Document ID: FDA-2021-N-0002-0045
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
Posted Date: 2022-03-29T04:00Z

[Federal Register Volume 87, Number 60 (Tuesday, March 29, 2022)]
[Rules and Regulations]
[Pages 17942-17949]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-06395]

[[Page 17942]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 516, 520, 522, 524, 529, 556, and 558

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

New Animal Drugs; Approval of New Animal Drug Applications; 
Change of Sponsor

AGENCY: Food and Drug Administration, Department of Health and Human 
Services (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 October, November, and December 2021. FDA 
is informing the public of the availability of summaries of the basis 
of approval and of environmental review documents, where applicable. 
The animal drug regulations are also being amended to improve the 
accuracy of the regulations.

DATES: This rule is effective March 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 October, November, and December 
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 October, November, and December 2021
--------------------------------------------------------------------------------------------------------------------------------------------------------
       Approval date        File No.         Sponsor              Product name              Species          Effect of the action     Public documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
October 1, 2021...........   200-691  Virbac AH, Inc., P.O.  RAC 45 CATTLE          Cattle................  Original approval as   FOI Summary.
                                       Box 162059, Fort       (ractopamine                                   a generic copy of
                                       Worth, TX 76161.       hydrochloride Type A                           NADA 141-221.
                                                              medicated article).
October 20, 2021..........   200-604  Dechra Veterinary      Amoxicillin and        Dogs and cats.........  Original approval as   FOI Summary.
                                       Products LLC, 7015     Clavulanate                                    a generic copy of
                                       College Blvd., Suite   Potassium for Oral                             NADA 055-101.
                                       525, Overland Park,    Suspension.
                                       KS 66211.
October 28, 2021..........   200-588  Sparhawk               Florfenicol Injection  Cattle................  Original approval as   FOI Summary.
                                       Laboratories, Inc.,    (florfenicol)                                  a generic copy of
                                       12340 Santa Fe Trail   Injectable Solution.                           NADA 141-063.
                                       Dr., Lenexa, KS
                                       66215.
October 29, 2021..........   200-628  Sparhawk               Enrofloxacin 100       Cattle and swine......  Original approval as   FOI Summary.
                                       Laboratories, Inc.,    (enrofloxacin)                                 a generic copy of
                                       12340 Santa Fe Trail   Injectable Solution.                           NADA 141-068.
                                       Dr., Lenexa, KS
                                       66215.
October 29, 2021..........   141-348  Zoetis Inc., 333       SYNOVEX ONE Grower     Cattle................  Supplemental approval  FOI Summary.
                                       Portage St.,           (trenbolone acetate                            adding cattle fed in
                                       Kalamazoo, MI 49007.   and estradiol                                  confinement for
                                                              benzoate extended-                             slaughter.
                                                              release implants).
November 1, 2021..........   200-711  Ceva Sante Animale,    TULAVEN 100            Cattle and swine......  Original approval as   FOI Summary.
                                       10 Avenue de la        (tulathromycin                                 a generic copy of
                                       Ballasti[egrave]re,    injection)                                     NADA 141-244.
                                       33500 Libourne,        Injectable Solution.
                                       France.
November 3, 2021..........   200-712  Ceva Sante Animale,    TULAVEN 25             Cattle and swine......  Original approval as   FOI Summary.
                                       10 Avenue de la        (tulathromycin                                 a generic copy of
                                       Ballasti[egrave]re,    injection)                                     NADA 141-349.
                                       33500 Libourne,        Injectable Solution.
                                       France.
November 3, 2021..........   141-508  Elanco US Inc., 2500   EXPERIOR (lubabegron)  Cattle................  Supplemental approval  FOI Summary.
                                       Innovation Way,        Type A medicated                               adding tolerances
                                       Greenfield, IN 46140.  article.                                       for residues in
                                                                                                             edible tissues of
                                                                                                             cattle.
November 12, 2021.........   200-668  Virbac AH, Inc., P.O.  TULISSIN 25            Cattle and swine......  Original approval as   FOI Summary.
                                       Box 162059, Fort       (tulathromycin                                 a generic copy of
                                       Worth, TX 76161.       injection)                                     NADA 141-349.
                                                              Injectable Solution.
November 15, 2021.........   200-253  Bimeda Animal Health   PROSTAMATE (dinoprost  Cattle................  Supplemental approval  FOI Summary.
                                       Ltd., 1B The Herbert   tromethamine                                   for use with
                                       Building, The Park,    injection)                                     gonadorelin or with
                                       Carrickmines, Dublin   Injectable Solution.                           progesterone
                                       18, Ireland.                                                          intravaginal inserts.
November 15, 2021.........   200-669  Virbac AH, Inc., P.O.  TULISSIN 100           Cattle and swine......  Original approval as   FOI Summary.
                                       Box 162059, Fort       (tulathromycin                                 a generic copy of
                                       Worth, TX 76161.       injection)                                     NADA 141-244.
                                                              Injectable Solution.

[[Page 17943]]

 
November 22, 2021.........   200-695  Virbac AH, Inc., P.O.  TIA 12.5% (tiamulin    Swine.................  Original approval as   FOI Summary.
                                       Box 162059, Fort       hydrogen fumarate)                             a generic copy of
                                       Worth, TX 76161.       Liquid Concentrate.                            NADA 140-916.
November 24, 2021.........   200-714  Aurora                 BARRIER for Cats       Cats..................  Original approval as   FOI Summary.
                                       Pharmaceutical, Inc,   (imidacloprid and                              a generic copy of
                                       1196 Highway 3         moxidectin) Topical                            NADA 141-254.
                                       South, Northfield,     Solution.
                                       MN 55057-3009.
December 10, 2021.........   200-705  Elanco US Inc., 2500   ZOASHIELD (zoalene)    Chickens and turkeys..  Original approval as   FOI Summary.
                                       Innovation Way,        Type A medicated                               a generic copy of
                                       Greenfield, IN 46140.  article and BMD                                NADA 141-085.
                                                              (bacitracin
                                                              methylenedisalicylat
                                                              e) Type A medicated
                                                              article.
December 21, 2021.........   141-552  Jaguar Animal Health,  CANALEVIA-CA1          Dogs..................  Conditional approval   FOI Summary.
                                       200 Pine St., suite    (crofelemer delayed-                           for treatment of
                                       600, San Francisco,    release tablets).                              chemotherapy-induced
                                       CA 94104.                                                             diarrhea.
December 23, 2021.........   141-521  Zoetis Inc., 333       SIMPARICA TRIO         Dogs..................  Supplemental approval  FOI Summary.
                                       Portage St.,           (sarolaner,                                    for the prevention
                                       Kalamazoo, MI 49007.   moxidectin, and                                of Borrelia
                                                              pyrantel chewable                              burgdorferi
                                                              tablets) Chewable                              infection as a
                                                              Tablet.                                        direct result of
                                                                                                             killing Ixodes
                                                                                                             scapularis vector
                                                                                                             ticks and for the
                                                                                                             treatment and
                                                                                                             control of L4 and
                                                                                                             immature adult
                                                                                                             Ancylostoma caninum.
--------------------------------------------------------------------------------------------------------------------------------------------------------

II. Change of Sponsor

    Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140 has 
informed FDA that it has transferred ownership of, and all rights and 
interest in, the NADAs and ANADAs listed below to Dechra, Ltd., 
Snaygill Industrial Estate, Keighley Rd., Skipton, North Yorkshire, 
BD23 2RW, United Kingdom:

------------------------------------------------------------------------
             File No.                           Product name
------------------------------------------------------------------------
047-955...........................  ROMPUN (xylazine hydrochloride)
                                     Injectable (20 mg).
047-956...........................  ROMPUN (xylazine hydrochloride)
                                     Injectable (100 mg).
200-322...........................  Butorphanol Tartrate Injection.
200-408...........................  Butorphanol Tartrate Injection.
------------------------------------------------------------------------

    Thorn Bioscience LLC, 1044 East Chestnut St., Louisville, KY 40204 
has informed FDA that it has transferred ownership of, and all rights 
and interest in, NADA 141-319 for SUCROMATE Equine (deslorelin acetate 
injection) to Dechra, Ltd., Snaygill Industrial Estate, Keighley Rd., 
Skipton, North Yorkshire, BD23 2RW, United Kingdom.
    As provided in the regulatory text, the animal drug regulations are 
amended to reflect these changes of sponsorship.

III. Technical Amendments

    FDA is making the following amendments to improve the accuracy of 
the animal drug regulations:
     21 CFR 510.600 is amended to add Jaguar Animal Health and 
remove Thorn Bioscience LLC from the list of sponsors of approved 
applications.
     21 CFR 520.88h is amended to correct indications for use 
in cats of an oral suspension containing amoxicillin and clavulanate.
     21 CFR 520.2455 is amended to correct a spelling error in 
the limitations for use of tiamulin in drinking water of swine.
     21 CFR 522.230 is amended to add the caution that 
buprenorphine injectable solution is a Schedule III opioid under the 
Controlled Substances Act.
     21 CFR 522.690 is amended to reflect revised indications 
for use of dinoprost tromethamine injectable solution in mares.
     21 CFR 522.1940 is amended to reflect the approved classes 
of cattle and limitations for use of progesterone and estradiol 
benzoate ear implants.
     21 CFR 522.2343 is amended to reflect the approved classes 
of cattle and limitations for use of testosterone propionate and 
estradiol benzoate ear implants.
     21 CFR 556.240 is amended to reflect the use of revised 
food consumption values in establishing permitted concentrations of 
residues of estradiol and related esters in edible tissues of cattle. 
The basis for this action is explained in the FOI Summary for 
supplemental NADA 141-348, approved October 29, 2021. The section is 
also amended to reflect a cross reference for testosterone propionate 
and estradiol benzoate implants, recently redesignated as 21 CFR 
522.2343.
     21 CFR 558.254 is amended to reflect the approved 
conditions of use for famphur in feed.
     21 CFR 558.355 is amended to reflect use of medicated 
feeds containing monensin alone or in combination with bacitracin 
methylenedisalicylate in revised classes of chickens.
     21 CFR 558.555 is amended to correct a spelling error in 
the permitted combination use of semduramicin in medicated feed.
     21 CFR 558.633 is amended to revise expiration dates for 
use of pelleted or crumbled tylvalosin medicated swine feeds.
     21 CFR 558.680 is amended to reflect the correct sponsor 
of an application for use of Type C medicated turkey feeds containing 
zoalene.

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

[[Page 17944]]

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 Part 516

    Administrative practice and procedure, Animal drugs, Confidential 
business information, Reporting and recordkeeping requirements.

21 CFR Parts 520, 522, 524, and 529

    Animal drugs.

21 CFR Part 556

    Animal drugs, Dairy products, Foods, Meat and meat products.

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, 516, 520, 522, 524, 529, 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), add in alphabetical order an entry 
for ``Jaguar Animal Health'' and remove the entry for ``Thorn 
Bioscience LLC''; and
0
b. In the table in paragraph (c)(2), remove the entry for ``051330'' 
and add in numerical order an entry for ``086149''.
    The 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
------------------------------------------------------------------------
 
                              * * * * * * *
Jaguar Animal Health, 200 Pine St., Suite 600, San                086149
 Francisco, CA 94104....................................
 
                              * * * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
    Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                              * * * * * * *
086149...................  Jaguar Animal Health, 200 Pine St., Suite
                            600,
                           San Francisco, CA 94104.
 
                              * * * * * * *
------------------------------------------------------------------------

PART 516--NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES

0
3. The authority citation for part 516 continues to read as follows:

    Authority  21 U.S.C. 360ccc, 360ccc-2, 371.

0
4. Add Sec.  516.498 to subpart C to read as follows:

Sec.  516.498  Crofelemer.

    (a) Specifications. Each delayed-release tablet contains 125 
milligrams (mg) crofelemer.
    (b) Sponsor. See No. 086149 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer 1 tablet orally twice 
daily for 3 days for dogs weighing <=140 pounds. Administer 2 tablets 
orally twice daily for 3 days for dogs weighing >140 pounds.
    (2) Indications for use. For the treatment of chemotherapy-induced 
diarrhea in dogs.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian. It is a violation of Federal law 
to use this product other than as directed in the labeling.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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

0
6. Revise Sec.  520.88h to read as follows:

Sec.  520.88h  Amoxicillin trihydrate and clavulanate potassium for 
oral suspension.

    (a) Specifications. When constituted, each milliliter (mL) of 
suspension contains amoxicillin trihydrate equivalent to 50 milligrams 
(mg) amoxicillin and clavulanate potassium equivalent to 12.5 mg 
clavulanic acid.
    (b) Sponsors. See Nos. 017033, 054771, and 069043 in Sec.  
510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. 6.25 mg/lb (1 mL/10 lb 
of body weight) twice a day. Skin and soft tissue infections such as 
abscesses, cellulitis, wounds, superficial/juvenile pyoderma, and 
periodontal infections should be treated for 5 to 7 days or for 48 
hours after all signs have subsided. If no

[[Page 17945]]

response is seen after 5 days of treatment, therapy should be 
discontinued and the case reevaluated. Deep pyoderma may require 
treatment for 21 days; the maximum duration of treatment should not 
exceed 30 days.
    (ii) Indications for use. Treatment of skin and soft tissue 
infections such as wounds, abscesses, cellulitis, superficial/juvenile 
and deep pyoderma due to susceptible strains of the following 
organisms: Beta-lactamase-producing Staphylococcus aureus, non-beta-
lactamase-producing Staphylococcus aureus, Staphylococcus spp., 
Streptococcus spp., and Escherichia coli. Treatment of periodontal 
infections due to susceptible strains of both aerobic and anaerobic 
bacteria.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Cats--(i) Amount. 62.5 mg (1 mL) twice daily. Skin and soft 
tissue infections such as abscesses and cellulitis/dermatitis should be 
treated for 5 to 7 days or 48 hours after all symptoms have subsided, 
not to exceed 30 days. If no response is seen after 3 days of 
treatment, therapy should be discontinued and the case reevaluated. 
Urinary tract infections may require treatment for 10 to 14 days or 
longer. The maximum duration of treatment should not exceed 30 days.
    (ii) Indications for use. Treatment of skin and soft tissue 
infections, such as wounds, abscesses, and cellulitis/dermatitis due to 
susceptible strains of the following organisms: Beta-lactamase-
producing Staphylococcus aureus, non-beta-lactamase-producing 
Staphylococcus aureus, Staphylococcus spp., Streptococcus spp., 
Escherichia coli, Pasteurella multocida, and Pasteurella spp. Urinary 
tract infections (cystitis) due to susceptible strains of E. coli.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
7. In Sec.  520.2090, revise paragraph (c)(2) to read as follows:

Sec.  520.2090  Sarolaner, moxidectin, and pyrantel.

* * * * *
    (c) * * *
    (2) Indications for use. For the prevention of heartworm disease 
caused by Dirofilaria immitis and for the treatment and control of 
roundworm (immature adult and adult Toxocara canis and adult Toxascaris 
leonina) and hookworm (L4, immature adult, and adult Ancylostoma 
caninum and adult Uncinaria stenocephala) infections. Kills adult fleas 
(Ctenocephalides felis) and is indicated for the treatment and 
prevention of flea infestations, and the treatment and control of tick 
infestations with Amblyomma americanum (lone star tick), Amblyomma 
maculatum (Gulf Coast tick), Dermacentor variabilis (American dog 
tick), Ixodes scapularis (black-legged tick), and Rhipicephalus 
sanguineus (brown dog tick) for 1 month in dogs and puppies 8 weeks of 
age and older, and weighing 2.8 pounds or greater. For the prevention 
of Borrelia burgdorferi infections as a direct result of killing Ixodes 
scapularis vector ticks.
* * * * *

0
8. In Sec.  520.2455:
0
a. Revise paragraphs (b)(1) through (4); and
0
b. In paragraph (d)(2), remove ``semduramycin'' and in its place add 
``semduramicin.''
    The revisions read as follows:

Sec.  520.2455  Tiamulin.

* * * * *
    (b) * * *
    (1) No. 058198 for products described in paragraph (a) of this 
section.
    (2) No. 066104 for product described in paragraph (a)(1) of this 
section.
    (3) Nos. 016592, 051311, and 061133 for product described in 
paragraph (a)(2) of this section.
    (4) No. 054771 for product described in paragraph (a)(3) of this 
section.
* * * * *

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

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

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

0
10. In Sec.  522.246, revise paragraphs (b)(2) and (3) to read as 
follows:

Sec.  522.246  Butorphanol.

* * * * *
    (b) * * *
    (2) No. 043264 for use of the product described in paragraph (a)(2) 
of this section as in paragraph (d)(2) of this section.
    (3) Nos. 000061, 043264, and 059399 for use of the product 
described in paragraph (a)(3) of this section as in paragraph (d)(3) of 
this section.
* * * * *

Sec.  522.533  [Amended]

0
11. In Sec.  522.533, in paragraph (b)(2), remove ``051330'' and in its 
place add ``043264''.

0
12. In Sec.  522.690:
0
a. Revise paragraphs (a) and (b);
0
b. Revise paragraph (d)(1) introductory text and paragraph (d)(1)(i);
0
c. Add paragraph (d)(2) introductory text;
0
d. Revise paragraph (d)(2)(ii);
0
e. Add paragraph (d)(3) introductory text;
0
f. Revise paragraph (d)(3)(ii); and
0
g. Remove paragraph (d)(4).
    The revisions and additions read as follows:

Sec.  522.690  Dinoprost.

    (a) Specifications. Each milliliter (mL) of solution contains 
dinoprost tromethamine equivalent to:
    (1) 5 milligrams (mg) dinoprost; or
    (2) 12.5 mg dinoprost.
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter as 
follows:
    (1) Nos. 054771 and 061133 for use of product described in 
paragraph (a)(1) as in paragraph (d) of this section.
    (2) No. 054771 for use of product described in paragraph (a)(2) as 
in paragraph (d)(1) of this section.
* * * * *
    (d) * * *
    (1) Cattle. Administer products described in paragraph (a) of this 
section as follows:
    (i) Amount. 25 mg as an intramuscular injection of the 5 mg/mL 
product or as an intramuscular or subcutaneous injection of the 12.5 
mg/mL product.
* * * * *
    (2) * * * Administer product described in paragraph (a)(1) of this 
section as follows:
* * * * *
    (ii) Indications for use. (A) For controlling the timing of estrus 
in estrous cycling mares.
    (B) For difficult-to-breed mares (clinically anestrous mares that 
have a corpus luteum).
* * * * *
    (3) * * * Administer product described in paragraph (a)(1) of this 
section as follows:
* * * * *
    (ii) Indications for use. For parturition induction in swine.

0
13. In Sec.  522.812, revise paragraph (b)(2) to read as follows:

Sec.  522.812  Enrofloxacin.

* * * * *
    (b) * * *
    (2) Nos. 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.
* * * * *

Sec.  522.955  [Amended]

0
14. In Sec.  522.955, in paragraph (b)(3), remove ``No. 086050'' and in 
its place

[[Page 17946]]

add ``Nos. 058005 and 086050''; and in paragraph (d)(1)(ii)(C), remove 
``No. 000061'' and in its place add ``Nos. 000061, 058005, and 
086050''.

0
15. In Sec.  522.1077, revise paragraph (d)(1)(iv) to read as follows:

Sec.  522.1077  Gonadorelin.

* * * * *
    (d) * * *
    (1) * * *
    (iv) Dinoprost injection for use as in paragraph (e)(1)(vi) of this 
section as provided by Nos. 054771 and 061133 in Sec.  510.600(c) of 
this chapter.
* * * * *

0
16. In Sec.  522.1940, revise the paragraph (c)(1) heading, paragraph 
(c)(1)(iii), the paragraph (c)(2) heading, and paragraph (c)(2)(iii) to 
read as follows:

Sec.  522.1940  Progesterone and estradiol benzoate.

* * * * *
    (c) * * *
    (1) Suckling beef calves at least 45 days old and up to 400 lb of 
body weight--* * *
* * * * *
    (iii) Limitations. For subcutaneous ear implantation, one dose per 
animal. Do not use in beef calves less than 45 days of age, dairy 
calves, and veal calves because effectiveness and safety have not been 
established. Do not use in animals intended for subsequent breeding, or 
in dairy cows. A withdrawal period has not been established for this 
product in preruminating calves. Do not use in calves to be processed 
for veal.
    (2) Growing beef steers weighing 400 lb or more--* * *
* * * * *
    (iii) Limitations. For subcutaneous ear implantation, one dose per 
animal. Do not use in beef calves less than 45 days of age, dairy 
calves, and veal calves because effectiveness and safety have not been 
established. Do not use in animals intended for subsequent breeding, or 
in dairy cows. A withdrawal period has not been established for this 
product in preruminating calves. Do not use in calves to be processed 
for veal.
* * * * *

0
17. In Sec.  522.2343, revise paragraph (c) introductory text and 
paragraph (c)(3) to read as follows:

Sec.  522.2343  Testosterone propionate and estradiol benzoate.

* * * * *
    (c) Conditions of use. For implantation in growing beef heifers 
weighing 400 lb or more as follows:
* * * * *
    (3) Limitations. For subcutaneous ear implantation, one dose per 
animal. Not for use in dairy or beef replacement heifers. Do not use in 
beef calves less than 2 months of age, dairy calves, and veal calves 
because safety and effectiveness have not been established. A 
withdrawal period has not been established for this product in 
preruminating calves. Do not use in calves to be processed for veal.

0
18. In Sec.  522.2478, redesignate paragraph (d)(3) as paragraph 
(d)(4); add new paragraph (d)(3); and revise newly redesignated 
paragraph (d)(4) heading and paragraph (d)(4)(i)(C) to read as follows:

Sec.  522.2478  Trenbolone acetate and estradiol benzoate.

* * * * *
    (d) * * *
    (3) Growing beef steers and heifers fed in confinement for 
slaughter. (i) For an implant as described in paragraph (a)(2)(ii) of 
this section:
    (A) Amount. 150 mg trenbolone acetate and 21 mg estradiol benzoate 
in an extended-release implant.
    (B) Indications for use. For increased rate of weight gain for up 
to 200 days.
    (C) Limitations. Implant pellets subcutaneously in ear only. Not 
approved for repeated implantation (reimplantation) with this or any 
other cattle ear implant within each separate production phase. Safety 
and effectiveness following reimplantation have not been evaluated. Do 
not use in beef calves less than 2 months of age, dairy calves, and 
veal calves because effectiveness and safety have not been established. 
Do not 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. Do not use in dairy cows or in 
animals intended for subsequent breeding. Use in these cattle may cause 
drug residues in milk and/or in calves born to these cows.
    (ii) [Reserved]
    (4) Growing beef steers and heifers on pasture (stocker, feeder, 
and slaughter). (i) * * *
    (C) Limitations. Implant pellets subcutaneously in ear only. Not 
approved for repeated implantation (reimplantation) with this or any 
other cattle ear implant within each separate production phase. Safety 
and effectiveness following reimplantation have not been evaluated. Do 
not use in beef calves less than 2 months of age, dairy calves, and 
veal calves because effectiveness and safety have not been established. 
Do not 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. Do not use in dairy cows or in animals 
intended for subsequent breeding. Use in these cattle may cause drug 
residues in milk and/or in calves born to these cows.
* * * * *

0
19. In 522.2630, revise paragraphs (b)(1) and (2) to read as follows:

Sec.  522.2630  Tulathromycin.

* * * * *
    (b) * * *
    (1) Nos. 013744, 051311, 054771, 058198, and 061133 for use of 
product described in paragraph (a)(1) as in paragraphs (d)(1)(i) and 
(ii), (d)(1)(iii)(A), and (d)(2) of this section.
    (2) Nos. 013744, 051311, and 054771 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.
* * * * *

0
20. In Sec.  522.2662, revise paragraph (b)(3) to read as follows:

Sec.  522.2662  Xylazine.

* * * * *
    (b) * * *
    (3) Nos. 043264 and 061651 for use of product described in 
paragraph (a)(1) of this section as in paragraph (d)(1) of this 
section; and product described in paragraph (a)(2) of this section as 
in paragraphs (d)(2), (d)(3)(i), (d)(3)(ii)(A), and (d)(3)(iii) of this 
section.
* * * * *

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

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

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

0
22. In Sec.  524.1146, revise paragraphs (b)(2) and (3) to read as 
follows:

Sec.  524.1146  Imidacloprid and moxidectin.

* * * * *
    (b) * * *
    (2) Nos. 051072, 017030, 058198, and 061651 for use of product 
described in paragraph (a)(2) of this section as in paragraph (d)(2) of 
this section.
    (3) Nos. 051072 and 058198 for use of product described in 
paragraph (a)(2) of this section as in paragraph (d)(3) of this 
section.
* * * * *

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

0
23. The authority citation for part 529 continues to read as follows:

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

[[Page 17947]]

0
24. In Sec.  529.1940, revise the last sentence in paragraph 
(e)(1)(iii) to read as follows:

Sec.  529.1940  Progesterone intravaginal inserts.

* * * * *
    (e) * * *
    (1) * * *
    (iii) * * * Dinoprost injection for use as in paragraphs 
(e)(1)(ii)(A) and (B) of this section as in Sec.  522.690 of this 
chapter, provided by Nos. 054771 and 061133 in Sec.  510.600(c) of this 
chapter.
* * * * *

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

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

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

0
26. In 556.240, revise paragraphs (b)(1) and (c) to read as follows:

Sec.  556.240  Estradiol and related esters.

* * * * *
    (b) * * *
    (1) Cattle. (i) Muscle: 0.2 ppb.
    (ii) Liver: 0.6 ppb.
    (iii) Kidney: 1.2 ppb.
    (iv) Fat: 1.2 ppb.
* * * * *
    (c) Related conditions of use. See Sec. Sec.  522.840, 522.850, 
522.1940, 522.2343, 522.2477, and 522.2478 of this chapter.

0
27. In Sec.  556.370, revise paragraph (b) to read as follows:

Sec.  556.370  Lubabegron.

* * * * *
    (b) Tolerances. The tolerances for lubabegron (marker residue) are:
    (1) Cattle. (i) Liver (target tissue): 10 ppb.
    (ii) Muscle: 3 ppb.
    (iii) Kidney: 20 ppb.
    (2) [Reserved]
* * * * *

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

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

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

0
29. In Sec.  558.254, revise paragraph (e) to read as follows:

Sec.  558.254  Famphur.

* * * * *
    (e) Conditions of use. It is used in cattle feed as follows:

----------------------------------------------------------------------------------------------------------------
            Famphur amount                    Indications for use                 Limitations            Sponsor
----------------------------------------------------------------------------------------------------------------
(1) To provide 1.1 milligrams per       Beef cattle and nonlactating    Feed for 30 days. Withdraw        000061
 pound (mg/lb) body weight per day.      dairy cattle: For control of    from dry dairy cows and
                                         grubs and as an aid in          heifers 21 days prior to
                                         control of sucking lice.        freshening. Withdraw 4 days
                                                                         prior to slaughter.
(2) To provide 2.3 mg/lb body weight    Beef cattle and nonlactating    Feed for 10 days. Withdraw        000061
 per day.                                dairy cattle: For control of    from dry dairy cows and
                                         grubs.                          heifers 21 days prior to
                                                                         freshening. Withdraw 4 days
                                                                         prior to slaughter.
----------------------------------------------------------------------------------------------------------------

0
30. In Sec.  558.355, revise paragraphs (d)(8)(vi) and (f)(1)(ii), 
(iv), and (vi) to read as follows:

Sec.  558.355  Monensin.

* * * * *
    (d) * * *
    (8) * * *
    (vi) Not for replacement chickens intended to become broiler 
breeding chickens.
* * * * *
    (f) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
                            Combination in grams/
   Monensin in grams/ton             ton             Indications for use            Limitations          Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(ii) 90 to 110............                        Layer replacement          Feed continuously as the     058198
                                                   chickens: As an aid in     sole ration. Do not feed
                                                   the prevention of          to chickens over 16
                                                   coccidiosis caused by E.   weeks of age. Do not
                                                   necatrix, E. tenella, E.   feed to laying chickens.
                                                   acervulina, E. brunetti,
                                                   E. mivati, and E. maxima.
 
                                                  * * * * * * *
(iv) 90 to 110............  Bacitracin            Layer replacement          Feed continuously as sole    054771
                             methylenedisalicyla   chickens: As an aid in     ration. Do not feed to
                             te, 4 to 50.          the prevention of          chickens over 16 weeks
                                                   coccidiosis caused by E.   of age. Do not feed to
                                                   necatrix, E. tenella, E.   laying chickens.
                                                   acervulina, E. brunetti,   Monensin sodium provided
                                                   E. mivati, and E.          by No. 058198,
                                                   maxima, and for            bacitracin
                                                   increased rate of weight   methylenedisalicylate
                                                   gain and improved feed     provided by No. 054771
                                                   efficiency.                in Sec.   510.600(c) of
                                                                              this chapter.
 
                                                  * * * * * * *
(vi) 90 to 110............  Bacitracin            Broiler and layer          Feed continuously as sole    054771
                             methylenedisalicyla   replacement chickens: As   ration. Do not feed to
                             te, 50.               an aid in the prevention   chickens over 16 weeks
                                                   of coccidiosis caused by   of age. Do not feed to
                                                   E. necatrix, E. tenella,   laying chickens.
                                                   E. acervulina, E.          Monensin sodium provided
                                                   brunetti, E. mivati, and   by No. 058198,
                                                   E. maxima, and for         bacitracin
                                                   improved feed              methylenedisalicylate
                                                   efficiency, and as an      provided by No. 054771
                                                   aid in the prevention of   in Sec.   510.600(c) of
                                                   necrotic enteritis         this chapter.
                                                   caused or complicated by
                                                   Clostridium spp. or
                                                   other organisms
                                                   susceptible to
                                                   bacitracin.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

0
31. In Sec.  558.500, revise paragraphs (b) and (e)(2)(i), (iii), and 
(vi) to read as follows:

Sec.  558.500  Ractopamine.

* * * * *
    (b) Sponsors. See sponsor numbers in Sec.  510.600(c) of this 
chapter.
    (1) No. 058198: Type A medicated articles containing 9 or 45.4 
grams per pound (g/lb) ractopamine hydrochloride.

[[Page 17948]]

    (2) Nos. 016592, 051311, and 054771: Type A medicated articles 
containing 45.4 g/lb ractopamine hydrochloride.
* * * * *
    (e) * * *
    (2) * * *

----------------------------------------------------------------------------------------------------------------
                                 Combination in grams/
    Ractopamine in grams/ton              ton             Indications for use         Limitations        Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 8.2 to 24.6................                         Cattle fed in           Feed continuously as      016592
                                                         confinement for         sole ration during       051311
                                                         slaughter: For          the last 28 to 42        054771
                                                         increased rate of       days on feed. Not for    058198
                                                         weight gain and         animals intended for
                                                         improved feed           breeding.
                                                         efficiency during the
                                                         last 28 to 42 days on
                                                         feed.
 
                                                  * * * * * * *
(iii) 9.8 to 24.6..............                         Cattle fed in           Feed continuously as      016592
                                                         confinement for         sole ration during       051311
                                                         slaughter: For          the last 28 to 42        054771
                                                         increased rate of       days on feed. Not for    058198
                                                         weight gain, improved   animals intended for
                                                         feed efficiency, and    breeding.
                                                         increased carcass
                                                         leanness during the
                                                         last 28 to 42 days on
                                                         feed.
 
                                                  * * * * * * *
(vi) Not to exceed 800; to       .....................  Cattle fed in           Top dress ractopamine     016592
 provide 70 to 400 mg/head/day.                          confinement for         at a minimum of 1.0      051311
                                                         slaughter: For          lb/head/day of           054771
                                                         increased rate of       medicated feed           058198
                                                         weight gain and         continuously during
                                                         improved feed           the last 28 to 42
                                                         efficiency during the   days on feed. Not for
                                                         last 28 to 42 days on   animals intended for
                                                         feed.                   breeding..
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

Sec.  558.555  [Amended]

0
32. In Sec.  558.555, in paragraph (f), remove ``Semduramycin'' and in 
its place add ``Semduramicin''.

0
33. In Sec.  558.633, revise paragraph (d)(3) to read as follows:

Sec.  558.633  Tylvalosin.

* * * * *
    (d) * * *
    (3) Pelleted Type C medicated feeds must bear an expiration date of 
30 days after the date of manufacture. Crumbled Type C medicated feeds 
must bear an expiration date of 7 days after the date of manufacture.
* * * * *

0
34. In Sec.  558.680, revise paragraphs (d)(1)(iii), (iv), (vii), and 
(viii) and (d)(2) to read as follows:

Sec.  558.680  Zoalene.

* * * * *
    (d) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
                                 Combination in grams/
      Zoalene in grams/ton                ton             Indications for use         Limitations        Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(iii) 36.3 to 113.5............  Bacitracin             Replacement chickens:   Feed continuously as      054771
                                  methylenedisalicylat   For development of      the sole ration as in    058198
                                  e, 50.                 active immunity to      the subtable in item
                                                         coccidiosis; and as     (i). Grower ration
                                                         an aid in the control   not to be fed to
                                                         of necrotic enteritis   birds over 14 weeks
                                                         caused or complicated   of age. Bacitracin
                                                         by Clostridium spp.     methylenedisalicylate
                                                         or other organisms      as provided by No.
                                                         susceptible to          054771 in Sec.
                                                         bacitracin.             510.600(c) of this
                                                                                 chapter.
(iv) 36.3 to 113.5.............  Bacitracin             Replacement chickens:   Feed continuously as      054771
                                  methylenedisalicylat   For development of      sole ration as in the    058198
                                  e, 100 to 200.         active immunity to      subtable in item (i).
                                                         coccidiosis; and as     To control necrotic
                                                         an aid in the control   enteritis, start
                                                         of necrotic enteritis   medication at first
                                                         caused or complicated   clinical signs of
                                                         by Clostridium spp.     disease; vary
                                                         or other organisms      bacitracin dosage
                                                         susceptible to          based on the severity
                                                         bacitracin.             of infection;
                                                                                 administer
                                                                                 continuously for 5 to
                                                                                 7 days or as long as
                                                                                 clinical signs
                                                                                 persist, then reduce
                                                                                 bacitracin to
                                                                                 prevention level (50
                                                                                 g/ton). Bacitracin
                                                                                 methylenedisalicylate
                                                                                 as provided by No.
                                                                                 054771 in Sec.
                                                                                 510.600(c) of this
                                                                                 chapter.
 
                                                  * * * * * * *
(vii) 113.5....................  Bacitracin             Broiler chickens: For   Feed continuously as      054771
                                  methylenedisalicylat   prevention and          the sole ration.         058198
                                  e, 50.                 control of              Bacitracin
                                                         coccidiosis; and as     methylenedisalicylate
                                                         an aid in the           as provided by No.
                                                         prevention of           054771 in Sec.
                                                         necrotic enteritis      510.600(c) of this
                                                         caused or complicated   chapter.
                                                         by Clostridium spp.
                                                         or other organisms
                                                         susceptible to
                                                         bacitracin.
(viii) 113.5...................  Bacitracin             Broiler chickens: For   Feed continuously as      054771
                                  methylenedisalicylat   prevention and          sole ration. To          058198
                                  e,.                    control of              control necrotic
                                 100 to 200...........   coccidiosis; and as     enteritis, start
                                                         an aid in the control   medication at first
                                                         of necrotic enteritis   clinical signs of
                                                         caused or complicated   disease; vary
                                                         by Clostridium spp.     bacitracin dosage
                                                         or other organisms      based on the severity
                                                         susceptible to          of infection;
                                                         bacitracin.             administer
                                                                                 continuously for 5 to
                                                                                 7 days or as long as
                                                                                 clinical signs
                                                                                 persist, then reduce
                                                                                 bacitracin to
                                                                                 prevention level (50
                                                                                 g/ton). Bacitracin
                                                                                 methylenedisalicylate
                                                                                 as provided by No.
                                                                                 054771 in Sec.
                                                                                 510.600(c) of this
                                                                                 chapter.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

    (2) Turkeys--

[[Page 17949]]

----------------------------------------------------------------------------------------------------------------
                                  Combination in
     Zoalene in grams/ton           grams/ton          Indications for use           Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 113.5 to 170.3...........                       Growing turkeys: For      Feed continuously as        054771
                                                     prevention and control    sole ration. For           058198
                                                     of coccidiosis.           turkeys grown for meat
                                                                               purposes only. Not to
                                                                               be fed to laying birds.
(ii) 113.5 to 170.3..........  Bacitracin           Growing turkeys: For      Feed continuously as        054771
                                methylenedisalicyl   prevention and control    sole ration until 14 to    058198
                                ate, 4 to 50.        of coccidiosis; and for   16 weeks of age. For
                                                     increased rate of         turkeys grown for meat
                                                     weight gain and           purposes only. Not to
                                                     improved feed             be fed to laying birds.
                                                     efficiency.
----------------------------------------------------------------------------------------------------------------

* * * * *

    Dated: March 21, 2022.
Andi Lipstein Fristedt,
Deputy Commissioner for Policy, Legislation, and International Affairs, 
U.S. Food and Drug Administration.
[FR Doc. 2022-06395 Filed 3-28-22; 8:45 am]
BILLING CODE 4164-01-P