II

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.

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)—

13 (A) by striking ‘‘; and (D), and inserting

14 ‘‘; (D)’’; and

15 (B) by inserting before the period ‘‘; and

16 (E) human tissue in combination with a drug

17 as described in clause (A), (B), (C), or (D)’’;

18 (2) in paragraph (h), by striking ‘‘implant,’’

19 and inserting ‘‘implant, human tissue (other than

20 banked human tissue),’’; and

21 (3) by adding at the end the following new

22 paragraph:

23 ‘‘(ff)(1) The term ‘tissue’ means an aggregate of cells

24 or their intercellular substance that form a structural ma25 terial.
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1 ‘‘(2)(A) The term ‘banked human tissue’ means any

2 tissue—

3 ‘‘(i) derived from a human body that is in4 tended for administration to a human for the diag5 nosis, cure, mitigation, treatment, or prevention of

6 any condition or disease;

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

8 by methods to prevent the transmission of infectious

9 disease and to preserve clinical usefulness; and

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

11 functional characteristics.

12 ‘‘(B) Such term does not include—

13 ‘‘(i) whole organs, including hearts, kidneys, liv14 ers, lungs, pancreases, or any other organ containing

15 vasculature that carries blood after transplantation;

16 ‘‘(ii) blood, blood products, bone marrow, repro17 ductive tissue, or human milk; or

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

19 or processed during a single surgical procedure.

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

21 that procures, processes, stores, or distributes banked

22 human tissue.’’.

23 SEC. 4. REGULATION OF HUMAN TISSUE BANKS.

24 Chapter V is amended by adding at the end the fol25 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 PRACTICES.—The Sec16 retary shall by regulation establish good tissue banking

17 practices, by human tissue banks, that 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 fail3 ures;

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 the Tissue Advisory

21 Committee under section 546, that such an

22 exemption does not affect the safety and

23 effectiveness of the operations of such

24 bank; or
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1 ‘‘(C)(i) the human tissue bank has on file

2 with the Secretary an application for an exemp3 tion from the requirements of subsection (a),

4 (b), or (c) in order to conduct an investigation

5 of new or existing standards, methods, or uses

6 relating to tissue;

7 ‘‘(ii) such application is submitted with a

8 proposed scientific protocol for such investiga9 tion; and

10 ‘‘(iii) the Secretary has determined that

11 such investigation does not affect the safety and

12 effectiveness of the operations of such bank and

13 that patients of the bank will be protected by

14 a requirement of adequate informed consent.

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

16 operating permit to a human tissue bank if the Sec17 retary determines the bank meets the requirements

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

19 tissues banked by the bank and the methods of pro20 curement, processing, storage, and distribution of

21 such tissue which the Secretary had determined to

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

23 such period as specified by the Secretary but not for

24 more than 3 years.
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1 ‘‘(3) AMENDMENT.—The Secretary shall allow

2 a human tissue bank that has a permit issued under

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

4 amendment the human tissue bank is still in compli5 ance with paragraph (1).

6 ‘‘(4) REVOCATION.—The Secretary shall revoke,

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

8 issued under paragraph (2) if the Secretary deter9 mines that the bank is operating in a manner that

10 is inconsistent with its permit and that places the

11 bank out of compliance with paragraph (1).

12 ‘‘(e) REGISTRATION.—Each human tissue bank, ex13 cept human tissue banks that operate solely for research

14 or teaching, shall under regulations of the Secretary be

15 required to register in accordance with the requirements

16 of section 510 as made applicable under such regulations.

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

18 the regulations required by subsections (a), (b), (c), (d),

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

20 the Human Tissue for Transplantation Act of 1993. Such

21 regulations shall be based on adequate scientific evidence.

22 ‘‘TISSUE ADVISORY COMMITTEE

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

24 establish a national advisory committee to be known as

25 the Tissue Advisory Committee (hereafter in this section

26 referred to as the ‘advisory committee’). The advisory
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1 committee shall be established within 1 year of the date

2 of the enactment of the Human Tissue for Transplan3 tation Act of 1993.

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

5 be comprised of not fewer than 13 or more than 19 indi6 viduals who are not officers or employees of the Federal

7 Government. The Secretary shall make appointments to

8 the advisory committee from among physicians, other

9 health care practitioners, and representatives of human

10 tissue bank consumers and industry groups whose clinical

11 practice, research specialization, or expertise include a sig12 nificant focus on tissue transplantation by human tissue

13 banks.

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

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

16 standards and regulations for human tissue banks

17 under section 545;

18 ‘‘(2) report on new developments concerning tis19 sue transplantation;

20 ‘‘(3) advise the Secretary on appropriate stand21 ards for the prevention of infectious disease trans22 mission by banked human tissues;

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

24 standards for good tissue banking practices under

25 section 545(b);
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1 ‘‘(5) advise the Secretary in the development of

2 regulations to ensure that adequate directions for

3 use of banked human tissues are provided by human

4 tissue banks;

5 ‘‘(6) make recommendations in the establish6 ment of mechanisms to investigate consumer com7 plaints; and

8 ‘‘(7) perform such other activities as the Sec9 retary may require.

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

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

12 its operation.

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

14 chairperson of the advisory committee from among mem15 bers of the advisory committee.’’.

16 ‘‘(f) PERSONNEL MATTERS.—

17 ‘‘(1) MEMBERS.—

18 ‘‘(A) COMPENSATION.—Each member of

19 the advisory committee shall be compensated at

20 a rate equal to the daily equivalent of the an21 nual rate of basic pay prescribed for level IV of

22 the Executive Schedule under section 5315 of

23 title 5, United States Code, for each pay (in24 cluding travel time) during which such member
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1 is engaged in the performance of the duties of

2 the advisory committee.

3 ‘‘(B) TRAVEL.—The members of the advi4 sory committee shall be allowed travel expenses,

5 including per diem in lieu of subsistence, at

6 rates authorized for employees of agencies

7 under subchapter I of chapter 57 of title 5,

8 United States Code, while away from their

9 homes or regular places of business in the per10 formance of services for the advisory committee.

11 ‘‘(2) OTHER PERSONNEL.—

12 ‘‘(A) IN GENERAL.—The Chairperson of

13 the advisory committee may, without regard to

14 the civil service laws and regulations, appoint

15 and terminate such other additional personnel

16 as may be necessary to enable the advisory

17 committee to perform its duties.

18 ‘‘(B) COMPENSATION.—The Chairperson

19 of the advisory committee may fix the com20 pensation of personnel described in subpara21 graph (A) without regard to provisions of chap22 ter 51 and subchapter III of chapter 53 of title

23 5, United States Code, relating to classification

24 of positions and General Schedule pay rates, ex25 cept that the rate of pay for such personnel
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1 may not exceed the rate payable for level V of

2 the Executive Schedule under section 5316 of

3 such title.’’.

4 SEC. 5. ENFORCEMENT.

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

6 is amended—

7 (1) in the matter preceding subsection (a), by

8 striking ‘‘drug’’ and inserting ‘‘drug, banked human

9 tissue,’’;

10 (2) in subsection (a)(2)(B), by striking ‘‘drug’’

11 each place such term appears and inserting ‘‘drug or

12 banked human tissue’’;

13 (3) in subsection (d), by striking ‘‘drug’’ and

14 inserting ‘‘drug or banked human tissue’’; and

15 (4) by adding at the end thereof the following

16 new subsection:

17 ‘‘(j)(1) If it is a banked human tissue and the mate18 rials, facilities, or controls used for its procurement, proc19 essing, storage, or distribution are not in conformity with

20 the requirements of section 545(b).

21 ‘‘(2) If it is a banked human tissue for which an ex22 emption has been granted under section 545(d)(1)(C) to

23 permit investigation use of human tissue and the person

24 granted such exemption or any investigator fails to comply

25 with the requirements of such section.’’; and
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1 (5) in the title of the section, by striking

2 ‘‘DRUGS’’ and inserting ‘‘DRUGS OR BANKED HUMAN

3 TISSUE’’.

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

5 amended—

6 (1) in paragraph (f), by striking ‘‘drug’’ each

7 place such term appears and inserting ‘‘drug,

8 banked human tissue,’’;

9 (2) in the first sentence of paragraph (h), by

10 striking ‘‘drug’’ and inserting ‘‘drug or banked

11 human tissue’’;

12 (3) in paragraph (i), by striking ‘‘drug’’ each

13 place such term appears and inserting ‘‘drug or

14 banked human tissue’’;

15 (4) in paragraph (o) by striking ‘‘510(e)’’ and

16 inserting ‘‘510(e) or if an application or other infor17 mation respecting it was not provided as required by

18 section 545(d),’’;

19 (5) by adding at the end the following new

20 paragraph:

21 ‘‘(u)(1) If it is banked human tissue subject to regu22 lation under section 545(c) unless it bears such labeling

23 as may be required.
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1 ‘‘(2) If it is a banked human tissue distributed or

2 offered for sale in any State and its promotion or advertis3 ing is false or misleading in any particular.’’; and

4 (6) in the title of the section, by striking

5 ‘‘DRUGS’’ and inserting ‘‘DRUGS, BANKED HUMAN

6 TISSUE,’’.

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

8 331) is amended—

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

10 (l), by striking ‘‘drug,’’ each place such term ap11 pears and inserting ‘‘drug, banked human tissue,’’;

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

13 and inserting ‘‘404, 505, or 545’’;

14 (3) in paragraph (j), by striking ‘‘520,’’ and in15 serting ‘‘520, 545,’’;

16 (4) in paragraph (p), by striking ‘‘510,’’ and in17 serting ‘‘510 or 545(e),’’;

18 (5) in paragraphs (q)(2), by striking ‘‘device’’

19 and inserting ‘‘device or banked human tissue’’; and

20 (6) in paragraph (r), by striking ‘‘device’’ each

21 place such term appears and inserting ‘‘device or

22 banked human tissue’’.

23 (d) PENALTIES.—Section 303(g) (21 U.S.C. 333(g))

24 is amended by striking ‘‘devices’’ and inserting ‘‘devices

25 or banked human tissues’’.
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1 (e) SEIZURES.—Section 304 (21 U.S.C. 334) is

2 amended—

3 (1) in subsections (a)(1) and (d)(1), by striking

4 ‘‘drug,’’ and inserting ‘‘drug, banked human tis5 sue,’’;

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

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

8 banked human tissue, and (E)’’; and

9 (3) in subsection (g)(1)—

10 (A) by striking ‘‘or a vehicle, a device’’ and

11 inserting ‘‘or a vehicle, a device or banked

12 human tissue’’; and

13 (B) by striking ‘‘device’’ each place such

14 term appears and inserting ‘‘device or banked

15 human tissue’’.

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

17 is amended—

18 (1) in subsection (b), by striking ‘‘drug,’’ and

19 inserting ‘‘drug, banked human tissue,’’; and

20 (2) in subsection (d), by striking ‘‘drugs’’ and

21 inserting ‘‘drugs, or banked human tissues’’.

22 (g) RECORDS OF INTERSTATE SHIPMENT.—Section

23 703 (21 U.S.C. 373) is amended—
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1 (1) by striking ‘‘drugs,’’ each place such term

2 appears and inserting ‘‘drugs, banked human tis3 sues,’’; and

4 (2) by striking ‘‘drug,’’ each place such term

5 appears and inserting ‘‘drug, banked human tis6 sue,’’.

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

8 amended—

9 (1) in subsection (a)(1)(A), by striking

10 ‘‘drugs,’’ each place such term appears and inserting

11 ‘‘drugs, banked human tissues,’’;

12 (2) in the first sentence after paragraph (1)(B)

13 of subsection (a), by striking ‘‘prescription drugs’’

14 each place such term appears and inserting ‘‘pre15 scription drugs, banked human tissues,’’; and

16 (3) in subsection (b), by striking ‘‘drug,’’ and

17 inserting ‘‘drug, banked human tissue,’’.

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

19 is amended by striking ‘‘drugs,’’ and inserting ‘‘drugs,

20 banked human tissues,’’.

21 (j) INTERSTATE COMMERCE PRESUMPTION.—Sec22 tion 709 (21 U.S.C. 379a) is amended by striking ‘‘de23 vice’’ and inserting ‘‘device or banked human tissue’’.

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

25 381) is amended—
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1 (1) in the first sentence of subsection (a), by

2 striking ‘‘drugs,’’ and inserting ‘‘drugs, banked

3 human tissues,’’;

4 (2) in subsection (a)(3), by striking ‘‘505’’ and

5 inserting ‘‘505 or 545’’; and

6 (3) in subsections (b) and (e)(1), by striking

7 ‘‘drug,’’ and inserting ‘‘drug, banked human tis8 sue,’’.

9 SEC. 6. FUNDING.

10 (a) IMPOSITION.—

11 (1) IN GENERAL.—Each human tissue bank—

12 (A) that has a permit issued under section

13 545(d) of the Federal Food, Drug, and Cos14 metic Act shall pay a fee for such permit; and

15 (B) that is registered under section 545(e)

16 of such Act shall pay a fee for such registra17 tion.

18 (2) USE OF FEES.—The fees imposed under

19 this subsection are imposed to cover the costs of the

20 Secretary in the implementation of sections 545 and

21 546 of the Federal Food, Drug, and Cosmetic Act.

22 (b) FEE AMOUNT.—The Secretary of Health and

23 Human Services shall determine the amount of the fees

24 imposed by subsection (a) on the basis of the gross reve25 nue of the human tissue bank paying the fee that relates
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1 to the procurement, processing, storage, and distribution

2 of human tissue.

3 (c) CREDITING AND AVAILABILITY OF FEES.—

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

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

6 the appropriation account for salaries and expenses

7 of the Secretary of Health and Human Services and

8 shall be available in accordance with appropriation

9 Acts until expended without fiscal year limitation.

10 (2) COLLECTIONS.—The fees imposed under

11 subsection (a)—

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

13 an amount equal to the amount specified in ap14 propriation Acts for such fiscal year; and

15 (B) shall only be collected and available to

16 defray the costs of implementing sections 545

17 and 546 of the Federal Food, Drug, and Cos18 metic Act.

19 (d) EFFECTIVE DATE.—The fee authorized by sub20 section (a)(1) shall take effect 4 years after the date of

21 the enactment of this Act and the fee authorized by sub22 section (a)(2) shall take effect 1 year after the date of

23 the enactment of this Act.
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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 of Health and Human

9 Services issued June 26, 1991 (56 FR 29177), acting

10 through the Food and Drug Administration, that human

11 heart valves are replacement heart valves subject to pre12 market approval under section 515 of the Federal Food,

13 Drug, and Cosmetic Act (21 U.S.C. 360e) shall have no

14 legal force and effect.

Æ

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