text: To amend the Federal Food, Drug, and Cosmetic Act to ensure that human 
  tissue intended for transplantation is safe and effective 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.
  
      (a) Short Title.--This Act may be cited as the ``Human Tissue for 
  Transplantation Act of 1993''.
      (b) Reference.--Whenever in this Act an amendment or repeal is 
  expressed in terms of an amendment to, or repeal of, a section or other 
  provision, the reference shall be considered to be made to a section or 
  other provision of the Federal Food, Drug, and Cosmetic Act.
  
  SEC. 2. FINDINGS.
  
      The Congress finds that reasonable assurance of the safety and 
  effectiveness of human tissue for transplantation through regulatory 
  oversight is necessary to protect the public health against the 
  transmission of infectious disease or the conduct of medical therapy 
  with human tissue unfit for use.
  
  SEC. 3. DEFINITIONS.
  
      Section 201 (21 U.S.C. 321) is amended--
              (1) in the first sentence of paragraph (g)(1), by striking 
          ``, and (D), and inserting ``, (D)'' and by inserting before 
          the period ``, and (E) human tissue in combination with a drug 
          as described in clause (A), (B), (C), or (D)'',
              (2) in paragraph (h), by inserting after ``implant,'' the 
          following: ``human tissue (other than banked human tissue),'', 
          and
              (3) by adding at the end the following:
      ``(gg)(1) The term `tissue' means an aggregate of cells or their 
  intercellular substance that form a structural material.
      ``(2)(A) The term `banked human tissue' means any tissue--
              ``(i) derived from a human body that is intended for 
          administration to a human for the diagnosis, cure, mitigation, 
          treatment or prevention of any condition or disease,
              ``(ii) procured, processed, stored, or distributed by 
          methods to prevent the transmission of infectious disease and 
          to preserve clinical usefulness, and
              ``(iii) not intended to change tissue structure or 
          functional characteristics.
      ``(B) Such term does not include--
              ``(i) whole organs, including hearts, kidneys, livers, 
          lungs, pancreases, or any other organ containing vasculature 
          that carries blood after transplantation,
              ``(ii) blood, blood products, bone marrow, reproductive 
          tissue, or human milk, or
              ``(iii) autograft human tissue that is not stored or 
          processed during a single surgical procedure.''.
      ``(3) The term `human tissue bank' means a person that procures, 
  processes, stores, or distributes banked human tissue.''.
  
  SEC. 4. REGULATION OF HUMAN TISSUE BANKS
  
      Chapter V is amended by adding at the end the following:
  
                     ``Subchapter D-Human Tissue Banks
  
                     ``regulation of human tissue banks
  
      ``Sec. 545. (a) Prevention of Disease Transmission.--To prevent the 
  transmission of infectious disease by the use of banked human tissue, 
  the Secretary may by regulation require--
              ``(1) the screening of donors of tissue,
              ``(2) the testing of donors of tissue and tissue donated, 
          and
              ``(3) recordkeeping by human tissue banks, including 
          records that provide a method to track tissue from a donor to a 
          recipient and from a recipient to a donor, taking into account 
          the privacy interest of donors, donor families, and recipients.
      ``(b) Good Tissue Banking Practice.--The Secretary shall by 
  regulation establish good tissue banking practices by human tissue 
  banks which may require--
              ``(1) ascertainment of donor suitability,
              ``(2) recovery of cadaveric or living donor tissue,
              ``(3) tissue screening and acceptance,
              ``(4) validation of the manufacturing, equipment, and 
          facilities used for banked human tissue,
              ``(5) finished tissue inspection and control,
              ``(6) inspection for quality control,
              ``(7) investigation of failures involving banked human 
          tissue and files of complaints about such failures,
              ``(8) recordkeeping,
              ``(9) assurance of the quality of banked human tissue,
              ``(10) personnel requirements, including a requirement for 
          a medical director who is a physician licensed to practice 
          medicine in the State in which the bank is located, and
              ``(11) special practices for specific tissues.
      ``(c) Labeling, Advertising, and Promotion.--The Secretary may by 
  regulation prescribe requirements for the labeling, advertising, and 
  promotion of banked human tissue by human tissue banks. Such 
  requirements shall include--
              ``(1) requirements for adequate direction for use, and
              ``(2) information about results from the use of banked 
          human tissue according to directions or under customary and 
          usual conditions.
      ``(d) Operating Permits.--
              ``(1) In general.--The Secretary shall by regulation 
          require human tissue banks to acquire a permit for operation. 
          Such a permit may be acquired by a human tissue bank if--
                      ``(A) the human tissue bank has on file with the 
                  Secretary an application for such permit which 
                  demonstrates, through supporting documentation, that 
                  the bank is in compliance with the requirements of 
                  subsections (a), (b), and (c),
                      ``(B) the human tissue bank has on file with the 
                  Secretary an application for an exemption from the 
                  requirements of subsection (a), (b), or (c) and the 
                  Secretary has approved such application based upon--
                              ``(i) data from well controlled scientific 
                          studies designed to provide reasonable 
                          assurance that an exemption from such 
                          requirements is safe and does not reduce 
                          clinical utility, or
                              ``(ii) a determination by the Secretary, 
                          after consultation with a Tissue Advisory 
                          Committee, that such an exemption does not 
                          affect the safety and effectiveness of the 
                          operations of such bank, or
                      ``(C) the human tissue bank has on file with the 
                  Secretary an application for an exemption from the 
                  requirements of subsection (a), (b), or (c) to 
                  investigate new or existing standards, methods, or uses 
                  relating to tissue, such application is submitted with 
                  a proposed scientific protocol for such investigation, 
                  and the Secretary has determined that such 
                  investigation does not affect the safety and 
                  effectiveness of the operations of such bank and that 
                  patients of the bank will be protected by a requirement 
                  of adequate informed consent.
              ``(2) Permits.--The Secretary shall issue an operating 
          permit to a human tissue bank if the Secretary determines the 
          bank meets the requirements of paragraph (1). Such a permit 
          shall identify the tissues banked by the bank and the methods 
          of procurement, processing, storage, and distribution of such 
          tissue which the Secretary had determined to be safe and 
          effective. A permit shall be valid for such period as specified 
          by the Secretary but not for more than 3 years.
              ``(3) Amendment.--The Secretary shall allow a human tissue 
          bank which has a permit issued under paragraph (2) to amend the 
          permit if under the amendment the human tissue bank is still in 
          compliance with paragraph (1).
              ``(4) Revocation.--The Secretary shall revoke, in whole or 
          in part, a permit of a human tissue bank issued under paragraph 
          (2) if the Secretary determines that the bank is operating in a 
          manner which is inconsistent with its permit and which places 
          the bank out of compliance with paragraph (1).
      ``(e) Registration.--Each human tissue bank, except human tissue 
  banks that operate solely for research or teaching, shall under 
  regulations of the Secretary be required to register in accordance with 
  the requirements of section 510 as made applicable under such 
  regulations.
      ``(f) Regulations.--The Secretary shall promulgate the regulations 
  required by subsection (a), (b), (c), (d), and (e) within 5 years of 
  the date of the enactment of the Human Tissue for Transplantation Act 
  of 1993 and shall be based on adequate scientific evidence.
  
                        ``tissue advisory committees
  
      ``Sec. 546. (a) In General.--The Secretary shall establish a 
  national advisory committee to be known as the Tissue Advisory 
  Committee (hereinafter in this section referred to as the `advisory 
  committee'). The advisory committee shall be established within one 
  year of the date of the enactment of the Human Tissue for 
  Transplantation Act of 1993.
      ``(b) Composition.--The advisory committee shall be comprised of 
  not fewer than 13 or more than 19 individuals who are not officers or 
  employees of the Federal Government. The Secretary shall make 
  appointments to the advisory committee from among physicians, other 
  health care practitioners, and representatives of human tissue bank 
  consumers and industry groups whose clinical practice, research 
  specialization, or expertise include a significant focus on tissue 
  transplantation by human tissue banks.
      ``(c) Functions.--The advisory committee shall--
              ``(1) advise the Secretary on appropriate quality standards 
          and regulations for human tissue banks under section 545,
              ``(2) report on new developments concerning tissue 
          transplantation,
              ``(3) advise the Secretary on appropriate standards for the 
          prevention of infectious disease transmission by banked human 
          tissues,
              ``(4) advise the Secretary on appropriate quality standards 
          for good tissue banking practices under section 545(b),
              ``(5) advise the Secretary in the development of 
          regulations to ensure that adequate directions for use of 
          banked human tissues are provided by human tissue banks,
              ``(6) make recommendations in the establishment of 
          mechanisms to investigate consumer complaints, and
              ``(7) perform such other activities as the Secretary may 
          require.
      ``(d) Meetings.--The advisory committee shall meet not less often 
  than quarterly during the first 3 years of its operation.
      ``(e) Chairperson.--The Secretary shall appoint the chairperson of 
  the advisory committee from among members of the advisory committee.''.
  
  SEC. 5. ENFORCEMENT.
  
      (a) Adulteration.--Section 501 (21 U.S.C. 351) is amended--
              (1) by inserting ``, banked human tissue,'' after ``drug'' 
          before paragraph (a),
              (2) in paragraphs (a)(2)(B) and (d), by inserting ``or 
          banked human tissue'' after ``drug'' each place it occurs,
              (3) by adding at the end the following:
      ``(j)(1) If it is banked human tissue and the materials, 
  facilities, or controls used for its procurement, processing, 
  distribution, or storage are not in conformity with the requirements of 
  section 545(b).
      ``(2) If it is banked human tissue for which an exemption for 
  investigation use of human tissue has been granted under section 
  545(d)(1)(D) and the person granted such exemption or any investigator 
  fails to comply with the requirements of such section.'', and
              (4) in the title to the section, by inserting ``or banked 
          human tissue'' after ``drugs.
      (b) Misbranding.--Section 502 (21 U.S.C. 352) is amended--
              (1) by inserting ``, banked human tissue,'' after ``drug'' 
          before paragraph (a),
              (2) in paragraph (f), the first sentence of paragraph (h), 
          and (i), by inserting ``or banked human tissue'' after ``drug'' 
          each place it occurs
              (3) in paragraph (o), by inserting ``or if an application 
          or other information respecting it was not provided as required 
          by section 545(d),'' after ``510(e)'',
              (4) by adding at the end the following:
      ``(u)(1) If it is banked human tissue subject to regulation under 
  section 545(c) unless it bears such labeling as may be required.
      ``(2) If it is a banked human tissue distributed or offered for 
  sale in any State and its promotion or advertising is false or 
  misleading in any particular.'', and
              (5) in the title to the section, by inserting ``or banked 
          human tissue'' after ``drugs.
      (c) Prohibited Acts.--Section 301 (21 U.S.C. 331) is amended--
              (1) in paragraphs (a), (b), (c), (g), (h), (k), and (l), by 
          inserting ``, banked human tissue'' after ``drug'' each place 
          it occurs,
              (2) in paragraph (d), by striking ``404 or 505'' and 
          inserting ``404, 505, or 545'',
              (3) in paragraph (j), by inserting ``, 545'' after ``520'',
              (4) in paragraph (p), by striking ``510,'' and inserting 
          ``510 or 545(e),'', and
              (5) in paragraphs (q)(2) and (r), by inserting ``or banked 
          human tissue'' after ``device''.
      (d) Penalties.--Section 303(f) (21 U.S.C. 333(f)) is amended by 
  inserting ``or banked human tissues'' after ``devices''.
      (e) Seizures.--Section 304 (21 U.S.C. 334) is amended--
              (1) in subsections (a)(1) and (d)(1), by inserting ``, 
          banked human tissue'' after ``drug'',
              (2) in subsection (a)(1), by striking ``, and (D)'' and 
          inserting ``(D) Any adulterated or misbranded banked human 
          tissue, and (E)'', and
              (3) in subsection (g)(1), by striking ``or a vehicle, a 
          device'' and inserting ``, a vehicle, a device, or banked human 
          tissue'' and by inserting after each other occurrence of 
          ``device'' the following: ``or banked human tissue''.
      (f) Investigations.--Section 702 (21 U.S.C. 372) is amended--
              (1) in subsection (b), by inserting ``, banked human 
          tissue'' after ``drug'', and
              (2) in subsection (d), by inserting ``or banked human 
          tissues'' after ``drugs''.
      (g) Records of Interstate Shipment.--Section 703 (21 U.S.C. 373) is 
  amended--
              (1) by inserting ``or banked human tissues'' after 
          ``drugs'' each place it occurs, and
              (2) by inserting ``or banked human tissue'' after ``drug'' 
          each place it occurs.
      (h) Inspections.--Section 704 (21 U.S.C. 374) is amended--
              (1) in subsection (a)(1)(A), by inserting ``, banked human 
          tissues'' after ``drugs'' each place it occurs,
              (2) in subsection (a)(1)(B), by inserting ``, banked human 
          tissues'' after ``prescription drugs'' each place it occurs, 
          and
              (3) in subsection (b), by inserting ``, banked human 
          tissue'' after ``drug''.
      (i) Publicity.--Section 705(b) (21 U.S.C. 375(b)) is amended by 
  inserting ``, banked human tissues'' after ``drugs''.
      (j) Interstate Commerce Presumption.--Section 709 (21 U.S.C. 379a) 
  is amended by inserting ``or banked human tissue'' after ``device''.
      (k) Imports and Exports.--Section 801 (21 U.S.C 381) is amended--
              (1) in the first sentence of subsection (a), by inserting 
          ``, banked human tissues'' and ``drugs'',
              (2) in subsection (a)(3), by inserting ``or 545'' after 
          ``505'', and
              (3) in subsections (b) and (e)(1), by inserting ``, banked 
          human tissue'' after ``drug''.
  
  SEC. 6. FUNDING.
  
      (a) Imposition.--Each human tissue bank--
              (1) which has a permit issued under section 545(d) shall 
          pay a fee for such permit, and
              (2) which is registered under section 545(e) shall pay a 
          fee for such registration.
  The fees imposed under this subsection are imposed to cover the costs 
  of the Secretary in the implementation of sections 545 and 546.
      (b) Fee Amount.--The Secretary shall determine the amount of the 
  fees imposed by subsection (a) on the basis of the gross revenue of the 
  human tissue bank paying the fee which relates to the procurement, 
  processing, storage, and distribution of human tissue.
      (c) Crediting and Availability of Fees.--
              (1) In general.--Fees collected for a fiscal year pursuant 
          to subsection (a) shall be credited to the appropriation 
          account for salaries and expenses of the Secretary and shall be 
          available in accordance with appropriation Acts until expended 
          without fiscal year limitation.
              (2) Collections.--The fees imposed under subsection (a)--
                      (A) shall be collected in each fiscal year in an 
                  amount equal to the amount specified in appropriation 
                  Acts for such fiscal year, and
                      (B) shall only be collected and available to defray 
                  the costs of implementing sections 545 and 546.
      (d) Effective Date.--The fee authorized by subsection (a)(1) shall 
  take effect 4 years after the date of the enactment of the Human Tissue 
  for Transplantation Act of 1993 and the fee authorized by subsection 
  (a)(2) shall take effect one year after the date of the enactment.
  
  SEC. 7. HUMAN HEART VALVES.
  
      (a) Enforcement.--The Secretary of Health and Human Services may 
  not enforce the Secretary's regulation, promulgated on May 13, 1987, 
  and published at page 18162 of 52 Federal Register, insofar as such 
  regulation applies to human heart valves.
      (b) Premarket Approval Determination.--The determination of the 
  Secretary issued June 26, 1991 (56 FR 29177), acting through the Food 
  and Drug Administration, that human heart valves are replacement heart 
  valves subject to premarket approval under section 515 of the Federal 
  Food, Drug, and Cosmetic Act (21 U.S.C. 360e) shall have no legal force 
  and effect.
target: Human Tissue for Transplantation Act of 1993 - Amends the Federal Food, Drug, and Cosmetic Act to provide for the regulation of human tissue banks and tissue banking practices. 
  Directs the Secretary of Health and Human Services to establish a Tissue Advisory Committee for advice on standards and regulations. 
  Provides for the use of tissue bank permit fees to cover costs of implementing this Act. 
  Prohibits the Secretary from enforcing existing regulations that treat human heart valves as medical devices subject to premarket approval.  Rescinds the determination by the Secretary that human heart valves must undergo premarket approval.
feat_title: Human Tissue for Transplantation Act of 1993