05-12497. Public Notice

AGENCY:

Centers for Disease Control and Prevention (CDC), Health and Human Services (HHS).

ACTION:

Notice.

SUMMARY:

The Centers for Disease Control and Prevention (CDC), National Center for Infectious Disease (NCID), Division of Bacterial and Mycotic Diseases (DBMD) through its component Branches 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). DBMD provides technical support for the Nation's prevention and control efforts for human anthrax disease. Since 2001, DBMD has been collecting anthrax immune plasma from Department of Defense volunteers who received the licensed Anthrax Vaccine Adsorbed (AVA) according to the licensed schedule. DBMD has contracted with industry to produce anthrax immune globulin (AIG) from the collected anthrax immune plasma using anion-exchange chromatography. Since 2003, DBMD has been evaluating the efficacy and pharmacokinetics of AIG in small animals. Preliminary results of these studies are now available, and are being released to the public domain to facilitate development of immunotherapeutic agents for treatment of human inhalational anthrax disease. DBMD will continue to conduct AIG studies in animals, and will release data to the public as soon as the results become available.

Persons or organizations who are interested in receiving the preliminary animal AIG study results, and in receiving future updates, should contact CDC and provide a mailing address.

CDC prefers to receive requests for data electronically. These requests can be e-mailed to the attention of Michael J. Detmer at [e-mail]. Mailed responses can be sent to the following address: Michael J. Detmer, Division of Bacterial and Mycotic Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention, 1600 Clifton Rd., NE., Mail Stop C-09, Atlanta, GA 30333.

FOR FURTHER INFORMATION CONTACT:

Technical: Clare A. Dykewicz, M.D., M.P.H. Division of Bacterial and Mycotic Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention (CDC), 1600 Clifton Rd. NE., Mail Stop C 09, Atlanta, GA 30333. Telephone [phone], e-mail: [e-mail].

Dated: June 13, 2005.

James D. Seligman,

Associate Director for Program Services, Centers for Disease Control and Prevention.