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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 | |
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Legal Deadline:
None |
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Timetable:
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| Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
| Federalism: No | |
| Included in the Regulatory Plan: No | |
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Agency Contact: Philip L. Chao Senior Policy Analyst Department of Health and Human Services Food and Drug Administration Room 15-61 (HF-23), Office of Policy and Planning (HF-23), Room 14C-17, 5600 Fishers Lane, Rockville, MD 20857 Phone:301 827-0587 Fax:301 827-4774 Email: philip.chao@fda.hhs.gov |
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