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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

Timetable:

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:240 402-2784 Fax:240-402-2657 Email: linda.kahl@fda.hhs.gov