Page:United States Statutes at Large Volume 114 Part 2.djvu/852

 114 STAT. 1549A-38 PUBLIC LAW 106-387 —APPENDIX and shall require that such information be kept in strict confidence and used only for purposes of testing under this Act; and "(3) may include such additional provisions as the Secretary determines to be appropriate to provide for the protection of trade secrets and commercial or financial information that is privileged or confidential. "(f) COUNTRY LIMITATION.— Regulations under subsection (a) shall provide that covered products may be imported pursuant to such subsection only from a country, union, or economic area that is listed in subparagraph (A) of section 802(b)(1) or designated by the Secretary, subject to such limitations as the Secretary determines to be appropriate to protect the public health. "(g) SUSPENSION OF IMPORTATIONS. —The Secretary shall require that importations of specific covered products or importations by specific importers pursuant to subsection (a) be immediately suspended upon discovery of a pattern of importation of such products or by such importers that is counterfeit or in violation of any requirement pursuant to this section, until an investigation is completed and the Secretary determines that the public is adequately protected from counterfeit and violative covered products being imported pursuant to subsection (a). " (h) PROHIBITED AGREEMENTS.—No manufacturer of a covered product may enter into a contract or agreement that includes a provision to prevent the sale or distribution of covered products imported pursuant to subsection (a), " (i) STUDIES; REPORTS. — "(1) STUDY BY SECRETARY. — "(A) IN GENERAL. — The Secretary shall conduct, or contract with an entity to conduct, a study on the imports permitted pursuant to subsection (a), including consideration of the information received under subsection (d). In conducting such study, the Secretary or entity shall— "(i) evaluate the compliance of importers with regulations under subsection (a), and the number of shipments pursuant to such subsection, if any, that have been determined to be counterfeit, misbranded, or adulterated, and determine how such compliance contrasts with the number of shipments of prescription drugs transported within the United States that have been determined to be counterfeit, misbranded, or adulterated; and "(ii) consult with the United States Trade Representative and the Commissioner of Patents and Trademarks to evaluate the effect of importations pursuant to subsection (a) on trade and patent rights under Federal law. "(B) REPORT. —Not later than 2 years after the effective date of final regulations under subsection (a), the Secretary shall prepare and submit to the Congress a report describing the findings of the study under subparagraph (A). " (2) STUDY BY GENERAL ACCOUNTING OFFICE. —The Comptroller General of the United States shall conduct a study to determine the effect of this section on the price of covered products sold to consumers at retail. Not later than 18 months after the effective date of final regulations under subsection

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