Title: Consensual Donation and Research Integrity Act of 2021
Policy area: Health

Summary:
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)]

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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.
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