Consensual Donation and Research Integrity Act of 2021

I 117TH CONGRESS 1ST SESSION H. R. 4062 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 JUNE 22, 2021 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 2021’’. 5 VerDate Sep 11 2014 23:07 Jul 09, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H4062.IH H4062 kjohnson on DSK79L0C42PROD with BILLS 2 •HR 4062 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) EXCEPTION.—Paragraph (1) does not 23 apply to the Organ Procurement and Transplan- 24 tation Network under section 372 and any entity 25 that is a member of the Network pursuant to section 26 VerDate Sep 11 2014 23:07 Jul 09, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H4062.IH H4062 kjohnson on DSK79L0C42PROD with BILLS 3 •HR 4062 IH 121.3 of title 42, Code of Federal Regulations (or 1 any successor regulations). 2 ‘‘(3) CONTENTS OF APPLICATION.—An appli- 3 cant for registration or renewal of registration under 4 this section shall submit an application to the Sec- 5 retary containing such information as the Secretary 6 may by regulation require on the activities to be car- 7 ried out pursuant to the registration. Unless the 8 Secretary specifies otherwise by regulation, an appli- 9 cation shall include— 10 ‘‘(A) the name of the applicant, including 11 all trade names under which the applicant con- 12 ducts business; 13 ‘‘(B) the date on which the applicant first 14 began or will begin commencing activities de- 15 scribed in paragraph (1); 16 ‘‘(C) a list of all addresses at which the 17 applicant conducts business; 18 ‘‘(D) a description of the premises and 19 equipment used by the applicant; 20 ‘‘(E) a description of the types of service 21 provided by the applicant; 22 ‘‘(F) an identification of a representative 23 of the applicant who has attained the age of 18 24 VerDate Sep 11 2014 23:07 Jul 09, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H4062.IH H4062 kjohnson on DSK79L0C42PROD with BILLS 4 •HR 4062 IH and has the authority to ensure that the appli- 1 cant complies with this section; 2 ‘‘(G) 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 ‘‘(H) an assurance that the applicant will 7 keep records in accordance with subsection (c); 8 ‘‘(I) an assurance that the applicant will 9 label and package all human bodies or human 10 body parts in accordance with subsection (d); 11 and 12 ‘‘(J) an assurance that the applicant will 13 limit the use and disclosure of information in 14 accordance with the regulations promulgated 15 pursuant to subsection (e). 16 ‘‘(4) FEES.— 17 ‘‘(A) AUTHORITY.—The Secretary shall es- 18 tablish a fee for registration under paragraph 19 (1) and renewal under paragraph (5) in an 20 amount in accordance with subparagraph (B). 21 ‘‘(B) AMOUNT.—The Secretary shall deter- 22 mine the amount of the fees authorized by sub- 23 paragraph (A) on an annual basis based on the 24 projected cost of implementing and enforcing 25 VerDate Sep 11 2014 23:07 Jul 09, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H4062.IH H4062 kjohnson on DSK79L0C42PROD with BILLS 5 •HR 4062 IH this section, including the cost of inspections 1 under subsection (b). 2 ‘‘(C) COLLECTIONS AND APPROPRIATIONS 3 ACTS.—The fees authorized by subparagraph 4 (A) shall be available for obligation only to the 5 extent and in the amounts provided in advance 6 in appropriations Acts. 7 ‘‘(5) REGISTRATION RENEWAL.—The Secretary 8 shall require that the registration of a registrant be 9 renewed by such registrant at such intervals as the 10 Secretary determines appropriate. 11 ‘‘(6) CHANGE OF INFORMATION.—Not later 12 than 30 days after any change of any information 13 listed in paragraph (3), an applicant or registrant 14 shall notify the Secretary of such change in writing 15 as prescribed by regulation by the Secretary. 16 ‘‘(b) INSPECTIONS.—The Secretary shall inspect at 17 regular intervals (to be prescribed by the Secretary) the 18 premises described in subsection (a)(3)(D). 19 ‘‘(c) RECORD KEEPING.— 20 ‘‘(1) IN GENERAL.—A registrant shall maintain 21 a record for each case in which the registrant ac- 22 quires a human body or human body part. 23 ‘‘(2) RECORD REQUIREMENTS.—A record under 24 paragraph (1) shall contain such information as the 25 VerDate Sep 11 2014 23:07 Jul 09, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H4062.IH H4062 kjohnson on DSK79L0C42PROD with BILLS 6 •HR 4062 IH Secretary may by regulation require. Unless the Sec- 1 retary specifies otherwise by regulation, a record 2 under paragraph (1) shall include the following: 3 ‘‘(A) Documentation that the donor has 4 knowingly consented to the transfer of the 5 human body or human body part (not for use 6 in transplantation) involved for education, re- 7 search, or the advancement of medical, dental, 8 or mortuary science in accordance with all ap- 9 plicable laws pertaining to the disposition of 10 human remains. 11 ‘‘(B) Documentation that the donor has 12 been informed of the obligation of the reg- 13 istrant under subsection (e) to dispose of the 14 human body or human body part. 15 ‘‘(C) The date and time of the donation or 16 transfer from the donor. 17 ‘‘(D) The name of the person, including 18 any trade or business name, who transferred 19 the human body or human body part to the reg- 20 istrant, if applicable. 21 ‘‘(E) The full name and most recent ad- 22 dress of the donor. 23 ‘‘(F) A description of the human body or 24 human body part being acquired or transferred. 25 VerDate Sep 11 2014 23:07 Jul 09, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H4062.IH H4062 kjohnson on DSK79L0C42PROD with BILLS 7 •HR 4062 IH ‘‘(G) The medical history of the donor, in- 1 cluding the autopsy report if an autopsy was 2 conducted. 3 ‘‘(H) The identity and address of each per- 4 son that has been in possession of the human 5 body or human body part prior to the reg- 6 istrant, including any funeral home, coroner, 7 hospital, organ procurement organization, or 8 tissue bank. 9 ‘‘(I) Documentation of the use and disposi- 10 tion of each human body or human body part 11 by the registrant. 12 ‘‘(J) Documentation of the name and ad- 13 dress of each person to whom the registrant 14 transfers such human body or human body 15 part. 16 ‘‘(d) LABELING AND PACKAGING.— 17 ‘‘(1) IN GENERAL.—A registrant shall ensure 18 that all human bodies and human body parts in the 19 possession of, or transferred by, a registrant are la- 20 beled and packaged in accordance with paragraphs 21 (2) and (3). 22 ‘‘(2) LABELING REQUIREMENTS.— 23 VerDate Sep 11 2014 23:07 Jul 09, 2021 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H4062.IH H4062 kjohnson on DSK79L0C42PROD with BILLS 8 •HR 4062 IH ‘‘(A) PLACEMENT.—The labeling required 1 by paragraph (1) shall be affixed beneath the 2 outer packaging. 3 ‘‘(B) CONTENTS.—The labeling required 4 by paragraph (1) shall contain such information 5 as the Secretary may by regulation require con- 6 sistent with any applicable Federal privacy pro- 7 visions. Unless the Secretary specifies otherwise 8 by regulation, a label under paragraph (1) shall 9 include the following: 10 ‘‘(i) The proper name of the donor. 11 ‘‘(ii) A description of the contents of 12 the packaging, indicating whether it is a 13 human body or human body parts, includ- 14 ing a list of all such parts. 15 ‘‘(iii) The name, address, and any ap- 16 plicable license or registration number of 17 the person transferring the human body or 18 human body part. 19 ‘‘(iv) The tissue types of the human 20 body or human body part. 21 ‘‘(v) The cause of death of the donor, 22 if applicable and known. 23 ‘‘(vi) Serological test results, if any 24 such results exist. 25 VerDate Sep 11 2014 23:07 Jul 09, 2021 Jkt 019200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H4062.IH H4062 kjohnson on DSK79L0C42PROD with BILLS 9 •HR 4062 IH ‘‘(vii) Any known infectious disease 1 agents of such human body or human body 2 part. 3 ‘‘(viii) A statement about the use of 4 personal protective equipment and uni- 5 versal precautions when handling a human 6 body or human body part as required by 7 law. 8 ‘‘(ix) The statement ‘not for trans- 9 plantation.’. 10 ‘‘(3) PACKAGING REQUIREMENTS.—Each 11 human body or human body part described in para- 12 graph (1) shall be wrapped and packaged in such 13 manner as the Secretary may by regulation require. 14 Unless the Secretary specifies otherwise by regula- 15 tion, each such human body or human body part 16 shall be wrapped and packaged in a manner that— 17 ‘‘(A) mitigates potential contamination and 18 cross contamination; 19 ‘‘(B) mitigates potential safety hazards; 20 ‘‘(C) is sealed to prevent leakage; and 21 ‘‘(D) ensures the integrity of the human 22 body or human body part. 23 ‘‘(e) LIMITATIONS ON USE AND DISCLOSURE OF IN- 24 FORMATION.—Individually identifiable information relat- 25 VerDate Sep 11 2014 23:07 Jul 09, 2021 Jkt 019200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H4062.IH H4062 kjohnson on DSK79L0C42PROD with BILLS 10 •HR 4062 IH ing to the donor of a human body or human body part 1 acquired or transferred pursuant to a registration under 2 this section shall be used and disclosed only for such pur- 3 poses (including the return of remains for burial) as the 4 Secretary may explicitly authorize by regulation. 5 ‘‘(f) DISPOSITION.—The registrant shall ensure the 6 proper disposition of a human body or human body part, 7 in accordance with applicable Federal and State law, by— 8 ‘‘(1) returning the human body or human body 9 part to a relative or personal representative of the 10 donor or carrying out the disposition of such human 11 body or human body part; or 12 ‘‘(2) if the registrant is transferring the human 13 body or human body part to another person, con- 14 tracting with such person to assume the obligation 15 described in paragraph (1). 16 ‘‘(g) VIOLATIONS.— 17 ‘‘(1) IN GENERAL.—Any person who violates a 18 requirement of this section shall be fined in accord- 19 ance with title 18, United States Code. 20 ‘‘(2) REVOCATION OF REGISTRATION.—The 21 Secretary may suspend or revoke the registration of 22 any registrant found to be in violation of this sec- 23 tion. 24 VerDate Sep 11 2014 23:07 Jul 09, 2021 Jkt 019200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H4062.IH H4062 kjohnson on DSK79L0C42PROD with BILLS 11 •HR 4062 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 ‘‘(h) 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 23:07 Jul 09, 2021 Jkt 019200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H4062.IH H4062 kjohnson on DSK79L0C42PROD with BILLS 12 •HR 4062 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 23:07 Jul 09, 2021 Jkt 019200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6301 E:\BILLS\H4062.IH H4062 kjohnson on DSK79L0C42PROD with BILLS