Page:United States Statutes at Large Volume 116 Part 1.djvu/701

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PUBLIC LAW 107-188—JUNE 12, 2002 116 STAT. 675 and investigations. The memorandum of understanding shall contain provisions regarding reimbursement. Such provisions may, at the sole discretion of the head of the other department or agency, require reimbursement, in whole or in part, from the Secretary for the examinations or investigations performed under this section by the officers or employees of the other department or agency. "(B) A memorandum of understanding under subparagraph (A) between the Secretary and another Federal department or agency is effective only in the case of examinations or inspections at facilities or other locations that are jointly regulated by the Secretary and such department or agency. "(C) For any fiscal year in which the Secretary and the head Reports, of another Federal department or agency carries out one or more examinations or inspections under a memorandum of understanding under subparagraph (A), the Secretary and the head of such department or agency shall with respect to their respective departments or agencies submit to the committees of jurisdiction (authorizing and appropriating) in the House of Representatives and the Senate a report that provides, for such year— "(i) the number of officers or employees that carried out one or more programs, projects, or activities under such memorandum; "(ii) the number of additional articles that were inspected or examined as a result of such memorandum; and "(iii) the number of additional examinations or investigations that were carried out pursuant to such memorandum.". SEC. 315. RULE OF CONSTRUCTION. 21 USC 331 note. Nothing in this title, or an amendment made by this title, shall be construed to alter the jurisdiction between the Secretaries of Agriculture and of Health and Human Services, under applicable statutes and regulations. Subtitle B—Protection of Drug Supply SEC. 321. ANNUAL REGISTRATION OF FOREIGN MANUFACTURERS; SHIPPING INFORMATION; DRUG AND DEVICE LISTING. (a) ANNUAL REGISTRATION; LISTING. —Section 510 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360) is amended— (1) in subsection (i)(l)— (A) by striking "Any establishment" and inserting "On or before December 31 of each year, any establishment"; and (B) by striking "shall register" and all that follows and inserting the following: "shall, through electronic means in accordance with the criteria of the Secretary, 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 (2) in subsection (j)(l), in the first sentence, by striking "or (d)" and inserting "(d), or (i)".