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

The Centers for Disease Control and Prevention (CDC), Coordinating Center for Infectious Disease (CCID), through its component Centers and Divisions has lead technical responsibility for a number of Category A, B and C bioterrorism agents and their associated toxins (Bacillus anthracis, Clostridium botulinum, Brucella sps., Burkholderia sps., Staphylococcus entertoxin B, other food- or waterborne bacterial pathogens, and other bacterial agents). CCID uses epidemiologic, laboratory, clinical, and biostatistical sciences to control and prevent bacterial and mycotic infectious disease. The Centers also conduct applied research in a variety of settings, and translate the findings of this research into public health practice. The purpose of this announcement is to make interested parties aware that CCID is currently engaged in a research activity to establish and evaluate an intravenous infusion rabbit model for delivery of therapeutic molecules for the treatment of inhalation anthrax. The activity is in the early stage of feasibility assessment. The protocols for these studies may be made available to interested parties upon request. The short term objective of making these protocols available is to promote standardization of the approach to in vivo model development for anthrax therapy evaluation to meet the Nation's bioterrorism defense needs. The longer term objective is to develop these or subsequent protocols into standardized in vivo models that may meet the Food and Drug Administration (FDA) acceptance criteria for product development and licensure. Interested organizations may request an electronic copy of the protocols by contacting CDC at the address below. To ensure a response, requests must be submitted within thirty days of publication of this notice. Responses are preferred in electronic format and can be e-mailed to the attention of Dr. Conrad Quinn at CQUINN@CDC.GOV. Mailed responses can be sent to the following address: Dr. Conrad Quinn, Division of Bacterial Diseases, Coordinating Center for Infectious Diseases, Centers for Disease Control and Prevention, 1600 Clifton Rd., NE., Mail Stop C-09, Atlanta, GA 30333.

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.