REGISTRATION OF FOREIGN ESTABLISHMENTS.

SEC. 417. REGISTRATION OF FOREIGN ESTABLISHMENTS. Section 510(i) (21 U.S.C. 360(i)) is amended to read as follows: “(i)(1) 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 name 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 officials 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).”.