0910-AF54 200510 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Use of Materials Derived From Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants The regulation would prohibit the use of certain cattle material in the manufacture of medical products for humans and drugs for ruminants, and would require recordkeeping for products containing or manufactured with cattle materials to enable monitoring and enforcement of the prohibitions. The rule would prohibit the same cattle material that is prohibited in the previous FDA IFR that applies to foods and cosmetics. These include certain high risk tissues (e.g., brain, skull, eyes, spinal cord, trigeminal ganglia, parts of the vertebral column, and dorsal root ganglia) from cattle 30 months and older, tonsils and the distal ileum of cattle of any age, mechanically separated beef, material from nonambulatory disabled cattle, and material from cattle not inspected and passed for human consumption. The prohibitions would apply only to materials derived from animals slaughtered after the effective dates of the rules. The prohibitions would not apply to tallow that met a specified purity standard. The rule would provide criteria for deviations from the requirements based on a showing of safety or appropriate benefit to risk ratio. Other Significant Previously Published in The Unified Agenda Long-Term Actions No No 21 CFR 116 21 CFR 226.60 21 CFR 300.200 21 CFR 500 21 CFR 600.16 21 CFR 895 21 CFR 1271.465 21 CFR 1271.470 21 USC 501 21 USC 502 21 USC 505 21 USC 512 21 USC 516 21 USC 519 21 USC 701 21 USC 704 21 USC 801 42 USC 351 42 USC 361 No NPRM To Be Determined No No None No NA Not Collected 0910-AF55 Merged with Eric Flamm 0910 Food and Drug Administration FDA 301 796-4726 301 847-3541 eric.flamm@fda.hhs.gov Office of the Commissioner, WO1, Room 4315B, 10903 New Hampshire Ave., Silver Spring MD 20993