Daily Rules, Proposed Rules, and Notices of the Federal Government
Alpharma, Inc., 440 Rte. 22, Bridgewater, NJ 08807, filed ANADA 200-478 for use of ALBAC 50 (bacitracin zinc) and NICARB (nicarbazin) single-ingredient Type A medicated articles to make two-way combination drug Type C medicated feeds for broiler chickens. Alpharma, Inc.'s, ANADA 200-478 is approved as a generic copy of NADA 141-146, sponsored by Phibro Animal Health, for combination use of BACIFERM (bacitracin zinc) and NICARB. The application is approved as of January 21, 2010, and the regulations are amended in 21 CFR 558.366 to reflect the approval.
In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
The agency has determined under 21 CFR 25.33 that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
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.
Animal drugs, Animal feeds.
21 U.S.C. 360b, 371.