Page:United States Statutes at Large Volume 111 Part 3.djvu/291

 PUBLIC LAW 105-115—NOV. 21, 1997 111 STAT. 2379 that identifies such classification or such component, and the reasons for such determination. The Secretary may not modify such statement except with the written consent of the person, or for public health reasons based on scientific evidence. "(c) INACTION OF SECRETARY.— If the Secretary does not provide the statement within the 60-day period described in subsection (b), the recommendation made by the person under subsection (a) shall be considered to be a final determination by the Secretary of such classification of the product, or the component of the Food and Drug Administration that will regulate the product, as applicable, and may not be modified by the Secretary except with the written consent of the person, or for public health reasons based on scientific evidence.". SEC. 417. REGISTRATION OF FOREIGN ESTABLISHMENTS. Section 510(i) (21 U.S.C. 360(i)) is amended to read as follows: "(i)(l) Any establishment within any foreign country engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or a device that is imported or offered for import into the United States shall register with the Secretary the name and place of business of the establishment and the nsune of the United States agent for the establishment. "(2) The establishment shall also provide the information required by subsection (j). "(3) The Secretary is authorized to enter into cooperative arrangements with officisils of foreign countries to ensure that adequate and effective means are available for purposes of determining, from time to time, whether drugs or devices manufactured, prepared, propagated, compounded, or processed by an establishment described in paragraph (1), if imported or offered for import into the United States, shall be refused admission on any of the grounds set forth in section 801(a).". SEC. 418. CLARIFICATION OF SEIZURE AUTHORITY. Section 304(d)(1) (21 U.S.C. 334(d)(1)) is amended— (1) in the fifth sentence, by striking "paragraphs (1) and (2) of section 801(e)" and inserting "subparagraphs (A) and (B) of section 801(e)(1)"; and (2) by inserting after the fifth sentence the following: "Any person seeking to export an imported article pursuant to any of the provisions of this subsection shall establish that the article was intended for export at the time the article entered commerce.". SEC. 419. INTERSTATE COMMERCE. Section 709 (21 U.S.C. 379a) is amended by striking "a device" and inserting "a device, food, drug, or cosmetic". SEC. 420. SAFETY REPORT DISCLAIMERS. Chapter VII (21 U.S.C. 371 et seq.), as amended by section 412, is further amended by adding at the end the following: "SUBCHAPTER G—SAFETY REPORTS "SEC. 756. SAFETY REPORT DISCLAIMERS. 21 USC 379V. "With respect to any entity that submits or is required to submit a safety report or other information in connection with the safety of a product (including a product that is a food, drug.

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