Daily Rules, Proposed Rules, and Notices of the Federal Government
Teva Animal Health, Inc., 3915 South 48th Street Ter., St. Joseph, MO 64503, has informed FDA that it has transferred ownership of, and all rights and interest in, ANADA 200-258 for Sulfadimethoxine Soluble Powder, ANADA 200-344 for Tiamulin Soluble Antibiotic, and ANADA 200-345 for Lincomycin-Spectinomycin Soluble Powder to Phibro Animal Health Corp., 65 Challenger Rd., 3d floor, Ridgefield Park, NJ 07660.
In addition, Phibro Animal Health Corp. has informed FDA of a change of address to GlenPointe Centre East, 3d floor, 300 Frank W. Burr Blvd., suite 21, Teaneck, NJ 07666. Eka Chemicals, Inc., 1775 West Oak Commons Ct., Marietta, GA 30062 has informed FDA of a change of address to 1850 Parkway Pl. SE., suite 1200, Marietta, GA 30067. Accordingly, the Agency is amending the regulations in 21 CFR 510.600 to reflect these changes.
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.
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 parts 510 and 520 are amended as follows:
21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
(c) * * *
(1) * * *
(2) * * *
21 U.S.C. 360b.