2011-21721. New Animal Drugs; Ampicillin Trihydrate, Bacitracin Methylene Disalicylate, Flunixin, Gonadotropin Releasing Factor Analog-Diphtheria Toxoid Conjugate, Methylprednisolone, and Sulfamethazine

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; correcting amendments.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect revised human food safety warnings on dosage form new animal drug product labeling that have not been codified. The regulations are also being amended to correct the wording of certain other conditions of use, to correct minor errors, and to revise some sections to reflect a current format. These actions are being taken to comply with the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and to improve the accuracy and readability of the regulations.

DATES:

This rule is effective August 25, 2011.

FOR FURTHER INFORMATION CONTACT:

George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9019, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

FDA has found that the animal drug regulations do not reflect certain human food safety warnings that have been updated on labeling of various dosage form new animal drug products. At this time, the regulations are being amended to reflect approved labeling. The regulations are also being amended to correct the wording of certain other conditions of use and to correct minor errors. As the opportunity has presented itself, some sections have been revised to a current format. These actions are being taken to comply with the FD&C Act and to improve the accuracy and readability of the regulations.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Parts 520 and 522

• Animal drugs

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR parts 520 and 522 are amended as follows:

PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

1. The authority citation for 21 CFR part 520 continues to read as follows:

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

2. In § 520.154a, revise the section heading and paragraphs (d)(1)(i), (d)(2)(i), (d)(2)(ii), (d)(2)(ii)(A), and (d)(4)(i) to read as follows:

§ 520.154a

Bacitracin methylene disalicylate.

* * * * *

(d) * * *

(1) * * *

(i) Amount. 400 milligrams (mg) per gallon (gal) in drinking water.

* * * * *

(2) * * *

(i) Amount. 100 mg per gal in drinking water.

* * * * *

(ii) Amount. 200 to 400 mg per gal in drinking water. Administer continuously 5 to 7 days or as long as clinical signs persist, then reduce to prevention levels (100 mg/gal).

(A) Indications for use. Treatment of necrotic enteritis caused by C. perfringens susceptible to bacitracin methylene disalicylate.

* * * * *

(4) * * *

(i) Amount. 400 mg per gal in drinking water.

* * * * *

3. Revise § 520.970 to read as follows:

§ 520.970

Flunixin.

(a) Specifications. (1) Each 10-gram (g) packet of granules contains flunixin meglumine equivalent to 250 milligrams (mg) of flunixin.

(2) Each 30-g syringe of paste contains flunixin meglumine equivalent to 1,500 mg of flunixin.

(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.

(c) Conditions of use in horses—(1) Amount. 0.5 mg of flunixin per pound of body weight per day.

(2) Indications for use. For alleviation of inflammation and pain associated with musculoskeletal disorders.

(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 520.970a

[Removed]

4. Remove § 520.970a.

§ 520.970b

[Removed]

5. Remove § 520.970b.

PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

6. The authority citation for 21 CFR part 522 continues to read as follows:

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

7. In § 522.90b, revise paragraph (d)(2)(iii) to read as follows:

§ 522.90b

Ampicillin trihydrate.

* * * * *

(d) * * *

(2) * * *

(iii) Limitations. Do not treat cattle for more than 7 days. Milk from treated cows must not be used for food during treatment and for 48 hours (4 milkings) after the last treatment. Cattle must not be slaughtered for food during treatment and for 144 hours (6 days) after the last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

8. In § 522.1083, revise the section heading and paragraph (a) to read as follows:

§ 522.1083

Gonadotropin releasing factor analog-diphtheria toxoid conjugate.

(a) Specifications. Each milliliter of solution contains 0.2 milligrams (mg) gonadotropin releasing factor analog-diphtheria toxoid conjugate.

* * * * *

9. In § 522.1410, revise the section heading, remove and reserve paragraph (c), and revise paragraphs (a) and (d) to read as follows:

§ 522.1410

Methylprednisolone.

(a) Specifications. Each milliliter of suspension contains 20 or 40 milligrams (mg) of methylprednisolone acetate.

(b) * * *

(c) [Reserved]

(d) Conditions of use—(1) Dogs—(i) Amount. Administer 2 to 40 mg (up to 120 mg in extremely large breeds or dogs with severe involvement) by intramuscular injection or up to 20 mg by intrasynovial injection.

(ii) Indications for use. For treatment of inflammation and related disorders; treatment of allergic and dermatologic disorders; and as supportive therapy to antibacterial treatment of severe infections.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Cats—(i) Amount. Administer 10 to 20 mg by intramuscular injection.

(ii) Indications for use. For treatment of inflammation and related disorders; treatment of allergic and dermatologic disorders; and as supportive therapy to antibacterial treatment of severe infections.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(3) Horses—(i) Amount. Administer 200 mg by intramuscular injection or 40 to 240 mg by intrasynovial injection.

(ii) Indications for use. For treatment of inflammation and related disorders.

(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

10. In § 522.2260, revise paragraphs (a), (d)(1), and (d)(3) to read as follows:

§ 522.2260

Sulfamethazine.

(a) Specifications. Each milliliter (mL) of solution contains 250 milligrams (mg) sulfamethazine sodium.

* * * * *

(d) * * *

(1) Amount. Initially administer 20 mL for each 50 pounds (lb) of body weight (100 mg/lb) by intravenous injection, followed by 20 mL per 100 lb of body weight (50 mg/lb) by intravenous injection, daily thereafter. Treatment should not exceed a total of 5 consecutive days.

* * * * *

(3) Limitations. Withdraw medication from cattle 10 days prior to slaughter. Do not use in female dairy cattle 20 months of age or older. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Dated: August 18, 2011.

Bernadette Dunham,

Director, Center for Veterinary Medicine.