[Federal Register Volume 86, Number 43 (Monday, March 8, 2021)]
[Rules and Regulations]
[Pages 13181-13191]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-04453]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 516, 520, 522, 524, 526, 529, 556, and 558

[Docket No. FDA-2020-N-0002]


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

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 2020. 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 March 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, 
george.haibel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Approval Actions

    FDA is amending the animal drug regulations to reflect approval 
actions for NADAs and ANADAs during April, May, and June 2020, 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.

                              Table 1--Original and Supplemental NADAs and ANADAs Approved During April, May, and June 2020
--------------------------------------------------------------------------------------------------------------------------------------------------------
     Approval date        File No.          Sponsor              Product name              Species          Effect of the action     Public documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
April 2, 2020..........    141-527  Bayer HealthCare LLC,   BAYTRIL 100-CA1        Cattle................  Conditional approval   FOI Summary.
                                     Animal Health           (enrofloxacin)                                 for the treatment of
                                     Division, P.O. Box      Injectable Solution.                           clinical
                                     390, Shawnee Mission,                                                  anaplasmosis in
                                     KS 66201.                                                              certain classes of
                                                                                                            cattle.
April 10, 2020.........    141-533  Boehringer Ingelheim    ASERVO EQUIHALER       Horses................  Original approval for  FOI Summary.
                                     Animal Health USA,      (ciclesonide                                   the management of
                                     Inc., 3239 Satellite    inhalation spray).                             clinical signs
                                     Blvd., Duluth, GA                                                      associated with
                                     30096.                                                                 severe equine asthma
                                                                                                            in horses.

[[Page 13182]]

 
April 22, 2020.........    200-673  Aurora Pharmaceutical,  REVOLT (selamectin)    Dogs and cats.........  Original approval as   FOI Summary.
                                     Inc., 1196 Highway 3    Topical Solution.                              a generic copy of
                                     South, Northfield, MN                                                  NADA 141-152.
                                     55057-3009.
April 27, 2020.........    200-674  Modern Veterinary       Detomidine             Horses................  Original approval as   FOI Summary.
                                     Therapeutics, LLC,      Hydrochloride                                  a generic copy of
                                     14343 SW 119th Ave.,    (detomidine                                    NADA 140-862.
                                     Miami, FL 33186.        hydrochloride)
                                                             Injectable Solution.
May 14, 2020...........    200-679  Huvepharma EOOD, 5th    OPTIGRID (ractopamine  Cattle................  Original approval as   FOI Summary.
                                     Floor, 3A Nikolay       HCl) Type A                                    a generic copy of
                                     Haytov Str., 1113       Medicated Article.                             NADA 141-221.
                                     Sophia, Bulgaria.
May 21, 2020...........    200-680  Felix Pharmaceuticals   Enrofloxacin flavored  Dogs..................  Original approval as   FOI Summary.
                                     Pvt. Ltd., 25-28        tablets.                                       a generic copy of
                                     North Wall Quay,                                                       NADA 140-441.
                                     Dublin 1, Ireland.
May 27, 2020...........    200-638  V[eacute]toquinol USA,  IMOXI Topical          Cats..................  Original approval as   FOI Summary.
                                     Inc., 4250 N Sylvania   Solution for Cats                              a generic copy of
                                     Ave., Fort Worth, TX    (imidacloprid and                              NADA 141-254.
                                     76137.                  moxidectin).
May 28, 2020...........    200-510  Pharmgate, Inc., 1800   Chlortetracycline      Cattle................  Supplemental approval  N/A.
                                     Sir Tyler Dr.,          Type B and Type C                              for use of DERACIN
                                     Wilmington, NC 28405.   medicated feeds.                               (chlortetracycline)
                                                                                                            Type A medicated
                                                                                                            articles in the
                                                                                                            manufacture of Type
                                                                                                            B and Type C
                                                                                                            medicated feeds for
                                                                                                            control of bacterial
                                                                                                            pneumonia in beef
                                                                                                            cattle and
                                                                                                            replacement dairy
                                                                                                            heifers.
June 1, 2020...........    200-134  Intervet, Inc., 2       FERTAGYL               Cattle................  Supplemental approval  FOI Summary.
                                     Giralda Farms,          (gonadorelin)                                  for fixed-time
                                     Madison, NJ 07940.      Injectable Solution.                           artificial
                                                                                                            insemination in beef
                                                                                                            cows.
June 2, 2020...........    200-682  Huvepharma EOOD, 5th    VETMULIN 12.5%         Swine.................  Original approval as   FOI Summary.
                                     Floor, 3A Nikolay       (tiamulin hydrogen                             a generic copy of
                                     Haytov Str., 1113       fumarate) Liquid                               NADA 140-916.
                                     Sophia, Bulgaria.       concentrate.
June 4, 2020...........    200-399  Huvepharma EOOD, 5th    CYCLEGUARD             Cattle................  Original approval as   FOI Summary.
                                     Floor, 3A Nikolay       (melengestrol                                  a generic copy of
                                     Haytov Str., 1113       acetate Type A                                 NADA 039-402.
                                     Sophia, Bulgaria.       liquid medicated
                                                             article).
June 15, 2020..........    141-534  Orion Corp.,            CLEVOR (ropinirole     Dogs..................  Original approval for  FOI Summary.
                                     Orionintie 1, 02200     ophthalmic solution).                          the induction of
                                     Espoo, Finland.                                                        vomiting in dogs.
June 18, 2020..........    141-535  Zoetis Inc., 333        Chlortetracycline,     Cattle................  Original approval for  FOI Summary.
                                     Portage St.,            sulfamethazine, and                            use of AUREO S 700
                                     Kalamazoo, MI 49007.    lasalocid Type B and                           (chlortetracycline
                                                             Type C medicated                               and sulfamethazine)
                                                             feeds.                                         and BOVATEC
                                                                                                            (lasalocid) in the
                                                                                                            manufacture of Type
                                                                                                            B and Type C
                                                                                                            medicated feeds for
                                                                                                            beef steers and
                                                                                                            heifers fed in
                                                                                                            confinement for
                                                                                                            slaughter.
--------------------------------------------------------------------------------------------------------------------------------------------------------

II. Changes of Sponsor

    Virbac AH, Inc., P.O. Box 162059, Fort Worth, TX 76161 has informed 
FDA that it has transferred ownership of, and all rights and interest 
in, NADA 141-084 for SENTINEL (lufenuron and milbemycin oxime) Flavor 
Tabs, NADA 141-204 for the SENTINEL Flavor Tabs and CAPSTAR 
(nitenpyram) Flea Management System, and NADA 141-333 for SENTINEL 
SPECTRUM (lufenuron, milbemycin oxime, and praziquantel) Chews to 
Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940. Also, Sparhawk 
Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 66215 has 
informed FDA that it has transferred ownership of, and all rights and 
interest in, A 200-348 for ECOMECTIN (ivermectin) Cattle Pour-On to 
Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sofia, 
Bulgaria. The animal drug regulations will be amended to reflect these 
changes of sponsor.

III. Technical Amendments

    FDA is making the following amendments to improve the accuracy and 
readability of the animal drug regulations:
     The entries in 21 CFR 510.600(c), 520.304, and 520.812 for 
Dechra Veterinary Products LLC are being amended to reflect the firm's 
current drug labeler code.
     The entries in 21 CFR 510.600(c) for Cronus Pharma 
Specialities India Private Ltd. are being amended to reflect the firm's 
current address.
     Conditions for use in 21 CFR 520.100 for use of amprolium 
crumbles in calves are being removed because no approved NADA exists 
for this dosage form product.
     The regulations in part 526 (21 CFR part 526) for 
intramammary dosage form drugs are being amended to reflect a current 
format and improve readability.
     The section in part 529 (21 CFR part 529) for sevofluorane 
anesthetic gas is being redesignated to reflect a current 
organizational scheme for dosage form new animal drugs.
     Cross references in part 556 (21 CFR part 556) to related 
approved uses of new animal drugs are being amended as conforming 
changes to improve the accuracy of the regulations.
     The table in 21 CFR 558.4 is being amended to reflect the 
correct format for displaying assay limits for component drugs in 
fixed-ratio, combination drug Type A medicated articles and Type B and 
Type C medicated feeds.
     Three tabular entries in 21 CFR 558.68 are being amended 
to reflect the approved conditions of use of certain feed use 
combinations, which had been removed in error.

[[Page 13183]]

     Typographical errors are being corrected wherever they 
have been found.

IV. Legal Authority

    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. This 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 the conditions of use of an approved or conditionally approved new 
animal drug and the name and address of the drug's sponsor in a 
``notice, which upon publication shall be effective as a regulation.'' 
A notice published pursuant to section 512(i) is not subject to the 
notice-and-comment rulemaking requirements of the Administrative 
Procedure Act, 5 U.S.C. 551 et seq. See section 512(i) of the FD&C Act 
(21 U.S.C. 360b(i)); 21 CFR 10.40(e)(3); S. Rep. 90-1308, at 5 (1968).
    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, 526, and 529

    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, 516, 520, 522, 524, 526, 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):
0
i. Revise the entries for ``Cronus Pharma Specialities India Private 
Ltd.'' and ``Dechra Veterinary Products LLC'';
0
ii. Add an entry in alphabetical order for ``Felix Pharmaceuticals Pvt. 
Ltd.''; and
0
iii. Revise the entry for ``Pharmgate, Inc.''; and
0
b. In the table in paragraph (c)(2):
0
i. Add an entry in numerical order for ``017033'';
0
ii. Remove the entry for ``026637'';
0
iii. Revise the entries for ``069043'' and ``069254''; and
0
iv. Add an entry in numerical order for ``086101''.
    The additions and 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
------------------------------------------------------------------------
 
                              * * * * * * *
Cronus Pharma Specialities India Private Ltd., Sy No-99/          069043
 1, GMR Hyderabad Aviation SEZ Ltd., Mamidipalli
 Village, Shamshabad Mandal, Ranga Reddy, Hyderabad
 Telangana 501218, India................................
 
                              * * * * * * *
Dechra Veterinary Products LLC, 7015 College Blvd.,               017033
 Suite 525, Overland Park, KS 66211.....................
 
                              * * * * * * *
Felix Pharmaceuticals Pvt. Ltd., 25-28 North Wall Quay,           086101
 Dublin 1, Ireland......................................
 
                              * * * * * * *
Pharmgate Inc., 1800 Sir Tyler Dr., Wilmington, NC 28405          069254
 
                              * * * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
    Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                              * * * * * * *
017033..................  Dechra Veterinary Products LLC, 7015 College
                           Blvd., Suite 525, Overland Park, KS 66211.
 
                              * * * * * * *
069043..................  Cronus Pharma Specialities India Private Ltd.,
                           Sy No-99/1, GMR Hyderabad Aviation SEZ Ltd.,
                           Mamidipalli Village, Shamshabad Mandal, Ranga
                           Reddy, Hyderabad Telangana 501218, India.
 

[[Page 13184]]

 
                              * * * * * * *
069254..................  Pharmgate Inc., 1800 Sir Tyler Dr.,
                           Wilmington, NC 28405.
 
                              * * * * * * *
086101..................  Felix Pharmaceuticals Pvt. Ltd., 25-28 North
                           Wall Quay, Dublin 1, Ireland.
 
                              * * * * * * *
------------------------------------------------------------------------

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-1, 360ccc-2, 371.


0
4. Add Sec.  516.812 to subpart E to read as follows:


Sec.  516.812   Enrofloxacin.

    (a) Specifications. Each milliliter (mL) of solution contains 100 
milligrams (mg) enrofloxacin.
    (b) Sponsor. See No. 000859 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in cattle--(1) Amount. Administer, by 
subcutaneous injection, a single dose of 12.5 mg/kilogram of body 
weight (5.7 mL/100 pounds of body weight). Administered dose volume 
should not exceed 20 mL per injection site.
    (2) Indications for use. For the treatment of clinical anaplasmosis 
associated with Anaplasma marginale in replacement dairy heifers under 
20 months of age and all classes of beef cattle except beef calves less 
than 2 months of age and beef bulls intended for breeding (any age). 
Not for use in any other class of dairy cattle or in veal calves.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian. Federal law prohibits the extra-
label use of this drug in food-producing animals. Cattle intended for 
human consumption must not be slaughtered within 28 days from the last 
treatment. This product is not approved for use in female dairy cattle 
20 months 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. A 
withdrawal period has not been established for this product in pre-
ruminating calves. Do not use in calves to be processed for veal.

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. In Sec.  520.100, remove paragraph (a)(3), revise paragraph (b)(2), 
add paragraph (b)(3), and revise paragraph (d)(2) introductory text.
    The revisions and addition read as follows:


Sec.  520.100   Amprolium.

* * * * *
    (b) * * *
    (2) No. 066104 for use of product described in paragraph (a)(1) of 
this section as in paragraph (d) of this section.
    (3) No. 051072 for use of product described in paragraph (a)(1) of 
this section as in paragraph (d)(1) of this section.
* * * * *
    (d) * * *
    (2) Calves. Administer concentrate solution or soluble powder as a 
drench or in drinking water as follows:
* * * * *

0
7. In Sec.  520.304, revise paragraph (b), remove reserved paragraph 
(c), and redesignate paragraph (d) as paragraph (c).
    The revision reads as follows:


Sec.  520.304  Carprofen.

* * * * *
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for 
use as in paragraph (c) of this section.
    (1) Nos. 017033, 054771, 055529, and 062250 for use of products 
described in paragraph (a) as in paragraph (c) of this section.
    (2) No. 000859 for use of product described in paragraph (a)(2) as 
in paragraph (c) of this section.
* * * * *

0
8. In Sec.  520.812, revise paragraphs (a) and (b) to read as follows:


Sec.  520.812   Enrofloxacin.

    (a) Specifications--(1) Each tablet contains:
    (i) 22.7, 68.0, or 136.0 milligrams (mg) enrofloxacin; or
    (ii) 22.7, 68.0, 136.0, or 272 mg enrofloxacin.
    (2) Each chewable tablet contains 22.7, 68.0, or 136.0 mg 
enrofloxacin.
    (3) Each soft chewable tablet contains 22.7, 68.0, or 136.0 mg 
enrofloxacin.
    (b) Sponsors. See sponsor numbers in Sec.  510.600(c) of this 
chapter for use as in paragraph (c) of this section.
    (1) No. 000859 for use of products described in paragraphs 
(a)(1)(i), (a)(2), and (a)(3) of this section.
    (2) No. 017033 for use of product described in paragraph (a)(1)(i) 
of this section.
    (3) No. 058198 for use of product described in paragraph (a)(1)(ii) 
of this section.
    (4) No. 086101 for use of product described in paragraph (a)(2) of 
this section.
* * * * *


Sec.  520.1443   [Amended]

0
9. In Sec.  520.1443, in paragraph (b), remove ``051311'' and in its 
place add ``000061''.


Sec.  520.1447   [Amended]

0
10. In Sec.  520.1447, in paragraph (b), remove ``051311'' and in its 
place add ``000061''.


Sec.  520.1510  [Amended]

0
11. In Sec.  520.1510, in paragraph (b)(2), remove ``051311'' and in 
its place add ``000061''.


Sec.  520.2455  [Amended]

0
12. In Sec.  520.2455, in paragraph (b)(4), remove ``No. 061133'' and 
in its place add ``Nos. 016592 and 061133''.

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

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

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


Sec.  522.536  [Amended]

0
14. In Sec.  522.536, in paragraph (b), remove ``No. 052483'' and in 
its place add ``Nos. 015914 and 052483''.

0
15. In Sec.  522.1077:
0
a. Revise paragraphs (a)(3), (b), (d), and (e)(1)(i);
0
b. Remove paragraph (e)(1)(ii);
0
c. Redesignate paragraphs (e)(1)(iii) through (e)(1)(vii) as paragraphs 
(e)(1)(ii) through (e)(1)(vi);
0
d. Revise newly redesignated paragraphs (e)(1)(ii) and (iii); and

[[Page 13185]]

0
e. Remove and reserve paragraph (e)(2).
    The revisions read as follows:


Sec.  522.1077  Gonadorelin.

    (a) * * *
    (3) 50 [mu]g of gonadorelin as gonadorelin diacetate tetrahydrate 
(equivalent to 43 [mu]g gonadorelin); or
* * * * *
    (b) Sponsors. See sponsor numbers in Sec.  510.600(c) of this 
chapter.
    (1) No. 000061 for use of the 43-[mu]g/mL product described in 
paragraph (a)(1) as in paragraphs (e)(1)(i) and (iii) of this section.
    (2) No. 068504 for use of the 100-[mu]g/mL product described in 
paragraph (a)(2) as in paragraph (e)(1)(iv) of this section.
    (3) No. 061133 for use of the 50-[mu]g/mL product described in 
paragraph (a)(3) as in paragraphs (e)(1)(i) of this section.
    (4) No. 000010 for use of the 43-[mu]g/mL product described in 
paragraph (a)(3) as in paragraphs (e)(1)(i) and (v) of this section.
    (5) No. 054771 for use of the 50-[mu]g/mL product described in 
paragraph (a)(4) as in paragraphs (e)(1)(ii) and (vi) of this section.
* * * * *
    (d) Special considerations--(1) Concurrent luteolytic drug use is 
approved as follows:
    (i) Cloprostenol injection for use as in paragraph (e)(1)(iii) of 
this section as provided by No. 000061 in Sec.  510.600(c) of this 
chapter.
    (ii) Cloprostenol injection for use as in paragraph (e)(1)(iv) of 
this section as provided by No. 068504 in Sec.  510.600(c) of this 
chapter.
    (iii) Cloprostenol injection for use as in paragraph (e)(1)(v) of 
this section as provided by Nos. 000010 in Sec.  510.600(c) of this 
chapter.
    (iv) Dinoprost injection for use as in paragraphs (e)(1)(vi) of 
this section as provided by No. 054771 in Sec.  510.600(c) of this 
chapter.
    (2) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
    (e) * * *
    (1) Indications for use and amounts--(i) For the treatment of 
ovarian follicular cysts in dairy cattle: Administer 86 [mu]g 
gonadorelin (No. 000061) or 100 [mu]g gonadorelin diacetate 
tetrahydrate (Nos. 000010 and 061133) by intramuscular or intravenous 
injection.
    (ii) For the treatment of ovarian follicular cysts in cattle: 
Administer 100 [mu]g gonadorelin hydrochloride by intramuscular 
injection.
    (iii) For use with cloprostenol sodium to synchronize estrous 
cycles to allow for fixed-time artificial insemination (FTAI) in beef 
cows and lactating dairy cows: Administer to each cow 86 [mu]g 
gonadorelin by intramuscular injection, followed 6 to 8 days later by 
500 [mu]g cloprostenol by intramuscular injection, followed 30 to 72 
hours later by 86 [mu]g gonadorelin by intramuscular injection.
* * * * *

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 paragraph (b)(2) and add paragraph (b)(3) 
to read as follows:


Sec.  524.1146  Imidacloprid and moxidectin.

* * * * *
    (b) * * *
    (2) Nos. 000859 and 017030 for use of product described in 
paragraph (a)(2) of this section as in paragraph (d)(2) of this 
section.
    (3) No. 000859 for use of product described in paragraph (a)(2) of 
this section as in paragraph (d)(3) of this section.
* * * * *


Sec.  524.1193  [Amended]

0
18. In Sec.  524.1193, in paragraph (b)(2), remove ``016592, 054925, 
and 058005'' and in its place add ``016592 and 054925''.

0
19. Add Sec.  524.2080 to read as follows:


Sec.  524.2080  Ropinirole.

    (a) Specifications. Each milliliter of solution contains 30 
milligrams (mg) ropinirole (equivalent to 34.2 mg ropinirole 
hydrochloride).
    (b) Sponsor. See No. 052483 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Using the table provided in 
labeling, administer the number of eye drops topically, corresponding 
to body weight, that results in a target dose of 3.75 mg per square 
meter (mg/m\2\) (dose band 2.7 to 5.4 mg/m\2\). If the dog does not 
vomit within 20 minutes of the first dose, then a second dose may be 
administered.
    (2) Indications for use. For the induction of vomiting in dogs.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.


Sec.  524.2098   [Amended]

0
20. In Sec.  524.2098, in paragraph (b), remove ``Nos. 054771, 055529, 
and 061651'' and in its place add ``Nos. 051072, 054771, 055529, and 
061651''.

PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS

0
21. The authority citation for part 526 continues to read as follows:

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


0
22. In Sec.  526.88, revise the section heading, paragraph (a), the 
paragraph (d) subject heading, and paragraphs (d)(1) and (3) to read as 
follows:


Sec.  526.88  Amoxicillin.

    (a) Specifications. Each single-dose, 10-milliliter syringe 
contains amoxicillin trihydrate equivalent to 62.5 milligrams (mg) 
amoxicillin.
* * * * *
    (d) Conditions of use in lactating cows--(1) Amount. Infuse the 
contents of one syringe (equivalent to 62.5 mg amoxicillin) into each 
infected quarter every 12 hours for a maximum of 3 doses.
* * * * *
    (3) Limitations. Milk taken from animals during treatment and for 
60 hours (5 milkings) after the last treatment must not be used for 
food. Treated animals must not be slaughtered for food purposes within 
12 days after the last treatment. Federal law restricts this drug to 
use by or on the order of a licensed veterinarian.

0
23. In Sec.  526.313, revise paragraphs (a) and (d) and add paragraph 
(e) to read as follows:


Sec.  526. 313  Ceftiofur.

    (a) Specifications. Each single-dose, 10-milliliter syringe 
contains:
    (1) 125 milligrams (mg) ceftiofur equivalents as the hydrochloride 
salt; or
    (2) 500 mg ceftiofur equivalents as the hydrochloride salt.
* * * * *
    (d) Conditions of use for syringe described in paragraph (a)(1) of 
this section in lactating cows--(1) Amount. Infuse the contents of one 
syringe (125 mg ceftiofur equivalents) into each affected quarter. 
Repeat treatment in 24 hours. Once daily treatment may be repeated for 
up to 8 consecutive days.
    (2) Indications for use. For the treatment of clinical mastitis 
associated with coagulase-negative staphylococci, Streptococcus 
dysgalactiae, and Escherichia coli; and the treatment of diagnosed 
subclinical mastitis associated with coagulase-negative staphylococci 
and S. dysgalactiae.
    (3) Limitations. Milk taken from cows during treatment (a maximum 
of 8 daily infusions) and for 72 hours after the last treatment must 
not be used for human consumption. Following label use for up to 8 
consecutive days, a 2-day preslaughter withdrawal period is

[[Page 13186]]

required. Federal law restricts this drug to use by or on the order of 
a licensed veterinarian.
    (4) Special considerations. Federal law prohibits extralabel use of 
this drug in lactating dairy cattle for disease prevention purposes; at 
unapproved doses; frequencies, durations, or routes of administration; 
and in unapproved major food-producing species/production classes.
    (e) Conditions of use for syringe described in paragraph (a)(2) of 
this section in dry cows--(1) Amount. Infuse the contents of one 
syringe (500 mg ceftiofur equivalents) into each affected quarter at 
the time of dry off.
    (2) Indications for use. For the treatment of subclinical mastitis 
in dairy cattle at the time of dry off associated with Staphylococcus 
aureus, Streptococcus dysgalactiae, and Streptococcus uberis.
    (3) Limitations. Milk taken from cows completing a 30-day dry-off 
period may be used for food with no milk discard due to ceftiofur 
residues. Following intramammary infusion, a 16-day preslaughter 
withdrawal period is required for treated cows. No preslaughter 
withdrawal period is required for neonatal calves from treated cows 
regardless of colostrum consumption. Federal law restricts this drug to 
use by or on the order of a licensed veterinarian.
    (4) Special considerations. Federal law prohibits extralabel use of 
this drug in dry dairy cattle for disease prevention purposes; at 
unapproved doses; frequencies, durations, or routes of administration; 
and in unapproved major food-producing species/production classes.

0
24. In Sec.  526.363, revise paragraphs (a) and (d) to read as follows:


Sec.  526. 363  Cephapirin benzathine.

    (a) Specifications. Each single-dose, 10-milliliter syringe 
contains 300 milligrams cephapirin activity (as cephapirin benzathine).
* * * * *
    (d) Conditions of use in dry cows--(1) Amount. Infuse the contents 
of one syringe (300 mg cephapirin activity) into each quarter following 
last milking, but no later than 30 days before calving.
    (2) Indications for use. For the treatment of mastitis caused by 
susceptible strains of Streptococcus agalactiae and Staphylococcus 
aureus, including penicillin-resistant strains.
    (3) Limitations. For use in dry cows only. Milk from treated cows 
must not be used for food during the first 72 hours after calving. 
Animals infused with this product must not be slaughtered for food 
until 42 days after the latest infusion.

0
25. In Sec.  526.365, revise paragraphs (a) and (d)(1) to read as 
follows:


Sec.  526.365  Cephapirin sodium.

    (a) Specifications. Each single-dose, 10-milliliter syringe 
contains 200 milligrams (mg) cephapirin sodium activity.
* * * * *
    (d) * * *
    (1) Amount. Infuse the contents of one syringe (200 mg cephapirin 
activity) into each infected quarter immediately after the quarter has 
been completely milked out. Do not milk out for 12 hours. Repeat once 
only in 12 hours.
* * * * *

0
26. Revise Sec.  526.464 to read as follows:


Sec.  526.464  Cloxacillin benzathine.

    (a) Specifications. Each single-dose, 7.5- or 10-milliliter syringe 
contains cloxacillin benzathine equivalent to 500 milligrams (mg) 
cloxacillin.
    (b) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.165 of this chapter.
    (d) Conditions of use in dry cows--(1) Amount. Infuse the contents 
of one syringe (equivalent to 500 mg cloxacillin) into each quarter 
immediately after last milking, but no later than 30 days before 
calving.
    (2) Indications for use. For the treatment of mastitis caused by 
Staphylococcus aureus and Streptococcus agalactiae including penicillin 
resistant strains in dairy cows during the dry period.
    (3) Limitations. Animals infused with this product must not be 
slaughtered for food until 30 days after the latest infusion. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.


Sec.  526.464a  [Removed]

0
27. Remove Sec.  526.464a.


Sec.  525.464b  [Redesignated as Sec.  526.464]

0
28. Redesignate Sec.  526.464b as Sec.  526.465 and revise the section 
heading and paragraphs (a) and (d) to read as follows:


Sec.  526.465  Cloxacillin sodium.

    (a) Specifications. Each single-dose, 10-milliliter syringe 
contains cloxacillin sodium equivalent to 200 milligrams (mg) 
cloxacillin.
* * * * *
    (d) Conditions of use in lactating cows--(1) Amount. Infuse the 
contents of one syringe (equivalent to 200 mg cloxacillin) into each 
infected quarter. Treatment should be repeated at 12-hour intervals for 
a total of 3 doses.
    (2) Indications for use. For the treatment of mastitis in lactating 
cows due to Streptococcus agalactiae and Staphylococcus aureus, 
nonpenicillinase-producing strains.
    (3) Limitations. Milk taken from treated animals within 48 hours (4 
milkings) after the latest treatment should not be used for food. 
Treated animals should not be slaughtered for food within 10 days after 
the latest treatment. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
29. Revise Sec.  526.820 to read as follows:


Sec.  526.820  Erythromycin.

    (a) Specifications--(1) Each single-dose, 6-milliliter (mL) syringe 
contains 300 milligrams (mg) erythromycin (as the base).
    (2) Each single-dose, 12-mL syringe contains 600 mg erythromycin 
(as the base).
    (b) Sponsors. See Nos. 054771 and 061133 in Sec.  510.600(c) of 
this chapter.
    (c) Related tolerances. See Sec.  556.230 of this chapter.
    (d) Conditions of use for syringe described in paragraph (a)(1) of 
this section in lactating cows--(1) Amount. Infuse the contents of one 
6-mL syringe (300 mg erythromycin base) into each infected quarter. 
Repeat infusion at 12-hour intervals for a maximum of 3 infusions.
    (2) Indications for use. For the treatment of mastitis due to 
Staphylococcus aureus, Streptococcus agalactiae, Streptococcus 
dysgalactiae, and Streptococcus uberis in lactating cows.
    (3) Limitations. Milk taken from animals during treatment and for 
36 hours (3 milkings) after the latest treatment must not be used for 
food.
    (e) Conditions of use for syringe described in paragraph (a)(2) of 
this section in dry cows--(1) Amount. Infuse the contents of one 12-mL 
syringe (600 mg erythromycin base) into each infected quarter at the 
time of drying off.
    (2) Indications for use. For the treatment of mastitis due to 
Staphylococcus aureus, Streptococcus agalactiae, Streptococcus 
dysgalactiae, and Streptococcus uberis in dry cows.
    (3) Limitations. For use in dry cows only.
0
30. In Sec.  526.1130, revise paragraph (a), the paragraph (d) subject 
heading, and paragraphs (d)(1) and (2) to read as follows:

[[Page 13187]]

Sec.  526.1130  Hetacillin.

    (a) Specifications. Each single-dose, 10-milliliter syringe 
contains hetacillin potassium equivalent of 62.5 milligrams (mg) 
ampicillin.
* * * * *
    (d) Conditions of use in lactating cows--(1) Amount. Infuse the 
contents of one syringe (equivalent to 62.5 mg ampicillin) into each 
infected quarter. Repeat at 24-hour intervals for a maximum of 3 
treatments.
    (2) Indications for use. For the treatment of acute, chronic, or 
subclinical mastitis in lactating cows caused by susceptible strains of 
Streptococcus agalactiae, Streptococcus dysgalactiae, Staphylococcus 
aureus, and Escherichia coli.
* * * * *

0
31. Revise Sec.  526.1590 to read as follows:


Sec.  526.1590  Novobiocin.

    (a) Specifications. Each single-dose, 10-milliliter syringe 
contains:
    (1) 150 milligrams (mg) of novobiocin equivalents as sodium 
novobiocin, or
    (2) 400 mg of novobiocin equivalents as sodium novobiocin.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.460 of this chapter.
    (d) Conditions of use for syringe described in paragraph (a)(1) of 
this section in lactating cows--(1) Amount. Infuse the contents of one 
syringe (equivalent to 150 mg novobiocin) into each infected quarter 
after milking. Repeat treatment once after 24 hours. Do not milk for at 
least 6 hours after treatment.
    (2) Indications for use. For the treatment of mastitis caused by 
susceptible strains of Staphylococcus aureus in lactating cows.
    (3) Limitations. Milk taken from treated animals within 72 hours (6 
milkings) after latest treatment should not be used for food. Do not 
slaughter treated animals for food for 15 days following latest 
treatment. Federal law restricts this drug to use by or on the order of 
a licensed veterinarian.
    (e) Conditions of use for syringe described in paragraph (a)(2) of 
this section in dry cows--(1) Amount. Infuse the contents of one 
syringe (equivalent to 400 mg novobiocin) into each quarter at the time 
of drying off.
    (2) Indications for use. For the treatment of mastitis caused by 
susceptible strains of Staphylococcus aureus and Streptococcus 
agalactiae in dry cows.
    (3) Limitations. For udder installation for the treatment of 
mastitis in dry cows only. Infuse each quarter at the time of drying 
off, but not less than 30 days prior to calving. Do not slaughter 
treated animals for food for 30 days following udder infusion.

0
32. Revise Sec.  526.1696 to read as follows:


Sec.  526.1696  Penicillin G procaine.

    (a) Specifications. Each single-dose, 10-milliliter syringe 
contains penicillin G procaine equivalent to 100,000 units of 
penicillin G.
    (b) Sponsors. See Nos. 010515 and 061133 in Sec.  510.600(c) of 
this chapter.
    (c) Related tolerances. See Sec.  556.510 of this chapter.
    (d) Conditions of use in lactating cows--(1) Amount. Infuse the 
contents of one 10-milliliter syringe (equivalent to 100,000 units 
penicillin G) into each infected quarter. Treatment may be repeated at 
12-hour intervals for not more than 3 doses, as indicated by clinical 
response.
    (2) Indications for use. For the treatment of mastitis caused by 
Streptococcus agalactiae, S. dysgalactiae, and S. uberus in lactating 
cows.
    (3) Limitations. For intramammary infusion in lactating cows only. 
Discard all milk for 60 hours (5 milkings) after the latest treatment. 
Animals intended for human consumption must not be slaughtered within 3 
days of latest treatment.
    (e) Conditions of use in dry cows--(1) Amount. Infuse the contents 
of one 10-milliliter syringe (equivalent to 100,000 units penicillin G) 
into each infected quarter at time of drying-off.
    (2) Indications for use. For the treatment of mastitis caused by 
Streptococcus agalactiae in dry cows.
    (3) Limitations. For intramammary infusion in dry cows only. 
Animals intended for human consumption must not be slaughtered within 
14 days of last treatment. Discard all milk for 72 hours (6 milkings) 
following calving, or later as indicated by the marketable quality of 
the milk.


Sec.  526.1696a  [Removed]

0
33. Remove Sec.  526.1696a.


Sec.  526.1696b  [Redesignated as Sec.  526.1697]

0
34. Redesignate Sec.  526.1696b as Sec.  526.1697 and revise the 
section heading and paragraphs (a) and (d) and add paragraph (e).
    The revisions and addition read as follows:


Sec.  526.1697  Penicillin G procaine and dihydrostreptomycin.

    (a) Specifications. Each single-use, 10-milliliter syringe contains 
a suspension of:
    (1) Penicillin G procaine equivalent to 200,000 units penicillin G 
and dihydrostreptomycin sulfate equivalent to 300 milligrams 
dihydrostreptomycin; or
    (2) Penicillin G procaine equivalent to 1 million units penicillin 
G and dihydrostreptomycin sulfate equivalent to 1 gram 
dihydrostreptomycin.
* * * * *
    (d) Conditions of use for syringe described in paragraph (a)(1) of 
this section in dry cows--(1) Amount. Infuse the contents of one 
syringe (equivalent to 200,000 units penicillin G and 300 milligrams 
dihydrostreptomycin) into each quarter at the last milking prior to 
drying off.
    (2) Indications for use. For the treatment of subclinical mastitis 
in dairy cows at the time of drying off, specifically against 
infections caused by Staphylococcus aureus and Streptococcus 
agalactiae.
    (3) Limitations. For use in dry cows only. Not to be used within 6 
weeks of calving. Milk taken from cows within 24 hours (2 milkings) 
after calving must not be used for food. Animals infused with this drug 
must not be slaughtered for food within 60 days of treatment or within 
24 hours after calving.
    (e) Conditions of use for syringe described in paragraph (a)(2) of 
this section in dry cows--(1) Amount. Infuse the contents of one 
syringe (equivalent to 1 million units penicillin G and 1 gram 
dihydrostreptomycin) into each quarter at the last milking prior to 
drying off.
    (2) Indications for use. To reduce the frequency of existing 
infection and to prevent new infections with Staphylococcus aureus in 
dry cows.
    (3) Limitations. Not for use in lactating cows. Not to be used 
within 6 weeks of calving. Milk taken from cows within 96 hours (8 
milkings) after calving must not be used for food. Animals infused with 
this drug must not be slaughtered for food within 60 days from the time 
of infusion or within 96 hours after calving. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.


Sec.  526.1696c   [Removed]

0
35. Remove Sec.  526.1696c.


Sec.  526.1696d   [Redesignated as Sec.  526.1698]

0
36. Redesignate Sec.  526.1696d as Sec.  526.1698 and revise the 
section heading and paragraphs (a) and (d) and add paragraph (e).
    The revisions and addition read as follows:

[[Page 13188]]

Sec.  526.1698  Penicillin G procaine and novobiocin.

    (a) Specifications. Each single-use, 10-milliliter syringe contains 
a suspension of:
    (1) Penicillin G procaine equivalent to 100,000 units penicillin G 
and 150 milligrams (mg) novobiocin as novobiocin sodium; or
    (2) Penicillin G procaine equivalent to 200,000 units penicillin G 
and 400 mg novobiocin as novobiocin sodium.
* * * * *
    (d) Conditions of use for syringe described in paragraph (a)(1) of 
this section in lactating cows--(1) Amount. Infuse the contents of one 
syringe (equivalent to 100,000 units penicillin G and 150 mg 
novobiocin) into each infected quarter after milking. Repeat once after 
24 hours.
    (2) Indications for use. For the treatment of mastitis caused by 
susceptible strains of Staphylococcus aureus, Streptococcus agalactiae, 
Streptococcus dysgalactiae, and Streptococcus uberis in lactating cows.
    (3) Limitations. For udder instillation in lactating cows only. Do 
not milk for at least 6 hours after treatment; thereafter, milk at 
regular intervals. Milk taken from treated animals within 72 hours (6 
milkings) after the latest treatment must not be used for food. Treated 
animals must not be slaughtered for food for 15 days following the 
latest treatment. If redness, swelling, or abnormal milk persists, 
discontinue use and consult a veterinarian.
    (e) Conditions of use for syringe described in paragraph (a)(2) of 
this section in lactating cows--(1) Amount. Infuse the contents of one 
syringe (equivalent to 200,000 units penicillin G and 400 mg 
novobiocin) into each quarter at dry off.
    (2) Indications for use. For the treatment of subclinical mastitis 
caused by susceptible strains of Staphylococcus aureus and 
Streptococcus agalactiae in dry cows.
    (3) Limitations. For udder instillation in dry cows only. Do not 
use less than 30 days prior to calving. Milk from treated cows must not 
be used for food during the first 72 hours after calving. Treated 
animals must not be slaughtered for food for 30 days following udder 
infusion.

0
37. In Sec.  526.1810, revise paragraph (a), the paragraph (d) subject 
heading, and the first sentence of paragraph (d)(1) to read as follows:


Sec.  526.1810  Pirlimycin.

    (a) Specifications. Each single-dose, 10-milliliter syringe 
contains 50 milligrams (mg) of pirlimycin (as pirlimycin 
hydrochloride).
* * * * *
    (d) Conditions of use in lactating cows--(1) Amount. Infuse the 
contents of one syringe (50 mg pirlimycin) into each infected quarter. 
* * *
* * * * *

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

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

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


0
39. Add Sec.  529.443 to read as follows:


Sec.  529.443  Ciclesonide.

    (a) Specifications. A non-pressurized metered dose inhaler and drug 
cartridge combination containing a solution of 30 milligrams/milliliter 
of the prodrug ciclesonide. Each actuation releases 343 micrograms 
(mcg) of ciclesonide.
    (b) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer an initial dose of 8 
actuations (2,744 mcg ciclesonide) twice daily for 5 days, followed by 
12 actuations (4,116 mcg ciclesonide) once daily for 5 days.
    (2) Indications for use. For the management of clinical signs 
associated with severe equine asthma.
    (3) 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.


Sec.  529.2150  [Redesignated as Sec.  529.2110]

0
40. Redesignate Sec.  529.2150 as Sec.  529.2110.

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

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

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


Sec.  556.38  [Amended]

0
42. In Sec.  556.38, in paragraph (c), add ``520.88e,'' after 
``520.88d,''.


Sec.  556.165  [Amended]

0
43. In Sec.  556.165, in paragraph (c), remove ``Sec. Sec.  526.464a 
and 526.464b'' and in its place add ``Sec. Sec.  526.464 and 526.465''.


Sec.  556.170  [Amended]

0
44. In Sec.  556.170, in paragraph (c), remove ``520.543'' and in its 
place add ``520.534''.


Sec.  556.180  [Amended]

0
45. In Sec.  556.180, in paragraph (c), remove ``558.205'' and in its 
place add ``558.198''.


Sec.  556.185  [Amended]

0
46. In Sec.  556.185, in paragraph (c), remove ``Sec.  558.198'' and in 
its place add ``Sec.  558.205''.


Sec.  556.226  [Amended]

0
47. In Sec.  556.226, in paragraph (c), remove ``Sec.  522.812'' and in 
its place add ``Sec. Sec.  516.812 and 522.812''.


Sec.  556.300  [Amended]

0
48. In Sec.  556.300, in paragraph (c), remove ``Sec. Sec.  522.1044a, 
520.1044b, 520.1044c, and 524.1044e'' and in its place add ``Sec. Sec.  
520.1044a, 520.1044b, 520.1044c, 522.1044, 524.1044e, and 529.1044b''.


Sec.  556.360  [Amended]

0
49. In Sec.  556.360, in paragraph (c), add ``520.1265,'' after 
``520.1260,''.


Sec.  556.510  [Amended]

0
50. In Sec.  556.510, in paragraph (c), remove ``526.1696a, 526.1696b, 
526.1696c, and 526.1696d'' and in its place add ``526.1696, 526.1697, 
and 526.1698''.


Sec.  556.670  [Amended]

0
51. In Sec.  556.670, in paragraph (c), remove ``Sec. Sec.  520.2218'' 
and add ``Sec. Sec.  520.445, 520.2218'' in its place.

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

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

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


0
53. In Sec.  558.68, revise paragraphs (e)(1)(ii), (iii), and (v) to 
read as follows:


Sec.  558.68  Avilamycin.

* * * * *
    (e) * * *
    (1) * * *

[[Page 13189]]



------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
   Avilamycin in  grams/ton     Combination in  grams/ton              Indications for use                                              Limitations                                    Sponsor
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 
                                                                                          * * * * * * *
(ii) 13.6 to 40.9.............  Monensin, 90 to 110......  Broiler chickens: For the prevention of      Feed as the sole ration for 21 consecutive days. To assure responsible            058198
                                                            mortality caused by necrotic enteritis       antimicrobial drug use in broiler chickens, treatment administration must
                                                            associated with Clostridium perfringens;     begin on or before 18 days of age. See Sec.   558.355(d) of this chapter.
                                                            and as an aid in the prevention of           Monensin as provided by No. 058198 in Sec.   510.600(c) of this chapter.
                                                            coccidiosis caused by Eimeria necatrix, E.
                                                            tenella, E. acervulina, E. brunetti, E.
                                                            mivati, and E. maxima.
(iii) 13.6 to 40.9............  Narasin, 54 to 90........  Broiler chickens: For the prevention of      Feed as the sole ration for 21 consecutive days to chickens that are at           058198
                                                            mortality caused by necrotic enteritis       risk of developing, but not yet showing clinical signs of, necrotic
                                                            associated with Clostridium perfringens;     enteritis associated with Clostridium perfringens. To assure responsible
                                                            and for the prevention of coccidiosis        antimicrobial drug use in broiler chickens, treatment administration must
                                                            caused by Eimeria necatrix, E. tenella, E.   begin on or before 18 days of age. Do not allow adult turkeys, horses, or
                                                            acervulina, E. brunetti, E. mivati, and E.   other equines access to narasin formulations. Ingestion of narasin by
                                                            maxima.                                      these species has been fatal. Narasin as provided by No. 058198 in Sec.
                                                                                                         510.600(c) of this chapter.
 
                                                                                          * * * * * * *
(v) 13.6 to 40.9..............  Salinomycin sodium, 40 to  Broiler chickens: For the prevention of      Feed as the sole ration for 21 consecutive days. Feed to chickens that are        058198
                                 60.                        mortality caused by necrotic enteritis       at risk of developing, but not yet showing clinical signs of, necrotic
                                                            associated with Clostridium perfringens;     enteritis associated with Clostridium perfringens. Not approved for use
                                                            and for the prevention of coccidiosis        with pellet binders. To assure responsible antimicrobial drug use in
                                                            caused by Eimeria tenella, E. necatrix, E.   broiler chickens, treatment administration must begin on or before 18 days
                                                            acervulina, E. maxima, E. brunetti, and E.   of age. The safety of avilamycin has not been established in chickens
                                                            mivati.                                      intended for breeding purposes. Avilamycin has not been demonstrated to be
                                                                                                         effective in broiler chickens showing clinical signs of necrotic enteritis
                                                                                                         prior to the start of medication. Do not feed to laying hens producing
                                                                                                         eggs for human consumption. May be fatal if fed to adult turkeys or to
                                                                                                         horses. Salinomycin as provided by No. 016592 in Sec.   510.600(c) of this
                                                                                                         chapter.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *

0
54. In Sec.  558.128, revise paragraphs (e)(4)(xv) and (xvi) to read as 
follows:


Sec.  558.128  Chlortetracycline.

* * * * *
    (e) * * *
    (4) * * *

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
   Chlortetracycline  amount    Combination in  grams/ton              Indications for use                                              Limitations                                    Sponsor
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 
                                                                                          * * * * * * *
(xv) 350 mg/head/day..........  .........................  1. Beef cattle: For control of bacterial     To sponsor No. 054771 under NADAs 046-699 and 049-287, No. 066104 under           054771
                                                            pneumonia associated with shipping fever     NADA 092-286, and No. 069254 under NADA 048-480: withdraw 48 hours prior         069254
                                                            complex caused by Pasteurella spp.           to slaughter. To sponsor No. 069254 under NADA 138-935 and ANADA 200-510:
                                                            susceptible to chlortetracycline.            zero withdrawal period.
                                .........................  2. Beef cattle (under 700 lb): For control   Withdraw 48 hours prior to slaughter. To sponsor No. 054771 under NADAs 046-      054771
                                                            of active infection of anaplasmosis caused   699 and 049-287, No. 066104 under NADA 092-286, and No. 069254 under NADA        069254
                                                            by A. marginale susceptible to               048-480: withdraw 48 hours prior to slaughter. To sponsor No. 054771 under
                                                            chlortetracycline.                           NADA 048-761 and No. 069254 under NADA 138-935 and ANADA 200-510: zero
                                                                                                         withdrawal time.
(xvi) 20 to 350 g/ton.........  .........................  Beef cattle and replacement dairy heifers:   Feed to provide chlortetracycline at the rate of 350 mg per head per day.         054771
                                                            For control of bacterial pneumonia           This drug is not approved for use in female dairy cattle 20 months of age        069254
                                                            associated with shipping fever complex       or older, including dry dairy cows. Use in these cattle may cause drug
                                                            caused by Pasteurella spp. susceptible to    residues in milk and/or in calves born to these cows. A withdrawal period
                                                            chlortetracycline.                           has not been established for this product in pre-ruminating calves. Do not
                                                                                                         use in calves to be processed for veal. To sponsor No. 054771 under NADA
                                                                                                         048-761 and No. 069254 under ANADA 200-510: zero withdrawal period.
 
                                                                                          * * * * * * *
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *

0
55. In Sec.  558.140, revise paragraph (b)(1), redesignate paragraph 
(b)(2) as paragraph (b)(3), add new paragraph (b)(2), and revise 
paragraph (e)(1).
    The revisions and addition read as follows:


Sec.  558.140  Chlortetracycline and sulfamethazine.

* * * * *
    (b) * * *
    (1) No. 054771 for use of product described in paragraph (a)(1) as 
in paragraph (e)(1) of this section.
    (2) No. 069254 for use of product described in paragraph (a)(1) as 
in paragraph (e)(1)(i) of this section.
* * * * *
    (e) * * *
    (1) Cattle--

[[Page 13190]]



------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
    Chlortetracycline  and
  sulfamethazine  amount each   Combination in  grams/ton              Indications for use                                              Limitations                                    Sponsors
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
(i) To provide 350 milligrams   .........................  Beef cattle: As an aid in the maintenance    Feed for 28 days. Withdraw 7 days prior to slaughter. A withdrawal period         054771
 per head per day.                                          of weight gains in the presence of           has not been established for this product in pre-ruminating calves. Do not       069254
                                                            respiratory disease such as shipping         use in calves to be processed for veal.
                                                            fever.
(ii) 35 to 105 g/ton, each....  Lasalocid, 10 to 30......  Beef steers and heifers fed in confinement   Feed continuously for 28 days to provide 350 mg chlortetracycline, 350 mg         054771
                                                            for slaughter: As an aid in the              sulfamethazine, and 100 to 300 mg lasalocid per head per day. Do not allow
                                                            maintenance of weight gains in the           horses or other equines access to Type C feeds containing lasalocid as
                                                            presence of respiratory disease such as      ingestion may be fatal. Safety of lasalocid for use in unapproved species
                                                            shipping fever, and for improved feed        has not been established. Withdraw 7 days prior to slaughter. A withdrawal
                                                            efficiency.                                  period has not been established for this product in pre-ruminating calves.
                                                                                                         Do not use in calves to be processed for veal. Lasalocid as provided by
                                                                                                         No. 054771 in Sec.   510.600(c) of this chapter.
(iii) 35 to 42.2 g/ton, each..  Lasalocid, 25 to 30......  Beef steers and heifers fed in confinement   Feed continuously for 28 days to provide 350 mg chlortetracycline, 350 mg         054771
                                                            for slaughter: As an aid in the              sulfamethazine, and 250 to 300 mg lasalocid per head per day. Do not allow
                                                            maintenance of weight gains in the           horses or other equines access to Type C feeds containing lasalocid as
                                                            presence of respiratory disease such as      ingestion may be fatal. Safety of lasalocid for use in unapproved species
                                                            shipping fever, and for improved feed        has not been established. Withdraw 7 days prior to slaughter. A withdrawal
                                                            efficiency and increased rate of weight      period has not been established for this product in pre-ruminating calves.
                                                            gain.                                        Do not use in calves to be processed for veal. Lasalocid as provided by
                                                                                                         No. 054771 in Sec.   510.600(c) of this chapter.
(iv) 35 to 700 g/ton, each....  Lasalocid, 30 to 181.8...  Beef cattle up to 800 lb: As an aid in the   Hand feed continuously for 28 days to provide 350 mg chlortetracycline, 350       054771
                                                            maintenance of weight gains in the           mg sulfamethazine, and 1 mg lasalocid per 2.2 lb body weight per day up to
                                                            presence of respiratory disease such as      a maximum of 360 mg lasalocid per head per day. Do not allow horses or
                                                            shipping fever, and for control of           other equines access to Type C feeds containing lasalocid as ingestion may
                                                            coccidiosis caused by Eimeria bovis and E.   be fatal. Safety of lasalocid for use in unapproved species has not been
                                                            zuernii.                                     established. Withdraw 7 days prior to slaughter. A withdrawal period has
                                                                                                         not been established for this product in pre-ruminating calves. Do not use
                                                                                                         in calves to be processed for veal. Lasalocid as provided by No. 054771 in
                                                                                                         Sec.   510.600(c) of this chapter.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *

0
56. In Sec.  558.311, redesignate paragraphs (e)(5)(ii) through (vi) as 
paragraphs (e)(5)(iii) through (vii) and add new paragraph (e)(5)(ii) 
to read as follows:


Sec.  558.311  Lasalocid.

* * * * *
    (e) * * *
    (5) * * *
    (ii) Chlortetracycline and sulfamethazine as in Sec.  558.140.
* * * * *

0
57. In Sec.  558.342, in paragraph (b)(2), remove ``No. 058198'' and in 
its place add ``Nos. 016592 and 058198'' and revise paragraph 
(e)(1)(i).
    The revision reads as follows:


Sec.  558.342  Melengestrol.

* * * * *
    (e) * * *
    (1) * * *

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 Melengestrol  acetate in  mg/
           head/day             Combination in  grams/ton              Indications for use                                              Limitations                                    Sponsor
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
(i) 0.25 to 0.5...............  .........................  Heifers fed in confinement for slaughter:    Administer 0.5 to 2.0 pounds (lb)/head/day of medicated feed containing           016592
                                                            For increased rate of weight gain,           0.125 to 1.0 mg melengestrol acetate/lb to provide 0.25 to 0.5 mg                054771
                                                            improved feed efficiency, and suppression    melengestrol acetate/head/day.                                                   058198
                                                            of estrus (heat).
 
                                                                                          * * * * * * *
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *

0
58. In Sec.  558.500, in paragraph (b), remove ``Nos. 054771 and 
058198'' and in its place add ``Nos. 016592, 054771, and 058198'' and 
revise paragraphs (e)(2)(i), (iii), and (vi).
    The revisions read as follows:


Sec.  558.500  Ractopamine.

* * * * *
    (e) * * *
    (2) * * *

--------------------------------------------------------------------------------------------------------------------------------------------------------
                             Combination in  grams/
 Ractopamine in  grams/ton            ton                     Indications for use                              Limitations                     Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
(i) 8.2 to 24.6............  .....................  Cattle fed in confinement for            Feed continuously as sole ration during the          016592
                                                     slaughter: For increased rate of         last 28 to 42 days on feed.                         054771
                                                     weight gain and improved feed                                                                058198
                                                     efficiency during the last 28 to 42
                                                     days on feed
 

[[Page 13191]]

 
                                                                      * * * * * * *
(iii) 9.8 to 24.6..........  .....................  Cattle fed in confinement for            Feed continuously as sole ration during the          016592
                                                     slaughter: For increased rate of         last 28 to 42 days on feed.                         054771
                                                     weight gain, improved feed efficiency,                                                       058198
                                                     and increased carcass leanness during
                                                     the last 28 to 42 days on feed
 
                                                                      * * * * * * *
(vi) Not to exceed 800; to   .....................  Cattle fed in confinement for            Top dress in a minimum of 1 lb of medicated          016592
 provide 70 to 400 mg/head/                          slaughter: For increased rate of         feed.                                               054771
 day.                                                weight gain and improved feed                                                                058198
                                                     efficiency during the last 28 to 42
                                                     days on feed
 
                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *

    Dated: February 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-04453 Filed 3-5-21; 8:45 am]
BILLING CODE 4164-01-P


