Page:United States Statutes at Large Volume 116 Part 2.djvu/827

 PUBLIC LAW 107-250—OCT. 26, 2002 116 STAT. 1609 "(13) The Secretary shall include in the annual report required under section 903(g) the names of all accredited persons and the particular activities under this subsection for which each such person is accredited and the name of each accredited person whose accreditation has been withdrawn during the year. "(14) Notwithstanding any provision of this subsection, this subsection does not have any legal effect on any agreement described in section 803(b) between the Secretary and a foreign country.". (b) MAINTENANCE OF RECORDS. —Section 704(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(f)) is amended— (1) in paragraph (1), in the first sentence, by striking "A person accredited" and all that follows through "shall maintain records" and inserting the following: "An accredited person described in paragraph (3) shall maintain records"; (2) in paragraph (2), by striking "a person accredited under section 523" and inserting "an accredited person described in paragraph (3)"; and (3) by adding at the end the following paragraph: "(3) For purposes of paragraphs (1) and (2), an accredited person described in this paragraph is a person who— "(A) is accredited under subsection (g); or "(B) is accredited under section 523.". (c) CrviL MONEY PENALTY.—Section 303(g)(1)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333(g)(1)(A)) is amended by adding at the end the following: "For purposes of the preceding sentence, a person accredited under paragraph (2) of section 704(g) who is substantially not in compliance with the standards of accreditation under such section, or who poses a threat to public health or fails to act in a manner that is consistent with the purposes of such section, shall be considered to have violated a requirement of this Act that relates to devices.". (d) PROHIBITED ACTS. —Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the following: "(gg) The Imowing failure of a person accredited under paragraph (2) of section 704(g) to comply with paragraph (7)(E) of such section; the knowing inclusion by such a person of false information in an inspection report under paragraph (7)(A) of such section; or the knowing failure of such a person to include material facts in such a report.". (e) CONFORMING AMENDMENT.— Section 510(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(h)) is amended by inserting after "duly designated by the Secretary" the following: ", or by persons accredited to conduct inspections under section 704(g),". SEC. 202. THIRD PARTY REVIEW OF PREMARKET NOTIFICATION. Section 523 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360m) is amended— (1) in subsection (c), by striking "The authority" and all that follows and inserting the following: "The authority provided by this section terminates October 1, 2007."; and (2) by adding at the end the following subsection: "(d) REPORT. —Not later than January 10, 2007, the Secretary Deadline, shall conduct a study based on the experience under the program under this section and submit to the Committee on Energy and

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