[Federal Register Volume 71, Number 228 (Tuesday, November 28, 2006)]
[Rules and Regulations]
[Page 68738]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-20126]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Neomycin

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 Sparhawk Laboratories, Inc. The ANADA 
provides for use of neomycin sulfate oral solution in livestock for the 
treatment and control of bacterial enteritis.

DATES: This rule is effective November 28, 2006.

FOR FURTHER INFORMATION CONTACT:  John K. Harshman, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Sparhawk Laboratories, Inc., 12340 Santa Fe 
Trail Dr., Lenexa, KS 66215, filed ANADA 200-379 for the use of 
Neomycin Liquid in cattle, swine, sheep, and goats for the treatment 
and control of bacterial enteritis. Sparhawk Laboratories, Inc.'s 
Neomycin Liquid is approved as a generic copy of Pharmacia &Upjohn 
Co.'s BIOSOL Liquid, sponsored by Pharmacia & Upjohn Co., a Division of 
Pfizer, Inc., under ANADA 200-113. The ANADA is approved as of October 
24, 2006, and the regulations in 21 CFR 520.1484 are amended 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 
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.
    FDA 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.

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.  520.1484  [Amended]

0
2. In paragraph (b)(3) of Sec.  520.1484, add ``058005,'' in numerical 
sequence.

    Dated: November 16, 2006.
Bernadette Dunham,
Deputy Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. E6-20126 Filed 11-27-06; 8:45 am]
BILLING CODE 4160-01-S