Civil penalties for violation of requirements for human cell and tissue products

Section 368 of the Public Health Service Act (42 U.S.C. 271) is amended by adding at the end the following: (d) (1) Any person who, on or after the date of the enactment of the Shandra Eisenga Human Cell and Tissue Product Safety Act, violates a requirement of subparts C or D of section 1271 of title 21, Code of Federal Regulations, (or successor regulations) with respect to human cell or tissue products regulated under section 361 shall be liable to the United States for a civil penalty in an amount not to exceed the sum of— (A) (i) $20,000 for each violation; and (ii) in the case of a violation that continues after the Secretary provides written notice to such person, $20,000 for each subsequent day on which the violation continues; and (B) an amount equal to the retail value of the human cell and tissue products that are the subject of the violation. (2) The total civil penalty under paragraph (1) may not exceed $10,000,000 for all such violations adjudicated in a single proceeding. (3) In this subsection, the term human cell and tissue products has the meaning given the term human cells, tissues, or cellular or tissue-based products in section 1271.3(d) of title 21, Code of Federal Regulations (or successor regulations)..