Page:United States Statutes at Large Volume 121.djvu/962

 PUBLIC LAW 110–85—SEPT. 27, 2007

121 STAT. 941

dkrause on GSDDPC44 with PUBLAW

‘‘(2) A civil penalty under paragraph (1) shall be assessed by the Secretary by an order made on the record after providing written notice to the person to be assessed a civil penalty and an opportunity for a hearing in accordance with this paragraph and section 554 of title 5, United States Code. If upon receipt of the written notice, the person to be assessed a civil penalty objects and requests a hearing, then in the course of any investigation related to such hearing, the Secretary may issue subpoenas requiring the attendance and testimony of witnesses and the production of evidence that relates to the matter under investigation, including information pertaining to the factors described in paragraph (3). ‘‘(3) The Secretary, in determining the amount of the civil penalty under paragraph (1), shall take into account the nature, circumstances, extent, and gravity of the violation or violations, including the following factors: ‘‘(A) Whether the person submitted the advertisement or a similar advertisement for review under section 736A. ‘‘(B) Whether the person submitted the advertisement for review if required under section 503B. ‘‘(C) Whether, after submission of the advertisement as described in subparagraph (A) or (B), the person disseminated or caused another party to disseminate the advertisement before the end of the 45-day comment period. ‘‘(D) Whether the person incorporated any comments made by the Secretary with regard to the advertisement into the advertisement prior to its dissemination. ‘‘(E) Whether the person ceased distribution of the advertisement upon receipt of the written notice referred to in paragraph (2) for such advertisement. ‘‘(F) Whether the person had the advertisement reviewed by qualified medical, regulatory, and legal reviewers prior to its dissemination. ‘‘(G) Whether the violations were material. ‘‘(H) Whether the person who created the advertisement or caused the advertisement to be created acted in good faith. ‘‘(I) Whether the person who created the advertisement or caused the advertisement to be created has been assessed a civil penalty under this provision within the previous 1year period. ‘‘(J) The scope and extent of any voluntary, subsequent remedial action by the person. ‘‘(K) Such other matters, as justice may require. ‘‘(4)(A) Subject to subparagraph (B), no person shall be required to pay a civil penalty under paragraph (1) if the person submitted the advertisement to the Secretary and disseminated or caused another party to disseminate such advertisement after incorporating each comment received from the Secretary. ‘‘(B) The Secretary may retract or modify any prior comments the Secretary has provided to an advertisement submitted to the Secretary based on new information or changed circumstances, so long as the Secretary provides written notice to the person of the new views of the Secretary on the advertisement and provides a reasonable time for modification or correction of the advertisement prior to seeking any civil penalty under paragraph (1). ‘‘(5) The Secretary may compromise, modify, or remit, with or without conditions, any civil penalty which may be assessed

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