Medical Device Sterilization Challenge Act of 2019
This bill establishes programs to encourage research on the sterilization of medical devices.
[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3044 Introduced in House (IH)]
<DOC>
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
Committee on Energy and Commerce, and in addition to the Committee on
Science, Space, and Technology, for a period to be subsequently
determined 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 Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Medical Device Sterilization
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 ``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 program, 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 associated with
ethylene oxide sterilization, including through reduction of--
(A) the exposure to workers in such facilities; 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 throughput.
(4) Provision of new or improved approaches to measuring,
monitoring, and controlling ethylene oxide emissions, including
detection at very low levels.
(5) Analysis of public health risks of emissions from
currently-available data with respect to emissions 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 members of the public.
(6) Enabling of minimally disruptive conversion of exiting
device sterilization facilities that use ethylene oxide to
convert to less-toxic methods of sterilization.
(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 competition that shall define the scope
and detail of, and provide the requirements for, the prize
competitions under this section. Such committee shall be
composed of--
(A) members from the Federal agency, department, or
office that most appropriately corresponds with the
topic of the prize competition, 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 competition
under paragraphs (4) and (5) of subsection (b),
the Administrator or designee of the
Environmental Protection Agency; and
(B) representatives of any other entities, as
determined appropriate by the Director, including State
and local governments and the private sector.
(2) Defining topic areas.--The prize committee may modify
and define the scope of the prize 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 determine the incentive for
such prize competition. In determining the incentive, the
committee may consider--
(A) a cash prize;
(B) access to Government facilities, a cooperative
research and development agreement, or other method;
(C) with respect to for a product of use or promise
to the Federal Government, a commitment 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 mentoring
programs;
(E) consultation and mentoring through the
regulatory pathway towards approval for use; or
(F) any other incentive provided for by law.
(4) Judging criteria.--The prize committee for each prize
competition shall establish judging criteria 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 section, 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 Director 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 existing authority to award grants on a
competitive basis to investigator-initiated research projects that may
lead to the development, implementation, and assessment of novel
sterilization methods, including traineeships for those who perform
this research in academic and industrial settings.
(b) National Institutes of Health.--The Director of the National
Institutes of Health shall--
(1) support or conduct research on the health effects of--
(A) novel sterilization methods, particularly those
methods that are well-suited for materials for which
ethylene oxide is currently the best available
sterilization method, including research on the
efficacy of the method on a broad range of materials
commonly used in medical devices, on individuals who
receive medical devices;
(B) emissions from such novel sterilization methods
on individuals in the surrounding communities; and
(C) ethylene oxide, particularly on the morbidity
secondary to occupational or environmental exposure at
levels measured near sources that emit ethylene oxide;
and
(2) award grants, on a competitive basis, to enable
institutions to support graduate students and postdoctoral
fellows who perform research on novel 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
sterilization 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).
<all>
Introduced in House
Introduced in House
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Science, Space, and Technology, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Science, Space, and Technology, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Subcommittee on Health.
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