Department of Health and Human Services June 9, 2009 – Federal Register Recent Federal Regulation Documents

The Food Safety and Inspection Service (FSIS) and the Food and Drug Administration/Center for Food Safety and Applied Nutrition (FDA/ CFSAN) are holding a public meeting to present the background, approach, scope, and data needs for a recently initiated interagency risk assessment of the public health impact of foodborne Listeria monocytogenes (L. monocytogenes) in some ready-to-eat foods that are sliced, prepared, or packaged in retail facilities. The purpose of this ``Interagency Retail L. monocytogenes Risk Assessment'' is to ascertain the effect on the public health of current practices and potential interventions that reduce or prevent L. monocytogenes contamination in ready-to-eat foods. FSIS and FDA invite interested individuals, organizations, and other stakeholders to participate in the meeting and comment on this topic.

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Q8(R1) Pharmaceutical Development.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The ICH Q8(R1) guidance includes the previously published parent guidance entitled ``Q8 Pharmaceutical Development'' (Q8 parent guidance) (71 FR 29344; May 22, 2006) and a newly added annex. The annex provides further clarification of key concepts outlined in the Q8 parent guidance and describes the principles of quality by design (QbD). The annex is intended to show how concepts and tools (e.g., design space) outlined in the Q8 parent guidance could be put into practice by the applicant for all dosage forms.