[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[S. 2195 Introduced in Senate (IS)]







104th CONGRESS
  2d Session
                                S. 2195

 To provide for the regulation of human tissue for transplantation to 
 ensure that such tissue is handled in a manner to preserve its safety 
                  and purity, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            October 3, 1996

    Mr. Wyden (for himself, Mr. Dodd, and Mr. Simon) introduced the 
 following bill; which was read twice and referred to the Committee on 
                       Labor and Human Resources

_______________________________________________________________________

                                 A BILL


 
 To provide for the regulation of human tissue for transplantation to 
 ensure that such tissue is handled in a manner to preserve its safety 
                  and purity, 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. HUMAN TISSUE.

    (a) In General.--Section 201 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321) is amended by adding at the end the 
following:
    ``(hh)(1) The term `human tissue' means a collection of similar 
human cells which--
            ``(A) is intended for use in the diagnosis, cure, 
        mitigation, treatment, or prevention of a disease or condition 
        in a human or for reproduction;
            ``(B) achieves its primary intended purpose through repair 
        or replacement of bodily tissue by structural support or 
        cellular function;
            ``(C) may have been propagated or otherwise processed 
        before use;
            ``(D) may be combined with substances that are safe under 
        conditions of intended use and not intended to provide a 
        therapeutic effect; and
            ``(E) includes reproductive tissue, demineralized bone, 
        heart valves, dura mater, and manipulated autologous cells.
    ``(2) The term `human tissue' does not include vascularized human 
organs, gene therapy, blood, soluble blood components, milk, or 
products made by combining human tissue with biomaterials.
    ``(3) Human tissue is not a drug, biological product, or device 
unless reclassified by the Secretary pursuant to section 352A of the 
Public Health Service Act.''.
    (b) Regulation of Human Tissue.--Subpart 1 of part F of title III 
of the Public Health Service Act (42 U.S.C. 262 et seq.) is amended by 
adding at the end the following section:

                      ``regulation of human tissue

    ``Sec. 352A. (a) Subject to Regulation.--
            ``(1) In general.--Human tissue shall be subject to 
        regulation under this section only if the Secretary publishes a 
        finding in the Federal Register, after a hearing before the 
        Commissioner, that voluntary regulation under generally 
        accepted scientific standards is inadequate to protect the 
        public health with respect to any particular type of human 
        tissue or human tissue generally.
            ``(2) Exception.--Human tissue shall not be subject to 
        regulation as a drug, biological product, or device unless it 
        is reclassified under subsection (f).
    ``(b) Registration.--
            ``(1) In general.--Any person subject to regulation under 
        this section who recovers, processes, stores, or distributes 
        human tissue for transplantation or implantation in the United 
        States shall register in accordance with the registration 
        procedures established for drugs under section 510 of the 
        Federal Food, Drug, and Cosmetic Act. Such registration shall 
        contain the name of the person, the location of its facilities, 
        a list of the types of human tissue recovered, processed, 
        stored, or distributed by such person, and a brief description 
        of the basic method or methods of processing of such tissue.
            ``(2) Authorized activities.--A person registered in 
        accordance with paragraph (1) shall be deemed to be authorized 
        to conduct human tissue recovery, processing, storage, and 
        distribution activities as identified in the applicable 
        registration unless--
                    ``(A)(i) the Secretary determines, upon inspection, 
                that such person fails to meet applicable operating 
                standards under subsection (c);
                    ``(ii) the Secretary notifies such person of a 
                determination under clause (i), advises the person of 
                the steps necessary to meet such standards, and 
                provides the person with a reasonable opportunity to 
                establish compliance with the standards;
                    ``(iii) the Secretary determines, after an 
                opportunity for an informal hearing, that the person 
                has failed to establish compliance as provided for in 
                clause (ii) within the applicable period and such 
                failure constitutes a threat to the public health; and
                    ``(iv) the Secretary suspends or revokes the 
                authority to conduct such activities;
                    ``(B) the Secretary determines, after an 
                opportunity for an informal hearing, that such person 
                has failed to comply with any patient registry or other 
                retrospective patient data requirement, and the 
                Secretary suspends or revokes the authority to conduct 
                such activities; or
                    ``(C) the Secretary determines that such person 
                presents an immediate or substantial danger to the 
                public health, and the Secretary suspends or revokes 
                the authority to conduct such activities, in which case 
                an informal hearing shall be conducted within 5 
                business days of the date of such suspension or 
                revocation.
    ``(c) Operating Standards.--The Secretary may establish, after 
notice and opportunity for comment, operating standards for human 
tissue that shall be limited to the following general requirements for 
the recovery, processing, storage, and shipment of human tissue:
            ``(1) Requirements for infection control designed to 
        prevent transmission of disease.
            ``(2) Requirements for processing practices that assure the 
        safety of, and prevent damage to, human tissue.
            ``(3) Requirements for labeling and recordkeeping to 
        identify the type of tissue and any added foreign substance and 
        to permit tracing.
    ``(d) Labeling and Advertising.--Statements made in labeling, 
advertising or promotional materials regarding clinical benefit with 
respect to human tissue shall consist only of accurate and balanced 
representations that are consistent with sound scientific information, 
including current data from a registry required or established under 
subsection (e), if available.
    ``(e) Registry.--A person registered under subsection (b) may be 
required by the Secretary to maintain a patient registry or meet other 
retrospective patient data requirements if, after notice and an 
opportunity for comment, the Secretary determines that such tissue has 
been commercially available within the United States for a period of 
less than 5 years and that such data requirement is necessary to 
protect the public health.
    ``(f) Reclassifications.--
            ``(1) Human tissue.--The Secretary may reclassify a 
        particular type of human tissue as a drug, biological product 
        or device if, after notice and an opportunity for comment, the 
        Secretary determines that--
                    ``(A) with respect to the particular type of human 
                tissue--
                            ``(i) the tissue is subject to a patient 
                        registry or other retrospective data 
                        requirement under which the collection of 
                        information has been required for at least 5 
                        years (or such other time period as agreed to 
                        by the Secretary and the registered person); 
                        and
                            ``(ii) the information received from such 
                        patient registry or other retrospective data 
                        requirement is insufficient to confirm the 
                        safety and clinical benefit from the use of 
                        such tissue; or
                    ``(B) a particular type of human tissue should be 
                reclassified because it presents an imminent hazard to 
                public health.
            ``(2) Upon secretarial action.--The Secretary may 
        reclassify a human drug, biological product or medical device 
        as human tissue if the Secretary determines, after notice and 
        an opportunity for comment, that such previous classification 
        is not necessary to protect public health.
            ``(3) Upon petition.--The Secretary may reclassify a drug, 
        biological product, medical device, or human tissue upon the 
        petition of the sponsor of such drug, biological product or 
        device, or the registered person for such human tissue, if, 
        after notice and an opportunity to comment, the Secretary finds 
        that such reclassification is consistent with the protection of 
        public health.
    ``(g) Enforcement.--
            ``(1) In general.--If the Secretary determines that any 
        person has violated any provision of this section or any 
        regulations promulgated under this section, and the Secretary 
        determines that the violation constitutes a significant risk to 
        the public health, the Secretary may issue an order that such 
        person cease distribution of human tissue, or that human tissue 
        recovered, processed, stored or distributed by such person be 
        retained, recalled, or destroyed. After receipt of such an 
        order, the person in possession of the human tissue shall not 
        distribute or dispose of the human tissue in any manner 
        inconsistent with the provisions of the order.
            ``(2) Hearing.--A person subject to the order under 
        paragraph (1) may obtain an informal hearing regarding the 
        order if the person requests such a hearing not later than 5 
        days after receiving the order. If the person does make such a 
        request within such period, the Secretary shall conduct the 
hearing within 30 days after receiving the request and shall issue an 
order not later than 15 days after the hearing is conducted. Such order 
shall be considered a final order of the Secretary.
    ``(h) Inspection.--Each person registered under subsection (b) 
shall be subject to inspection under section 704 of the Federal Food, 
Drug, and Cosmetic Act. The Secretary may, with the concurrence of the 
registered person, authorize an inspection to be conducted by any 
person specifically accredited by the Secretary to conduct such 
inspection under section 712 of such Act.
    ``(i) Cord Blood.--
            ``(1) In general.--This section (including provisions 
        regarding reclassification) shall apply with respect to cord 
        blood to the same extent and in the same manner as this section 
        applies with respect to human tissue.
            ``(2) Implementation.--The Secretary shall implement this 
        section with respect to cord blood under regulations 
        promulgated after notice and opportunity to comment.
    ``(j) Eyes.--The Secretary shall not regulate eyes until such time 
as the Secretary makes a finding under this section that voluntary 
regulation under generally accepted standards is inadequate to protect 
the public health.''.
    (c) Transition.--The requirements of the interim regulation, 
promulgated by the Secretary of Health and Human Services on December 
11, 1993, shall remain in effect until amended or withdrawn by the 
Secretary. Any modifications to such regulations after the date of the 
enactment of this Act are subject to this Act and the amendments made 
by this Act.
    (d) Effective Date.--The amendment made by subsection (c) shall 
take effect on June 30, 1997.
    (e) Conforming Amendments.--
            (1) Adulteration provision.--Section 501 of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 351) is amended--
                    (A) in the first sentence by striking ``drug or 
                device'' and inserting ``drug, device or human 
                tissue''; and
                    (B) by adding at the end thereof the following:
    ``(j) if it is human tissue and it is recovered, processed, stored, 
or distributed by--
            ``(1) a registered person under section 352A of the Public 
        Health Service Act whose failure to comply with standards 
        constitutes a threat to public health; or
            ``(2) a person who is required under such section to 
        register but has failed to do so.''.
            (2) Misbranding provisions.--Section 502 of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amended:
                    (A) in the section heading, but striking 
                ``MISBRANDED DRUGS AND DEVICES'' and inserting the 
                following: ``MISBRANDED DRUGS, DEVICES, AND HUMAN 
                TISSUE''; and
                    (B) in the first sentence, by striking ``drug or 
                device'' and inserting ``drug, device or human 
                tissue''.
            (3) Prohibited acts.--Section 301 of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding at 
        the end thereof the following:
    ``(v) The adulteration or misbranding of any human tissue.''.
            (4) Seizure.--Section 304 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 334) is amended--
                    (A) in subsection (a)(2)(D), by inserting ``or 
                human tissue'' after ``device''; and
                    (B) in the first sentence of subsection (d)(1), by 
                striking ``or cosmetic'' and inserting ``cosmetic, or 
                human tissue''.
            (5) Inspection.--Section 704(a)(1) of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 374(a)(1)) is amended--
                    (A) in the first sentence, by inserting ``human 
                tissue,'' after ``device,'' each place such appears; 
                and
                    (B) in the second sentence, by inserting ``human 
                tissue,'' after ``drugs,'' each place such appears.
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