01-17104. Oral Dosage Form New Animal Drugs; Chlortetracycline Powder

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 an abbreviated new animal drug application (ANADA) filed by Pennfield Oil Co. The ANADA provides for oral use of chlortetracycline soluble powder in solutions administered to cattle, swine, chickens, and turkeys for the control and treatment of various bacterial diseases. Technical amendments are also being made.

DATES:

This rule is effective July 10, 2001.

FOR FURTHER INFORMATION CONTACT:

Lonnie W. Luther, Center for Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0209.

SUPPLEMENTARY INFORMATION:

Pennfield Oil Co., 14040 Industrial Rd., Omaha, NE 68137, filed ANADA 200-295 for Pennchlor^TM 64 (chlortetracycline) Soluble Powder. The application provides for oral use of chlortetracycline soluble powder administered in drinking water or in solutions dosed by mouth in cattle, swine, chickens, and turkeys for the control and treatment of various diseases caused by bacteria susceptible to chlortetracycline. Pennfield Oil Co.'s Pennchlor^TM 64 is approved as a generic copy of American Cyanamid’s Aureomycin® (chlortetracycline) Soluble Powder Concentrate, approved under NADA 65-440. The ANADA is approved as of April 27, 2001, and the regulations are amended in 21 CFR 520.445b to reflect the approval. The basis of approval is discussed in the freedom of information summary.

Section 520.445b is further amended in paragraph (d)(4)(iii)(C) by removing the Pennfield Oil Co. drug labeler code (DLC #053389) which was added in error (59 FR 39438, August 3, 1994) and by correcting the drug labeler code for ADM Animal Health & Nutrition Division (DLC #017519) which in error was not changed in this paragraph when the drug labeler code was changed elsewhere in this section (62 FR 27691, May 21, 1997). Publication of this document constitutes final action on these changes under the Administrative Procedure Act (5 U.S.C. 553). Notice and public procedure are unnecessary because FDA is merely correcting nonsubstantive errors.

In accordance with the freedom of information provisions of 21 CFR part 20 and 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 Dockets Management Branch (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 520

• 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 520 is 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.

§ 520.445b

[Amended]

2. Section 520.445b Chlortetracycline powder (chlortetracycline hydrochloride or chlortetracycline bisulfate) is amended in paragraph (b) by removing “as in paragraphs (d)(1)(i)(A) and (d)(2)(i)(A)” and adding in its place “as in paragraph (d)”; and in paragraph (d)(4)(iii)(C) by removing “, 012286, and 053389” and adding in its place “and 017519”.

Dated: June 27, 2001.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.