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HHS/FDA RIN: 0910-AC19 Publication ID: Spring 2003 
Title: Use of Materials Derived From Bovine and Ovine Animals in FDA-Regulated Products 
Abstract: The U.S. Department of Agriculture's Animal and Plant Health Inspection Service maintains, by regulation in 9 CFR 94.18(a), a list of countries: 1) where bovine spongiform encephalopathy (BSE) exists; and 2) that present an undue risk of introducing BSE into the United States. This proposed rule would restrict, in FDA-regulated products, the use of most materials derived from bovine and ovine animals born, raised, or slaughtered in a country listed in 9 CFR 94.18(a). In addition, there would be a waiver provision that could be used under appropriate criteria. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
CFR Citation: Not Yet Determined     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: Not Yet Determined   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  03/00/2004    
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Undetermined 
Federalism: Undetermined 
Included in the Regulatory Plan: No 
Agency Contact:
Rebecca Buckner
Consumer Safety Officer
Department of Health and Human Services
Food and Drug Administration
HFS-306, Center for Food Safety and Applied Nutrition (HFS-316), 5100 Paint Branch Parkway,
College Park, MD 20740
Phone:301 436-1486
Fax:301 436-2632
Email: rebecca.buckner@fda.hhs.gov