Use of Materials Derived From Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants; Reopening of the Comment Period

摘要

The Food and Drug Administration (FDA) is reopening until May 14, 2007, the comment period for the proposed rule published in the Federal Register of January 12, 2007 (72 FR 1582). The proposed rule would prohibit the use of certain cattle material in, or in the manufacture (including processing) of, drugs, biologics, and medical devices intended for use in humans and human cells, tissues, and cellular and tissue-based products (HCT/Ps) (collectively, medical products for humans), and in drugs intended for use in ruminant animals (drugs for ruminants) and would also require new recordkeeping provisions for medical products for humans and drugs for ruminants that are manufactured from or otherwise contain material from cattle. The agency is reopening the comment period in response to a request for more time to enable industry to generate more information on products that might be affected by the rule.