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HHS/FDA RIN: 0910-AF54 Publication ID: Spring 2008 
Title: Use of Materials Derived From Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants 
Abstract: 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 rule. 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. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Long-Term Actions 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 211.116; 21 CFR 226.60; 21 CFR 300.200; 21 CFR 500.200; 21 CFR 530; 21 CFR 600.16; 21 CFR 895.102; 21 CFR 1271.465; 21 CFR 1271.470 
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 355; 21 USC 360b; 21 USC 360f; 21 USC 360i; 21 USC 371; 21 USC 374; 21 USC 381; 42 USC 262; 42 USC 264; 42 USC 271 
Legal Deadline:  None
Action Date FR Cite
NPRM  01/12/2007  72 FR 1582 
NPRM Comment Period End  03/13/2007   
NPRM Comment Period Reopened  03/30/2007   
Final Action  06/00/2009   
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Related RINs: Merged with 0910-AF55 
Agency Contact:
Eric Flamm
Senior Policy Advisor, Office of Policy
Department of Health and Human Services
Food and Drug Administration
Office of the Commissioner, WO1, Room 4315B, 10903 New Hampshire Ave.,
Silver Spring, MD 20993
Phone:301 796-4726
Fax:301 847-3541

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