REGISTRATION.

SEC. 222. REGISTRATION.(a) Annual Registration of Producers of Drugs and Devices.—Section 510(b) (21 U.S.C. 360(b)) is amended—(1) by striking “(b) On or before” and inserting “(b)(1) On or before”;(2) by striking “or a device or devices”; and(3) by adding at the end the following:“(2) During the period beginning on October 1 and ending on December 31 of each year, every person who owns or operates any establishment in any State engaged in the manufacture, preparation, propagation, compounding, or processing of a device or devices shall register with the Secretary his name, places of business, and all such establishments.”.(b) Registration of Foreign Establishments.—Section 510(i)(1) (21 U.S.C. 360(i)(1)) is amended by striking “On or before December 31” and all that follows and inserting the following: “Any establishment within any foreign country engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or device that is imported or offered for import into the United States shall, through electronic means in accordance with the criteria of the Secretary—“(A) upon first engaging in any such activity, immediately register with the Secretary the name and place of business of the establishment, the name of the United States agent for the establishment, the name of each importer of such drug or device in the United States that is known to the establishment, and the name of each person who imports or offers for import such drug or device to the United States for purposes of importation; and“(B) each establishment subject to the requirements of subparagraph (A) shall thereafter—“(i) with respect to drugs, register with the Secretary on or before December 31 of each year; and“(ii) with respect to devices, register with the Secretary during the period beginning on October 1 and ending on December 31 of each year.”.