(1) and (2) to read as 
follows:


Sec.  558.205  Diclazuril.

* * * * *
    (d) * * *
    (1) Chickens. For chickens it is used as follows:

----------------------------------------------------------------------------------------------------------------
   Diclazuril grams/ton    Combination grams/ton      Indications for use          Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 0.91.................  .....................  Broiler chickens: For the   Feed continuously as        058198
                                                   prevention of coccidiosis   the sole ration. Do
                                                   caused by Eimeria           not feed to birds
                                                   tenella, E. necatrix, E.    producing eggs for
                                                   acervulina, E. brunetti,    human consumption.
                                                   E. mitis (mivati), and E.
                                                   maxima. Because
                                                   diclazuril is effective
                                                   against E. maxima later
                                                   in its life cycle,
                                                   subclinical intestinal
                                                   lesions may be present
                                                   for a short time after
                                                   infection. Diclazuril was
                                                   shown in studies to
                                                   reduce lesion scores and
                                                   improve performance and
                                                   health of birds
                                                   challenged with E. maxima.

[[Page 10971]]

 
(ii) 0.91................  Bacitracin             Broiler chickens: For the   Feed continuously as        058198
                            methylenedisalicylat   prevention of coccidiosis   the sole ration. Do
                            e, 4 to 50.            caused by Eimeria           not feed to birds
                                                   tenella, E. necatrix, E.    producing eggs for
                                                   acervulina, E. brunetti,    human consumption.
                                                   E. mitis (mivati), and E.   Bacitracin
                                                   maxima, and for increased   methylenedisalicylat
                                                   rate of weight gain and     e provided by No.
                                                   improved feed efficiency.   054771 in Sec.
                                                   Because diclazuril is       510.600(c) of this
                                                   effective against E.        chapter.
                                                   maxima later in its life
                                                   cycle, subclinical
                                                   intestinal lesions may be
                                                   present for a short time
                                                   after infection.
                                                   Diclazuril was shown in
                                                   studies to reduce lesion
                                                   scores and improve
                                                   performance and health of
                                                   birds challenged with E.
                                                   maxima.
(iii) 0.91...............  Bambermycins, 1 to 2.  Broiler chickens: For the   Feed continuously as        058198
                                                   prevention of coccidiosis   the sole ration. Do
                                                   caused by Eimeria           not feed to birds
                                                   tenella, E. necatrix, E.    producing eggs for
                                                   acervulina, E. brunetti,    human consumption.
                                                   E. mitis (mivati), and E.   Bambermycins
                                                   maxima, and for increased   provided by No.
                                                   rate of weight gain and     016592 in Sec.
                                                   improved feed efficiency.   510.600(c) of this
                                                   Because diclazuril is       chapter.
                                                   effective against E.
                                                   maxima later in its life
                                                   cycle, subclinical
                                                   intestinal lesions may be
                                                   present for a short time
                                                   after infection.
                                                   Diclazuril was shown in
                                                   studies to reduce lesion
                                                   scores and improve
                                                   performance and health of
                                                   birds challenged with E.
                                                   maxima.
----------------------------------------------------------------------------------------------------------------

    (2) Turkeys. For turkeys it is used as follows:

----------------------------------------------------------------------------------------------------------------
   Diclazuril grams/ton    Combination grams/ton      Indications for use          Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 0.91.................  .....................  Growing turkeys: For the    Feed continuously as        058198
                                                   prevention of coccidiosis   the sole ration. Do
                                                   caused by Eimeria           not feed to breeding
                                                   adenoeides, E.              turkeys. Do not feed
                                                   gallopavonis, and E.        to birds producing
                                                   meleagrimitis.              eggs for human
                                                                               consumption.
(ii) 0.91................  Bacitracin             Growing turkeys: For the    Feed continuously as        058198
                            methylenedisalicylat   prevention of coccidiosis   the sole ration. Do
                            e, 4 to 50.            caused by Eimeria           not feed to breeding
                                                   adenoeides, E.              turkeys. Do not feed
                                                   gallopavonis, and E.        to birds producing
                                                   meleagrimitis, and for      eggs for human
                                                   increased rate of weight    consumption.
                                                   gain and improved feed      Bacitracin
                                                   efficiency.                 methylenedisalicylat
                                                                               e as provided by No.
                                                                               054771 in Sec.
                                                                               510.600(c) of this
                                                                               chapter.
(iii) 0.91...............  Bambermycins 1 to 2..  Growing turkeys: For the    Feed continuously as        058198
                                                   prevention of coccidiosis   the sole ration. Do
                                                   caused by Eimeria           not feed to breeding
                                                   adenoeides, E.              turkeys. Do not feed
                                                   gallopavonis, and E.        to birds producing
                                                   meleagrimitis, and for      eggs for human
                                                   improved feed efficiency.   consumption.
                                                                               Bambermycins as
                                                                               provided by No.
                                                                               016592 in Sec.
                                                                               510.600(c) of this
                                                                               chapter.
(iv) 0.91................  Bambermycins 2.......  Growing turkeys: For the    Feed continuously as        058198
                                                   prevention of coccidiosis   the sole ration. Do
                                                   caused by Eimeria           not feed to breeding
                                                   adenoeides, E.              turkeys. Do not feed
                                                   gallopavonis, and E.        to birds producing
                                                   meleagrimitis, and for      eggs for human
                                                   increased rate of weight    consumption.
                                                   gain and improved feed      Bambermycins as
                                                   efficiency.                 provided by No.
                                                                               016592 in Sec.
                                                                               510.600(c) of this
                                                                               chapter.
----------------------------------------------------------------------------------------------------------------

Sec.  558.254   [Amended]

0
38. In Sec.  558.254, in paragraph (e) introductory text, remove 
``Table 2--Size Proxies for SRCs in 2016''.

0
39. In Sec.  558.261, revise paragraph (e)(2)(ii) to read as follows:


Sec.  558.261  Florfenicol.

* * * * *
    (e) * * *
    (2) * * *

[[Page 10972]]



----------------------------------------------------------------------------------------------------------------
  Florfenicol in grams/ton of feed          Indications for use                       Limitations
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(ii) 182 to 1,816...................  Freshwater-reared salmonids:     Feed as a sole ration for 10 consecutive
                                       For the control of mortality     days to deliver 10 to 15 mg florfenicol
                                       due to coldwater disease         per kg of fish. Feed containing
                                       associated with Flavobacterium   florfenicol shall not be fed for more
                                       psychrophilum and furunculosis   than 10 days. Following administration,
                                       associated with Aeromonas        fish should be reevaluated by a licensed
                                       salmonicida.                     veterinarian before initiating a further
                                                                        course of therapy. The effects of
                                                                        florfenicol on reproductive performance
                                                                        have not been determined. Feeds
                                                                        containing florfenicol must be withdrawn
                                                                        15 days prior to slaughter.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

0
39. In Sec.  558.311, add paragraph (e)(3)(ix) to read as follows:


Sec.  558.311  Lasalocid.

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

----------------------------------------------------------------------------------------------------------------
           Lasalocid amount               Indications for use                Limitations               Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(ix) 60 to 300 mg of lasalocid per     Growing beef steers and   Feed continuously as a Type C free-      054771
 head per day.                          heifers on pasture        choice medicated feed at a rate
                                        (stocker, feeder, and     of 60 to 300 mg of lasalocid per
                                        slaughter) and            head per day. Daily intakes of
                                        replacement beef and      lasalocid in excess of 200 mg/
                                        dairy heifers on          head/day have not been shown to
                                        pasture: For increased    be more effective than 200 mg/
                                        rate of weight gain.      head/day.
----------------------------------------------------------------------------------------------------------------

* * * * *

0
40. In Sec.  558.450, revise paragraph (e)(5)(ii), redesignate 
paragraphs (e)(5)(iii) through (vii) as paragraphs (e)(5)(iv) through 
(viii), and add new paragraph (e)(5)(iii) to read as follows:


Sec.  558.450  Oxytetracycline.

* * * * *
    (e) * * *
    (5) * * *

----------------------------------------------------------------------------------------------------------------
          Oxytetracycline amount               Indications for use              Limitations            Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(ii) 200 mg/colony as a dust (200 mg/oz)   Honey bees: For control of   Apply every 4 to 5 days for       066104
 or syrup (200 mg/5 lb).                    American foulbrood caused    a total of three                 069254
                                            by Paenibacillus larvae      applications. Remove at
                                            and European foulbrood       least 6 weeks prior to
                                            caused by Melissococcus      main honey flow.
                                            plutonius susceptible to
                                            oxytetracycline.
(iii) 800 mg/colony as an extender patty   Honey bees: For control of   Use as a single                   066104
 (800 mg/patty).                            American foulbrood caused    application. Remove at           069254
                                            by Paenibacillus larvae      least 6 weeks prior to
                                            and European foulbrood       main honey flow.
                                            caused by Melissococcus
                                            plutonius susceptible to
                                            oxytetracycline.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

0
41. In Sec.  558.633, revise paragraph (d)(3) to read as follows:


Sec.  558.633  Tylvalosin.

* * * * *
    (d) * * *
    (3) An expiration date of 1 week is required for tylvalosin Type C 
medicated swine feeds in pelleted or crumbled form. Pelleted Type C 
medicated feeds must bear an expiration date of 30 days after the date 
of manufacture. Crumbled Type C medicated feeds must bear an expiration 
date of 7 days after the date of manufacture.
* * * * *

0
42. In Sec.  558.635, revise paragraph (e)(1)(iv) to read as follows:


Sec.  558.635  Virginiamycin.

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

[[Page 10973]]



----------------------------------------------------------------------------------------------------------------
Virginiamycin in grams/   Combination in grams/
          ton                      ton                Indications for use           Limitations        Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(iv) 20................  Diclazuril, 0.91......  Broiler chickens: For          Feed continuously         058198
                                                  prevention of necrotic         as the sole
                                                  enteritis caused by            ration. Do not
                                                  Clostridium perfringens        feed to birds
                                                  susceptible to                 producing eggs for
                                                  virginiamycin; and for the     human consumption.
                                                  prevention of coccidiosis      Diclazuril as
                                                  caused by Eimeria tenella,     provided by No.
                                                  E. necatrix, E. acervulina,    058198 in Sec.
                                                  E. brunetti, E. mitis          510.600(c) of this
                                                  (mivati), and E. maxima.       chapter.
                                                  Because diclazuril is
                                                  effective against E. maxima
                                                  later in its life cycle,
                                                  subclinical intestinal
                                                  lesions may be present for a
                                                  short time after infection.
                                                  Diclazuril was shown in
                                                  studies to reduce lesions
                                                  scores and improve
                                                  performance and health of
                                                  birds challenged with E.
                                                  maxima.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

    Dated: February 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-03538 Filed 2-25-22; 8:45 am]
BILLING CODE 4164-01-P