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 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. 

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 consensual 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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Consensual Donation 

5 and Research Integrity Act of 2019’’. 


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1 SEC. 2. HUMAN BODIES AND HUMAN BODY PARTS DO2 NATED OR TRANSFERRED FOR EDUCATION, 

3 RESEARCH, OR THE ADVANCEMENT OF MED4 ICAL, DENTAL, OR MORTUARY SCIENCE AND 

5 NOT FOR USE IN HUMAN TRANSPLANTATION. 

6 (a) IN GENERAL.—Title III of the Public Health 

7 Service Act (42 U.S.C. 241 et seq.) is amended by insert8 ing after section 373 the following new section: 

9 ‘‘SEC. 373A. HUMAN BODIES AND HUMAN BODY PARTS DO10 NATED OR TRANSFERRED FOR EDUCATION, 

11 RESEARCH, OR THE ADVANCEMENT OF MED12 ICAL, DENTAL, OR MORTUARY SCIENCE AND 

13 NOT FOR USE IN HUMAN TRANSPLANTATION. 

14 ‘‘(a) REGISTRATION.— 

15 ‘‘(1) IN GENERAL.—A person who acquires or 

16 transfers in or affecting interstate commerce a 

17 human body or human body part for education, re18 search, or the advancement of medical, dental, or 

19 mortuary science (and not for use in human trans20 plantation) shall register with the Secretary at such 

21 time and in such manner as the Secretary may re22 quire. 

23 ‘‘(2) CONTENTS OF APPLICATION.—An appli24 cant for registration or renewal of registration under 

25 this section shall submit an application to the Sec26 retary containing such information as the Secretary 


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1 may by regulation require on the activities to be car2 ried out pursuant to the registration. Unless the 

3 Secretary specifies otherwise by regulation, an appli4 cation shall include— 

5 ‘‘(A) the name of the applicant, including 

6 all trade names under which the applicant con7 ducts business; 

8 ‘‘(B) the date on which the applicant first 

9 began or will begin commencing activities de10 scribed in paragraph (1); 

11 ‘‘(C) a list of all addresses at which the 

12 applicant conducts business; 

13 ‘‘(D) a description of the premises and 

14 equipment used by the applicant; 

15 ‘‘(E) a description of the types of service 

16 provided by the applicant; 

17 ‘‘(F) an identification of a representative 

18 of the applicant who has attained the age of 18 

19 and has the authority to ensure that the appli20 cant complies with this section; 

21 ‘‘(G) an assurance that the applicant will 

22 keep records in accordance with subsection (c); 

23 ‘‘(H) an assurance that the applicant will 

24 label and package all human bodies or human 


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1 body parts in accordance with subsection (d); 

2 and 

3 ‘‘(I) an assurance that the Secretary will 

4 be permitted to inspect the premises and 

5 records of the applicant at the times and in the 

6 manners prescribed under subsection (b). 

7 ‘‘(3) FEES.— 

8 ‘‘(A) AUTHORITY.—The Secretary shall es9 tablish a fee for registration under paragraph 

10 (1) and renewal under paragraph (4) in an 

11 amount in accordance with subparagraph (B). 

12 ‘‘(B) AMOUNT.—The Secretary shall deter13 mine the amount of the fees authorized by sub14 paragraph (A) on an annual basis based on the 

15 projected cost of implementing and enforcing 

16 this section, including the cost of inspections 

17 under subsection (b). 

18 ‘‘(C) COLLECTIONS AND APPROPRIATIONS

19 ACTS.—The fees authorized by subparagraph 

20 (A) shall be available for obligation only to the 

21 extent and in the amounts provided in advance 

22 in appropriations Acts. 

23 ‘‘(4) REGISTRATION RENEWAL.—The Secretary 

24 shall require that the registration of a registrant be 


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1 renewed by such registrant at such intervals as the 

2 Secretary determines appropriate. 

3 ‘‘(5) CHANGE OF INFORMATION.—Not later 

4 than 30 days after any change of any information 

5 listed in paragraph (2), an applicant or registrant 

6 shall notify the Secretary of such change in writing 

7 as prescribed by regulation by the Secretary. 

8 ‘‘(b) INSPECTIONS.—The Secretary shall inspect at 

9 regular intervals (to be prescribed by the Secretary) the 

10 premises described in subsection (a)(2)(D). 

11 ‘‘(c) RECORD KEEPING.— 

12 ‘‘(1) IN GENERAL.—A registrant shall compile 

13 or maintain a record for each case in which the reg14 istrant acquires a human body or human body part. 

15 ‘‘(2) RECORD REQUIREMENTS.—A record under 

16 paragraph (1) shall contain such information as the 

17 Secretary may by regulation require. Unless the Sec18 retary specifies otherwise by regulation, a record 

19 under paragraph (1) shall include the following: 

20 ‘‘(A) Documentation that the donor has 

21 knowingly consented to the transfer of the 

22 human body or human body part (not for use 

23 in transplantation) involved for education, re24 search, or the advancement of medical, dental, 

25 or mortuary science in accordance with all apVerDate Sep 11 2014 01:04 Apr 02, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H1835.IH H1835

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1 plicable laws pertaining to the disposition of 

2 human remains. 

3 ‘‘(B) Documentation that the donor has 

4 been informed of the obligation of the reg5 istrant under subsection (e) to dispose of the 

6 human body or human body part. 

7 ‘‘(C) The date and time of the donation or 

8 transfer from the donor. 

9 ‘‘(D) The name of the person, including 

10 any trade or business name, who transferred 

11 the human body or human body part to the reg12 istrant, if applicable. 

13 ‘‘(E) The full name and most recent ad14 dress of the donor. 

15 ‘‘(F) A description of the human body or 

16 human body part being acquired or transferred. 

17 ‘‘(G) The medical history of the donor, in18 cluding the autopsy report if an autopsy was 

19 conducted. 

20 ‘‘(H) The identity and address of each per21 son that has been in possession of the human 

22 body or human body part prior to the reg23 istrant, including any funeral home, coroner, 

24 hospital, organ procurement organization, or 

25 tissue bank. 


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1 ‘‘(I) Documentation of the use and disposi2 tion of each human body or human body part 

3 by the registrant. 

4 ‘‘(J) Documentation of the name and ad5 dress of each person to whom the registrant 

6 transfers such human body or human body 

7 part. 

8 ‘‘(d) LABELING AND PACKAGING.— 

9 ‘‘(1) IN GENERAL.—A registrant shall ensure 

10 that all human bodies and human body parts in the 

11 possession of, or transferred by, a registrant are la12 beled and packaged in accordance with paragraphs 

13 (2) and (3). 

14 ‘‘(2) LABELING REQUIREMENTS.—A label 

15 under paragraph (1) shall contain such information 

16 as the Secretary may by regulation require con17 sistent with any applicable Federal privacy provi18 sions. Unless the Secretary specifies otherwise by 

19 regulation, a label under paragraph (1) shall include 

20 the following: 

21 ‘‘(A) The proper name of the donor. 

22 ‘‘(B) A description of the contents of the 

23 package, indicating whether it is a human body 

24 or human body parts, including a list of all 

25 such parts. 


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1 ‘‘(C) The name, address, and any applica2 ble license or registration number of the person 

3 transferring the human body or human body 

4 part. 

5 ‘‘(D) The tissue types of the human body 

6 or human body part. 

7 ‘‘(E) The cause of death of the donor, if 

8 applicable and known. 

9 ‘‘(F) Serological test results, if any such 

10 results exist. 

11 ‘‘(G) Any known infectious disease agents 

12 of such human body or human body part. 

13 ‘‘(H) A statement about the use of per14 sonal protective equipment and universal pre15 cautions when handling a human body or 

16 human body part as required by law. 

17 ‘‘(I) The statement ‘not for transplan18 tation.’. 

19 ‘‘(3) PACKAGING REQUIREMENTS.—Each 

20 human body or human body part described in para21 graph (1) shall be wrapped and packaged in such 

22 manner as the Secretary may by regulation require. 

23 Unless the Secretary specifies otherwise by regula24 tion, each such human body or human body part 

25 shall be wrapped and packaged in a manner that— 


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1 ‘‘(A) mitigates potential contamination and 

2 cross contamination; 

3 ‘‘(B) mitigates potential safety hazards; 

4 ‘‘(C) is sealed to prevent leakage; and 

5 ‘‘(D) ensures the integrity of the human 

6 body or human body part. 

7 ‘‘(e) DISPOSITION.—The registrant shall ensure the 

8 proper disposition of a human body or human body part, 

9 in accordance with applicable Federal and State law, by— 

10 ‘‘(1) returning the human body or human body 

11 part to a relative or personal representative of the 

12 donor or carrying out the disposition of such human 

13 body or human body part; or 

14 ‘‘(2) if the registrant is transferring the human 

15 body or human body part to another person, con16 tracting with such person to assume the obligation 

17 described in paragraph (1). 

18 ‘‘(f) VIOLATIONS.— 

19 ‘‘(1) IN GENERAL.—Any person who violates a 

20 requirement of this section shall be fined in accord21 ance with title 18, United States Code. 

22 ‘‘(2) REVOCATION OF REGISTRATION.—The 

23 Secretary may suspend or revoke the registration of 

24 any registrant found to be in violation of this sec25 tion. 


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1 ‘‘(3) ALTERATION OR FALSIFICATION OF

2 LABEL.—It shall be a violation of this section for 

3 any person to alter or falsify any information in a 

4 label required by subsection (d). 

5 ‘‘(g) DEFINITIONS.—In this section: 

6 ‘‘(1) DONOR.—The term ‘donor’ means a per7 son who has knowingly consented in accordance with 

8 applicable law to the transfer of such person’s de9 ceased body or deceased or living body part (not for 

10 use in transplantation) for education, research, or 

11 the advancement of medical, dental, or mortuary 

12 science. 

13 ‘‘(2) EDUCATION.—The term ‘education’ means 

14 the use of a human body or body parts for teaching 

15 or training individuals, including medical, dental, or 

16 mortuary science students or professionals, with re17 gard to the anatomy and characteristics of the 

18 human body, disease detection, and such other uses 

19 as may be specified by the Secretary by regulation. 

20 ‘‘(3) HUMAN BODY.—The term ‘human body’ 

21 means a deceased human body. 

22 ‘‘(4) HUMAN BODY PART.—The terms ‘human 

23 body part’ or ‘body part’ mean an organ, tissue, eye, 

24 bone, blood vessel or any other portion of a deceased 

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1 ical gift or other transfer made pursuant to State 

2 law, but do not include— 

3 ‘‘(A) blood drawn for medical purposes; or 

4 ‘‘(B) a growing cell line. 

5 ‘‘(5) RESEARCH.—The term ‘research’ does not 

6 include an autopsy or examination, conducted as 

7 part of a criminal investigation.’’. 

8 (b) RULE OF APPLICABILITY.—The amendments 

9 made by this section shall apply with respect to any acqui10 sition or transfer of a human body or human body parts 

11 after the date that is 2 years after the date of the enact12 ment of this Act. 

Æ 


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