Consensual Donation and Research Integrity Act of 2019

I 116TH CONGRESS 1ST SESSION H. R. 1835 To amend the Public Health Service Act to ensure the consensual donation and respectful disposition of human bodies and human body parts do- nated or transferred for education, research, or the advancement of medical, dental, or mortuary science and not for use in human transplan- tation, and for other purposes. IN THE HOUSE OF REPRESENTATIVES MARCH 18, 2019 Mr. RUSH (for himself and Mr. BILIRAKIS) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend the Public Health Service Act to ensure the con- sensual donation and respectful disposition of human bodies and human body parts donated or transferred for education, research, or the advancement of medical, dental, or mortuary science and not for use in human transplantation, and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Consensual Donation 4 and Research Integrity Act of 2019’’. 5 VerDate Sep 11 2014 01:04 Apr 02, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H1835.IH H1835 pamtmann on DSKBFK8HB2PROD with BILLS 2 •HR 1835 IH SEC. 2. HUMAN BODIES AND HUMAN BODY PARTS DO- 1 NATED OR TRANSFERRED FOR EDUCATION, 2 RESEARCH, OR THE ADVANCEMENT OF MED- 3 ICAL, DENTAL, OR MORTUARY SCIENCE AND 4 NOT FOR USE IN HUMAN TRANSPLANTATION. 5 (a) IN GENERAL.—Title III of the Public Health 6 Service Act (42 U.S.C. 241 et seq.) is amended by insert- 7 ing after section 373 the following new section: 8 ‘‘SEC. 373A. HUMAN BODIES AND HUMAN BODY PARTS DO- 9 NATED OR TRANSFERRED FOR EDUCATION, 10 RESEARCH, OR THE ADVANCEMENT OF MED- 11 ICAL, DENTAL, OR MORTUARY SCIENCE AND 12 NOT FOR USE IN HUMAN TRANSPLANTATION. 13 ‘‘(a) REGISTRATION.— 14 ‘‘(1) IN GENERAL.—A person who acquires or 15 transfers in or affecting interstate commerce a 16 human body or human body part for education, re- 17 search, or the advancement of medical, dental, or 18 mortuary science (and not for use in human trans- 19 plantation) shall register with the Secretary at such 20 time and in such manner as the Secretary may re- 21 quire. 22 ‘‘(2) CONTENTS OF APPLICATION.—An appli- 23 cant for registration or renewal of registration under 24 this section shall submit an application to the Sec- 25 retary containing such information as the Secretary 26 VerDate Sep 11 2014 01:04 Apr 02, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H1835.IH H1835 pamtmann on DSKBFK8HB2PROD with BILLS 3 •HR 1835 IH may by regulation require on the activities to be car- 1 ried out pursuant to the registration. Unless the 2 Secretary specifies otherwise by regulation, an appli- 3 cation shall include— 4 ‘‘(A) the name of the applicant, including 5 all trade names under which the applicant con- 6 ducts business; 7 ‘‘(B) the date on which the applicant first 8 began or will begin commencing activities de- 9 scribed in paragraph (1); 10 ‘‘(C) a list of all addresses at which the 11 applicant conducts business; 12 ‘‘(D) a description of the premises and 13 equipment used by the applicant; 14 ‘‘(E) a description of the types of service 15 provided by the applicant; 16 ‘‘(F) an identification of a representative 17 of the applicant who has attained the age of 18 18 and has the authority to ensure that the appli- 19 cant complies with this section; 20 ‘‘(G) an assurance that the applicant will 21 keep records in accordance with subsection (c); 22 ‘‘(H) an assurance that the applicant will 23 label and package all human bodies or human 24 VerDate Sep 11 2014 01:04 Apr 02, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H1835.IH H1835 pamtmann on DSKBFK8HB2PROD with BILLS 4 •HR 1835 IH body parts in accordance with subsection (d); 1 and 2 ‘‘(I) an assurance that the Secretary will 3 be permitted to inspect the premises and 4 records of the applicant at the times and in the 5 manners prescribed under subsection (b). 6 ‘‘(3) FEES.— 7 ‘‘(A) AUTHORITY.—The Secretary shall es- 8 tablish a fee for registration under paragraph 9 (1) and renewal under paragraph (4) in an 10 amount in accordance with subparagraph (B). 11 ‘‘(B) AMOUNT.—The Secretary shall deter- 12 mine the amount of the fees authorized by sub- 13 paragraph (A) on an annual basis based on the 14 projected cost of implementing and enforcing 15 this section, including the cost of inspections 16 under subsection (b). 17 ‘‘(C) COLLECTIONS AND APPROPRIATIONS 18 ACTS.—The fees authorized by subparagraph 19 (A) shall be available for obligation only to the 20 extent and in the amounts provided in advance 21 in appropriations Acts. 22 ‘‘(4) REGISTRATION RENEWAL.—The Secretary 23 shall require that the registration of a registrant be 24 VerDate Sep 11 2014 01:04 Apr 02, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H1835.IH H1835 pamtmann on DSKBFK8HB2PROD with BILLS 5 •HR 1835 IH renewed by such registrant at such intervals as the 1 Secretary determines appropriate. 2 ‘‘(5) CHANGE OF INFORMATION.—Not later 3 than 30 days after any change of any information 4 listed in paragraph (2), an applicant or registrant 5 shall notify the Secretary of such change in writing 6 as prescribed by regulation by the Secretary. 7 ‘‘(b) INSPECTIONS.—The Secretary shall inspect at 8 regular intervals (to be prescribed by the Secretary) the 9 premises described in subsection (a)(2)(D). 10 ‘‘(c) RECORD KEEPING.— 11 ‘‘(1) IN GENERAL.—A registrant shall compile 12 or maintain a record for each case in which the reg- 13 istrant acquires a human body or human body part. 14 ‘‘(2) RECORD REQUIREMENTS.—A record under 15 paragraph (1) shall contain such information as the 16 Secretary may by regulation require. Unless the Sec- 17 retary specifies otherwise by regulation, a record 18 under paragraph (1) shall include the following: 19 ‘‘(A) Documentation that the donor has 20 knowingly consented to the transfer of the 21 human body or human body part (not for use 22 in transplantation) involved for education, re- 23 search, or the advancement of medical, dental, 24 or mortuary science in accordance with all ap- 25 VerDate Sep 11 2014 01:04 Apr 02, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H1835.IH H1835 pamtmann on DSKBFK8HB2PROD with BILLS 6 •HR 1835 IH plicable laws pertaining to the disposition of 1 human remains. 2 ‘‘(B) Documentation that the donor has 3 been informed of the obligation of the reg- 4 istrant under subsection (e) to dispose of the 5 human body or human body part. 6 ‘‘(C) The date and time of the donation or 7 transfer from the donor. 8 ‘‘(D) The name of the person, including 9 any trade or business name, who transferred 10 the human body or human body part to the reg- 11 istrant, if applicable. 12 ‘‘(E) The full name and most recent ad- 13 dress of the donor. 14 ‘‘(F) A description of the human body or 15 human body part being acquired or transferred. 16 ‘‘(G) The medical history of the donor, in- 17 cluding the autopsy report if an autopsy was 18 conducted. 19 ‘‘(H) The identity and address of each per- 20 son that has been in possession of the human 21 body or human body part prior to the reg- 22 istrant, including any funeral home, coroner, 23 hospital, organ procurement organization, or 24 tissue bank. 25 VerDate Sep 11 2014 01:04 Apr 02, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H1835.IH H1835 pamtmann on DSKBFK8HB2PROD with BILLS 7 •HR 1835 IH ‘‘(I) Documentation of the use and disposi- 1 tion of each human body or human body part 2 by the registrant. 3 ‘‘(J) Documentation of the name and ad- 4 dress of each person to whom the registrant 5 transfers such human body or human body 6 part. 7 ‘‘(d) LABELING AND PACKAGING.— 8 ‘‘(1) IN GENERAL.—A registrant shall ensure 9 that all human bodies and human body parts in the 10 possession of, or transferred by, a registrant are la- 11 beled and packaged in accordance with paragraphs 12 (2) and (3). 13 ‘‘(2) LABELING REQUIREMENTS.—A label 14 under paragraph (1) shall contain such information 15 as the Secretary may by regulation require con- 16 sistent with any applicable Federal privacy provi- 17 sions. Unless the Secretary specifies otherwise by 18 regulation, a label under paragraph (1) shall include 19 the following: 20 ‘‘(A) The proper name of the donor. 21 ‘‘(B) A description of the contents of the 22 package, indicating whether it is a human body 23 or human body parts, including a list of all 24 such parts. 25 VerDate Sep 11 2014 01:04 Apr 02, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H1835.IH H1835 pamtmann on DSKBFK8HB2PROD with BILLS 8 •HR 1835 IH ‘‘(C) The name, address, and any applica- 1 ble license or registration number of the person 2 transferring the human body or human body 3 part. 4 ‘‘(D) The tissue types of the human body 5 or human body part. 6 ‘‘(E) The cause of death of the donor, if 7 applicable and known. 8 ‘‘(F) Serological test results, if any such 9 results exist. 10 ‘‘(G) Any known infectious disease agents 11 of such human body or human body part. 12 ‘‘(H) A statement about the use of per- 13 sonal protective equipment and universal pre- 14 cautions when handling a human body or 15 human body part as required by law. 16 ‘‘(I) The statement ‘not for transplan- 17 tation.’. 18 ‘‘(3) PACKAGING REQUIREMENTS.—Each 19 human body or human body part described in para- 20 graph (1) shall be wrapped and packaged in such 21 manner as the Secretary may by regulation require. 22 Unless the Secretary specifies otherwise by regula- 23 tion, each such human body or human body part 24 shall be wrapped and packaged in a manner that— 25 VerDate Sep 11 2014 01:04 Apr 02, 2019 Jkt 089200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H1835.IH H1835 pamtmann on DSKBFK8HB2PROD with BILLS 9 •HR 1835 IH ‘‘(A) mitigates potential contamination and 1 cross contamination; 2 ‘‘(B) mitigates potential safety hazards; 3 ‘‘(C) is sealed to prevent leakage; and 4 ‘‘(D) ensures the integrity of the human 5 body or human body part. 6 ‘‘(e) DISPOSITION.—The registrant shall ensure the 7 proper disposition of a human body or human body part, 8 in accordance with applicable Federal and State law, by— 9 ‘‘(1) returning the human body or human body 10 part to a relative or personal representative of the 11 donor or carrying out the disposition of such human 12 body or human body part; or 13 ‘‘(2) if the registrant is transferring the human 14 body or human body part to another person, con- 15 tracting with such person to assume the obligation 16 described in paragraph (1). 17 ‘‘(f) VIOLATIONS.— 18 ‘‘(1) IN GENERAL.—Any person who violates a 19 requirement of this section shall be fined in accord- 20 ance with title 18, United States Code. 21 ‘‘(2) REVOCATION OF REGISTRATION.—The 22 Secretary may suspend or revoke the registration of 23 any registrant found to be in violation of this sec- 24 tion. 25 VerDate Sep 11 2014 01:04 Apr 02, 2019 Jkt 089200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H1835.IH H1835 pamtmann on DSKBFK8HB2PROD with BILLS 10 •HR 1835 IH ‘‘(3) ALTERATION OR FALSIFICATION OF 1 LABEL.—It shall be a violation of this section for 2 any person to alter or falsify any information in a 3 label required by subsection (d). 4 ‘‘(g) DEFINITIONS.—In this section: 5 ‘‘(1) DONOR.—The term ‘donor’ means a per- 6 son who has knowingly consented in accordance with 7 applicable law to the transfer of such person’s de- 8 ceased body or deceased or living body part (not for 9 use in transplantation) for education, research, or 10 the advancement of medical, dental, or mortuary 11 science. 12 ‘‘(2) EDUCATION.—The term ‘education’ means 13 the use of a human body or body parts for teaching 14 or training individuals, including medical, dental, or 15 mortuary science students or professionals, with re- 16 gard to the anatomy and characteristics of the 17 human body, disease detection, and such other uses 18 as may be specified by the Secretary by regulation. 19 ‘‘(3) HUMAN BODY.—The term ‘human body’ 20 means a deceased human body. 21 ‘‘(4) HUMAN BODY PART.—The terms ‘human 22 body part’ or ‘body part’ mean an organ, tissue, eye, 23 bone, blood vessel or any other portion of a deceased 24 or living human body that is subject to an anatom- 25 VerDate Sep 11 2014 01:04 Apr 02, 2019 Jkt 089200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H1835.IH H1835 pamtmann on DSKBFK8HB2PROD with BILLS 11 •HR 1835 IH ical gift or other transfer made pursuant to State 1 law, but do not include— 2 ‘‘(A) blood drawn for medical purposes; or 3 ‘‘(B) a growing cell line. 4 ‘‘(5) RESEARCH.—The term ‘research’ does not 5 include an autopsy or examination, conducted as 6 part of a criminal investigation.’’. 7 (b) RULE OF APPLICABILITY.—The amendments 8 made by this section shall apply with respect to any acqui- 9 sition or transfer of a human body or human body parts 10 after the date that is 2 years after the date of the enact- 11 ment of this Act. 12 Æ VerDate Sep 11 2014 01:04 Apr 02, 2019 Jkt 089200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6301 E:\BILLS\H1835.IH H1835 pamtmann on DSKBFK8HB2PROD with BILLS