II 

117TH CONGRESS 

2D SESSION S. 4929 

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 SENATE OF THE UNITED STATES 

SEPTEMBER 22, 2022 

Mr. MURPHY (for himself and Mr. TILLIS) introduced the following bill; which 

was read twice and referred to the Committee on Health, Education, 

Labor, 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 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 2022’’. 


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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 or for final disposition of a human body 

21 or body parts) shall register with the Secretary at 

22 such time and in such manner as the Secretary may 

23 require. 

24 ‘‘(2) EXCEPTION.—Paragraph (1) does not 

25 apply to the Organ Procurement and Transplan26 tation Network under section 372 and any entity 


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1 that is a member of the Network pursuant to section 

2 121.3 of title 42, Code of Federal Regulations (or 

3 any successor regulations) and funeral service pro4 fessionals in regard to the preparation, transpor5 tation, and final disposition of the human body or 

6 body parts. 

7 ‘‘(3) CONTENTS OF APPLICATION.—An appli8 cant for registration or renewal of registration under 

9 this section shall submit an application to the Sec10 retary containing such information as the Secretary 

11 may by regulation require on the activities to be car12 ried out pursuant to the registration. Unless the 

13 Secretary specifies otherwise by regulation, an appli14 cation shall include— 

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

16 all trade names under which the applicant con17 ducts business; 

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

19 began or will begin commencing activities de20 scribed in paragraph (1); 

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

22 applicant conducts business; 

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

24 equipment used by the applicant; 


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

2 provided by the applicant; 

3 ‘‘(F) an identification of a representative 

4 of the applicant who has attained the age of 18 

5 and has the authority to ensure that the appli6 cant complies with this section; 

7 ‘‘(G) an assurance that the Secretary will 

8 be permitted to inspect the premises and 

9 records of the applicant at the times and in the 

10 manners prescribed under subsection (b); 

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

12 keep records in accordance with subsection (c); 

13 ‘‘(I) an assurance that the applicant will 

14 label and package all human bodies or human 

15 body parts in accordance with subsection (d); 

16 and 

17 ‘‘(J) an assurance that the applicant will 

18 limit the use and disclosure of information in 

19 accordance with the regulations promulgated 

20 pursuant to subsection (e). 

21 ‘‘(4) FEES.— 

22 ‘‘(A) AUTHORITY.—The Secretary shall es23 tablish a fee for registration under paragraph 

24 (1) and renewal under paragraph (5) in an 

25 amount in accordance with subparagraph (B). 


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1 ‘‘(B) AMOUNT.—The Secretary shall deter2 mine the amount of the fees authorized by sub3 paragraph (A) on an annual basis based on the 

4 projected cost of implementing and enforcing 

5 this section, including the cost of inspections 

6 under subsection (b). 

7 ‘‘(C) COLLECTIONS AND APPROPRIATIONS

8 ACTS.—The fees authorized by subparagraph 

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

10 extent and in the amounts provided in advance 

11 in appropriations Acts. 

12 ‘‘(5) REGISTRATION RENEWAL.—The Secretary 

13 shall require that the registration of a registrant be 

14 renewed by such registrant at such intervals as the 

15 Secretary determines appropriate. 

16 ‘‘(6) CHANGE OF INFORMATION.—Not later 

17 than 30 days after any change of any information 

18 listed in paragraph (3), an applicant or registrant 

19 shall notify the Secretary of such change in writing 

20 as prescribed by regulation by the Secretary. 

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

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

23 premises described in subsection (a)(3)(D). 

24 ‘‘(c) RECORD KEEPING.— 


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1 ‘‘(1) IN GENERAL.—A registrant shall maintain 

2 a record for each case in which the registrant ac3 quires a human body or human body part. 

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

5 paragraph (1) shall contain such information as the 

6 Secretary may by regulation require. Unless the Sec7 retary specifies otherwise by regulation, a record 

8 under paragraph (1) shall include the following: 

9 ‘‘(A) Documentation that the donor has 

10 knowingly consented to the transfer of the 

11 human body or human body part (not for use 

12 in transplantation) involved for education, re13 search, or the advancement of medical, dental, 

14 or mortuary science in accordance with all ap15 plicable laws pertaining to the disposition of 

16 human remains. 

17 ‘‘(B) Documentation that the donor has 

18 been informed of the obligation of the reg19 istrant under subsection (e) to dispose of the 

20 human body or human body part. 

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

22 transfer from the donor. 

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

24 any trade or business name, who transferred 


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1 the human body or human body part to the reg2 istrant, if applicable. 

3 ‘‘(E) The full name and most recent ad4 dress of the donor. 

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

6 human body part being acquired or transferred. 

7 ‘‘(G) The medical history of the donor, in8 cluding the autopsy report if an autopsy was 

9 conducted. 

10 ‘‘(H) The identity and address of each per11 son that has been in possession of the human 

12 body or human body part prior to the reg13 istrant, including any funeral home, coroner, 

14 hospital, organ procurement organization, or 

15 tissue bank. 

16 ‘‘(I) Documentation of the use and disposi17 tion of each human body or human body part 

18 by the registrant. 

19 ‘‘(J) Documentation of the name and ad20 dress of each person to whom the registrant 

21 transfers such human body or human body 

22 part. 

23 ‘‘(d) LABELING AND PACKAGING.— 

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

25 that all human bodies and human body parts in the 


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1 possession of, or transferred by, a registrant are la2 beled and packaged in accordance with paragraphs 

3 (2) and (3) and that a proper chain of custody is 

4 maintained. 

5 ‘‘(2) LABELING REQUIREMENTS.— 

6 ‘‘(A) PLACEMENT.—The labeling required 

7 by paragraph (1) shall be affixed beneath the 

8 outer packaging. 

9 ‘‘(B) CONTENTS.—The labeling required 

10 by paragraph (1) shall contain such information 

11 as the Secretary may by regulation require con12 sistent with any applicable Federal privacy pro13 visions. Unless the Secretary specifies otherwise 

14 by regulation, a label under paragraph (1) shall 

15 include the following: 

16 ‘‘(i) The proper name of the donor. 

17 ‘‘(ii) A description of the contents of 

18 the packaging, indicating whether it is a 

19 human body or human body parts, includ20 ing a list of all such parts. 

21 ‘‘(iii) The name, address, and any ap22 plicable license or registration number of 

23 the person transferring the human body or 

24 human body part. 


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1 ‘‘(iv) The tissue types of the human 

2 body or human body part. 

3 ‘‘(v) The cause of death of the donor, 

4 if applicable and known. 

5 ‘‘(vi) Serological test results, if any 

6 such results exist. 

7 ‘‘(vii) Record of the presence of radio8 active materials or implants. 

9 ‘‘(viii) Any known infectious disease 

10 agents of such human body or human body 

11 part. 

12 ‘‘(ix) A statement about the use of 

13 personal protective equipment and uni14 versal precautions when handling a human 

15 body or human body part as required by 

16 law. 

17 ‘‘(x) 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) LIMITATIONS ON USE AND DISCLOSURE OF IN8 FORMATION.—Individually identifiable information relat9 ing to the donor of a human body or human body part 

10 acquired or transferred pursuant to a registration under 

11 this section shall be used and disclosed only for such pur12 poses (including the return of remains for burial) as the 

13 Secretary may explicitly authorize by regulation. 

14 ‘‘(f) DISPOSITION.—The registrant shall ensure the 

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

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

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

18 part to a relative or personal representative of the 

19 donor or carrying out the disposition of such human 

20 body or human body part in accordance with the 

21 written instructions of the person or persons with 

22 the right to control the disposition of the human 

23 body or body parts; or 

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

25 body or human body part to another person, conVerDate Sep 11 2014 02:22 Oct 04, 2022 Jkt 039200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S4929.IS S4929

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1 tracting with such person to assume the obligation 

2 described in paragraph (1). 

3 ‘‘(g) VIOLATIONS.— 

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

5 requirement of this section shall be fined in accord6 ance with title 18, United States Code. 

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

8 Secretary may suspend or revoke the registration of 

9 any registrant found to be in violation of this sec10 tion. 

11 ‘‘(3) ALTERATION OR FALSIFICATION OF

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

13 any person to alter or falsify any information in a 

14 label required by subsection (d). 

15 ‘‘(h) DEFINITIONS.—In this section: 

16 ‘‘(1) DONOR.—The term ‘donor’ means a per17 son who has knowingly consented in accordance with 

18 applicable law to the transfer of such person’s de19 ceased body or deceased or living body part (not for 

20 use in transplantation) for education, research, or 

21 the advancement of medical, dental, or mortuary 

22 science. 

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

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

25 or training individuals, including medical, dental, or 


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1 mortuary science students or professionals, with re2 gard to the anatomy and characteristics of the 

3 human body, disease detection, and such other uses 

4 as may be specified by the Secretary by regulation. 

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

6 means a deceased human body. 

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

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

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

10 or living human body that is subject to an anatom11 ical gift or other transfer made pursuant to State 

12 law, but do not include— 

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

14 ‘‘(B) a growing cell line. 

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

16 include an autopsy or examination, conducted as 

17 part of a criminal investigation.’’. 

18 (b) RULE OF APPLICABILITY.—The amendments 

19 made by this section shall apply with respect to any acqui20 sition or transfer of a human body or human body parts 

21 after the date that is 2 years after the date of the enact22 ment of this Act. 

Æ 


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