[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[S. 2531 Introduced in Senate (IS)]







107th CONGRESS
  2d Session
                                S. 2531

To amend the Public Health Service Act to authorize the Commissioner of 
   Food and Drugs to conduct oversight of any entity engaged in the 
 recovery, screening, testing, processing, storage, or distribution of 
              human tissue or human tissue-based products.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              May 17, 2002

  Ms. Collins introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
To amend the Public Health Service Act to authorize the Commissioner of 
   Food and Drugs to conduct oversight of any entity engaged in the 
 recovery, screening, testing, processing, storage, or distribution of 
              human tissue or human tissue-based products.

    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 ``Human Tissue Transplant Safety Act 
of 2002''.

SEC. 2. OVERSIGHT OF ENTITIES ENGAGING IN ACTIVITIES RELATING TO HUMAN 
              TISSUE AND TISSUE-BASED PRODUCTS.

    Part G of the Public Health Service Act (42 U.S.C. 361 et seq.) is 
amended by adding at the end the following:

``SEC. 369A. OVERSIGHT OF ENTITIES ENGAGING IN ACTIVITIES RELATING TO 
              HUMAN TISSUE AND TISSUE-BASED PRODUCTS.

    ``(a) Definitions.--In this section:
            ``(1) Commissioner.--The term `Commissioner' means the 
        Commissioner of Food and Drugs.
            ``(2) Covered entity.--The term `covered entity' means any 
        entity located in the United States that engages in the 
        recovery, screening, testing, processing, storage, or 
        distribution of human tissue or a tissue-based product.
            ``(3) Human tissue or a tissue-based product.--The term 
        `human tissue or a tissue-based product' has the meaning given 
        the term `human cells, tissues, or cellular tissue-based 
        products' in section 1271.3(d)(2) of title 21, Code of Federal 
        Regulations.
    ``(b) Oversight of Entities.--
            ``(1) Registration.--As a condition of conducting business 
        in the United States, each covered entity shall submit to the 
        Commissioner a request for registration that includes such 
        information relating to the identity and operations of the 
        covered entity as the Commissioner may require.
            ``(2) Inspection.--The Commissioner may conduct such 
        inspections of entities as the Commissioner determines are 
        appropriate to evaluate and ensure compliance with--
                    ``(A) this section; and
                    ``(B) regulations promulgated under subsection (c).
            ``(3) Adverse incidents.--
                    ``(A) In general.--If an adverse incident relating 
                to human tissue or a tissue-based product (as defined 
                by the Commissioner) occurs at a covered entity, the 
                covered entity shall report the adverse incident to the 
                Commissioner not later than 15 days after the 
                occurrence of the adverse incident.
                    ``(B) Reporting mechanism; database.--As soon as 
                practicable after the date of enactment of this 
                section, the Commissioner, in consultation with the 
                Director of the Centers for Disease Control and 
                Prevention, shall develop--
                            ``(i) a single, simple reporting mechanism 
                        for use in reporting adverse incidents under 
                        subparagraph (A); and
                            ``(ii) a database for information received 
                        in relation to any adverse incident reported 
                        under subparagraph (A).
    ``(c) Regulations.--
            ``(1) In general.--As soon as practicable after the date of 
        enactment of this section, the Commissioner shall promulgate 
        regulations to carry out this section, including--
                    ``(A) a description of the information required to 
                be submitted for the registration of a covered entity 
                under subsection (b)(1);
                    ``(B) a definition of the term `adverse incident' 
                for purposes of subsection (b)(3); and
                    ``(C) such other regulations relating to the 
                operation of covered entities as the Commissioner 
                determines are necessary.
            ``(2) Enforcement.--If the Commissioner determines that a 
        covered entity has violated a regulation promulgated under 
        paragraph (1), the Commissioner may suspend or revoke the 
        registration of the covered entity.''.
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