Daily Rules, Proposed Rules, and Notices of the Federal Government
Alpharma, Inc., 440 Rte. 22, Bridgewater, NJ 08807 filed a supplement to NADA 65-140 that provides for revised labeling for DURAMYCIN-10 (tetracycline hydrochloride), a soluble powder containing 25 grams of tetracycline hydrochloride per pound used to make medicated drinking water for calves, swine, chickens, and turkeys for the treatment and control of various bacterial diseases. The supplemental application is approved as of January 12, 2010, and the regulations are amended in 21 CFR 520.2345d to reflect the approval.
In addition, FDA has noticed that this approved concentration of tetracycline soluble powder has not been codified for this sponsor. At this time, the regulations are being amended to reflect approval of this product. This change is being made to improve the accuracy of the animal drug regulations.
Approval of this supplemental NADA did not require review of additional safety or effectiveness data or information. Therefore, a freedom of information summary is not required.
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.
21 U.S.C. 360b.
(b)* * *
(2) No. 000010: 102.4 and 324 grams per pound as in paragraph (d) of this section.
(3) No. 046573: 25, 102.4, and 324 grams per pound as in paragraph (d) of this section.