Page:United States Statutes at Large Volume 120.djvu/3503

 120 STAT. 3472

21 USC 379aa note.

21 USC 352 note.

21 USC 379aa note.

PUBLIC LAW 109–462—DEC. 22, 2006

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) MODIFICATIONS.—The Secretary of Health and Human Services may modify requirements under the amendments made by this section in accordance with section 553 of title 5, United States Code, to maintain consistency with international harmonization efforts over time. (c) 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 704(a);’’ and inserting ‘‘, 704(a), or 760;’’; and (2) striking ‘‘, or 564’’ and inserting ‘‘, 564, or 760’’. (d) MISBRANDING.—Section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amended by adding at the end the following: ‘‘(x) If it is a nonprescription drug (as defined in section 760) that is marketed in the United States, unless the label of such drug includes a domestic address or domestic phone number through which the responsible person (as described in section 760) may receive a report of a serious adverse event (as defined in section 760) with such drug.’’. (e) EFFECTIVE DATES.— (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 502(x) of the Federal Food, Drug, and Cosmetic Act (as added by this section) shall apply to any nonprescription drug (as defined in such section 502(x)) 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 described under the amendments made by this Act. SEC. 3. SERIOUS ADVERSE EVENT REPORTING FOR DIETARY SUPPLEMENTS.

(a) IN GENERAL.—Chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is amended by adding at the end the following: 21 USC 379aa–1.

‘‘SEC. 761. SERIOUS ADVERSE EVENT REPORTING FOR DIETARY SUPPLEMENTS.

‘‘(a) DEFINITIONS.—In this section: ‘‘(1) ADVERSE EVENT.—The term ‘adverse event’ means any health-related event associated with the use of a dietary supplement that is adverse. ‘‘(2) SERIOUS ADVERSE EVENT.—The term ‘serious adverse event’ is an adverse event that—

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