10964 Federal Register / Vol. 87, No. 39 / Monday, February 28, 2022 / Rules and Regulations 

identified in paragraphs (h)(1) through (3) of 

this AD may be installed on any airplane 

unless the requirements of paragraph (i) of 

this AD have been accomplished on that 

affected assembly. 

(l) Credit for Previous Actions 

This paragraph provides credit for the 

actions specified in paragraphs (h) or (i) of 

this AD, if those actions were performed 

before the effective date of this AD using the 

service information specified in paragraphs 

(l)(1) through (5) of this AD. 

(1) AVOX Systems Inc. Service Bulletin 

10015804–35–01, dated March 6, 2019. 

(2) AVOX Systems Inc. Alert Service 

Bulletin 10015804–35–01, Revision 01, dated 

July 9, 2019. 

(3) AVOX Systems Inc. Alert Service 

Bulletin 10015804–35–02, Revision 1, dated 

September 4, 2019. 

(4) AVOX Systems Inc. Service Bulletin 

10015804–35–03, dated April 11, 2019. 

(5) AVOX Systems Inc. Alert Service 

Bulletin 10015804–35–03, Revision 01, dated 

May 21, 2019. 

(m) Alternative Methods of Compliance 

(AMOCs) 

(1) The Manager, New York ACO Branch, 

FAA, has the authority to approve AMOCs 

for this AD, if requested using the procedures 

found in 14 CFR 39.19. In accordance with 

14 CFR 39.19, send your request to your 

principal inspector or local Flight Standards 

District Office, as appropriate. If sending 

information directly to the manager of the 

certification office, send it to ATTN: Program 

Manager, Continuing Operational Safety, 

FAA, New York ACO Branch, 1600 Stewart 

Avenue, Suite 410, Westbury, NY 11590; 

telephone 516–228–7300; fax 516–794–5531. 

(2) Before using any approved AMOC, 

notify your appropriate principal inspector, 

or lacking a principal inspector, the manager 

of the local flight standards district office/ 

certificate holding district office. 

(n) Related Information 

(1) For more information about this AD, 

contact Elizabeth Dowling, Aerospace 

Engineer, Mechanical Systems and 

Administrative Services Section, FAA, New 

York ACO Branch, 1600 Stewart Avenue, 

Suite 410, Westbury, NY 11590; telephone 

516–228–7300; email 9-avs-nyaco-cos@

faa.gov. 

(2) Service information identified in this 

AD that is not incorporated by reference is 

available at the addresses specified in 

paragraphs (o)(3) and (4) of this AD. 

(o) Material Incorporated by Reference 

(1) The Director of the Federal Register 

approved the incorporation by reference 

(IBR) of the service information listed in this 

paragraph under 5 U.S.C. 552(a) and 1 CFR 

part 51. 

(2) You must use this service information 

as applicable to do the actions required by 

this AD, unless the AD specifies otherwise. 

(i) AVOX Systems Inc. Alert Service 

Bulletin 10015804–35–01, Revision 02, dated 

October 16, 2019. 

(ii) AVOX Systems Inc. Alert Service 

Bulletin 10015804–35–02, Revision 2, dated 

October 31, 2019. 

(iii) AVOX Systems Inc. Alert Service 

Bulletin 10015804–35–03, Revision 02, dated 

October 15, 2019. 

(3) For service information identified in 

this AD, contact AVOX Systems Inc., 225 

Erie Street, Lancaster, NY 14086; telephone 

716–683–5100; internet https://

www.safranaerosystems.com. 

(4) You may view this service information 

at the FAA, Airworthiness Products Section, 

Operational Safety Branch, 2200 South 216th 

St., Des Moines, WA. For information on the 

availability of this material at the FAA, call 

206–231–3195. 

(5) You may view this service information 

that is incorporated by reference at the 

National Archives and Records 

Administration (NARA). For information on 

the availability of this material at NARA, 

fr.inspection@nara.gov, or go to: https://

www.archives.gov/federal-register/cfr/ibrlocations.html. 

Issued on February 11, 2022. 

Lance T. Gant, 

Director, Compliance & Airworthiness 

Division, Aircraft Certification Service. 

[FR Doc. 2022–04146 Filed 2–25–22; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 500, 510, 516, 520, 522, 

524, 529, 556, and 558 

[Docket No. FDA–2021–N–0002] 

New Animal Drugs; Approval of New 

Animal Drug Applications; Withdrawal 

of Approval of a New Animal Drug 

Application; 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), 

abbreviated new animal drug 

applications (ANADAs), and a 

conditionally approved new animal 

drug application (cNADA) during July, 

August, and September 2021. FDA is 

informing the public of the availability 

of summaries of the basis of approval 

and of environmental review 

documents, where applicable. The 

animal drug regulations are also being 

amended to improve the accuracy of the 

regulations. 

DATES: This rule is effective February 

28, 2022. The incorporation by reference 

of certain material listed in this rule is 

approved by the Director of the Federal 

Register as February 28, 2022. The 

incorporation by reference of other 

material listed in this rule was approved 

by the Director of the Federal Register 

as of November 25, 2011. 

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. Approvals 

FDA is amending the animal drug 

regulations to reflect approval actions 

for NADAs and ANADAs during July, 

August, and September 2021, as listed 

in table 1. In addition, FDA is informing 

the public of the availability, where 

applicable, of documentation of 

environmental review required under 

the National Environmental Policy Act 

(NEPA) and, for actions requiring 

review of safety or effectiveness data, 

summaries of the basis of approval (FOI 

Summaries) under the Freedom of 

Information Act (FOIA). These public 

documents may be seen in the office of 

the Dockets Management Staff (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852, between 9 a.m. and 4 p.m., 

Monday through Friday, 240–402–7500. 

Persons with access to the internet may 

obtain these documents at the CVM 

FOIA Electronic Reading Room: https:// 

www.fda.gov/about-fda/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/approved-animal-drugproducts-green-book. 

FDA has verified the website 

addresses as of the date this document 

publishes in the Federal Register, but 

websites are subject to change over time. 


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Federal Register / Vol. 87, No. 39 / Monday, February 28, 2022 / Rules and Regulations 10965 

TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING JULY, AUGUST, AND SEPTEMBER

2021 

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

documents 

July 7, 2021 .......... 200–703 Dechra Veterinary 

Products LLC, 

7015 College Blvd., 

Suite 525, Overland Park, KS 

66211.

Carprofen Tablets ..... Dogs ................ Original approval as 

a generic copy of 

NADA 141–053.

FOI Summary. 

July 15, 2021 ........ 141–545 VetDC, Inc., 320 E 

Vine Dr., Suite 

218, Fort Collins, 

CO 80524.

TANOVEA 

(rabacfosadine for 

injection) Powder 

for Injection.

Dogs ................ Full approval of conditionally approved 

cNADA 141–475 

for the treatment of 

lymphoma.

FOI Summary. 

August 2, 2021 ..... 200–708 Felix Pharmaceuticals PVT Ltd., 

25–288 North Wall 

Quay, Dublin, 1, 

Ireland.

Enrofloxacin Antibacterial Injectable 

Solution 2.27%.

Dogs ................ Original approval as 

a generic copy of 

NADA 140–913.

FOI Summary. 

August 16, 2021 ... 200–618 Virbac AH, Inc., PO 

Box 162059, Fort 

Worth, TX 76161.

ZOLETIL (tiletamine 

and zolazepam for 

Injection).

Dogs and cats Original approval as 

a generic copy of 

NADA 106–111.

FOI Summary. 

August 18, 2021 ... 200–709 Cronus Pharma Specialties India Private Ltd., Sy No99/1, M/s GMR 

Hyderabad Aviation 

SEZ Ltd., 

Mamidipalli Village, 

Shamshabad 

Mandal, Ranga 

Reddy, Hyderabad, 

Telangana, 

501218, India.

Amoxicillin and 

Clavulanate Potassium for Oral Suspension.

Dogs and cats Original approval as 

a generic copy of 

NADA 055–101.

FOI Summary. 

August 19, 2021 ... 141–063 Intervet, Inc., 2 

Giralda Farms, 

Madison, NJ 07940.

NUFLOR–S 

(florfenicol) 

Injectable Solution.

Swine ............... Supplemental approval for the treatment of swine respiratory disease.FOI Summary. 

II. Withdrawal of Approval 

Elanco US Inc., 2500 Innovation Way, 

Greenfield, IN 46140, has requested that 

FDA withdraw approval of NADA 093– 

329 for use of a sustained-release bolus 

containing sulfamethazine in cattle 

because the product is no longer 

manufactured or marketed. As provided 

in the regulatory text of this document, 

the animal drug regulations are 

amended to reflect this action. 

Elsewhere in this issue of the Federal 

Register, FDA gave notice that approval 

of NADA 093–329, and all supplements 

and amendments thereto, is withdrawn. 

III. Change of Sponsor 

VetDC, Inc., 320 E Vine Dr., Suite 218, 

Fort Collins, CO 80524, has informed 

FDA that it has transferred ownership 

of, and all rights and interest in, newly 

approved NADA 141–545 for 

TANOVEA (rabacfosadine) for Injection 

to Elanco US Inc., 2500 Innovation Way, 

Greenfield, IN 46140. The codification 

of this application in new 21 CFR 

522.2065 will reflect this change of 

sponsorship. 

IV. Technical Amendments 

FDA is making the following 

amendments to improve the accuracy of 

the animal drug regulations: 

• 21 CFR 500.1410 is amended to add 

uncooked edible tissues of swine to the 

standard for residues of n-methyl-2- 

pyrrolidone. 

• 21 CFR 510.600 is amended to have 

sponsor addresses conform to the 

current style. 

• 21 CFR 520.905c is amended to 

reflect the current label indications for 

use of fenbendazole paste in horses. 

• 21 CFR 520.1044c is amended to 

reflect a current swine pathogen name 

for gentamicin soluble powder. 

• 21 CFR 520.1660d is amended to 

revise conditions of use of 

oxytetracycline in drinking water of 

swine to reflect approved applications. 

• 21 CFR 520.1780 is amended to 

revise the indications for use of 

pimobendan tablets in dogs. 

• 21 CFR 520.2130 is amended to 

remove the 90-milligram strength for 

spinosad chewable tablets. 

• 21 CFR 520.2220a is amended to 

add human food safety warnings for use 

of sulfadimethoxine concentrate 

solution and soluble powder. 

• 21 CFR 520.2260b is amended to 

reflect the voluntary withdrawal of 

approval of an application for sustainedrelease boluses containing 

sulfamethazine and to correct the 

spelling of a disease condition. 

• 21 CFR 520.2604 is amended to 

revise indications for use of tablets in 

dogs containing trimeprazine with 

prednisolone. 

• 21 CFR 522.558 is amended to 

reflect the drug labeler code for the 

current sponsor of a dexmedetomidine 

injectable solution. 

• 21 CFR 522.840 is amended to 

reflect the current classes of cattle 

approved for use of estradiol ear 

implants. 

• 21 CFR 522.842 for testosterone 

propionate and estradiol benzoate 

implants is renamed to list the drug 

with the higher concentration first and 

redesignated to be listed in alphabetical 

order. 

• 21 CFR 522.955 is amended to 

reflect the current scientific name of a 

bovine pathogen and the withdrawal 


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10966 Federal Register / Vol. 87, No. 39 / Monday, February 28, 2022 / Rules and Regulations 

periods for different formulations of 

florfenicol injectable solution. 

• 21 CFR 522.1156 is amended to add 

subcutaneous administration to the 

approved conditions of use of imidocarb 

dipropionate solution in dogs. 

• 21 CFR 522.2477 is amended to 

reorganize an approved use of 

trenbolone acetate and estradiol 

implants in steers. 

• 21 CFR 524.770 is amended to 

reflect current label dosage information 

and human food safety warnings. 

• 21 CFR 529.1030 is redesignated as 

§ 529.1004 in conformity with an 

announced FDA numbering system (40 

FR 13802, March 27, 1975). 

• 21 CFR 529.1940 is amended to add 

limitations to the use of progesterone 

intravaginal inserts in cows. 

• 21 CFR 558.59 is amended to 

reference apramycin’s status as a 

veterinary feed directive (VFD) drug and 

to add current limitations on VFD refills 

for apramycin medicated feeds. 

• 21 CFR 558.205 is amended to 

reflect a current egg food safety warning 

for broiler chickens and growing turkeys 

fed Type C medicated feeds containing 

diclazuril. 

• 21 CFR 558.254 is amended to 

remove an erroneous table title. 

• 21 CFR 558.261 is amended to 

correct the upper inclusion rate for 

florfenicol in Type C medicated feed for 

freshwater-reared salmonids. 

• 21 CFR 558.311 is being amended 

to codify free-choice Type C medicated 

cattle feeds containing lasalocid. 

• 21 CFR 558.450 is amended to add 

conditions of use in honey bees for a 

Type C extender patty containing 

oxytetracycline. 

• 21 CFR 558.633 is amended to add 

manufacturing limitations for use of 

Type C medicated swine feeds 

containing tylvalosin. 

• 21 CFR 558.635 is amended to 

reflect a current egg food safety warning 

for broiler chickens fed Type C 

medicated feeds containing 

virginiamycin and diclazuril. 

V. Incorporation by Reference 

FDA is incorporating by reference an 

analytical method approved by the 

Office of the Federal Register in 

accordance with 5 U.S.C. 552(a) and 1 

CFR part 51. To obtain a copy of the 

analytical method, go to: https://

www.fda.gov/about-fda/centerveterinary-medicine/cvm-foiaelectronic-reading-room. You may 

inspect a copy at the office of the 

Dockets Management Staff (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, Rm. 1061, Rockville, MD 

20852, 240–402–7500, between 9 a.m. 

and 4 p.m., Monday through Friday. 

This standard adds a method of 

detection for total for residues of the 

carcinogenic excipient n-methyl-2- 

pyrrolidone in uncooked edible swine 

tissues to a section established for a 

method for residues of n-methyl-2- 

pyrrolidone in uncooked edible cattle 

tissues. 

VI. Legal Authority 

This final rule is issued under section 

512(i) of the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) (21 

U.S.C.360b(i)), which requires Federal 

Register publication of ‘‘notice[s] . . . 

effective as a regulation,’’ of the 

conditions of use of approved new 

animal drugs. This rule sets forth 

technical amendments to the regulations 

to codify recent actions on approved 

new animal drug applications and 

corrections to improve the accuracy of 

the regulations, and as such does not 

impose any burden on regulated 

entities. 

Although denominated a rule 

pursuant to the FD&C Act, this 

document does not meet the definition 

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because 

it is a ‘‘rule of particular applicability.’’ 

Therefore, it is not subject to the 

congressional review requirements in 5 

U.S.C. 801–808. Likewise, this is not a 

rule subject to Executive Order 12866, 

which defines a rule as ‘‘an agency 

statement of general applicability and 

future effect, which the agency intends 

to have the force and effect of law, that 

is designed to implement, interpret, or 

prescribe law or policy or to describe 

the procedure or practice requirements 

of an agency.’’ 

List of Subjects 

21 CFR Part 500 

Animal drugs, Animal feeds, Cancer, 

Incorporation by reference, Labeling, 

Packaging and containers, 

Polychlorinated biphenyls (PCBs). 

21 CFR Part 510 

Administrative practice and 

procedure, Animal drugs, Labeling, 

Reporting and recordkeeping 

requirements. 

21 CFR Part 516 

Administrative practice and 

procedure, Animal drugs, Confidential 

business information, Reporting and 

recordkeeping requirements. 

21 CFR Parts 520, 522, 524, and 529 

Animal drugs. 

21 CFR Part 556 

Animal drugs, 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 500, 

510, 516, 520, 522, 524, 529, 556, and 

558 are amended as follows: 

PART 500—GENERAL 

■ 1. The authority citation for part 500 

continues to read as follows: 

Authority: 21 U.S.C. 321, 331, 342, 343, 

348, 351, 352, 353, 360b, 371, 379e. 

■ 2. Revise § 500.1410 to read as 

follows: 

§ 500.1410 N-methyl-2-pyrrolidone. 

(a) Standard for residues. No residues 

of n-methyl-2-pyrrolidone may be found 

in the uncooked edible tissues of cattle 

and swine as determined by methods in 

paragraph (b) of this section. 

(b) Incorporation by reference. The 

standards required in this section are 

incorporated by reference into this 

section with the approval of the Director 

of the Federal Register under 5 U.S.C. 

552(a) and 1 CFR part 51. All approved 

material is available for inspection at 

the Food and Drug Administration’s 

Dockets Management Staff (HFA–305), 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852, 240–402–7500, between 9 

a.m. and 4 p.m., Monday through 

Friday. It may be obtained from the 

sources indicated elsewhere in 

paragraph (b) of this section and at: 

https://www.fda.gov/about-fda/centerveterinary-medicine/cvm-foiaelectronic-reading-room. It is also 

available for inspection at the National 

Archives and Records Administration 

(NARA). For information on the 

availability of this material at NARA, 

email fr.inspection@nara.gov, or go to: 

www.archives.gov/federal-register/cfr/ 

ibr-locations.html. 

(1) Food and Drug Administration, 

Center for Veterinary Medicine, 7500 

Standish Pl., Rockville, MD 20855, 240– 

402–7002. 

(i) ‘‘Method of Analysis: N-methyl-2- 

pyrrolidone,’’ September 26, 2011; the 

method of analysis for uncooked edible 

tissues of cattle. 

(ii) [Reserved] 

(2) Merck Animal Health, 29160 

Intervet Lane, Millsboro, DE 19966, 1– 

800–211–3573. 

(i) ‘‘Determinative and Confirmatory 

Procedures for the Analysis of NMethyl-2-pyrrolidone (NMP) in Swine 

Liver Tissue using LC–MS/MS,’’ July 20, 

2017; the method of analysis for 

uncooked edible tissues of swine. 

(ii) [Reserved] 


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Federal Register / Vol. 87, No. 39 / Monday, February 28, 2022 / Rules and Regulations 10967 

(c) Related conditions of use. See 

§§ 522.814 and 522.955 of this chapter. 

PART 510—NEW ANIMAL DRUGS 

■ 3. The authority citation for part 510 

continues to read as follows: 

Authority: 21 U.S.C. 321, 331, 351, 352, 

353, 360b, 371, 379e. 

§ 510.600 [Amended] 

■ 4. In § 510.600: 

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

revise the entries for ‘‘Anzac Animal 

Health, LLC’’, ‘‘AquaBounty 

Technologies, Inc.’’, ‘‘Dechra Veterinary 

Products LLC’’, ‘‘Halocarbon Products 

Corp.’’, ‘‘Kindred Biosciences, Inc.’’, 

‘‘Mizner Bioscience LLC’’, ‘‘QBiotics 

Group Ltd.’’, ‘‘Revivicor, Inc.’’, and 

‘‘Ridley USA, Inc.’’, remove ‘‘Suite’’ and 

in its place add ‘‘suite’’; and 

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

revise the entries for ‘‘012164’’, 

‘‘017033’’, ‘‘067949’’, ‘‘086039’’, 

‘‘086053’’, ‘‘086073’’, ‘‘086078’’, 

‘‘086132’’, and ‘‘086134’’. 

The revisions read as follows: 

(c) * * * 

(1) ALPHABETICAL LISTING OF SPONSORS

Firm name and address Drug labeler 

code 

*******

Anivive Lifesciences, Inc., 3250 Airflite Way, Suite 400, Long Beach, CA 90807 ............................................................................. 086121 

Anzac Animal Health, LLC, 218 Millwell Dr., suite B, Maryland Heights, MO 63043 ......................................................................... 086073 

AquaBounty Technologies, Inc., 2 Mill and Main Pl., Suite 395, Maynard, MA 01754 ...................................................................... 086053 

* * * * * * * 

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

* * * * * * * 

Halocarbon Products Corp., 6525 The Corners Pkwy., Suite 200, Peachtree Corners, GA 30092 .................................................. 012164 

* * * * * * * 

Kindred Biosciences, Inc., 1555 Bayshore Hwy., Suite 200, Burlingame, CA 94010 ........................................................................ 086078 

* * * * * * * 

Mizner Bioscience LLC, 225 NE Mizner Blvd., Suite 760, Boca Raton, FL 33432 ............................................................................ 086039 

*******

QBiotics Group Ltd., Suite 3A, Level 1, 165 Moggill Rd., Taringa, Queensland 4068, Australia ...................................................... 086132 

*******

Revivicor, Inc., a wholly owned subsidiary of United Therapeutics Corp., 1700 Kraft Dr., Suite 2400, Blacksburg, VA 24060 ....... 086134 

Ridley USA, Inc., 111 W Cherry St., Suite 500, Mankato, MN 56001 ................................................................................................ 067949 

*******

(2) NUMERICAL LISTING OF SPONSORS

Drug labeler 

code Firm name and address 

*******

012164 ............ Halocarbon Products Corp., 6525 The Corners Pkwy., Suite 200, Peachtree Corners, GA 30092. 

*******

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

*******

067949 ............ Ridley USA, Inc., 111 W Cherry St., Suite 500, Mankato, MN 56001. 

*******

086039 ............ Mizner Bioscience LLC, 225 NE Mizner Blvd., Suite 760, Boca Raton, FL 33432. 

*******

086053 ............ AquaBounty Technologies, Inc., 2 Mill and Main Pl., Suite 395, Maynard, MA 01754. 

*******

086073 ............ Anzac Animal Health, LLC, 218 Millwell Dr., Suite B, Maryland Heights, MO 63043. 

086078 ............ Kindred Biosciences, Inc., 1555 Bayshore Hwy., Suite 200, Burlingame, CA 94010. 

*******

086121 ............ Anivive Lifesciences, Inc., 3250 Airflite Way, Suite 400, Long Beach, CA 90807. 

086132 ............ QBiotics Group Ltd., Suite 3A, Level 1, 165 Moggill Rd., Taringa, Queensland 4068, Australia. 

086134 ............ Revivicor, Inc., a wholly owned subsidiary of United Therapeutics Corp., 1700 Kraft Dr., Suite 2400, Blacksburg, VA 24060 

*******


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10968 Federal Register / Vol. 87, No. 39 / Monday, February 28, 2022 / Rules and Regulations 

PART 516—NEW ANIMAL DRUGS FOR 

MINOR USE AND MINOR SPECIES 

■ 5. The authority citation for part 516 

continues to read as follows: 

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

371. 

§ 516.2065 [Removed] 

■ 6. Remove § 516.2065. 

PART 520—ORAL DOSAGE FORM 

NEW ANIMAL DRUGS 

■ 7. The authority citation for part 520 

continues to read as follows: 

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

■ 8. Revise § 520.88h to read as follows: 

§ 520.88h Amoxicillin trihydrate and 

clavulanate potassium for oral suspension. 

(a) Specifications. When constituted, 

each milliliter (mL) of suspension 

contains amoxicillin trihydrate 

equivalent to 50 milligrams (mg) 

amoxicillin and clavulanate potassium 

equivalent to 12.5 mg clavulanic acid. 

(b) Sponsors. See Nos. 054771 and 

069043 in § 510.600(c) of this chapter. 

(c) Conditions of use—(1) Dogs—(i) 

Amount. 6.25 mg/lb (1 mL/10 lb of body 

weight) twice a day. Skin and soft tissue 

infections such as abscesses, cellulitis, 

wounds, superficial/juvenile pyoderma, 

and periodontal infections should be 

treated for 5 to 7 days or for 48 hours 

after all signs have subsided. If no 

response is seen after 5 days of 

treatment, therapy should be 

discontinued and the case reevaluated. 

Deep pyoderma may require treatment 

for 21 days; the maximum duration of 

treatment should not exceed 30 days. 

(ii) Indications for use. Treatment of 

skin and soft tissue infections such as 

wounds, abscesses, cellulitis, 

superficial/juvenile and deep pyoderma 

due to susceptible strains of the 

following organisms: beta-lactamaseproducing Staphylococcus aureus, nonbeta-lactamase-producing 

Staphylococcus aureus, Staphylococcus 

spp., Streptococcus spp., and 

Escherichia coli. Treatment of 

periodontal infections due to 

susceptible strains of both aerobic and 

anaerobic bacteria. 

(iii) Limitations. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian. 

(2) Cats—(i) Amount. 62.5 mg (1 mL) 

twice daily. Skin and soft tissue 

infections such as abscesses and 

cellulitis/dermatitis should be treated 

for 5 to 7 days or 48 hours after all 

symptoms have subsided, not to exceed 

30 days. If no response is seen after 3 

days of treatment, therapy should be 

discontinued and the case reevaluated. 

Urinary tract infections may require 

treatment for 10 to 14 days or longer. 

The maximum duration of treatment 

should not exceed 30 days. 

(ii) Indications for use. Treatment of 

skin and soft tissue infections, such as 

wounds, abscesses, and cellulitis/ 

dermatitis due to susceptible strains of 

the following organisms: beta-lactamaseproducing Staphylococcus aureus, nonbeta-lactamase-producing 

Staphylococcus aureus, Staphylococcus 

spp., Streptococcus spp., Escherichia 

coli, Pasteurella multocida, and 

Pasteurella spp. Urinary tract infections 

(cystitis) due to susceptible strains of E. 

coli. 

(iii) Limitations. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian. 

■ 9. In § 520.905c, revise paragraphs 

(e)(1)(i) to read as follows: 

§ 520.905c Fenbendazole paste. 

* * * * * 

(e) * * * 

(1) * * * 

(i) Indications for use and amounts. 

(A) For the treatment and control of 

large strongyles (Strongylus edentatus, 

S. equinus, S. vulgaris), small 

strongyles, and pinworms (Oxyuris 

equi). For large strongyles, small 

strongyles, and pinworms, the 

recommended dose is 5 mg/kg (2.3 mg/ 

lb). 

(B) For treatment and control of 

ascarids (Parascaris equorum). For 

ascarids, the recommended dose is 10 

mg/kg (4.6 mg/lb). 

(C) For treatment and control of 

hypobiotic (encysted early third-stage), 

late third-stage, and fourth-stage 

cyathostome larvae, as well as fourthstage Strongylus vulgaris larvae, the 

recommended dose is 10 mg/kg (4.6 mg/ 

lb) daily for 5 consecutive days. 

(D) For the control of arteritis caused 

by fourth-stage larvae of Strongylus 

vulgaris in horses. 

(E) Fenbendazole paste 10 percent 

may be used concomitantly with 

approved forms of trichlorfon for the 

indications provided in paragraph 

(e)(1)(i)(A) of this section and for 

treating infections of stomach bots as 

provided in § 520.2520. 

* * * * * 

■ 10. In § 520.1044c, revise paragraph 

(d)(2) to read as follows: 

§ 520.1044c Gentamicin sulfate powder. 

* * * * * 

(d) * * * 

(2) Indications for use. For control 

and treatment of colibacillosis in 

weanling swine caused by strains of 

Escherichia coli sensitive to gentamicin, 

and for control and treatment of swine 

dysentery associated with Brachyspira 

hyodysenteriae. 

* * * * * 

■ 11. In § 520.1660d, revise paragraphs 

(d)(1)(iii)(A) and (C) to read as follows: 

§ 520.1660d Oxytetracycline powder. 

* * * * * 

(d) * * * 

(1) * * * 

(iii) * * * 

(A) Amount. Administer 10 

milligrams per pound of body weight 

daily in drinking water. Administer up 

to 14 days; do not use for more than 14 

consecutive days those products 

sponsored by Nos. 054771, 061133, and 

069254. Administer up to 5 days; do not 

use for more than 5 consecutive days 

those products sponsored by Nos. 

016592 and 061133. 

* * * * * 

(C) Limitations. Withdraw zero days 

prior to slaughter. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian. 

* * * * * 

■ 12. In § 520.1780, revise paragraph 

(c)(2) to read as follows: 

§ 520.1780 Pimobendan. 

* * * * * 

(c) * * * 

(2) Indications for use. For the 

management of the signs of mild, 

moderate, or severe congestive heart 

failure in dogs due to clinical 

myxomatous mitral valve disease 

(MMVD) or dilated cardiomyopathy 

(DCM); for use with concurrent therapy 

for congestive heart failure (e.g., 

furosemide, etc.) as appropriate on a 

case-by-case basis. 

* * * * * 

■ 13. In § 520.2130, revise paragraph (a) 

to read as follows: 

§ 520.2130 Spinosad. 

(a) Specifications. Each chewable 

tablet contains 140, 270, 560, 810, or 

1620 milligrams (mg) spinosad. 

* * * * * 

■ 14. In § 520.2220a, revise paragraphs 

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

follows: 

§ 520.2220a Sulfadimethoxine oral 

solution and soluble powder. 

* * * * * 

(d) * * * 

(1) * * * 

(iii) Limitations. Withdraw 5 days 

before slaughter. Do not administer to 

chickens over 16 weeks (112 days) of 

age. Federal law restricts this drug to 

use by or on the order of a licensed 

veterinarian. 


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(2) * * * 

(iii) Limitations. Withdraw 5 days 

before slaughter. Do not administer to 

turkeys over 24 weeks (168 days) of age. 

Federal law restricts this drug to use by 

or on the order of a licensed 

veterinarian. 

* * * * * 

§ 520.2260b [Amended] 

■ 15. In § 520.2260b, remove and 

reserve paragraphs (b) and (e); and in 

paragraph (f)(2)(ii) remove ‘‘diptheria’’ 

and in its place add ‘‘diphtheria’’. 

■ 16. In § 520.2604, revise paragraph 

(c)(2) to read as follows: 

§ 520.2604 Trimeprazine with prednisolone 

tablets. 

* * * * * 

(c) * * * 

(2) Indications for use. For the relief 

of itching regardless of cause; and for 

reduction of inflammation commonly 

associated with most skin disorders of 

dogs such as eczema, caused by internal 

disorders, otitis, and dermatitis, allergic, 

parasitic, pustular, and nonspecific 

origins. As adjunctive therapy in 

various cough conditions including 

treatment of ‘‘kennel cough’’ or 

tracheobronchitis, bronchitis including 

allergic bronchitis, infections, and 

coughs of nonspecific origin. 

* * * * * 

PART 522—IMPLANTATION OR 

INJECTABLE DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 17. The authority citation for part 522 

continues to read as follows: 

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

§ 522.558 [Amended] 

■ 18. In § 522.558, in paragraph (b)(1), 

remove ‘‘026637’’ and in its place add 

‘‘017033’’. 

■ 19. In § 522.812, revise paragraph 

(b)(1) to read as follows: 

§ 522.812 Enrofloxacin. 

* * * * * 

(b) * * * 

(1) Nos. 016729, 017033, 055529, 

058198, and 086101 for use of product 

described in paragraph (a)(1) as in 

paragraph (e)(1) of this section; and 

* * * * * 

§ 522.840 [Amended] 

■ 20. In § 522.840, in paragraph (d)(2), 

in the first sentence, remove ‘‘confined 

steers and heifers’’ and in its place add 

‘‘steers and heifers fed in confinement 

for slaughter’’. 

§ 522.842 [Redesignated as § 522.2343] 

■ 21. Redesignate § 522.842 as 

§ 522.2343. 

■ 22. In § 522.955: 

■ a. Revise paragraph (b)(2); 

■ b. Redesignate paragraph (b)(3) as 

paragraph (b)(4) and add new paragraph 

(b)(3); 

■ c. In paragraphs (d)(1)(ii)(A)(2) and 

(d)(1)(ii)(B)(2), remove ‘‘Haemophilus 

somnus’’ and in its place add 

‘‘Histophilus somni’’; 

■ d. Revise paragraph (d)(1)(ii)(C); and 

■ e. Add paragraph (d)(2). 

The revisions and additions read as 

follows: 

§ 522.955 Florfenicol. 

* * * * * 

(b) * * * 

(2) No. 000061 for use of product 

described in paragraph (a)(2) of this 

section as in paragraphs (d)(1)(ii) and 

(d)(2) of this section. 

(3) No. 086050 for use of product 

described in paragraph (a)(2) of this 

section as in paragraph (d)(1)(ii) of this 

section. 

* * * * * 

(d) * * * 

(1) * * * 

(ii) * * * 

(C) Limitations. Animals intended for 

human consumption must not be 

slaughtered within 28 days of the last 

intramuscular treatment. No. 000061: 

Animals intended for human 

consumption must not be slaughtered 

within 38 days of subcutaneous 

treatment. No. 055529: Animals 

intended for human consumption must 

not be slaughtered within 33 days of 

subcutaneous 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 in pre-ruminating calves. Do 

not use in calves to be processed for 

veal. Federal law restricts this drug to 

use by or on the order of a licensed 

veterinarian. 

(2) Swine—(i) 300 mg/mL florfenicol 

in the inactive vehicles n-methyl-2- 

pyrrolidone, propylene glycol, and 

polyethylene glycol: 

(A) Amount. 15 mg/kg of body weight 

as an intramuscular injection. A second 

dose should be administered 48 hours 

later. 

(B) Indications for use. For the 

treatment of swine respiratory disease 

associated with Actinobacillus 

pleuropneumoniae, Pasteurella 

multocida, Salmonella Choleraesuis, 

Streptococcus suis, Bordetella 

bronchiseptica, and Glaesserella 

(Haemophilus) parasuis in swine except 

for nursing piglets and swine of 

reproductive age intended for breeding. 

(C) Limitations. Swine intended for 

human consumption must not be 

slaughtered within 11 days of the last 

intramuscular treatment. Federal law 

restricts this drug to use by or on the 

order of a licensed veterinarian. 

(ii) [Reserved] 

■ 23. In § 522.1156, revise paragraph 

(c)(1) to read as follows: 

§ 522.1156 Imidocarb solution. 

* * * * * 

(c) * * * 

(1) Amount. Administer 6.6 mg per 

kilogram (3 mg per pound) of body 

weight by intramuscular or 

subcutaneous injection. Repeat the dose 

after 2 weeks for a total of two 

treatments. 

* * * * * 

■ 24. Add § 522.2065 to read as follows: 

§ 522.2065 Rabacfosadine. 

(a) Specifications. Each vial of powder 

contains 16.4 milligrams (mg) 

rabacfosadine. Each milliliter of 

constituted solution contains 8.2 mg 

rabacfosadine. 

(b) Sponsor. See No. 058198 in 

§ 510.600(c) of this chapter. 

(c) Conditions of use in dogs—(1) 

Amount. Administer rabacfosadine at 1 

mg/kilogram body weight as a 30- 

minute intravenous infusion, once every 

3 weeks, for up to 5 doses. 

(2) Indications for use. For the 

treatment of lymphoma in dogs. 

(3) Limitations. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian. 

■ 25. Revise the section heading of 

newly designated § 522.2343 to read as 

follows: 

§ 522.2343 Testosterone propionate and 

estradiol benzoate. 

■ 26. In § 522.2470, revise paragraph (b) 

introductory text to read as follows: 

§ 522.2470 Tiletamine and zolazepam for 

injection. 

* * * * * 

(b) Sponsors. See Nos. 026637, 

051311, and 054771 in § 510.600(c) of 

this chapter. 

* * * * * 

■ 27. In § 522.2477, revise paragraph 

(b)(2), remove paragraph (d)(1)(i)(G), 

and add paragraph (d)(6) to read as 

follows: 

§ 522.2477 Trenbolone acetate and 

estradiol. 

* * * * * 

(b) * * * 


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(2) No. 000061 for use as in 

paragraphs (d)(1)(i)(A), (d)(1)(i)(C), 

(d)(1)(i)(D), (d)(1)(ii), (d)(1)(iii), 

(d)(2)(i)(A), (d)(2)(i)(C), (d)(2)(i)(D), 

(d)(2)(ii), (d)(2)(iii), (d)(3)(i)(A), 

(d)(3)(ii), (d)(3)(iii), (d)(4), (d)(5), and 

(d)(6) of this section. 

* * * * * 

(d) * * * 

(6) Steers fed in confinement for 

slaughter—(i) Amount. Each extendedrelease implant contains 200 mg 

trenbolone acetate and 40 mg estradiol 

(one implant consisting of 6 coated and 

4 uncoated pellets, each containing 20 

mg trenbolone acetate and 4 mg 

estradiol). 

(ii) Indications for use. For increased 

rate of weight gain and improved feed 

efficiency for up to 200 days after 

implantation. 

(iii) Limitations. Administer implant 

subcutaneously in the ear only. Do not 

use in lactating dairy cows or in animals 

intended for subsequent breeding. Use 

in these cattle may cause drug residues 

in milk and/or in calves born to these 

cows. A withdrawal period has not been 

established for this product in preruminating calves. Do not use in calves 

to be processed for veal. Effectiveness 

and animal safety in veal calves have 

not been established. Not approved for 

repeated implantation (reimplantation) 

with this or any other cattle ear implant 

during the production phase(s) 

identified on labeling (steers fed in 

confinement for slaughter) unless 

otherwise indicated on labeling because 

safety and effectiveness have not been 

evaluated. 

PART 524—OPHTHALMIC AND 

TOPICAL DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 28. The authority citation for part 524 

continues to read as follows: 

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

■ 29. In § 524.770, revise paragraphs 

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

§ 524.770 Doramectin. 

* * * * * 

(e) * * * 

(1) Amount. Administer topically 1 

mL (5 mg doramectin) per 22 lb (10 kg) 

of body weight. 

* * * * * 

(3) Limitations. Cattle must not be 

slaughtered for human consumption 

within 45 days of treatment. Not for use 

in female dairy cattle 20 months of age 

or older. A withdrawal period has not 

been established for this product in preruminating calves. Do not use in calves 

to be processed for veal. 

PART 529—CERTAIN OTHER DOSAGE 

FORM NEW ANIMAL DRUGS 

■ 30. The authority citation for part 529 

continues to read as follows: 

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

§ 529.1030 [Redesignated as § 529.1004] 

■ 31. Redesignate § 529.1030 as 

§ 529.1004. 

■ 32. In § 529.1940, revise paragraph 

(e)(1)(iii) to read as follows: 

§ 529.1940 Progesterone intravaginal 

inserts. 

* * * * * 

(e) * * * 

(1) * * * 

(iii) Limitations. Do not use in beef or 

dairy heifers of insufficient size or age 

for breeding or in animals with 

abnormal, immature, or infected genital 

tracts. Do not use in anestrous lactating 

dairy cows less than 42 days or greater 

than 78 days postpartum. Do not use in 

lactating dairy cows less than 40 days 

postpartum. Do not use in beef cows 

that are less than 20 days postpartum. 

Do not use an insert more than once. To 

prevent the potential transmission of 

venereal and bloodborne diseases, the 

inserts should be disposed after a single 

use. Administration of vaginal inserts 

for periods greater than 7 days may 

result in reduced fertility. Dinoprost 

injection for use in paragraphs 

(e)(1)(ii)(A) and (e)(1)(ii)(B) of this 

section as in § 522.690 of this chapter, 

as provided by No. 054771 in 

§ 510.600(c) of this chapter. 

* * * * * 

PART 556—TOLERANCES FOR 

RESIDUES OF NEW ANIMAL DRUGS 

IN FOOD 

■ 33. The authority citation for part 556 

continues to read as follows: 

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

■ 34. In § 556.710, revise paragraph (c) 

to read as follows: 

§ 556.710 Testosterone. 

* * * * * 

(c) Related conditions of use. See 

§ 522.2343 of this chapter. 

PART 558—NEW ANIMAL DRUGS FOR 

USE IN ANIMAL FEEDS 

■ 35. The authority citation for part 558 

continues to read as follows: 

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

360ccc–1, 371. 

■ 36. In § 558.59, redesignate paragraph 

(d) as paragraph (e) and add new 

paragraph (d) to read as follows: 

§ 558.59 Apramycin. 

* * * * * 

(d) Special considerations. (1) Federal 

law restricts medicated feed containing 

this veterinary feed directive (VFD) drug 

to use by or on the order of a licensed 

veterinarian. See § 558.6 for additional 

requirements. 

(2) The expiration date of VFDs for 

apramycin medicated feeds must not 

exceed 6 months from the date of 

issuance. VFDs for apramycin shall not 

be refilled. 

* * * * * 

■ 37. In § 558.205, revise paragraphs 

(d)(1) and (2) to read as follows: 

§ 558.205 Diclazuril. 

* * * * * 

(d) * * * 

(1) Chickens. For chickens it is used 

as follows: 

Diclazuril 

grams/ton 

Combination 

grams/ton Indications for use Limitations Sponsor 

(i) 0.91 ............ ...................................... Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, 

E. acervulina, E. brunetti, E. mitis (mivati), 

and E. maxima. Because diclazuril is effective against E. maxima later in its life cycle, 

subclinical intestinal lesions may be present 

for a short time after infection. Diclazuril was 

shown in studies to reduce lesion scores and 

improve performance and health of birds 

challenged with E. maxima.

Feed continuously as the sole ration. Do not feed to birds producing eggs for human consumption.058198 


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Diclazuril 

grams/ton 

Combination 

grams/ton Indications for use Limitations Sponsor 

(ii) 0.91 ........... Bacitracin 

methylenedisalicylate, 

4 to 50.

Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, 

E. acervulina, E. brunetti, E. mitis (mivati), 

and E. maxima, and for increased rate of 

weight gain and improved feed efficiency. Because diclazuril is effective against E. maxima later in its life cycle, subclinical intestinal 

lesions may be present for a short time after 

infection. Diclazuril was shown in studies to 

reduce lesion scores and improve performance and health of birds challenged with E. 

maxima.

Feed continuously as the sole ration. Do not feed to birds producing eggs for human consumption. Bacitracin 

methylenedisalicylate provided by 

No. 054771 in § 510.600(c) of 

this chapter.

058198 

(iii) 0.91 .......... Bambermycins, 1 to 2 .. Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, 

E. acervulina, E. brunetti, E. mitis (mivati), 

and E. maxima, and for increased rate of 

weight gain and improved feed efficiency. Because diclazuril is effective against E. maxima later in its life cycle, subclinical intestinal 

lesions may be present for a short time after 

infection. Diclazuril was shown in studies to 

reduce lesion scores and improve performance and health of birds challenged with E. 

maxima.

Feed continuously as the sole ration. Do not feed to birds producing eggs for human consumption. Bambermycins provided by 

No. 016592 in § 510.600(c) of 

this chapter.

058198 

(2) Turkeys. For turkeys it is used as 

follows: 

Diclazuril 

grams/ton 

Combination 

grams/ton Indications for use Limitations Sponsor 

(i) 0.91 ............ ...................................... Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. 

gallopavonis, and E. meleagrimitis.

Feed continuously as the sole ration. Do not feed to breeding turkeys. Do not feed to birds producing eggs for human consumption.058198 

(ii) 0.91 ........... Bacitracin 

methylenedisalicylate, 

4 to 50.

Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. 

gallopavonis, and E. meleagrimitis, and for increased rate of weight gain and improved 

feed efficiency.

Feed continuously as the sole ration. Do not feed to breeding turkeys. Do not feed to birds producing eggs for human consumption. Bacitracin 

methylenedisalicylate as provided 

by No. 054771 in § 510.600(c) of 

this chapter.

058198 

(iii) 0.91 .......... Bambermycins 1 to 2 ... Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. 

gallopavonis, and E. meleagrimitis, and for 

improved feed efficiency.

Feed continuously as the sole ration. Do not feed to breeding turkeys. Do not feed to birds producing eggs for human consumption. Bambermycins as provided 

by No. 016592 in § 510.600(c) of 

this chapter.

058198 

(iv) 0.91 .......... Bambermycins 2 .......... Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. 

gallopavonis, and E. meleagrimitis, and for increased rate of weight gain and improved 

feed efficiency.

Feed continuously as the sole ration. Do not feed to breeding turkeys. Do not feed to birds producing eggs for human consumption. Bambermycins as provided 

by No. 016592 in § 510.600(c) of 

this chapter.

058198 

§ 558.254 [Amended] 

■ 38. In § 558.254, in paragraph (e) 

introductory text, remove ‘‘Table 2— 

Size Proxies for SRCs in 2016’’. 

■ 39. In § 558.261, revise paragraph 

(e)(2)(ii) to read as follows: 

§ 558.261 Florfenicol. 

* * * * * 

(e) * * * 

(2) * * * 


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Florfenicol in 

grams/ton of feed Indications for use Limitations 

*******

(ii) 182 to 1,816 ......... Freshwater-reared salmonids: For the control 

of mortality due to coldwater disease associated with Flavobacterium psychrophilum and 

furunculosis associated with Aeromonas 

salmonicida.

Feed as a sole ration for 10 consecutive days to deliver 10 to 15 mg 

florfenicol per kg of fish. Feed containing florfenicol shall not be fed 

for more than 10 days. Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course 

of therapy. The effects of florfenicol on reproductive performance 

have not been determined. Feeds containing florfenicol must be 

withdrawn 15 days prior to slaughter. 

*******

* * * * * 

■ 39. In § 558.311, add paragraph 

(e)(3)(ix) to read as follows: 

§ 558.311 Lasalocid. 

* * * * * 

(e) * * * 

(3) * * * 

Lasalocid 

amount Indications for use Limitations Sponsor 

*******

(ix) 60 to 300 

mg of 

lasalocid per 

head per day.

Growing beef steers and heifers on pasture (stocker, feeder, and slaughter) 

and replacement beef and dairy heifers on pasture: For increased rate of 

weight gain.

Feed continuously as a Type C free-choice medicated feed at a 

rate of 60 to 300 mg of lasalocid per head per day. Daily intakes 

of lasalocid in excess of 200 mg/head/day have not been shown 

to be more effective than 200 mg/head/day.

054771 

* * * * * 

■ 40. In § 558.450, revise paragraph 

(e)(5)(ii), redesignate paragraphs 

(e)(5)(iii) through (vii) as paragraphs 

(e)(5)(iv) through (viii), and add new 

paragraph (e)(5)(iii) to read as follows: 

§ 558.450 Oxytetracycline. 

* * * * * 

(e) * * * 

(5) * * * 

Oxytetracycline 

amount Indications for use Limitations Sponsor 

*******

(ii) 200 mg/colony as 

a dust (200 mg/oz) 

or syrup (200 mg/5 

lb).

Honey bees: For control of American foulbrood caused by 

Paenibacillus larvae and European foulbrood caused by 

Melissococcus plutonius susceptible to oxytetracycline.

Apply every 4 to 5 days for a total of 

three applications. Remove at least 6 

weeks prior to main honey flow.

066104 

069254 

(iii) 800 mg/colony as 

an extender patty 

(800 mg/patty).

Honey bees: For control of American foulbrood caused by 

Paenibacillus larvae and European foulbrood caused by 

Melissococcus plutonius susceptible to oxytetracycline.

Use as a single application. Remove at 

least 6 weeks prior to main honey flow.

066104 

069254 

*******

* * * * * 

■ 41. In § 558.633, revise paragraph 

(d)(3) to read as follows: 

§ 558.633 Tylvalosin. 

* * * * * 

(d) * * * 

(3) An expiration date of 1 week is 

required for tylvalosin Type C 

medicated swine feeds in pelleted or 

crumbled form. Pelleted Type C 

medicated feeds must bear an expiration 

date of 30 days after the date of 

manufacture. Crumbled Type C 

medicated feeds must bear an expiration 

date of 7 days after the date of 

manufacture. 

* * * * * 

■ 42. In § 558.635, revise paragraph 

(e)(1)(iv) to read as follows: 

§ 558.635 Virginiamycin. 

* * * * * 

(e) * * * 

(1) * * * 


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Virginiamycin 

in grams/ton 

Combination 

in grams/ton Indications for use Limitations Sponsor 

*******

(iv) 20 .............. Diclazuril, 0.91 Broiler chickens: For prevention of necrotic enteritis 

caused by Clostridium perfringens susceptible to 

virginiamycin; and for the prevention of coccidiosis 

caused by Eimeria tenella, E. necatrix, E. acervulina, 

E. brunetti, E. mitis (mivati), and E. maxima. Because 

diclazuril is effective against E. maxima later in its life 

cycle, subclinical intestinal lesions may be present for a 

short time after infection. Diclazuril was shown in studies to reduce lesions scores and improve performance 

and health of birds challenged with E. maxima.

Feed continuously as the sole ration. Do not feed to birds producing eggs for human consumption. Diclazuril as provided 

by No. 058198 in § 510.600(c) 

of this chapter.

058198 

*******

* * * * * 

Dated: February 14, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–03538 Filed 2–25–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket Number USCG–2022–0084] 

RIN 1625–AA87 

Security Zone; Lower Mississippi 

River, New Orleans, LA 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a temporary security zone 

for all navigable waters within 400 

yards of the Left Descending Bank (LDB) 

of the Lower Mississippi River (LMR) 

MM 94.4 and MM 95.1, Above Head of 

Passes (AHP), New Orleans, LA. This 

security zone is necessary to provide 

security and protection for visiting 

personnel during the events related to 

the Mardi Gras Celebrations. Entry of 

vessels or persons into this zone is 

prohibited unless specifically 

authorized by the Captain of the Port 

New Orleans (COTP) or a designated 

representative. 

DATES: This rule is effective from 6 p.m. 

on February 25, 2022, through 11:59 

p.m. on March 1, 2022. 

ADDRESSES: To view documents 

mentioned in this preamble as being 

available in the docket, go to https://

www.regulations.gov, type USCG–2022– 

0084 in the search box and click 

‘‘Search.’’ Next, in the Document Type 

column, select ‘‘Supporting & Related 

Material.’’ 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call or 

email Lieutenant Commander, William 

A. Stewart, Sector New Orleans, U.S. 

Coast Guard; telephone 504–365–2246, 

email William.A.Stewart@uscg.mil. 

SUPPLEMENTARY INFORMATION: 

I. Table of Abbreviations 

CFR Code of Federal Regulations 

COTP Captain of the Port Sector New 

Orleans 

DHS Department of Homeland Security 

FR Federal Register 

TFR Temporary Final Rule 

§ Section 

U.S.C. United States Code 

II. Background Information and 

Regulatory History 

The Coast Guard is issuing this 

temporary rule without prior notice and 

opportunity to comment pursuant to 

authority under section 4(a) of the 

Administrative Procedure Act (APA) (5 

U.S.C. 553(b)). This provision 

authorizes an agency to issue a rule 

without prior notice and opportunity to 

comment when the agency for good 

cause finds that those procedures are 

‘‘impracticable, unnecessary, or contrary 

to the public interest.’’ Under 5 U.S.C. 

553(b)(B), the Coast Guard finds that 

good cause exists for not publishing a 

notice of proposed rulemaking (NPRM) 

with respect to this rule because it 

would be impracticable. We must 

establish this security zone by February 

25, 2022 in order to provide proper 

security for these visiting personnel, 

and we do not have sufficient time to 

request and respond to comments. 

Under 5 U.S.C. 553(d)(3), the Coast 

Guard finds that good cause exists for 

making this rule effective less than 30 

days after publication in the Federal 

Register. Delaying the effective date of 

this rule would be contrary to the public 

interest because immediate action is 

needed to provide adequate security to 

protect the public. 

III. Legal Authority and Need for Rule 

The Coast Guard is issuing this rule 

under authority in 46 U.S.C. 70034 

(previously 33 U.S.C. 1231). The 

Captain of the Port New Orleans (COTP) 

has determined that the increased 

number of personnel anticipated to be 

visiting the city during the Mardi Gras 

Celebration requires certain security 

measures to ensure that the persons and 

property are kept secure during the 

events. The Coast Guard determined 

that a temporary security zone is needed 

for this and related events that will be 

taking place adjacent to a portion of 

Lower Mississippi River (LMR). 

IV. Discussion of the Rule 

This rule establishes a security zone 

from 6 p.m. on February 25, 2022 

through 11:59 p.m. on March 1, 2022. 

The security zone will cover all 

navigable waters within 400 yards of the 

Left Descending Bank (LDB) of the LMR 

from MM 94.4 and MM 95.1, Above 

Head of Passes (AHP), New Orleans, LA. 

This zone is necessary in order to 

provide to provide waterside security 

for the protection of visitors attending 

the events related to the Mardi Gras 

Celebrations. No vessel or person will 

be permitted to enter the security zone 

without obtaining permission from the 

COTP or a designated representative. A 

designated representative is a 

commissioned, warrant, or petty officer 

of the U.S. Coast Guard assigned to 

units under the operational control of 

USCG Sector New Orleans. They may be 

contacted on VHF–FM Channel 16 or 67 

or by telephone at 504–365–2545. 

Persons and vessels permitted to enter 

this security zone must transit at their 

slowest safe speed and comply with all 

lawful directions issued by the COTP or 

the designated representative. 

The COTP or a designated 

representative will inform the public of 

the enforcement times and date for this 

regulated area through Broadcast 

Notices to Mariners (BNMs), Local 


khammond on DSKJM1Z7X2PROD with RULES