2024-24820. New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address

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. ( print page 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.
*         *         *         *         *         *         *

( print page 85426)

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.

* * * * *

( print page 85427)

(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 food-producing 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 ( print page 85428) 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 µg/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) * * * ( print page 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
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