II

104TH CONGRESS

2D SESSION S. 2195

To provide for the regulation of human tissue for transplantation to ensure

that such tissue is handled in a manner to preserve its safety and

purity, and for other purposes.

IN THE SENATE OF THE UNITED STATES

OCTOBER 3, 1996

Mr. WYDEN (for himself, Mr. DODD, and Mr. SIMON) introduced the following

bill; which was read twice and referred to the Committee on Labor and

Human Resources

A BILL

To provide for the regulation of human tissue for transplantation to ensure that such tissue is handled in a manner

to preserve its safety and purity, 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. HUMAN TISSUE.

4 (a) IN GENERAL.—Section 201 of the Federal Food,

5 Drug, and Cosmetic Act (21 U.S.C. 321) is amended by

6 adding at the end the following:

7 ‘‘(hh)(1) The term ‘human tissue’ means a collection

8 of similar human cells which—
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1 ‘‘(A) is intended for use in the diagnosis, cure,

2 mitigation, treatment, or prevention of a disease or

3 condition in a human or for reproduction;

4 ‘‘(B) achieves its primary intended purpose

5 through repair or replacement of bodily tissue by

6 structural support or cellular function;

7 ‘‘(C) may have been propagated or otherwise

8 processed before use;

9 ‘‘(D) may be combined with substances that are

10 safe under conditions of intended use and not in11 tended to provide a therapeutic effect; and

12 ‘‘(E) includes reproductive tissue, demineralized

13 bone, heart valves, dura mater, and manipulated

14 autologous cells.

15 ‘‘(2) The term ‘human tissue’ does not include

16 vascularized human organs, gene therapy, blood, soluble

17 blood components, milk, or products made by combining

18 human tissue with biomaterials.

19 ‘‘(3) Human tissue is not a drug, biological product,

20 or device unless reclassified by the Secretary pursuant to

21 section 352A of the Public Health Service Act.’’.

22 (b) REGULATION OF HUMAN TISSUE.—Subpart 1 of

23 part F of title III of the Public Health Service Act (42

24 U.S.C. 262 et seq.) is amended by adding at the end the

25 following section:
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1 ‘‘REGULATION OF HUMAN TISSUE

2 ‘‘SEC. 352A. (a) SUBJECT TO REGULATION.—

3 ‘‘(1) IN GENERAL.—Human tissue shall be sub4 ject to regulation under this section only if the Sec5 retary publishes a finding in the Federal Register,

6 after a hearing before the Commissioner, that vol7 untary regulation under generally accepted scientific

8 standards is inadequate to protect the public health

9 with respect to any particular type of human tissue

10 or human tissue generally.

11 ‘‘(2) EXCEPTION.—Human tissue shall not be

12 subject to regulation as a drug, biological product,

13 or device unless it is reclassified under subsection

14 (f).

15 ‘‘(b) REGISTRATION.—

16 ‘‘(1) IN GENERAL.—Any person subject to regu17 lation under this section who recovers, processes,

18 stores, or distributes human tissue for transplan19 tation or implantation in the United States shall

20 register in accordance with the registration proce21 dures established for drugs under section 510 of the

22 Federal Food, Drug, and Cosmetic Act. Such reg23 istration shall contain the name of the person, the

24 location of its facilities, a list of the types of human

25 tissue recovered, processed, stored, or distributed by
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1 such person, and a brief description of the basic

2 method or methods of processing of such tissue.

3 ‘‘(2) AUTHORIZED ACTIVITIES.—A person reg4 istered in accordance with paragraph (1) shall be

5 deemed to be authorized to conduct human tissue re6 covery, processing, storage, and distribution activi7 ties as identified in the applicable registration un8 less—

9 ‘‘(A)(i) the Secretary determines, upon in10 spection, that such person fails to meet applica11 ble operating standards under subsection (c);

12 ‘‘(ii) the Secretary notifies such person of

13 a determination under clause (i), advises the

14 person of the steps necessary to meet such

15 standards, and provides the person with a rea16 sonable opportunity to establish compliance

17 with the standards;

18 ‘‘(iii) the Secretary determines, after an

19 opportunity for an informal hearing, that the

20 person has failed to establish compliance as

21 provided for in clause (ii) within the applicable

22 period and such failure constitutes a threat to

23 the public health; and

24 ‘‘(iv) the Secretary suspends or revokes the

25 authority to conduct such activities;
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1 ‘‘(B) the Secretary determines, after an

2 opportunity for an informal hearing, that such

3 person has failed to comply with any patient

4 registry or other retrospective patient data re5 quirement, and the Secretary suspends or re6 vokes the authority to conduct such activities;

7 or

8 ‘‘(C) the Secretary determines that such

9 person presents an immediate or substantial

10 danger to the public health, and the Secretary

11 suspends or revokes the authority to conduct

12 such activities, in which case an informal hear13 ing shall be conducted within 5 business days of

14 the date of such suspension or revocation.

15 ‘‘(c) OPERATING STANDARDS.—The Secretary may

16 establish, after notice and opportunity for comment, oper17 ating standards for human tissue that shall be limited to

18 the following general requirements for the recovery, proc19 essing, storage, and shipment of human tissue:

20 ‘‘(1) Requirements for infection control de21 signed to prevent transmission of disease.

22 ‘‘(2) Requirements for processing practices that

23 assure the safety of, and prevent damage to, human

24 tissue.
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1 ‘‘(3) Requirements for labeling and record2 keeping to identify the type of tissue and any added

3 foreign substance and to permit tracing.

4 ‘‘(d) LABELING AND ADVERTISING.—Statements

5 made in labeling, advertising or promotional materials re6 garding clinical benefit with respect to human tissue shall

7 consist only of accurate and balanced representations that

8 are consistent with sound scientific information, including

9 current data from a registry required or established under

10 subsection (e), if available.

11 ‘‘(e) REGISTRY.—A person registered under sub12 section (b) may be required by the Secretary to maintain

13 a patient registry or meet other retrospective patient data

14 requirements if, after notice and an opportunity for com15 ment, the Secretary determines that such tissue has been

16 commercially available within the United States for a pe17 riod of less than 5 years and that such data requirement

18 is necessary to protect the public health.

19 ‘‘(f) RECLASSIFICATIONS.—

20 ‘‘(1) HUMAN TISSUE.—The Secretary may re21 classify a particular type of human tissue as a drug,

22 biological product or device if, after notice and an

23 opportunity for comment, the Secretary determines

24 that—
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1 ‘‘(A) with respect to the particular type of

2 human tissue—

3 ‘‘(i) the tissue is subject to a patient

4 registry or other retrospective data require5 ment under which the collection of infor6 mation has been required for at least 5

7 years (or such other time period as agreed

8 to by the Secretary and the registered per9 son); and

10 ‘‘(ii) the information received from

11 such patient registry or other retrospective

12 data requirement is insufficient to confirm

13 the safety and clinical benefit from the use

14 of such tissue; or

15 ‘‘(B) a particular type of human tissue

16 should be reclassified because it presents an im17 minent hazard to public health.

18 ‘‘(2) UPON SECRETARIAL ACTION.—The Sec19 retary may reclassify a human drug, biological prod20 uct or medical device as human tissue if the Sec21 retary determines, after notice and an opportunity

22 for comment, that such previous classification is not

23 necessary to protect public health.

24 ‘‘(3) UPON PETITION.—The Secretary may re25 classify a drug, biological product, medical device, or
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1 human tissue upon the petition of the sponsor of

2 such drug, biological product or device, or the reg3 istered person for such human tissue, if, after notice

4 and an opportunity to comment, the Secretary finds

5 that such reclassification is consistent with the pro6 tection of public health.

7 ‘‘(g) ENFORCEMENT.—

8 ‘‘(1) IN GENERAL.—If the Secretary determines

9 that any person has violated any provision of this

10 section or any regulations promulgated under this

11 section, and the Secretary determines that the viola12 tion constitutes a significant risk to the public

13 health, the Secretary may issue an order that such

14 person cease distribution of human tissue, or that

15 human tissue recovered, processed, stored or distrib16 uted by such person be retained, recalled, or de17 stroyed. After receipt of such an order, the person

18 in possession of the human tissue shall not distrib19 ute or dispose of the human tissue in any manner

20 inconsistent with the provisions of the order.

21 ‘‘(2) HEARING.—A person subject to the order

22 under paragraph (1) may obtain an informal hearing

23 regarding the order if the person requests such a

24 hearing not later than 5 days after receiving the

25 order. If the person does make such a request within
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1 such period, the Secretary shall conduct the hearing

2 within 30 days after receiving the request and shall

3 issue an order not later than 15 days after the hear4 ing is conducted. Such order shall be considered a

5 final order of the Secretary.

6 ‘‘(h) INSPECTION.—Each person registered under

7 subsection (b) shall be subject to inspection under section

8 704 of the Federal Food, Drug, and Cosmetic Act. The

9 Secretary may, with the concurrence of the registered per10 son, authorize an inspection to be conducted by any person

11 specifically accredited by the Secretary to conduct such in12 spection under section 712 of such Act.

13 ‘‘(i) CORD BLOOD.—

14 ‘‘(1) IN GENERAL.—This section (including pro15 visions regarding reclassification) shall apply with

16 respect to cord blood to the same extent and in the

17 same manner as this section applies with respect to

18 human tissue.

19 ‘‘(2) IMPLEMENTATION.—The Secretary shall

20 implement this section with respect to cord blood

21 under regulations promulgated after notice and op22 portunity to comment.

23 ‘‘(j) EYES.—The Secretary shall not regulate eyes

24 until such time as the Secretary makes a finding under

25 this section that voluntary regulation under generally ac-
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1 cepted standards is inadequate to protect the public

2 health.’’.

3 (c) TRANSITION.—The requirements of the interim

4 regulation, promulgated by the Secretary of Health and

5 Human Services on December 11, 1993, shall remain in

6 effect until amended or withdrawn by the Secretary. Any

7 modifications to such regulations after the date of the en8 actment of this Act are subject to this Act and the amend9 ments made by this Act.

10 (d) EFFECTIVE DATE.—The amendment made by

11 subsection (c) shall take effect on June 30, 1997.

12 (e) CONFORMING AMENDMENTS.—

13 (1) ADULTERATION PROVISION.—Section 501

14 of the Federal Food, Drug, and Cosmetic Act (21

15 U.S.C. 351) is amended—

16 (A) in the first sentence by striking ‘‘drug

17 or device’’ and inserting ‘‘drug, device or

18 human tissue’’; and

19 (B) by adding at the end thereof the fol20 lowing:

21 ‘‘(j) if it is human tissue and it is recovered, proc22 essed, stored, or distributed by—

23 ‘‘(1) a registered person under section 352A of

24 the Public Health Service Act whose failure to com-
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1 ply with standards constitutes a threat to public

2 health; or

3 ‘‘(2) a person who is required under such sec4 tion to register but has failed to do so.’’.

5 (2) MISBRANDING PROVISIONS.—Section 502 of

6 the Federal Food, Drug, and Cosmetic Act (21

7 U.S.C. 352) is amended:

8 (A) in the section heading, but striking

9 ‘‘MISBRANDED DRUGS AND DEVICES’’

10 and inserting the following: ‘‘MISBRANDED

11 DRUGS, DEVICES, AND HUMAN TIS12 SUE’’; and

13 (B) in the first sentence, by striking ‘‘drug

14 or device’’ and inserting ‘‘drug, device or

15 human tissue’’.

16 (3) PROHIBITED ACTS.—Section 301 of the

17 Federal Food, Drug, and Cosmetic Act (21 U.S.C.

18 331) is amended by adding at the end thereof the

19 following:

20 ‘‘(v) The adulteration or misbranding of any human

21 tissue.’’.

22 (4) SEIZURE.—Section 304 of the Federal

23 Food, Drug, and Cosmetic Act (21 U.S.C. 334) is

24 amended—
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1 (A) in subsection (a)(2)(D), by inserting

2 ‘‘or human tissue’’ after ‘‘device’’; and

3 (B) in the first sentence of subsection

4 (d)(1), by striking ‘‘or cosmetic’’ and inserting

5 ‘‘cosmetic, or human tissue’’.

6 (5) INSPECTION.—Section 704(a)(1) of the

7 Federal Food, Drug, and Cosmetic Act (21 U.S.C.

8 374(a)(1)) is amended—

9 (A) in the first sentence, by inserting

10 ‘‘human tissue,’’ after ‘‘device,’’ each place such

11 appears; and

12 (B) in the second sentence, by inserting

13 ‘‘human tissue,’’ after ‘‘drugs,’’ each place such

14 appears.

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