Page:United States Statutes at Large Volume 120.djvu/3505

 120 STAT. 3474

PUBLIC LAW 109–462—DEC. 22, 2006

‘‘(1) MAINTENANCE.—The responsible person shall maintain records related to each report of an adverse event received by the responsible person for a period of 6 years. ‘‘(2) RECORDS INSPECTION.— ‘‘(A) IN GENERAL.—The responsible person shall permit an authorized person to have access to records required to be maintained under this section during an inspection pursuant to section 704. ‘‘(B) AUTHORIZED PERSON.—For purposes of this paragraph, the term ‘authorized person’ means an officer or employee of the Department of Health and Human Services, who has— ‘‘(i) appropriate credentials, as determined by the Secretary; and ‘‘(ii) been duly designated by the Secretary to have access to the records required under this section. ‘‘(f) PROTECTED INFORMATION.—A serious adverse event report submitted to the Secretary under this section, including any new medical information submitted under subsection (c)(2), or an adverse event report voluntarily submitted to the Secretary shall be considered to be— ‘‘(1) a safety report under section 756 and may be accompanied by a statement, which shall be a part of any report that is released for public disclosure, that denies that the report or the records constitute an admission that the product involved caused or contributed to the adverse event; and ‘‘(2) a record about an individual under section 552a of title 5, United States Code (commonly referred to as the ‘Privacy Act of 1974’) and a medical or similar file the disclosure of which would constitute a violation of section 552 of such title 5 (commonly referred to as the ‘Freedom of Information Act’), and shall not be publicly disclosed unless all personally identifiable information is redacted. ‘‘(g) RULE OF CONSTRUCTION.—The submission of any adverse event report in compliance with this section shall not be construed as an admission that the dietary supplement involved caused or contributed to the adverse event. ‘‘(h) PREEMPTION.— ‘‘(1) IN GENERAL.—No State or local government shall establish or continue in effect any law, regulation, order, or other requirement, related to a mandatory system for adverse event reports for dietary supplements, that is different from, in addition to, or otherwise not identical to, this section. ‘‘(2) EFFECT OF SECTION.— ‘‘(A) IN GENERAL.—Nothing in this section shall affect the authority of the Secretary to provide adverse event reports and information to any health, food, or drug officer or employee of any State, territory, or political subdivision of a State or territory, under a memorandum of understanding between the Secretary and such State, territory, or political subdivision. ‘‘(B) PERSONALLY-IDENTIFIABLE INFORMATION.—Notwithstanding any other provision of law, personally-identifiable information in adverse event reports provided by the Secretary to any health, food, or drug officer or employee of any State, territory, or political subdivision of a State or territory, shall not—

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