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-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Consensual Donation 
and Research Integrity Act of 2021’’. 
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SEC. 2. HUMAN BODIES AND HUMAN BODY PARTS DO-
NATED OR TRANSFERRED FOR EDUCATION, 
RESEARCH, OR THE ADVANCEMENT OF MED-
ICAL, DENTAL, OR MORTUARY SCIENCE AND 
NOT FOR USE IN HUMAN TRANSPLANTATION. 
(a) IN GENERAL.—Title III of the Public Health 
Service Act (42 U.S.C. 241 et seq.) is amended by insert-
ing after section 373 the following new section: 
‘‘SEC. 373A. HUMAN BODIES AND HUMAN BODY PARTS DO-
NATED OR TRANSFERRED FOR EDUCATION, 
RESEARCH, OR THE ADVANCEMENT OF MED-
ICAL, DENTAL, OR MORTUARY SCIENCE AND 
NOT FOR USE IN HUMAN TRANSPLANTATION. 
‘‘(a) REGISTRATION.— 
‘‘(1) IN GENERAL.—A person who acquires or 
transfers in or affecting interstate commerce a 
human body or human body part for education, re-
search, or the advancement of medical, dental, or 
mortuary science (and not for use in human trans-
plantation) shall register with the Secretary at such 
time and in such manner as the Secretary may re-
quire. 
‘‘(2) EXCEPTION.—Paragraph (1) does not 
apply to the Organ Procurement and Transplan-
tation Network under section 372 and any entity 
that is a member of the Network pursuant to section 
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121.3 of title 42, Code of Federal Regulations (or 
any successor regulations). 
‘‘(3) CONTENTS
OF
APPLICATION.—An appli-
cant for registration or renewal of registration under 
this section shall submit an application to the Sec-
retary containing such information as the Secretary 
may by regulation require on the activities to be car-
ried out pursuant to the registration. Unless the 
Secretary specifies otherwise by regulation, an appli-
cation shall include— 
‘‘(A) the name of the applicant, including 
all trade names under which the applicant con-
ducts business; 
‘‘(B) the date on which the applicant first 
began or will begin commencing activities de-
scribed in paragraph (1); 
‘‘(C) a list of all addresses at which the 
applicant conducts business; 
‘‘(D) a description of the premises and 
equipment used by the applicant; 
‘‘(E) a description of the types of service 
provided by the applicant; 
‘‘(F) an identification of a representative 
of the applicant who has attained the age of 18 
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this section, including the cost of inspections 
under subsection (b). 
‘‘(C) COLLECTIONS AND APPROPRIATIONS 
ACTS.—The fees authorized by subparagraph 
(A) shall be available for obligation only to the 
extent and in the amounts provided in advance 
in appropriations Acts. 
‘‘(5) REGISTRATION RENEWAL.—The Secretary 
shall require that the registration of a registrant be 
renewed by such registrant at such intervals as the 
Secretary determines appropriate. 
‘‘(6) CHANGE
OF
INFORMATION.—Not later 
than 30 days after any change of any information 
listed in paragraph (3), an applicant or registrant 
shall notify the Secretary of such change in writing 
as prescribed by regulation by the Secretary. 
‘‘(b) INSPECTIONS.—The Secretary shall inspect at 
regular intervals (to be prescribed by the Secretary) the 
premises described in subsection (a)(3)(D). 
‘‘(c) RECORD KEEPING.— 
‘‘(1) IN GENERAL.—A registrant shall maintain 
a record for each case in which the registrant ac-
quires a human body or human body part. 
‘‘(2) RECORD REQUIREMENTS.—A record under 
paragraph (1) shall contain such information as the 
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Secretary may by regulation require. Unless the Sec-
retary specifies otherwise by regulation, a record 
under paragraph (1) shall include the following: 
‘‘(A) Documentation that the donor has 
knowingly consented to the transfer of the 
human body or human body part (not for use 
in transplantation) involved for education, re-
search, or the advancement of medical, dental, 
or mortuary science in accordance with all ap-
plicable laws pertaining to the disposition of 
human remains. 
‘‘(B) Documentation that the donor has 
been informed of the obligation of the reg-
istrant under subsection (e) to dispose of the 
human body or human body part. 
‘‘(C) The date and time of the donation or 
transfer from the donor. 
‘‘(D) The name of the person, including 
any trade or business name, who transferred 
the human body or human body part to the reg-
istrant, if applicable. 
‘‘(E) The full name and most recent ad-
dress of the donor. 
‘‘(F) A description of the human body or 
human body part being acquired or transferred. 
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‘‘(G) The medical history of the donor, in-
cluding the autopsy report if an autopsy was 
conducted. 
‘‘(H) The identity and address of each per-
son that has been in possession of the human 
body or human body part prior to the reg-
istrant, including any funeral home, coroner, 
hospital, organ procurement organization, or 
tissue bank. 
‘‘(I) Documentation of the use and disposi-
tion of each human body or human body part 
by the registrant. 
‘‘(J) Documentation of the name and ad-
dress of each person to whom the registrant 
transfers such human body or human body 
part. 
‘‘(d) LABELING AND PACKAGING.— 
‘‘(1) IN GENERAL.—A registrant shall ensure 
that all human bodies and human body parts in the 
possession of, or transferred by, a registrant are la-
beled and packaged in accordance with paragraphs 
(2) and (3). 
‘‘(2) LABELING REQUIREMENTS.— 
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‘‘(A) PLACEMENT.—The labeling required 
by paragraph (1) shall be affixed beneath the 
outer packaging. 
‘‘(B) CONTENTS.—The labeling required 
by paragraph (1) shall contain such information 
as the Secretary may by regulation require con-
sistent with any applicable Federal privacy pro-
visions. Unless the Secretary specifies otherwise 
by regulation, a label under paragraph (1) shall 
include the following: 
‘‘(i) The proper name of the donor. 
‘‘(ii) A description of the contents of 
the packaging, indicating whether it is a 
human body or human body parts, includ-
ing a list of all such parts. 
‘‘(iii) The name, address, and any ap-
plicable license or registration number of 
the person transferring the human body or 
human body part. 
‘‘(iv) The tissue types of the human 
body or human body part. 
‘‘(v) The cause of death of the donor, 
if applicable and known. 
‘‘(vi) Serological test results, if any 
such results exist. 
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‘‘(vii) Any known infectious disease 
agents of such human body or human body 
part. 
‘‘(viii) A statement about the use of 
personal protective equipment and uni-
versal precautions when handling a human 
body or human body part as required by 
law. 
‘‘(ix) The statement ‘not for trans-
plantation.’. 
‘‘(3) 
PACKAGING
REQUIREMENTS.—Each 
human body or human body part described in para-
graph (1) shall be wrapped and packaged in such 
manner as the Secretary may by regulation require. 
Unless the Secretary specifies otherwise by regula-
tion, each such human body or human body part 
shall be wrapped and packaged in a manner that— 
‘‘(A) mitigates potential contamination and 
cross contamination; 
‘‘(B) mitigates potential safety hazards; 
‘‘(C) is sealed to prevent leakage; and 
‘‘(D) ensures the integrity of the human 
body or human body part. 
‘‘(e) LIMITATIONS ON USE AND DISCLOSURE OF IN-
FORMATION.—Individually identifiable information relat-
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ing to the donor of a human body or human body part 
acquired or transferred pursuant to a registration under 
this section shall be used and disclosed only for such pur-
poses (including the return of remains for burial) as the 
Secretary may explicitly authorize by regulation. 
‘‘(f) DISPOSITION.—The registrant shall ensure the 
proper disposition of a human body or human body part, 
in accordance with applicable Federal and State law, by— 
‘‘(1) returning the human body or human body 
part to a relative or personal representative of the 
donor or carrying out the disposition of such human 
body or human body part; or 
‘‘(2) if the registrant is transferring the human 
body or human body part to another person, con-
tracting with such person to assume the obligation 
described in paragraph (1). 
‘‘(g) VIOLATIONS.— 
‘‘(1) IN GENERAL.—Any person who violates a 
requirement of this section shall be fined in accord-
ance with title 18, United States Code. 
‘‘(2) REVOCATION
OF
REGISTRATION.—The 
Secretary may suspend or revoke the registration of 
any registrant found to be in violation of this sec-
tion. 
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