,i #aaeth ,,congress #ast ,session ,h4 ,r4 #bjbb ,,in ,,the ,,house ,,of ,,representatives ,april #f1 #bjag,mr4 ,gosar introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to ensure certain safety measures are utilized in the interest of public health security with respect to labeling and transporting human tissue specimen or collection of specimens into interstate commerce4 #a4 ,short title ,this ,act may be cited as the ,label and ,transport ,tissues ,safely ,act of #bjag or as the ,,latts ,act of #bjag4 #b4 ,in general 7a7 ,non-,transplant ,tissue ,bank license 7#a7 ,prohibition ,no person may introduce or deliver for introduction into interstate commerce any human tissue specimen for medical research or education unless-- 7,a7 a non-transplant tissue bank license is in effect for the entity introducing the human tissue specimen into interstate commerce2 7,b7 each package of the human tissue specimen is labeled with-- 7i7 the proper name of the human tissue specimen contained in the package2 7ii7 the name1 address1 and applicable license number of the source tissue bank of the human tissue specimen2 7iii7 a unique donor identifier1 the tissue type1 the cause of death1 serological test results1 and any known infectious disease agents2 7iv7 a statement about the mandatory use of personal protective equipment and universal precautions when handling human tissue2 and 7v7 the statement not for transplantation2 and 7,c7 each package of the human tissue specimen is wrapped and packaged in a manner that-- 7i7 mitigates potential contamination and cross contamination2 7ii7 mitigates potential safety hazards2 7iii7 is sealed to prevent leakage2 and 7iv7 ensures the integrity of the tissue4 7#b7 ,procedures established 7,a7 ,in general ,the ,secretary of ,health and ,human ,services shall establish1 by rule1 requirements for the approval1 suspension1 and revocation of non-transplant tissue bank licenses4 7,b7 ,approval ,the ,secretary shall approve a non-transplant tissue bank license application-- 7i7 on the basis of a demonstration that-- 7,i7 the human tissue specimens of the applicant are legally donated1 properly screened for communicable disease agents1 properly labeled1 transported1 and stored1 and used according to the donor's donation authorization2 7,,ii7 each facility in which the human tissue specimens of the applicant are donated1 recovered1 processed1 packed1 or held meets standards designed to ensure that the human tissue specimens do not pose a communicable disease risk to the general public2 and 7,,iii7 the applicant creates1 compiles1 and maintains a complete record on each donor from which it recovers a human body or human tissue specimen for educational or research purposes1 which record shall include1 at a minimum-- 7aa7 documentation demonstrating that the donor or the agent making the donation on the donor's behalf has knowingly consented to the anatomical donation for educational or research purposes2 7bb7 documentation showing that the donor or the agent making the donation on the donor's behalf has been informed as to whether the body or human tissue specimens shall be returned to a relative or personal representative or whether the applicant shall arrange and carry out the disposition of the human body or human tissue specimens2 7cc7 documentation of the identity and address of each entity which has been in possession of the human body or human tissue specimen before the applicant took possession1 such as a funeral home1 coroner1 hospital1 organ procurement organization1 or tissue bank2 and 7dd7 documentation on the use and disposition of each human body or human tissue specimen1 including the name and address of each person or entity that receives the human body or human tissue specimen directly from the applicant2 and 7ii7 only if the applicant 7or other appropriate person7 consents to the inspection of the facility that is the subject of the application1 in accordance with subsection 7c74 7#c7 ,requirements for exemption ,the ,secretary shall prescribe requirements under which a human tissue specimen shall be exempt from the requirements of paragraph 7#a74 7b7 ,falsely labeling or marking package or container2 altering label or mark ,no person shall falsely label or mark any package or container of any human tissue specimen or alter any label or mark on the package or container of the human tissue specimen so as to falsify the label or mark4 7c7 ,inspection of facilities 7#a7 ,in general ,any officer1 agent1 or employee of the ,department of ,health and ,human ,services1 authorized by the ,secretary for the purpose1 may during all reasonable hours enter and inspect any facility that is subject to a non-transplant tissue bank license under this section4 7#b7 ,inspection by nationally recognized accrediting bodies ,any authorized agent of a nationally recognized accrediting body authorized by the ,secretary for the purpose1 may during all reasonable hours enter and inspect any such facility4 7#c7 ,rule of construction ,nothing in this ,act limits any existing authority of the ,attorney ,general1 any ,state ,attorney ,general1 or local law enforcement to enter and inspect any such facility4 7d7 ,recall of specimen presenting imminent hazard2 violations 7#a7 ,recall ,upon a determination that a human tissue specimen or collection of specimens of a tissue bank licensed under this section presents an imminent or substantial hazard to the public health1 the ,secretary shall issue an order immediately ordering the recall of such batch1 lot1 or other quantity of such product4 ,an order under this paragraph shall be issued in accordance with section #eed of title #e1 ,united ,state ,code4 7#b7 ,violations ,any violation of a recall order under paragraph 7#a7 shall subject the violator to a civil penalty of up to #aj1jjj per day of violation4 ,the amount of a civil penalty under this paragraph shall1 effective ,december #a of each calendar year beginning #a year or more after the effective date of this paragraph1 be increased by the percent change in the ,consumer ,price ,index for the base quarter of such year over the ,consumer ,price ,index for the base quarter of the preceding year1 adjusted to the nearest #a_/aj of #a percent4 ,for purposes of this paragraph1 the term base quarter1 as used with respect to a year1 means the calendar quarter ending on ,september #cj of such year1 and the price index for a base quarter is the arithmetical mean of such index for the #c months comprising such quarter4 7e7 ,prohibitions of sales and purchases of human tissue specimen ,it shall be unlawful for any person to knowingly sell1 acquire1 receive1 or otherwise transfer any human tissue specimen for valuable consideration if the transfer affects interstate commerce4 7f7 ,penalties for offenses ,whoever violates any of the provisions of this section shall be imprisoned not more than #a year1 or fined not more than #aj1jjj1 or both4 ,section #cega of title #ah1 ,united ,states ,code1 shall not apply to an offense under this section4 7g7 ,construction with other laws ,nothing in this ,act 7other than subsection 7f77 shall be construed as in any way affecting1 modifying1 repealing1 or superseding any other provision of ,federal law4 7h7 ,definitions ,for the purposes of this section3 7#a7 ,unless the context indicates otherwise1 the term agent means the person who is expressly authorized to make an anatomical donation on the donor's behalf under ,state law4 7#b7 ,the term donor means a person whose body or whose human tissue specimen is the subject of an anatomical donation4 7#c7 ,the term human tissue specimen-- 7,a7 means legally donated anatomical segments1 cells1 or body fluids 7including a complete body7 that are recovered for medical research or education2 and 7,b7 does not include a biological product 7as defined in section #cea of the ,public ,health ,services ,act 7#db ,u4,s4,c4 #bfb774 7#d7 ,the term valuable consideration means something of value1 but does not include the reasonable payments associated with the removal1 transportation1 processing1 preservation1 quality control1 storage1 and lawful disposition of human tissue specimens4