Department of Health and Human Services May 7, 2009 – Federal Register Recent Federal Regulation Documents

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a meeting. The meeting is open to the public. Pre-registration is required for both public attendance and comment. Individuals who wish to attend the meeting and/or participate in the public comment session should either e-mail nvpo@hhs.gov or call 202-690-5566 to register.

The Food and Drug Administration (FDA) is announcing the opening of a docket to receive and to make available to the public reports and other relevant information received by FDA related to the Sentinel Initiative. The goal of the Sentinel Initiative is to develop a system that will ultimately enable FDA to actively monitor the safety of marketed regulated products. The information that will be made available is being developed primarily, but not exclusively, as a result of a series of contracts awarded by FDA to inform the development of the system. The information will be made available in the docket under the docket number at the top of this notice, as well as on FDA's Sentinel Initiative Web page (Sentinel Web page) at https:// www.fda.gov/oc/initiatives/advance/sentinel/. FDA welcomes interested parties, including individuals, to submit to this docket their views and perspectives on the information included in the docket or on any other aspect of the Sentinel Initiative.