Federal Register / Vol. 89, No. 39 / Tuesday, February 27, 2024 / Rules and Regulations 14407 

Country Entity License 

requirement 

License 

review policy Federal Register citation 

******

*******

UNITED ARAB 

EMIRATES.

* * * * * * 

Sandvine Incorporated, a.k.a., the following 

one alias: 

—Sandvine Inc. 

Business Central Tower, A BLOCK, 28th 

floor, Office No. 2805/06/07/08, Dubai 

Media City, United Arab Emirates. (See alternate addresses under Canada, India, 

Japan, and Malaysia.) 

For all items subject to the 

EAR (See § 744.11 of the 

EAR).

Presumption of denial ............ 89 FR [INSERT FR PAGE 

NUMBER February 27, 

2024. 

* * * * * * 

*******

* * * * * 

Thea D. Rozman Kendler, 

Assistant Secretary for Export 

Administration. 

[FR Doc. 2024–03674 Filed 2–26–24; 8:45 am] 

BILLING CODE 3510–33–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 510, 520, 522, 524, 529, 

556, and 558 

[Docket No. FDA–2023–N–0002] 

New Animal Drugs; Approval of New 

Animal Drug Applications; Withdrawal 

of Approval of New Animal Drug 

Applications, Change of Sponsor, 

Change of Sponsor Address 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; technical 

amendments. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

amending the animal drug regulations to 

reflect application-related actions for 

new animal drug applications (NADAs) 

and abbreviated new animal drug 

applications (ANADAs) during October, 

November, and December 2023. The 

animal drug regulations are also being 

amended to improve their accuracy and 

readability. 

DATES: This rule is effective February 

27, 2024. 

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 

October, November, and December 

2023, 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 (FOIA Summaries) 

under the Freedom of Information Act 

(FOIA). These documents, along with 

marketing exclusivity and patent 

information, may be obtained at Animal 

Drugs @FDA: https://animaldrugsatfda.

fda.gov/adafda/views/#/search. 

TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING OCTOBER, NOVEMBER, AND

DECEMBER 2023 REQUIRING EVIDENCE OF SAFETY AND/OR EFFECTIVENESS

Date of approval File No. Sponsor 

(drug labeler code) Product name Effect of the action 

21 CFR 

section 

October 11, 2023 ............ 141–572 Virbac AH, Inc., P.O. Box 162059, 

Fort Worth, TX 76161 (051311).

AYRADIA (metronidazole) oral solution.Original approval for the treatment 

of Giardia duodenalis infection in 

dogs.

520.1425 

October 13, 2023 ............ 141–336 ECO LLC, 344 Nassau St., Princeton, NJ 08540 (066916).AIVLOSIN (tylvalosin tartrate) Water 

Soluble Granules.

Supplemental approval adding females intended for breeding to 

approved classes of swine.

520.2645 

October 20, 2023 ............ 141–564 Pharmgate Inc., 1800 Sir Tyler Rd., 

Wilmington, NC 28405 (069254).

PENNCHLOR (chlortetracycline 

Type A medicated article) and 

RUMENSIN (monensin Type A 

medicated article).

Original approval for treatment of 

bacterial enteritis and pneumonia; 

and for increased rate of weight 

gain or prevention and control of 

coccidiosis in replacement beef 

and dairy heifers.

558.128 

November 8, 2023 .......... 200–758 Felix Pharmaceuticals Pvt. Ltd., 25– 

28 North Wall Quay, Dublin 1, 

Ireland (086101).

Enrofloxacin Injectable Solution ...... Original approval for treatment and 

control of bovine respiratory disease (BRD) in beef cattle and 

non-lactating dairy cattle and 

swine respiratory disease (SRD) 

and control of colibacillosis in 

groups or pens of weaned pigs, 

as a generic copy of NADA 141– 

068.

522.812 


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14408 Federal Register / Vol. 89, No. 39 / Tuesday, February 27, 2024 / Rules and Regulations 

TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING OCTOBER, NOVEMBER, AND

DECEMBER 2023 REQUIRING EVIDENCE OF SAFETY AND/OR EFFECTIVENESS—Continued 

Date of approval File No. Sponsor 

(drug labeler code) Product name Effect of the action 

21 CFR 

section 

November 17, 2023 ........ 141–580 Orion Corp., Orionintie 1, 02200 

Espoo, Finland (052483).

BONQAT (pregabalin) Oral Solution Original approval for alleviation of 

acute anxiety and fear associated 

with transportation and veterinary 

visits in cats.

520.1892 

December 14, 2023 ........ 141–502 Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 (054771).REVOLUTION PLUS (selamectin 

and sarolaner topical solution).

Supplemental approval for the treatment and control of tick infestations with Amblyomma 

americanum (lone star tick) in 

cats and kittens 8 weeks of age 

and older, and weighing 2.8 

pounds or greater.

524.2099 

December 21, 2023 ........ 200–760 Cronus Pharma Specialties India 

Private Ltd., Sy No-99/1, M/s 

GMR Hyderabad Aviation SEZ 

Ltd., Mamidipalli Village, 

Shamshabad Mandal, Ranga 

Reddy, Hyderabad, Telangana, 

501218, India (069043).

FLORFENIJECT (florfenicol) 

Injectable Solution.

Original approval for treatment of 

bovine respiratory disease (BRD) 

and bovine interdigital phlegmon; 

and for the control of respiratory 

disease in cattle at high risk of 

developing BRD, as a generic 

copy of NADA 141–063.

522.955 

December 22, 2023 ........ 200–762 Do .................................................... CAROFENVET (carprofen) 

Injectable Solution.

Original approval for the relief of 

pain and inflammation associated 

with osteoarthritis and for the 

control of postoperative pain associated with soft tissue and orthopedic surgeries, as a generic 

copy of NADA 141–199.

522.304 

December 22, 2023 ........ 200–764 Do .................................................... ENROPRO 22.7 (enrofloxacin) 

Injectable Solution.

Original approval for the management of diseases in dogs associated with bacteria susceptible to 

enrofloxacin, as a generic copy of 

NADA 140–913.

522.812 

December 22, 2023 ........ 200–765 Do .................................................... ENROPRO 100 (enrofloxacin) 

Injectable Solution.

Original approval for treatment and 

control of bovine respiratory disease (BRD) in beef cattle and 

non-lactating dairy cattle and 

swine respiratory disease (SRD) 

and control of colibacillosis in 

groups or pens of weaned pigs, 

as a generic copy of NADA 141– 

068.

522.812 

II. Withdrawals of Approval 

ADM Animal Nutrition, Inc., 1000 

North 30th St., Quincy, IL 62305–3115 

(drug labeler code 012286) requested 

that FDA withdraw approval of the four 

NADAs listed in table 2 because the 

products are no longer manufactured or 

marketed. As provided in the regulatory 

text of this document, the animal drug 

regulations are amended to reflect these 

actions. 

TABLE 2—APPLICATIONS FOR WHICH APPROVAL WAS VOLUNTARILY WITHDRAWN DURING OCTOBER, NOVEMBER, AND

DECEMBER 2023 

Date of withdrawal 

of approval File No. New animal drug 21 CFR section 

November 14, 2023 ........ 030–578 E–Z–EX Wormer Pellets (thiabendazole) ................................................................................................................... n/a 

Do .................................... 042–910 E–Z–EX WORMER MINTRATE Block (thiabendazole) Mineral Protein Block .......................................................... 558.600 

Do .................................... 118–877 BAN–A–WORM (pyrantel tartrate) Ton Pack ............................................................................................................. n/a 

Do .................................... 132–448 FLAVOMYCIN (bambermycins) Type A Medicated Article ........................................................................................ 558.95 

III. Change of Sponsor 

The sponsors of the approved 

applications listed in table 3 have 

informed FDA that they have transferred 

ownership of, and all rights and interest 

in, these applications to another 

sponsor. The regulations cited in table 

3 are amended to reflect these actions. 

TABLE 3—APPLICATIONS FOR WHICH OWNERSHIP WAS TRANSFERRED TO ANOTHER SPONSOR DURING OCTOBER, 

NOVEMBER, AND DECEMBER 2023 

File No. Product name Transferring sponsor 

(drug labeler code) 

New sponsor 

(drug labeler code) 

21 CFR 

section 

200–237 ... Isoflurane, U.S.P ......................................... Piramal Pharma Ltd., Ground Floor, 

Piramal Ananta, Agastya Corporate 

Park, Mumbai, Maharashtra, 400070, 

India (065085).

Piramal Critical Care, Inc., 3850 Schelden 

Circle, Bethlehem, PA 18017 (066794).

529.1186 


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Federal Register / Vol. 89, No. 39 / Tuesday, February 27, 2024 / Rules and Regulations 14409 

TABLE 3—APPLICATIONS FOR WHICH OWNERSHIP WAS TRANSFERRED TO ANOTHER SPONSOR DURING OCTOBER, 

NOVEMBER, AND DECEMBER 2023—Continued 

File No. Product name Transferring sponsor 

(drug labeler code) 

New sponsor 

(drug labeler code) 

21 CFR 

section 

200–576 ... Gentamicin Sulfate Ophthalmic Solution .... Akorn Operating Co. LLC, 5605 

Centerpoint Ct., Suite A, Gurnee, IL 

60031 (059399).

Domes Pharma S.A., ZAC de Champ 

Lamet, 3 rue Andre Citroen, Pont-duChateau, Auvergne-Rhoˆne-Alpes, 63430, 

France (086189).

524.1044a 

200–670 ... SENERGY (selamectin) Topical Solution ... Chanelle Pharmaceuticals Manufacturing 

Ltd., Loughrea, County Galway, Ireland 

(061651).

Virbac AH, Inc., P.O. Box 162059, Fort 

Worth, TX 76161 (051311).

524.2098 

200–700 ... PARASEDGE Multi for Dogs (Imidacloprid 

and moxidectin).

Do ................................................................ Do ................................................................ 524.1146 

200–701 ... PARASEDGE Multi for Cats (Imidacloprid 

and moxidectin).

Do ................................................................ Do ................................................................ 524.1146 

IV. Change of Sponsor Address 

Accord Healthcare, Inc. 1009 Slater 

Rd., Suite 210–B, Durham, NC 27703 

(drug labeler code 016729 in 21 CFR 

510.600(c)) has informed FDA that it has 

changed its address to 126 E Lincoln 

Ave., Rahway, NJ 07065. The entries in 

§ 510.600(c) are amended to reflect this 

action. 

V. Technical Amendments 

FDA is making the following 

amendments to improve the accuracy of 

the animal drug regulations. 

• 21 CFR 520.1408 is revised to 

reflect all approved strengths of 

methylprednisolone tablets for dogs and 

cats. 

• 21 CFR 556.730 is removed because 

there are no approved products 

containing thiabendazole for use in 

food-producing animals. 

• 21 CFR 558.4(d) is being revised in 

the Category II table by removing the 

row entry for ‘‘Thiabendazole’’ because 

there are no longer any approved feed 

products for use in food-producing 

animals. 

• 21 CFR 558.128 is revised to reflect 

withdrawal periods for different 

applications approved for use of 

chlortetracycline in cattle feed. 

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)). Although deemed 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’’ 

and 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. 

List of Subjects 

21 CFR Part 510 

Administrative practice and 

procedure, Animal drugs, Labeling, 

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 510, 

520, 522, 524, 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, in the table in 

paragraph (c)(1), revise the entry for 

‘‘Accord Healthcare, Inc.’’; and in the 

table in paragraph (c)(2), revise the entry 

for ‘‘016729’’ to 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 

*******

Accord Healthcare, Inc., 126 E Lincoln Ave., Rahway, NJ 07065 ...................................................................................................... 016729 

* * * * * * * 

(2) * * * 

Drug labeler code Firm name and address 

*******

016729 ................... Accord Healthcare, Inc., 126 E Lincoln Ave., Rahway, NJ 07065. 

*******


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14410 Federal Register / Vol. 89, No. 39 / Tuesday, February 27, 2024 / Rules and Regulations 

PART 520—ORAL DOSAGE FORM 

NEW ANIMAL DRUGS 

■ 3. The authority citation for part 520 

continues to read as follows: 

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

■ 4. In § 520.1408, revise paragraph (b) 

to read as follows: 

§ 520.1408 Methylprednisolone. 

* * * * * 

(b) Sponsors. See Nos. 054771 and 

069043 in § 510.600(c) of this chapter. 

* * * * * 

■ 5. Add § 520.1425 to read as follows: 

§ 520.1425 Metronidazole. 

(a) Specifications. Each milliliter of 

suspension contains 125 milligrams 

(mg) metronidazole. 

(b) Sponsor. See No. 051311 in 

§ 510.600(c) of this chapter. 

(c) Conditions of use—(1) Amount. 

Administer 25 mg per kilogram (11.3 mg 

per pound) of body weight twice daily 

for 5 consecutive days. 

(2) Indications for use. For the 

treatment of Giardia duodenalis 

infection in dogs. 

(3) Limitations. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian. 

■ 6. Add § 520.1892 to read as follows: 

§ 520.1892 Pregabalin. 

(a) Specifications. Each milliliter (mL) 

of solution contains 50 milligrams (mg) 

pregabalin. 

(b) Sponsor. See No. 052483 in 

§ 510.600(c) of this chapter. 

(c) Conditions of use—(1) Amount. 

Administer orally as a single dose of 5 

mg/kg (0.1 mL/kg) approximately 1.5 

hours before the start of the 

transportation or veterinary visit. 

(2) Indications for use. For alleviation 

of acute anxiety and fear associated with 

transportation and veterinary visits. 

(3) Limitations. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian. 

■ 7. In § 520.2645, revise paragraph 

(d)(2) to read as follows: 

§ 520.2645 Tylvalosin. 

* * * * * 

(d) * * * 

(2) Indications for use. For control of 

porcine proliferative enteropathy (PPE) 

associated with Lawsonia intracellularis 

infection in groups of swine intended 

for slaughter and female swine intended 

for breeding in buildings experiencing 

an outbreak of PPE; and for control of 

swine respiratory disease (SRD) 

associated with Bordetella 

bronchiseptica, Glaesserella 

(Haemophilus) parasuis, Pasteurella 

multocida, Streptococcus suis, and 

Mycoplasma hyopneumoniae in groups 

of swine intended for slaughter and 

female swine intended for breeding in 

buildings experiencing an outbreak of 

SRD. 

* * * * * 

PART 522—IMPLANTATION OR 

INJECTABLE DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 8. The authority citation for part 522 

continues to read as follows: 

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

■ 9. In § 522.304, revise paragraph (b) to 

read as follows: 

§ 522.304 Carprofen. 

* * * * * 

(b) Sponsors. See Nos. 016729, 

017033, 054771, 055529, and 069043 in 

§ 510.600(c) of this chapter. 

* * * * * 

■ 10. In § 522.812, revise paragraphs 

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

§ 522.812 Enrofloxacin. 

* * * * * 

(b) * * * 

(1) Nos. 016729, 017033, 055529, 

058198, 069043, and 086101 for use of 

product described in paragraph (a)(1) as 

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

(2) Nos. 051311, 055529, 058005, 

058198, 061133, 069043, and 086101 for 

use of product described in paragraph 

(a)(2) as in paragraphs (e)(2) and (3) of 

this section. 

* * * * * 

■ 11. In § 522.955, revise paragraph 

(b)(3) and the second sentence in 

paragraph (d)(1)(ii)(C) to read as follows: 

§ 522.955 Florfenicol. 

* * * * * 

(b) * * * 

(3) Nos. 058005, 058198, and 069043 

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. * * * Nos. 000061, 

058005, 058198, and 069043: Animals 

intended for human consumption must 

not be slaughtered within 38 days of 

subcutaneous treatment. * * * 

* * * * * 

PART 524—OPHTHALMIC AND 

TOPICAL DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 12. The authority citation for part 524 

continues to read as follows: 

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

■ 13. In 524.1044a, revise paragraph (b) 

to read as follows: 

§ 524.1044a Gentamicin ophthalmic 

solution. 

* * * * * 

(b) Sponsors. See Nos. 000061 and 

086189 in § 510.600(c) of this chapter. 

* * * * * 

■ 14. In 524.1146, revise paragraphs 

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

§ 524.1146 Imidacloprid and moxidectin. 

* * * * * 

(b) * * * 

(1) Nos. 017030, 051072, 051311, 

055529, and 058198 for use of product 

described in paragraph (a)(1) of this 

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

section. 

(2) Nos. 017030, 051072, 051311, 

055529, and 058198 for use of product 

described in paragraph (a)(2) of this 

section as in paragraph (d)(2) of this 

section. 

* * * * * 

■ 15. In 524.2098, revise paragraph (b) 

to read as follows: 

§ 524.2098 Selamectin. 

* * * * * 

(b) Sponsors. See Nos. 051072, 

051311, 054771, 055529, and 061133 in 

§ 510.600(c) of this chapter. 

* * * * * 

■ 16. In 524.2099, revise paragraph 

(c)(2) to read as follows: 

§ 524.2099 Selamectin and sarolaner. 

* * * * * 

(c) * * * 

(2) Indications for use. For the 

prevention of heartworm disease caused 

by Dirofilaria immitis. Kills adult fleas 

(Ctenocephalides felis) and is indicated 

for the treatment and prevention of flea 

infestations; the treatment and control 

of tick infestations with Amblyomma 

americanum (lone star tick), 

Amblyomma maculatum (Gulf Coast 

tick), Dermacentor variabilis (American 

dog tick), and Ixodes scapularis (blacklegged tick), the treatment and control of 

ear mite (Otodectes cynotis) infestations; 

and the treatment and control of 

roundworm (Toxocara cati) and 

intestinal hookworm (Ancylostoma 

tubaeforme) infections in cats and 

kittens 8 weeks of age and older, and 

weighing 2.8 pounds or greater. 

* * * * * 

PART 529—CERTAIN OTHER DOSAGE 

FORM NEW ANIMAL DRUGS 

■ 17. The authority citation for part 529 

continues to read as follows: 


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Federal Register / Vol. 89, No. 39 / Tuesday, February 27, 2024 / Rules and Regulations 14411 

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

■ 18. In § 529.1186, revise paragraph (b) 

to read as follows: 

§ 529.1186 Isoflurane. 

* * * * * 

(b) Sponsors. See Nos. 017033, 

054771, and 066794 in § 510.600(c) of 

this chapter. 

* * * * * 

PART 556—TOLERANCES FOR 

RESIDUES OF NEW ANIMAL DRUGS 

IN FOOD 

■ 19. The authority citation for part 556 

continues to read as follows: 

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

§ 556.730 [Removed] 

■ 20. Remove § 556.730. 

PART 558—NEW ANIMAL DRUGS FOR 

USE IN ANIMAL FEEDS 

■ 21. The authority citation for part 558 

continues to read as follows: 

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

360ccc–1, 371. 

§ 558.4 [Amended] 

■ 22. Amend § 558.4, by removing the 

entry for ‘‘Thiabendazole’’ in the 

Category II’’ table in paragraph (d). 

■ 23. In § 558.95, revise paragraphs (b), 

(e)(2)(i) and (ii), and (e)(3)(i) and (ii) to 

read as follows: 

§ 558.95 Bambermycins. 

* * * * * 

(b) Sponsor. See No. 016592 in 

§ 510.600(c) of this chapter. 

* * * * * 

(e) * * * 

(2) * * * 

Bambermycins 

in grams/ton Indications for use Limitations Sponsor 

(i) 1 to 2 .......... Growing turkeys: For improved feed efficiency ............... Feed continuously as the sole ration ............................... 016592 

(ii) 2 ................ Growing turkeys: For increased rate of weight gain and 

improved feed efficiency.

Feed continuously as the sole ration ............................... 016592 

(3) * * * 

Bambermycins 

in grams/ton Indications for use Limitations Sponsor 

(i) 2 ................. Growing-finishing swine: For increased rate of weight 

gain and improved feed efficiency.

Feed continuously as the sole ration ............................... 016592 

(ii) 2 to 4 ......... Growing-finishing swine: For improved feed efficiency ... Feed continuously as the sole ration ............................... 016592 

* * * * * 

■ 24. In § 558.128: 

■ a. Revise paragraphs (e)(4)(xvi) and 

(xvii); 

■ b. Redesignate paragraphs (e)(4)(xxi) 

through (lviii) as paragraphs (e)(4)(xxiii) 

through (lx); and 

■ c. Add new paragraphs (e)(4)(xxi) and 

(xxii). 

The revision and additions read as 

follows: 

§ 558.128 Chlortetracycline. 

* * * * * 

(e) * * * 

(4) * * * 

Chlortetracycline amount Combination 

in grams/ton Indications for use Limitations Sponsor 

*******

(xvi) to provide 10 mg/lb of body 

weight daily.

...................... Calves, beef and nonlactating dairy 

cattle: For treatment of bacterial 

enteritis caused by Escherichia coli 

and bacterial pneumonia caused 

by Pasteurella multocida organisms susceptible to chlortetracycline.

Feed approximately 400 g/ton, varying with body weight 

and feed consumption to provide 10 mg/lb per day. 

Treat for not more than 5 days. To sponsor No. 

054771 (NADAs 048–761 and 046–699) and to sponsor No. 069254 (ANADA 200–510): May be mixed in 

the cattle’s daily ration or administered as a topdress. In feed including milk replacers withdraw 10 

days prior to slaughter. To sponsor No. 054771 under 

NADA 046–699: 24-hour withdrawal period. To sponsor No. 054771 under NADA 048–761 and No. 

069254 under ANADA 200–510: Zero withdrawal period. See paragraph (d)(3) of this section.

054771 

066104 

069254 

(xvii) to provide 10 mg/lb of body 

weight daily.

...................... Calves (up to 250 lb): For the treatment of bacterial enteritis caused 

by Escherichia coli susceptible to 

chlortetracycline.

A withdrawal period has not been established for this 

product in pre-ruminating calves. Do not use in calves 

to be processed for veal.

066104 


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14412 Federal Register / Vol. 89, No. 39 / Tuesday, February 27, 2024 / Rules and Regulations 

Chlortetracycline amount Combination 

in grams/ton Indications for use Limitations Sponsor 

*******

(xxi) 400 to 2,000 g/ton ....................... Monensin, 15 

to 84.

Replacement beef and dairy heifers: 

For treatment of bacterial enteritis 

caused by Escherichia coli and 

bacterial pneumonia caused by 

Pasteurella multocida susceptible 

to chlortetracycline; and for the 

prevention and control of coccidiosis caused by Eimeria bovis and 

Eimeria zuernii.

For replacement beef and dairy heifers not currently 

being fed monensin: Feed as the sole ration for not 

more than 5 days to provide 10 mg chlortetracycline 

per pound of body weight per day and 0.14 to 0.42 

mg monensin per pound of body weight per day, depending upon severity of challenge, to provide 50 to 

100 mg monensin per head per day in a minimum of 

1 pound of Type C medicated feed. After 5 days, continue to feed monensin Type C medicated feed alone 

to provide 50 to 200 mg monensin per head per day 

in a minimum of 1 pound of Type C medicated feed.

For replacement beef and dairy heifers currently being 

fed monensin: Feed as the sole ration for not more 

than 5 days to provide 10 mg chlortetracycline per 

pound of body weight per day and 0.14 to 0.42 mg 

monensin per pound of body weight per day, depending upon severity of challenge, to provide 50 to 200 

mg monensin per head per day in a minimum of 1 

pound of Type C medicated feed. After 5 days, continue to feed monensin Type C medicated feed alone.

069254 

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 preruminating calves. Do not use in calves to be processed for veal.

Monensin as provided by No. 058198, chlortetracycline 

by No. 069254 in § 510.600(c) of this chapter.

(xxii) 400 to 2,000 g/ton ...................... Monensin, 15 

to 400.

Replacement beef and dairy heifers: 

For treatment of bacterial enteritis 

caused by Escherichia coli and 

bacterial pneumonia caused by 

Pasteurella multocida susceptible 

to chlortetracycline; and for increased rate of weight gain.

For replacement beef and dairy heifers not currently 

being fed monensin: Feed as the sole ration for not 

more than 5 days to provide 10 mg chlortetracycline 

per pound of body weight per day and 50 to 100 mg 

monensin per head per day in a minimum of 1 pound 

of Type C medicated feed. After 5 days, continue to 

feed monensin Type C medicated feed alone to provide 50 to 200 mg monensin per head per day in a 

minimum of 1 pound of Type C medicated feed.

For replacement beef and dairy heifers currently being 

fed monensin: Feed as the sole ration for not more 

than 5 days to provide 10 mg chlortetracycline per 

pound of body weight per day and 50 to 200 mg 

monensin per head per day in a minimum of 1 pound 

of Type C medicated feed. After 5 days, continue to 

feed monensin Type C medicated feed alone.

069254 

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 preruminating calves. Do not use in calves to be processed for veal.

Monensin as provided by No. 058198, chlortetracycline 

by No. 069254 in § 510.600(c) of this chapter.

*******

§ 558.600 [Removed] 

■ 25. Remove § 558.600. 

Dated: February 20, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–03765 Filed 2–26–24; 8:45 am] 

BILLING CODE 4164–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R09–OAR–2022–0604; FRL–10574– 

02–R9] 

Air Plan Approval; CA; San Joaquin 

Valley Air Pollution Control District 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is taking final action to 

approve revisions to the San Joaquin 

Valley Air Pollution Control District 

(SJVAPCD) portion of the California 

State Implementation Plan (SIP). The 

revisions were submitted by the 

California Air Resources Board (CARB), 

on behalf of SJVAPCD, in response to 

the EPA’s May 22, 2015 finding of 

substantial inadequacy and SIP call for 

certain provisions in the SIP related to 

exemptions and affirmative defenses 

applicable to excess emissions during 

startup, shutdown, and malfunction 

(SSM) events. The EPA is finalizing 

approval of the SIP revisions because 

the Agency has determined that they are 

in accordance with the requirements for 

SIP provisions under the Clean Air Act 

(CAA or the Act) and correct 


lotter on DSK11XQN23PROD with RULES1