Rule2022-20836
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
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 29, 2022
Effective
September 29, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) 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.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 188 (Thursday, September 29, 2022)</title>
</head>
<body><pre>
[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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,
<a href="/cdn-cgi/l/email-protection#0c6b69637e6b6922646d656e69604c6a686d2264647f226b637a"><span class="__cf_email__" data-cfemail="b1d6d4dec3d6d49fd9d0d8d3d4ddf1d7d5d09fd9d9c29fd6dec7">[email protected]</span></a>.
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: <a href="https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room">https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room</a>. Marketing exclusivity and patent information may be
accessed in FDA's publication, ``Approved Animal Drug Products Online
(Green Book)'' at: <a href="https://www.fda.gov/animal-veterinary/products/approved-animal-drug-products-green-book">https://www.fda.gov/animal-veterinary/products/approved-animal-drug-products-green-book</a>.
FDA has verified the website addresses as of the date this document
publishes in the Federal Register, but websites are subject to change
over time.
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:
<bullet> 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.
<bullet> 21 CFR 516.812 is amended to reflect a current drug
labeler code for a use of enrofloxacin injectable solution in cattle.
<bullet> 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.
<bullet> 21 CFR 520.530 is amended to conform to content codified
for animal drugs available by veterinary prescription.
<bullet> 21 CFR 520.905a is amended to reflect revised conditions
of use for fenbendazole suspension in horses.
<bullet> 21 CFR 520.928 is amended to reflect correct directions
for administration of firocoxib chewable tablets in dogs.
<bullet> 21 CFR 520.1242a is amended to reflect revised indications
for use of a levamisol powder in cattle and sheep.
<bullet> 21 CFR 520.1720a is amended to correct an error in the
strength of approved phenylbutazone boluses.
<bullet> 21 CFR 520.1870 is amended to remove an undefined acronym
in the conditions for use of praziquantel tablets.
<bullet> 21 CFR 520.1872 is amended to conform to content codified
for animal drugs available by veterinary prescription.
<bullet> 21 CFR 520.2325a is amended to reflect instructions for
use of sulfaquinoxaline powder and solution in poultry and cattle.
<bullet> 21 CFR 520.2598 is amended to reflect revised indications
for use for trilostane capsules in dogs.
<bullet> 21 CFR 522.533 is amended to revise the indications for
use of deslorelin injectable solution in mares.
<bullet> 21 CFR 522.2615 is amended to reflect revised human food
safety warnings for tripelennamine injectable solution in cattle.
<bullet> 21 CFR 524.1001 is amended to correct a spelling error in
the heading and specifications for fluralaner and moxidectin topical
solution.
<bullet> 21 CFR 524.2098 is amended to reflect all sponsors of
approved applications for selamectin topical solution in dogs and cats.
<bullet> 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.
<bullet> 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.
<bullet> 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: <a href="https://www.fda.gov/animal-veterinary/animal-food-feeds/medicated-feeds">https://www.fda.gov/animal-veterinary/animal-food-feeds/medicated-feeds</a>.
* * * * *
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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on September 29, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.