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HHS/FDA

RIN: 0910-AF54

Publication ID: Spring 2007

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 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.
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

Timetable:

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	10/00/2008

Regulatory Flexibility Analysis Required: No	Government Levels Affected: None
Small Entities Affected: No	Federalism: No
Included in the Regulatory Plan: 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 Email: eric.flamm@fda.hhs.gov