Daily Rules, Proposed Rules, and Notices of the Federal Government
The sponsors of the four approved NADAs listed in table 1 of this document have requested that FDA withdraw approval because the products are no longer manufactured or marketed:
Elsewhere in this issue of the
Following these withdrawals of approval, Endo Pharmaceuticals Inc. and United Vaccines, A Harlan Sprague Dawley, Inc., Co., will no longer be the sponsor of an approved application. Accordingly, 21 CFR 510.600(c) is being amended to remove the entries for these firms.
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 the authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR parts 510 and 522 are amended as follows:
21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
21 U.S.C. 360b.