[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3547 Introduced in House (IH)]

103d CONGRESS
  1st Session
                                H. R. 3547

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.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           November 19, 1993

  Mr. Wyden introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
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.