Federal Register / Vol. 86, No. 43 / Monday, March 8, 2021 / Rules and Regulations 13181 

Country Entity License 

requirement 

License 

review policy 

Federal Register 

Citation 

Myanmar Economic Corporation, a.k.a., 

the following one alias: 

—MEC. 

Corner of Ahlone Road and Strand 

Road, Ahlone Township, Yangon, 

Myanmar. 

For all items subject to 

the EAR. (See § 744.11 

of the EAR). 

Presumption of denial ...... 86 FR [INSERT FR PAGE 

NUMBER], 3/8/2021. 

Myanmar Economic Holdings Limited, 

a.k.a., the following eight aliases: 

—MEHL; 

—Myanma Economic Holdings Limited; 

—Myanma Economic Holdings Public 

Company Limited; 

—Myanmar Business Holdings Public 

Company Limited; 

—Myanmar Economic Holdings Public 

Company Limited; 

—UMEH; 

—Union of Myanmar Economic Holdings Company Limited; and 

—Union of Myanmar Economic Holdings Limited. 

189–191 Maha Bandoola Road, 

Botahtaung Township, Yangon, 

Burma. 

For all items subject to 

the EAR. (See § 744.11 

of the EAR). 

Presumption of denial ...... 86 FR [INSERT FR PAGE 

NUMBER], 3/8/2021. 

* * * * * * * 

Matthew S. Borman, 

Deputy Assistant Secretary for Export 

Administration. 

[FR Doc. 2021–04794 Filed 3–4–21; 4:15 pm] 

BILLING CODE P 

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/centerveterinary-medicine/cvm-foiaelectronic-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/approvedanimal-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, 

Animal Health Division, 

P.O. Box 390, Shawnee 

Mission, KS 66201.

BAYTRIL 100–CA1 

(enrofloxacin) Injectable 

Solution.

Cattle .............. Conditional approval for the treatment 

of clinical anaplasmosis in certain 

classes of cattle.

FOI Summary. 

April 10, 2020 ... 141–533 Boehringer Ingelheim Animal Health USA, Inc., 

3239 Satellite Blvd., Duluth, GA 30096.

ASERVO EQUIHALER 

(ciclesonide inhalation 

spray).

Horses ............ Original approval for the management 

of clinical signs associated with severe equine asthma in horses.

FOI Summary. 


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13182 Federal Register / Vol. 86, No. 43 / Monday, March 8, 2021 / Rules and Regulations 

TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING APRIL, MAY, AND JUNE 2020— 

Continued 

Approval date File No. Sponsor Product name Species Effect of the action Public 

documents 

April 22, 2020 ... 200–673 Aurora Pharmaceutical, 

Inc., 1196 Highway 3 

South, Northfield, MN 

55057–3009.

REVOLT (selamectin) 

Topical Solution.

Dogs and cats Original approval as a generic copy of 

NADA 141–152.

FOI Summary. 

April 27, 2020 ... 200–674 Modern Veterinary Therapeutics, LLC, 14343 SW 

119th Ave., Miami, FL 

33186.

Detomidine Hydrochloride 

(detomidine hydrochloride) Injectable Solution.

Horses ............ Original approval as a generic copy of 

NADA 140–862.

FOI Summary. 

May 14, 2020 .... 200–679 Huvepharma EOOD, 5th 

Floor, 3A Nikolay 

Haytov Str., 1113 Sophia, Bulgaria.

OPTIGRID (ractopamine 

HCl) Type A Medicated 

Article.

Cattle .............. Original approval as a generic copy of 

NADA 141–221.

FOI Summary. 

May 21, 2020 .... 200–680 Felix Pharmaceuticals Pvt. 

Ltd., 25–28 North Wall 

Quay, Dublin 1, Ireland.

Enrofloxacin flavored tablets.Dogs ............... Original approval as a generic copy of 

NADA 140–441.

FOI Summary. 

May 27, 2020 .... 200–638 Ve ́toquinol USA, Inc., 

4250 N Sylvania Ave., 

Fort Worth, TX 76137.

IMOXI Topical Solution for 

Cats (imidacloprid and 

moxidectin).

Cats ................ Original approval as a generic copy of 

NADA 141–254.

FOI Summary. 

May 28, 2020 .... 200–510 Pharmgate, Inc., 1800 Sir 

Tyler Dr., Wilmington, 

NC 28405.

Chlortetracycline Type B 

and Type C medicated 

feeds.

Cattle .............. Supplemental approval for use of 

DERACIN (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.

N/A. 

June 1, 2020 ..... 200–134 Intervet, Inc., 2 Giralda 

Farms, Madison, NJ 

07940.

FERTAGYL (gonadorelin) 

Injectable Solution.

Cattle .............. Supplemental approval for fixed-time artificial insemination in beef cows.FOI Summary. 

June 2, 2020 ..... 200–682 Huvepharma EOOD, 5th 

Floor, 3A Nikolay 

Haytov Str., 1113 Sophia, Bulgaria.

VETMULIN 12.5% 

(tiamulin hydrogen fumarate) Liquid concentrate.

Swine ............. Original approval as a generic copy of 

NADA 140–916.

FOI Summary. 

June 4, 2020 ..... 200–399 Huvepharma EOOD, 5th 

Floor, 3A Nikolay 

Haytov Str., 1113 Sophia, Bulgaria.

CYCLEGUARD 

(melengestrol acetate 

Type A liquid medicated 

article).

Cattle .............. Original approval as a generic copy of 

NADA 039–402.

FOI Summary. 

June 15, 2020 ... 141–534 Orion Corp., Orionintie 1, 

02200 Espoo, Finland.

CLEVOR (ropinirole ophthalmic solution).Dogs ............... Original approval for the induction of 

vomiting in dogs.

FOI Summary. 

June 18, 2020 ... 141–535 Zoetis Inc., 333 Portage 

St., Kalamazoo, MI 

49007.

Chlortetracycline, 

sulfamethazine, and 

lasalocid Type B and 

Type C medicated feeds.

Cattle .............. Original approval for use of AUREO S 

700 (chlortetracycline and 

sulfamethazine) and BOVATEC 

(lasalocid) in the manufacture of Type 

B and Type C medicated feeds for 

beef steers and heifers fed in confinement for slaughter.

FOI Summary. 

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 PourOn 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. 


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Federal Register / Vol. 86, No. 43 / Monday, March 8, 2021 / Rules and Regulations 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 

■ 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. 

■ 2. In § 510.600— 

■ a. In the table in paragraph (c)(1): 

■ i. Revise the entries for ‘‘Cronus 

Pharma Specialities India Private Ltd.’’ 

and ‘‘Dechra Veterinary Products LLC’’; 

■ ii. Add an entry in alphabetical order 

for ‘‘Felix Pharmaceuticals Pvt. Ltd.’’; 

and 

■ iii. Revise the entry for ‘‘Pharmgate, 

Inc.’’; and 

■ b. In the table in paragraph (c)(2): 

■ i. Add an entry in numerical order for 

‘‘017033’’; 

■ ii. Remove the entry for ‘‘026637’’; 

■ iii. Revise the entries for ‘‘069043’’ 

and ‘‘069254’’; and 

■ iv. Add an entry in numerical order 

for ‘‘086101’’. 

The additions and revisions read as 

follows: 

§ 510.600 Names, addresses, and drug 

labeler codes of sponsors of approved 

applications. 

* * * * * 

(c) * * * 

(1) * * * 

Firm name and address Drug labeler 

code 

*******

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 .................................................................................. 069043 

* * * * * * * 

Dechra Veterinary Products LLC, 7015 College Blvd., Suite 525, Overland Park, KS 66211 ........................................................... 017033 

*******

Felix Pharmaceuticals Pvt. Ltd., 25–28 North Wall Quay, Dublin 1, Ireland ...................................................................................... 086101 

*******

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. 


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Drug labeler 

code Firm name and address 

*******

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 

■ 3. The authority citation for part 516 

continues to read as follows: 

Authority: 21 U.S.C. 360ccc–1, 360ccc–2, 

371. 

■ 4. Add § 516.812 to subpart E to read 

as follows: 

§ 516.812 Enrofloxacin. 

(a) Specifications. Each milliliter (mL) 

of solution contains 100 milligrams (mg) 

enrofloxacin. 

(b) Sponsor. See No. 000859 in 

§ 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 

■ 5. The authority citation for part 520 

continues to read as follows: 

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

■ 6. In § 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: 

§ 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: 

* * * * * 

■ 7. In § 520.304, revise paragraph (b), 

remove reserved paragraph (c), and 

redesignate paragraph (d) as paragraph 

(c). 

The revision reads as follows: 

§ 520.304 Carprofen. 

* * * * * 

(b) Sponsors. See sponsors in 

§ 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. 

* * * * * 

■ 8. In § 520.812, revise paragraphs (a) 

and (b) to read as follows: 

§ 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 

§ 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. 

* * * * * 

§ 520.1443 [Amended] 

■ 9. In § 520.1443, in paragraph (b), 

remove ‘‘051311’’ and in its place add 

‘‘000061’’. 

§ 520.1447 [Amended] 

■ 10. In § 520.1447, in paragraph (b), 

remove ‘‘051311’’ and in its place add 

‘‘000061’’. 

§ 520.1510 [Amended] 

■ 11. In § 520.1510, in paragraph (b)(2), 

remove ‘‘051311’’ and in its place add 

‘‘000061’’. 

§ 520.2455 [Amended] 

■ 12. In § 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 

■ 13. The authority citation for part 522 

continues to read as follows: 

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

§ 522.536 [Amended] 

■ 14. In § 522.536, in paragraph (b), 

remove ‘‘No. 052483’’ and in its place 

add ‘‘Nos. 015914 and 052483’’. 

■ 15. In § 522.1077: 

■ a. Revise paragraphs (a)(3), (b), (d), 

and (e)(1)(i); 

■ b. Remove paragraph (e)(1)(ii); 

■ c. Redesignate paragraphs (e)(1)(iii) 

through (e)(1)(vii) as paragraphs 

(e)(1)(ii) through (e)(1)(vi); 

■ d. Revise newly redesignated 

paragraphs (e)(1)(ii) and (iii); and 


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■ e. Remove and reserve paragraph 

(e)(2). 

The revisions read as follows: 

§ 522.1077 Gonadorelin. 

(a) * * * 

(3) 50 mg of gonadorelin as 

gonadorelin diacetate tetrahydrate 

(equivalent to 43 mg gonadorelin); or 

* * * * * 

(b) Sponsors. See sponsor numbers in 

§ 510.600(c) of this chapter. 

(1) No. 000061 for use of the 43-mg/ 

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-mg/ 

mL product described in paragraph 

(a)(2) as in paragraph (e)(1)(iv) of this 

section. 

(3) No. 061133 for use of the 50-mg/ 

mL product described in paragraph 

(a)(3) as in paragraphs (e)(1)(i) of this 

section. 

(4) No. 000010 for use of the 43-mg/ 

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-mg/ 

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 § 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 § 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 § 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 § 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 mg 

gonadorelin (No. 000061) or 100 mg 

gonadorelin diacetate tetrahydrate (Nos. 

000010 and 061133) by intramuscular or 

intravenous injection. 

(ii) For the treatment of ovarian 

follicular cysts in cattle: Administer 100 

mg 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 mg 

gonadorelin by intramuscular injection, 

followed 6 to 8 days later by 500 mg 

cloprostenol by intramuscular injection, 

followed 30 to 72 hours later by 86 mg 

gonadorelin by intramuscular injection. 

* * * * * 

PART 524—OPHTHALMIC AND 

TOPICAL DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 16. The authority citation for part 524 

continues to read as follows: 

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

■ 17. In § 524.1146, revise paragraph 

(b)(2) and add paragraph (b)(3) to read 

as follows: 

§ 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. 

* * * * * 

§ 524.1193 [Amended] 

■ 18. In § 524.1193, in paragraph (b)(2), 

remove ‘‘016592, 054925, and 058005’’ 

and in its place add ‘‘016592 and 

054925’’. 

■ 19. Add § 524.2080 to read as follows: 

§ 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 

§ 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/m2) (dose band 2.7 

to 5.4 mg/m2). 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. 

§ 524.2098 [Amended] 

■ 20. In § 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 

■ 21. The authority citation for part 526 

continues to read as follows: 

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

■ 22. In § 526.88, revise the section 

heading, paragraph (a), the paragraph 

(d) subject heading, and paragraphs 

(d)(1) and (3) to read as follows: 

§ 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. 

■ 23. In § 526.313, revise paragraphs (a) 

and (d) and add paragraph (e) to read as 

follows: 

§ 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 


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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. 

■ 24. In § 526.363, revise paragraphs (a) 

and (d) to read as follows: 

§ 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. 

■ 25. In § 526.365, revise paragraphs (a) 

and (d)(1) to read as follows: 

§ 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. 

* * * * * 

■ 26. Revise § 526.464 to read as 

follows: 

§ 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 

§ 510.600(c) of this chapter. 

(c) Related tolerances. See § 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. 

§ 526.464a [Removed] 

■ 27. Remove § 526.464a. 

§ 525.464b [Redesignated as § 526.464] 

■ 28. Redesignate § 526.464b as 

§ 526.465 and revise the section heading 

and paragraphs (a) and (d) to read as 

follows: 

§ 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. 

■ 29. Revise § 526.820 to read as 

follows: 

§ 526.820 Erythromycin. 

(a) Specifications—(1) Each singledose, 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 § 510.600(c) of this chapter. 

(c) Related tolerances. See § 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. 

■ 30. In § 526.1130, revise paragraph (a), 

the paragraph (d) subject heading, and 

paragraphs (d)(1) and (2) to read as 

follows: 


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§ 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. 

* * * * * 

■ 31. Revise § 526.1590 to read as 

follows: 

§ 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 

§ 510.600(c) of this chapter. 

(c) Related tolerances. See § 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. 

■ 32. Revise § 526.1696 to read as 

follows: 

§ 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 § 510.600(c) of this chapter. 

(c) Related tolerances. See § 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. 

§ 526.1696a [Removed] 

■ 33. Remove § 526.1696a. 

§ 526.1696b [Redesignated as § 526.1697] 

■ 34. Redesignate § 526.1696b as 

§ 526.1697 and revise the section 

heading and paragraphs (a) and (d) and 

add paragraph (e). 

The revisions and addition read as 

follows: 

§ 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. 

§ 526.1696c [Removed] 

■ 35. Remove § 526.1696c. 

§ 526.1696d [Redesignated as § 526.1698] 

■ 36. Redesignate § 526.1696d as 

§ 526.1698 and revise the section 

heading and paragraphs (a) and (d) and 

add paragraph (e). 

The revisions and addition read as 

follows: 


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13188 Federal Register / Vol. 86, No. 43 / Monday, March 8, 2021 / Rules and Regulations 

§ 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. 

■ 37. In § 526.1810, revise paragraph (a), 

the paragraph (d) subject heading, and 

the first sentence of paragraph (d)(1) to 

read as follows: 

§ 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 

■ 38. The authority citation for part 529 

continues to read as follows: 

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

■ 39. Add § 529.443 to read as follows: 

§ 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 

§ 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. 

§ 529.2150 [Redesignated as § 529.2110] 

■ 40. Redesignate § 529.2150 as 

§ 529.2110. 

PART 556—TOLERANCES FOR 

RESIDUES OF NEW ANIMAL DRUGS 

IN FOOD 

■ 41. The authority citation for part 556 

continues to read as follows: 

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

§ 556.38 [Amended] 

■ 42. In § 556.38, in paragraph (c), add 

‘‘520.88e,’’ after ‘‘520.88d,’’. 

§ 556.165 [Amended] 

■ 43. In § 556.165, in paragraph (c), 

remove ‘‘§§ 526.464a and 526.464b’’ and 

in its place add ‘‘§§ 526.464 and 

526.465’’. 

§ 556.170 [Amended] 

■ 44. In § 556.170, in paragraph (c), 

remove ‘‘520.543’’ and in its place add 

‘‘520.534’’. 

§ 556.180 [Amended] 

■ 45. In § 556.180, in paragraph (c), 

remove ‘‘558.205’’ and in its place add 

‘‘558.198’’. 

§ 556.185 [Amended] 

■ 46. In § 556.185, in paragraph (c), 

remove ‘‘§ 558.198’’ and in its place add 

‘‘§ 558.205’’. 

§ 556.226 [Amended] 

■ 47. In § 556.226, in paragraph (c), 

remove ‘‘§ 522.812’’ and in its place add 

‘‘§§ 516.812 and 522.812’’. 

§ 556.300 [Amended] 

■ 48. In § 556.300, in paragraph (c), 

remove ‘‘§§ 522.1044a, 520.1044b, 

520.1044c, and 524.1044e’’ and in its 

place add ‘‘§§ 520.1044a, 520.1044b, 

520.1044c, 522.1044, 524.1044e, and 

529.1044b’’. 

§ 556.360 [Amended] 

■ 49. In § 556.360, in paragraph (c), add 

‘‘520.1265,’’ after ‘‘520.1260,’’. 

§ 556.510 [Amended] 

■ 50. In § 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’’. 

§ 556.670 [Amended] 

■ 51. In § 556.670, in paragraph (c), 

remove ‘‘§§ 520.2218’’ and add 

‘‘§§ 520.445, 520.2218’’ in its place. 

PART 558—NEW ANIMAL DRUGS FOR 

USE IN ANIMAL FEEDS 

■ 52. The authority citation for part 558 

continues to read as follows: 

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

360ccc–1, 371. 

■ 53. In § 558.68, revise paragraphs 

(e)(1)(ii), (iii), and (v) to read as follows: 

§ 558.68 Avilamycin. 

* * * * * 

(e) * * * 

(1) * * * 


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Federal Register / Vol. 86, No. 43 / Monday, March 8, 2021 / Rules and Regulations 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 mortality caused by necrotic 

enteritis associated with Clostridium perfringens; and as an 

aid in the prevention of coccidiosis caused by Eimeria necatrix, 

E. tenella, E. acervulina, E. 

brunetti, E. mivati, and E. maxima. 

Feed as the sole ration for 21 consecutive days. To assure responsible 

antimicrobial drug use in broiler chickens, treatment administration 

must begin on or before 18 days of age. See § 558.355(d) of this 

chapter. Monensin as provided by No. 058198 in § 510.600(c) of this 

chapter. 

058198 

(iii) 13.6 to 40.9 .... Narasin, 54 to 90 Broiler chickens: For the prevention 

of mortality caused by necrotic 

enteritis associated with Clostridium perfringens; and for the 

prevention of coccidiosis caused 

by Eimeria necatrix, E. tenella, E. 

acervulina, E. brunetti, E. mivati, 

and E. maxima. 

Feed as the sole ration for 21 consecutive days to chickens that are at 

risk of developing, but not yet showing clinical signs of, necrotic enteritis associated with Clostridium perfringens. To assure responsible 

antimicrobial drug use in broiler chickens, treatment administration 

must begin on or before 18 days of age. Do not allow adult turkeys, 

horses, or other equines access to narasin formulations. Ingestion of 

narasin by these species has been fatal. Narasin as provided by No. 

058198 in § 510.600(c) of this chapter. 

058198 

* * * * * * * 

(v) 13.6 to 40.9 ..... Salinomycin sodium, 40 to 60.Broiler chickens: For the prevention 

of mortality caused by necrotic 

enteritis associated with Clostridium perfringens; and for the 

prevention of coccidiosis caused 

by Eimeria tenella, E. necatrix, E. 

acervulina, E. maxima, E. 

brunetti, and E. mivati. 

Feed as the sole ration for 21 consecutive days. Feed to chickens that 

are at risk of developing, but not yet showing clinical signs of, necrotic enteritis associated with Clostridium perfringens. Not approved 

for use with pellet binders. To assure responsible antimicrobial drug 

use in broiler chickens, treatment administration must begin on or 

before 18 days of age. The safety of avilamycin has not been established in chickens 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 § 510.600(c) of this chapter. 

058198 

* * * * * 

■ 54. In § 558.128, revise paragraphs 

(e)(4)(xv) and (xvi) to read as follows: 

§ 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 pneumonia associated with 

shipping fever complex caused 

by Pasteurella spp. susceptible 

to chlortetracycline. 

To sponsor No. 054771 under NADAs 046–699 and 049–287, No. 

066104 under NADA 092–286, and No. 069254 under NADA 048– 

480: withdraw 48 hours prior to slaughter. To sponsor No. 069254 

under NADA 138–935 and ANADA 200–510: zero withdrawal period. 

054771 

069254 

............................ 2. Beef cattle (under 700 lb): For 

control of active infection of 

anaplasmosis caused by A. 

marginale susceptible to chlortetracycline. 

Withdraw 48 hours prior to slaughter. To sponsor No. 054771 under 

NADAs 046–699 and 049–287, No. 066104 under NADA 092–286, 

and No. 069254 under NADA 048–480: withdraw 48 hours prior to 

slaughter. To sponsor No. 054771 under NADA 048–761 and No. 

069254 under NADA 138–935 and ANADA 200–510: zero withdrawal time. 

054771 

069254 

(xvi) 20 to 350 g/ 

ton.

............................ Beef cattle and replacement dairy 

heifers: For control of bacterial 

pneumonia associated with shipping fever complex caused by 

Pasteurella spp. susceptible to 

chlortetracycline. 

Feed to provide chlortetracycline at the rate of 350 mg per head per 

day. This drug 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. To sponsor No. 054771 under NADA 048–761 and No. 069254 

under ANADA 200–510: zero withdrawal period. 

054771 

069254 

*******

* * * * * 

■ 55. In § 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: 

§ 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— 


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13190 Federal Register / Vol. 86, No. 43 / Monday, March 8, 2021 / Rules and Regulations 

Chlortetracycline 

and sulfamethazine 

amount each 

Combination in 

grams/ton Indications for use Limitations Sponsors 

(i) To provide 350 

milligrams per 

head per day.

............................ Beef cattle: As an aid in the maintenance of weight gains in the 

presence of respiratory disease 

such as shipping fever. 

Feed for 28 days. 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. 

054771 

069254 

(ii) 35 to 105 g/ton, 

each.

Lasalocid, 10 to 

30.

Beef steers and heifers fed in confinement for slaughter: As an aid 

in the maintenance of weight 

gains in the presence of respiratory disease such as shipping 

fever, and for improved feed efficiency. 

Feed continuously for 28 days to provide 350 mg chlortetracycline, 350 

mg sulfamethazine, and 100 to 300 mg lasalocid per head per day. 

Do not allow horses or other equines access to Type C feeds containing lasalocid as ingestion may be fatal. Safety of lasalocid for 

use in unapproved species has not been 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 

§ 510.600(c) of this chapter. 

054771 

(iii) 35 to 42.2 g/ 

ton, each.

Lasalocid, 25 to 

30.

Beef steers and heifers fed in confinement for slaughter: As an aid 

in the maintenance of weight 

gains in the presence of respiratory disease such as shipping 

fever, and for improved feed efficiency and increased rate of 

weight gain. 

Feed continuously for 28 days to provide 350 mg chlortetracycline, 350 

mg sulfamethazine, and 250 to 300 mg lasalocid per head per day. 

Do not allow horses or other equines access to Type C feeds containing lasalocid as ingestion may be fatal. Safety of lasalocid for 

use in unapproved species has not been 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 

§ 510.600(c) of this chapter. 

054771 

(iv) 35 to 700 g/ 

ton, each.

Lasalocid, 30 to 

181.8.

Beef cattle up to 800 lb: As an aid 

in the maintenance of weight 

gains in the presence of respiratory disease such as shipping 

fever, and for control of coccidiosis caused by Eimeria bovis 

and E. zuernii. 

Hand feed continuously for 28 days to provide 350 mg chlortetracycline, 350 mg sulfamethazine, and 1 mg lasalocid per 2.2 lb body 

weight per day up to a maximum of 360 mg lasalocid per head per 

day. Do not allow horses or other equines access to Type C feeds 

containing lasalocid as ingestion may be fatal. Safety of lasalocid for 

use in unapproved species has not been 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 

§ 510.600(c) of this chapter. 

054771 

* * * * * 

■ 56. In § 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: 

§ 558.311 Lasalocid. 

* * * * * 

(e) * * * 

(5) * * * 

(ii) Chlortetracycline and 

sulfamethazine as in § 558.140. 

* * * * * 

■ 57. In § 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: 

§ 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: For increased rate of 

weight gain, improved feed efficiency, and suppression of 

estrus (heat). 

Administer 0.5 to 2.0 pounds (lb)/head/day of medicated feed containing 0.125 to 1.0 mg melengestrol acetate/lb to provide 0.25 to 

0.5 mg melengestrol acetate/head/day. 

016592 

054771 

058198 

* * * * * * * 

* * * * * 

■ 58. In § 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: 

§ 558.500 Ractopamine. 

* * * * * 

(e) * * * 

(2) * * * 

Ractopamine in 

grams/ton 

Combination in 

grams/ton Indications for use Limitations Sponsor 

(i) 8.2 to 24.6 ........ ............................ Cattle fed in confinement for 

slaughter: For increased rate of 

weight gain and improved feed 

efficiency during the last 28 to 42 

days on feed 

Feed continuously as sole ration during the last 28 to 42 days on feed 016592 

054771 

058198 


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Federal Register / Vol. 86, No. 43 / Monday, March 8, 2021 / Rules and Regulations 13191 

Ractopamine in 

grams/ton 

Combination in 

grams/ton Indications for use Limitations Sponsor 

*******

(iii) 9.8 to 24.6 ...... ............................ Cattle fed in confinement for 

slaughter: For increased rate of 

weight gain, improved feed efficiency, and increased carcass 

leanness during the last 28 to 42 

days on feed 

Feed continuously as sole ration during the last 28 to 42 days on feed 016592 

054771 

058198 

* * * * * * * 

(vi) Not to exceed 

800; to provide 

70 to 400 mg/ 

head/day.

............................ Cattle fed in confinement for 

slaughter: For increased rate of 

weight gain and improved feed 

efficiency during the last 28 to 42 

days on feed 

Top dress in a minimum of 1 lb of medicated feed ................................. 016592 

054771 

058198 

* * * * * * * 

* * * * * 

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 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

[TD 9926] 

RIN 1545–BO60 

Title: Withholding of Tax and 

Information Reporting With Respect to 

Interests in Partnerships Engaged in a 

U.S. Trade or Business; Correcting 

Amendment 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Correcting amendment. 

SUMMARY: This document contains a 

correction to final regulations (Treasury 

Decision 9926) that were published in 

the Federal Register on Monday, 

November 30, 2020. The final 

regulations provide guidance related to 

the withholding of tax and information 

reporting with respect to certain 

dispositions of interests in partnerships 

engaged in a trade or business within 

the United States. 

DATES: This correction is effective on 

March 8, 2021 and applies to 

partnership taxable years beginning on 

or after November 30, 2020. See 

§ 1.1446–7. 

FOR FURTHER INFORMATION CONTACT: 

Chadwick Rowland or Ronald M. 

Gootzeit (202) 317–6937 (not toll-free 

numbers). 

SUPPLEMENTARY INFORMATION: 

Background 

The final regulations (TD 9926) that 

are the subject of this correction are 

issued under section 1446 of the Code. 

Need for Correction 

As published, November 30, 2020 (85 

FR 76910), the final regulations (TD 

9926) contain an error that needs to be 

corrected. 

List of Subjects in 26 CFR Part 1 

Income taxes, Reporting and 

recordkeeping requirements. 

Correction of Publication 

Accordingly, 26 CFR part 1 is 

corrected by making the following 

correcting amendments: 

PART 1—INCOME TAXES 

■ Paragraph 1. The authority citation 

for part 1 continues to read in part as 

follows: 

Authority: 26 U.S.C. 7805 * * * 

■ Par. 2. Amend § 1.1446–4, by revising 

the last seven sentences of paragraph 

(f)(1).’’ 

§ 1.1446–4 Publicly traded partnerships. 

* * * * * 

(f)* * * (1) * * * LTP makes a 

distribution subject to section 1446 of 

$100 to UTP during its taxable year 

beginning January 1, 2020, and 

withholds 37 percent (the highest rate in 

section 1) ($37) of that distribution 

under section 1446. UTP receives a net 

distribution of $63 which it 

immediately redistributes to its 

partners. UTP has a liability to pay 37 

percent of the total actual and deemed 

distribution it makes to its foreign 

partners as a section 1446 withholding 

tax. UTP may credit the $37 withheld by 

LTP against this liability as if it were 

paid by UTP. See §§ 1.1462–1(b) and 

1.1446–5(b)(1). When UTP distributes 

the $63 it actually receives from LTP to 

its partners, UTP is treated for purposes 

of section 1446 as if it made a 

distribution of $100 to its partners ($63 

actual distribution and $37 deemed 

distribution). UTP’s partners (U.S. and 

foreign) may claim a credit against their 

U.S. income tax liability for their 

allocable share of the $37 of 1446 tax 

paid on their behalf. 

* * * * * 

Crystal Pemberton, 

Senior Federal Register Liaison, Legal 

Processing Division, Associate Chief Counsel, 

(Procedure and Administration). 

[FR Doc. 2021–00504 Filed 3–5–21; 8:45 am] 

BILLING CODE 4830–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R04–OAR–2019–0661; FRL–10019– 

92–Region 4] 

Air Plan Approval; GA: NonInterference Demonstration and 

Maintenance Plan Revision for the 

Removal of Transportation Control 

Measures in the Atlanta Area 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is approving a State 

Implementation Plan (SIP) revision 

submitted by Georgia, through the 

Georgia Environmental Protection 

Division (GA EPD), on September 16, 

2019, for the purpose of removing 

certain transportation control measures 

(TCMs) from the SIP for the thirteen 

counties in the Atlanta, Georgia, area. 

EPA is also approving Georgia’s update 

to the 2008 8-hour ozone maintenance 

plan that was submitted in the 

September 16, 2019, SIP revision. 

Specifically, EPA is approving the 

updated mobile emissions inventory, 


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