[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[S. 1702 Introduced in Senate (IS)]

103d CONGRESS
  1st Session
                                S. 1702

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 SENATE OF THE UNITED STATES

            November 19 (legislative day, November 2), 1993

   Mr. Simon introduced the following bill; which was read twice and 
         referred to the Committee on Labor and Human Resources

_______________________________________________________________________

                                 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)--
                    (A) by striking ``; and (D), and inserting ``; 
                (D)''; and
                    (B) 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 striking ``implant,'' and 
        inserting ``implant, human tissue (other than banked human 
        tissue),''; and
            (3) by adding at the end the following new paragraph:
    ``(ff)(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 Practices.--The Secretary shall by 
regulation establish good tissue banking practices, by human tissue 
banks, that 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 the Tissue Advisory 
                        Committee under section 546, that such an 
                        exemption does not affect the safety and 
                        effectiveness of the operations of such bank; 
                        or
                    ``(C)(i) the human tissue bank has on file with the 
                Secretary an application for an exemption from the 
                requirements of subsection (a), (b), or (c) in order to 
                conduct an investigation of new or existing standards, 
                methods, or uses relating to tissue;
                    ``(ii) such application is submitted with a 
                proposed scientific protocol for such investigation; 
                and
                    ``(iii) 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 that 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 that is inconsistent with its permit and that 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 subsections (a), (b), (c), (d), and (e) within 5 years of 
the date of the enactment of the Human Tissue for Transplantation Act 
of 1993. Such regulations shall be based on adequate scientific 
evidence.

                      ``tissue advisory committee

    ``Sec. 546. (a) In General.--The Secretary shall establish a 
national advisory committee to be known as the Tissue Advisory 
Committee (hereafter in this section referred to as the `advisory 
committee'). The advisory committee shall be established within 1 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.''.
    ``(f) Personnel Matters.--
            ``(1) Members.--
                    ``(A) Compensation.--Each member of the advisory 
                committee shall be compensated at a rate equal to the 
                daily equivalent of the annual rate of basic pay 
                prescribed for level IV of the Executive Schedule under 
                section 5315 of title 5, United States Code, for each 
                pay (including travel time) during which such member is 
                engaged in the performance of the duties of the 
                advisory committee.
                    ``(B) Travel.--The members of the advisory 
                committee shall be allowed travel expenses, including 
                per diem in lieu of subsistence, at rates authorized 
                for employees of agencies under subchapter I of chapter 
                57 of title 5, United States Code, while away from 
                their homes or regular places of business in the 
                performance of services for the advisory committee.
            ``(2) Other personnel.--
                    ``(A) In general.--The Chairperson of the advisory 
                committee may, without regard to the civil service laws 
                and regulations, appoint and terminate such other 
                additional personnel as may be necessary to enable the 
                advisory committee to perform its duties.
                    ``(B) Compensation.--The Chairperson of the 
                advisory committee may fix the compensation of 
                personnel described in subparagraph (A) without regard 
                to provisions of chapter 51 and subchapter III of 
                chapter 53 of title 5, United States Code, relating to 
                classification of positions and General Schedule pay 
                rates, except that the rate of pay for such personnel 
                may not exceed the rate payable for level V of the 
                Executive Schedule under section 5316 of such title.''.

SEC. 5. ENFORCEMENT.

    (a) Adulteration.--Section 501 (21 U.S.C. 351) is amended--
            (1) in the matter preceding subsection (a), by striking 
        ``drug'' and inserting ``drug, banked human tissue,'';
            (2) in subsection (a)(2)(B), by striking ``drug'' each 
        place such term appears and inserting ``drug or banked human 
        tissue'';
            (3) in subsection (d), by striking ``drug'' and inserting 
        ``drug or banked human tissue''; and
            (4) by adding at the end thereof the following new 
        subsection:
    ``(j)(1) If it is a banked human tissue and the materials, 
facilities, or controls used for its procurement, processing, storage, 
or distribution are not in conformity with the requirements of section 
545(b).
    ``(2) If it is a banked human tissue for which an exemption has 
been granted under section 545(d)(1)(C) to permit investigation use of 
human tissue and the person granted such exemption or any investigator 
fails to comply with the requirements of such section.''; and
            (5) in the title of the section, by striking ``drugs'' and 
        inserting ``drugs or banked human tissue''.
    (b) Misbranding.--Section 502 (21 U.S.C. 352) is amended--
            (1) in paragraph (f), by striking ``drug'' each place such 
        term appears and inserting ``drug, banked human tissue,'';
            (2) in the first sentence of paragraph (h), by striking 
        ``drug'' and inserting ``drug or banked human tissue'';
            (3) in paragraph (i), by striking ``drug'' each place such 
        term appears and inserting ``drug or banked human tissue'';
            (4) in paragraph (o) by striking ``510(e)'' and inserting 
        ``510(e) or if an application or other information respecting 
        it was not provided as required by section 545(d),'';
            (5) by adding at the end the following new paragraph:
    ``(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
            (6) in the title of the section, by striking ``drugs'' and 
        inserting ``drugs, banked human tissue,''.
    (c) Prohibited Acts.--Section 301 (21 U.S.C. 331) is amended--
            (1) in paragraphs (a), (b), (c), (g), (h), (k), and (l), by 
        striking ``drug,'' each place such term appears and inserting 
        ``drug, banked human tissue,'';
            (2) in paragraph (d), by striking ``404 or 505'' and 
        inserting ``404, 505, or 545'';
            (3) in paragraph (j), by striking ``520,'' and inserting 
        ``520, 545,'';
            (4) in paragraph (p), by striking ``510,'' and inserting 
        ``510 or 545(e),'';
            (5) in paragraphs (q)(2), by striking ``device'' and 
        inserting ``device or banked human tissue''; and
            (6) in paragraph (r), by striking ``device'' each place 
        such term appears and inserting ``device or banked human 
        tissue''.
    (d) Penalties.--Section 303(g) (21 U.S.C. 333(g)) is amended by 
striking ``devices'' and inserting ``devices or banked human tissues''.
    (e) Seizures.--Section 304 (21 U.S.C. 334) is amended--
            (1) in subsections (a)(1) and (d)(1), by striking ``drug,'' 
        and inserting ``drug, banked human tissue,'';
            (2) in subsection (a)(2), by striking ``and (D)'' and 
        inserting ``(D) Any adulterated or misbranded banked human 
        tissue, and (E)''; and
            (3) in subsection (g)(1)--
                    (A) by striking ``or a vehicle, a device'' and 
                inserting ``or a vehicle, a device or banked human 
                tissue''; and
                    (B) by striking ``device'' each place such term 
                appears and inserting ``device or banked human 
                tissue''.
    (f) Investigations.--Section 702 (21 U.S.C. 372) is amended--
            (1) in subsection (b), by striking ``drug,'' and inserting 
        ``drug, banked human tissue,''; and
            (2) in subsection (d), by striking ``drugs'' and inserting 
        ``drugs, or banked human tissues''.
    (g) Records of Interstate Shipment.--Section 703 (21 U.S.C. 373) is 
amended--
            (1) by striking ``drugs,'' each place such term appears and 
        inserting ``drugs, banked human tissues,''; and
            (2) by striking ``drug,'' each place such term appears and 
        inserting ``drug, banked human tissue,''.
    (h) Inspections.--Section 704 (21 U.S.C. 374) is amended--
            (1) in subsection (a)(1)(A), by striking ``drugs,'' each 
        place such term appears and inserting ``drugs, banked human 
        tissues,'';
            (2) in the first sentence after paragraph (1)(B) of 
        subsection (a), by striking ``prescription drugs'' each place 
        such term appears and inserting ``prescription drugs, banked 
        human tissues,''; and
            (3) in subsection (b), by striking ``drug,'' and inserting 
        ``drug, banked human tissue,''.
    (i) Publicity.--Section 705(b) (21 U.S.C. 375(b)) is amended by 
striking ``drugs,'' and inserting ``drugs, banked human tissues,''.
    (j) Interstate Commerce Presumption.--Section 709 (21 U.S.C. 379a) 
is amended by striking ``device'' and inserting ``device or banked 
human tissue''.
    (k) Imports and Exports.--Section 801 (21 U.S.C 381) is amended--
            (1) in the first sentence of subsection (a), by striking 
        ``drugs,'' and inserting ``drugs, banked human tissues,'';
            (2) in subsection (a)(3), by striking ``505'' and inserting 
        ``505 or 545''; and
            (3) in subsections (b) and (e)(1), by striking ``drug,'' 
        and inserting ``drug, banked human tissue,''.

SEC. 6. FUNDING.

    (a) Imposition.--
            (1) In general.--Each human tissue bank--
                    (A) that has a permit issued under section 545(d) 
                of the Federal Food, Drug, and Cosmetic Act shall pay a 
                fee for such permit; and
                    (B) that is registered under section 545(e) of such 
                Act shall pay a fee for such registration.
            (2) Use of fees.--The fees imposed under this subsection 
        are imposed to cover the costs of the Secretary in the 
        implementation of sections 545 and 546 of the Federal Food, 
        Drug, and Cosmetic Act.
    (b) Fee Amount.--The Secretary of Health and Human Services 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 that 
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 of Health 
        and Human Services 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 of the 
                Federal Food, Drug, and Cosmetic Act.
    (d) Effective Date.--The fee authorized by subsection (a)(1) shall 
take effect 4 years after the date of the enactment of this Act and the 
fee authorized by subsection (a)(2) shall take effect 1 year after the 
date of the enactment of this Act.

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 of Health and Human Services 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.

                                 <all>

S 1702 IS----2