119-hr2589

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2589 Introduced in House

    (IH) ]

<DOC>

119th CONGRESS
 1st Session
 H. R. 2589

 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

 April 2, 2025

Mr. Bilirakis (for himself and Mrs. Fletcher) 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 2025''.

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 human bodies and 
 sells for profit a whole human body or human body part in or 
 affecting interstate commerce 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), funeral service professionals in regard 
 to the preparation, transportation, and final disposition of 
 the human body or body parts, and schools of medicine, 
 dentistry, and mortuary science and research, training 
 organizations, and other entities that do not sell for profit a 
 whole body or body part.
 ``

    (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) and that a proper chain 
 of custody is maintained.
 ``

    (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) Record of the presence of 
 radioactive materials or implants.
 ``
            (viii) Any known infectious disease 
 agents of such human body or human body part.
 ``
            (ix) 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.
 ``
            (x) 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 in 
 accordance with the written instructions of the person or 
 persons with the right to control the disposition of the human 
 body or body parts; 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.
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