[Federal Register Volume 86, Number 213 (Monday, November 8, 2021)]
[Rules and Regulations]
[Pages 61682-61687]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-24075]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 524, 556, and 558

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


New Animal Drugs; Approval of New Animal Drug Applications; 
Changes of Sponsor 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 April, May, and June 2021. FDA is 
informing the public of the availability of summaries of the basis of 
approval and of environmental review documents, where applicable. The 
animal drug regulations are also being amended to improve the accuracy 
and readability of the regulations.

DATES: This rule is effective November 8, 2021.

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 April, May, and June 2021, as 
listed in table 1. In addition, FDA is informing the public of the 
availability, where applicable, of documentation of environmental 
review required under the National Environmental Policy Act (NEPA) and, 
for actions requiring review of safety or effectiveness data, summaries 
of the basis of approval (FOI Summaries) under the Freedom of 
Information Act (FOIA). These public documents may be seen in the 
office of the Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500. Persons 
with access to the internet may obtain these documents at the CVM FOIA 
Electronic Reading Room: https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room. Marketing 
exclusivity and patent information may be accessed in FDA's 
publication, ``Approved Animal Drug Products Online (Green Book)'' at: 
https://www.fda.gov/animal-veterinary/products/approved-animal-drug-products-green-book.
    FDA has verified the website addresses as of the date this document 
publishes in the Federal Register, but websites are subject to change 
over time.

                              Table 1--Original and Supplemental NADAs and ANADAs Approved During April, May, and June 2021
--------------------------------------------------------------------------------------------------------------------------------------------------------
       Approval date        File No.         Sponsor              Product name              Species          Effect of the action    Public  documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
April 5, 2021.............   200-697  Accord Healthcare,     Enrofloxacin           Dogs..................  Original approval as   FOI Summary.
                                       Inc., 1009 Slater      Injectable Solution                            a generic copy of
                                       Rd., Suite 210-B,      2.27%.                                         NADA 140-913.
                                       Durham, NC 27703.

[[Page 61683]]

 
April 12, 2021............   141-528  Elanco US Inc., 2500   CREDELIO CAT           Cats..................  Supplemental approval  FOI Summary.
                                       Innovation Way,        (lotilaner) Chewable                           for treatment and
                                       Greenfield, IN 46140.  Tablets.                                       control of black-
                                                                                                             legged tick
                                                                                                             infestations for one
                                                                                                             month in cats and
                                                                                                             kittens.
April 23, 2021............   200-702  Cronus Pharma          Amoxicillin and        Dogs and cats.........  Original approval as   FOI Summary.
                                       Specialties India      Clavulanate                                    a generic copy of
                                       Private Ltd., Sy No-   Potassium Tablets.                             NADA 055-099.
                                       99/1, M/s GMR
                                       Hyderabad Aviation
                                       SEZ Ltd.,
                                       Mamidipalli Village,
                                       Shamshabad Mandal,
                                       Ranga Reddy,
                                       Hyderabad,
                                       Telangana, 501218,
                                       India.
April 26, 2021............   139-189  Intervet, Inc., 2      SAFE-GUARD             Cattle................  Supplemental approval  FOI Summary.
                                       Giralda Farms,         (fenbendazole) Type                            providing for a
                                       Madison, NJ 07940.     C free-choice                                  tolerance and tissue
                                                              medicated feed                                 withdrawal periods
                                                              blocks.                                        in accordance with a
                                                                                                             repartitioning of
                                                                                                             the acceptable daily
                                                                                                             intake (ADI); and
                                                                                                             the addition of
                                                                                                             indications for
                                                                                                             4th[dash]stage
                                                                                                             larval forms of
                                                                                                             certain
                                                                                                             endoparasites.
May 18, 2021..............   141-452  Zoetis Inc., 333       SIMPARICA (sarolaner)  Dogs..................  Supplemental approval  FOI Summary.
                                       Portage St.,           Chewables.                                     for the prevention
                                       Kalamazoo, MI 49007.                                                  of Borrelia
                                                                                                             burgdorferi
                                                                                                             infection as a
                                                                                                             direct result of
                                                                                                             killing Ixodes
                                                                                                             scapularis vector
                                                                                                             ticks.
May 26, 2021..............   140-269  Do...................  KETOFEN (ketoprofen)   Cattle................  Supplemental approval  FOI Summary.
                                                              Injectable Solution.                           for control of
                                                                                                             pyrexia associated
                                                                                                             with bovine
                                                                                                             respiratory disease
                                                                                                             (BRD) and
                                                                                                             establishing a
                                                                                                             tolerance for
                                                                                                             residues of
                                                                                                             ketoprofen in edible
                                                                                                             tissues of cattle.
June 1, 2021..............   141-543  Do...................  DRAXXIN KP             Cattle................  Original approval for  FOI Summary.
                                                              (tulathromycin and                             the treatment of
                                                              ketoprofen)                                    bovine respiratory
                                                              Injectable Solution.                           disease (BRD) and
                                                                                                             control of pyrexia
                                                                                                             associated with BRD
                                                                                                             in certain classes
                                                                                                             of cattle.
June 10, 2021.............   200-700  Chanelle               PARASEDGE Multi for    Dogs..................  Original approval as   FOI Summary.
                                       Pharmaceuticals        Dogs (imidacloprid                             a generic copy of
                                       Manufacturing Ltd.,    and moxidectin)                                NADA 141-234.
                                       Loughrea, County       Topical Solution.
                                       Galway, Ireland.
June 10, 2021.............   200-701  Do...................  PARASEDGE Multi for    Cats..................  Original approval as   FOI Summary.
                                                              Cats (imidacloprid                             a generic copy of
                                                              and moxidectin)                                NADA 141-254.
                                                              Topical Solution.
June 14, 2021.............   128-620  Intervet, Inc., 2      SAFE-GUARD             ......................  Supplemental approval  FOI Summary.
                                       Giralda Farms,         (fenbendazole)                                 to establish a milk
                                       Madison, NJ 07940.     Suspension.                                    discard time in
                                                                                                             cattle and a goat
                                                                                                             tissue tolerance in
                                                                                                             accordance with
                                                                                                             repartitioning of
                                                                                                             the ADI.
June 14, 2021.............   200-704  Felix Pharmaceuticals  Deracoxib Chewable     Dogs..................  Original approval as   FOI Summary.
                                       PVT Ltd., 25-28        Tablets.                                       a generic copy of
                                       North Wall Quay,                                                      NADA 141-203.
                                       Dublin, 1, Ireland.
June 28, 2021.............   200-706  Do...................  Carprofen Chewable     Dogs..................  Original approval as   FOI Summary.
                                                              Tablets.                                       a generic copy of
                                                                                                             NADA 141-111.
--------------------------------------------------------------------------------------------------------------------------------------------------------

II. Change of Sponsor's Address

    Alexion Pharmaceuticals, Inc., 100 College St., New Haven, CT 06510 
has informed FDA that it has changed its address to 121 Seaport Blvd., 
Boston, MA 02210.
    Purina Animal Nutrition LLC, 1080 County Road F West, Shoreview, MN 
55126-2910 has informed FDA that it has changed its address to 4001 
Lexington Ave., North Arden Hills, MN 55126-2910.

III. Technical Amendments

    FDA is making the following amendment to improve the accuracy of 
the animal drug regulations:
     21 CFR 520.304 is amended to reflect the currently 
approved strengths of carprofen chewable tablets.
     21 CFR part 522 is amended to organize sections for 
injectable pentobarbital drugs by their titles in alphabetic sequence.
     21 CFR 558.128 is amended to add introductory text 
identifying the paragraph for medicated cattle feeds containing 
chlortetracycline.
     21 CFR 558.355 is amended to add introductory text 
identifying the paragraph for medicated cattle feeds containing 
monensin.

IV. 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

[[Page 61684]]

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 520, 522, and 524

    Animal drugs.

21 CFR Part 556

    Animal drugs, Food.

21 CFR Part 558

    Animal drugs, Animal feeds.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
510, 520, 522, 524, 556, 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), revise the entries for ``Alexion 
Pharmaceuticals, Inc.'' and ``Purina Animal Nutrition LLC;'' and
0
b. In the table in paragraph (c)(2), revise the entries for ``017800'' 
and ``069334''.
    The revisions 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
------------------------------------------------------------------------
 
                              * * * * * * *
Alexion Pharmaceuticals, Inc., 121 Seaport Blvd.,                 069334
 Boston, MA 02210.......................................
 
                              * * * * * * *
Purina Animal Nutrition LLC, 4001 Lexington Ave., North           017800
 Arden Hills, MN 55126-2910.............................
 
                              * * * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
    Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                              * * * * * * *
017800...................  Purina Animal Nutrition LLC, 4001 Lexington
                            Ave., North Arden Hills, MN 55126-2910.
 
                              * * * * * * *
069334...................  Alexion Pharmaceuticals, Inc., 121 Seaport
                            Blvd., Boston, MA 02210.
 
                              * * * * * * *
------------------------------------------------------------------------

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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


0
4. In Sec.  520.88g, revise paragraph (b)(2) to read as follows:


Sec.  520.88g  Amoxicillin trihydrate and clavulanate potassium 
tablets.

* * * * *
    (b) * * *
    (2) Nos. 026637 and 069043 for use of tablets as in paragraph (c) 
of this section.
* * * * *

0
5. In Sec.  520.304, revise paragraph (b)(2) to read as follows:


Sec.  520.304  Carprofen.

* * * * *
    (b) * * *
    (2) Nos. 058198 and 086101 for use of product described in 
paragraph (a)(2) as in paragraph (c) of this section.
* * * * *

0
6. In Sec.  520.538, remove paragraph (c) and redesignate paragraph (d) 
as new paragraph (c); and revise paragraph (b) to read as follows:


Sec.  520.538  Deracoxib.

* * * * *
    (b) Sponsors. See Nos. 013744, 058198, and 086101 in Sec.  
510.600(c) of this chapter.
* * * * *

0
7. In Sec.  520.905a, revise paragraphs (e)(2), (3), and (4) to read as 
follows:


Sec.  520.905a  Fenbendazole suspension.

* * * * *
    (e) * * *
    (2) Beef and dairy cattle--(i) Amount. Administer orally 2.3 mg/lb 
of body weight (5 mg/kg).
    (ii) Indications for use. For the treatment and control of: 
Lungworms: Adult (Dictyocaulus viviparus); Stomach worms: Adult brown 
stomach worms (Ostertagia ostertagi); adult and fourth-stage larvae 
barberpole worms (Haemonchus contortus and H. placei); adult and 
fourth-stage larvae small stomach worms (Trichostrongylus axei); 
Intestinal worms (adult and fourth-stage larvae): Hookworms (Bunostomum 
phlebotomum), thread-necked intestinal worms (Nematodirus helvetianus), 
small intestinal worms (Cooperia punctata and C. oncophora), bankrupt 
worms (Trichostrongylus colubriformis), and nodular worms 
(Oesophagostomum radiatum).
    (iii) Limitations. Milk taken from cows during treatment and for 48 
hours

[[Page 61685]]

after the last treatment must not be used for human consumption. Cattle 
must not be slaughtered for human consumption within 8 days following 
last treatment with this drug product. Not for use in beef calves less 
than 2 months of age, dairy calves, and veal calves. A withdrawal 
period has not been established for this product in preruminating 
calves.
    (3) Beef cattle--(i) Amount. Administer orally 4.6 mg/lb of body 
weight (10 mg/kg).
    (ii) Indications for use. For the treatment and control of stomach 
worms (fourth-stage inhibited larvae/type II ostertagiasis), Ostertagia 
ostertagi, and tapeworms, Moniezia benedeni.
    (iii) Limitations. Cattle must not be slaughtered for human 
consumption within 8 days following last treatment with this drug 
product. Not for use in beef calves less than 2 months of age, dairy 
calves, and veal calves. A withdrawal period has not been established 
for this product in preruminating calves. Federal law restricts this 
drug to use by or on the order of a licensed veterinarian.
    (4) Goats--(i) Amount. Administer orally 2.3 mg/lb of body weight 
(5 mg/kg).
    (ii) Indications for use. For the treatment and control of stomach 
worms (adults) Haemonchus contortus and Teladorsagia circumcincta.
    (iii) Limitations. Goats must not be slaughtered for human 
consumption within 6 days following last treatment with this drug 
product. Because a milk discard time has not been established, do not 
use in lactating goats.
* * * * *


Sec.  520.905e  [Removed]

0
8. Remove Sec.  520.905e.

0
9. In Sec.  520.1286, revise paragraph (c)(2)(ii) to read as follows:


Sec.  520.1286  Lotilaner.

* * * * *
    (c) * * *
    (2) * * *
    (ii) Indications for use. Kills adult fleas, and for the treatment 
and prevention of flea infestations (Ctenocephalides felis) for 1 month 
in cats and kittens 8 weeks of age and older, and weighing 2.0 pounds 
or greater; and for the treatment and control of Ixodes scapularis 
(black-legged tick) for 1 month in cats and kittens 6 months of age and 
older, and weighing 2.0 pounds or greater.
* * * * *

0
10. In Sec.  520.2086, in paragraph (c)(2), add a sentence at the end 
of the paragraph to read as follows:


Sec.  520.2086  Sarolaner.

* * * * *
    (c) * * *
    (2) * * * For the prevention of Borrelia burgdorferi infections as 
a direct result of killing Ixodes scapularis vector ticks.
* * * * *

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
11. The authority citation for part 522 continues to read as follows:

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

0
12. In Sec.  522.812, revise paragraphs (b)(1) and (e)(1)(i) to read as 
follows:


Sec.  522.812  Enrofloxacin.

* * * * *
    (b) * * *
    (1) Nos. 016729, 017033, 055529, and 058198 for use of product 
described in paragraph (a)(1) of this section as in paragraph (e)(1) of 
this section; and
* * * * *
    (e) * * *
    (1) * * *
    (i) Amount. 2.5 mg per kilogram (/kg) of body weight (1.13 mg per 
pound) as a single, intramuscular, initial dose followed by use of 
tablets twice daily for 2 to 3 days beyond cessation of clinical signs 
to a maximum of 30 days.
* * * * *

0
13. Revise Sec.  522.1225 to read as follows:


Sec.  522.1225  Ketoprofen.

    (a) Specifications. Each milliliter of solution contains 100 
milligrams (mg) ketoprofen.
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter.
    (1) No. 054771 for use as in paragraphs (d)(1) and (d)(2) of this 
section.
    (2) No. 061133 for use as in paragraph (d)(1) of this section.
    (c) Related tolerances. See Sec.  556.345 of this chapter.
    (d) Conditions of use--(1) Horses--(i) Amount. Administer by 
intravenous injection 1.0 mg per pound (/lb) of body weight once daily 
for up to 5 days.
    (ii) Indications for use. For alleviation of inflammation and pain 
associated with musculoskeletal disorders in horses.
    (iii) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.
    (2) Cattle--(i) Amount. Administer by subcutaneous injection 3 mg 
per kilogram (1.36 mg/lb) of body weight once daily for up to 3 days.
    (ii) Indications for use. For the control of pyrexia associated 
with bovine respiratory disease (BRD) in beef heifers, beef steers, 
beef calves 2 months of age and older, beef bulls, replacement dairy 
heifers, and dairy bulls.
    (iii) Limitations. Not for use in reproducing animals over 1 year 
of age. Cattle must not be slaughtered for human consumption within 48 
hours following last treatment with this drug product. Not for use in 
female dairy cattle 1 year of age or older, including dry dairy cows; 
use in these cattle may cause drug residues in milk and/or in calves 
born to these cows or heifers. 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.


Sec.  Sec.  522.1697, 522.1698, and 522.1704  [Redesignated]

0
14. Redesignate Sec. Sec.  522.1697, 522.1698, and 522.1704 as 
Sec. Sec.  522.1700, 522.1702, and 522.1703.

0
15. Add Sec.  522.2632 to read as follows:


Sec.  522.2632  Tulathromycin and ketoprofen.

    (a) Specifications. Each milliliter of solution contains 100 
milligrams (mg) tulathromycin and 120 milligrams (mg) ketoprofen.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec. Sec.  556.345 and 556.745 of this 
chapter.
    (d) Conditions of use--(1) Cattle--(i) Amount. Administer as a 
single subcutaneous injection 2.5 mg tulathromycin and 3 mg ketoprofen 
per kilogram (1.1 mL/100 lb) of body weight.
    (ii) Indications for use. For the treatment of bovine respiratory 
disease (BRD) associated with Mannheimia haemolytica, Pasteurella 
multocida, Histophilus somni, and Mycoplasma bovis, and control of 
pyrexia associated with BRD in beef steers, beef heifers, beef calves 2 
months of age and older, beef bulls, dairy bulls, and replacement dairy 
heifers.
    (iii) Limitations. Not for use in reproducing animals over 1 year 
of age. Cattle must not be slaughtered for human consumption within 18 
days following last treatment with this drug product. Not for use in 
female dairy cattle 1 year of age or older, including dry dairy cows; 
use in these cattle may cause drug residues in milk and/or in calves 
born to these cows or heifers. Not for use in beef calves less than 2 
months of age, dairy calves, and veal calves. A withdrawal period has 
not been

[[Page 61686]]

established for this product in pre-ruminating calves. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.
    (2) [Reserved]

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

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

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


0
17. In Sec.  524.1146, revise paragraphs (b)(1) and (2) to read as 
follows:


Sec.  524.1146  Imidacloprid and moxidectin.

* * * * *
    (b) * * *
    (1) Nos. 017030, 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, 058198, and 061651 for use of product described in 
paragraph (a)(2) of this section as in paragraph (d)(2) of this 
section.
* * * * *

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

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

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

0
19. In Sec.  556.275, revise paragraph (c) to read as follows:


Sec.  556.275  Fenbendazole.

* * * * *
    (c) Related conditions of use. See Sec. Sec.  520.905a, 520.905b, 
520.905c, 520.905d, and 558.258 of this chapter.

0
20. Add Sec.  556.345 to read as follows:


Sec.  556.345  Ketoprofen.

    (a) Acceptable daily intake (ADI). The ADI for total residue of 
ketoprofen is 5 [micro]g/kg of body weight per day.
    (b) Tolerances. The tolerances for ketoprofen (marker residue) are:
    (1) Cattle. (i) Kidney (target tissue): 0.36 ppm.
    (ii) [Reserved]
    (c) Related conditions of use. See Sec. Sec.  522.1225 and 522.2632 
of this chapter.

0
21. In Sec.  556.745, revise paragraph (c) to read as follows:


Sec.  556.745  Tulathromycin.

* * * * *
    (c) Related conditions of use. See Sec. Sec.  522.2630 and 522.2632 
of this chapter.

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

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

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


0
23. In Sec.  558.128, revise paragraph (e)(4) introductory text to read 
as follows:


Sec.  558.128  Chlortetracycline.

* * * * *
    (e) * * *
    (4) Cattle. It is used as follows:
* * * * *

0
24. In Sec.  558.258, revise paragraph (e)(3)(iii) to read as follows:


Sec.  558.258  Fenbendazole.

* * * * *
    (e) * * *
    (3) * * *
    (iii) Free-choice medicated feeds--(A) Proprietary formulas (Sec.  
510.455(e)(2) of this chapter). The following feeds can be manufactured 
only per an approved proprietary formula and specifications:

 
----------------------------------------------------------------------------------------------------------------
         Amount fenbendazole                Indications for use                Limitations             Sponsor
----------------------------------------------------------------------------------------------------------------
(1) 750 mg/lb of protein block (to     Beef cattle: For the           Feed free choice at a rate of       000061
 provide 5 mg/kg body weight (2.27 mg/  treatment and control of:      0.1 pound of block per 100
 lb)).                                  Lungworms: adult               pounds of body weight per
                                        (Dictyocaulus viviparus);      day for 3 days to deliver a
                                        Stomach worms: Adult brown     total of 2.27 mg
                                        stomach worms (Ostertagia      fenbendazole per pound of
                                        ostertagi), adult and fourth-  body weight. Cattle must not
                                        stage larvae barberpole        be slaughtered for human
                                        worms (Haemonchus              consumption within 16 days
                                        contortus), fourth-stage       following last treatment
                                        larvae barberpole worms (H.    with this drug product. Not
                                        placei), and adult and         for use in female dairy
                                        fourth-stage larvae small      cattle 20 months of age or
                                        stomach worms                  older, including dry dairy
                                        (Trichostrongylus axei);       cows. Use in these cattle
                                        Intestinal worms (adult and    may cause drug residues in
                                        fourth-stage larvae):          milk and/or in calves born
                                        Hookworms (Bunostomum          to these cows or heifers.
                                        phlebotomum), thread-necked    Not for use in beef calves
                                        intestinal worms               less than 2 months of age,
                                        (Nematodirus helvetianus),     dairy calves, and veal
                                        small intestinal worms         calves. A withdrawal period
                                        (Cooperia punctata and C.      has not been established for
                                        oncophora), bankrupt worms     this product in pre-
                                        (Trichostrongylus              ruminating calves.
                                        colubriformis), and nodular
                                        worms (Oesophagostomum
                                        radiatum).
(2) 750 mg/lb of molasses block (to    Beef cattle: For the           Feed free choice at a rate of       000061
 provide 5 mg/kg body weight (2.27 mg/  treatment and control of:      0.1 pound of block per 100
 lb)).                                  Lungworms: adult               pounds of body weight per
                                        (Dictyocaulus viviparus);      day for 3 days to deliver a
                                        Stomach worms: Adult brown     total of 2.27 mg
                                        stomach worms (Ostertagia      fenbendazole per pound of
                                        ostertagi), adult and fourth-  body weight. Cattle must not
                                        stage larvae barberpole        be slaughtered for human
                                        worms (Haemonchus              consumption within 11 days
                                        contortus), fourth-stage       following last treatment
                                        larvae barberpole worms (H.    with this drug product. Not
                                        placei), and adult and         for use in female dairy
                                        fourth-stage larvae small      cattle 20 months of age or
                                        stomach worms                  older, including dry dairy
                                        (Trichostrongylus axei);       cows. Use in these cattle
                                        Intestinal worms (adult and    may cause drug residues in
                                        fourth-stage larvae):          milk and/or in calves born
                                        Hookworms (Bunostomum          to these cows or heifers.
                                        phlebotomum), thread-necked    Not for use in beef calves
                                        intestinal worms               less than 2 months of age,
                                        (Nematodirus helvetianus),     dairy calves, and veal
                                        small intestinal worms         calves. A withdrawal period
                                        (Cooperia punctata and C.      has not been established for
                                        oncophora), bankrupt worms     this product in pre-
                                        (Trichostrongylus              ruminating calves.
                                        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:

[[Page 61687]]

 
    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 article.....            5.51             n/a
(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% sugars)....            0.98        4-04-695
    Potassium iodide....................            0.01        6-03-759
    Fenbendazole 20% Type A article.....            2.10             n/a
(iii) Free-choice, liquid Type C feed:
    Cane molasses \2\...................          80.902        4-13-251
    Water...............................            9.36             n/a
    Urea solution, 55%..................            7.05        5-05-707
    Phosphoric acid 75% (feed grade)....            2.00        6-03-707
    Xantham gum.........................            0.20        8-15-818
    Trace minerals......................            0.20             n/a
    Vitamin premix......................            0.01             n/a
    Fenbendazole 20% Type A article.....           0.278             n/a
------------------------------------------------------------------------
\1\ The content 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. Formulation modifications require
  FDA approval prior to marketing. Selenium is not approved for the free-
  choice formulations described in paragraph (e)(3)(iii) of this
  section. Free-choice cattle feeds containing selenium must comply with
  published regulations (see 21 CFR 573.920).
\2\ The percentage of cane molasses and water in the formulation may be
  adjusted as needed in order to bring the brix value of the molasses to
  the industry standard of 79.5 brix.

    (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. Retreatment 
may be needed after 4 to 6 weeks. Cattle must not be slaughtered within 
13 days following last treatment. For dairy cattle the milk discard 
time is zero hours. A withdrawal period has not been established for 
this product in pre-ruminating calves. Do not use in calves to be 
processed for veal.
* * * * *

0
25. In Sec.  558.355, add a heading to paragraph (f)(3) to read as 
follows:


Sec.  558.355  Monensin.

* * * * *
    (f) * * *
    (3) Cattle--
* * * * *

    Dated: October 28, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-24075 Filed 11-5-21; 8:45 am]
BILLING CODE 4164-01-P