Department of Health and Human Services October 14, 2010 – Federal Register Recent Federal Regulation Documents

Statement of Organizations, Functions, and Delegations of Authority The Administration for Children and Families has reorganized the Administration on Developmental Disabilities. This reorganization includes the organization and its substructure components as listed in this document. This reorganization eliminates the Office of Operations and Discretionary Grants, renames the Office of Programs to the Office of Program Support, and establishes a new office, Office of Innovation. The notice also serves to re-establish the Deputy Commissioner position.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Investigational New Drug Applications (INDs)Determining Whether Human Research Studies Can Be Conducted Without an IND.'' This draft guidance is intended to assist clinical investigators, sponsors, and sponsor-investigators in determining whether planned human research studies must be conducted under an investigational new drug application (IND). The guidance describes the basic criteria for when an IND is required, describes specific situations in which an IND is not required, and discusses a range of issues that, in FDA's experience, have been the source of confusion or misperceptions about the application of the IND requirements.

The Administration on Aging (AoA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.