Office of the Secretary February 2, 2005 – Federal Register Recent Federal Regulation Documents

The Secretary of the Department of Health and Human Services is issuing this notice pursuant to section 564(b)(4) of the Federal Food, Drug, and Cosmetic Act to justify the emergency use of Anthrax Vaccine Adsorbed (AVA) for prevention of inhalation anthrax. The Secretary provides notice of the determination of the Department of Defense that there is a significant potential for a military emergency involving a heightened risk to United States military forces of attack with anthrax. The determination of the Department of Defense was effective as of December 10, 2004. The Secretary also provides notice that, on the basis of such determination, he has declared an emergency justifying the authorization of the emergency use of AVA.

This notice announces three consultation meetings that will be held to obtain oral and written comments concerning (1) a proposed policy on fiduciary trust records management for Self-Determination (Title I) and Self-Governance (Title IV) Tribes/Consortia; and (2) proposed language to be negotiated as part of the 2006 Title I and Title IV funding agreements regarding fiduciary trust records management. These meetings support the Department of the Interior's (Department's) administrative policy on tribal consultation by encouraging maximum direct participation of representatives of tribal governments, tribal organizations and other interested persons on important Departmental issues and processes. In developing the proposed policy and language, the Department had pre-scoping telephone conversations with tribal leaders and staff; held a scoping meeting as part of a 2-day conference on Indian trust records management; formed a Tribal Fiduciary Trust Records Management Workgroup; held four workgroup meetings; transmitted a tribal leader letter soliciting comments on the proposed policy language to be presented for consultation; and engaged in discussions with tribal leaders and staff at the Fall Self-Governance Conference. The proposed policy and language incorporates many valuable comments received to date. The upcoming consultation will provide another opportunity for Indian tribes and interested parties to comment on proposed federal policy and funding agreement language regarding fiduciary trust records management for Title I and Title IV Tribes/Consortia. Once final decisions are made regarding the policy and the funding agreement language, guidance will be provided to the Director, Bureau of Indian Affairs and the Director, Office of Self-Governance and Self- Determination regarding language to be negotiated as part of the 2006 Title I and Title IV funding agreements regarding fiduciary trust records management.