PUBLIC LAW 110–85—SEPT. 27, 2007
121 STAT. 853
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.’’. SEC. 223. FILING OF LISTS OF DRUGS AND DEVICES MANUFACTURED, PREPARED, PROPAGATED, AND COMPOUNDED BY REGISTRANTS; STATEMENTS; ACCOMPANYING DISCLOSURES.
Reports. Deadlines.
Section 510(j)(2) (21 U.S.C. 360(j)(2)) is amended, in the matter preceding subparagraph (A), by striking ‘‘Each person’’ and all that follows through ‘‘the following information:’’ and inserting ‘‘Each person who registers with the Secretary under this section shall report to the Secretary, with regard to drugs once during the month of June of each year and once during the month of December of each year, and with regard to devices once each year during the period beginning on October 1 and ending on December 31, the following information:’’. SEC. 224. ELECTRONIC REGISTRATION AND LISTING.
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Section 510(p) (21 U.S.C. 360(p)) is amended to read as follows: ‘‘(p) Registrations and listings under this section (including the submission of updated information) shall be submitted to the Secretary by electronic means unless the Secretary grants a request for waiver of such requirement because use of electronic means is not reasonable for the person requesting such waiver.’’.
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