This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by

the Superintendent of Documents.

Rules and Regulations Federal Register

85423 

Vol. 89, No. 208 

Monday, October 28, 2024 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 73 

[Docket No. FAA–2023–1957; Airspace 

Docket No. 23–AAL–28] 

RIN 2120–AA66 

Amendment of Jet Route J–133 and 

Establishment of Area Navigation 

Route Q–801 in the Vicinity of 

Anchorage, AK 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final rule; correction. 

SUMMARY: This action corrects a final 

rule correction published in the Federal 

Register of September 19, 2024, that 

amends Jet Route J–133 and establishes 

Area Navigation Route (RNAV) Q–801 

in the vicinity of Anchorage, AK. This 

action corrects a typographical error in 

the regulatory text for J–133. 

DATES: Effective date: 0901 UTC October 

31, 2024. 

ADDRESSES: FAA Order JO 7400.11J, 

Airspace Designations and Reporting 

Points, and subsequent amendments can 

be viewed online at www.faa.gov/air_

traffic/publications/. You may also 

contact the Rules and Regulations 

Group, Office of Policy, Federal 

Aviation Administration, 600 

Independence Avenue SW, Washington, 

DC 20597; telephone: (202) 267–8783. 

FOR FURTHER INFORMATION CONTACT: 

Steven Roff, Rules and Regulations 

Group, Office of Policy, Federal 

Aviation Administration, 600 

Independence Avenue SW, Washington, 

DC 20597; telephone (202) 267–8783. 

SUPPLEMENTARY INFORMATION: 

History 

The FAA published a final rule for 

Docket No. FAA–2023–1957 in the 

Federal Register (89 FR 70474; August 

30, 2024) that amended Jet Route J–133 

and established RNAV Q–801 in the 

vicinity of Anchorage, AK. Subsequent 

to publication, the FAA published a 

final rule correction for Docket No. 

FAA–2023–1957 in the Federal Register 

(89 FR 76713; September 19, 2024) that 

corrected a typographical error in the 

rule section of the final rule preamble, 

but inadvertently retained a 

typographical error in the regulatory 

text for J–133. The final rule and final 

rule correction listed the J–133 route 

points in a North to South order in 

error. The route points should be listed 

in a South to North order. This action 

corrects that error. 

Correction to Final Rule 

Accordingly, pursuant to the 

authority delegated to me, Amendment 

of Jet Route J–133 and Establishment of 

Area Navigation Route Q–801 in the 

Vicinity of Anchorage, AK, published in 

the Federal Register of September 19, 

2024 (89 FR 76713), FR Doc. 2024– 

21260, is corrected as follows: 

On page 76714, in the middle of 

column 1, the description for Jet Route 

J–133 is revised to read as follows: 

J–133 [Amended] 

From Anchorage, AK; to Galena, AK. 

* * * * * 

Issued in Washington, DC, on October 22, 

2024. 

Frank Lias, 

Manager, Rules and Regulations Group. 

[FR Doc. 2024–24934 Filed 10–25–24; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 510, 516, 520, 522, 524, 

529, 556, and 558 

[Docket No. FDA–2024–N–0002] 

New Animal Drugs; 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), 

abbreviated new animal drug 

applications (ANADAs), and 

conditionally approved new animal 

drug applications (CNADAs) during 

April, May, and June 2024. The animal 

drug regulations are also being amended 

to improve their accuracy and 

readability. 

DATES: This rule is effective October 28, 

2024. 

FOR FURTHER INFORMATION CONTACT: 

George K. Haibel, Center for Veterinary 

Medicine, 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, ANADAs, and CNADAs 

during April, May, and June 2024, 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. 


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85424 Federal Register / Vol. 89, No. 208 / Monday, October 28, 2024 / Rules and Regulations 

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

2024 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 

April 5, 2024 .......... 141–043 Zoetis Inc, 333 Portage St., Kalamazoo, MI 49007 (054771).SYNOVEX CHOICE (trenbolone acetate and estradiol benzoate) and 

SYNOVEX PRIMER (trenbolone 

acetate and estradiol benzoate).

Supplemental approval for increased 

rate of weight gain in growing beef 

steers and heifers in a dry lot.

522.2478 

April 9, 2024 .......... 141–550 Elanco US Inc., 2500 Innovation 

Way, Greenfield, IN 46140 

(058198).

PRADALEX (pradofloxacin injection) Original approval for treatment of bovine respiratory disease and swine 

respiratory disease.

522.1860 

556.530 

April 10, 2024 ........ 200–777 Felix Pharmaceuticals PVT Ltd., 25– 

28 North Wall Quay, Dublin 1, Ireland (086101).

Carprofen Injectable Solution ............ Original approval as a generic copy 

of NADA 141–199.

522.304 

April 25, 2024 ........ 200–728 Cronus Pharma Specialties India Private Ltd., Plot No. 9(B), Survey 

No. 99/1, GMR Hyderabad Aviation 

SEZ Ltd., Mamidipalle Village, 

Balapur Mandal, Shamshabad, 

Rangareddy, Hyderabad, 

Telangana, 500108, India (069043).

PIMOMEDIN (pimobendan) Tablets .. Original approval as a generic copy 

of NADA 141–033.

520.1780 

April 26, 2024 ........ 141–582 Warburton Technology Ltd., 36 

Fitzwilliam Square, Dublin, Dublin, 

D02HX82, Ireland (066679).

MULTIMIN 90 (zinc, copper, manganese, and selenium injection).Original approval as a supplemental 

source of zinc, copper, manganese, and selenium in cattle.

522.2694 

May 8, 2024 .......... 200–780 Aurora Pharmaceutical, Inc., 1196 

Highway 3 South, Northfield, MN 

55057–3009 (051072).

COCCIAID (amprolium) for Calves .... Original approval as a generic copy 

of NADA 013–149.

520.100 

May 9, 2024 .......... 200–782 Cronus Pharma Specialties India Private Ltd., Plot No. 9(B), Survey 

No. 99/1, GMR Hyderabad Aviation 

SEZ Ltd., Mamidipalle Village, 

Balapur Mandal, Shamshabad, 

Rangareddy, Hyderabad, 

Telangana, 500108, India (069043).

ENROPRO Silver Otic (enrofloxacin/ 

silver sulfadiazine) Otic Emulsion.

Original approval as a generic copy 

of NADA 141–176.

524.802 

May 10, 2024 ........ 141–577 Vetoquinol USA, Inc., 4250 N Sylvania Ave., Fort Worth, TX 76137 

(017030).

UPCARD–CA1 (torsemide oral solution).Conditional approval as concurrent 

therapy with pimobendan, 

spironolactone, and an angiotensin 

converting enzyme (ACE) inhibitor 

for the management of pulmonary 

edema in dogs with congestive 

heart failure caused by 

myxomatous mitral valve disease 

(MMVD).

516.2475 

May 16, 2024 ........ 200–781 Cronus Pharma Specialties India Private Ltd., Plot No. 9(B), Survey 

No. 99/1, GMR Hyderabad Aviation 

SEZ Ltd., Mamidipalle Village, 

Balapur Mandal, Shamshabad, 

Rangareddy, Hyderabad, 

Telangana, 500108, India (069043).

FLUNINE (flunixin meglumine injection).Original approval as a generic copy 

of NADA 101–479.

522.970 

May 23, 2024 ........ 131–675 Intervet, Inc., 126 E Lincoln Ave., 

Rahway, NJ 07065 (000061).

SAFE–GUARD 20% (fenbendazole) 

Type A medicated article.

Supplemental approval for the treatment and control of cecal worms 

(Aulonocephalus spp.) in wild quail.

558.258 

June 4, 2024 ......... 138–255 Sparhawk Laboratories, Inc., 12340 

Santa Fe Trail Dr., Lenexa, KS 

66215 (058005).

Iron Dextran 20% Injection (iron hydrogenated dextran injection) 

Injectable Solution.

Supplemental approval for the prevention or treatment of iron deficiency anemia in nursing piglets.522.1182 

June 11, 2024 ....... 200–787 ZyVet Animal Health, Inc., 73 Route 

31N, Pennington, NJ 08534 

(086117).

Phenylpropanolamine Hydrochloride 

Chewable Tablets.

Original approval for the control of 

urinary incontinence due to urethral 

sphincter hypotonus in dogs as a 

generic copy of NADA 141–324.

520.1760 

June 17, 2024 ....... 200–785 Felix Pharmaceuticals PVT Ltd., 25– 

28 North Wall Quay, Dublin 1, IRELAND.

Maropitant Citrate Tablets 

(maropitant citrate).

Original approval as a generic copy 

of NADA 141–262.

520.1315 

June 20, 2024 ....... 200–784 ZyVet Animal Health, Inc., 73 Route 

31N, Pennington, NJ 08534 

(086117).

Trimeprazine with prednisolone tablets.Original approval as a generic copy 

of NADA 012–437.

520.2604 

II. Change of Sponsor 

Elanco US Inc., 2500 Innovation Way, 

Greenfield, IN 46140 has informed FDA 

that it has transferred ownership of, and 

all rights and interest in, ANADA 200– 

582 for LONCOR 300 (florfenicol) 

Injectable Solution to Zoetis Inc, 333 

Portage St., Kalamazoo, MI 49007. As 

provided in the regulatory text of this 

document, the animal drug regulations 

are amended to reflect this action. 

III. Change of Sponsor Address 

Ivaoes Animal Health (drug labeler 

code 086064 in 21 CFR 510.600(c)) has 

informed FDA that it has changed its 

address to 2101 W Atlantic Blvd., Suite 

108, Pompano Beach, FL 33069. The 

entries in § 510.600(c) are amended to 

reflect this action. 

IV. Technical Amendments 

FDA is making the following 

amendments to improve the accuracy 

and readability of the animal drug 

regulations. 

• 21 CFR 510.600 is amended to 

revise the entries for Ivaoes Animal 

Health Inc. in the lists of sponsors of 

approved applications and to add 

entries for Warburton Technology Ltd. 


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Federal Register / Vol. 89, No. 208 / Monday, October 28, 2024 / Rules and Regulations 85425 

• 21 CFR 516.1760 is being amended 

to provide for additional strengths of 

phenobarbital tablets. 

• 21 CFR 520.2130 is amended to 

revise body weights of dogs and cats for 

treatment with spinosad chewable 

tablets. 

• 21 CFR 520.2598 is being amended 

to reflect an additional strength 

trilostane capsule. 

• 21 CFR 522.772 is amended to 

revise specific parasite indications and 

to reflect the prescription marketing 

status of doramectin and levamisole 

injectable solution for use in cattle. 

• 21 CFR 522.970 is amended to 

reflect approved food-producing animal 

species for separate sponsor products. 

• 21 CFR 522.1696b is amended to 

revise the preslaughter withdrawal 

period for cattle administered a 

penicillin G procaine aqueous 

suspension. 

• 21 CFR 529.1004 is amended to 

reflect approved conditions of use for 

formalin in finfish. 

• 21 CFR 529.1150 is amended to 

reflect approved conditions of use for 

hydrogen peroxide in freshwater-reared 

salmonids. 

• 21 CFR 556.275 is amended by 

adding a tolerance for residues of 

fenbendazole in edible tissues of quail 

established as a consequence of the 

supplemental approval of fenbendazole 

medicated quail feed. 

• 21 CFR 556.530 is added to provide 

tolerances for residues of pradofloxacin 

in edible tissues of cattle and swine. 

• 21 CFR 558.261 is being amended 

to reflect incorporation levels of 

florfenicol in medicated feed for 

freshwater-reared salmonids. 

• 21 CFR 558.450 is being amended 

to provide inclusion rates for 

oxytetracycline in medicated feed for 

finfish. 

V. 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 Part 516 

Administrative practice and 

procedure, Animal drugs, Confidential 

business information, Reporting and 

recordkeeping requirements. 

21 CFR Parts 520, 522, 524, and 529 

Animal drugs. 

21 CFR Part 556 

Animal drugs, Dairy products, Foods, 

Meat and meat products. 

21 CFR Part 558 

Animal drugs, Animal feeds. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR parts 510, 

516, 520, 522, 524, 529, 556, and 558 are 

amended as follows: 

PART 510—NEW ANIMAL DRUGS 

■ 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(c): 

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

revise the entry for ‘‘Ivaoes Animal 

Health’’ and add in alphabetical order 

an entry for ‘‘Warburton Technology 

Ltd.’’; and 

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

an entry in numerical order for 

‘‘066679’’ and revise the entry for 

‘‘086064’’. 

The revisions and additions 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 

*******

Ivaoes Animal Health, 2101 W Atlantic Blvd., Suite 108, Pompano Beach, FL 33069 ...................................................................... 086064 

* * * * * * * 

Warburton Technology Ltd., 36 Fitzwilliam Square, Dublin 2, Dublin, D02HX82, Ireland .................................................................. 066679 

* * * * * * * 

(2) * * * 

Drug labeler 

code Firm name and address 

*******

066679 ............ Warburton Technology Ltd., 36 Fitzwilliam Square, Dublin 2, Dublin, D02HX82, Ireland. 

*******

086064 ............ Ivaoes Animal Health, 2101 W Atlantic Blvd., Suite 108, Pompano Beach, FL 33069. 

*******


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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. In § 516.1760, revise paragraph (a) 

to read as follows: 

§ 516.1760 Phenobarbital. 

(a) Specifications. Each tablet 

contains 15, 16.2, 30, 32.4, 60, 64.8, 97.2 

or 100 milligrams (mg) phenobarbital. 

* * * * * 

■ 5. Add § 516.2475 to subpart E to read 

as follows: 

§ 516.2475 Torsemide. 

(a) Specifications. Each milliliter of 

solution contains 0.2 milligrams (mg) 

torsemide. 

(b) Sponsor. See No. 017030 in 

§ 510.600(c) of this chapter. 

(c) Conditions of use in dogs—(1) 

Amount. Administer orally once daily at 

a dose of 0.05 to 0.2 mg/lb (0.11 to 0.44 

mg/kg) of bodyweight. 

(2) Indications for use. For use as 

concurrent therapy with pimobendan, 

spironolactone, and an angiotensin 

converting enzyme (ACE) inhibitor for 

the management of pulmonary edema in 

dogs with congestive heart failure 

caused by myxomatous mitral valve 

disease (MMVD). 

(3) Limitations. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian. It is a violation 

of Federal law to use this product other 

than as directed in the labeling. 

PART 520—ORAL DOSAGE FORM 

NEW ANIMAL DRUGS 

■ 6. The authority citation for part 520 

continues to read as follows: 

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

■ 7. In § 520.100, revise paragraph 

(b)(2), and remove paragraph (b)(3) to 

read as follows: 

§ 520.100 Amprolium. 

* * * * * 

(b) * * * 

(2) Nos. 051072 and 066104 for use of 

product described in paragraph (a)(1) of 

this section as in paragraph (d) of this 

section. 

* * * * * 

■ 8. In § 520.1315, revise paragraph (b) 

to read as follows: 

§ 520.1315 Maropitant. 

* * * * * 

(b) Sponsors. See Nos. 054771, 

086101, and 086117 in § 510.600(c) of 

this chapter. 

* * * * * 

■ 9. In § 520.1760, revise paragraph (b) 

to read as follows: 

§ 520.1760 Phenylpropanolamine. 

* * * * * 

(b) Sponsors. See sponsors in 

§ 510.600(c) of this chapter for use as in 

paragraph (c) of this section: 

(1) Nos. 055246 and 086117 for use of 

product described in paragraph (a)(1) of 

this section as in paragraphs (c)(1)(i) 

and (c)(2) and (3) of this section. 

(2) No. 055246 for use of product 

described in paragraph (a)(2) of this 

section as in paragraph (c)(1)(ii) and 

(c)(2) and)(3) of this section. 

* * * * * 

■ 10. In § 520.1780, revise paragraph (b) 

to read as follows: 

§ 520.1780 Pimobendan tablets. 

* * * * * 

(b) Sponsors. See Nos. 000010 and 

069043 in § 510.600(c) of this chapter. 

* * * * * 

§ 520.2130 [Amended] 

■ 11. In § 520.2130: 

■ a. In paragraph (d)(1)(ii), remove the 

text ‘‘3.3 pounds’’ and in its place add 

the text ‘‘5.0 pounds’’; and 

■ b. In paragraph (d)(2)(ii), remove the 

text ‘‘2 pounds’’ and in its place add the 

text ‘‘4.1 pounds’’. 

■ 12. In § 520.2598, revise paragraph (a) 

to read as follows: 

§ 520.2598 Trilostane. 

(a) Specifications. Each capsule 

contains 5, 10, 20, 30, 60, or 120 

milligrams (mg) trilostane. 

* * * * * 

■ 13. In § 520.2604, revise paragraph (b) 

to read as follows: 

§ 520.2604 Trimeprazine and prednisolone 

tablets. 

* * * * * 

(b) Sponsors. See Nos. 054771 and 

086117 in § 510.600(c) of this chapter. 

* * * * * 

PART 522—IMPLANTATION OR 

INJECTABLE DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 14. The authority citation for part 522 

continues to read as follows: 

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

■ 15. In § 522.304, revise paragraph (b) 

to read as follows: 

§ 522.304 Carprofen. 

* * * * * 

(b) Sponsors. See Nos. 016729, 

017033, 054771, 055529, 069043, and 

086101 in § 510.600(c) of this chapter. 

* * * * * 

■ 16. In § 522.772: 

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

■ b. In paragraph (d)(1)(iii), add a 

sentence to the end of the paragraph. 

The revision and addition read as 

follows: 

§ 522.772 Doramectin and levamisole. 

* * * * * 

(d) * * * 

(1) * * * 

(ii) Indications for use. For treatment 

and control of gastrointestinal 

roundworms (adults and fourth stage 

larvae): Ostertagia ostertagi (including 

inhibited larvae), O. lyrata, 

Haemonchus placei, Trichostrongylus 

axei, T. colubriformis, T. longispicularis 

(adults only), Oncophora, Cooperia 

pectinata (adults only), C. punctata, C. 

surnabada, Bunostomum phlebotomum 

(adults only), Strongyloides papillosus 

(adults only), Oesophagostomum 

radiatum, Trichuris spp. (adults only) 

and Nematodirus helvetianus (adults 

only); lungworms (adults and fourth 

stage larvae): Dictyocaulus viviparus; 

eyeworms (adults): Thelazia spp.; grubs 

(parasitic stages): Hypoderma bovis and 

H. lineatum; sucking lice: 

Haematopinus eurysternus, Linognathus 

vituli, and Solenopotes capillatus; 

mange mites: Psoroptes bovis and 

Sarcoptes scabiei in beef cattle 2 months 

of age and older and replacement dairy 

heifers less than 20 months of age. Not 

for use in beef bulls intended for 

breeding over 1 year of age, dairy calves, 

and veal calves. 

(iii) * * * Federal law restricts this 

drug to use by or on the order of a 

licensed veterinarian. 

* * * * * 

§ 522.955 [Amended] 

■ 17. In § 522.955: 

■ a. In paragraph (b)(3), remove the text 

‘‘Nos. 058005, 058198, and 069043’’ and 

in its place add the text ‘‘Nos. 054771, 

058005, and 069043’’; and 

■ b. In paragraph (d)(1)(ii)(C), in the 

second sentence, remove the text ‘‘Nos. 

000061, 058005, 058198, and 069043’’ 

and in its place add the text ‘‘Nos. 

000061, 054771, 058005, and 069043’’. 

■ 18. In § 522.970, revise paragraphs 

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

§ 522.970 Flunixin. 

* * * * * 

(b) * * * 

(1) See Nos. 000061, 055529, and 

061133 for use as in paragraph (e) of this 

section. 

* * * * * 


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(3) See Nos. 016592, 058198, and 

069043 for use as in paragraphs (e)(1) 

and (2) of this section. 

* * * * * 

■ 19. In § 522.1182, revise introductory 

text of paragraph (b)(7) to read as 

follows: 

§ 522.1182 Iron injection. 

* * * * * 

(b) * * * 

(7) Nos. 016592, 042552, and 058005 

for use product described in paragraph 

(a)(2) of this section as follows: 

* * * * * 

■ 20. In § 522.1696b, revise paragraph 

(d)(2)(iii)(B) to read as follows: 

§ 522.1696b Penicillin G procaine aqueous 

suspension. 

* * * * * 

(d) * * * 

(2) * * * 

(iii) * * * 

(B) For Nos. 016592 and 055529: 

treatment should not exceed 4 

consecutive days. A withdrawal period 

has not been established for this product 

in pre-ruminating calves. Discontinue 

treatment for the following number of 

days before slaughter: cattle—14; 

sheep—9; and swine—7. 

* * * * * 

■ 21. Add § 522.1860 to read as follows: 

§ 522.1860 Pradofloxacin. 

(a) Specifications. Each milliliter (mL) 

of solution contains 200 milligrams (mg) 

pradofloxacin. 

(b) Sponsor. See No. 058198 in 

§ 510.600(c) of this chapter. 

(c) Related tolerances. See § 556.530 

of this chapter. 

(d) Conditions of use—(1) Cattle—(i) 

Amount. Administer a single dose of 10 

mg/kg (2.3 mL/100 lb) body weight by 

subcutaneous injection. 

(ii) Indications for use. Cattle 

intended for slaughter (beef calves 2 

months of age and older, growing beef 

steers, growing beef heifers, and beef 

bulls intended for slaughter), and in 

cattle intended for breeding less than 1 

year of age (replacement beef and dairy 

heifers less than 1 year of age and beef 

and dairy bulls less than 1 year of age): 

for the treatment of bovine respiratory 

disease associated with Mannheimia 

haemolytica, Pasteurella multocida, 

Histophilus somni, and Mycoplasma 

bovis. 

(iii) Limitations. Cattle intended for 

human consumption must not be 

slaughtered within 4 days of treatment. 

Not for use in female dairy cattle 1 year 

of age and older, including dry dairy 

cows; use in these cattle may cause drug 

residues in milk and/or in calves born 

to these cows. Not for use in beef calves 

less than 2 months of age, dairy calves, 

and veal calves. A withdrawal period 

has not been established for this product 

in pre-ruminating calves. Federal law 

restricts this drug to use by or on the 

order of a licensed veterinarian. Federal 

law prohibits the extralabel use of this 

drug in food-producing animals. 

(2) Swine—(i) Amount. Administer a 

single dose of 7.5 mg/kg (1.7 mL/100 lb) 

body weight by intramuscular injection. 

(ii) Indications for use. Weaned swine 

intended for slaughter (nursery, 

growing, and finishing swine, boars 

intended for slaughter, barrows, gilts 

intended for slaughter, and sows 

intended for slaughter): for the 

treatment of swine respiratory disease 

associated with Bordetella 

bronchiseptica, Glaesserella 

(Haemophilus) parasuis, Pasteurella 

multocida, Streptococcus suis, and 

Mycoplasma hyopneumoniae. 

(iii) Limitations. Swine intended for 

human consumption must not be 

slaughtered within 2 days of treatment. 

Federal law restricts this drug to use by 

or on the order of a licensed 

veterinarian. Federal law prohibits the 

extralabel use of this drug in foodproducing animals. 

■ 22. In § 522.2478: 

■ a. Redesignate paragraphs (a)(1)(i) and 

(ii) as paragraphs (a)(1)(ii) and (iii); 

■ b. Add new paragraph (a)(1)(i); 

■ c. Revise paragraphs (d)(1)(i)(A), (B), 

and (D); and 

■ d. Add paragraph (d)(3). 

The revisions and additions read as 

follows: 

§ 522.2478 Trenbolone acetate and 

estradiol benzoate. 

(a) * * * 

(1) * * * 

(i) 50 milligrams (mg) trenbolone 

acetate and 7 mg estradiol benzoate (one 

implant consisting of two pellets, each 

pellet containing 25 mg trenbolone 

acetate and 3.5 mg estradiol benzoate) 

per implant dose. 

* * * * * 

(d) * * * 

(1) * * * 

(i) * * * 

(A) An implant containing 100 mg 

trenbolone acetate and 14 mg estradiol 

benzoate as described in paragraph 

(a)(1)(ii) of this section for increased rate 

of weight gain in growing beef steers fed 

in confinement for slaughter and for 

increased rate of weight gain and 

improved feed efficiency in growing 

beef heifers fed in confinement for 

slaughter. For increased rate of weight 

gain for up to 200 days in a 

reimplantation program where an 

implant as described in paragraph 

(a)(1)(ii) of this section is the first 

implant and an implant as described in 

paragraph (a)(1)(ii) or (iii) or (a)(2)(ii) of 

this section is administered 60 to 120 

days later. 

(B) An implant containing 200 mg 

trenbolone acetate and 28 mg estradiol 

benzoate as described in paragraph 

(a)(1)(iii) of this section for increased 

rate of weight gain and improved feed 

efficiency in growing beef steers fed in 

confinement for slaughter and for 

increased rate of weight gain in growing 

beef heifers fed in confinement for 

slaughter. For increased rate of weight 

gain for up to 200 days in a 

reimplantation program where an 

implant as described in paragraph 

(a)(1)(ii) of this section is the first 

implant and an implant as described in 

paragraph (a)(1)(iii) of this section is 

administered 60 to 120 days later. 

* * * * * 

(D) An extended-release implant 

containing 200 mg trenbolone acetate 

and 28 mg estradiol benzoate as 

described in paragraph (a)(2)(ii) of this 

section for increased rate of weight gain 

and improved feed efficiency for up to 

200 days. For increased rate of weight 

gain for up to 200 days in a 

reimplantation program where an 

implant as described in paragraph 

(a)(1)(ii) of this section is the first 

implant and an implant as described in 

paragraph (a)(2)(ii) of this section is 

administered 60 to 120 days later. 

* * * * * 

(3) Growing beef steers and heifers in 

a dry lot—(i) Amount and indications 

for use. (A) An implant containing 50 

mg trenbolone acetate and 7 mg 

estradiol benzoate as described in 

paragraph (a)(1)(i) of this section for 

increased rate of weight gain in growing 

beef steers and heifers in a dry lot. 

(B) An implant containing 100 mg 

trenbolone acetate and 14 mg estradiol 

benzoate as described in paragraph 

(a)(1)(ii) of this section for increased rate 

of weight gain in growing beef steers 

and heifers in a dry lot. 

(ii) Limitations. Implant pellets 

subcutaneously in ear only. Not 

approved for repeated implantation 

(reimplantation) with this or any other 

cattle ear implant in growing beef steers 

and heifers in a dry lot. Safety and 

effectiveness following reimplantation 

have not been evaluated. Do not use in 

beef calves less than 2 months of age, 

dairy calves, and veal calves because 

effectiveness and safety have not been 

established. A withdrawal period has 

not been established for this product in 

pre-ruminating calves. Do not use in 

dairy cows or in animals intended for 

subsequent breeding. Use in these cattle 


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may cause drug residues in milk and/or 

in calves born to these cows. 

■ 23. Add § 522.2694 to read as follows: 

§ 522.2694 Zinc, copper, manganese, and 

selenium. 

(a) Specifications. Each milliliter (mL) 

of solution contains 60 milligrams (mg) 

zinc as zinc oxide, 15 mg copper as 

copper carbonate, 10 mg manganese as 

manganese carbonate, and 5 mg 

selenium as sodium selenite. 

(b) Sponsor. See No. 066679 in 

§ 510.600(c) of this chapter. 

(c) Conditions of use—(1) Amount. 

Administer a single dose by 

subcutaneous injection to cattle up to 1 

year of age, 1 mL/100 lb bodyweight; to 

cattle from 1 to 2 years of age, 1 mL/150 

lb bodyweight, and to cattle over 2 years 

of age, 1 mL/200 lb bodyweight. 

(2) Indications for use. As a 

supplemental source of zinc, copper, 

manganese, and selenium in cattle. 

(3) Limitations. Cattle must not be 

slaughtered for human food 

consumption within 14 days of the last 

treatment. Federal law restricts this drug 

to use by or on the order of a licensed 

veterinarian. 

PART 524—OPHTHALMIC AND 

TOPICAL DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 24. The authority citation for part 524 

continues to read as follows: 

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

■ 25. In § 524.802, revise paragraph (b) 

to read as follows: 

§ 524.802 Enrofloxacin and silver 

sulfadiazine otic emulsion. 

* * * * * 

(b) Sponsors. See Nos. 058198 and 

069043 in § 510.600(c) of this chapter. 

* * * * * 

PART 529—CERTAIN OTHER DOSAGE 

FORM NEW ANIMAL DRUGS 

■ 26. The authority citation for part 529 

continues to read as follows: 

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

■ 27. In § 529.1004, in the table in 

paragraph (d)(2)(ii), revise footnote 1 to 

read as follows: 

§ 529.1004 Formalin. 

* * * * * 

(d) * * * 

(2) * * * 

(ii) * * * 

Aquatic species 

Administer in tanks and raceways for up to 1 hour 

(microliter/liter or part per million 

(μL/L or ppm)) 

Administer in earthen ponds single treatment 

(μL/L or ppm) 

*******

1 Use the lower concentration when ponds are heavily loaded with phytoplankton or fish to avoid oxygen depletion due to the biological oxygen 

demand by decay of dead phytoplankton. Alternatively, a higher concentration may be used if dissolved oxygen is strictly monitored. 

* * * * * 

■ 28. In § 529.1150, revise paragraph 

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

§ 529.1150 Hydrogen peroxide. 

* * * * * 

(c) * * * 

(1) * * * 

(iv) Freshwater-reared salmonids for 

the treatment and control of 

Gyrodactylus spp: 100 mg/L for 30 

minutes, or 50 mg/L for 60 minutes, in 

a continuous flow water supply or as a 

static bath once per day on alternate 

days for three treatments. 

* * * * * 

PART 556—TOLERANCES FOR 

RESIDUES OF NEW ANIMAL DRUGS 

IN FOOD 

■ 29. The authority citation for part 556 

continues to read as follows: 

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

■ 30. In § 556.275, add paragraph (b)(6) 

to read as follows: 

§ 556.275 Fenbendazole. 

* * * * * 

(b) * * * 

(6) Quail. (i) Liver (target tissue): 6 

ppm fenbendazole sulfone (marker 

residue). 

(ii) [Reserved] 

* * * * * 

■ 31. Add § 556.530 to subpart B to read 

as follows: 

§ 556.530 Pradofloxacin. 

(a) Acceptable daily intake (ADI). The 

ADI for total residue of pradofloxacin is 

2 mg/kg of body weight per day. 

(b) Tolerances. The tolerances for 

pradofloxacin (marker residue) are: 

(1) Cattle. Kidney (target tissue): 30 

ppb. 

(2) Swine. Kidney (target tissue): 1 

ppm. 

(c) Related conditions of use. See 

§ 522.1860 of this chapter. 

PART 558—NEW ANIMAL DRUGS FOR 

USE IN ANIMAL FEEDS 

■ 32. The authority citation for part 558 

continues to read as follows: 

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

360ccc–1, 371. 

■ 32. In § 558.258, add heading to 

paragraph (e)(1) and add paragraph 

(e)(5)(iv) to read as follows: 

§ 558.258 Fenbendazole. 

* * * * * 

(e) * * * 

(1) Turkeys. 

* * * * * 

(5) * * * 

Species/class Fenbendazole 

grams per ton Indications for use Limitations Sponsor 

*******

(iv) Wild quail .............. 90.7 For the treatment and control of Gastrointestinal 

worms: cecal worms (Aulonocephalus spp.).

Feed for 21 consecutive days. Prior withdrawal of 

feed is not necessary.

000061 

* * * * * 

■ 33. In § 558.261, revise paragraph 

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

§ 558.261 Florfenicol. 

* * * * * 

(e) * * * 

(2) * * * 


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Federal Register / Vol. 89, No. 208 / Monday, October 28, 2024 / Rules and Regulations 85429 

Florfenicol in grams/ton of 

feed Indications for use Limitations 

*******

(ii) 182 to 2,724 ............... 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. 

*******

* * * * * 

■ 34. In § 558.450, revise paragraphs 

(e)(5)(iv), (v), and (vi) to read as follows: 

§ 558.450 Oxytetracycline. 

* * * * * 

(5) * * * 

Oxytetracycline amount Indications for use Limitations Sponsor 

*******

(iv) 333 to 7,500 g/ton to 

provide 2.5 to 3.75 g/ 

100 lb of fish/day.

1. Freshwater-reared salmonids: for control of ulcer disease 

caused by Haemophilus piscium, furunculosis caused by 

Aeromonas salmonicida, bacterial hemorrhagic septicemia 

caused by A. hydrophila, and pseudomonas disease.

Administer in mixed ration for 10 days. Do not liberate fish or 

slaughter fish for food for 21 days following the last administration of medicated feed.

066104 

2. Catfish: for control of bacterial hemorrhagic septicemia 

caused by A. hydrophila and pseudomonas disease.

Administer in mixed ration for 10 days. Do not liberate fish or 

slaughter fish for food for 21 days following the last administration of medicated feed. Do not administer when water 

temperature is below 16.7 °C (62 °F).

066104 

(v) 500 to 7,500 g/ton to 

provide 3.75 g/100 lb of 

fish/day.

1. Freshwater-reared salmonids: for control of mortality due to 

coldwater disease associated with Flavobacterium 

psychrophilum or for control of mortality due to columnaris 

disease associated with Flavobacterium columnare.

Administer in mixed ration for 10 days. Do not liberate fish or 

slaughter fish for food for 21 days following the last administration of medicated feed.

066104 

2. Freshwater-reared salmonids weighing up to 55 grams: for 

marking of the skeletal tissue.

Feed for 10 days. Immediate release is permitted following 

last feeding of medicated feed.

066104 

3. Catfish: for control of mortality due to columnaris disease 

associated with Flavobacterium columnare.

Administer in mixed ration for 10 days. Do not liberate fish or 

slaughter fish for food for 21 days following the last administration of medicated feed. Do not administer when water 

temperature is below 16.7 °C (62 °F).

066104 

(vi) 1.25 to 25 g/kg to 

provide 11.35 g/100 lb 

of fish/day.

Pacific salmon not over 30 grams body weight: for marking of 

the skeletal tissue.

Administer medicated feed as the sole ration for 4 consecutive days. Do not liberate for at least 7 days following last 

feeding of medicated feed.

066104 

*******

* * * * * 

Dated: October 21, 2024. 

Eric Flamm, 

Acting Associate Commissioner for Policy. 

[FR Doc. 2024–24820 Filed 10–25–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF STATE 

22 CFR Part 92 

[Public Notice: 12553] 

RIN 1400–AF89 

Notarial and Related Services 

AGENCY: Bureau of Consular Affairs, 

Department of State. 

ACTION: Final rule. 

SUMMARY: The Bureau of Consular 

Affairs amends its notarial rules to 

reflect that the Director, Deputy 

Directors, and regional Division Chiefs 

of the Office of American Citizens 

Services and Crisis Management, 

Overseas Citizens Services will 

designate U.S. citizen employees of the 

Department of State abroad, who are not 

diplomatic or consular officers, to 

perform notarial services. This change 

will streamline the designation process 

allowing expedited designation to 

provide this and expedite notarial 

service where needed at U.S. embassies 

and consulates abroad. 

DATES: This rule is effective on 

November 27, 2024. 

FOR FURTHER INFORMATION CONTACT: 

Thales Dus, U.S. Department of State, 

CA/OCS/MSU, SA–17, 10th Floor, 

Washington, DC 20522–1707, 

OCSRegs@state.gov, 202–485–6020. 

SUPPLEMENTARY INFORMATION: This final 

rule modifies the Department’s 

regulations on Notarial and Related 

Services in 22 CFR part 92. 

Amendments to § 92.1 authorize the 

Director, Deputy Directors and regional 

Division Chiefs of the Office of 

American Citizens Services and Crisis 

Management, Bureau of Consular 

Affairs, to designate U.S. citizen 

employees of the U.S. Department of 

State abroad, who are not diplomatic or 

consular officers, to perform notarial 

services at U.S. diplomatic and consular 

offices abroad. This change will replace 

the authorization for the Deputy 

Assistant Secretary for Overseas 

Citizens Services as the sole Department 

official able to designate U.S. citizen 

employees of the Department abroad as 

notarizing officers. 

The Department is making this change 

to improve efficiencies in the process of 

designating Department employees as 

notarizing officers at U.S. embassies and 

consulates abroad. Demand for notarial 

services at 230 diplomatic and consular 

posts abroad varies from year to year but 

the trend line for requests for notarial 

services is ever increasing. The 

authority to designate U.S. citizen 

Department employees as notarizing 

officers has been a key resource for 

addressing increasing demand at posts 

abroad. The changes to this regulation 

authorizing an increase in the number of 

persons able to make such designations 

will place the Department on a more 


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