I
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 Representa-
tives 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 amend-
ment 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 provi-
sion 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 transplan-
tation through regulatory oversight is necessary to protect
the public health against the transmission of infectious
disease or the conduct of medical therapy with human tis-
sue 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 in-
serting 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 ‘‘im-
plant,’’ 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 in-
tended for administration to a human for the diag-
nosis, 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, liv-
ers, lungs, pancreases, or any other organ containing
vasculature that carries blood after transplantation,
‘‘(ii) blood, blood products, bone marrow, repro-
ductive 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 fol-
lowing:
‘‘SUBCHAPTER D-HUMAN TISSUE BANKS
‘‘REGULATION OF HUMAN TISSUE BANKS
‘‘SEC. 545. (a) PREVENTION OF DISEASE TRANS-
MISSION.—To prevent the transmission of infectious dis-
ease 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, in-
cluding records that provide a method to track tis-
sue 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 Sec-
retary 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 tis-
sue,
‘‘(3) tissue screening and acceptance,
‘‘(4) validation of the manufacturing, equip-
ment, 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 re-
quirement 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 reg-
ulation require human tissue banks to acquire a per-
mit 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 per-
mit 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 exemp-
tion from the requirements of subsection (a),
(b), or (c) and the Secretary has approved such
application based upon—
‘‘(i) data from well controlled sci-
entific studies designed to provide reason-
able assurance that an exemption from
such requirements is safe and does not re-
duce 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 exemp-
tion from the requirements of subsection (a),
(b), or (c) to investigate new or existing stand-
ards, methods, or uses relating to tissue, such
application is submitted with a proposed sci-
entific protocol for such investigation, and the
Secretary has determined that such investiga-
tion does not affect the safety and effectiveness
of the operations of such bank and that pa-
tients of the bank will be protected by a re-
quirement of adequate informed consent.
‘‘(2) PERMITS.—The Secretary shall issue an
operating permit to a human tissue bank if the Sec-
retary determines the bank meets the requirements
of paragraph (1). Such a permit shall identify the
tissues banked by the bank and the methods of pro-
curement, 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 deter-
mines 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, ex-
cept 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 Transplan-
tation Act of 1993.
‘‘(b) COMPOSITION.—The advisory committee shall
be comprised of not fewer than 13 or more than 19 indi-
viduals 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 sig-
nificant 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 tis-
sue transplantation,
‘‘(3) advise the Secretary on appropriate stand-
ards for the prevention of infectious disease trans-
mission 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 establish-
ment of mechanisms to investigate consumer com-
plaints, and
‘‘(7) perform such other activities as the Sec-
retary 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 mem-
bers 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 insert-
ing ‘‘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 mate-
rials, facilities, or controls used for its procurement, proc-
essing, distribution, or storage are not in conformity with
the requirements of section 545(b).
‘‘(2) If it is banked human tissue for which an exemp-
tion for investigation use of human tissue has been grant-
ed 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 para-
graph (h), and (i), by inserting ‘‘or banked human
tissue’’ after ‘‘drug’’ each place it occurs
(3) in paragraph (o), by inserting ‘‘or if an ap-
plication 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 regu-
lation 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 advertis-
ing 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 in-
serting ‘‘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 insert-
ing ‘‘, 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