Daily Rules, Proposed Rules, and Notices of the Federal Government
FDA is amending the animal drug regulations to reflect original and supplemental approval actions during July 2012, as listed in table 1. In addition, FDA is informing the public of the availability, where applicable, of documentation of environmental review required under the National Environmental Policy Act (NEPA) and, for actions requiring review of safety or effectiveness data, summaries of the basis of approval (FOI Summaries) under the Freedom of Information Act (FOIA). These public documents 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. Persons with access to the Internet may obtain these documents at the Center for Veterinary Medicine FOIA Electronic Reading Room:
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, Food.
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 520, 522, and 556 are amended as follows:
21 U.S.C. 360b.
(b) * * *
(4) No. 061623 for use of product described in paragraph (a)(1) of this section as in paragraph (d)(2); and for use of product described in paragraph (a)(2) of this section as in paragraphs (d)(1) and (d)(2) of this section.
21 U.S.C. 360b.
(e) * * *
(2) * * *
21 U.S.C. 342, 360b, 371.