| 1 | 1 | | I |
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| 2 | 2 | | 119THCONGRESS |
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| 3 | 3 | | 1 |
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| 4 | 4 | | STSESSION H. R. 2589 |
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| 5 | 5 | | To amend the Public Health Service Act to ensure the consensual donation |
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| 6 | 6 | | and respectful disposition of human bodies and human body parts do- |
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| 7 | 7 | | nated or transferred for education, research, or the advancement of |
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| 8 | 8 | | medical, dental, or mortuary science and not for use in human transplan- |
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| 9 | 9 | | tation, and for other purposes. |
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| 10 | 10 | | IN THE HOUSE OF REPRESENTATIVES |
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| 11 | 11 | | APRIL2, 2025 |
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| 12 | 12 | | Mr. B |
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| 13 | 13 | | ILIRAKIS(for himself and Mrs. FLETCHER) introduced the following bill; |
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| 14 | 14 | | which was referred to the Committee on Energy and Commerce |
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| 15 | 15 | | A BILL |
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| 16 | 16 | | To amend the Public Health Service Act to ensure the con- |
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| 17 | 17 | | sensual donation and respectful disposition of human |
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| 18 | 18 | | bodies and human body parts donated or transferred |
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| 19 | 19 | | for education, research, or the advancement of medical, |
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| 20 | 20 | | dental, or mortuary science and not for use in human |
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| 21 | 21 | | transplantation, and for other purposes. |
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| 22 | 22 | | Be it enacted by the Senate and House of Representa-1 |
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| 23 | 23 | | tives of the United States of America in Congress assembled, 2 |
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| 24 | 24 | | SECTION 1. SHORT TITLE. 3 |
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| 25 | 25 | | This Act may be cited as the ‘‘Consensual Donation 4 |
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| 26 | 26 | | and Research Integrity Act of 2025’’. 5 |
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| 29 | 29 | | •HR 2589 IH |
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| 30 | 30 | | SEC. 2. HUMAN BODIES AND HUMAN BODY PARTS DO-1 |
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| 31 | 31 | | NATED OR TRANSFERRED FOR EDUCATION, 2 |
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| 32 | 32 | | RESEARCH, OR THE ADVANCEMENT OF MED-3 |
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| 33 | 33 | | ICAL, DENTAL, OR MORTUARY SCIENCE AND 4 |
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| 34 | 34 | | NOT FOR USE IN HUMAN TRANSPLANTATION. 5 |
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| 35 | 35 | | (a) I |
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| 36 | 36 | | NGENERAL.—Title III of the Public Health 6 |
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| 37 | 37 | | Service Act (42 U.S.C. 241 et seq.) is amended by insert-7 |
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| 38 | 38 | | ing after section 373 the following new section: 8 |
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| 39 | 39 | | ‘‘SEC. 373A. HUMAN BODIES AND HUMAN BODY PARTS DO-9 |
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| 40 | 40 | | NATED OR TRANSFERRED FOR EDUCATION, 10 |
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| 41 | 41 | | RESEARCH, OR THE ADVANCEMENT OF MED-11 |
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| 42 | 42 | | ICAL, DENTAL, OR MORTUARY SCIENCE AND 12 |
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| 43 | 43 | | NOT FOR USE IN HUMAN TRANSPLANTATION. 13 |
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| 44 | 44 | | ‘‘(a) R |
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| 45 | 45 | | EGISTRATION.— 14 |
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| 46 | 46 | | ‘‘(1) I |
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| 47 | 47 | | N GENERAL.—A person who acquires 15 |
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| 48 | 48 | | human bodies and sells for profit a whole human 16 |
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| 49 | 49 | | body or human body part in or affecting interstate 17 |
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| 50 | 50 | | commerce shall register with the Secretary at such 18 |
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| 51 | 51 | | time and in such manner as the Secretary may re-19 |
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| 52 | 52 | | quire. 20 |
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| 53 | 53 | | ‘‘(2) E |
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| 54 | 54 | | XCEPTION.—Paragraph (1) does not 21 |
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| 55 | 55 | | apply to the Organ Procurement and Transplan-22 |
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| 56 | 56 | | tation Network under section 372 and any entity 23 |
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| 57 | 57 | | that is a member of the Network pursuant to section 24 |
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| 58 | 58 | | 121.3 of title 42, Code of Federal Regulations (or 25 |
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| 59 | 59 | | any successor regulations), funeral service profes-26 |
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| 62 | 62 | | •HR 2589 IH |
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| 63 | 63 | | sionals in regard to the preparation, transportation, 1 |
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| 64 | 64 | | and final disposition of the human body or body 2 |
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| 65 | 65 | | parts, and schools of medicine, dentistry, and mor-3 |
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| 66 | 66 | | tuary science and research, training organizations, 4 |
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| 67 | 67 | | and other entities that do not sell for profit a whole 5 |
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| 68 | 68 | | body or body part. 6 |
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| 69 | 69 | | ‘‘(3) C |
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| 70 | 70 | | ONTENTS OF APPLICATION .—An appli-7 |
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| 71 | 71 | | cant for registration or renewal of registration under 8 |
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| 72 | 72 | | this section shall submit an application to the Sec-9 |
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| 73 | 73 | | retary containing such information as the Secretary 10 |
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| 74 | 74 | | may by regulation require on the activities to be car-11 |
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| 75 | 75 | | ried out pursuant to the registration. Unless the 12 |
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| 76 | 76 | | Secretary specifies otherwise by regulation, an appli-13 |
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| 77 | 77 | | cation shall include— 14 |
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| 78 | 78 | | ‘‘(A) the name of the applicant, including 15 |
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| 79 | 79 | | all trade names under which the applicant con-16 |
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| 80 | 80 | | ducts business; 17 |
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| 81 | 81 | | ‘‘(B) the date on which the applicant first 18 |
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| 82 | 82 | | began or will begin commencing activities de-19 |
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| 83 | 83 | | scribed in paragraph (1); 20 |
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| 84 | 84 | | ‘‘(C) a list of all addresses at which the 21 |
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| 85 | 85 | | applicant conducts business; 22 |
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| 86 | 86 | | ‘‘(D) a description of the premises and 23 |
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| 87 | 87 | | equipment used by the applicant; 24 |
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| 91 | 91 | | ‘‘(E) a description of the types of service 1 |
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| 92 | 92 | | provided by the applicant; 2 |
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| 93 | 93 | | ‘‘(F) an identification of a representative 3 |
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| 94 | 94 | | of the applicant who has attained the age of 18 4 |
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| 95 | 95 | | and has the authority to ensure that the appli-5 |
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| 96 | 96 | | cant complies with this section; 6 |
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| 97 | 97 | | ‘‘(G) an assurance that the Secretary will 7 |
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| 98 | 98 | | be permitted to inspect the premises and 8 |
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| 99 | 99 | | records of the applicant at the times and in the 9 |
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| 100 | 100 | | manners prescribed under subsection (b); 10 |
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| 101 | 101 | | ‘‘(H) an assurance that the applicant will 11 |
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| 102 | 102 | | keep records in accordance with subsection (c); 12 |
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| 103 | 103 | | ‘‘(I) an assurance that the applicant will 13 |
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| 104 | 104 | | label and package all human bodies or human 14 |
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| 105 | 105 | | body parts in accordance with subsection (d); 15 |
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| 106 | 106 | | and 16 |
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| 107 | 107 | | ‘‘(J) an assurance that the applicant will 17 |
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| 108 | 108 | | limit the use and disclosure of information in 18 |
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| 109 | 109 | | accordance with the regulations promulgated 19 |
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| 110 | 110 | | pursuant to subsection (e). 20 |
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| 111 | 111 | | ‘‘(4) F |
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| 112 | 112 | | EES.— 21 |
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| 113 | 113 | | ‘‘(A) A |
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| 114 | 114 | | UTHORITY.—The Secretary shall es-22 |
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| 115 | 115 | | tablish a fee for registration under paragraph 23 |
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| 116 | 116 | | (1) and renewal under paragraph (5) in an 24 |
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| 117 | 117 | | amount in accordance with subparagraph (B). 25 |
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| 121 | 121 | | ‘‘(B) AMOUNT.—The Secretary shall deter-1 |
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| 122 | 122 | | mine the amount of the fees authorized by sub-2 |
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| 123 | 123 | | paragraph (A) on an annual basis based on the 3 |
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| 124 | 124 | | projected cost of implementing and enforcing 4 |
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| 125 | 125 | | this section, including the cost of inspections 5 |
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| 126 | 126 | | under subsection (b). 6 |
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| 127 | 127 | | ‘‘(C) C |
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| 128 | 128 | | OLLECTIONS AND APPROPRIATIONS 7 |
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| 129 | 129 | | ACTS.—The fees authorized by subparagraph 8 |
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| 130 | 130 | | (A) shall be available for obligation only to the 9 |
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| 131 | 131 | | extent and in the amounts provided in advance 10 |
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| 132 | 132 | | in appropriations Acts. 11 |
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| 133 | 133 | | ‘‘(5) R |
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| 134 | 134 | | EGISTRATION RENEWAL .—The Secretary 12 |
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| 135 | 135 | | shall require that the registration of a registrant be 13 |
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| 136 | 136 | | renewed by such registrant at such intervals as the 14 |
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| 137 | 137 | | Secretary determines appropriate. 15 |
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| 138 | 138 | | ‘‘(6) C |
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| 139 | 139 | | HANGE OF INFORMATION .—Not later 16 |
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| 140 | 140 | | than 30 days after any change of any information 17 |
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| 141 | 141 | | listed in paragraph (3), an applicant or registrant 18 |
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| 142 | 142 | | shall notify the Secretary of such change in writing 19 |
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| 143 | 143 | | as prescribed by regulation by the Secretary. 20 |
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| 144 | 144 | | ‘‘(b) I |
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| 145 | 145 | | NSPECTIONS.—The Secretary shall inspect at 21 |
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| 146 | 146 | | regular intervals (to be prescribed by the Secretary) the 22 |
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| 147 | 147 | | premises described in subsection (a)(3)(D). 23 |
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| 148 | 148 | | ‘‘(c) R |
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| 149 | 149 | | ECORDKEEPING.— 24 |
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| 152 | 152 | | •HR 2589 IH |
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| 153 | 153 | | ‘‘(1) IN GENERAL.—A registrant shall maintain 1 |
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| 154 | 154 | | a record for each case in which the registrant ac-2 |
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| 155 | 155 | | quires a human body or human body part. 3 |
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| 156 | 156 | | ‘‘(2) R |
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| 157 | 157 | | ECORD REQUIREMENTS .—A record under 4 |
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| 158 | 158 | | paragraph (1) shall contain such information as the 5 |
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| 159 | 159 | | Secretary may by regulation require. Unless the Sec-6 |
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| 160 | 160 | | retary specifies otherwise by regulation, a record 7 |
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| 161 | 161 | | under paragraph (1) shall include the following: 8 |
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| 162 | 162 | | ‘‘(A) Documentation that the donor has 9 |
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| 163 | 163 | | knowingly consented to the transfer of the 10 |
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| 164 | 164 | | human body or human body part (not for use 11 |
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| 165 | 165 | | in transplantation) involved for education, re-12 |
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| 166 | 166 | | search, or the advancement of medical, dental, 13 |
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| 167 | 167 | | or mortuary science in accordance with all ap-14 |
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| 168 | 168 | | plicable laws pertaining to the disposition of 15 |
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| 169 | 169 | | human remains. 16 |
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| 170 | 170 | | ‘‘(B) Documentation that the donor has 17 |
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| 171 | 171 | | been informed of the obligation of the reg-18 |
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| 172 | 172 | | istrant under subsection (e) to dispose of the 19 |
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| 173 | 173 | | human body or human body part. 20 |
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| 174 | 174 | | ‘‘(C) The date and time of the donation or 21 |
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| 175 | 175 | | transfer from the donor. 22 |
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| 176 | 176 | | ‘‘(D) The name of the person, including 23 |
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| 177 | 177 | | any trade or business name, who transferred 24 |
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| 180 | 180 | | •HR 2589 IH |
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| 181 | 181 | | the human body or human body part to the reg-1 |
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| 182 | 182 | | istrant, if applicable. 2 |
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| 183 | 183 | | ‘‘(E) The full name and most recent ad-3 |
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| 184 | 184 | | dress of the donor. 4 |
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| 185 | 185 | | ‘‘(F) A description of the human body or 5 |
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| 186 | 186 | | human body part being acquired or transferred. 6 |
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| 187 | 187 | | ‘‘(G) The medical history of the donor, in-7 |
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| 188 | 188 | | cluding the autopsy report if an autopsy was 8 |
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| 189 | 189 | | conducted. 9 |
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| 190 | 190 | | ‘‘(H) The identity and address of each per-10 |
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| 191 | 191 | | son that has been in possession of the human 11 |
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| 192 | 192 | | body or human body part prior to the reg-12 |
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| 193 | 193 | | istrant, including any funeral home, coroner, 13 |
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| 194 | 194 | | hospital, organ procurement organization, or 14 |
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| 195 | 195 | | tissue bank. 15 |
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| 196 | 196 | | ‘‘(I) Documentation of the use and disposi-16 |
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| 197 | 197 | | tion of each human body or human body part 17 |
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| 198 | 198 | | by the registrant. 18 |
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| 199 | 199 | | ‘‘(J) Documentation of the name and ad-19 |
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| 200 | 200 | | dress of each person to whom the registrant 20 |
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| 201 | 201 | | transfers such human body or human body 21 |
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| 202 | 202 | | part. 22 |
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| 203 | 203 | | ‘‘(d) L |
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| 204 | 204 | | ABELING ANDPACKAGING.— 23 |
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| 205 | 205 | | ‘‘(1) I |
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| 206 | 206 | | N GENERAL.—A registrant shall ensure 24 |
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| 207 | 207 | | that all human bodies and human body parts in the 25 |
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| 210 | 210 | | •HR 2589 IH |
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| 211 | 211 | | possession of, or transferred by, a registrant are la-1 |
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| 212 | 212 | | beled and packaged in accordance with paragraphs 2 |
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| 213 | 213 | | (2) and (3) and that a proper chain of custody is 3 |
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| 214 | 214 | | maintained. 4 |
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| 215 | 215 | | ‘‘(2) L |
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| 216 | 216 | | ABELING REQUIREMENTS .— 5 |
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| 217 | 217 | | ‘‘(A) P |
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| 218 | 218 | | LACEMENT.—The labeling required 6 |
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| 219 | 219 | | by paragraph (1) shall be affixed beneath the 7 |
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| 220 | 220 | | outer packaging. 8 |
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| 221 | 221 | | ‘‘(B) C |
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| 222 | 222 | | ONTENTS.—The labeling required 9 |
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| 223 | 223 | | by paragraph (1) shall contain such information 10 |
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| 224 | 224 | | as the Secretary may by regulation require con-11 |
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| 225 | 225 | | sistent with any applicable Federal privacy pro-12 |
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| 226 | 226 | | visions. Unless the Secretary specifies otherwise 13 |
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| 227 | 227 | | by regulation, a label under paragraph (1) shall 14 |
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| 228 | 228 | | include the following: 15 |
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| 229 | 229 | | ‘‘(i) The proper name of the donor. 16 |
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| 230 | 230 | | ‘‘(ii) A description of the contents of 17 |
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| 231 | 231 | | the packaging, indicating whether it is a 18 |
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| 232 | 232 | | human body or human body parts, includ-19 |
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| 233 | 233 | | ing a list of all such parts. 20 |
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| 234 | 234 | | ‘‘(iii) The name, address, and any ap-21 |
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| 235 | 235 | | plicable license or registration number of 22 |
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| 236 | 236 | | the person transferring the human body or 23 |
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| 237 | 237 | | human body part. 24 |
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| 241 | 241 | | ‘‘(iv) The tissue types of the human 1 |
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| 242 | 242 | | body or human body part. 2 |
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| 243 | 243 | | ‘‘(v) The cause of death of the donor, 3 |
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| 244 | 244 | | if applicable and known. 4 |
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| 245 | 245 | | ‘‘(vi) Serological test results, if any 5 |
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| 246 | 246 | | such results exist. 6 |
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| 247 | 247 | | ‘‘(vii) Record of the presence of radio-7 |
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| 248 | 248 | | active materials or implants. 8 |
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| 249 | 249 | | ‘‘(viii) Any known infectious disease 9 |
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| 250 | 250 | | agents of such human body or human body 10 |
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| 251 | 251 | | part. 11 |
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| 252 | 252 | | ‘‘(ix) A statement about the use of 12 |
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| 253 | 253 | | personal protective equipment and uni-13 |
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| 254 | 254 | | versal precautions when handling a human 14 |
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| 255 | 255 | | body or human body part as required by 15 |
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| 256 | 256 | | law. 16 |
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| 257 | 257 | | ‘‘(x) The statement ‘not for transplan-17 |
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| 258 | 258 | | tation’. 18 |
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| 259 | 259 | | ‘‘(3) P |
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| 260 | 260 | | ACKAGING REQUIREMENTS .—Each 19 |
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| 261 | 261 | | human body or human body part described in para-20 |
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| 262 | 262 | | graph (1) shall be wrapped and packaged in such 21 |
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| 263 | 263 | | manner as the Secretary may by regulation require. 22 |
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| 264 | 264 | | Unless the Secretary specifies otherwise by regula-23 |
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| 265 | 265 | | tion, each such human body or human body part 24 |
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| 266 | 266 | | shall be wrapped and packaged in a manner that— 25 |
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| 269 | 269 | | •HR 2589 IH |
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| 270 | 270 | | ‘‘(A) mitigates potential contamination and 1 |
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| 271 | 271 | | cross contamination; 2 |
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| 272 | 272 | | ‘‘(B) mitigates potential safety hazards; 3 |
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| 273 | 273 | | ‘‘(C) is sealed to prevent leakage; and 4 |
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| 274 | 274 | | ‘‘(D) ensures the integrity of the human 5 |
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| 275 | 275 | | body or human body part. 6 |
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| 276 | 276 | | ‘‘(e) L |
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| 277 | 277 | | IMITATIONS ONUSE ANDDISCLOSURE OFIN-7 |
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| 278 | 278 | | FORMATION.—Individually identifiable information relat-8 |
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| 279 | 279 | | ing to the donor of a human body or human body part 9 |
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| 280 | 280 | | acquired or transferred pursuant to a registration under 10 |
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| 281 | 281 | | this section shall be used and disclosed only for such pur-11 |
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| 282 | 282 | | poses (including the return of remains for burial) as the 12 |
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| 283 | 283 | | Secretary may explicitly authorize by regulation. 13 |
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| 284 | 284 | | ‘‘(f) D |
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| 285 | 285 | | ISPOSITION.—The registrant shall ensure the 14 |
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| 286 | 286 | | proper disposition of a human body or human body part, 15 |
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| 287 | 287 | | in accordance with applicable Federal and State law, by— 16 |
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| 288 | 288 | | ‘‘(1) returning the human body or human body 17 |
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| 289 | 289 | | part to a relative or personal representative of the 18 |
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| 290 | 290 | | donor or carrying out the disposition of such human 19 |
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| 291 | 291 | | body or human body part in accordance with the 20 |
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| 292 | 292 | | written instructions of the person or persons with 21 |
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| 293 | 293 | | the right to control the disposition of the human 22 |
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| 294 | 294 | | body or body parts; or 23 |
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| 295 | 295 | | ‘‘(2) if the registrant is transferring the human 24 |
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| 296 | 296 | | body or human body part to another person, con-25 |
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| 299 | 299 | | •HR 2589 IH |
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| 300 | 300 | | tracting with such person to assume the obligation 1 |
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| 301 | 301 | | described in paragraph (1). 2 |
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| 302 | 302 | | ‘‘(g) V |
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| 303 | 303 | | IOLATIONS.— 3 |
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| 304 | 304 | | ‘‘(1) I |
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| 305 | 305 | | N GENERAL.—Any person who violates a 4 |
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| 306 | 306 | | requirement of this section shall be fined in accord-5 |
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| 307 | 307 | | ance with title 18, United States Code. 6 |
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| 308 | 308 | | ‘‘(2) R |
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| 309 | 309 | | EVOCATION OF REGISTRATION .—The 7 |
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| 310 | 310 | | Secretary may suspend or revoke the registration of 8 |
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| 311 | 311 | | any registrant found to be in violation of this sec-9 |
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| 312 | 312 | | tion. 10 |
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| 313 | 313 | | ‘‘(3) A |
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| 314 | 314 | | LTERATION OR FALSIFICATION OF 11 |
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| 315 | 315 | | LABEL.—It shall be a violation of this section for 12 |
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| 316 | 316 | | any person to alter or falsify any information in a 13 |
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| 317 | 317 | | label required by subsection (d). 14 |
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| 318 | 318 | | ‘‘(h) D |
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| 319 | 319 | | EFINITIONS.—In this section: 15 |
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| 320 | 320 | | ‘‘(1) D |
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| 321 | 321 | | ONOR.—The term ‘donor’ means a per-16 |
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| 322 | 322 | | son who has knowingly consented in accordance with 17 |
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| 323 | 323 | | applicable law to the transfer of such person’s de-18 |
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| 324 | 324 | | ceased body or deceased or living body part (not for 19 |
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| 325 | 325 | | use in transplantation) for education, research, or 20 |
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| 326 | 326 | | the advancement of medical, dental, or mortuary 21 |
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| 327 | 327 | | science. 22 |
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| 328 | 328 | | ‘‘(2) E |
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| 329 | 329 | | DUCATION.—The term ‘education’ means 23 |
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| 330 | 330 | | the use of a human body or body parts for teaching 24 |
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| 331 | 331 | | or training individuals, including medical, dental, or 25 |
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| 334 | 334 | | •HR 2589 IH |
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| 335 | 335 | | mortuary science students or professionals, with re-1 |
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| 336 | 336 | | gard to the anatomy and characteristics of the 2 |
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| 337 | 337 | | human body, disease detection, and such other uses 3 |
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| 338 | 338 | | as may be specified by the Secretary by regulation. 4 |
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| 339 | 339 | | ‘‘(3) H |
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| 340 | 340 | | UMAN BODY.—The term ‘human body’ 5 |
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| 341 | 341 | | means a deceased human body. 6 |
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| 342 | 342 | | ‘‘(4) H |
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| 343 | 343 | | UMAN BODY PART .—The terms ‘human 7 |
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| 344 | 344 | | body part’ or ‘body part’ mean an organ, tissue, eye, 8 |
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| 345 | 345 | | bone, blood vessel or any other portion of a deceased 9 |
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| 346 | 346 | | or living human body that is subject to an anatom-10 |
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| 347 | 347 | | ical gift or other transfer made pursuant to State 11 |
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| 348 | 348 | | law, but do not include— 12 |
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| 349 | 349 | | ‘‘(A) blood drawn for medical purposes; or 13 |
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| 350 | 350 | | ‘‘(B) a growing cell line. 14 |
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| 351 | 351 | | ‘‘(5) R |
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| 352 | 352 | | ESEARCH.—The term ‘research’ does not 15 |
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| 353 | 353 | | include an autopsy or examination, conducted as 16 |
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| 354 | 354 | | part of a criminal investigation.’’. 17 |
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| 355 | 355 | | (b) R |
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| 356 | 356 | | ULE OFAPPLICABILITY.—The amendments 18 |
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| 357 | 357 | | made by this section shall apply with respect to any acqui-19 |
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| 358 | 358 | | sition or transfer of a human body or human body parts 20 |
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| 359 | 359 | | after the date that is 2 years after the date of the enact-21 |
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| 360 | 360 | | ment of this Act. 22 |
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| 361 | 361 | | Æ |
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| 362 | 362 | | VerDate Sep 11 2014 22:27 Apr 07, 2025 Jkt 059200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6301 E:\BILLS\H2589.IH H2589 |
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| 363 | 363 | | ssavage on LAPJG3WLY3PROD with BILLS |
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