Department of Health and Human Services December 6, 2011 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is extending the comment period until January 19, 2012, for an advance notice of proposed rulemaking (ANPRM) that was published in the Federal Register of September 9, 2011 (76 FR 55835). In that document, FDA requested comments, data, research, or other information related to non-face-to- face sale and distribution of tobacco products; the advertising, promotion, and marketing of such products; and the advertising of tobacco products via the Internet, email, direct mail, telephone, smart phones, and other communication technologies that can be directed to specific recipients. The Agency is extending the comment period in response to a request to give interested parties additional time to comment.

The Food and Drug Administration's (FDA's) Center for Biologics Evaluation and Research (CBER) is announcing an invitation for participation in its Regulatory Site Visit Training Program (RSVP). This training program is intended to give CBER regulatory review, compliance, and other relevant staff an opportunity to visit biologics facilities. These visits are intended to allow CBER staff to directly observe routine manufacturing practices and to give CBER staff a better understanding of the biologics industry, including its challenges and operations. The purpose of this document is to invite biologics facilities to contact CBER for more information if they are interested in participating in this program.