Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for three new animal drug applications (NADAs) from Sweetlix LLC to Ridley U.S. Holdings, Inc.
This rule is effective October 28, 2004.Start Further Info
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@example.com.End Further Info End Preamble Start Supplemental Information
Sweetlix LLC, 175 South Main St., suite 150, Salt Lake City, UT 84111, has informed FDA that it has transferred ownership of, and all rights and interest in, the following three approved NADAs to Ridley U.S. Holdings, Inc., 424 North Riverfront Dr., P.O. Box 8500, Mankato, MN 56002-8500:
|Application Number||21 CFR Section||Trade Name|
|NADA 033-733||520.1840||Sweetlix Bloat Guard Block|
|Start Printed Page 62811|
|NADA 109-471||520.1448a||Cattle Block M|
|NADA 136-214||520.1846||Enproal Bloat Blox|
Accordingly, the agency is amending the regulations in 21 CFR 520.1448a, 520.1840, and 520.1846 to reflect the transfer of ownership.
Following these changes of sponsorship, Sweetlix LLC is no longer the sponsor of an approved application. In addition, Ridley U.S. Holdings, Inc., is not currently listed in the animal drug regulations as a sponsor of an approved application. Accordingly, § 510.600(c) is being amended to remove the entries for Sweetlix LLC and to add entries for Ridley U.S. Holdings, Inc.
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.Start List of Subjects
List of Subjects
- Administrative practice and procedure
- Animal drugs
- Reporting and recordkeeping requirements
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,End Amendment Part Start Part
PART 510—NEW ANIMAL DRUGSEnd Part Start Amendment Part
1. The authority citation forEnd Amendment Part Start Amendment Part
2. Section 510.600 is amended in the table in paragraph (c)(1) by removing the entry for “Sweetlix LLC” and by alphabetically adding an entry for “Ridley U.S. Holdings, Inc.” and in the table in paragraph (c)(2) by removing the entry for “036904” and by adding an entry for “067949” to read as follows:End Amendment Part
(c) * * *
(1) * * *
|Firm name and address||Drug labeler code|
|* * * * *|
|Ridley U.S. Holdings, Inc., 424 North Riverfront Dr., P.O. Box 8500, Mankato, MN 56002-8500||067949|
|* * * * *|
(2) * * *
|Drug labeler code||Firm name and address|
|* * * * *|
|067949||Ridley U.S. Holdings, Inc., 424 N. Riverfront Dr., P.O. Box 8500, Mankato, MN 56002-8500|
|* * * * *|
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGSEnd Part Start Amendment Part
3. The authority citation forEnd Amendment Part
4. Section 520.1448a is amended in paragraph (a)(2) by removing “036904” and by adding in its place “No. 067949.”End Amendment Part
5. Section 520.1840 is amended in paragraph (b)(3) by removing “036904” and by adding in its place “067949.”End Amendment Part
6. Section 520.1846 is amended in paragraph (b) by removing “050112” and by adding in its place “067949.”End Amendment Part Start Signature
Dated: October 20, 2004.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. 04-24112 Filed 10-27-04; 8:45 am]
BILLING CODE 4160-01-S