,,ii #aahth ,,congress #ast ,session ,s4 #baia ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,june #bb1 #bjbc,mr4 ,murphy 7for himself and ,mr4 ,tillis7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to amend the ,public ,health ,service ,act to ensure the consensual donation and respectful disposition of human bodies and human body parts donated or transferred for education1 research1 or the advancement of medical1 dental1 or mortuary science and not for use in human transplantation1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,consensual ,donation and ,research ,integrity ,act of #bjbc4 #b4 ,human bodies and human body parts donated or transferred for education1 research1 or the advancement of medical1 dental1 or mortuary science and not for use in human transplantation 7a7 ,in general ,title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bda et seq47 is amended by inserting after section #cgc the following new section3 #cgc;,a4 ,human bodies and human body parts donated or transferred for education1 research1 or the advancement of medical1 dental1 or mortuary science and not for use in human transplantation 7a7 ,registration 7#a7 ,in general ,a person who acquires human bodies and sells for profit a whole human body or human body part in or affecting interstate commerce shall register with the ,secretary at such time and in such manner as the ,secretary may require4 7#b7 ,exception ,paragraph 7#a7 does not apply to the ,organ ,procurement and ,transplantation ,network under section #cgb and any entity that is a member of the ,network pursuant to section #aba4c of title #db1 ,code of ,federal ,regulations 7or any successor regulations71 funeral service professionals in regard to the preparation1 transportation1 and final disposition of the human body or body parts1 and schools of medicine1 dentistry1 and mortuary science and research1 training organizations1 and other entities that do not sell for profit a whole body or body part4 7#c7 ,contents of application ,an applicant for registration or renewal of registration under this section shall submit an application to the ,secretary containing such information as the ,secretary may by regulation require on the activities to be carried out pursuant to the registration4 ,unless the ,secretary specifies otherwise by regulation1 an application shall include-- 7,a7 the name of the applicant1 including all trade names under which the applicant conducts business2 7,b7 the date on which the applicant first began or will begin commencing activities described in paragraph 7#a72 7,c7 a list of all addresses at which the applicant conducts business2 7,d7 a description of the premises and equipment used by the applicant2 7,e7 a description of the types of service provided by the applicant2 7,f7 an identification of a representative of the applicant who has attained the age of #ah and has the authority to ensure that the applicant complies with this section2 7,g7 an assurance that the ,secretary will be permitted to inspect the premises and records of the applicant at the times and in the manners prescribed under subsection 7b72 7,h7 an assurance that the applicant will keep records in accordance with subsection 7c72 7,i7 an assurance that the applicant will label and package all human bodies or human body parts in accordance with subsection 7d72 and 7,j7 an assurance that the applicant will limit the use and disclosure of information in accordance with the regulations promulgated pursuant to subsection 7e74 7#d7 ,fees 7,a7 ,authority ,the ,secretary shall establish a fee for registration under paragraph 7#a7 and renewal under paragraph 7#e7 in an amount in accordance with subparagraph 7,b74 7,b7 ,amount ,the ,secretary shall determine the amount of the fees authorized by subparagraph 7,a7 on an annual basis based on the projected cost of implementing and enforcing this section1 including the cost of inspections under subsection 7b74 7,c7 ,collections and appropriations acts ,the fees authorized by subparagraph 7,a7 shall be available for obligation only to the extent and in the amounts provided in advance in appropriations ,acts4 7#e7 ,registration renewal ,the ,secretary shall require that the registration of a registrant be renewed by such registrant at such intervals as the ,secretary determines appropriate4 7#f7 ,change of information ,not later than #cj days after any change of any information listed in paragraph 7#c71 an applicant or registrant shall notify the ,secretary of such change in writing as prescribed by regulation by the ,secretary4 7b7 ,inspections ,the ,secretary shall inspect at regular intervals 7to be prescribed by the ,secretary7 the premises described in subsection 7a77#c77;,d74 7c7 ,record keeping 7#a7 ,in general ,a registrant shall maintain a record for each case in which the registrant acquires a human body or human body part4 7#b7 ,record requirements ,a record under paragraph 7#a7 shall contain such information as the ,secretary may by regulation require4 ,unless the ,secretary specifies otherwise by regulation1 a record under paragraph 7#a7 shall include the following3 7,a7 ,documentation that the donor has knowingly consented to the transfer of the human body or human body part 7not for use in transplantation7 involved for education1 research1 or the advancement of medical1 dental1 or mortuary science in accordance with all applicable laws pertaining to the disposition of human remains4 7,b7 ,documentation that the donor has been informed of the obligation of the registrant under subsection 7e7 to dispose of the human body or human body part4 7,c7 ,the date and time of the donation or transfer from the donor4 7,d7 ,the name of the person1 including any trade or business name1 who transferred the human body or human body part to the registrant1 if applicable4 7,e7 ,the full name and most recent address of the donor4 7,f7 ,a description of the human body or human body part being acquired or transferred4 7,g7 ,the medical history of the donor1 including the autopsy report if an autopsy was conducted4 7,h7 ,the identity and address of each person that has been in possession of the human body or human body part prior to the registrant1 including any funeral home1 coroner1 hospital1 organ procurement organization1 or tissue bank4 7,i7 ,documentation of the use and disposition of each human body or human body part by the registrant4 7,j7 ,documentation of the name and address of each person to whom the registrant transfers such human body or human body part4 7d7 ,labeling and packaging 7#a7 ,in general ,a registrant shall ensure that all human bodies and human body parts in the possession of1 or transferred by1 a registrant are labeled and packaged in accordance with paragraphs 7#b7 and 7#c7 and that a proper chain of custody is maintained4 7#b7 ,labeling requirements 7,a7 ,placement ,the labeling required by paragraph 7#a7 shall be affixed beneath the outer packaging4 7,b7 ,contents ,the labeling required by paragraph 7#a7 shall contain such information as the ,secretary may by regulation require consistent with any applicable ,federal privacy provisions4 ,unless the ,secretary specifies otherwise by regulation1 a label under paragraph 7#a7 shall include the following3 7i7 ,the proper name of the donor4 7ii7 ,a description of the contents of the packaging1 indicating whether it is a human body or human body parts1 including a list of all such parts4 7iii7 ,the name1 address1 and any applicable license or registration number of the person transferring the human body or human body part4 7iv7 ,the tissue types of the human body or human body part4 7v7 ,the cause of death of the donor1 if applicable and known4 7vi7 ,serological test results1 if any such results exist4 7vii7 ,record of the presence of radioactive materials or implants4 7viii7 ,any known infectious disease agents of such human body or human body part4 7ix7 ,a statement about the use of personal protective equipment and universal precautions when handling a human body or human body part as required by law4 7x7 ,the statement not for transplantation4 7#c7 ,packaging requirements ,each human body or human body part described in paragraph 7#a7 shall be wrapped and packaged in such manner as the ,secretary may by regulation require4 ,unless the ,secretary specifies otherwise by regulation1 each such human body or human body part shall be wrapped and packaged in a manner that-- 7,a7 mitigates potential contamination and cross contamination2 7,b7 mitigates potential safety hazards2 7,c7 is sealed to prevent leakage2 and 7,d7 ensures the integrity of the human body or human body part4 7e7 ,limitations on use and disclosure of information ,individually identifiable information relating to the donor of a human body or human body part acquired or transferred pursuant to a registration under this section shall be used and disclosed only for such purposes 7including the return of remains for burial7 as the ,secretary may explicitly authorize by regulation4 7f7 ,disposition ,the registrant shall ensure the proper disposition of a human body or human body part1 in accordance with applicable ,federal and ,state law1 by-- 7#a7 returning the human body or human body part to a relative or personal representative of the donor or carrying out the disposition of such human body or human body part in accordance with the written instructions of the person or persons with the right to control the disposition of the human body or body parts2 or 7#b7 if the registrant is transferring the human body or human body part to another person1 contracting with such person to assume the obligation described in paragraph 7#a74 7g7 ,violations 7#a7 ,in general ,any person who violates a requirement of this section shall be fined in accordance with title #ah1 ,united ,states ,code4 7#b7 ,revocation of registration ,the ,secretary may suspend or revoke the registration of any registrant found to be in violation of this section4 7#c7 ,alteration or falsification of label ,it shall be a violation of this section for any person to alter or falsify any information in a label required by subsection 7d74 7h7 ,definitions ,in this section3 7#a7 ,donor ,the term donor means a person who has knowingly consented in accordance with applicable law to the transfer of such person's deceased body or deceased or living body part 7not for use in transplantation7 for education1 research1 or the advancement of medical1 dental1 or mortuary science4 7#b7 ,education ,the term education means the use of a human body or body parts for teaching or training individuals1 including medical1 dental1 or mortuary science students or professionals1 with regard to the anatomy and characteristics of the human body1 disease detection1 and such other uses as may be specified by the ,secretary by regulation4 7#c7 ,human body ,the term human body means a deceased human body4 7#d7 ,human body part ,the terms human body part or body part mean an organ1 tissue1 eye1 bone1 blood vessel or any other portion of a deceased or living human body that is subject to an anatomical gift or other transfer made pursuant to ,state law1 but do not include-- 7,a7 blood drawn for medical purposes2 or 7,b7 a growing cell line4 7#e7 ,research ,the term research does not include an autopsy or examination1 conducted as part of a criminal investigation4 4 7b7 ,rule of applicability ,the amendments made by this section shall apply with respect to any acquisition or transfer of a human body or human body parts after the date that is #b years after the date of the enactment of this ,act4