[Congressional Record Volume 142, Number 143 (Monday, October 21, 1996)]
[Senate]
[Pages S12465-S12466]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                    HUMAN TISSUES SAFETY ACT OF 1996

 Mr. WYDEN. Mr. President, I inadvertently neglected to ask 
that a copy of legislation I introduced with Senators Dodd and Simon be 
printed in the October 3, 1996, Congressional Record.
  I request that this bill, the Human Tissues Safety Act of 1996, be 
printed in the Congressional Record to be dated October 21, 1996.
  The bill follows:

                                S. 2195

       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

[[Page S12466]]

     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 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, by 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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