[Federal Register Volume 68, Number 28 (Tuesday, February 11, 2003)]
[Rules and Regulations]
[Page 6820]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-3351]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs for Use in Animal Feeds; Salinomycin

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 a supplemental abbreviated new 
animal drug application (ANADA) filed by Intervet, Inc. The 
supplemental ANADA provides for use of a salinomycin Type A medicated 
article to make Type C medicated feeds used for the prevention of 
coccidiosis in roaster and replacement (breeder and layer) chickens and 
for the prevention of coccidiosis in quail.

DATES: This rule is effective February 11, 2003.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Intervet, Inc., P.O. Box 318, 405 State St., 
Millsboro, DE 19966, filed a supplement to ANADA 200-075 that provides 
for use of SACOX (salinomycin) Type A medicated article to make Type C 
medicated feeds used for the prevention of coccidiosis in roaster and 
replacement (breeder and layer) chickens and for the prevention of 
coccidiosis in quail. The supplemental ANADA is approved as of November 
8, 2002, and the regulations are amended in 21 CFR 558.550 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 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.
    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 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.


Sec.  558.550  [Amended]

    2. Section 558.550 Salinomycin is amended in paragraph (a)(2) by 
adding ``(d)(2)(i),'' numerically.

    Dated: January 21, 2003.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center of Veterinary 
Medicine.
[FR Doc. 03-3351 Filed 2-10-03; 8:45 am]
BILLING CODE 4160-01-S