II 

109TH CONGRESS 

2D SESSION S. 2609 

To improve the oversight and regulation of tissue banks and the tissue 

donation process, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

APRIL 7, 2006 

Mr. SCHUMER (for himself and Mr. LEAHY) introduced the following bill; 

which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To improve the oversight and regulation of tissue banks 

and the tissue donation process, 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 This Act may be cited as the ‘‘Safe Tissue Act’’. 

5 SEC. 2. DEFINITIONS. 

6 In this Act: 

7 (1) ESTABLISHMENT.—The term ‘‘establish8 ment’’ has the meaning given such term in section 

9 1271.3 of title 21, Code of Federal Regulations (or 

10 any successor regulation). 


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1 (2) HUMAN CELLS, TISSUES, OR CELLULAR OR

2 TISSUE-BASED PRODUCTS.—The term ‘‘human cells, 

3 tissues, or cellular or tissue-based products’’ has the 

4 meaning given such term in section 1271.3 of title 

5 21, Code of Federal Regulations (or any successor 

6 regulation). 

7 (3) SECRETARY.—The term ‘‘Secretary’’ means 

8 the Secretary of Health and Human Services. 

9 SEC. 3. INSPECTIONS AND AUDITS BY THE FOOD AND DRUG 

10 ADMINISTRATION. 

11 (a) INSPECTIONS OF TISSUE BANKS.— 

12 (1) IN GENERAL.—Notwithstanding section 

13 1271.400(b) of title 21, Code of Federal Regula14 tions, the Food and Drug Administration shall in15 spect each establishment regulated by such section 

16 not less than once every 2 years. 

17 (2) USER FEES.—The Secretary may establish 

18 a user fee program applicable to each establishment 

19 under part 1271 of title 21, Code of Federal Regula20 tions, to fund the inspections required by paragraph 

21 (1). 

22 (b) AUDITS OF TISSUE BANKS.—The Food and Drug 

23 Administration shall conduct periodic audits of all docu24 mentation submitted by each establishment under part 

25 1271 of title 21, Code of Federal Regulations, to deterVerDate Aug 31 2005 18:50 Apr 13, 2006 Jkt 049200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S2609.IS S2609

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1 mine compliance with all applicable requirements, includ2 ing those requirements related to ensuring— 

3 (1) that human cells, tissues, or cellular or tis4 sue-based products are obtained by the establish5 ment legally; 

6 (2) that donor eligibility and donor medical his7 tory interviews are based on accurate information 

8 that was not provided or obtained in a fraudulent 

9 manner; and 

10 (3) current good tissue practice. 

11 SEC. 4. DEVELOPMENT OF MODEL CONSENT FORM. 

12 (a) IN GENERAL.—The Secretary shall publish in the 

13 Federal Register a model form containing minimum re14 quirements for establishments to use in obtaining consent 

15 from a potential donor, or the legally authorized represent16 ative of a potential donor, of human cells, tissues, or cel17 lular or tissue-based products. 

18 (b) CONTENT.—The model form under subsection (a) 

19 shall include— 

20 (1) requirements for obtaining consent from a 

21 potential donor, or the legally authorized representa22 tive of a potential donor, regarding— 

23 (A) the type of human cells, tissues, or cel24 lular or tissue-based product to be donated; 


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1 (B) the purpose for which such human 

2 cells, tissues, or cellular or tissue-based prod3 ucts shall be used, such as transplantation for 

4 medical purposes, transplantation for cosmetic 

5 purposes, therapy, research, or medical edu6 cation; and 

7 (C) other matters as determined appro8 priate by the Secretary; 

9 (2) a requirement that an establishment provide 

10 assurance to the Secretary and a potential donor, or 

11 the legally authorized representative of a potential 

12 donor, that such an establishment will only obtain 

13 consent directly from such donor or representative; 

14 and 

15 (3) a requirement that an establishment— 

16 (A) provide, upon request, to the potential 

17 donor, or the legally authorized representative 

18 of a potential donor, a description of the recov19 ery process for human cells, tissues, or cellular 

20 or tissue-based products; 

21 (B) inform such donor or representative of 

22 the right to receive such a description; and 

23 (C) inform such donor or representative of 

24 whether the establishment is accredited under 


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1 the regulations promulgated by the Secretary 

2 pursuant to section 5. 

3 (c) USE OF MODEL FORM.—The Secretary shall pro4 mulgate regulations requiring that establishments provide 

5 and obtain no less information than that specified in the 

6 model form under subsection (a) prior to accepting a do7 nation of human cells, tissues, or cellular or tissue-based 

8 products. 

9 (d) ENFORCEMENT.— 

10 (1) FAILURE TO COMPLY WITH REQUIRE11 MENTS.—An establishment, or an individual em12 ployed by an establishment, that fails to comply with 

13 the requirements of the model form under subsection 

14 (a) shall be subject to a civil penalty of not more 

15 than $5,000. 

16 (2) USE OF FRAUDULENT INFORMATION.—An 

17 establishment, or an individual employed by an es18 tablishment, that knowingly uses fraudulent infor19 mation for, or fraudulent means of, obtaining the 

20 consent described under the model form under sub21 section (a) shall be— 

22 (A) fined not more than $10,000, or im23 prisoned for not more than 6 months, or both, 

24 for the first such violation; and 


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1 (B) fined not more than $250,000, or im2 prisoned for not more than 10 years, or both, 

3 for the second and any subsequent such viola4 tion. 

5 (e) PREEMPTION.—The model form regulations pro6 mulgated under subsection (c) shall supercede any provi7 sions of the law with respect to obtaining consent from 

8 a potential donor, or legally authorized representative of 

9 a potential donor, of human cells, tissues, or cellular or 

10 tissue-based products, of the State in which an establish11 ment operates to the extent such law is less stringent than 

12 the requirements imposed under such subsection. 

13 SEC. 5. ACCREDITATION OF ESTABLISHMENTS AND PER14 SONNEL. 

15 (a) IN GENERAL.—The Secretary shall promulgate 

16 regulations to accredit— 

17 (1) establishments; and 

18 (2) the personnel of establishments who partici19 pate in the recovery, processing, storage, labeling, 

20 packaging, or distribution of human cells, tissues, or 

21 cellular or tissue-based products. 

22 (b) AUTHORITY OF SECRETARY.—In promulgating 

23 the regulations under subsection (a), the Secretary shall— 


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1 (1) establish an accreditation process modeled 

2 after the Joint Commission on Accreditation of 

3 Healthcare Organizations; or 

4 (2) adopt an accreditation process established 

5 by a private entity that is in effect as of the date 

6 of enactment of this Act. 

7 SEC. 6. DETERMINATION OF REASONABLE PAYMENTS. 

8 The Secretary shall promulgate regulations defining 

9 ‘‘reasonable payments’’ for the purposes of section 

10 301(c)(2) of the National Organ Transplant Act (42 

11 U.S.C. 274e(c)(2)), as such section relates to human tis12 sue and tissue-based products regulated under part 1271 

13 of title 21, United States Code. 

Æ 


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