Document ID: FDA-2009-N-0665-0059
Agency: fda
Document Type: Notice
Title: Oral Dosage Form New Animal Drugs; Sulfadimethoxine - Final Rule
Posted Date: 2009-11-20T05:00Z

[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]                         

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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.

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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.

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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]

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