Department of Health and Human Services February 2, 2005 – Federal Register Recent Federal Regulation Documents

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.

Title XX of the Public Health Service Act, 42 U.S.C. 300z. et seq., authorizes the Secretary of Health and Human Services to award grants for demonstration projects to provide services to pregnant and nonpregnant adolescents, adolescent parents, and their families. These grants are for public or private nonprofit organizations or agencies to find effective means of strengthening families by providing an array of services that help prevent repeat pregnancy and provide adolescent mothers, fathers and/or male partners, and their babies with services that enhance their well-being. Faith-based organizations are encouraged to apply. See heading ``Care Services'' for additional information. The Office of Adolescent Pregnancy Programs (OAPP) of the Office of Population Affairs (OPA) requests applications for care demonstration grants under the Adolescent Family Life (AFL) Demonstration Projects Program, as authorized by Title XX of the Public Health Service Act. These Title XX grants should clearly and consistently establish comprehensive and integrated approaches to the delivery of care services to pregnant adolescents, adolescent parents, their children, their extended family members, fathers of their children, and/or male partners to whom they are married or in a long-term relationship.