Department of Health and Human Services September 28, 2006 – Federal Register Recent Federal Regulation Documents

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Federal Food, Drug, and Cosmetic Act (the act) requires the Food and Drug Administration (FDA) to review each agreement, guidance, or practice that is specific to the assignment of combination products to agency centers and to determine whether the agreement, guidance, or practice is consistent with the requirements of the act. In carrying out the review, the agency is to consult with stakeholders and directors of the agency centers, and then determine whether to continue in effect, modify, revise, or eliminate such an agreement, guidance, or practice. The agency has completed its initial review of relevant agreements, guidances, and practices, and has consulted with directors of the agency centers. This document provides the preliminary results of the agency's review and requests stakeholder comments to fulfill the act's requirement for stakeholder consultation prior to the agency's final determination whether to continue the agreements, guidance, or practices in effect, or to modify, revise, or eliminate them.

As stipulated in the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Chronic Fatigue Syndrome Advisory Committee (CFSAC) will hold a meeting. The meeting is open to the public.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by IVX Animal Health, Inc. The supplemental ANADA provides for a new container size, a 40-gram dropper bottle, from which gentamicin sulfate, betamethasone valerate, clotrimazole ointment may be administered for the treatment of acute and chronic canine otitis externa.