I 
108TH CONGRESS 
2D SESSION 
H. R. 4151 
To amend the Public Health Service Act to authorize the Commissioner 
of Food and Drugs to conduct oversight of any entity engaged in the 
recovery, screening, testing, processing, storage, or distribution of human 
tissue or human tissue-based products. 
IN THE HOUSE OF REPRESENTATIVES 
APRIL 2, 2004 
Mr. KLINE (for himself, Mr. KENNEDY of Minnesota, Ms. MCCOLLUM, Mr. 
RAMSTAD, Mr. PETERSON of Minnesota, Mr. GUTKNECHT, Mr. SABO, 
Mr. OBERSTAR, Mrs. MUSGRAVE, Mr. MCINNIS, Mr. HEFLEY, and Mr. 
BEAUPREZ) introduced the following bill; which was referred to the Com-
mittee on Energy and Commerce 
A BILL 
To amend the Public Health Service Act to authorize the 
Commissioner of Food and Drugs to conduct oversight 
of any entity engaged in the recovery, screening, testing, 
processing, storage, or distribution of human tissue or 
human tissue-based products. 
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 ‘‘Brian Lykins Human 
Tissue Transplant Safety Act of 2004’’.
SEC. 2. OVERSIGHT OF ENTITIES ENGAGING IN ACTIVITIES 
RELATING TO HUMAN CELL, TISSUE, OR CEL-
LULAR OR TISSUE-BASED PRODUCTS. 
Section 361 of the Public Health Service Act (42 
U.S.C. 264) is amended— 
(1) by striking the section heading and all that 
follows through ‘‘(a) The’’ and inserting the fol-
lowing: 
‘‘SEC. 361. CONTROL OF COMMUNICABLE DISEASES. 
‘‘(a) PREVENTION OF COMMUNICABLE DISEASES.— 
‘‘(1) IN GENERAL.—The’’; 
(2) in subsection (b), by striking ‘‘(b) Regula-
tions prescribed under this section’’ and inserting 
the following: 
‘‘(2) LIMITATION
ON
PURPOSE.—Regulations 
prescribed under this subsection’’; 
(3) in subsection (c), by striking ‘‘(c) Except as 
provided in subsection (d), regulations prescribed 
under this section’’ and inserting the following: 
‘‘(3) LIMITATION ON INDIVIDUALS.—Except as 
provided in paragraph (4), regulations prescribed 
under this subsection’’; 
(4) in subsection (d)— 
(A) by striking the third sentence and all 
that follows through the end and inserting the 
following:
‘‘(B) DEFINITIONS.—In this paragraph: 
‘‘(i) QUALIFYING
STAGE.—The term 
‘qualifying stage’, with respect to a com-
municable disease, means that such dis-
ease— 
‘‘(I) is in a communicable stage; 
or 
‘‘(II) is in a precommunicable 
stage, if the disease would be likely to 
cause a public health emergency if 
transmitted to other individuals. 
‘‘(ii) STATE.—The term ‘State’ in-
cludes, in addition to the several States, 
only the District of Columbia.’’; 
(B) in paragraph (1), by redesignating 
subparagraphs (A) and (B) as clauses (i) and 
(ii), respectively; and 
(C) by striking ‘‘(d)(1) Regulations pre-
scribed under this section’’ and inserting the 
following: 
‘‘(4) CIRCUMSTANCES OF QUARANTINE.— 
‘‘(A) 
IN
GENERAL.—Regulations 
pre-
scribed under this subsection’’; 
(5) in subsection (e)—
tissue-based product in a manner that affects 
interstate commerce. 
‘‘(C) HUMAN CELL, TISSUE, OR CELLULAR 
OR
TISSUE-BASED
PRODUCT.—The 
term 
‘human cell, tissue, or cellular or tissue-based 
product’ means 1 of the articles defined as 
‘human cells, tissues, or cellular or tissue-based 
products’ in section 1271.3(d)(2) of title 21, 
Code of Federal Regulations. 
‘‘(2) OVERSIGHT OF ENTITIES.— 
‘‘(A) IN
GENERAL.—No covered entity 
shall engage in an activity described in para-
graph (1)(B) unless the entity is in compliance 
with this paragraph and the regulations pro-
mulgated under paragraph (3). 
‘‘(B) REGISTRATION AND LISTING.—Each 
covered entity shall submit to the Commissioner 
a request for registration and listing and shall 
submit, for such registration and listing, such 
information relating to the identity and oper-
ations of the covered entity as the Commis-
sioner may require. 
‘‘(C) 
INSPECTION.—The 
Commissioner 
may conduct such inspections of covered enti-
ties as the Commissioner determines are appro-
priate to evaluate and ensure compliance with— 
‘‘(i) this paragraph; and 
‘‘(ii) regulations promulgated under 
paragraph (3). 
‘‘(D) ADVERSE REACTIONS.— 
‘‘(i) IN GENERAL.—If an adverse re-
action (as defined by the Commissioner) 
relating to a human cell, tissue, or cellular 
or tissue-based product occurs at the facil-
ity of a covered entity and the covered en-
tity receives notification of the adverse re-
action, the covered entity shall report the 
adverse reaction to the Commissioner not 
later than 15 calendar days after the date 
on which the covered entity receives the 
notification. 
‘‘(ii) REPORTING MECHANISM; DATA-
BASE.—As soon as practicable, the Com-
missioner, in consultation with the Direc-
tor of the Centers for Disease Control and 
Prevention, shall develop— 
‘‘(I) a single, simple reporting 
mechanism for use in reporting ad-
verse reactions under clause (i); and
‘‘(II) a database for information 
received in relation to any adverse re-
action reported under clause (i). 
‘‘(3) REGULATIONS.— 
‘‘(A) IN
GENERAL.—Not later than 90 
days after the date of enactment of the Human 
Tissue Transplant Safety Act of 2003, the 
Commissioner shall promulgate regulations to 
carry out this subsection, including— 
‘‘(i) regulations specifying a descrip-
tion of the information required to be sub-
mitted for the registration and listing of a 
covered entity under paragraph (2)(B); 
‘‘(ii) regulations specifying a defini-
tion of the term ‘adverse reaction’ for pur-
poses of paragraph (2)(D); 
‘‘(iii) regulations specifying proce-
dures for donor eligibility screening and 
testing, good tissue practices, and proce-
dures for inspection, enforcement, and any 
other reasonable means to ensure that a 
human cell, tissue, or cellular or tissue- 
based product is free from communicable 
disease and maintains function and integ-
rity during recovery, screening, testing,
processing, storage, labeling, packaging, 
and distribution to a patient; and 
‘‘(iv) such other regulations relating 
to the operation of covered entities as the 
Commissioner determines are necessary. 
‘‘(B) ENFORCEMENT.—If the Commis-
sioner determines that a covered entity has vio-
lated paragraph (2) or a regulation promul-
gated under subparagraph (A), the Commis-
sioner (including a designee of the Commis-
sioner) may after providing notice and an op-
portunity for a hearing— 
‘‘(i) issue an order requiring— 
‘‘(I) any person that distributed 
the human cell, tissue, or cellular or 
tissue-based product involved in the 
violation to recall or destroy the cell, 
tissue, or product, as appropriate; and 
‘‘(II) any covered entity in pos-
session of the cell, tissue, or product 
to retain it until— 
‘‘(aa) the cell, tissue or 
product is recalled by the manu-
facturer or is destroyed or dis-
posed of as specified by the Com-
missioner; or 
‘‘(bb) the safety of the cell, 
tissue, or product is confirmed by 
the Commissioner; 
‘‘(ii) condemn, and seize or destroy, 
the cell, tissue, or product; 
‘‘(iii) issue an order requiring the cov-
ered entity to cease the activity that re-
sulted in the violation so that the covered 
entity is in compliance with the regulation; 
or 
‘‘(iv) suspend or revoke the registra-
tion and listing under this subsection of 
the covered entity that violated the regula-
tion. 
‘‘(4) APPLICABILITY.—Nothing in this sub-
section shall be construed to affect the regulation of 
human cell, tissue, or cellular or tissue-based prod-
ucts as biological products under section 351 or 
drugs or devices under the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 301 et seq.). 
‘‘(5) AUTHORIZATION
OF
APPROPRIATIONS.— 
There are authorized to be appropriated to carry out 
this subsection such sums as may be necessary.’’.