E9-16733. New Animal Drugs for Use in Animal Feeds; Lasalocid; Roxarsone

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; technical amendment.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Alpharma Inc. The NADA provides for use of single-ingredient Type A medicated articles containing lasalocid and roxarsone to formulate two-way combination drug Type C medicated feeds for use in growing turkeys.

DATES:

This rule is effective July 15, 2009.

FOR FURTHER INFORMATION CONTACT:

Timothy Schell, Center for Veterinary Medicine (HFV-128), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8116, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Alpharma Inc., 440 Rte. 22, Bridgewater, NJ 08807, filed NADA 141-293 that provides for use of AVATEC (lasalocid sodium) and 3-NITRO (roxarsone) single-ingredient Type A medicated articles to formulate two-way combination drug Type C medicated feeds for use in growing turkeys. The NADA is approved as of May 22, 2009, and the regulations are amended in 21 CFR 558.311 and § 558.530 (21 CFR 558.530) to reflect the approval.

In addition, FDA is amending § 558.530 to remove an incorrect human food safety warning and to revise an animal safety limitation for use of roxarsone in chicken and turkey feeds. The food safety warning restricting use of roxarsone in poultry producing eggs for human consumption was codified in error during a change from text to table format in 2005 (70 FR 41958; July 21, 2005). The animal safety warning is revised to reflect recommendations of the National Academy of Sciences-National Research Council (NAS-NRC) Drug Efficacy Study in 1970 (35 FR 14273; September 10, 1970), following their evaluation of the product. NAS-NRC's recommended warning was restated, but not codified, at the time of Drug Efficacy Study Implementation's finalization of NADA 7-891 for a roxarsone Type A medicated article in 1981 (46 FR 52330; October 27, 1981). The revised warning for medicated feed use agrees with the warning that is codified for roxarsone oral dosage forms in 21 CFR part 520.

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.

The agency has determined under 21 CFR 25.33 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 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 and redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is amended as follows:

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

1. The authority citation for 21 CFR part 558 continues to read as follows:

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

2. In § 558.311, in the table in paragraph (e)(1)(xv), alphabetically add a new entry for “Roxarsone 22.7 to 45.4” to read as follows:

§ 558.311

Lasalocid.

(e) * * *

(1) * * *

Lasalocid sodium activity in grams per ton	Combination in grams per ton	Indications for use	Limitations	Sponsor
(xv) 68 (0.0075 pct) to 113 (0.0125 pct).	*	*       *	*        *	*
*         *         *         *         *         *         *
	Roxarsone 22.7 to 45.4	Growing turkeys: For prevention of coccidiosis caused by E. meleagrimitis, E. gallopavonis, and E. adenoeides, increased rate of weight gain, improved feed efficiency, and improved pigmentation.	Feed continuously as the sole ration. Roxarsone provided by No. 046573 in § 510.600(c) in this chapter.	046573
*         *         *         *         *         *         *

§ 558.530

[Amended]

3. Amend § 558.530 as follows:

a. In the table in paragraph (d)(1)(i), in the “Limitations” column, remove the phrase “do not feed to chickens producing eggs for human consumption;” and remove the phrase “may result in leg weakness” and in its place add the phrase “may result in weakness or paralysis of the legs” and

b. In the table in paragraph (d)(2)(i), in the “Limitations” column, remove the phrase “do not feed to turkeys producing eggs for human consumption;” and remove the phrase “may result in leg weakness” and in its place add the phrase “may result in weakness or paralysis of the legs”.

Dated: July 9, 2009.

Bernadette Dunham,

Director, Center for Veterinary Medicine.