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[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>
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