[Federal Register Volume 70, Number 33 (Friday, February 18, 2005)]
[Rules and Regulations]
[Pages 8289-8290]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-3178]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Sulfamethazine Sustained-
Release Boluses; Change of Sponsor

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect a change of sponsor for a new animal drug 
application (NADA) from Boehringer Ingelheim Vetmedica, Inc. to Phoenix 
Scientific, Inc.

DATES: This rule is effective February 18, 2005.

FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for 
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-6967, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Boehringer Ingelheim Vetmedica, Inc., 2621 
North Belt Hwy., St. Joseph, MO 64506-2002, has informed FDA that it 
has transferred ownership of, and all rights and interest in, NADA 140-
270 for Sulfamethazine Sustained Release Bolus to Phoenix Scientific, 
Inc., 3915 South 48th St. Terr., St. Joseph, MO 64503.
    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:


[[Page 8290]]


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


Sec.  520.2260b  [Amended]

0
2. Section 520.2260b is amended in paragraph (f)(1) by removing 
``000010'' and by adding in its place ``059130''.

    Dated: February 8, 2005.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 05-3178 Filed 2-17-05; 8:45 am]
BILLING CODE 4160-01-S