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.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled

3 SECTION 1. SHORT TITLE.

4 (a) SHORT TITLE.—This Act may be cited as the

5 ‘‘Human Tissue for Transplantation Act of 1993’’.

6 (b) REFERENCE.—Whenever in this Act an amend7 ment or repeal is expressed in terms of an amendment

8 to, or repeal of, a section or other provision, the reference
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1 shall be considered to be made to a section or other provi2 sion of the Federal Food, Drug, and Cosmetic Act.

3 SEC. 2. FINDINGS.

4 The Congress finds that reasonable assurance of the

5 safety and effectiveness of human tissue for transplan6 tation through regulatory oversight is necessary to protect

7 the public health against the transmission of infectious

8 disease or the conduct of medical therapy with human tis9 sue unfit for use.

10 SEC. 3. DEFINITIONS.

11 Section 201 (21 U.S.C. 321) is amended—

12 (1) in the first sentence of paragraph (g)(1), by

13 striking ‘‘, and (D), and inserting ‘‘, (D)’’ and by in14 serting before the period ‘‘, and (E) human tissue in

15 combination with a drug as described in clause (A),

16 (B), (C), or (D)’’,

17 (2) in paragraph (h), by inserting after ‘‘im18 plant,’’ the following: ‘‘human tissue (other than

19 banked human tissue),’’, and

20 (3) by adding at the end the following:

21 ‘‘(gg)(1) The term ‘tissue’ means an aggregate of

22 cells or their intercellular substance that form a structural

23 material.

24 ‘‘(2)(A) The term ‘banked human tissue’ means any

25 tissue—
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1 ‘‘(i) derived from a human body that is in2 tended for administration to a human for the diag3 nosis, cure, mitigation, treatment or prevention of

4 any condition or disease,

5 ‘‘(ii) procured, processed, stored, or distributed

6 by methods to prevent the transmission of infectious

7 disease and to preserve clinical usefulness, and

8 ‘‘(iii) not intended to change tissue structure or

9 functional characteristics.

10 ‘‘(B) Such term does not include—

11 ‘‘(i) whole organs, including hearts, kidneys, liv12 ers, lungs, pancreases, or any other organ containing

13 vasculature that carries blood after transplantation,

14 ‘‘(ii) blood, blood products, bone marrow, repro15 ductive tissue, or human milk, or

16 ‘‘(iii) autograft human tissue that is not stored

17 or processed during a single surgical procedure.’’.

18 ‘‘(3) The term ‘human tissue bank’ means a person

19 that procures, processes, stores, or distributes banked

20 human tissue.’’.

21 SEC. 4. REGULATION OF HUMAN TISSUE BANKS

22 Chapter V is amended by adding at the end the fol23 lowing:
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1 ‘‘SUBCHAPTER D-HUMAN TISSUE BANKS

2 ‘‘REGULATION OF HUMAN TISSUE BANKS

3 ‘‘SEC. 545. (a) PREVENTION OF DISEASE TRANS4 MISSION.—To prevent the transmission of infectious dis5 ease by the use of banked human tissue, the Secretary

6 may by regulation require—

7 ‘‘(1) the screening of donors of tissue,

8 ‘‘(2) the testing of donors of tissue and tissue

9 donated, and

10 ‘‘(3) recordkeeping by human tissue banks, in11 cluding records that provide a method to track tis12 sue from a donor to a recipient and from a recipient

13 to a donor, taking into account the privacy interest

14 of donors, donor families, and recipients.

15 ‘‘(b) GOOD TISSUE BANKING PRACTICE.—The Sec16 retary shall by regulation establish good tissue banking

17 practices by human tissue banks which may require—

18 ‘‘(1) ascertainment of donor suitability,

19 ‘‘(2) recovery of cadaveric or living donor tis20 sue,

21 ‘‘(3) tissue screening and acceptance,

22 ‘‘(4) validation of the manufacturing, equip23 ment, and facilities used for banked human tissue,

24 ‘‘(5) finished tissue inspection and control,

25 ‘‘(6) inspection for quality control,
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1 ‘‘(7) investigation of failures involving banked

2 human tissue and files of complaints about such

3 failures,

4 ‘‘(8) recordkeeping,

5 ‘‘(9) assurance of the quality of banked human

6 tissue,

7 ‘‘(10) personnel requirements, including a re8 quirement for a medical director who is a physician

9 licensed to practice medicine in the State in which

10 the bank is located, and

11 ‘‘(11) special practices for specific tissues.

12 ‘‘(c) LABELING, ADVERTISING, AND PROMOTION.—

13 The Secretary may by regulation prescribe requirements

14 for the labeling, advertising, and promotion of banked

15 human tissue by human tissue banks. Such requirements

16 shall include—

17 ‘‘(1) requirements for adequate direction for

18 use, and

19 ‘‘(2) information about results from the use of

20 banked human tissue according to directions or

21 under customary and usual conditions.

22 ‘‘(d) OPERATING PERMITS.—

23 ‘‘(1) IN GENERAL.—The Secretary shall by reg24 ulation require human tissue banks to acquire a per-
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1 mit for operation. Such a permit may be acquired by

2 a human tissue bank if—

3 ‘‘(A) the human tissue bank has on file

4 with the Secretary an application for such per5 mit which demonstrates, through supporting

6 documentation, that the bank is in compliance

7 with the requirements of subsections (a), (b),

8 and (c),

9 ‘‘(B) the human tissue bank has on file

10 with the Secretary an application for an exemp11 tion from the requirements of subsection (a),

12 (b), or (c) and the Secretary has approved such

13 application based upon—

14 ‘‘(i) data from well controlled sci15 entific studies designed to provide reason16 able assurance that an exemption from

17 such requirements is safe and does not re18 duce clinical utility, or

19 ‘‘(ii) a determination by the Secretary,

20 after consultation with a Tissue Advisory

21 Committee, that such an exemption does

22 not affect the safety and effectiveness of

23 the operations of such bank, or

24 ‘‘(C) the human tissue bank has on file

25 with the Secretary an application for an exemp-
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1 tion from the requirements of subsection (a),

2 (b), or (c) to investigate new or existing stand3 ards, methods, or uses relating to tissue, such

4 application is submitted with a proposed sci5 entific protocol for such investigation, and the

6 Secretary has determined that such investiga7 tion does not affect the safety and effectiveness

8 of the operations of such bank and that pa9 tients of the bank will be protected by a re10 quirement of adequate informed consent.

11 ‘‘(2) PERMITS.—The Secretary shall issue an

12 operating permit to a human tissue bank if the Sec13 retary determines the bank meets the requirements

14 of paragraph (1). Such a permit shall identify the

15 tissues banked by the bank and the methods of pro16 curement, processing, storage, and distribution of

17 such tissue which the Secretary had determined to

18 be safe and effective. A permit shall be valid for

19 such period as specified by the Secretary but not for

20 more than 3 years.

21 ‘‘(3) AMENDMENT.—The Secretary shall allow

22 a human tissue bank which has a permit issued

23 under paragraph (2) to amend the permit if under

24 the amendment the human tissue bank is still in

25 compliance with paragraph (1).
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1 ‘‘(4) REVOCATION.—The Secretary shall revoke,

2 in whole or in part, a permit of a human tissue bank

3 issued under paragraph (2) if the Secretary deter4 mines that the bank is operating in a manner which

5 is inconsistent with its permit and which places the

6 bank out of compliance with paragraph (1).

7 ‘‘(e) REGISTRATION.—Each human tissue bank, ex8 cept human tissue banks that operate solely for research

9 or teaching, shall under regulations of the Secretary be

10 required to register in accordance with the requirements

11 of section 510 as made applicable under such regulations.

12 ‘‘(f) REGULATIONS.—The Secretary shall promulgate

13 the regulations required by subsection (a), (b), (c), (d),

14 and (e) within 5 years of the date of the enactment of

15 the Human Tissue for Transplantation Act of 1993 and

16 shall be based on adequate scientific evidence.

17 ‘‘TISSUE ADVISORY COMMITTEES

18 ‘‘SEC. 546. (a) IN GENERAL.—The Secretary shall

19 establish a national advisory committee to be known as

20 the Tissue Advisory Committee (hereinafter in this section

21 referred to as the ‘advisory committee’). The advisory

22 committee shall be established within one year of the date

23 of the enactment of the Human Tissue for Transplan24 tation Act of 1993.

25 ‘‘(b) COMPOSITION.—The advisory committee shall

26 be comprised of not fewer than 13 or more than 19 indi-
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1 viduals who are not officers or employees of the Federal

2 Government. The Secretary shall make appointments to

3 the advisory committee from among physicians, other

4 health care practitioners, and representatives of human

5 tissue bank consumers and industry groups whose clinical

6 practice, research specialization, or expertise include a sig7 nificant focus on tissue transplantation by human tissue

8 banks.

9 ‘‘(c) FUNCTIONS.—The advisory committee shall—

10 ‘‘(1) advise the Secretary on appropriate quality

11 standards and regulations for human tissue banks

12 under section 545,

13 ‘‘(2) report on new developments concerning tis14 sue transplantation,

15 ‘‘(3) advise the Secretary on appropriate stand16 ards for the prevention of infectious disease trans17 mission by banked human tissues,

18 ‘‘(4) advise the Secretary on appropriate quality

19 standards for good tissue banking practices under

20 section 545(b),

21 ‘‘(5) advise the Secretary in the development of

22 regulations to ensure that adequate directions for

23 use of banked human tissues are provided by human

24 tissue banks,
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1 ‘‘(6) make recommendations in the establish2 ment of mechanisms to investigate consumer com3 plaints, and

4 ‘‘(7) perform such other activities as the Sec5 retary may require.

6 ‘‘(d) MEETINGS.—The advisory committee shall meet

7 not less often than quarterly during the first 3 years of

8 its operation.

9 ‘‘(e) CHAIRPERSON.—The Secretary shall appoint the

10 chairperson of the advisory committee from among mem11 bers of the advisory committee.’’.

12 SEC. 5. ENFORCEMENT.

13 (a) ADULTERATION.—Section 501 (21 U.S.C. 351)

14 is amended—

15 (1) by inserting ‘‘, banked human tissue,’’ after

16 ‘‘drug’’ before paragraph (a),

17 (2) in paragraphs (a)(2)(B) and (d), by insert18 ing ‘‘or banked human tissue’’ after ‘‘drug’’ each

19 place it occurs,

20 (3) by adding at the end the following:

21 ‘‘(j)(1) If it is banked human tissue and the mate22 rials, facilities, or controls used for its procurement, proc23 essing, distribution, or storage are not in conformity with

24 the requirements of section 545(b).
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1 ‘‘(2) If it is banked human tissue for which an exemp2 tion for investigation use of human tissue has been grant3 ed under section 545(d)(1)(D) and the person granted

4 such exemption or any investigator fails to comply with

5 the requirements of such section.’’, and

6 (4) in the title to the section, by inserting ‘‘OR

7 BANKED HUMAN TISSUE’’ after ‘‘DRUGS.

8 (b) MISBRANDING.—Section 502 (21 U.S.C. 352) is

9 amended—

10 (1) by inserting ‘‘, banked human tissue,’’ after

11 ‘‘drug’’ before paragraph (a),

12 (2) in paragraph (f), the first sentence of para13 graph (h), and (i), by inserting ‘‘or banked human

14 tissue’’ after ‘‘drug’’ each place it occurs

15 (3) in paragraph (o), by inserting ‘‘or if an ap16 plication or other information respecting it was not

17 provided as required by section 545(d),’’ after

18 ‘‘510(e)’’,

19 (4) by adding at the end the following:

20 ‘‘(u)(1) If it is banked human tissue subject to regu21 lation under section 545(c) unless it bears such labeling

22 as may be required.

23 ‘‘(2) If it is a banked human tissue distributed or

24 offered for sale in any State and its promotion or advertis25 ing is false or misleading in any particular.’’, and
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1 (5) in the title to the section, by inserting ‘‘OR

2 BANKED HUMAN TISSUE’’ after ‘‘DRUGS.

3 (c) PROHIBITED ACTS.—Section 301 (21 U.S.C.

4 331) is amended—

5 (1) in paragraphs (a), (b), (c), (g), (h), (k), and

6 (l), by inserting ‘‘, banked human tissue’’ after

7 ‘‘drug’’ each place it occurs,

8 (2) in paragraph (d), by striking ‘‘404 or 505’’

9 and inserting ‘‘404, 505, or 545’’,

10 (3) in paragraph (j), by inserting ‘‘, 545’’ after

11 ‘‘520’’,

12 (4) in paragraph (p), by striking ‘‘510,’’ and in13 serting ‘‘510 or 545(e),’’, and

14 (5) in paragraphs (q)(2) and (r), by inserting

15 ‘‘or banked human tissue’’ after ‘‘device’’.

16 (d) PENALTIES.—Section 303(f) (21 U.S.C. 333(f))

17 is amended by inserting ‘‘or banked human tissues’’ after

18 ‘‘devices’’.

19 (e) SEIZURES.—Section 304 (21 U.S.C. 334) is

20 amended—

21 (1) in subsections (a)(1) and (d)(1), by insert22 ing ‘‘, banked human tissue’’ after ‘‘drug’’,

23 (2) in subsection (a)(1), by striking ‘‘, and (D)’’

24 and inserting ‘‘(D) Any adulterated or misbranded

25 banked human tissue, and (E)’’, and
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1 (3) in subsection (g)(1), by striking ‘‘or a vehi2 cle, a device’’ and inserting ‘‘, a vehicle, a device, or

3 banked human tissue’’ and by inserting after each

4 other occurrence of ‘‘device’’ the following: ‘‘or

5 banked human tissue’’.

6 (f) INVESTIGATIONS.—Section 702 (21 U.S.C. 372)

7 is amended—

8 (1) in subsection (b), by inserting ‘‘, banked

9 human tissue’’ after ‘‘drug’’, and

10 (2) in subsection (d), by inserting ‘‘or banked

11 human tissues’’ after ‘‘drugs’’.

12 (g) RECORDS OF INTERSTATE SHIPMENT.—Section

13 703 (21 U.S.C. 373) is amended—

14 (1) by inserting ‘‘or banked human tissues’’

15 after ‘‘drugs’’ each place it occurs, and

16 (2) by inserting ‘‘or banked human tissue’’

17 after ‘‘drug’’ each place it occurs.

18 (h) INSPECTIONS.—Section 704 (21 U.S.C. 374) is

19 amended—

20 (1) in subsection (a)(1)(A), by inserting ‘‘,

21 banked human tissues’’ after ‘‘drugs’’ each place it

22 occurs,

23 (2) in subsection (a)(1)(B), by inserting ‘‘,

24 banked human tissues’’ after ‘‘prescription drugs’’

25 each place it occurs, and
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1 (3) in subsection (b), by inserting ‘‘, banked

2 human tissue’’ after ‘‘drug’’.

3 (i) PUBLICITY.—Section 705(b) (21 U.S.C. 375(b))

4 is amended by inserting ‘‘, banked human tissues’’ after

5 ‘‘drugs’’.

6 (j) INTERSTATE COMMERCE PRESUMPTION.—Sec7 tion 709 (21 U.S.C. 379a) is amended by inserting ‘‘or

8 banked human tissue’’ after ‘‘device’’.

9 (k) IMPORTS AND EXPORTS.—Section 801 (21 U.S.C

10 381) is amended—

11 (1) in the first sentence of subsection (a), by in12 serting ‘‘, banked human tissues’’ and ‘‘drugs’’,

13 (2) in subsection (a)(3), by inserting ‘‘or 545’’

14 after ‘‘505’’, and

15 (3) in subsections (b) and (e)(1), by inserting

16 ‘‘, banked human tissue’’ after ‘‘drug’’.

17 SEC. 6. FUNDING.

18 (a) IMPOSITION.—Each human tissue bank—

19 (1) which has a permit issued under section

20 545(d) shall pay a fee for such permit, and

21 (2) which is registered under section 545(e)

22 shall pay a fee for such registration.

23 The fees imposed under this subsection are imposed to

24 cover the costs of the Secretary in the implementation of

25 sections 545 and 546.
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1 (b) FEE AMOUNT.—The Secretary shall determine

2 the amount of the fees imposed by subsection (a) on the

3 basis of the gross revenue of the human tissue bank pay4 ing the fee which relates to the procurement, processing,

5 storage, and distribution of human tissue.

6 (c) CREDITING AND AVAILABILITY OF FEES.—

7 (1) IN GENERAL.—Fees collected for a fiscal

8 year pursuant to subsection (a) shall be credited to

9 the appropriation account for salaries and expenses

10 of the Secretary and shall be available in accordance

11 with appropriation Acts until expended without fiscal

12 year limitation.

13 (2) COLLECTIONS.—The fees imposed under

14 subsection (a)—

15 (A) shall be collected in each fiscal year in

16 an amount equal to the amount specified in ap17 propriation Acts for such fiscal year, and

18 (B) shall only be collected and available to

19 defray the costs of implementing sections 545

20 and 546.

21 (d) EFFECTIVE DATE.—The fee authorized by sub22 section (a)(1) shall take effect 4 years after the date of

23 the enactment of the Human Tissue for Transplantation

24 Act of 1993 and the fee authorized by subsection (a)(2)

25 shall take effect one year after the date of the enactment.
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1 SEC. 7. HUMAN HEART VALVES.

2 (a) ENFORCEMENT.—The Secretary of Health and

3 Human Services may not enforce the Secretary’s regula4 tion, promulgated on May 13, 1987, and published at page

5 18162 of 52 Federal Register, insofar as such regulation

6 applies to human heart valves.

7 (b) PREMARKET APPROVAL DETERMINATION.—The

8 determination of the Secretary issued June 26, 1991 (56

9 FR 29177), acting through the Food and Drug Adminis10 tration, that human heart valves are replacement heart

11 valves subject to premarket approval under section 515

12 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

13 360e) shall have no legal force and effect.