Page:United States Statutes at Large Volume 120.djvu/3506

 PUBLIC LAW 109–462—DEC. 22, 2006

120 STAT. 3475

‘‘(i) be made publicly available pursuant to any State or other law requiring disclosure of information or records; or ‘‘(ii) otherwise be disclosed or distributed to any party without the written consent of the Secretary and the person submitting such information to the Secretary. ‘‘(C) USE OF SAFETY REPORTS.—Nothing in this section shall permit a State, territory, or political subdivision of a State or territory, to use any safety report received from the Secretary in a manner inconsistent with subsection (g) or section 756. ‘‘(i) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section such sums as may be necessary.’’. (b) PROHIBITED ACT.—Section 301(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(e)) is amended by— (1) striking ‘‘, or 760;’’ and inserting ‘‘, 760, or 761;’’; and (2) striking ‘‘, or 760’’ and inserting ‘‘, 760, or 761’’. (c) MISBRANDING.—Section 403 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343) is amended by adding at the end the following: ‘‘(y) If it is a dietary supplement that is marketed in the United States, unless the label of such dietary supplement includes a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement.’’. (d) EFFECTIVE DATE.— (1) IN GENERAL.—Except as provided in paragraph (2), the amendments made by this section shall take effect 1 year after the date of enactment of this Act. (2) MISBRANDING.—Section 403(y) of the Federal Food, Drug, and Cosmetic Act (as added by this section) shall apply to any dietary supplement labeled on or after the date that is 1 year after the date of enactment of this Act. (3) GUIDANCE.—Not later than 270 days after the date of enactment of this Act, the Secretary of Health and Human Services shall issue guidance on the minimum data elements that should be included in a serious adverse event report as described under the amendments made by this Act.

21 USC 343 note.

21 USC 379aa note.

SEC. 4. PROHIBITION OF FALSIFICATION OF REPORTS.

(a) IN GENERAL.—Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the following: ‘‘(ii) The falsification of a report of a serious adverse event submitted to a responsible person (as defined under section 760 or 761) or the falsification of a serious adverse event report (as defined under section 760 or 761) submitted to the Secretary.’’. (b) EFFECTIVE DATE.—The amendment made by this section shall take effect 1 year after the date of enactment of this Act.

21 USC 331 note.

SEC. 5. IMPORTATION OF CERTAIN NONPRESCRIPTION DRUGS AND DIETARY SUPPLEMENTS.

(a) IN GENERAL.—Section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381) is amended— (1) in subsection (a), by inserting after the third sentence the following: ‘‘If such article is subject to a requirement under

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