[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 2609 Introduced in Senate (IS)]








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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Safe Tissue Act''.

SEC. 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.

SEC. 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.

SEC. 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.

SEC. 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.

SEC. 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.
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