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HHS/FDA RIN: 0910-AF55 Publication ID: Spring 2005 
Title: Requirements for Human and Animal Medical Products Manufactured From, Processed With, or Otherwise Containing Material From Cattle 
Abstract: This is a companion rulemaking to FDAs rule entitled "Use of Materials Derived From Cattle in Human and Animal Medical Products," to be published in the same issue of the Federal Register. The rule would propose recordkeeping requirements for human and animal medical products that contain cattle material. Manufacturers and sponsors of such products would have to establish and maintain records to demonstrate that prohibited materials were not used in their manufacture. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: No  Unfunded Mandates: No 
CFR Citation: 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 
Legal Authority: Not Yet Determined 
Legal Deadline:  None
Timetable:
Action Date FR Cite
Withdrawn  03/11/2005   
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: Undetermined 
Included in the Regulatory Plan: No 
Related RINs: Merged with 0910-AF54 
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

 
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