Rule2022-03538
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; Change of Sponsor
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
February 28, 2022
Effective
February 28, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 39 (Monday, February 28, 2022)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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,
<a href="/cdn-cgi/l/email-protection#3e595b514c595b10565f575c5b527e585a5f1056564d10595148"><span class="__cf_email__" data-cfemail="5e393b312c393b70363f373c3b321e383a3f7036362d70393128">[email protected]</span></a>.
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: <a href="https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room">https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room</a>. Marketing
exclusivity and patent information may be accessed in FDA's
publication, ``Approved Animal Drug Products Online (Green Book)'' at:
<a href="https://www.fda.gov/animal-veterinary/products/approved-animal-drug-products-green-book">https://www.fda.gov/animal-veterinary/products/approved-animal-drug-products-green-book</a>.
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:
<bullet> 21 CFR 500.1410 is amended to add uncooked edible tissues
of swine to the standard for residues of n-methyl-2-pyrrolidone.
<bullet> 21 CFR 510.600 is amended to have sponsor addresses
conform to the current style.
<bullet> 21 CFR 520.905c is amended to reflect the current label
indications for use of fenbendazole paste in horses.
<bullet> 21 CFR 520.1044c is amended to reflect a current swine
pathogen name for gentamicin soluble powder.
<bullet> 21 CFR 520.1660d is amended to revise conditions of use of
oxytetracycline in drinking water of swine to reflect approved
applications.
<bullet> 21 CFR 520.1780 is amended to revise the indications for
use of pimobendan tablets in dogs.
<bullet> 21 CFR 520.2130 is amended to remove the 90-milligram
strength for spinosad chewable tablets.
<bullet> 21 CFR 520.2220a is amended to add human food safety
warnings for use of sulfadimethoxine concentrate solution and soluble
powder.
<bullet> 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.
<bullet> 21 CFR 520.2604 is amended to revise indications for use
of tablets in dogs containing trimeprazine with prednisolone.
<bullet> 21 CFR 522.558 is amended to reflect the drug labeler code
for the current sponsor of a dexmedetomidine injectable solution.
<bullet> 21 CFR 522.840 is amended to reflect the current classes
of cattle approved for use of estradiol ear implants.
<bullet> 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.
<bullet> 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.
<bullet> 21 CFR 522.1156 is amended to add subcutaneous
administration to the approved conditions of use of imidocarb
dipropionate solution in dogs.
<bullet> 21 CFR 522.2477 is amended to reorganize an approved use
of trenbolone acetate and estradiol implants in steers.
<bullet> 21 CFR 524.770 is amended to reflect current label dosage
information and human food safety warnings.
<bullet> 21 CFR 529.1030 is redesignated as Sec. 529.1004 in
conformity with an announced FDA numbering system (40 FR 13802, March
27, 1975).
<bullet> 21 CFR 529.1940 is amended to add limitations to the use
of progesterone intravaginal inserts in cows.
<bullet> 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.
<bullet> 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.
<bullet> 21 CFR 558.254 is amended to remove an erroneous table
title.
<bullet> 21 CFR 558.261 is amended to correct the upper inclusion
rate for florfenicol in Type C medicated feed for freshwater-reared
salmonids.
<bullet> 21 CFR 558.311 is being amended to codify free-choice Type
C medicated cattle feeds containing lasalocid.
<bullet> 21 CFR 558.450 is amended to add conditions of use in
honey bees for a Type C extender patty containing oxytetracycline.
<bullet> 21 CFR 558.633 is amended to add manufacturing limitations
for use of Type C medicated swine feeds containing tylvalosin.
<bullet> 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:
<a href="https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room">https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room</a>. 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:
<a href="https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room">https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room</a>. 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
<a href="/cdn-cgi/l/email-protection#dbbda9f5b2b5a8abbeb8afb2b4b59bb5baa9baf5bcb4ad"><span class="__cf_email__" data-cfemail="4127336f282f3231242235282e2f012f2033206f262e37">[email protected]</span></a>, or go to: <a href="http://www.archives.gov/federal-register/cfr/ibr-locations.html">www.archives.gov/federal-register/cfr/ibr-locations.html</a>.
(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
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