I 
114TH CONGRESS 
2D SESSION 
H. R. 6463 
To direct the Secretary of Health and Human Services to issue guidance 
with respect to three-dimensional human tissue models, and for other 
purposes. 
IN THE HOUSE OF REPRESENTATIVES 
DECEMBER 7, 2016 
Mr. COLLINS of New York (for himself and Mr. LONG) introduced the 
following bill; which was referred to the Committee on Energy and Commerce 
A BILL 
To direct the Secretary of Health and Human Services to 
issue guidance with respect to three-dimensional human 
tissue models, 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 ‘‘Patient Safety and 
Toxicology Modernization Act of 2016’’. 
SEC. 2. FINDINGS. 
Congress finds the following: 
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(1) Preclinical testing serves a fundamental role 
in characterizing the potential risks and benefits as-
sociated with regulated medicines and products. 
(2) Critical gaps remain in the understanding 
of the relationship between patient response and pre-
clinical findings. 
(3) Serious, rare, and unexpected adverse 
events may be observed in clinical trials or post-
approval, particularly toxicology effects not identi-
fied in animals that may harm human organs. 
(4) Patient efficacy, safety, dosage information, 
and speedier access to new medicines will benefit 
from models that are more predictive than animals 
and that mimic key elements of human organs. 
(5) A 2011 report by the Food and Drug Ad-
ministration, 
entitled 
‘‘Advancing 
Regulatory 
Science at FDA’’, prioritized toxicology testing and 
the development of models of human adverse re-
sponse as one of the areas of regulatory science 
where new or enhanced engagement by the agency is 
essential to the continued success of the public 
health and regulatory mission of the Food and Drug 
Administration. 
(6) The Food and Drug Administration’s 2016 
draft commitment letter concerning the reauthoriza-
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tion of fees relating to drugs under part 2 of sub-
chapter C of chapter VII of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379g et seq.) proposes 
a process to add new preclinical models that will not 
be finalized until at least 2021. 
(7) Peer-reviewed data is readily available to il-
lustrate the benefits of commercially available 
human tissue models to improve the drug discovery 
process by replicating key elements of living human 
tissue. 
(8) The Food and Drug Administration should 
take immediate steps to validate new models, includ-
ing three-dimensional human tissue models, that im-
prove regulatory decisionmaking in preclinical, clin-
ical, labeling, and postmarket safety and efficacy 
testing, or other uses by product sponsors. 
SEC. 3. GUIDANCE WITH RESPECT TO THREE-DIMENSIONAL 
HUMAN TISSUE MODELS. 
(a) IN GENERAL.—Not later than December 31, 
2018, the Secretary of Health and Human Services, acting 
through the Commissioner of Food and Drugs, shall issue 
guidance addressing— 
(1) the development and use of novel tools for 
toxicology and efficacy testing, including three-di-
mensional human tissue models; and 
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(2) the use of three-dimensional human tissue 
models for preclinical, clinical, and postmarket safe-
ty and efficacy testing, labeling, or other uses by 
product sponsors. 
(b) PERIODIC UPDATES.—The Secretary shall peri-
odically update the guidance issued under subsection (a). 
SEC. 4. RULE OF CONSTRUCTION. 
Nothing in this Act shall be construed to prohibit or 
limit the use of three-dimensional human tissue models by 
product sponsors with respect to— 
(1) obtaining approval or licensure of a drug or 
biological product, including a combination product, 
under section 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355) or section 351 of the 
Public Health Service Act (42 U.S.C. 262); or 
(2) meeting the requirements of a regulatory 
decision issued by the Secretary of Health and 
Human Services. 
SEC. 5. DEFINITIONS. 
In this Act: 
(1) BIOLOGICAL PRODUCT.—The term ‘‘biologi-
cal product’’ has the meaning given such term in 
section 351(i) of the Public Health Service Act (42 
U.S.C. 262(i)). 
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(2) COMBINATION PRODUCT.—The term ‘‘com-
bination product’’ means a combination product de-
scribed in section 503(g) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 353(g)). 
(3) DRUG.—The term ‘‘drug’’ has the meaning 
given such term in section 201 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 321). 
(4) 
THREE-DIMENSIONAL
HUMAN
TISSUE 
MODEL.—The term ‘‘three-dimensional human tissue 
model’’ means a three-dimensional model that— 
(A) approximates human tissue composi-
tion and physiology using spatially controlled 
deposition of adult human cells or cell-con-
taining materials in user-defined, geometric pat-
terns; 
(B) can be used to detect toxicity that is 
not identifiable in animal models; 
(C) can be used to test the efficacy of a 
drug that is not possible or not able to be suffi-
ciently tested in an animal model; and 
(D) can predict toxicity in clinical testing 
or detect toxicity in known clinical failures. 
Æ 
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