06-3352. New Animal Drugs for Use in Animal Feeds; Chlortetracycline

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 supplemental new animal drug application (NADA) filed by Pennfield Oil Co. that provides for a 0-day preslaughter withdrawal time following use of chlortetracycline in cattle feed.

DATES:

This rule is effective April 7, 2006.

FOR FURTHER INFORMATION CONTACT:

Joan C. Gotthardt, Center for Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Pennfield Oil Co., 14040 Industrial Rd., Omaha, NE 68144, filed a supplement to NADA 138-935 for PENNCHLOR (chlortetracycline) Type A medicated articles used for making medicated feeds for the treatment of various bacterial diseases of livestock. The supplemental NADA provides for a 0-day withdrawal time before slaughter when Type C medicated feeds containing chlortetracycline are fed to cattle. The application is approved as of February 28, 2006, and the regulations are amended in 21 CFR 558.128 to reflect the approval. The basis of approval is discussed in the freedom of information summary.

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 these applications 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(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 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.

§ 558.128

[Amended]

2. In § 558.128, amend the table in paragraph (e)(4) in the “Limitations” column as follows:

a. In paragraph (ii), remove “To sponsor No. 046573: zero withdrawal time. To sponsor No. 053389: 1 d withdrawal time.” and add in its place “To sponsor Nos. 046573 and 048164: zero withdrawal time.”;

b. In paragraph (iv) in entry 1, remove “To sponsor No. 053389: 1 d withdrawal time. To sponsor No. 046573: zero withdrawal time.” and add in its place “To sponsor Nos. 046573 and 048164: zero withdrawal time.”; and

c. In paragraph (viii) in entries 1 and 2, remove “For sponsor 046573: zero withdrawal time. For sponsor 053389: 1 d withdrawal time.” and add in its place “To sponsor Nos. 046573 and 048164: zero withdrawal time.”.

Dated: March 30, 2006.

Steven D. Vaughn,

Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.