II 109th CONGRESS 2d Session S. 2609 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.

Short title

This Act may be cited as the Safe Tissue Act.

2.

Definitions

In this Act: (1)

Establishment

The term establishment has the meaning given such term in section 1271.3 of title 21, Code of Federal Regulations (or any successor regulation). (2)

Human cells, tissues, or cellular or tissue-based products

The term human cells, tissues, or cellular or tissue-based products has the meaning given such term in section 1271.3 of title 21, Code of Federal Regulations (or any successor regulation). (3)

Secretary

The term Secretary means the Secretary of Health and Human Services.

3.

Inspections and audits by the Food and Drug Administration

(a)

Inspections of tissue banks

(1)

In general

Notwithstanding section 1271.400(b) of title 21, Code of Federal Regulations, the Food and Drug Administration shall inspect each establishment regulated by such section not less than once every 2 years. (2)

User fees

The Secretary may establish a user fee program applicable to each establishment under part 1271 of title 21, Code of Federal Regulations, to fund the inspections required by paragraph (1). (b)

Audits of tissue banks

The Food and Drug Administration shall conduct periodic audits of all documentation submitted by each establishment under part 1271 of title 21, Code of Federal Regulations, to determine compliance with all applicable requirements, including those requirements related to ensuring— (1)that human cells, tissues, or cellular or tissue-based products are obtained by the establishment legally; (2)that donor eligibility and donor medical history interviews are based on accurate information that was not provided or obtained in a fraudulent manner; and (3)current good tissue practice.

4.

Development of model consent form

(a)

In general

The Secretary shall publish in the Federal Register a model form containing minimum requirements for establishments to use in obtaining consent from a potential donor, or the legally authorized representative of a potential donor, of human cells, tissues, or cellular or tissue-based products. (b)

Content

The model form under subsection (a) shall include— (1)requirements for obtaining consent from a potential donor, or the legally authorized representative of a potential donor, regarding— (A)the type of human cells, tissues, or cellular or tissue-based product to be donated; (B)the purpose for which such human cells, tissues, or cellular or tissue-based products shall be used, such as transplantation for medical purposes, transplantation for cosmetic purposes, therapy, research, or medical education; and (C)other matters as determined appropriate by the Secretary; (2)a requirement that an establishment provide assurance to the Secretary and a potential donor, or the legally authorized representative of a potential donor, that such an establishment will only obtain consent directly from such donor or representative; and (3)a requirement that an establishment— (A)provide, upon request, to the potential donor, or the legally authorized representative of a potential donor, a description of the recovery process for human cells, tissues, or cellular or tissue-based products; (B)inform such donor or representative of the right to receive such a description; and (C)inform such donor or representative of whether the establishment is accredited under the regulations promulgated by the Secretary pursuant to section 5. (c)

Use of model form

The Secretary shall promulgate regulations requiring that establishments provide and obtain no less information than that specified in the model form under subsection (a) prior to accepting a donation of human cells, tissues, or cellular or tissue-based products. (d)

Enforcement

(1)

Failure to comply with requirements

An establishment, or an individual employed by an establishment, that fails to comply with the requirements of the model form under subsection (a) shall be subject to a civil penalty of not more than $5,000. (2)

Use of fraudulent information

An establishment, or an individual employed by an establishment, that knowingly uses fraudulent information for, or fraudulent means of, obtaining the consent described under the model form under subsection (a) shall be— (A)fined not more than $10,000, or imprisoned for not more than 6 months, or both, for the first such violation; and (B)fined not more than $250,000, or imprisoned for not more than 10 years, or both, for the second and any subsequent such violation. (e)

Preemption

The model form regulations promulgated under subsection (c) shall supercede any provisions of the law with respect to obtaining consent from a potential donor, or legally authorized representative of a potential donor, of human cells, tissues, or cellular or tissue-based products, of the State in which an establishment operates to the extent such law is less stringent than the requirements imposed under such subsection.

5.

Accreditation of establishments and personnel

(a)

In general

The Secretary shall promulgate regulations to accredit— (1)establishments; and (2)the personnel of establishments who participate in the recovery, processing, storage, labeling, packaging, or distribution of human cells, tissues, or cellular or tissue-based products. (b)

Authority of Secretary

In promulgating the regulations under subsection (a), the Secretary shall— (1)establish an accreditation process modeled after the Joint Commission on Accreditation of Healthcare Organizations; or (2)adopt an accreditation process established by a private entity that is in effect as of the date of enactment of this Act.

6.

Determination of reasonable payments

The Secretary shall promulgate regulations defining reasonable payments for the purposes of section 301(c)(2) of the National Organ Transplant Act (42 U.S.C. 274e(c)(2)), as such section relates to human tissue and tissue-based products regulated under part 1271 of title 21, United States Code.