Department of Health and Human Services January 20, 2010 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled ``Heart Valves Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications.'' This draft guidance document describes FDA's recommendations about investigational device exemption and premarket approval applications for heart valves. This draft guidance document is not final, nor is it in effect at this time.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of a an exclusive license to practice the following invention as embodied in the following patent applications: E-145-2004/0,1,2,3,4, Purcell et al., ``Monoclonal Antibodies Against Orthopoxviruses'', United States Patent Application 12/142,594, filed June 19, 2008 to BioFactura, Inc., having a place of business in Rockville, Maryland. The patent rights in this invention have been assigned to the United States of America.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's name from Fort Dodge Animal Health, A Division of Wyeth Holdings Corp. to Fort Dodge Animal Health, Division of Wyeth Holdings Corp., a wholly owned subsidiary of Pfizer, Inc. In a separate action, FDA is amending the animal drug regulations to reflect a change of sponsor's name from Fort Dodge Animal Health, Division of Wyeth to Fort Dodge Animal Health, Division of Wyeth, a wholly owned subsidiary of Pfizer, Inc. In each case, the