Page:United States Statutes at Large Volume 110 Part 2.djvu/461

 PUBLIC L^W 104-134—APR. 26, 1996 110 STAT. 1321-314 the disposition of the imported article, including portions that have been destroyed, and the manner in which such person complied with the requirements of this paragraph; and "(C) any imported component, part, or accessory of a drug or device and any food additive, color additive, or dietary supplement not incorporated as described in subparagraph (A) is destroyed or exported by the owner or consignee. "(4) The importation into the United States of blood, blood components, source plasma, or source leukocytes or of a component, accessory, or part thereof is not permitted pursuant to paragraph (3) unless the importation complies with section 351(a) of the Public Health Service Act or the Secretary permits the importation under appropriate circumstances and conditions, as determined by the Secretary. The importation of tissue or a component or part of tissue is not permitted pursuant to paragraph (3) unless the importation complies with section 361 of the Public Health Service Act."; (b) EXPORT OF CERTAIN PRODUCTS.— Section 801 (21 U.S.C. 381) is amended— (1) in subsection (e)(1), by striking the second sentence; (2) in subsection (e)(2)— (A) by striking "the Secretary" and inserting "either (i) the Secretary"; and (B) by inserting before the period at the end thereof the following: "or (ii) the device is eligible for export under section 802"; and (3) in subsection (e), by adding at the end thereof the following:; "(3) A new animal drug that requires approval under section 512 shall not be exported pursuant to paragraph (1) if such drug has been banned in the United States. "(4)(A) Any person who exports a drug, animal drug, or device may request that the Secretary— "(i) certify in writing that the exported drug, animal drug, or device meets the requirements of paragraph (1) or section 802; or "(ii) certify in writing that the drug, animal drug, or device being exported meets the applicable requirements of this Act upon a showing that the drug or device meets the applicable requirements of this Act. The Secretary shall issue such a certification within 20 days of Certification, the receipt of a request for such certification. "(B) If the Secretary issues a written export certification within the 20 days prescribed by subparagraph (A), a fee for such certification may be charged but shall not exceed $175 for each certification. Fees collected for a fiscal year pursuant to this subparagraph shall be credited to the appropriation account for salaries and expenses of the Food and Drug Administration and shall be available in accordance with appropriations Acts until expended without fiscal year limitation. Such fees shall be collected in each fiscal year in an amount equal to the amount specified in appropriations Acts for such fiscal year and shall only be collected and available for the costs of the Food and Drug Administration.". (c) LABELING OF EXPORTED DRUGS. — Section 801 (21 U.S.C. 381) is amended by adding at the end the following: "(f)(1) If a drug being exported in accordance with subsection (e) is being exported to a country that has different or additional

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