I 
110TH CONGRESS 
1ST SESSION H. R. 2731 
To improve the oversight and regulation of tissue banks and the tissue 
donation process, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JUNE 14, 2007 
Mr. PALLONE (for himself and Mr. GENE GREEN of Texas) introduced the 
following bill; which was referred to the Committee on Energy and Commerce 
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 Representa-
tives 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 ‘‘establish-
ment’’ has the meaning given such term in section 
1271.3 of title 21, Code of Federal Regulations (or 
any successor regulation). 
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(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 is 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 Regula-
tions, the Food and Drug Administration shall in-
spect 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 Regula-
tions, to fund the inspections required by paragraph 
(1). 
(b) AUDITS OF TISSUE BANKS.—The Food and Drug 
Administration shall conduct periodic audits of all docu-
mentation submitted by each establishment under part 
1271 of title 21, Code of Federal Regulations, to deter-
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mine compliance with all applicable requirements, includ-
ing those requirements related to ensuring— 
(1) that human cells, tissues, or cellular or tis-
sue-based products are obtained by the establish-
ment legally; 
(2) that donor eligibility and donor medical his-
tory 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 re-
quirements for establishments to use in obtaining consent 
from a potential donor, or the legally authorized represent-
ative of a potential donor, of human cells, tissues, or cel-
lular 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 representa-
tive of a potential donor, regarding— 
(A) the type of human cells, tissues, or cel-
lular or tissue-based product to be donated; 
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(B) the purpose for which such human 
cells, tissues, or cellular or tissue-based prod-
ucts shall be used, such as transplantation for 
medical purposes, transplantation for cosmetic 
purposes, therapy, research, or medical edu-
cation; and 
(C) other matters as determined appro-
priate 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 recov-
ery 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 
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the regulations promulgated by the Secretary 
pursuant to section 5. 
(c) USE OF MODEL FORM.—The Secretary shall pro-
mulgate regulations requiring that establishments provide 
and obtain no less information than that specified in the 
model form under subsection (a) prior to accepting a do-
nation of human cells, tissues, or cellular or tissue-based 
products. 
(d) ENFORCEMENT.— 
(1) FAILURE
TO
COMPLY
WITH
REQUIRE-
MENTS.—An establishment, or an individual em-
ployed 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 es-
tablishment, that knowingly uses fraudulent infor-
mation for, or fraudulent means of, obtaining the 
consent described under the model form under sub-
section (a) shall be— 
(A) fined not more than $10,000, or im-
prisoned for not more than 6 months, or both, 
for the first such violation; and 
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(B) fined not more than $250,000, or im-
prisoned for not more than 10 years, or both, 
for the second and any subsequent such viola-
tion. 
(e) PREEMPTION.—The model form regulations pro-
mulgated under subsection (c) shall supercede any provi-
sions 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 establish-
ment operates to the extent such law is less stringent than 
the requirements imposed under such subsection. 
SEC. 5. ACCREDITATION OF ESTABLISHMENTS AND PER-
SONNEL. 
(a) IN GENERAL.—The Secretary shall promulgate 
regulations to accredit— 
(1) establishments; and 
(2) the personnel of establishments who partici-
pate 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— 
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(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 tis-
sue and tissue-based products regulated under part 1271 
of title 21, Code of Federal Regulations. 
Æ 
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