E8-8346. Implantation or Injectable Dosage Form New Animal Drugs; Florfenicol

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Schering-Plough Animal Health Corp. The NADA provides for use of florfenicol injectable solution for the treatment of bovine respiratory disease.

DATES:

This rule is effective April 18, 2008.

FOR FURTHER INFORMATION CONTACT:

Cindy L. Burnsteel, Center for Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8341, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Schering-Plough Animal Health Corp., 556 Morris Ave., Summit, NJ 07901, filed NADA 141-265 for veterinary prescription use of NUFLOR GOLD (florfenicol) Injectable Solution by subcutaneous injection in beef and non-lactating dairy cattle for the treatment of bovine respiratory disease. The NADA is approved as of March 21, 2008, and the regulations are amended in 21 CFR 522.955 to reflect the approval.

In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 3 years of marketing exclusivity beginning on the date of approval.

The agency has determined under 21 CFR 25.33(a)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

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 Part 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 part 522 is amended as follows:

PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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

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

2. Revise § 522.955 to read as follows:

§ 522.955

Florfenicol.

(a) Specifications. Each milliliter (mL) of solution contains:

(1) 300 milligrams (mg) florfenicol in the inactive vehicles 2-pyrrolidone and triacetin.

(2) 300 mg florfenicol in the inactive vehicle n-methyl-2-pyrrolidone.

(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter for use of product described in paragraph (a)(1) as in paragraph (d)(1)(i) and for use of product described in paragraph (a)(2) as in paragraph (d)(1)(ii).

(c) Related tolerance. See § 556.283 of this chapter.

(d) Conditions of use—(1) Cattle—(i) 300 mg/mL florfenicol in 2-pyrrolidone and triacetin (inactive vehicles).

(A) Amount. 40 mg/kilogram (kg) body weight as a single subcutaneous injection.

(B) Indications for use. For treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in beef and non-lactating dairy cattle.

(C) Limitations. Do not slaughter within 44 days of last treatment. Do not use in female dairy cattle 20 months of age or older. Use may cause milk residues. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(ii) 300 mg/mL florfenicol in n-methyl-2-pyrrolidone (inactive vehicle).

(A)(1) Amount. 20 mg/kg of body weight as an intramuscular injection. A second dose should be administered 48 hours later. Alternatively, 40 mg/kg of body weight as a single subcutaneous injection may be used.

(2) Indications for use. For treatment of BRD associated with Mannheimia (Pasteurella) haemolytica, P. multocida, and Haemophilus somnus. For treatment of bovine interdigital phlegmon (foot rot, acute interdigital necrobacillosis, infectious pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus.

(B)(1) Amount. 40 mg/kg of body weight as a single subcutaneous injection.

(2) Indications for use. For control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia (Pasteurella) haemolytica, P. multocida, and Haemophilus somnus.

(C) Limitations. Do not slaughter within 28 days of last intramuscular treatment or within 38 days of subcutaneous treatment. Do not use in female dairy cattle 20 months of age or older. Use may cause milk residues. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) [Reserved]

Dated: April 4, 2008.

Bernadette Dunham,

Director, Center for Veterinary Medicine.