Department of Health and Human Services November 4, 2013 – Federal Register Recent Federal Regulation Documents
Results 101 - 116 of 116
Draft Risk Profile on Pathogens and Filth in Spices; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a draft risk profile entitled ``FDA Draft Risk Profile: Pathogens and Filth in Spices'' (draft risk profile). Our main objectives were to: Describe the nature and extent of the public health risk posed by consumption of spices in the United States by identifying the most commonly occurring microbial hazards and filth in spice; describe and evaluate current mitigation and control options designed to reduce the public health risk posed by consumption of contaminated spices in the United States; identify potential additional mitigation or control options designed to reduce the public health risk posed by the consumption of contaminated spices in the United States; and identify data gaps and research needs. The draft risk profile is intended to provide information for FDA risk managers to use in regulatory decision making related to the safety of spices in the U.S. food supply. The information may also be useful to stakeholders and interested parties such as spice producers and importers, spice and food manufacturers, retail food establishments, and consumers.
Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products
The Food and Drug Administration (FDA or the Agency) is proposing to amend its regulations to implement certain drug shortages provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). The proposed rule would require all applicants of covered approved drugs or biological productsincluding certain applicants of blood or blood components for transfusion and all manufacturers of covered drugs marketed without an approved applicationto notify FDA electronically of a permanent discontinuance or an interruption in manufacturing of the product that is likely to lead to a meaningful disruption in supply (or a significant disruption in supply for blood or blood components) of the product in the United States.
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