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; 
VerDate Aug 31 2005 
09:23 Apr 28, 2006
Jkt 049200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H5209.IH
H5209
cprice-sewell on PROD1PC66 with BILLS
(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 
VerDate Aug 31 2005 
09:23 Apr 28, 2006
Jkt 049200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H5209.IH
H5209
cprice-sewell on PROD1PC66 with BILLS
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 
VerDate Aug 31 2005 
09:23 Apr 28, 2006
Jkt 049200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H5209.IH
H5209
cprice-sewell on PROD1PC66 with BILLS
(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— 
VerDate Aug 31 2005 
09:23 Apr 28, 2006
Jkt 049200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6201
E:\BILLS\H5209.IH
H5209
cprice-sewell on PROD1PC66 with BILLS