Consensual Donation and Research Integrity Act of 2021
This bill requires entities that acquire or transfer human bodies or body parts for education, research, or the advancement of medical, dental, or mortuary science to register with the Department of Health and Human Services.
Registered entities must comply with record-keeping, labeling, packaging, and disposition requirements. The registration and related requirements do not apply to the acquisition or transfer of human bodies or body parts for use in human transplantation.
[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4062 Introduced in House (IH)]
<DOC>
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 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
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 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.
Be it enacted by the Senate and House of Representatives 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''.
SEC. 2. 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.
(a) In General.--Title III of the Public Health Service Act (42
U.S.C. 241 et seq.) is amended by inserting after section 373 the
following new section:
``SEC. 373A. 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.
``(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, research, or the advancement of medical, dental,
or mortuary science (and not for use in human transplantation)
shall register with the Secretary at such time and in such
manner as the Secretary may require.
``(2) Exception.--Paragraph (1) does not apply to the Organ
Procurement and Transplantation Network under section 372 and
any entity that is a member of the Network pursuant to section
121.3 of title 42, Code of Federal Regulations (or any
successor regulations).
``(3) Contents of application.--An applicant for
registration or renewal of registration under this section
shall submit an application to the Secretary containing such
information as the Secretary may by regulation require on the
activities to be carried out pursuant to the registration.
Unless the Secretary specifies otherwise by regulation, an
application shall include--
``(A) the name of the applicant, including all
trade names under which the applicant conducts
business;
``(B) the date on which the applicant first began
or will begin commencing activities described 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 and has the
authority to ensure that the applicant complies with
this section;
``(G) an assurance that the Secretary will be
permitted to inspect the premises and records of the
applicant at the times and in the manners prescribed
under subsection (b);
``(H) an assurance that the applicant will keep
records in accordance with subsection (c);
``(I) an assurance that the applicant will label
and package all human bodies or human body parts in
accordance with subsection (d); and
``(J) an assurance that the applicant will limit
the use and disclosure of information in accordance
with the regulations promulgated pursuant to subsection
(e).
``(4) Fees.--
``(A) Authority.--The Secretary shall establish a
fee for registration under paragraph (1) and renewal
under paragraph (5) in an amount in accordance with
subparagraph (B).
``(B) Amount.--The Secretary shall determine the
amount of the fees authorized by subparagraph (A) on an
annual basis based on the projected cost of
implementing and enforcing 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 acquires a human body or
human body part.
``(2) Record requirements.--A record under paragraph (1)
shall contain such information as the Secretary may by
regulation require. Unless the Secretary 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, research, or the advancement of medical,
dental, or mortuary science in accordance with all
applicable laws pertaining to the disposition of human
remains.
``(B) Documentation that the donor has been
informed of the obligation of the registrant 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 registrant, if applicable.
``(E) The full name and most recent address of the
donor.
``(F) A description of the human body or human body
part being acquired or transferred.
``(G) The medical history of the donor, including
the autopsy report if an autopsy was conducted.
``(H) The identity and address of each person that
has been in possession of the human body or human body
part prior to the registrant, including any funeral
home, coroner, hospital, organ procurement
organization, or tissue bank.
``(I) Documentation of the use and disposition of
each human body or human body part by the registrant.
``(J) Documentation of the name and address 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 labeled and packaged in
accordance with paragraphs (2) and (3).
``(2) Labeling requirements.--
``(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 consistent with any applicable
Federal privacy provisions. 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, including a list of
all such parts.
``(iii) The name, address, and any
applicable 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.
``(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 universal
precautions when handling a human body or human
body part as required by law.
``(ix) The statement `not for
transplantation.'.
``(3) Packaging requirements.--Each human body or human
body part described in paragraph (1) shall be wrapped and
packaged in such manner as the Secretary may by regulation
require. Unless the Secretary specifies otherwise by
regulation, 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 Information.--
Individually identifiable information relating 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 purposes (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, contracting 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 accordance 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 section.
``(3) Alteration or falsification of label.--It shall be a
violation of this section for any person to alter or falsify
any information in a label required by subsection (d).
``(h) Definitions.--In this section:
``(1) Donor.--The term `donor' means a person who has
knowingly consented in accordance with applicable law to the
transfer of such person's deceased body or deceased or living
body part (not for use in transplantation) for education,
research, or the advancement of medical, dental, or mortuary
science.
``(2) Education.--The term `education' means the use of a
human body or body parts for teaching or training individuals,
including medical, dental, or mortuary science students or
professionals, with regard to the anatomy and characteristics
of the human body, disease detection, and such other uses as
may be specified by the Secretary by regulation.
``(3) Human body.--The term `human body' means a deceased
human body.
``(4) Human body part.--The terms `human body part' or
`body part' mean an organ, tissue, eye, bone, blood vessel or
any other portion of a deceased or living human body that is
subject to an anatomical gift or other transfer made pursuant
to State law, but do not include--
``(A) blood drawn for medical purposes; or
``(B) a growing cell line.
``(5) Research.--The term `research' does not include an
autopsy or examination, conducted as part of a criminal
investigation.''.
(b) Rule of Applicability.--The amendments made by this section
shall apply with respect to any acquisition or transfer of a human body
or human body parts after the date that is 2 years after the date of
the enactment of this Act.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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