Consensual Donation and Research Integrity Act of 2021

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. Short title This Act may be cited as the Consensual Donation and Research Integrity Act of 2021 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. 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 (2) Education The term education (3) Human body The term human body (4) Human body part The terms human body part body part (A) blood drawn for medical purposes; or (B) a growing cell line. (5) Research The term research . (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.

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.