New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Name and Address, 58957-58968 [2022-20836]
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Federal Register / Vol. 87, No. 188 / Thursday, September 29, 2022 / Rules and Regulations
given on the report forms and
instructions.
(a) Response required. A response is
required from persons subject to the
reporting requirements of the BE–13,
Survey of New Foreign Direct
Investment in the United States,
contained herein, whether or not they
are contacted by BEA. Also, a person, or
their agent, who is contacted by BEA
about reporting in this survey, either by
sending them a report form or by
written inquiry, must respond in writing
pursuant to this section. This may be
accomplished by filing the properly
completed BE–13 report (BE–13A, BE–
13B, BE–13D, BE–13E, or BE–13 Claim
for Exemption).
(b) Who must report. A BE–13 report
is required of any U.S. business
enterprise, except certain private funds,
see exception in paragraph (b)(4) of this
section, in which:
(1) A foreign direct investment in the
United States relationship is created;
(2) An existing U.S. affiliate of a
foreign parent establishes a new U.S.
business enterprise, expands its U.S.
operations, or acquires a U.S. business
enterprise; or
(3) BEA requests a cost update (Form
BE–13E) for a U.S. business enterprise
that previously filed Form BE–13B or
BE–13D.
(4) Certain private funds are exempt
from reporting on the BE–13 survey. If
a U.S. business enterprise is a private
fund and does not own, directly or
indirectly, 10 percent or more of another
business enterprise that is not also a
private fund or a holding company, it is
not required to file any BE–13 report
except to indicate exemption from the
survey if contacted by BEA.
(c) Forms to be filed. Depending on
the type of investment transaction, U.S.
affiliates would report their information
on one of five forms—BE–13A, BE–13B,
BE–13D, BE–13E, or BE–13 Claim for
Exemption.
(1) Form BE–13A—report for a U.S.
business enterprise when a foreign
entity acquires a voting interest
(directly, or indirectly through an
existing U.S. affiliate) in that U.S.
business enterprise including segments,
operating units, or real estate; and
(i) The total cost of the acquisition is
greater than $3 million; and
(ii) By this acquisition, the foreign
entity now owns at least 10 percent of
the voting interest (directly, or
indirectly through an existing U.S.
affiliate) in the acquired U.S. business
enterprise.
(2) Form BE–13B—report for a U.S.
business enterprise when it is
established by a foreign entity or by an
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existing U.S. affiliate of a foreign parent;
and
(i) The expected total cost to establish
the new U.S. business enterprise is
greater than $3 million; and
(ii) The foreign entity owns at least 10
percent of the voting interest (directly,
or indirectly through an existing U.S.
affiliate) in the new U.S. business
enterprise.
(3) Form BE–13D—report for an
existing U.S. affiliate of a foreign parent
when it expands its operations to
include a new facility where business is
conducted, and the expected total cost
of the expansion is greater than $3
million.
(4) Form BE–13E—report for a U.S.
business enterprise that previously filed
Form BE–13B or BE–13D. Form BE–13E
collects updated cost information and
will be collected annually for three
years after the year of the establishment
or expansion of the U.S. business
enterprise.
(5) Form BE–13 Claim for
Exemption—report for a U.S. business
enterprise that:
(i) Was contacted by BEA but does not
meet the requirements for filing Forms
BE–13A, BE–13B, or BE–13D; or
(ii) Whether or not contacted by BEA,
met all requirements for filing Forms
BE–13A, BE–13B, or BE–13D except the
$3 million reporting threshold.
(d) Due date. The BE–13 forms are
due no later than 45 calendar days after
the acquisition is completed, the new U.
S. business enterprise is established, the
expansion is begun, the cost update is
requested, or a notification letter is
received from BEA by a U.S. business
enterprise that does not meet the filing
requirements for the survey.
§ 227.201
58957
Disclosure requirements.
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(z) Any written communication or
broadcast script provided in accordance
with § 227.206 or, if within 30 days of
the initial filing of the offering
statement, § 230.241 of this chapter.
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[FR Doc. 2022–21290 Filed 9–28–22; 8:45 am]
BILLING CODE 0099–10–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 515, 516, 520, 522,
524, 529, and 558
[Docket No. FDA–2022–N–0002]
New Animal Drugs; Approval of New
Animal Drug Applications; Withdrawal
of Approval of New Animal Drug
Applications; Change of Sponsor;
Change of Sponsor Name and Address
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendments.
ACTION:
Regulation Crowdfunding, General
Rules and Regulations
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)
and abbreviated new animal drug
applications (ANADAs) during January,
February, and March 2022. FDA is
informing the public of the availability
of summaries of the basis of approval
and of environmental review
documents, where applicable. The
animal drug regulations are also being
amended to improve the accuracy of the
regulations.
DATES: This rule is effective September
29, 2022.
FOR FURTHER INFORMATION CONTACT:
George K. Haibel, Center for Veterinary
Medicine (HFV–6), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–5689,
george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
CFR Correction
I. Approvals
This rule is being published by the
Office of the Federal Register to correct
an editorial or technical error that
appeared in the most recent annual
revision of the Code of Federal
Regulations.
■ In Title 17 of the Code of Federal
Regulations, Parts 200 to 239, revised as
of April 1, 2022, amend § 227.201 by
adding paragraph (z) to read as follows:
FDA is amending the animal drug
regulations to reflect approval actions
for NADAs and ANADAs during
January, February, and March 2022, as
listed in table 1. In addition, FDA is
informing the public of the availability,
where applicable, of documentation of
environmental review required under
the National Environmental Policy Act
(NEPA) and, for actions requiring
[FR Doc. 2022–21116 Filed 9–28–22; 8:45 am]
BILLING CODE 3510–06–P
SECURITIES AND EXCHANGE
COMMISSION
17 CFR Part 227
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SUMMARY:
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Federal Register / Vol. 87, No. 188 / Thursday, September 29, 2022 / Rules and Regulations
review of safety or effectiveness data,
summaries of the basis of approval (FOI
Summaries) under the Freedom of
Information Act (FOIA). These public
documents may be seen in the office of
the Dockets Management Staff (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852, between 9 a.m. and 4 p.m.,
Monday through Friday, 240–402–7500.
Persons with access to the internet may
obtain these documents at the CVM
FOIA Electronic Reading Room: https://
www.fda.gov/about-fda/centerveterinary-medicine/cvm-foiaelectronic-reading-room. Marketing
exclusivity and patent information may
be accessed in FDA’s publication,
‘‘Approved Animal Drug Products
Online (Green Book)’’ at: https://
www.fda.gov/animal-veterinary/
products/approved-animal-drugproducts-green-book.
FDA has verified the website
addresses as of the date this document
publishes in the Federal Register, but
websites are subject to change over time.
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING JANUARY, FEBRUARY, AND MARCH
2022
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Approval date
File No.
Sponsor
Product name
Species
Effect of the action
Supplemental approval to
establish withdrawal periods in accordance with
repartitioning of acceptable daily intake; and to
add fourth-stage larval
indications for certain
endoparasites of cattle.
Original approval for the
control of pain associated with osteoarthritis.
Original approval for the
control of postoperative
pain associated with
surgical procedures.
Original approval as a generic copy of NADA
141–361.
Public
documents
January 10, 2022 .............
131–675
Intervet, Inc., 2 Giralda
Farms, Madison, NJ
07940.
SAFE–GUARD
(fenbendazole), Type A
Medicated Article.
Cattle ...............
January 13, 2022 .............
141–546
141–547
SOLENSIA (frunevetmab
injection), Injectable Solution.
ZORBIUM (buprenorphine
transdermal solution),
Transdermal Solution.
Cats .................
January 20, 2022 .............
Zoetis Inc, 333 Portage
St., Kalamazoo, MI
49007.
Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140.
January 25, 2022 .............
200–707
TILMOVET AC
(tilmicosin), Solution.
Swine ...............
January 28, 2022 .............
200–716
MIDAMOX for Dogs
(imidacloprid and
moxidectin), Topical Solution.
Dogs ................
Original approval as a generic copy of NADA
141–251.
FOI Summary.
February 7, 2022 .............
200–665
Original approval as a generic copy of NADA
141–349.
Original approval as a generic copy of NADA
140–916.
FOI Summary.
200–717
INCREXXA 25
(tulathromycin injection),
Injectable Solution.
TIAGARD 12.5% (tiamulin
hydrogen fumarate), Liquid Concentrate.
Cattle and
Swine.
February 7, 2022 .............
February 7, 2022 .............
200–718
Huvepharma EOOD, 5th
Floor, 3A Nikolay
Haytov Str.,1113 Sofia,
Bulgaria.
Norbrook Laboratories
Ltd., Carnbane Industrial
Estate, Newry, County
Down, BT35 6QQ,
United Kingdom.
Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140.
Aurora Pharmaceutical,
Inc,1196 Highway 3
South, Northfield, MN
55057–3009.
......do ................................
Dogs ................
Original approval as a generic copy of NADA
141–251.
FOI Summary.
February 9, 2022 .............
200–715
Cattle and
Swine.
200–720
Original approval as a generic copy of NADA
141–244.
Original approval as a generic copy of NADA
140–441.
FOI Summary.
March 11, 2022 ................
March 23, 2022 ................
200–723
Intervet, Inc., 2 Giralda
Farms, Madison, NJ
07940.
Norbrook Laboratories
Ltd., Carnbane Industrial
Estate, Newry, County
Down, BT35 6QQ,
United Kingdom.
......do ................................
BARRIER for Dogs
(imidacloprid and
moxidectin), Topical Solution.
AROVYN (tulathromycin
injection), Injectable Solution.
ENROFLOX
(enrofloxacin),
Chewable Tablets.
Cattle and
Swine.
200–721
......do ................................
Original approval as a generic copy of NADA
141–244.
Original approval as a generic copy of NADA
141–254.
FOI Summary.
March 28, 2022 ................
March 28, 2022 ................
200–722
......do ................................
TULIEVE (tulathromycin
injection), Injectable Solution.
MIDAMOX for Cats
(imidacloprid and
moxidectin), Topical Solution.
FIROX (firocoxib),
Chewable Tablets.
FOI Summary.
March 28, 2022 ................
200–688
TENOTRYL (enrofloxacin),
Injectable Solution.
Cattle and
Swine.
March 30, 2022 ................
141–551
Virbac AH, Inc., P.O .Box
162059, Fort Worth, TX
76161.
Vetcare Oy, P.O. Box 26
(Liedontie 45),
Ma¨ntsa¨la¨, Uusimaa,
04601, Finland.
ZENALPHA
(medetomidine and
vatinoxan injection).
Dogs ................
Original approval as a generic copy of NADA
141–230.
Original approval as a generic copy of NADA
141–068.
Original approval for use
as a sedative and analgesic to facilitate clinical examination, clinical
procedures, and minor
surgical procedures.
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Cats .................
Swine ...............
Dogs ................
Cats .................
Dogs ................
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FOI Summary.
FOI Summary.
FOI Summary.
FOI Summary.
FOI Summary.
FOI Summary.
FOI Summary.
FOI Summary.
Federal Register / Vol. 87, No. 188 / Thursday, September 29, 2022 / Rules and Regulations
II. Withdrawals of Approval
Lloyd, Inc., 604 W. Thomas Ave.,
Shenandoah, IA 51601, has requested
that FDA withdraw approval of NADA
140–908 for VET–METH Bolus, a bolus
containing sulfamethazine for use in
cattle because the product is no longer
manufactured or marketed. As provided
in the regulatory text of this document,
the animal drug regulations in 21 CFR
520.2260a are amended to reflect this
action.
Ridley USA, Inc., 111 W. Cherry St.,
Suite 500, Mankato, MN 56001, has
requested that FDA withdraw approval
of NADA 136–214 for VMS Bloat Blox,
an oral dosage form containing
polyoxyethylene (23) lauryl ether for
use in beef and nonlactating dairy cattle
because the product is no longer
manufactured or marketed. As provided
in the regulatory text of this document,
the animal drug regulations in 21 CFR
520.1846 are amended to reflect this
action.
III. Changes of Sponsorship
Halocarbon Products Corp., 6525 The
Corners Pkwy., Suite 200, Peachtree
Corners, GA 30092 has informed FDA
that it has transferred ownership of, and
all rights and interest in, ANADA 200–
129 for Isoflurane, USP and ANADA
200–467 for Sevoflurane to Dechra
Veterinary Products LLC, 7015 College
Blvd., Suite 525, Overland Park, KS
66211. As provided in the regulatory
text, the animal drug regulations in 21
CFR 529.1186 and 529.2110,
respectively, are amended to reflect
these changes of sponsorship.
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IV. Change of Sponsor’s Name and
Address
Mylan Institutional, Inc., 12720 Dairy
Ashford Rd., Sugar Land, TX 77478 has
informed FDA that it has changed its
name and address to Mylan
Institutional, Inc., a Viatris Company,
3711 Collins Ferry Rd., Morgantown,
WV 26505. As provided in the
regulatory text, the animal drug
regulations in § 510.600(c) (21 CFR
510.600(c)) are amended to reflect this
change of a sponsor’s name and address.
V. Technical Amendments
FDA is making the following
amendments to improve the accuracy of
the animal drug regulations:
• Section 510.600 is amended to
remove the entry for Halocarbon
Products Corp. from, and add Vetcare
Oy to, the list of sponsors of approved
applications. The entries for Mylan
Institutional, Inc. and Norbrook
Laboratories Ltd. are revised as well.
• 21 CFR 516.812 is amended to
reflect a current drug labeler code for a
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use of enrofloxacin injectable solution
in cattle.
• 21 CFR 520.88g is amended reflect
a current sponsor drug labeler code and
revised indications for use of tablets
containing amoxicillin and clavulanate
in dogs and cats.
• 21 CFR 520.530 is amended to
conform to content codified for animal
drugs available by veterinary
prescription.
• 21 CFR 520.905a is amended to
reflect revised conditions of use for
fenbendazole suspension in horses.
• 21 CFR 520.928 is amended to
reflect correct directions for
administration of firocoxib chewable
tablets in dogs.
• 21 CFR 520.1242a is amended to
reflect revised indications for use of a
levamisol powder in cattle and sheep.
• 21 CFR 520.1720a is amended to
correct an error in the strength of
approved phenylbutazone boluses.
• 21 CFR 520.1870 is amended to
remove an undefined acronym in the
conditions for use of praziquantel
tablets.
• 21 CFR 520.1872 is amended to
conform to content codified for animal
drugs available by veterinary
prescription.
• 21 CFR 520.2325a is amended to
reflect instructions for use of
sulfaquinoxaline powder and solution
in poultry and cattle.
• 21 CFR 520.2598 is amended to
reflect revised indications for use for
trilostane capsules in dogs.
• 21 CFR 522.533 is amended to
revise the indications for use of
deslorelin injectable solution in mares.
• 21 CFR 522.2615 is amended to
reflect revised human food safety
warnings for tripelennamine injectable
solution in cattle.
• 21 CFR 524.1001 is amended to
correct a spelling error in the heading
and specifications for fluralaner and
moxidectin topical solution.
• 21 CFR 524.2098 is amended to
reflect all sponsors of approved
applications for selamectin topical
solution in dogs and cats.
• 21 CFR 558.4 is amended in the
Category II table to reflect the correct
assay limits for Type C medicated feeds
manufactured using nicarbazin powder.
• 21 CFR 558.128 is amended to
reflect the class of cattle and
incorporation level for single-ingredient
and combination-drug medicated feeds
containing chlortetracycline used for
control of anaplasmosis in cattle.
• 21 CFR 558.633 is amended to
clarify expiration dates for medicated
feeds containing tylvalosin.
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58959
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 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
21 CFR Parts 515 and 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 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR parts 510,
515, 516, 520, 522, 524, 529, and 558 are
amended as follows:
PART 510—NEW ANIMAL DRUGS
1. The authority citation for part 510
continues to read as follows:
■
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
2. In § 510.600:
a. In the table in paragraph (c)(1),
remove the entry for ‘‘Halocarbon
■
■
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Federal Register / Vol. 87, No. 188 / Thursday, September 29, 2022 / Rules and Regulations
Products Corp.’’; revise the entries for
‘‘Mylan Institutional, Inc.’’ and
‘‘Norbrook Laboratories Ltd.’’; and add
in alphabetical order an entry for
‘‘Vetcare Oy’’; and
■ b. In the table in paragraph (c)(2),
remove the entry for ‘‘012164’’; revise
the entries for ‘‘051079’’ and ‘‘055529’’;
and add in numerical order an entry for
‘‘086155’’.
The revisions and additions read as
follows:
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
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(c) * * *
(1) * * *
*
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Drug labeler
code
Firm name and address
*
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Mylan Institutional, Inc., a Viatris Company, 3711 Collins Ferry Rd., Morgantown, WV 26505 ........................................................
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Norbrook Laboratories Ltd., Carnbane Industrial Estate, Newry, County Down, BT35 6QQ, United Kingdom .................................
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Vetcare Oy, P.O. Box 26 (Liedontie 45), Ma¨ntsa¨la¨, Uusimaa, 04601, Finland ..................................................................................
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051079
055529
086155
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(2) * * *
Drug labeler
code
Firm name and address
*
051079 .........
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Mylan Institutional, Inc., a Viatris Company, 3711 Collins Ferry Rd., Morgantown, WV 26505.
*
055529 .........
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Norbrook Laboratories Ltd., Carnbane Industrial Estate, Newry, County Down, BT35 6QQ, United Kingdom.
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086155 .........
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Vetcare Oy, P.O. Box 26 (Liedontie 45), Ma¨ntsa¨la¨, Uusimaa, 04601, Finland.
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§ 516.812
3. The authority citation for part 515
continues to read as follows:
■
Authority: 21 U.S.C. 360b, 371.
4. In § 515.10, revise paragraph (a) to
read as follows:
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
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§ 515.10 Medicated feed mill license
applications.
PART 516—NEW ANIMAL DRUGS FOR
MINOR USE AND MINOR SPECIES
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7. The authority citation for part 520
continues to read as follows:
■
(a) Medicated feed mill license
applications (Form FDA 3448) may be
obtained from the Public Health Service,
Consolidated Forms and Publications
Distribution Center, Washington
Commerce Center, 3222 Hubbard Rd.,
Landover, MD 20785, or electronically
from the Center for Veterinary Medicine
at: https://www.fda.gov/animalveterinary/animal-food-feeds/
medicated-feeds.
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[Amended]
6. In § 516.812, in paragraph (b),
remove ‘‘000859’’ and in its place add
‘‘058198’’.
■
■
5. The authority citation for part 516
continues to read as follows:
*
Authority: 21 U.S.C. 360ccc–1, 360ccc–2,
371.
PART 515—MEDICATED FEED MILL
LICENSE
■
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Authority: 21 U.S.C. 360b.
8. In § 520.88g, revise paragraphs
(b)(2), (c)(1)(ii), and (c)(2)(ii) to read as
follows:
■
§ 520.88g Amoxicillin trihydrate and
clavulanate potassium tablets.
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(b) * * *
(2) Nos. 017033 and 069043 for use of
tablets as in paragraph (c) of this
section.
(c) * * *
(1) * * *
(ii) Indications for use. Treatment of
skin and soft tissue infections such as
wounds, abscesses, cellulitis,
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superficial/juvenile and deep pyoderma
due to susceptible strains of the
following organisms: Beta-lactamaseproducing Staphylococcus aureus, nonbeta-lactamase-producing
Staphylococcus aureus, Staphylococcus
spp., Streptococcus spp., and E. coli.
Periodontal infections due to
susceptible strains of both aerobic and
anaerobic bacteria.
*
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(2) * * *
(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: Betalactamase-producing Staphylococcus
aureus, non-beta-lactamase-producing
Staphylococcus aureus, Staphylococcus
spp., Streptococcus spp., E. coli, and
Pasteurella spp. Urinary tract infections
(cystitis) due to susceptible strains of E.
coli.
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§ 520.530
[Amended]
§ 520.812
Enrofloxacin.
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(b) * * *
(1) No. 058198 for use of products
described in paragraph (a) of this
section.
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(3) Nos. 055529 and 086101 for use of
product described in paragraph (a)(2) of
this section.
*
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■ 11. In § 520.905a, revise paragraphs
(e)(1)(ii) and (iii) to read as follows:
§ 520.905a
Fenbendazole suspension.
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(e) * * *
(1) * * *
(ii) Indications for use. For the
treatment and control of large strongyles
(Strongylus edentatus, S. equinus, S.
vulgaris, Triodontophorus species),
small strongyles (Cyathostomum
species, Cylicocyclus species,
Cylicostephanus species,
Cylicodontophorus species), pinworms
(Oxyuris equi) and ascarids (Parascaris
equorum).
(iii) Limitations. Do not use in horses
intended for human consumption.
*
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*
*
■ 12. In § 520.928, revise the section
heading and paragraphs (a), (b), and
(c)(1)(i) to read as follows:
khammond on DSKJM1Z7X2PROD with RULES
§ 520.928
Firocoxib.
(a) Specifications—(1) Each chewable
tablet contains 57 or 227 milligrams
(mg) firocoxib.
(2) Each tablet contains 57 mg
firocoxib.
(b) Sponsors. See sponsors in
§ 510.600(c) of this chapter as follows:
(1) Nos. 000010 and 055529 for use of
products described in paragraph (a)(1)
as in paragraph (c)(1) of this section;
and
(2) No. 000010 for use of the product
described in paragraph (a)(2) as in
paragraph (c)(2) of this section.
(c) * * *
(1) * * *
(i) Amount. 5 mg/kg (2.27 mg/lb) body
weight. Administer once daily as
needed for osteoarthritis and for 3 days
as needed for postoperative pain and
inflammation associated with soft-tissue
and orthopedic surgery. Administer
approximately 2 hours before soft tissue
or orthopedic surgery.
*
*
*
*
*
VerDate Sep<11>2014
16:48 Sep 28, 2022
13. In § 520.1242a, revise paragraph
(b)(3) to read as follows:
■
9. In § 520.530, remove paragraph (c)
and redesignate paragraph (d) as
paragraph (c).
■ 10. In § 520.812, revise paragraphs
(b)(1) and (3) to read as follows:
■
Jkt 256001
§ 520.1242a
Levamisol powder.
*
*
*
*
*
(b) * * *
(3) No. 016592 for use of 46.8- and
544.5-g packages as in paragraphs
(e)(1)(i), (e)(1)(ii)(B), and (e)(1)(iii) and
(e)(2)(i), (e)(2)(ii)(B), and (e)(2)(iii) of
this section.
*
*
*
*
*
■ 14. In § 520.1720a, revise paragraph
(a) to read as follows:
§ 520.1720a
boluses.
Phenylbutazone tablets and
(a) Specifications. Each tablet
contains 100, 200, or 400 milligrams
(mg), or 1 gram (g) phenylbutazone.
Each bolus contains 1, 2, or 4 g
phenylbutazone.
*
*
*
*
*
§ 520.1846
■
[Removed]
15. Remove § 520.1846.
§ 520.1870
[Amended]
16. In § 520.1870, in paragraph
(c)(2)(iii), in the third sentence, remove
‘‘OTC’’ and in its place add ‘‘over the
counter’’.
■ 17. In § 520.1872, revise paragraph
(c)(1)(iii) and add reserved paragraph
(c)(2) to read as follows:
■
§ 520.1872 Praziquantel, pyrantel pamoate,
and febantel tablets.
*
*
*
*
*
(c) * * *
(1) * * *
(iii) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
(2) [Reserved]
■ 18. Revise § 520.2260a to read as
follows:
§ 520.2260a
boluses.
Sulfamethazine oblets and
(a) Specifications. Each oblet or bolus
contains:
(1) 2.5, 5, or 15 grams sulfamethazine.
(2) 5 grams sulfamethazine.
(b) Sponsors. See sponsors in
§ 510.600(c) of this chapter for use of
products described in paragraph (a) of
this section.
(1) No. 016592 for use of products
described in paragraph (a)(1) of this
section.
(2) No. 054771 for use of product
described in paragraph (a)(2) of this
section.
(c) Related tolerances. See § 556.670
of this chapter.
(d) Conditions of use. (1) Oblets and
boluses described in paragraph (a)(1) of
this section:
PO 00000
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Fmt 4700
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58961
(i) Amount. Administer as a single
dose 100 milligrams per pound (mg/lb)
of body weight the first day and 50 mg/
lb of body weight on each following
day.
(ii) Indications for use. (A) Beef cattle
and nonlactating dairy cattle. For the
treatment of bacterial pneumonia and
bovine respiratory disease complex
(shipping fever complex) (Pasteurella
spp.), colibacillosis (bacterial scours)
(Escherichia coli), necrotic
pododermatitis (foot rot)
(Fusobacterium necrophorum), calf
diphtheria (Fusobacterium
necrophorum), acute mastitis
(Streptococcus spp.), acute metritis
(Streptococcus spp.), and coccidiosis
(Eimeria bovis and E. zurnii).
(B) Horses. For the treatment of
bacterial pneumonia (secondary
infections associated with Pasteurella
spp.), strangles (Streptococcus equi),
and bacterial enteritis (Escherichia coli).
(iii) Limitations. Administer daily
until animal’s temperature and
appearance are normal. If symptoms
persist after using for 2 or 3 days consult
a veterinarian. Fluid intake must be
adequate. Treatment should continue 24
to 48 hours beyond the remission of
disease symptoms, but not to exceed 5
consecutive days. Follow dosages
carefully. Do not treat cattle within 10
days of slaughter. Do not use in female
dairy cattle 20 months of age or older.
Use of sulfamethazine in this class of
cattle may cause milk residues. A
withdrawal period has not been
established in preruminating calves. Do
not use in calves to be processed for
veal. Do not use in horses intended for
human consumption.
(2) Boluses described in paragraph
(a)(2) of this section:
(i) Amount. Administer 10 grams (2
boluses) of sulfamethazine per 100
pounds of body weight the first day,
then 5 grams (1 bolus) of sulfamethazine
per 100 pounds of body weight daily for
up to 4 additional consecutive days.
(ii) Indications for use. (A)
Ruminating beef and dairy calves. For
treatment of the following diseases
caused by organisms susceptible to
sulfamethazine: bacterial scours
(colibacillosis) caused by Escherichia
coli; necrotic pododermatitis (foot rot)
and calf diphtheria caused by
Fusobacterium necrophorum; bacterial
pneumonia associated with Pasteurella
spp.; and coccidiosis caused by Eimeria
bovis and E. zurnii.
(B) [Reserved]
(iii) Limitations. Do not administer for
more than 5 consecutive days. Do not
treat calves within 11 days of slaughter.
Do not use in calves to be slaughtered
under 1 month of age or in calves being
E:\FR\FM\29SER1.SGM
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Federal Register / Vol. 87, No. 188 / Thursday, September 29, 2022 / Rules and Regulations
fed an all milk diet. Do not use in female
dairy cattle 20 months of age or older;
such use may cause drug residues in
milk. Administer with adequate
supervision. Follow recommended
dosages carefully. Fluid intake must be
adequate. If symptoms persist after 2 or
3 days, consult a veterinarian.
■ 19. In § 520.2325a, revise paragraphs
(c)(4)(iii) and (d) to read as follows:
§ 520.2325a
solution.
Sulfaquinoxaline powder and
*
*
*
*
*
(c) * * *
(4) * * *
(iii) In lieu of treatment as provided
in paragraph (c)(4)(ii) of this section,
administer 1 teaspoon of 25 percent
sulfaquinoxaline soluble powder per
day for each 125 pounds of body weight
for 3 to 5 days in drinking water.
(d) Limitations. A withdrawal period
has not been established in
preruminating calves. Do not use in
calves to be processed for veal. Not for
use in lactating dairy cattle. Do not give
to chickens, turkeys, or cattle within 10
days of slaughter for food. Do not
medicate chickens or turkeys producing
eggs for human consumption. Federal
law restricts this drug to use by or on
the order of a licensed veterinarian.
■ 20. In § 520.2455, revise paragraph
(b)(3) to read as follows:
§ 520.2455
Tiamulin.
*
*
*
*
*
(b) * * *
(3) Nos. 016592, 051072, 051311, and
061133 for product described in
paragraph (a)(2) of this section.
*
*
*
*
*
■ 21. In § 520.2471, revise paragraph (b)
to read as follows:
§ 520.2471
Tilmicosin.
*
*
*
*
*
(b) Sponsors. See Nos. 016592 and
058198 in § 510.600(c) of this chapter.
*
*
*
*
*
■ 22. In § 520.2598, revise paragraph
(c)(2) to read as follows:
§ 520.2598
Trilostane.
khammond on DSKJM1Z7X2PROD with RULES
*
*
*
*
(c) * * *
(2) Indications for use. For the
treatment of pituitary-dependent and
adrenal-dependent
hyperadrenocorticism in dogs.
*
*
*
*
*
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
23. The authority citation for part 522
continues to read as follows:
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Jkt 256001
24. In § 522.533, revise paragraphs
(c)(1)(ii) and (c)(2)(ii) to read as follows:
§ 522.533
Deslorelin.
*
*
*
*
*
(c) * * *
(1) * * *
(ii) Indications for use. For inducing
ovulation within 48 hours in estrous
mares with an ovarian follicle greater
than 30 millimeters (mm) in diameter.
*
*
*
*
*
(c) * * *
(2) * * *
(ii) Indications for use. For inducing
ovulation within 48 hours in cyclic
estrous mares with an ovarian follicle
between 30 and 40 mm in diameter.
*
*
*
*
*
■ 25. In § 522.812, revise paragraph
(b)(2) to read as follows:
§ 522.812
Enrofloxacin.
*
*
*
*
*
(b) * * *
(2) Nos. 051311, 055529, 058005,
058198, and 061133 for use of product
described in paragraph (a)(2) of this
section as in paragraphs (e)(2) and (3) of
this section.
*
*
*
*
*
■ 26. Add § 522.1008 to read as follows:
§ 522.1008
Frunevetmab.
Medetomidine and vatinoxan.
(a) Specifications. Each milliliter of
solution contains 0.5 milligrams (mg)
medetomidine hydrochloride and 10 mg
vatinoxan hydrochloride.
(b) Sponsor. See No. 086155 in
§ 510.600(c) of this chapter.
(c) Conditions of use—(1) Amount.
Administer by intramuscular injection a
dose based on body surface area (BSA).
Calculate the dose using 1 mg
medetomidine per square meter (/m2)
BSA or use the dosing table provided in
labeling.
PO 00000
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Fmt 4700
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(2) Indications for use. For use as a
sedative and analgesic in dogs to
facilitate clinical examination, clinical
procedures, and minor surgical
procedures.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
■ 28. In § 522.2615, revise paragraph
(d)(3)(iii) to read as follows:
§ 522.2615
Tripelennamine.
*
*
*
*
*
(d) * * *
(3) * * *
(iii) Limitations. Milk taken during
treatment and for 24 hours after the last
treatment must not be used for human
consumption. Cattle must not be
slaughtered for human consumption
within 4 days following the last
treatment with this drug product. Not
for use in beef calves less than 2 months
of age, dairy calves, and veal calves. A
withdrawal period has not been
established for this product in preruminating calves. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
■ 29. In § 522.2630, revise paragraphs
(b)(1) and (2) to read as follows:
§ 522.2630
Tulathromycin.
*
(a) Specifications. Each milliliter (mL)
of solution contains 7 milligrams (mg)
frunevetmab.
(b) Sponsor. See No. 054771 in
§ 510.600(c) of this chapter.
(c) Conditions of use—(1) Cats—(i)
Amount. Administer once a month by
subcutaneous injection the full contents
of one or two 1-mL vials to achieve a
minimum dosage of 0.45 mg/lb (1 mg/
kg) body weight.
(ii) Indications for use. For the control
of pain associated with osteoarthritis in
cats.
(iii) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
(2) [Reserved]
■ 27. Add § 522.1338 to read as follows:
§ 522.1338
*
■
Authority: 21 U.S.C. 360b.
■
*
*
*
*
(b) * * *
(1) Nos. 000061, 013744, 051311,
054771, 055529, 058198, and 061133 for
use of product described in paragraph
(a)(1) as in paragraphs (d)(1)(i), (d)(1)(ii),
(d)(1)(iii)(A), and (d)(2) of this section.
(2) Nos. 013744, 051311, 054771, and
058198 for use of product described in
paragraph (a)(2) as in paragraphs
(d)(1)(i), (d)(1)(ii)(B), (d)(1)(iii)(B), and
(d)(2) of this section.
*
*
*
*
*
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
30. The authority citation for part 524
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
■
31. Add § 524.230 to read as follows:
§ 524.230
Buprenorphine.
(a) Specifications. Each milliliter (mL)
of solution contains 20 milligrams (mg)
buprenorphine. The drug is supplied in
tubes containing 0.4 mL (8 mg) or 1.0
mL (20 mg).
(b) Sponsor. See No. 058198 in
§ 510.600(c) of this chapter.
(c) Conditions of use in cats—(1)
Amount. Administer topically to the
dorsal cervical area at the base of the
skull a single dose of 1.2 to 3.1 mg/lb
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(2.7 to 6.7 mg/kg) approximately 1 to 2
hours before surgery.
(2) Indications for use. For the control
of postoperative pain associated with
surgical procedures in cats.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian. Buprenorphine
is a Schedule III controlled substance.
■ 32. In § 524.1001, revise the section
heading and paragraph (a) to read as
follows:
§ 524.1001
§ 524.2098
Fluralaner and moxidectin.
(a) Specifications. Each milliliter of
solution contains 280 milligram (mg)
fluralaner and 14 mg moxidectin. Each
individually packaged tube contains
either 112.5 mg fluralaner and 5.6 mg
moxidectin; 250 mg fluralaner and 12.5
mg moxidectin; or 500 mg fluralaner
and 25 mg moxidectin.
*
*
*
*
*
■ 33. In § 524.1146, revise paragraphs
(b)(1) and (2) to read as follows:
§ 524.1146
described in paragraph (a)(1) of this
section as in paragraph (d)(1) of this
section.
(2) Nos. 017030, 051072, 055529,
058198, and 061651 for use of product
described in paragraph (a)(2) of this
section as in paragraph (d)(2) of this
section.
*
*
*
*
*
■ 34. In § 524.2098, revise paragraph (b)
to read as follows:
Imidacloprid and moxidectin.
*
Selamectin.
*
*
*
*
*
(b) Sponsors. See Nos. 051072,
054771, 055529, 061133, and 061651 in
§ 510.600(c) of this chapter.
*
*
*
*
*
37. In § 529.2110, revise paragraph (b)
to read as follows:
■
§ 529.2110
Sevoflurane.
*
*
*
*
*
(b) Sponsors. See Nos. 017033,
054771, and 066794 in § 510.600(c) of
this chapter.
*
*
*
*
*
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
38. The authority citation for part 558
continues to read as follows:
■
PART 529—CERTAIN OTHER DOSAGE
FORM NEW ANIMAL DRUGS
Authority: 21 U.S.C. 354, 360b, 360ccc,
360ccc-1, 371.
35. The authority citation for part 529
continues to read as follows:
■
■
Authority: 21 U.S.C. 360b.
36. In § 529.1186, revise paragraph (b)
to read as follows:
■
*
*
*
*
(b) * * *
(1) Nos. 017030, 051072, 055529,
058198, and 061651 for use of product
(b) Sponsors. See Nos. 017033,
054771, 065085, and 066794 in
§ 510.600(c) of this chapter.
*
*
*
*
*
§ 529.1186
Isoflurane.
*
*
*
*
39. In § 558.4, in paragraph (d), in the
‘‘Category II’’ table, revise the entry for
‘‘Nicarbazin (powder)’’ to read as
follows:
§ 558.4 Requirement of a medicated feed
mill license.
*
*
*
*
(d) * * *
*
*
CATEGORY II
Assay limits
percent 1 type
A
Drug
*
*
*
Nicarbazin (powder) ...................................................
*
* * * * * * *.
*
*
§ 558.128
■
*
Chlortetracycline amount
*
(iii) to provide 0.5 mg/lb of
body weight daily.
VerDate Sep<11>2014
*
16:48 Sep 28, 2022
*
*
*
9.08 g/lb (2.00%) .......................................................
*
*
*
*
*
*
40. In § 558.128, revise paragraphs
(e)(4)(iii) and (xli) to read as follows:
khammond on DSKJM1Z7X2PROD with RULES
96–104
*
Chlortetracycline.
*
*
(e) * * *
Assay limits
percent 1 type B/
C2
Type B maximum
(100x)
*
*
(4) * * *
Indications for use
Limitations
*
................................................
*
*
Beef cattle (over 700 lb): For
control of active infection of
anaplasmosis caused by
Anaplasma marginale susceptible to chlortetracycline.
*
Feed to provide chlortetracycline at the rate of 0.5
mg per pound of body
weight daily. Withdraw 48
hours prior to slaughter. To
sponsor Nos. 054771 and
069254: Zero withdrawal
time.
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*
*
Combination
in grams/ton
Jkt 256001
*
85–115/80–120
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E:\FR\FM\29SER1.SGM
29SER1
Sponsor
*
054771
066104
069254
58964
Federal Register / Vol. 87, No. 188 / Thursday, September 29, 2022 / Rules and Regulations
Combination
in grams/ton
Chlortetracycline amount
*
*
*
(xli) 25 to 2,800 g/ton to proLasalocid, 30 to 181.8;
vide 350 mg/head/day.
melengestrol acetate, 0.25
to 2 g/ton to provide 0.25 to
0.5 mg/head/day
melengestrol acetate.
*
* * * * * * *.
*
*
*
*
*
*
Limitations
*
*
Growing beef heifers fed in
confinement for slaughter
under 700 pounds: For
control of active infection of
anaplasmosis caused by
Anaplasma marginale susceptible to chlortetracycline,
control of coccidiosis
caused by Eimeria bovis
and E. zuernii, increased
rate of weight gain, improved feed efficiency, and
suppression of estrus
(heat).
*
The melengestrol acetate
Type C top-dress medicated feed must be top
dressed onto or mixed at
feeding with a Type C
medicated feed containing
25 to 2,800 g/ton of chlortetracycline and 30 to 181.8
g/ton lasalocid to provide
350 mg chlortetracycline
per head per day and 1 mg
lasalocid per 2.2 lb. of body
weight daily with a maximum of 360 mg lasalocid
per head per day. See
§ 558.311(d) of this chapter. Chlortetracycline,
lasalocid, and melengestrol
as provided by No. 054771
in § 510.600(c) of this chapter.
*
*
headings, and paragraphs (e)(2)(i) and
(e)(3) through (5) to read as follows:
*
41. In § 558.258, revise paragraph
(e)(1), paragraph (e)(2) table column
■
khammond on DSKJM1Z7X2PROD with RULES
Indications for use
Fenbendazole
grams per ton
Combination
grams per ton
Indications for use
(i) 14.5 .....................................
................................................
(ii) [Reserved] ..........................
................................................
Growing turkeys: For the
treatment and control of
gastrointestinal worms:
roundworms, adults and
larvae (Ascaridia
dissimilis); cecal worms,
adults and larvae
(Heterakis gallinarum), an
important vector of
Histomonas meleagridis
(Blackhead).
................................................
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Jkt 256001
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Sponsor
*
§ 558.258
*
054771
*
Fenbendazole.
*
*
(e) * * *
(1) * * *
*
*
Limitations
Feed continuously as the
sole ration for 6 days. For
growing turkeys only.
................................................
E:\FR\FM\29SER1.SGM
*
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000061
........................
58965
Federal Register / Vol. 87, No. 188 / Thursday, September 29, 2022 / Rules and Regulations
(2) Swine.
Fenbendazole
grams per ton
Combination
grams per ton
Indications for use
Limitations
(i) 10 to 300 ......................
.........................
Swine: For the treatment and control of Lungworms:
adult
(Metastrongylus
apri
and
M.
pudendotectus); Gastrointestinal worms: adult and
larvae (L3, 4 stages—liver, lung, intestinal forms)
large roundworms (Ascaris suum); adult nodular
worms
(Oesophagostomum
dentatum,
O.
quadrispinulatum); adult small stomach worms
(Hyostrongylus rubidus); adult and larvae (L2, 3,
4 stages—intestinal mucosal forms) whipworms
(Trichuris suis); and Kidney worms: adult and larvae (Stephanurus dentatus).
Feed as the sole ration to
provide 9 mg/kg of
body weight (4.08 mg/
lb) over a period of 3 to
12 consecutive days.
Swine must not be
slaughtered for human
consumption within 4
days following last
treatment with this drug
product.
*
*
*
*
*
*
Sponsor
000061
*
(3) Cattle.
Fenbendazole
grams per ton
Indications for use
Limitations
(i) 200 to 1,000 ..............
Dairy and beef cattle: For the treatment and control of: Lungworms: adult (Dictyocaulus
viviparus); Stomach worms: adult brown stomach worms (Ostertagia ostertagi), adult and
fourth-stage
larvae
barberpole
worms
(Haemonchus contortus), fourth-stage larvae
barberpole worms (H. placei), and adult and
fourth-stage larvae small stomach worms
(Trichostrongylus axei); Intestinal worms (adult
and
fourth-stage
larvae):
hookworms
(Bunostomum phlebotomum), thread-necked
intestinal worms (Nematodirus helvetianus),
small intestinal worms (Cooperia punctata and
C.
oncophora),
bankrupt
worms
(Trichostrongylus colubriformis), and nodular
worms (Oesophagostomum radiatum).
...............................................................................
Feed as the sole ration for 1 day to provide 5
mg/kg body weight (2.27 mg/lb). Milk taken
during treatment and for 60 hours after the last
treatment must not be used for human consumption. Cattle must not be slaughtered for
human consumption within 13 days following
last treatment with this drug product. Not for
use in beef calves less than 2 months of age,
dairy calves, and veal calves. A withdrawal period has not been established for this product
in pre-ruminating calves.
000061
...............................................................................
........................
(ii) [Reserved] ................
khammond on DSKJM1Z7X2PROD with RULES
(iii) Top dress medicated feed—(A)
Proprietary formulas. The following
feed can be manufactured only per an
Sponsor
approved proprietary formula and
specifications:
Fenbendazole
concentration
Indications for use
Limitations
(1) 2.27 g/lb ...................
Beef and dairy cattle: For the treatment and control of: Lungworms: adult (Dictyocaulus
viviparus); Stomach worms: adult brown stomach worms (Ostertagia ostertagi), adult and
fourth-stage
larvae
barberpole
worms
(Haemonchus contortus), fourth-stage larvae
barberpole worms (H. placei), and adult and
fourth-stage larvae small stomach worms
(Trichostrongylus axei); Intestinal worms (adult
and
fourth-stage
larvae):
hookworms
(Bunostomum phlebotomum), thread-necked
intestinal worms (Nematodirus helvetianus),
small intestinal worms (Cooperia punctata and
C.
oncophora),
bankrupt
worms
(Trichostrongylus colubriformis), and nodular
worms (Oesophagostomum radiatum).
...............................................................................
Feed as a top dress for 1 day to provide 5 mg/
kg body weight (2.27 mg/lb). Milk taken during
treatment and for 60 hours after the last treatment must not be used for human consumption. Cattle must not be slaughtered for human
consumption within 13 days following last
treatment with this drug product. Not for use in
beef calves less than 2 months of age, dairy
calves, and veal calves. A withdrawal period
has not been established for this product in
pre-ruminating calves.
000061
...............................................................................
........................
(2) [Reserved] ................
(B) [Reserved]
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(iv) Free-choice medicated feeds—(A)
Proprietary formulas (21 CFR
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Sponsor
510.455(e)(2)). The following feeds can
be manufactured only per an approved
proprietary formula and specifications:
E:\FR\FM\29SER1.SGM
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58966
Federal Register / Vol. 87, No. 188 / Thursday, September 29, 2022 / Rules and Regulations
Fenbendazole
concentration
Indications for use
Limitations
(1) 12,100 g/ton mineral
Beef cattle on pasture: For the treatment and
control of: Lungworms: adult (Dictyocaulus
viviparus); Stomach worms: adult brown stomach worms (Ostertagia ostertagi), adult and
fourth-stage
larvae
barberpole
worms
(Haemonchus contortus), fourth-stage larvae
barberpole worms (H. placei), and adult and
fourth-stage larvae small stomach worms
(Trichostrongylus axei); Intestinal worms (adult
and
fourth-stage
larvae):
hookworms
(Bunostomum phlebotomum), thread-necked
intestinal worms (Nematodirus helvetianus),
small intestinal worms (Cooperia punctata and
C.
oncophora),
bankrupt
worms
(Trichostrongylus colubriformis), and nodular
worms (Oesophagostomum radiatum).
Beef cattle on pasture: For the treatment and
control of: Lungworms: adult (Dictyocaulus
viviparus); Stomach worms: adult brown stomach worms (Ostertagia ostertagi), adult and
fourth-stage
larvae
barberpole
worms
(Haemonchus contortus), fourth-stage larvae
barberpole worms (H. placei), and adult and
fourth-stage larvae small stomach worms
(Trichostrongylus axei); Intestinal worms (adult
and
fourth-stage
larvae):
hookworms
(Bunostomum phlebotomum), thread-necked
intestinal worms (Nematodirus helvetianus),
small intestinal worms (Cooperia punctata and
C.
oncophora),
bankrupt
worms
(Trichostrongylus colubriformis), and nodular
worms (Oesophagostomum radiatum).
Feed free-choice at the rate of 0.0375 lb per 100
pounds of body weight over a 3- to 6-day period to provide a total of 2.27 mg fenbendazole
per pound of body weight. Not for use in dairy
cattle. Beef cattle must not be slaughtered for
human consumption within 13 days following
last treatment with this drug product. Not for
use in beef calves less than 2 months of age,
dairy calves, and veal calves. A withdrawal period has not been established for this product
in pre-ruminating calves.
000061
Feed free-choice at the rate of 0.10 lb (1.6 oz)
per 100 pounds of body weight over a 3- to 6day period, to deliver a total of 2.27 mg
fenbendazole per pound of body weight. Not
for use in dairy cattle. Beef cattle must not be
slaughtered for human consumption within 13
days following last treatment with this drug
product. Not for use in beef calves less than 2
months of age, dairy calves, and veal calves.
A withdrawal period has not been established
for this product in pre-ruminating calves.
000061
(2) 2.27 g/lb mineral ......
(B) Published formulas
(§ 510.455(e)(1) of this chapter). The
following feeds can be manufactured
only per one of the formulas and
specifications published below:
(1) Amount. 5 mg/kg body weight
(2.27 mg/lb), including the following
formulations:
Ingredient 1
khammond on DSKJM1Z7X2PROD with RULES
Sponsor
Percent
(i) Free-choice, dry Type C feed:
Salt (sodium chloride) ...........................................................................................................................
Monosodium phosphate .......................................................................................................................
Dried cane molasses ............................................................................................................................
Zinc sulfate ...........................................................................................................................................
Copper sulfate ......................................................................................................................................
Fenbendazole 20% Type A article .......................................................................................................
(ii) Free-choice, dry Type C feed:
Salt (sodium chloride) ...........................................................................................................................
Dicalcium phosphate (18.5% P) ...........................................................................................................
Calcium carbonate (38% Ca) ...............................................................................................................
Magnesium oxide (56% Mg) ................................................................................................................
Zinc sulfate ...........................................................................................................................................
Mineral oil .............................................................................................................................................
Dried cane molasses (46% sugars) .....................................................................................................
Potassium iodide ..................................................................................................................................
Fenbendazole 20% Type A article .......................................................................................................
(iii) Free-choice, liquid Type C feed 2:
Cane molasses 3 ...................................................................................................................................
Water ....................................................................................................................................................
Urea solution, 55% ...............................................................................................................................
Phosphoric acid 75% (feed grade) .......................................................................................................
Xantham gum .......................................................................................................................................
Trace minerals 4 ....................................................................................................................................
Vitamin premix 4 ....................................................................................................................................
Fenbendazole 20% Type A article .......................................................................................................
International Feed
No.
59.00
31.16
3.12
0.76
0.45
5.51
6–04–152
6–04–288
4–04–695
6–05–556
6–01–720
n/a
35.93
32.44
15.93
10.14
1.47
1.00
0.98
0.01
2.10
6–04–152
6–00–080
6–01–069
6–02–756
6–05–556
8–03–123
4–04–695
6–03–759
n/a
80.902
9.36
7.05
2.00
0.20
0.20
0.01
0.278
4–13–251
n/a
5–05–707
6–03–707
8–15–818
n/a
n/a
n/a
1 Formulation modifications require FDA approval prior to marketing. Selenium is not approved for use in the liquid, free-choice formulations
described in paragraph (e)(3)(iv)(B) of this section. Free-choice cattle feeds containing selenium must comply with published regulations (see 21
CFR 573.920).
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Federal Register / Vol. 87, No. 188 / Thursday, September 29, 2022 / Rules and Regulations
58967
2 The
labeling for the liquid free-choice Type C medicated feed must bear an expiration date of 12 weeks after the date of manufacture.
percentage of cane molasses and water in the formulation may be adjusted as needed to bring the brix value of the molasses to the industry standard of 79.5 brix.
4 The contents of any added vitamin and trace mineral may be varied; however, they should be comparable to those used by the manufacturer
for other free-choice cattle feeds.
3 The
(2) Indications for use. As in
paragraph (e)(3)(i) of this section.
(3) Limitations. Feed a total of 5 mg
of fenbendazole per kg (2.27 mg/lb) of
body weight to cattle over a 3- to 6-day
period. Milk taken during treatment and
for 60 hours after the last treatment
must not be used for human
consumption. Cattle must not be
slaughtered for human consumption
within 13 days following last treatment
with this drug product. Not for use in
beef calves less than 2 months of age,
dairy calves, and veal calves. A
withdrawal period has not been
established for this product in preruminating calves.
(4) Horses.
Fenbendazole
grams per ton
Indications for use
Limitations
(i) 4,540 .........................
5 mg/kg body weight (2.27 mg/lb) for the control
of large strongyles (Strongylus edentatus, S.
equinus, S. vulgaris, Triodontophorus spp.),
small
strongyles
(Cyathostomum
spp.,
Cylicocyclus spp., Cylicostephanus spp.), and
pinworms (Oxyuris equi); 10 mg/kg body
weight (4.54 mg/lb) for the control of ascarids
(Parascaris equorum).
(ii) [Reserved] ................
...............................................................................
Feed at the rate of 0.1 lb of feed per 100 lb of
body weight to provide 2.27 mg fenbendazole/
lb of body weight in a 1-day treatment or 0.2
lb of feed per 100 lb of body weight to provide
4.54 mg fenbendazole/lb of body weight in a
1-day treatment. All horses must be eating
normally to ensure that each animal consumes
an adequate amount of the medicated feed.
Do not use in horses intended for human consumption.
...............................................................................
........................
Sponsor
Sponsor
000061
(5) Zoo and wildlife animals.
Fenbendazole
grams per ton
Indications for use
Limitations
(i) Feral swine (Sus
scrofa):.
90 to 325 ...............
Use as a complete feed at a rate to provide 3 mg/
kg/day for 3 consecutive days. Prior withdrawal
of feed or water is not necessary. Retreatment
may be required in 6 weeks. Do not use 14
days before or during the hunting season.
000061
(ii) Ruminants (subfamily
Antilopinae,
Hippotraginae,
Caprinae).
50 to 300 ...............
Use as a complete feed at a rate to provide 2.5
mg/kg/day for 3 consecutive days. Prior withdrawal of feed or water is not necessary. Retreatment may be required in 6 weeks. Do not
use 14 days before or during the hunting season.
000061
(iii) Rocky mountain bighorn sheep (Ovis c.
canadensis).
375 to 1,000 ..........
For the treatment and
control of kidney worm
(Stephanurus
dentatus), roundworm
(Ascaris suum), nodular worm
(Oesophagostomum
dentatum).
For the treatment and
control of small stomach worm
(Trichostrongylus
spp.), thread necked
intestinal worm
(Nematodirus spp.),
barberpole worm
(Haemonchus spp.),
whipworm (Trichuris
spp.).
For the treatment and
control of
Protostrongylus spp..
Use as a complete feed at a rate to provide 10
mg/kg/day for 3 consecutive days. Prior withdrawal of feed or water is not necessary. Retreatment may be required in 6 weeks. Do not
use 14 days before or during the hunting season.
000061
khammond on DSKJM1Z7X2PROD with RULES
Species/Class
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Federal Register / Vol. 87, No. 188 / Thursday, September 29, 2022 / Rules and Regulations
*
*
*
§ 558.633
*
*
[Amended]
42. In § 558.633, in paragraph (d)(3),
remove the first sentence.
■
Dated: September 20, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–20836 Filed 9–28–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 300
[TD 9966]
RIN 1545–BQ17
User Fees Relating to Enrolled Agents
and Enrolled Retirement Plan Agents
Internal Revenue Service (IRS),
Treasury.
ACTION: Final regulations.
AGENCY:
These final regulations amend
existing regulations relating to user fees
for enrolled agents and enrolled
retirement plan agents. The final
regulations increase the renewal user fee
for enrolled retirement plan agents from
$67 to $140. In addition, the final
regulations increase both the enrollment
and renewal of enrollment user fees for
enrolled agents from $67 to $140. These
regulations affect individuals who are or
apply to become enrolled agents and
individuals who are enrolled retirement
plan agents. The Independent Offices
Appropriation Act of 1952 authorizes
charging user fees.
DATES:
Effective date: These regulations are
effective October 31, 2022.
Applicability date: For the date of
applicability, see §§ 300.5(d), 300.6(d),
and 300.09(d).
FOR FURTHER INFORMATION CONTACT:
Mark Shurtliff at (202) 317–6845 (not a
toll-free number).
SUPPLEMENTARY INFORMATION:
SUMMARY:
khammond on DSKJM1Z7X2PROD with RULES
Background
This document contains amendments
to the regulations in 26 CFR part 300—
User Fees. On March 1, 2022, a notice
of proposed rulemaking (REG–114209–
21) and notice of public hearing was
published in the Federal Register (87
FR 11366). The document proposed
amending the regulations relating to the
user fees for enrolled agents and
enrolled retirement plan agents. The
document proposed increasing the
amount of the renewal user fee for
VerDate Sep<11>2014
16:48 Sep 28, 2022
Jkt 256001
enrolled retirement plan agents from
$67 to $140. In addition, the document
proposed increasing both the enrollment
and renewal of enrollment user fees for
enrolled agents from $67 to $140. The
document contains a detailed
explanation of the legal background and
user fee calculations regarding the
amendments to these regulations.
Six comments responding to the
notice of proposed rulemaking were
received, including comments from the
National Association of Enrolled Agents
(NAEA). On May 3, 2022,
representatives from the NAEA,
Department of the Treasury (Treasury
Department), the IRS, and the Small
Business Administration (SBA), held a
teleconference to listen to NAEA’s
comments about the proposed
rulemaking. In addition, two requests to
speak at the scheduled public hearing
were received. A public hearing was
held on May 11, 2022. After
consideration of the written comments,
teleconference comments, and
testimony at the public hearing, the
Treasury Department and the IRS have
decided to adopt without modification
the regulations proposed by the notice
of proposed rulemaking.
Summary of Comments
The six comments submitted in
response to the notice of proposed
rulemaking and a summary of the
teleconference comments are available
at www.regulations.gov or upon request.
Some of the comments that were
submitted did not seek modification or
clarification of the user fee as set forth
in the proposed regulations. One
commenter expressed concern with how
the special enrollment examination for
enrolled agents (EA SEE) is being
administered. The commenter also
recommended using the user fees in
these regulations to provide resources
for tax professionals that would improve
the service they provide to their clients.
The user fees in these regulations are
not used by the Treasury Department or
the IRS to administer the EA SEE, or to
provide resources for tax professionals
that improve the service they provide to
their clients. Therefore, comments
regarding the EA SEE and additional
resources identified by the commenter
are outside the scope of these
regulations. Another commenter
suggested that the IRS should raise the
amount of the user fee to apply for or
renew a preparer tax identification
number (PTIN) in order to (1) lower the
cost of user fees relating to enrolled
agents and (2) encourage more
individuals to become enrolled agents.
These regulations do not relate to the
PTIN user fee or the PTIN program.
PO 00000
Frm 00022
Fmt 4700
Sfmt 4700
Therefore, comments regarding the
PTIN program and related user fees are
outside the scope of these regulations.
Finally, one commenter suggested that it
is inconsistent for the IRS to charge user
fees in order to administer the
enrollment and renewal of enrollment
program but not charge user fees for
other programs (for example,
participation in the Annual Filing
Season Program). Again, comments
regarding programs other than the
enrollment and renewal of enrollment
program are outside the scope of these
regulations. The summary of comments
below addresses those comments that
make recommendations concerning or
seeking clarification of the user fees set
forth in the proposed regulations
relating to the user fees for enrolled
agents and enrolled retirement plan
agents.
A. Amount of User Fees
Four commenters expressed concern
with the overall amount of the proposed
enrollment and renewal of enrollment
user fees and requested information
regarding why the user fees are
required.
The Independent Offices
Appropriation Act of 1952 (IOAA) (31
U.S.C. 9701) authorizes each agency to
promulgate regulations establishing the
charge for services provided by the
agency. The IOAA states that the
services provided by an agency should
be self-sustaining to the extent possible.
31 U.S.C. 9701(a). The IOAA provides
that user fee regulations are subject to
policies prescribed by the President,
which are currently set forth in the
Office of Management and Budget
(OMB) Circular A–25 (OMB Circular),
58 FR 38142 (July 15, 1993).
Section 6a(1) of OMB Circular A–25
states that when a service offered by a
Federal agency provides special benefits
to identifiable recipients beyond those
accruing to the general public, the
agency should establish a user fee to
recover the full cost of providing the
service. An agency that seeks to impose
a user fee for government-provided
services must calculate the full cost of
providing those services.
In accordance with OMB Circular A–
25, the IRS Return Preparer Office (RPO)
completed its 2021 biennial review of
the enrollment and renewal of
enrollment user fees associated with
enrolled agents and enrolled retirement
plan agents. As discussed in the notice
of proposed rulemaking, during its
review the RPO took into account the
increase in labor, benefits, and overhead
costs incurred in connection with
providing enrollment services to
individuals who enroll or renew
E:\FR\FM\29SER1.SGM
29SER1
]]>Agencies
[Federal Register Volume 87, Number 188 (Thursday, September 29, 2022)]
[Rules and Regulations]
[Pages 58957-58968]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-20836]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 515, 516, 520, 522, 524, 529, and 558
[Docket No. FDA-2022-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications;
Withdrawal of Approval of New Animal Drug Applications; Change of
Sponsor; Change of Sponsor Name and Address
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is amending the
animal drug regulations to reflect application-related actions for new
animal drug applications (NADAs) and abbreviated new animal drug
applications (ANADAs) during January, February, and March 2022. FDA is
informing the public of the availability of summaries of the basis of
approval and of environmental review documents, where applicable. The
animal drug regulations are also being amended to improve the accuracy
of the regulations.
DATES: This rule is effective September 29, 2022.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-402-5689,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Approvals
FDA is amending the animal drug regulations to reflect approval
actions for NADAs and ANADAs during January, February, and March 2022,
as listed in table 1. In addition, FDA is informing the public of the
availability, where applicable, of documentation of environmental
review required under the National Environmental Policy Act (NEPA) and,
for actions requiring
[[Page 58958]]
review of safety or effectiveness data, summaries of the basis of
approval (FOI Summaries) under the Freedom of Information Act (FOIA).
These public documents may be seen in the office of the Dockets
Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday
through Friday, 240-402-7500. Persons with access to the internet may
obtain these documents at the CVM FOIA Electronic Reading Room: https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room. Marketing exclusivity and patent information may be
accessed in FDA's publication, ``Approved Animal Drug Products Online
(Green Book)'' at: https://www.fda.gov/animal-veterinary/products/approved-animal-drug-products-green-book.
FDA has verified the website addresses as of the date this document
publishes in the Federal Register, but websites are subject to change
over time.
Table 1--Original and Supplemental NADAs and ANADAs Approved During January, February, and March 2022
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effect of the
Approval date File No. Sponsor Product name Species action Public documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
January 10, 2022............... 131-675 Intervet, Inc., 2 SAFE-GUARD Cattle............. Supplemental ....................
Giralda Farms, (fenbendazole), approval to
Madison, NJ 07940. Type A Medicated establish
Article. withdrawal periods
in accordance with
repartitioning of
acceptable daily
intake; and to add
fourth-stage
larval indications
for certain
endoparasites of
cattle.
January 13, 2022............... 141-546 Zoetis Inc, 333 SOLENSIA Cats............... Original approval FOI Summary.
Portage St., (frunevetmab for the control of
Kalamazoo, MI 49007. injection), pain associated
Injectable Solution. with
osteoarthritis.
January 20, 2022............... 141-547 Elanco US Inc., 2500 ZORBIUM Cats............... Original approval FOI Summary.
Innovation Way, (buprenorphine for the control of
Greenfield, IN transdermal postoperative pain
46140. solution), associated with
Transdermal surgical
Solution. procedures.
January 25, 2022............... 200-707 Huvepharma EOOD, 5th TILMOVET AC Swine.............. Original approval FOI Summary.
Floor, 3A Nikolay (tilmicosin), as a generic copy
Haytov Str.,1113 Solution. of NADA 141-361.
Sofia, Bulgaria.
January 28, 2022............... 200-716 Norbrook MIDAMOX for Dogs Dogs............... Original approval FOI Summary.
Laboratories Ltd., (imidacloprid and as a generic copy
Carnbane Industrial moxidectin), of NADA 141-251.
Estate, Newry, Topical Solution.
County Down, BT35
6QQ, United Kingdom.
February 7, 2022............... 200-665 Elanco US Inc., 2500 INCREXXA 25 Cattle and Swine... Original approval FOI Summary.
Innovation Way, (tulathromycin as a generic copy
Greenfield, IN injection), of NADA 141-349.
46140. Injectable Solution.
February 7, 2022............... 200-717 Aurora TIAGARD 12.5% Swine.............. Original approval FOI Summary.
Pharmaceutical, (tiamulin hydrogen as a generic copy
Inc,1196 Highway 3 fumarate), Liquid of NADA 140-916.
South, Northfield, Concentrate.
MN 55057-3009.
February 7, 2022............... 200-718 ......do............ BARRIER for Dogs Dogs............... Original approval FOI Summary.
(imidacloprid and as a generic copy
moxidectin), of NADA 141-251.
Topical Solution.
February 9, 2022............... 200-715 Intervet, Inc., 2 AROVYN Cattle and Swine... Original approval FOI Summary.
Giralda Farms, (tulathromycin as a generic copy
Madison, NJ 07940. injection), of NADA 141-244.
Injectable Solution.
March 11, 2022................. 200-720 Norbrook ENROFLOX Dogs............... Original approval FOI Summary.
Laboratories Ltd., (enrofloxacin), as a generic copy
Carnbane Industrial Chewable Tablets. of NADA 140-441.
Estate, Newry,
County Down, BT35
6QQ, United Kingdom.
March 23, 2022................. 200-723 ......do............ TULIEVE Cattle and Swine... Original approval FOI Summary.
(tulathromycin as a generic copy
injection), of NADA 141-244.
Injectable Solution.
March 28, 2022................. 200-721 ......do............ MIDAMOX for Cats Cats............... Original approval FOI Summary.
(imidacloprid and as a generic copy
moxidectin), of NADA 141-254.
Topical Solution.
March 28, 2022................. 200-722 ......do............ FIROX (firocoxib), Dogs............... Original approval FOI Summary.
Chewable Tablets. as a generic copy
of NADA 141-230.
March 28, 2022................. 200-688 Virbac AH, Inc., P.O TENOTRYL Cattle and Swine... Original approval FOI Summary.
.Box 162059, Fort (enrofloxacin), as a generic copy
Worth, TX 76161. Injectable Solution. of NADA 141-068.
March 30, 2022................. 141-551 Vetcare Oy, P.O. Box ZENALPHA Dogs............... Original approval FOI Summary.
26 (Liedontie 45), (medetomidine and for use as a
M[auml]nts[auml]l[a vatinoxan sedative and
uml], Uusimaa, injection). analgesic to
04601, Finland. facilitate
clinical
examination,
clinical
procedures, and
minor surgical
procedures.
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 58959]]
II. Withdrawals of Approval
Lloyd, Inc., 604 W. Thomas Ave., Shenandoah, IA 51601, has
requested that FDA withdraw approval of NADA 140-908 for VET-METH
Bolus, a bolus containing sulfamethazine for use in cattle because the
product is no longer manufactured or marketed. As provided in the
regulatory text of this document, the animal drug regulations in 21 CFR
520.2260a are amended to reflect this action.
Ridley USA, Inc., 111 W. Cherry St., Suite 500, Mankato, MN 56001,
has requested that FDA withdraw approval of NADA 136-214 for VMS Bloat
Blox, an oral dosage form containing polyoxyethylene (23) lauryl ether
for use in beef and nonlactating dairy cattle because the product is no
longer manufactured or marketed. As provided in the regulatory text of
this document, the animal drug regulations in 21 CFR 520.1846 are
amended to reflect this action.
III. Changes of Sponsorship
Halocarbon Products Corp., 6525 The Corners Pkwy., Suite 200,
Peachtree Corners, GA 30092 has informed FDA that it has transferred
ownership of, and all rights and interest in, ANADA 200-129 for
Isoflurane, USP and ANADA 200-467 for Sevoflurane to Dechra Veterinary
Products LLC, 7015 College Blvd., Suite 525, Overland Park, KS 66211.
As provided in the regulatory text, the animal drug regulations in 21
CFR 529.1186 and 529.2110, respectively, are amended to reflect these
changes of sponsorship.
IV. Change of Sponsor's Name and Address
Mylan Institutional, Inc., 12720 Dairy Ashford Rd., Sugar Land, TX
77478 has informed FDA that it has changed its name and address to
Mylan Institutional, Inc., a Viatris Company, 3711 Collins Ferry Rd.,
Morgantown, WV 26505. As provided in the regulatory text, the animal
drug regulations in Sec. 510.600(c) (21 CFR 510.600(c)) are amended to
reflect this change of a sponsor's name and address.
V. Technical Amendments
FDA is making the following amendments to improve the accuracy of
the animal drug regulations:
Section 510.600 is amended to remove the entry for
Halocarbon Products Corp. from, and add Vetcare Oy to, the list of
sponsors of approved applications. The entries for Mylan Institutional,
Inc. and Norbrook Laboratories Ltd. are revised as well.
21 CFR 516.812 is amended to reflect a current drug
labeler code for a use of enrofloxacin injectable solution in cattle.
21 CFR 520.88g is amended reflect a current sponsor drug
labeler code and revised indications for use of tablets containing
amoxicillin and clavulanate in dogs and cats.
21 CFR 520.530 is amended to conform to content codified
for animal drugs available by veterinary prescription.
21 CFR 520.905a is amended to reflect revised conditions
of use for fenbendazole suspension in horses.
21 CFR 520.928 is amended to reflect correct directions
for administration of firocoxib chewable tablets in dogs.
21 CFR 520.1242a is amended to reflect revised indications
for use of a levamisol powder in cattle and sheep.
21 CFR 520.1720a is amended to correct an error in the
strength of approved phenylbutazone boluses.
21 CFR 520.1870 is amended to remove an undefined acronym
in the conditions for use of praziquantel tablets.
21 CFR 520.1872 is amended to conform to content codified
for animal drugs available by veterinary prescription.
21 CFR 520.2325a is amended to reflect instructions for
use of sulfaquinoxaline powder and solution in poultry and cattle.
21 CFR 520.2598 is amended to reflect revised indications
for use for trilostane capsules in dogs.
21 CFR 522.533 is amended to revise the indications for
use of deslorelin injectable solution in mares.
21 CFR 522.2615 is amended to reflect revised human food
safety warnings for tripelennamine injectable solution in cattle.
21 CFR 524.1001 is amended to correct a spelling error in
the heading and specifications for fluralaner and moxidectin topical
solution.
21 CFR 524.2098 is amended to reflect all sponsors of
approved applications for selamectin topical solution in dogs and cats.
21 CFR 558.4 is amended in the Category II table to
reflect the correct assay limits for Type C medicated feeds
manufactured using nicarbazin powder.
21 CFR 558.128 is amended to reflect the class of cattle
and incorporation level for single-ingredient and combination-drug
medicated feeds containing chlortetracycline used for control of
anaplasmosis in cattle.
21 CFR 558.633 is amended to clarify expiration dates for
medicated feeds containing tylvalosin.
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 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Parts 515 and 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 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
510, 515, 516, 520, 522, 524, 529, and 558 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for part 510 continues to read as follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
0
2. In Sec. 510.600:
0
a. In the table in paragraph (c)(1), remove the entry for ``Halocarbon
[[Page 58960]]
Products Corp.''; revise the entries for ``Mylan Institutional, Inc.''
and ``Norbrook Laboratories Ltd.''; and add in alphabetical order an
entry for ``Vetcare Oy''; and
0
b. In the table in paragraph (c)(2), remove the entry for ``012164'';
revise the entries for ``051079'' and ``055529''; and add in numerical
order an entry for ``086155''.
The revisions and additions read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Drug labeler
Firm name and address code
------------------------------------------------------------------------
* * * * * * *
Mylan Institutional, Inc., a Viatris Company, 3711 051079
Collins Ferry Rd., Morgantown, WV 26505................
* * * * * * *
Norbrook Laboratories Ltd., Carnbane Industrial Estate, 055529
Newry, County Down, BT35 6QQ, United Kingdom...........
* * * * * * *
Vetcare Oy, P.O. Box 26 (Liedontie 45), 086155
M[auml]nts[auml]l[auml], Uusimaa, 04601, Finland.......
* * * * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * * * *
051079...................... Mylan Institutional, Inc., a Viatris
Company, 3711 Collins Ferry Rd.,
Morgantown, WV 26505.
* * * * * * *
055529...................... Norbrook Laboratories Ltd., Carnbane
Industrial Estate, Newry, County Down,
BT35 6QQ, United Kingdom.
* * * * * * *
086155...................... Vetcare Oy, P.O. Box 26 (Liedontie 45),
M[auml]nts[auml]l[auml], Uusimaa, 04601,
Finland.
* * * * * * *
------------------------------------------------------------------------
PART 515--MEDICATED FEED MILL LICENSE
0
3. The authority citation for part 515 continues to read as follows:
Authority: 21 U.S.C. 360b, 371.
0
4. In Sec. 515.10, revise paragraph (a) to read as follows:
Sec. 515.10 Medicated feed mill license applications.
(a) Medicated feed mill license applications (Form FDA 3448) may be
obtained from the Public Health Service, Consolidated Forms and
Publications Distribution Center, Washington Commerce Center, 3222
Hubbard Rd., Landover, MD 20785, or electronically from the Center for
Veterinary Medicine at: https://www.fda.gov/animal-veterinary/animal-food-feeds/medicated-feeds.
* * * * *
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-1, 360ccc-2, 371.
Sec. 516.812 [Amended]
0
6. In Sec. 516.812, in paragraph (b), remove ``000859'' and in its
place add ``058198''.
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. In Sec. 520.88g, revise paragraphs (b)(2), (c)(1)(ii), and
(c)(2)(ii) to read as follows:
Sec. 520.88g Amoxicillin trihydrate and clavulanate potassium
tablets.
* * * * *
(b) * * *
(2) Nos. 017033 and 069043 for use of tablets as in paragraph (c)
of this section.
(c) * * *
(1) * * *
(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 E. coli. Periodontal infections due to
susceptible strains of both aerobic and anaerobic bacteria.
* * * * *
(2) * * *
(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., E.
coli, and Pasteurella spp. Urinary tract infections (cystitis) due to
susceptible strains of E. coli.
* * * * *
[[Page 58961]]
Sec. 520.530 [Amended]
0
9. In Sec. 520.530, remove paragraph (c) and redesignate paragraph (d)
as paragraph (c).
0
10. In Sec. 520.812, revise paragraphs (b)(1) and (3) to read as
follows:
Sec. 520.812 Enrofloxacin.
* * * * *
(b) * * *
(1) No. 058198 for use of products described in paragraph (a) of
this section.
* * * * *
(3) Nos. 055529 and 086101 for use of product described in
paragraph (a)(2) of this section.
* * * * *
0
11. In Sec. 520.905a, revise paragraphs (e)(1)(ii) and (iii) to read
as follows:
Sec. 520.905a Fenbendazole suspension.
* * * * *
(e) * * *
(1) * * *
(ii) Indications for use. For the treatment and control of large
strongyles (Strongylus edentatus, S. equinus, S. vulgaris,
Triodontophorus species), small strongyles (Cyathostomum species,
Cylicocyclus species, Cylicostephanus species, Cylicodontophorus
species), pinworms (Oxyuris equi) and ascarids (Parascaris equorum).
(iii) Limitations. Do not use in horses intended for human
consumption.
* * * * *
0
12. In Sec. 520.928, revise the section heading and paragraphs (a),
(b), and (c)(1)(i) to read as follows:
Sec. 520.928 Firocoxib.
(a) Specifications--(1) Each chewable tablet contains 57 or 227
milligrams (mg) firocoxib.
(2) Each tablet contains 57 mg firocoxib.
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter as
follows:
(1) Nos. 000010 and 055529 for use of products described in
paragraph (a)(1) as in paragraph (c)(1) of this section; and
(2) No. 000010 for use of the product described in paragraph (a)(2)
as in paragraph (c)(2) of this section.
(c) * * *
(1) * * *
(i) Amount. 5 mg/kg (2.27 mg/lb) body weight. Administer once daily
as needed for osteoarthritis and for 3 days as needed for postoperative
pain and inflammation associated with soft-tissue and orthopedic
surgery. Administer approximately 2 hours before soft tissue or
orthopedic surgery.
* * * * *
0
13. In Sec. 520.1242a, revise paragraph (b)(3) to read as follows:
Sec. 520.1242a Levamisol powder.
* * * * *
(b) * * *
(3) No. 016592 for use of 46.8- and 544.5-g packages as in
paragraphs (e)(1)(i), (e)(1)(ii)(B), and (e)(1)(iii) and (e)(2)(i),
(e)(2)(ii)(B), and (e)(2)(iii) of this section.
* * * * *
0
14. In Sec. 520.1720a, revise paragraph (a) to read as follows:
Sec. 520.1720a Phenylbutazone tablets and boluses.
(a) Specifications. Each tablet contains 100, 200, or 400
milligrams (mg), or 1 gram (g) phenylbutazone. Each bolus contains 1,
2, or 4 g phenylbutazone.
* * * * *
Sec. 520.1846 [Removed]
0
15. Remove Sec. 520.1846.
Sec. 520.1870 [Amended]
0
16. In Sec. 520.1870, in paragraph (c)(2)(iii), in the third sentence,
remove ``OTC'' and in its place add ``over the counter''.
0
17. In Sec. 520.1872, revise paragraph (c)(1)(iii) and add reserved
paragraph (c)(2) to read as follows:
Sec. 520.1872 Praziquantel, pyrantel pamoate, and febantel tablets.
* * * * *
(c) * * *
(1) * * *
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
(2) [Reserved]
0
18. Revise Sec. 520.2260a to read as follows:
Sec. 520.2260a Sulfamethazine oblets and boluses.
(a) Specifications. Each oblet or bolus contains:
(1) 2.5, 5, or 15 grams sulfamethazine.
(2) 5 grams sulfamethazine.
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for
use of products described in paragraph (a) of this section.
(1) No. 016592 for use of products described in paragraph (a)(1) of
this section.
(2) No. 054771 for use of product described in paragraph (a)(2) of
this section.
(c) Related tolerances. See Sec. 556.670 of this chapter.
(d) Conditions of use. (1) Oblets and boluses described in
paragraph (a)(1) of this section:
(i) Amount. Administer as a single dose 100 milligrams per pound
(mg/lb) of body weight the first day and 50 mg/lb of body weight on
each following day.
(ii) Indications for use. (A) Beef cattle and nonlactating dairy
cattle. For the treatment of bacterial pneumonia and bovine respiratory
disease complex (shipping fever complex) (Pasteurella spp.),
colibacillosis (bacterial scours) (Escherichia coli), necrotic
pododermatitis (foot rot) (Fusobacterium necrophorum), calf diphtheria
(Fusobacterium necrophorum), acute mastitis (Streptococcus spp.), acute
metritis (Streptococcus spp.), and coccidiosis (Eimeria bovis and E.
zurnii).
(B) Horses. For the treatment of bacterial pneumonia (secondary
infections associated with Pasteurella spp.), strangles (Streptococcus
equi), and bacterial enteritis (Escherichia coli).
(iii) Limitations. Administer daily until animal's temperature and
appearance are normal. If symptoms persist after using for 2 or 3 days
consult a veterinarian. Fluid intake must be adequate. Treatment should
continue 24 to 48 hours beyond the remission of disease symptoms, but
not to exceed 5 consecutive days. Follow dosages carefully. Do not
treat cattle within 10 days of slaughter. Do not use in female dairy
cattle 20 months of age or older. Use of sulfamethazine in this class
of cattle may cause milk residues. A withdrawal period has not been
established in preruminating calves. Do not use in calves to be
processed for veal. Do not use in horses intended for human
consumption.
(2) Boluses described in paragraph (a)(2) of this section:
(i) Amount. Administer 10 grams (2 boluses) of sulfamethazine per
100 pounds of body weight the first day, then 5 grams (1 bolus) of
sulfamethazine per 100 pounds of body weight daily for up to 4
additional consecutive days.
(ii) Indications for use. (A) Ruminating beef and dairy calves. For
treatment of the following diseases caused by organisms susceptible to
sulfamethazine: bacterial scours (colibacillosis) caused by Escherichia
coli; necrotic pododermatitis (foot rot) and calf diphtheria caused by
Fusobacterium necrophorum; bacterial pneumonia associated with
Pasteurella spp.; and coccidiosis caused by Eimeria bovis and E.
zurnii.
(B) [Reserved]
(iii) Limitations. Do not administer for more than 5 consecutive
days. Do not treat calves within 11 days of slaughter. Do not use in
calves to be slaughtered under 1 month of age or in calves being
[[Page 58962]]
fed an all milk diet. Do not use in female dairy cattle 20 months of
age or older; such use may cause drug residues in milk. Administer with
adequate supervision. Follow recommended dosages carefully. Fluid
intake must be adequate. If symptoms persist after 2 or 3 days, consult
a veterinarian.
0
19. In Sec. 520.2325a, revise paragraphs (c)(4)(iii) and (d) to read
as follows:
Sec. 520.2325a Sulfaquinoxaline powder and solution.
* * * * *
(c) * * *
(4) * * *
(iii) In lieu of treatment as provided in paragraph (c)(4)(ii) of
this section, administer 1 teaspoon of 25 percent sulfaquinoxaline
soluble powder per day for each 125 pounds of body weight for 3 to 5
days in drinking water.
(d) Limitations. A withdrawal period has not been established in
preruminating calves. Do not use in calves to be processed for veal.
Not for use in lactating dairy cattle. Do not give to chickens,
turkeys, or cattle within 10 days of slaughter for food. Do not
medicate chickens or turkeys producing eggs for human consumption.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.
0
20. In Sec. 520.2455, revise paragraph (b)(3) to read as follows:
Sec. 520.2455 Tiamulin.
* * * * *
(b) * * *
(3) Nos. 016592, 051072, 051311, and 061133 for product described
in paragraph (a)(2) of this section.
* * * * *
0
21. In Sec. 520.2471, revise paragraph (b) to read as follows:
Sec. 520.2471 Tilmicosin.
* * * * *
(b) Sponsors. See Nos. 016592 and 058198 in Sec. 510.600(c) of
this chapter.
* * * * *
0
22. In Sec. 520.2598, revise paragraph (c)(2) to read as follows:
Sec. 520.2598 Trilostane.
* * * * *
(c) * * *
(2) Indications for use. For the treatment of pituitary-dependent
and adrenal-dependent hyperadrenocorticism in dogs.
* * * * *
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
23. The authority citation for part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
24. In Sec. 522.533, revise paragraphs (c)(1)(ii) and (c)(2)(ii) to
read as follows:
Sec. 522.533 Deslorelin.
* * * * *
(c) * * *
(1) * * *
(ii) Indications for use. For inducing ovulation within 48 hours in
estrous mares with an ovarian follicle greater than 30 millimeters (mm)
in diameter.
* * * * *
(c) * * *
(2) * * *
(ii) Indications for use. For inducing ovulation within 48 hours in
cyclic estrous mares with an ovarian follicle between 30 and 40 mm in
diameter.
* * * * *
0
25. In Sec. 522.812, revise paragraph (b)(2) to read as follows:
Sec. 522.812 Enrofloxacin.
* * * * *
(b) * * *
(2) Nos. 051311, 055529, 058005, 058198, and 061133 for use of
product described in paragraph (a)(2) of this section as in paragraphs
(e)(2) and (3) of this section.
* * * * *
0
26. Add Sec. 522.1008 to read as follows:
Sec. 522.1008 Frunevetmab.
(a) Specifications. Each milliliter (mL) of solution contains 7
milligrams (mg) frunevetmab.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Cats--(i) Amount. Administer once a
month by subcutaneous injection the full contents of one or two 1-mL
vials to achieve a minimum dosage of 0.45 mg/lb (1 mg/kg) body weight.
(ii) Indications for use. For the control of pain associated with
osteoarthritis in cats.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
(2) [Reserved]
0
27. Add Sec. 522.1338 to read as follows:
Sec. 522.1338 Medetomidine and vatinoxan.
(a) Specifications. Each milliliter of solution contains 0.5
milligrams (mg) medetomidine hydrochloride and 10 mg vatinoxan
hydrochloride.
(b) Sponsor. See No. 086155 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. Administer by intramuscular
injection a dose based on body surface area (BSA). Calculate the dose
using 1 mg medetomidine per square meter (/m\2\) BSA or use the dosing
table provided in labeling.
(2) Indications for use. For use as a sedative and analgesic in
dogs to facilitate clinical examination, clinical procedures, and minor
surgical procedures.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
28. In Sec. 522.2615, revise paragraph (d)(3)(iii) to read as follows:
Sec. 522.2615 Tripelennamine.
* * * * *
(d) * * *
(3) * * *
(iii) Limitations. Milk taken during treatment and for 24 hours
after the last treatment must not be used for human consumption. Cattle
must not be slaughtered for human consumption within 4 days following
the last treatment with this drug product. Not for use in beef calves
less than 2 months of age, dairy calves, and veal calves. A withdrawal
period has not been established for this product in pre-ruminating
calves. Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
0
29. In Sec. 522.2630, revise paragraphs (b)(1) and (2) to read as
follows:
Sec. 522.2630 Tulathromycin.
* * * * *
(b) * * *
(1) Nos. 000061, 013744, 051311, 054771, 055529, 058198, and 061133
for use of product described in paragraph (a)(1) as in paragraphs
(d)(1)(i), (d)(1)(ii), (d)(1)(iii)(A), and (d)(2) of this section.
(2) Nos. 013744, 051311, 054771, and 058198 for use of product
described in paragraph (a)(2) as in paragraphs (d)(1)(i),
(d)(1)(ii)(B), (d)(1)(iii)(B), and (d)(2) of this section.
* * * * *
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
30. The authority citation for part 524 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
31. Add Sec. 524.230 to read as follows:
Sec. 524.230 Buprenorphine.
(a) Specifications. Each milliliter (mL) of solution contains 20
milligrams (mg) buprenorphine. The drug is supplied in tubes containing
0.4 mL (8 mg) or 1.0 mL (20 mg).
(b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in cats--(1) Amount. Administer topically to
the dorsal cervical area at the base of the skull a single dose of 1.2
to 3.1 mg/lb
[[Page 58963]]
(2.7 to 6.7 mg/kg) approximately 1 to 2 hours before surgery.
(2) Indications for use. For the control of postoperative pain
associated with surgical procedures in cats.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian. Buprenorphine is a Schedule III
controlled substance.
0
32. In Sec. 524.1001, revise the section heading and paragraph (a) to
read as follows:
Sec. 524.1001 Fluralaner and moxidectin.
(a) Specifications. Each milliliter of solution contains 280
milligram (mg) fluralaner and 14 mg moxidectin. Each individually
packaged tube contains either 112.5 mg fluralaner and 5.6 mg
moxidectin; 250 mg fluralaner and 12.5 mg moxidectin; or 500 mg
fluralaner and 25 mg moxidectin.
* * * * *
0
33. In Sec. 524.1146, revise paragraphs (b)(1) and (2) to read as
follows:
Sec. 524.1146 Imidacloprid and moxidectin.
* * * * *
(b) * * *
(1) Nos. 017030, 051072, 055529, 058198, and 061651 for use of
product described in paragraph (a)(1) of this section as in paragraph
(d)(1) of this section.
(2) Nos. 017030, 051072, 055529, 058198, and 061651 for use of
product described in paragraph (a)(2) of this section as in paragraph
(d)(2) of this section.
* * * * *
0
34. In Sec. 524.2098, revise paragraph (b) to read as follows:
Sec. 524.2098 Selamectin.
* * * * *
(b) Sponsors. See Nos. 051072, 054771, 055529, 061133, and 061651
in Sec. 510.600(c) of this chapter.
* * * * *
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
0
35. The authority citation for part 529 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
36. In Sec. 529.1186, revise paragraph (b) to read as follows:
Sec. 529.1186 Isoflurane.
* * * * *
(b) Sponsors. See Nos. 017033, 054771, 065085, and 066794 in Sec.
510.600(c) of this chapter.
* * * * *
0
37. In Sec. 529.2110, revise paragraph (b) to read as follows:
Sec. 529.2110 Sevoflurane.
* * * * *
(b) Sponsors. See Nos. 017033, 054771, and 066794 in Sec.
510.600(c) of this chapter.
* * * * *
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
38. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
0
39. In Sec. 558.4, in paragraph (d), in the ``Category II'' table,
revise the entry for ``Nicarbazin (powder)'' to read as follows:
Sec. 558.4 Requirement of a medicated feed mill license.
* * * * *
(d) * * *
Category II
----------------------------------------------------------------------------------------------------------------
Assay limits Assay limits
Drug percent \1\ Type B maximum (100x) percent \1\ type
type A B/C \2\
----------------------------------------------------------------------------------------------------------------
* * * * * * *
Nicarbazin (powder)......................... 96-104 9.08 g/lb (2.00%).............. 85-115/80-120
* * * * * * *
* * * * * * *...............................
----------------------------------------------------------------------------------------------------------------
* * * * *
0
40. In Sec. 558.128, revise paragraphs (e)(4)(iii) and (xli) to read
as follows:
Sec. 558.128 Chlortetracycline.
* * * * *
(e) * * *
(4) * * *
----------------------------------------------------------------------------------------------------------------
Combination in
Chlortetracycline amount grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(iii) to provide 0.5 mg/lb of ................... Beef cattle (over Feed to provide 054771
body weight daily. 700 lb): For chlortetracycline 066104
control of active at the rate of 0.5 069254
infection of mg per pound of
anaplasmosis body weight daily.
caused by Withdraw 48 hours
Anaplasma prior to
marginale slaughter. To
susceptible to sponsor Nos.
chlortetracycline. 054771 and 069254:
Zero withdrawal
time.
[[Page 58964]]
* * * * * * *
(xli) 25 to 2,800 g/ton to Lasalocid, 30 to Growing beef The melengestrol 054771
provide 350 mg/head/day. 181.8; heifers fed in acetate Type C top-
melengestrol confinement for dress medicated
acetate, 0.25 to 2 slaughter under feed must be top
g/ton to provide 700 pounds: For dressed onto or
0.25 to 0.5 mg/ control of active mixed at feeding
head/day infection of with a Type C
melengestrol anaplasmosis medicated feed
acetate. caused by containing 25 to
Anaplasma 2,800 g/ton of
marginale chlortetracycline
susceptible to and 30 to 181.8 g/
chlortetracycline, ton lasalocid to
control of provide 350 mg
coccidiosis caused chlortetracycline
by Eimeria bovis per head per day
and E. zuernii, and 1 mg lasalocid
increased rate of per 2.2 lb. of
weight gain, body weight daily
improved feed with a maximum of
efficiency, and 360 mg lasalocid
suppression of per head per day.
estrus (heat). See Sec.
558.311(d) of this
chapter.
Chlortetracycline,
lasalocid, and
melengestrol as
provided by No.
054771 in Sec.
510.600(c) of this
chapter.
* * * * * * *
* * * * * * *....................
----------------------------------------------------------------------------------------------------------------
* * * * *
0
41. In Sec. 558.258, revise paragraph (e)(1), paragraph (e)(2) table
column headings, and paragraphs (e)(2)(i) and (e)(3) through (5) to
read as follows:
Sec. 558.258 Fenbendazole.
* * * * *
(e) * * *
(1) * * *
----------------------------------------------------------------------------------------------------------------
Combination grams
Fenbendazole grams per ton per ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 14.5......................... ................... Growing turkeys: Feed continuously 000061
For the treatment as the sole ration
and control of for 6 days. For
gastrointestinal growing turkeys
worms: roundworms, only.
adults and larvae
(Ascaridia
dissimilis); cecal
worms, adults and
larvae (Heterakis
gallinarum), an
important vector
of Histomonas
meleagridis
(Blackhead).
(ii) [Reserved].................. ................... ................... ................... ..............
----------------------------------------------------------------------------------------------------------------
[[Page 58965]]
(2) Swine.
----------------------------------------------------------------------------------------------------------------
Combination grams
Fenbendazole grams per ton per ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 10 to 300.................. .................. Swine: For the Feed as the sole 000061
treatment and control ration to provide
of Lungworms: adult 9 mg/kg of body
(Metastrongylus apri weight (4.08 mg/
and M. pudendotectus); lb) over a period
Gastrointestinal of 3 to 12
worms: adult and consecutive days.
larvae (L3, 4 stages-- Swine must not be
liver, lung, slaughtered for
intestinal forms) human consumption
large roundworms within 4 days
(Ascaris suum); adult following last
nodular worms treatment with
(Oesophagostomum this drug product.
dentatum, O.
quadrispinulatum);
adult small stomach
worms (Hyostrongylus
rubidus); adult and
larvae (L2, 3, 4
stages--intestinal
mucosal forms)
whipworms (Trichuris
suis); and Kidney
worms: adult and
larvae (Stephanurus
dentatus).
* * * * * * *
----------------------------------------------------------------------------------------------------------------
(3) Cattle.
----------------------------------------------------------------------------------------------------------------
Fenbendazole grams per ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 200 to 1,000.................... Dairy and beef cattle: For Feed as the sole ration for 000061
the treatment and control 1 day to provide 5 mg/kg
of: Lungworms: adult body weight (2.27 mg/lb).
(Dictyocaulus viviparus); Milk taken during treatment
Stomach worms: adult brown and for 60 hours after the
stomach worms (Ostertagia last treatment must not be
ostertagi), adult and used for human consumption.
fourth-stage larvae Cattle must not be
barberpole worms slaughtered for human
(Haemonchus contortus), consumption within 13 days
fourth-stage larvae following last treatment
barberpole worms (H. with this drug product. Not
placei), and adult and for use in beef calves less
fourth-stage larvae small than 2 months of age, dairy
stomach worms calves, and veal calves. A
(Trichostrongylus axei); withdrawal period has not
Intestinal worms (adult and been established for this
fourth-stage larvae): product in pre-ruminating
hookworms (Bunostomum calves.
phlebotomum), thread-necked
intestinal worms
(Nematodirus helvetianus),
small intestinal worms
(Cooperia punctata and C.
oncophora), bankrupt worms
(Trichostrongylus
colubriformis), and nodular
worms (Oesophagostomum
radiatum).
(ii) [Reserved]..................... ............................ ............................ ..............
----------------------------------------------------------------------------------------------------------------
(iii) Top dress medicated feed--(A) Proprietary formulas. The
following feed can be manufactured only per an approved proprietary
formula and specifications:
----------------------------------------------------------------------------------------------------------------
Fenbendazole concentration Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(1) 2.27 g/lb....................... Beef and dairy cattle: For Feed as a top dress for 1 000061
the treatment and control day to provide 5 mg/kg body
of: Lungworms: adult weight (2.27 mg/lb). Milk
(Dictyocaulus viviparus); taken during treatment and
Stomach worms: adult brown for 60 hours after the last
stomach worms (Ostertagia treatment must not be used
ostertagi), adult and for human consumption.
fourth-stage larvae Cattle must not be
barberpole worms slaughtered for human
(Haemonchus contortus), consumption within 13 days
fourth-stage larvae following last treatment
barberpole worms (H. with this drug product. Not
placei), and adult and for use in beef calves less
fourth-stage larvae small than 2 months of age, dairy
stomach worms calves, and veal calves. A
(Trichostrongylus axei); withdrawal period has not
Intestinal worms (adult and been established for this
fourth-stage larvae): product in pre-ruminating
hookworms (Bunostomum calves.
phlebotomum), thread-necked
intestinal worms
(Nematodirus helvetianus),
small intestinal worms
(Cooperia punctata and C.
oncophora), bankrupt worms
(Trichostrongylus
colubriformis), and nodular
worms (Oesophagostomum
radiatum).
(2) [Reserved]...................... ............................ ............................ ..............
----------------------------------------------------------------------------------------------------------------
(B) [Reserved]
(iv) Free-choice medicated feeds--(A) Proprietary formulas (21 CFR
510.455(e)(2)). The following feeds can be manufactured only per an
approved proprietary formula and specifications:
[[Page 58966]]
----------------------------------------------------------------------------------------------------------------
Fenbendazole concentration Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(1) 12,100 g/ton mineral............ Beef cattle on pasture: For Feed free-choice at the rate 000061
the treatment and control of 0.0375 lb per 100 pounds
of: Lungworms: adult of body weight over a 3- to
(Dictyocaulus viviparus); 6-day period to provide a
Stomach worms: adult brown total of 2.27 mg
stomach worms (Ostertagia fenbendazole per pound of
ostertagi), adult and body weight. Not for use in
fourth-stage larvae dairy cattle. Beef cattle
barberpole worms must not be slaughtered for
(Haemonchus contortus), human consumption within 13
fourth-stage larvae days following last
barberpole worms (H. treatment with this drug
placei), and adult and product. Not for use in
fourth-stage larvae small beef calves less than 2
stomach worms months of age, dairy
(Trichostrongylus axei); calves, and veal calves. A
Intestinal worms (adult and withdrawal period has not
fourth-stage larvae): been established for this
hookworms (Bunostomum product in pre-ruminating
phlebotomum), thread-necked calves.
intestinal worms
(Nematodirus helvetianus),
small intestinal worms
(Cooperia punctata and C.
oncophora), bankrupt worms
(Trichostrongylus
colubriformis), and nodular
worms (Oesophagostomum
radiatum).
(2) 2.27 g/lb mineral............... Beef cattle on pasture: For Feed free-choice at the rate 000061
the treatment and control of 0.10 lb (1.6 oz) per 100
of: Lungworms: adult pounds of body weight over
(Dictyocaulus viviparus); a 3- to 6-day period, to
Stomach worms: adult brown deliver a total of 2.27 mg
stomach worms (Ostertagia fenbendazole per pound of
ostertagi), adult and body weight. Not for use in
fourth-stage larvae dairy cattle. Beef cattle
barberpole worms must not be slaughtered for
(Haemonchus contortus), human consumption within 13
fourth-stage larvae days following last
barberpole worms (H. treatment with this drug
placei), and adult and product. Not for use in
fourth-stage larvae small beef calves less than 2
stomach worms months of age, dairy
(Trichostrongylus axei); calves, and veal calves. A
Intestinal worms (adult and withdrawal period has not
fourth-stage larvae): been established for this
hookworms (Bunostomum product in pre-ruminating
phlebotomum), thread-necked calves.
intestinal worms
(Nematodirus helvetianus),
small intestinal worms
(Cooperia punctata and C.
oncophora), bankrupt worms
(Trichostrongylus
colubriformis), and nodular
worms (Oesophagostomum
radiatum).
----------------------------------------------------------------------------------------------------------------
(B) Published formulas (Sec. 510.455(e)(1) of this chapter). The
following feeds can be manufactured only per one of the formulas and
specifications published below:
(1) Amount. 5 mg/kg body weight (2.27 mg/lb), including the
following formulations:
------------------------------------------------------------------------
International
Ingredient \1\ Percent Feed No.
------------------------------------------------------------------------
(i) Free-choice, dry Type C feed:
Salt (sodium chloride)........ 59.00 6-04-152
Monosodium phosphate.......... 31.16 6-04-288
Dried cane molasses........... 3.12 4-04-695
Zinc sulfate.................. 0.76 6-05-556
Copper sulfate................ 0.45 6-01-720
Fenbendazole 20% Type A 5.51 n/a
article......................
(ii) Free-choice, dry Type C feed:
Salt (sodium chloride)........ 35.93 6-04-152
Dicalcium phosphate (18.5% P). 32.44 6-00-080
Calcium carbonate (38% Ca).... 15.93 6-01-069
Magnesium oxide (56% Mg)...... 10.14 6-02-756
Zinc sulfate.................. 1.47 6-05-556
Mineral oil................... 1.00 8-03-123
Dried cane molasses (46% 0.98 4-04-695
sugars)......................
Potassium iodide.............. 0.01 6-03-759
Fenbendazole 20% Type A 2.10 n/a
article......................
(iii) Free-choice, liquid Type C
feed \2\:
Cane molasses \3\............. 80.902 4-13-251
Water......................... 9.36 n/a
Urea solution, 55%............ 7.05 5-05-707
Phosphoric acid 75% (feed 2.00 6-03-707
grade).......................
Xantham gum................... 0.20 8-15-818
Trace minerals \4\............ 0.20 n/a
Vitamin premix \4\............ 0.01 n/a
Fenbendazole 20% Type A 0.278 n/a
article......................
------------------------------------------------------------------------
\1\ Formulation modifications require FDA approval prior to marketing.
Selenium is not approved for use in the liquid, free-choice
formulations described in paragraph (e)(3)(iv)(B) of this section.
Free-choice cattle feeds containing selenium must comply with
published regulations (see 21 CFR 573.920).
[[Page 58967]]
\2\ The labeling for the liquid free-choice Type C medicated feed must
bear an expiration date of 12 weeks after the date of manufacture.
\3\ The percentage of cane molasses and water in the formulation may be
adjusted as needed to bring the brix value of the molasses to the
industry standard of 79.5 brix.
\4\ The contents of any added vitamin and trace mineral may be varied;
however, they should be comparable to those used by the manufacturer
for other free-choice cattle feeds.
(2) Indications for use. As in paragraph (e)(3)(i) of this section.
(3) Limitations. Feed a total of 5 mg of fenbendazole per kg (2.27
mg/lb) of body weight to cattle over a 3- to 6-day period. Milk taken
during treatment and for 60 hours after the last treatment must not be
used for human consumption. Cattle must not be slaughtered for human
consumption within 13 days following last treatment with this drug
product. Not for use in beef calves less than 2 months of age, dairy
calves, and veal calves. A withdrawal period has not been established
for this product in pre-ruminating calves.
(4) Horses.
----------------------------------------------------------------------------------------------------------------
Fenbendazole grams per ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 4,540........................... 5 mg/kg body weight (2.27 mg/ Feed at the rate of 0.1 lb 000061
lb) for the control of of feed per 100 lb of body
large strongyles weight to provide 2.27 mg
(Strongylus edentatus, S. fenbendazole/lb of body
equinus, S. vulgaris, weight in a 1-day treatment
Triodontophorus spp.), or 0.2 lb of feed per 100
small strongyles lb of body weight to
(Cyathostomum spp., provide 4.54 mg
Cylicocyclus spp., fenbendazole/lb of body
Cylicostephanus spp.), and weight in a 1-day
pinworms (Oxyuris equi); 10 treatment. All horses must
mg/kg body weight (4.54 mg/ be eating normally to
lb) for the control of ensure that each animal
ascarids (Parascaris consumes an adequate amount
equorum). of the medicated feed. Do
not use in horses intended
for human consumption.
(ii) [Reserved]..................... ............................ ............................ ..............
----------------------------------------------------------------------------------------------------------------
(5) Zoo and wildlife animals.
----------------------------------------------------------------------------------------------------------------
Fenbendazole grams Indications for
Species/Class per ton use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) Feral swine (Sus scrofa):.. 90 to 325......... For the treatment Use as a complete feed 000061
and control of at a rate to provide 3
kidney worm mg/kg/day for 3
(Stephanurus consecutive days.
dentatus), Prior withdrawal of
roundworm feed or water is not
(Ascaris suum), necessary. Retreatment
nodular worm may be required in 6
(Oesophagostomum weeks. Do not use 14
dentatum). days before or during
the hunting season.
(ii) Ruminants (subfamily 50 to 300......... For the treatment Use as a complete feed 000061
Antilopinae, Hippotraginae, and control of at a rate to provide
Caprinae). small stomach 2.5 mg/kg/day for 3
worm consecutive days.
(Trichostrongylus Prior withdrawal of
spp.), thread feed or water is not
necked intestinal necessary. Retreatment
worm (Nematodirus may be required in 6
spp.), barberpole weeks. Do not use 14
worm (Haemonchus days before or during
spp.), whipworm the hunting season.
(Trichuris spp.).
(iii) Rocky mountain bighorn 375 to 1,000...... For the treatment Use as a complete feed 000061
sheep (Ovis c. canadensis). and control of at a rate to provide
Protostrongylus 10 mg/kg/day for 3
spp.. consecutive days.
Prior withdrawal of
feed or water is not
necessary. Retreatment
may be required in 6
weeks. Do not use 14
days before or during
the hunting season.
----------------------------------------------------------------------------------------------------------------
[[Page 58968]]
* * * * *
Sec. 558.633 [Amended]
0
42. In Sec. 558.633, in paragraph (d)(3), remove the first sentence.
Dated: September 20, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-20836 Filed 9-28-22; 8:45 am]
BILLING CODE 4164-01-P
