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HHS/FDA RIN: 0910-AB24 Publication ID: Fall 2001 
Title: FDA Export Reform and Enhancement Act of 1996; Reporting and Recordkeeping Requirements for Unapproved or Violative Products Imported for Further Processing or Incorporation and Later Export 
Abstract: The final rule would establish reporting and recordkeeping requirements to implement sections 801(d)(3) and 801(d)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) as amended by the Food and Drug Administration (FDA) Export Reform and Enhancement Act of 1996. Section 801(d)(3) of the Act provides that, under prescribed conditions, drug and device components, food and color additives, and dietary supplements may be imported if they are to be further processed or incorporated into products that are to be exported from the United States in accordance with sections 801(e) or 802 of the Act or section 351(h) of the Public Health Service (PHS) Act. Section 801(d)(4) of the Act provides that blood, blood components, source plasma, or source leukocytes, or a component, accessory, or part thereof, may not be imported under section 801(d)(3) of the Act unless the importation complies with section 351(a) of the PHS Act or FDA permits the importation under FDA-determined appropriate circumstances and conditions. Additionally, section 801(d)(4) of the Act prohibits the importation of tissue or a component or part of tissue under section 801(d)(3) of the Act unless the importation complies with section 361 of the PHS Act. 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 1.84   
Legal Authority: 15 USC 1453 to 1455    21 USC 381    21 USC 382    21 USC 393    42 USC 216    21 USC 321    21 USC 343    21 USC 352    21 USC 355    21 USC 360b    21 USC 362    21 USC 371    21 USC 374   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  11/24/1998  63 FR 64930   
NPRM Comment Period End  02/08/1999    
Final Action  05/00/2002    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
Agency Contact:
Philip L. Chao
Supervisory Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Room 15-61 (HF-23), Center for Food Safety and Applied Nutrition, 5001 Campus Drive,
College Park, MD 20740
Phone:240 400-4053
Email: philip.chao@fda.hhs.gov