Document ID: FDA-2022-N-0002-0001
Agency: fda
Document Type: Rule
Title: 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
Posted Date: 2022-09-29T04:00Z

[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]

=======================================================================
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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