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HHS/FDA RIN: 0910-AG65 Publication ID: Fall 2011 
Title: Prior Notice of Imported Food 
Abstract: Public Law 111-353, section 304 amends section 801(m) (21 U.S.C. 381(m)) of the Federal Food, Drug, and Cosmetic Act to require an additional element of information be provided in a prior notice of imported food submitted to FDA. This change requires a person submitting a prior notice of imported food to the agency to report, among other things, "any country to which the article has been refused entry." 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 1.281 (Revision) 
Legal Authority: FDA Food Safety Modernization Act, PL 111-353, sec 304 
Legal Deadline:
Action Source Description Date
Other  Statutory  Public Law 111-353, sec 304 requires the Secretary to issue this interim final rule no later than 120 days following the date of enactment of PL 111-353.  05/04/2011 
Timetable:
Action Date FR Cite
Interim Final Rule  05/05/2011  76 FR 25542 
Interim Final Rule Effective  07/03/2011   
Interim Final Rule Comment Period End  08/03/2011   
Final Action  08/00/2012   
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.
RIN Data Printed in the FR: No 
Agency Contact:
Anthony C. Taube
Department of Health and Human Services
Food and Drug Administration
Office of Regulatory Affairs, Office of Regional Operations, 12420 Parklawn Drive, ELEM-4051,
Rockville, MD 20857
Phone:866 521-2297
Fax:703 261-8625
Email: anthony.taube@fda.hhs.gov

 
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