06-8261. New Animal Drugs for Use in Animal Feeds; Lasalocid

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 a supplemental new animal drug application (NADA) filed by Purina Mills, Inc. The supplemental NADA provides for the use of a lasalocid Type A medicated article containing 20 percent lasalocid activity per pound to make free-choice Type C medicated feed mineral blocks used for increased rate of weight gain in pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers).

DATES:

This rule is effective September 26, 2006.

FOR FURTHER INFORMATION CONTACT:

Eric S. Dubbin, Center for Veterinary Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0232, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Purina Mills, Inc., P.O. Box 66812, St. Louis, MO 63166-6812, filed a supplement to NADA 141-171 for use of BOVATEC 91 (lasalocid) Type A medicated article to make Purina Sugar Mag Block 1440 BVT Medicated Mineral Block, a free-choice Type C medicated feed used for increased rate of weight gain in pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers). The supplement provides for the use of a lasalocid Type A medicated article containing 20 percent lasalocid activity per pound. The supplemental NADA is approved as of August 18, 2006, and the regulations are amended in § 558.311 (21 CFR 558.311) to reflect the approval. The basis of approval is discussed in the freedom of information summary.

In addition, FDA is amending § 558.311 to remove redundant text in an entry for combination use of single-ingredient lasalocid and chlortetracycline in cattle feed which was published in error in the Federal Register of April 27, 2006 (71 FR 24816). This correction is being made to improve the accuracy of the regulations.

Approval of this supplemental NADA did not require review of additional safety or effectiveness data or information. Therefore, a freedom of information summary is not required.

The agency has determined under 21 CFR 25.33(a)(6) 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.

§ 558.311

[Amended]

2. In § 558.311, in paragraph (b)(8), after the number “15” add the words “and 20”; and in paragraph (e)(1)(xxvii) in the “Indications for use” column, remove “control of control of” and in its place add “control of”.

Dated: September 15, 2006.

Steven D. Vaughn,

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