I 
116TH CONGRESS 
1ST SESSION H. R. 3044 
To establish the Medical Device Sterilization Challenge, and for other 
purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 30, 2019 
Mr. LIPINSKI introduced the following bill; which was referred to the Com-
mittee on Energy and Commerce, and in addition to the Committee on 
Science, Space, and Technology, for a period to be subsequently deter-
mined by the Speaker, in each case for consideration of such provisions 
as fall within the jurisdiction of the committee concerned 
A BILL 
To establish the Medical Device Sterilization Challenge, 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 ‘‘Medical Device Steri-
lization Challenge Act of 2019’’. 
SEC. 2. MEDICAL DEVICE STERILIZATION CHALLENGES. 
(a) AUTHORITY.—Not later than 180 days after the 
date of enactment of this Act, the Commissioner of Food 
and Drugs shall establish a program to be known as 
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‘‘Medical Device Sterilization Challenge’’ for carrying out 
prize competitions described in this section under section 
24 of the Stevenson-Wydler Technology Innovation Act of 
1980 (15 U.S.C. 3719) relating to sterilization of medical 
devices. 
(b) PRIZE COMPETITIONS.—In carrying out the pro-
gram, the Director shall provide for prize competitions, 
including at least one prize competition to seek solutions 
with respect to each of the following goals: 
(1) Reduction of the human health hazards as-
sociated with ethylene oxide sterilization, including 
through reduction of— 
(A) the exposure to workers in such facili-
ties; and 
(B) environmental emissions of ethylene 
oxide. 
(2) Reduction of the amount of time required to 
effectively sterilize devices by a factor of 2 or more 
to sterilize the same type and number of devices over 
commonly-used ethylene oxide technology without a 
proportional increase in cost. 
(3) Achievement of rapid implementation of 
new sterilization agents or methods that minimize 
conversion costs without decreasing facility through-
put. 
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(4) Provision of new or improved approaches to 
measuring, monitoring, and controlling ethylene 
oxide emissions, including detection at very low lev-
els. 
(5) Analysis of public health risks of emissions 
from currently-available data with respect to emis-
sions of public health or provision of— 
(A) new or improved tools that use data to 
better model emissions over time at the regional 
or local scale; or 
(B) actionable information on the health 
and environmental impacts of ethylene oxide 
sterilization to government, industry, and mem-
bers of the public. 
(6) Enabling of minimally disruptive conversion 
of exiting device sterilization facilities that use ethyl-
ene oxide to convert to less-toxic methods of steri-
lization. 
(c) PRIZE COMMITTEES.— 
(1) IN GENERAL.—The Director of the Center 
for Devices and Radiological Health shall assemble 
a prize committee with respect to each prize com-
petition that shall define the scope and detail of, and 
provide the requirements for, the prize competitions 
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under this section. Such committee shall be com-
posed of— 
(A) members from the Federal agency, de-
partment, or office that most appropriately cor-
responds with the topic of the prize competi-
tion, including— 
(i) with respect to a prize competition 
under subsection (b)(1), the Director or 
designee of the National Institutes of 
Health; 
(ii) with respect to a prize competition 
under paragraphs (2), (3), (5), and (6) of 
subsection (b), the Director or designee of 
the National Science Foundation; and 
(iii) with respect to a prize competi-
tion under paragraphs (4) and (5) of sub-
section (b), the Administrator or designee 
of the Environmental Protection Agency; 
and 
(B) representatives of any other entities, 
as determined appropriate by the Director, in-
cluding State and local governments and the 
private sector. 
(2) DEFINING TOPIC AREAS.—The prize com-
mittee may modify and define the scope of the prize 
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areas described under subsection (b), so long as such 
modification is in accordance with descriptions in 
such subsection. 
(3) INCENTIVE FOR PRIZE COMPETITION.—The 
prize committee for each prize competition shall de-
termine the incentive for such prize competition. In 
determining the incentive, the committee may con-
sider— 
(A) a cash prize; 
(B) access to Government facilities, a coop-
erative research and development agreement, or 
other method; 
(C) with respect to for a product of use or 
promise to the Federal Government, a commit-
ment by the Federal Government to purchase a 
set number of units of a product from at an 
agreed-upon price before the product is brought 
to market; 
(D) participation in entrepreneurship men-
toring programs; 
(E) consultation and mentoring through 
the regulatory pathway towards approval for 
use; or 
(F) any other incentive provided for by 
law. 
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(4) JUDGING CRITERIA.—The prize committee 
for each prize competition shall establish judging cri-
teria for the competition that shall include— 
(A) potential for the solution to become a 
commercial product or service or advance 
knowledge to further the public good; 
(B) consideration of how likely the solution 
is to lead to subsequent research, development, 
or manufacturing in the United States; 
(C) the degree to which the solution will 
reduce the public health burden created by 
ethylene oxide sterilization of medical devices; 
and 
(D) the degree to which the solution will 
reduce emissions and the environmental health 
burden created by ethylene oxide emissions 
from the sterilization of medical devices. 
(5) CONSIDERATION.—In carrying out this sec-
tion, the committee shall take into consideration the 
best practices provided for in the challenges and 
prizes toolkit made publicly available on December 
15, 2016, by the General Services Administration. 
(d) ACCEPTANCE OF FUNDS.—In addition to such 
sums as may be appropriated or otherwise made available 
to the Director to award prizes under this section, the Di-
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rector may accept funds from other Federal agencies, and 
State and local governments to award prizes under this 
section. 
(e) ELIGIBILITY.—Notwithstanding section 24(g)(3) 
of the Stevenson-Wydler Technology Innovation Act of 
1980 (15 U.S.C. 3719(g)(3)), a group may be eligible for 
an award under this section if 1 member of such group 
is a citizen or permanent resident of the United States. 
(f) COMPLETION
OF PRIZE COMPETITIONS.—The 
prize competitions carried out under this section shall be 
completed not later than the date that is 5 years after 
the program is established under subsection (a). 
(g) AUTHORIZATION OF APPROPRIATIONS.—There is 
authorized to be appropriated $20,000,000 to carry out 
this section, to remain available until expended. 
SEC. 3. AGENCY ACTIVITIES TO SUPPORT NOVEL AND 
EARLY-STAGE TECHNOLOGY FOR MEDICAL 
DEVICE STERILIZATION. 
(a) NATIONAL SCIENCE FOUNDATION.—During the 
5 year period beginning on the date of the enactment of 
this Act, the National Science Foundation shall use exist-
ing authority to award grants on a competitive basis to 
investigator-initiated research projects that may lead to 
the development, implementation, and assessment of novel 
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sterilization methods, including traineeships for those who 
perform this research in academic and industrial settings. 
(b) NATIONAL INSTITUTES OF HEALTH.—The Direc-
tor of the National Institutes of Health shall— 
(1) support or conduct research on the health 
effects of— 
(A) novel sterilization methods, particu-
larly those methods that are well-suited for ma-
terials for which ethylene oxide is currently the 
best available sterilization method, including re-
search on the efficacy of the method on a broad 
range of materials commonly used in medical 
devices, on individuals who receive medical de-
vices; 
(B) emissions from such novel sterilization 
methods on individuals in the surrounding com-
munities; and 
(C) ethylene oxide, particularly on the mor-
bidity secondary to occupational or environ-
mental exposure at levels measured near 
sources that emit ethylene oxide; and 
(2) award grants, on a competitive basis, to en-
able institutions to support graduate students and 
postdoctoral fellows who perform research on novel 
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sterilization methods in both academic and industry 
settings. 
(c) ENVIRONMENTAL PROTECTION AGENCY.—The 
Environmental Protection Agency shall support or conduct 
research on how products, processes, and systems used to 
produce proposed alternatives to ethylene oxide steriliza-
tion will affect the environment. 
SEC. 4. GAO REPORT. 
Not later than 10 years after the implementation of 
this Act, the Comptroller General of the United States 
shall submit to Congress a report on the impact and the 
effectiveness of the provisions of this Act at achieving the 
goals described in subsection (b). 
Æ 
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