article: 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.
summary: 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.