A Notice by the Food and Drug Administration on 02/02/2005

SUMMARY:

The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for Anthrax Vaccine Adsorbed (AVA) for prevention of inhalation anthrax for individuals between 18 and 65 years of age who are deemed by the Department of Defense (DoD) to be at heightened risk of exposure due to attack with anthrax. FDA is issuing this Authorization under the Federal Food, Drug, and Cosmetic Act (the act), as requested by DoD. The Authorization contains, among other things, conditions on the emergency use of AVA. The Authorization follows the determination by DoD that there is a significant potential for a military emergency involving a heightened risk to U.S. military forces of attack with anthrax. On the basis of such determination, Secretary of Health and Human Services Tommy G. Thompson (the Secretary) declared an emergency justifying the authorization of the emergency use of AVA. The Authorization, which includes an explanation of the reasons for its issuance, is reprinted in this Notice.