Medical Device Sterilization Challenge Act of 2019

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- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Medical Device Steri- 4 lization Challenge Act of 2019’’. 5 SEC. 2. MEDICAL DEVICE STERILIZATION CHALLENGES. 6 (a) AUTHORITY.—Not later than 180 days after the 7 date of enactment of this Act, the Commissioner of Food 8 and Drugs shall establish a program to be known as 9 VerDate Sep 11 2014 04:09 Jun 08, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H3044.IH H3044 pamtmann on DSKBFK8HB2PROD with BILLS 2 •HR 3044 IH ‘‘Medical Device Sterilization Challenge’’ for carrying out 1 prize competitions described in this section under section 2 24 of the Stevenson-Wydler Technology Innovation Act of 3 1980 (15 U.S.C. 3719) relating to sterilization of medical 4 devices. 5 (b) PRIZE COMPETITIONS.—In carrying out the pro- 6 gram, the Director shall provide for prize competitions, 7 including at least one prize competition to seek solutions 8 with respect to each of the following goals: 9 (1) Reduction of the human health hazards as- 10 sociated with ethylene oxide sterilization, including 11 through reduction of— 12 (A) the exposure to workers in such facili- 13 ties; and 14 (B) environmental emissions of ethylene 15 oxide. 16 (2) Reduction of the amount of time required to 17 effectively sterilize devices by a factor of 2 or more 18 to sterilize the same type and number of devices over 19 commonly-used ethylene oxide technology without a 20 proportional increase in cost. 21 (3) Achievement of rapid implementation of 22 new sterilization agents or methods that minimize 23 conversion costs without decreasing facility through- 24 put. 25 VerDate Sep 11 2014 04:09 Jun 08, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H3044.IH H3044 pamtmann on DSKBFK8HB2PROD with BILLS 3 •HR 3044 IH (4) Provision of new or improved approaches to 1 measuring, monitoring, and controlling ethylene 2 oxide emissions, including detection at very low lev- 3 els. 4 (5) Analysis of public health risks of emissions 5 from currently-available data with respect to emis- 6 sions of public health or provision of— 7 (A) new or improved tools that use data to 8 better model emissions over time at the regional 9 or local scale; or 10 (B) actionable information on the health 11 and environmental impacts of ethylene oxide 12 sterilization to government, industry, and mem- 13 bers of the public. 14 (6) Enabling of minimally disruptive conversion 15 of exiting device sterilization facilities that use ethyl- 16 ene oxide to convert to less-toxic methods of steri- 17 lization. 18 (c) PRIZE COMMITTEES.— 19 (1) IN GENERAL.—The Director of the Center 20 for Devices and Radiological Health shall assemble 21 a prize committee with respect to each prize com- 22 petition that shall define the scope and detail of, and 23 provide the requirements for, the prize competitions 24 VerDate Sep 11 2014 04:09 Jun 08, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H3044.IH H3044 pamtmann on DSKBFK8HB2PROD with BILLS 4 •HR 3044 IH under this section. Such committee shall be com- 1 posed of— 2 (A) members from the Federal agency, de- 3 partment, or office that most appropriately cor- 4 responds with the topic of the prize competi- 5 tion, including— 6 (i) with respect to a prize competition 7 under subsection (b)(1), the Director or 8 designee of the National Institutes of 9 Health; 10 (ii) with respect to a prize competition 11 under paragraphs (2), (3), (5), and (6) of 12 subsection (b), the Director or designee of 13 the National Science Foundation; and 14 (iii) with respect to a prize competi- 15 tion under paragraphs (4) and (5) of sub- 16 section (b), the Administrator or designee 17 of the Environmental Protection Agency; 18 and 19 (B) representatives of any other entities, 20 as determined appropriate by the Director, in- 21 cluding State and local governments and the 22 private sector. 23 (2) DEFINING TOPIC AREAS.—The prize com- 24 mittee may modify and define the scope of the prize 25 VerDate Sep 11 2014 04:09 Jun 08, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H3044.IH H3044 pamtmann on DSKBFK8HB2PROD with BILLS 5 •HR 3044 IH areas described under subsection (b), so long as such 1 modification is in accordance with descriptions in 2 such subsection. 3 (3) INCENTIVE FOR PRIZE COMPETITION.—The 4 prize committee for each prize competition shall de- 5 termine the incentive for such prize competition. In 6 determining the incentive, the committee may con- 7 sider— 8 (A) a cash prize; 9 (B) access to Government facilities, a coop- 10 erative research and development agreement, or 11 other method; 12 (C) with respect to for a product of use or 13 promise to the Federal Government, a commit- 14 ment by the Federal Government to purchase a 15 set number of units of a product from at an 16 agreed-upon price before the product is brought 17 to market; 18 (D) participation in entrepreneurship men- 19 toring programs; 20 (E) consultation and mentoring through 21 the regulatory pathway towards approval for 22 use; or 23 (F) any other incentive provided for by 24 law. 25 VerDate Sep 11 2014 04:09 Jun 08, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H3044.IH H3044 pamtmann on DSKBFK8HB2PROD with BILLS 6 •HR 3044 IH (4) JUDGING CRITERIA.—The prize committee 1 for each prize competition shall establish judging cri- 2 teria for the competition that shall include— 3 (A) potential for the solution to become a 4 commercial product or service or advance 5 knowledge to further the public good; 6 (B) consideration of how likely the solution 7 is to lead to subsequent research, development, 8 or manufacturing in the United States; 9 (C) the degree to which the solution will 10 reduce the public health burden created by 11 ethylene oxide sterilization of medical devices; 12 and 13 (D) the degree to which the solution will 14 reduce emissions and the environmental health 15 burden created by ethylene oxide emissions 16 from the sterilization of medical devices. 17 (5) CONSIDERATION.—In carrying out this sec- 18 tion, the committee shall take into consideration the 19 best practices provided for in the challenges and 20 prizes toolkit made publicly available on December 21 15, 2016, by the General Services Administration. 22 (d) ACCEPTANCE OF FUNDS.—In addition to such 23 sums as may be appropriated or otherwise made available 24 to the Director to award prizes under this section, the Di- 25 VerDate Sep 11 2014 04:09 Jun 08, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H3044.IH H3044 pamtmann on DSKBFK8HB2PROD with BILLS 7 •HR 3044 IH rector may accept funds from other Federal agencies, and 1 State and local governments to award prizes under this 2 section. 3 (e) ELIGIBILITY.—Notwithstanding section 24(g)(3) 4 of the Stevenson-Wydler Technology Innovation Act of 5 1980 (15 U.S.C. 3719(g)(3)), a group may be eligible for 6 an award under this section if 1 member of such group 7 is a citizen or permanent resident of the United States. 8 (f) COMPLETION OF PRIZE COMPETITIONS.—The 9 prize competitions carried out under this section shall be 10 completed not later than the date that is 5 years after 11 the program is established under subsection (a). 12 (g) AUTHORIZATION OF APPROPRIATIONS.—There is 13 authorized to be appropriated $20,000,000 to carry out 14 this section, to remain available until expended. 15 SEC. 3. AGENCY ACTIVITIES TO SUPPORT NOVEL AND 16 EARLY-STAGE TECHNOLOGY FOR MEDICAL 17 DEVICE STERILIZATION. 18 (a) NATIONAL SCIENCE FOUNDATION.—During the 19 5 year period beginning on the date of the enactment of 20 this Act, the National Science Foundation shall use exist- 21 ing authority to award grants on a competitive basis to 22 investigator-initiated research projects that may lead to 23 the development, implementation, and assessment of novel 24 VerDate Sep 11 2014 04:09 Jun 08, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H3044.IH H3044 pamtmann on DSKBFK8HB2PROD with BILLS 8 •HR 3044 IH sterilization methods, including traineeships for those who 1 perform this research in academic and industrial settings. 2 (b) NATIONAL INSTITUTES OF HEALTH.—The Direc- 3 tor of the National Institutes of Health shall— 4 (1) support or conduct research on the health 5 effects of— 6 (A) novel sterilization methods, particu- 7 larly those methods that are well-suited for ma- 8 terials for which ethylene oxide is currently the 9 best available sterilization method, including re- 10 search on the efficacy of the method on a broad 11 range of materials commonly used in medical 12 devices, on individuals who receive medical de- 13 vices; 14 (B) emissions from such novel sterilization 15 methods on individuals in the surrounding com- 16 munities; and 17 (C) ethylene oxide, particularly on the mor- 18 bidity secondary to occupational or environ- 19 mental exposure at levels measured near 20 sources that emit ethylene oxide; and 21 (2) award grants, on a competitive basis, to en- 22 able institutions to support graduate students and 23 postdoctoral fellows who perform research on novel 24 VerDate Sep 11 2014 04:09 Jun 08, 2019 Jkt 089200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H3044.IH H3044 pamtmann on DSKBFK8HB2PROD with BILLS 9 •HR 3044 IH sterilization methods in both academic and industry 1 settings. 2 (c) ENVIRONMENTAL PROTECTION AGENCY.—The 3 Environmental Protection Agency shall support or conduct 4 research on how products, processes, and systems used to 5 produce proposed alternatives to ethylene oxide steriliza- 6 tion will affect the environment. 7 SEC. 4. GAO REPORT. 8 Not later than 10 years after the implementation of 9 this Act, the Comptroller General of the United States 10 shall submit to Congress a report on the impact and the 11 effectiveness of the provisions of this Act at achieving the 12 goals described in subsection (b). 13 Æ VerDate Sep 11 2014 04:09 Jun 08, 2019 Jkt 089200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6301 E:\BILLS\H3044.IH H3044 pamtmann on DSKBFK8HB2PROD with BILLS