Department of Health and Human Services June 23, 2005 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Phoenix Scientific, Inc. The NADA provides for veterinary prescription use of a solution containing embutramide, chloroquine phosphate, and lidocaine by intravenous injection for euthanasia of dogs.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Schering-Plough Animal Health Corp. The supplemental NADA provides for a new container size, a 7.5-gram dropper bottle, from which gentamicin sulfate, mometasone furoate, clotrimazole otic suspension may be administered for the treatment of otitis externa in dogs. The regulations are also being amended to correct the description of a previously approved container size. This action is being taken to improve the accuracy of the regulations.

The agencies listed in this document are amending the Federal Policy for the Protection of Human Subjects, which was published in the Federal Register on June 18, 1991, to change all references to the Office for Protection from Research Risks (OPRR) to the Office for Human Research Protections (OHRP); revise the footnote found at the end of Sec. .101(i) by deleting references to research involving fetuses, pregnant women, or human in vitro fertilization and subpart B of 45 CFR part 46; and update the Control Number for the approval by the Office of Management and Budget (OMB) of the information collection requirements of this Federal Policy.