New Animal Drugs; 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 three new animal drug applications (NADAs) from Sweetlix LLC to Ridley U.S. Holdings, Inc.

DATES:

This rule is effective October 28, 2004.

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: david.newkirk@fda.gov.

SUPPLEMENTARY 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:

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.

List of Subjects

21 CFR Part 510

• Administrative practice and procedure
• Animal drugs
• Labeling
• Reporting and recordkeeping requirements

21 CFR Part 520

• Animal drugs

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 510 and 520 are amended as follows:

PART 510—NEW ANIMAL DRUGS

1. The authority citation for 21 CFR parts 510 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

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:

(c) * * *

(1) * * *

(2) * * *

PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

3. The authority citation for 21 CFR part 520 continues to read as follows:

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

4. Section 520.1448a is amended in paragraph (a)(2) by removing “036904” and by adding in its place “No. 067949.”

5. Section 520.1840 is amended in paragraph (b)(3) by removing “036904” and by adding in its place “067949.”

6. Section 520.1846 is amended in paragraph (b) by removing “050112” and by adding in its place “067949.”