,i #aafth ,,congress #ast ,session ,h4 ,r4 #cjdd ,,in ,,the ,,house ,,of ,,representatives ,may #cj1 #bjai,mr4 ,lipinski introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce1 and in addition to the ,committee on ,science1 ,space1 and ,technology1 for a period to be subsequently determined by the ,speaker1 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 ,challenge1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,medical ,device ,sterilization ,challenge ,act of #bjai4 #b4 ,medical device sterilization challenges 7a7 ,authority ,not later than #ahj days after the date of enactment of this ,act1 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 #bd of the ,stevenson-,wydler ,technology ,innovation ,act of #aihj 7#ae ,u4,s4,c4 #cgai7 relating to sterilization of medical devices4 7b7 ,prize competitions ,in carrying out the program1 the ,director shall provide for prize competitions1 including at least one prize competition to seek solutions with respect to each of the following goals3 7#a7 ,reduction of the human health hazards associated with ethylene oxide sterilization1 including through reduction of-- 7,a7 the exposure to workers in such facilities2 and 7,b7 environmental emissions of ethylene oxide4 7#b7 ,reduction of the amount of time required to effectively sterilize devices by a factor of #b or more to sterilize the same type and number of devices over commonly-used ethylene oxide technology without a proportional increase in cost4 7#c7 ,achievement of rapid implementation of new sterilization agents or methods that minimize conversion costs without decreasing facility throughput4 7#d7 ,provision of new or improved approaches to measuring1 monitoring1 and controlling ethylene oxide emissions1 including detection at very low levels4 7#e7 ,analysis of public health risks of emissions from currently-available data with respect to emissions of public health or provision of-- 7,a7 new or improved tools that use data to better model emissions over time at the regional or local scale2 or 7,b7 actionable information on the health and environmental impacts of ethylene oxide sterilization to government1 industry1 and members of the public4 7#f7 ,enabling of minimally disruptive conversion of exiting device sterilization facilities that use ethylene oxide to convert to less-toxic methods of sterilization4 7c7 ,prize committees 7#a7 ,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 of1 and provide the requirements for1 the prize competitions under this section4 ,such committee shall be composed of-- 7,a7 members from the ,federal agency1 department1 or office that most appropriately corresponds with the topic of the prize competition1 including-- 7i7 with respect to a prize competition under subsection 7b77#a71 the ,director or designee of the ,national ,institutes of ,health2 7ii7 with respect to a prize competition under paragraphs 7#b71 7#c71 7#e71 and 7#f7 of subsection 7b71 the ,director or designee of the ,national ,science ,foundation2 and 7iii7 with respect to a prize competition under paragraphs 7#d7 and 7#e7 of subsection 7b71 the ,administrator or designee of the ,environmental ,protection ,agency2 and 7,b7 representatives of any other entities1 as determined appropriate by the ,director1 including ,state and local governments and the private sector4 7#b7 ,defining topic areas ,the prize committee may modify and define the scope of the prize areas described under subsection 7b71 so long as such modification is in accordance with descriptions in such subsection4 7#c7 ,incentive for prize competition ,the prize committee for each prize competition shall determine the incentive for such prize competition4 ,in determining the incentive1 the committee may consider-- 7,a7 a cash prize2 7,b7 access to ,government facilities1 a cooperative research and development agreement1 or other method2 7,c7 with respect to for a product of use or promise to the ,federal ,government1 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 market2 7,d7 participation in entrepreneurship mentoring programs2 7,e7 consultation and mentoring through the regulatory pathway towards approval for use2 or 7,f7 any other incentive provided for by law4 7#d7 ,judging criteria ,the prize committee for each prize competition shall establish judging criteria for the competition that shall include-- 7,a7 potential for the solution to become a commercial product or service or advance knowledge to further the public good2 7,b7 consideration of how likely the solution is to lead to subsequent research1 development1 or manufacturing in the ,united ,states2 7,c7 the degree to which the solution will reduce the public health burden created by ethylene oxide sterilization of medical devices2 and 7,d7 the degree to which the solution will reduce emissions and the environmental health burden created by ethylene oxide emissions from the sterilization of medical devices4 7#e7 ,consideration ,in carrying out this section1 the committee shall take into consideration the best practices provided for in the challenges and prizes toolkit made publicly available on ,december #ae1 #bjaf1 by the ,general ,services ,administration4 7d7 ,acceptance of funds ,in addition to such sums as may be appropriated or otherwise made available to the ,director to award prizes under this section1 the ,director may accept funds from other ,federal agencies1 and ,state and local governments to award prizes under this section4 7e7 ,eligibility ,notwithstanding section #bd7;g77#c7 of the ,stevenson-,wydler ,technology ,innovation ,act of #aihj 7#ae ,u4,s4,c4 #cgai7;g77#c771 a group may be eligible for an award under this section if #a member of such group is a citizen or permanent resident of the ,united ,states4 7f7 ,completion of prize competitions ,the prize competitions carried out under this section shall be completed not later than the date that is #e years after the program is established under subsection 7a74 7g7 ,authorization of appropriations ,there is authorized to be appropriated #bj1jjj1jjj to carry out this section1 to remain available until expended4 #c4 ,agency ,activities to ,support ,novel and ,early-,stage ,technology for ,medical ,device ,sterilization 7a7 ,national science foundation ,during the #e year period beginning on the date of the enactment of this ,act1 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 development1 implementation1 and assessment of novel sterilization methods1 including traineeships for those who perform this research in academic and industrial settings4 7b7 ,national institutes of health ,the ,director of the ,national ,institutes of ,health shall-- 7#a7 support or conduct research on the health effects of-- 7,a7 novel sterilization methods1 particularly those methods that are well-suited for materials for which ethylene oxide is currently the best available sterilization method1 including research on the efficacy of the method on a broad range of materials commonly used in medical devices1 on individuals who receive medical devices2 7,b7 emissions from such novel sterilization methods on individuals in the surrounding communities2 and 7,c7 ethylene oxide1 particularly on the morbidity secondary to occupational or environmental exposure at levels measured near sources that emit ethylene oxide2 and 7#b7 award grants1 on a competitive basis1 to enable institutions to support graduate students and postdoctoral fellows who perform research on novel sterilization methods in both academic and industry settings4 7c7 ,environmental protection agency ,the ,environmental ,protection ,agency shall support or conduct research on how products1 processes1 and systems used to produce proposed alternatives to ethylene oxide sterilization will affect the environment4 #d4 ,,gao ,report ,not later than #aj years after the implementation of this ,act1 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 7b74