Oral Dosage Form New Animal Drugs: Sulfadimethoxine

Federal Register: November 20, 2009 (Volume 74, Number 223)

Rules and Regulations

Page 60155-60156

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr20no09-7

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration 21 CFR Part 520

Docket No. FDA-2009-N-0665

Oral Dosage Form New Animal Drugs; Sulfadimethoxine

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 original abbreviated new animal drug application (ANADA) filed by First Priority, Inc. The ANADA provides for use of Sulfadimethoxine Soluble Powder in medicated drinking water of cattle, chickens, and turkeys for the treatment of various bacterial infections.

DATES: This rule is effective November 20, 2009.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for

Veterinary Medicine (HFV-104), Food and Drug Administration, 7500

Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail: john.harshman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: First Priority, Inc., 1590 Todd Farm Dr.,

Elgin, IL 60123, filed ANADA 200-443 for use of Sulfadimethoxine

Soluble Powder in medicated drinking water of cattle, chickens, and turkeys for the treatment of various bacterial infections. First

Priority, Inc.'s Sulfadimethoxine Soluble Powder is approved as a generic copy of ALBON (sulfadimethoxine) Soluble Powder, sponsored by

Pfizer, Inc., under NADA 46-285. The ANADA is approved as of October 28, 2009, and 21 CFR 520.2220a are amended to reflect the approval.

In accordance with the freedom of information provisions of 21 CFR part

Page 60156

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 520

Animal drugs. 0

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 0 1. The authority citation for 21 CFR part 520 continues to read as follows:

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

Sec. 520.2220a [Amended] 0 2. In Sec. 520.2220a, in paragraph (a)(2), add in numerical sequence

``058829''.

Dated: November 16, 2009.

Bernadette Dunham,

Director, Center for Veterinary Medicine.

FR Doc. E9-27885 Filed 11-19-09; 8:45 am

BILLING CODE 4160-01-S