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HHS/FDA RIN: 0910-AC15 Publication ID: Spring 2002 
Title: Premarket Notice Concerning Bioengineered Foods 
Abstract: The Food and Drug Administration (FDA) is requiring the submission to the agency of data and information regarding plant-derived bioengineered foods that would be consumed by humans or animals. FDA is requiring that this submission be made at least 120 days prior to the commercial distribution of such foods. FDA took this action to ensure that it has the appropriate amount of information about bioengineered foods to help to ensure that all market entry decisions by the industry are made consistently and in full compliance with the law. The action will permit the agency to assess on an ongoing basis whether plant-derived bioengineered foods comply with the standards of the Federal Food, Drug, and Cosmetic Act. 
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 192    21 CFR 592   
Legal Authority: 21 USC 342    21 USC 343    21 USC 348    21 USC 321    21 USC 371   
Legal Deadline:  None
Action Date FR Cite
NPRM  01/18/2001  66 FR 4706   
Final Rule  To Be Determined    
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
Agency Contact:
Linda Kahl
Senior Policy Analyst
Department of Health and Human Services
Food and Drug Administration
HFS-206, Center for Food Safety and Applied Nutrition (HFS-024), 5100 Paint Branch Parkway,
College Park, MD 20740
Phone:301 436-2784
Fax:301 436-2657

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