04-22915. New Animal Drugs; Change of Sponsors' Addresses

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect changes of address for Alpharma Inc.; Intervet Inc.; and Vètoquinol N.-A., Inc.

DATES:

This rule is effective October 13, 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: [e-mail].

SUPPLEMENTARY INFORMATION:

Alpharma Inc., One Executive Dr., P.O. Box 1399, Fort Lee, NJ 07024, has informed FDA of a change of address to One Executive Dr., Fort Lee, NJ 07024. Intervet, Inc., P.O. Box 318, 405 State St., Millsboro, DE 19966, has informed FDA of a change of address to 29160 Intervet Lane, P.O. Box 318, Millsboro, DE 19966. Vètoquinol N.-A., Inc., 2000 chemin Georges, Lavaltrie (PQ), Canada J0K 1H0, has informed FDA of a change of address to 2000 chemin Georges, Lavaltrie (PQ), Canada J5T 3S5. Accordingly, the agency is amending the regulations in 21 CFR 510.600 to reflect these changes of sponsors' addresses.

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 congressional review requirements in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 510

• Administrative practice and procedure
• Animal drugs
• Labeling
• 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, 21 CFR part 510 is amended as follows:

PART 510—NEW ANIMAL DRUGS

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

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

§ 510.600

[Amended]

2. Section 510.600 is amended:

a. In the table in paragraph (c)(1) in the entry for “Alpharma Inc.”, by removing “P.O. Box 1399,”;

b. In the table in paragraph (c)(1) in the entry for “Intervet, Inc.”, by removing “Intervet, Inc., P.O. Box 318, 405 State St.” and by adding in its place “Intervet Inc., P.O. Box 318, 29160 Intervet Lane”;

c. In the table in paragraph (c)(1) in the entry for “Vètoquinol N.-A., Inc.”, by removing “J0K 1H0” and by adding in its place “J5T 3S5”;

d. In the table in paragraph (c)(2) in the entry for “046573”, by removing “P.O. Box 1399”;

e. In the table in paragraph (c)(2) in the entry for “057926” by removing “Intervet, Inc., P.O. Box 318, 405 State St.” and by adding in its place “Intervet Inc., P.O. Box 318, 29160 Intervet Lane”; and

f. In the table in paragraph (c)(2) in the entry for “059320”, by removing “J0K 1H0” and by adding in its place “J5T 3S5”.

Dated: September 16, 2004.

Bernadette A. Dunham,

Deputy Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.