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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Patient Safety and 

5 Toxicology Modernization Act of 2016’’. 

6 SEC. 2. FINDINGS. 

7 Congress finds the following: 


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1 (1) Preclinical testing serves a fundamental role 

2 in characterizing the potential risks and benefits as3 sociated with regulated medicines and products. 

4 (2) Critical gaps remain in the understanding 

5 of the relationship between patient response and pre6 clinical findings. 

7 (3) Serious, rare, and unexpected adverse 

8 events may be observed in clinical trials or post9 approval, particularly toxicology effects not identi10 fied in animals that may harm human organs. 

11 (4) Patient efficacy, safety, dosage information, 

12 and speedier access to new medicines will benefit 

13 from models that are more predictive than animals 

14 and that mimic key elements of human organs. 

15 (5) A 2011 report by the Food and Drug Ad16 ministration, entitled ‘‘Advancing Regulatory 

17 Science at FDA’’, prioritized toxicology testing and 

18 the development of models of human adverse re19 sponse as one of the areas of regulatory science 

20 where new or enhanced engagement by the agency is 

21 essential to the continued success of the public 

22 health and regulatory mission of the Food and Drug 

23 Administration. 

24 (6) The Food and Drug Administration’s 2016 

25 draft commitment letter concerning the reauthorizaVerDate Sep 11 2014 01:11 Dec 10, 2016 Jkt 069200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H6463.IH H6463

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1 tion of fees relating to drugs under part 2 of sub2 chapter C of chapter VII of the Federal Food, Drug, 

3 and Cosmetic Act (21 U.S.C. 379g et seq.) proposes 

4 a process to add new preclinical models that will not 

5 be finalized until at least 2021. 

6 (7) Peer-reviewed data is readily available to il7 lustrate the benefits of commercially available 

8 human tissue models to improve the drug discovery 

9 process by replicating key elements of living human 

10 tissue. 

11 (8) The Food and Drug Administration should 

12 take immediate steps to validate new models, includ13 ing three-dimensional human tissue models, that im14 prove regulatory decisionmaking in preclinical, clin15 ical, labeling, and postmarket safety and efficacy 

16 testing, or other uses by product sponsors. 

17 SEC. 3. GUIDANCE WITH RESPECT TO THREE-DIMENSIONAL 

18 HUMAN TISSUE MODELS. 

19 (a) IN GENERAL.—Not later than December 31, 

20 2018, the Secretary of Health and Human Services, acting 

21 through the Commissioner of Food and Drugs, shall issue 

22 guidance addressing— 

23 (1) the development and use of novel tools for 

24 toxicology and efficacy testing, including three-di25 mensional human tissue models; and 


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1 (2) the use of three-dimensional human tissue 

2 models for preclinical, clinical, and postmarket safe3 ty and efficacy testing, labeling, or other uses by 

4 product sponsors. 

5 (b) PERIODIC UPDATES.—The Secretary shall peri6 odically update the guidance issued under subsection (a). 

7 SEC. 4. RULE OF CONSTRUCTION. 

8 Nothing in this Act shall be construed to prohibit or 

9 limit the use of three-dimensional human tissue models by 

10 product sponsors with respect to— 

11 (1) obtaining approval or licensure of a drug or 

12 biological product, including a combination product, 

13 under section 505 of the Federal Food, Drug, and 

14 Cosmetic Act (21 U.S.C. 355) or section 351 of the 

15 Public Health Service Act (42 U.S.C. 262); or 

16 (2) meeting the requirements of a regulatory 

17 decision issued by the Secretary of Health and 

18 Human Services. 

19 SEC. 5. DEFINITIONS. 

20 In this Act: 

21 (1) BIOLOGICAL PRODUCT.—The term ‘‘biologi22 cal product’’ has the meaning given such term in 

23 section 351(i) of the Public Health Service Act (42 

24 U.S.C. 262(i)). 


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1 (2) COMBINATION PRODUCT.—The term ‘‘com2 bination product’’ means a combination product de3 scribed in section 503(g) of the Federal Food, Drug, 

4 and Cosmetic Act (21 U.S.C. 353(g)). 

5 (3) DRUG.—The term ‘‘drug’’ has the meaning 

6 given such term in section 201 of the Federal Food, 

7 Drug, and Cosmetic Act (21 U.S.C. 321). 

8 (4) THREE-DIMENSIONAL HUMAN TISSUE

9 MODEL.—The term ‘‘three-dimensional human tissue 

10 model’’ means a three-dimensional model that— 

11 (A) approximates human tissue composi12 tion and physiology using spatially controlled 

13 deposition of adult human cells or cell-con14 taining materials in user-defined, geometric pat15 terns; 

16 (B) can be used to detect toxicity that is 

17 not identifiable in animal models; 

18 (C) can be used to test the efficacy of a 

19 drug that is not possible or not able to be suffi20 ciently tested in an animal model; and 

21 (D) can predict toxicity in clinical testing 

22 or detect toxicity in known clinical failures. 

Æ 


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