STAAR Act

II 116TH CONGRESS 1ST SESSION S. 2304 To amend the Public Health Service Act to enhance efforts to address antibiotic resistance, and for other purposes. IN THE SENATE OF THE UNITED STATES JULY 29, 2019 Mr. BROWN introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To amend the Public Health Service Act to enhance efforts to address antibiotic resistance, 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 ‘‘Strategies To Address 4 Antibiotic Resistance Act’’ or the ‘‘STAAR Act’’. 5 SEC. 2. COMBATING ANTIMICROBIAL RESISTANCE. 6 Section 319E of the Public Health Service Act (42 7 U.S.C. 247d–5) is amended— 8 (1) in subsection (a)— 9 VerDate Sep 11 2014 21:49 Aug 08, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S2304.IS S2304 jbell on DSK3GLQ082PROD with BILLS 2 •S 2304 IS (A) in paragraph (1), in the first sentence, 1 by striking ‘‘and coordinate Federal programs 2 relating to antimicrobial resistance’’ and insert- 3 ing ‘‘relating to antimicrobial resistance, coordi- 4 nate Federal programs relating to antimicrobial 5 resistance, and implement the objectives of the 6 National Action Plan for Combating Antibiotic- 7 Resistant Bacteria, published in March 2015 in 8 response to Executive Order 13676 of Sep- 9 tember 18, 2014 (79 Fed. Reg. 56931; relating 10 to combating antibiotic-resistant bacteria) (re- 11 ferred to in this section as the ‘Action Plan’)’’; 12 (B) by amending paragraph (2) to read as 13 follows: 14 ‘‘(2) MEMBERS OF TASK FORCE.—The task 15 force described in paragraph (1) shall be co-chaired 16 by the Secretary of Health and Human Services, the 17 Secretary of Agriculture, and the Secretary of De- 18 fense, and shall be composed of representatives of 19 relevant Federal agencies and such executive depart- 20 ments, agencies, or offices as the co-chairs may des- 21 ignate.’’; 22 (C) by amending paragraph (4) to read as 23 follows: 24 VerDate Sep 11 2014 04:19 Aug 07, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S2304.IS S2304 jbell on DSK3GLQ082PROD with BILLS 3 •S 2304 IS ‘‘(4) MEETINGS.—At least twice a year, the 1 task force described in paragraph (1) shall have a 2 public meeting to assess progress and obstacles to 3 implementing the objectives of the Action Plan. The 4 task force may discuss and review based on need or 5 concern the following (among other issues): 6 ‘‘(A) Federal activities to slow the emer- 7 gence of antimicrobial-resistant bacteria and 8 prevent the spread of resistant infections. Such 9 activities may include optimal use of vaccines 10 and other infection control measures to prevent 11 infections, implementation of health care poli- 12 cies and antimicrobial stewardship programs 13 that improve patient outcomes, regional efforts 14 to control transmission across community and 15 health care settings, and public awareness cam- 16 paigns. 17 ‘‘(B) Federal activities to strengthen na- 18 tional One-Health surveillance efforts, which 19 are efforts addressing the interactions between 20 human, animal, and environmental health, to 21 combat antibiotic resistance. One-Health sur- 22 veillance efforts to combat antibiotic resistance 23 may include enhanced data sharing and coordi- 24 nation of surveillance and laboratory systems 25 VerDate Sep 11 2014 04:19 Aug 07, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S2304.IS S2304 jbell on DSK3GLQ082PROD with BILLS 4 •S 2304 IS across human and animal settings, and en- 1 hanced monitoring of sales, usage, resistance, 2 and management practices of antibiotic drugs 3 along the food-production chain. Such surveil- 4 lance and laboratory systems may include the 5 National Healthcare Safety Network, the 6 Emerging Infections Program, the National 7 Antimicrobial Resistance Monitoring System, 8 the National Animal Health Monitoring Sys- 9 tem, the National Animal Health Laboratory 10 Network, the Veterinary Laboratory Investiga- 11 tion and Response Network, and the Antibiotic 12 Resistance Laboratory Network. 13 ‘‘(C) Federal efforts to advance the devel- 14 opment and use of rapid and innovative diag- 15 nostic tests for identification and characteriza- 16 tion of antibiotic-resistant bacteria. Such efforts 17 may include development of new diagnostic 18 tests and expansion of their availability and use 19 to improve treatment, infection control, and 20 outbreak response. 21 ‘‘(D) Federal efforts to accelerate basic 22 and applied research and development for new 23 antibiotic drugs, other therapeutics, prevention 24 efforts, and vaccines. Such efforts may include 25 VerDate Sep 11 2014 04:19 Aug 07, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S2304.IS S2304 jbell on DSK3GLQ082PROD with BILLS 5 •S 2304 IS support for basic and applied research, provi- 1 sion of scientific services and guidance to re- 2 searchers, and fostering of public-private part- 3 nerships. 4 ‘‘(E) Federal efforts to improve inter- 5 national collaboration and capacities for anti- 6 biotic-resistance prevention, surveillance, and 7 control and antibiotic research and develop- 8 ment. Such efforts may include collaborations 9 with foreign ministries of health and agri- 10 culture, the World Health Organization, the 11 Food and Agriculture Organization, the World 12 Organization for Animal Health, and other mul- 13 tinational organizations.’’; and 14 (D) by adding at the end the following: 15 ‘‘(5) AVAILABILITY OF INFORMATION.—The 16 task force described in paragraph (1), to the extent 17 permitted by law, shall— 18 ‘‘(A) provide the Presidential Advisory 19 Council on Combating Antibiotic-Resistant Bac- 20 teria described in section 505 of the Pandemic 21 and All-Hazards Preparedness and Advancing 22 Innovation Act of 2019 with such information 23 as may be required for carrying out the func- 24 tions of such Advisory Council, including infor- 25 VerDate Sep 11 2014 04:19 Aug 07, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S2304.IS S2304 jbell on DSK3GLQ082PROD with BILLS 6 •S 2304 IS mation on progress in advancing the Action 1 Plan, meeting minutes, and other key informa- 2 tion of the task force; and 3 ‘‘(B) ensure that all information described 4 in subparagraph (A) is made available on the 5 websites of the Department of Health and 6 Human Services, the Department of Agri- 7 culture, and the Department of Defense.’’; 8 (2) in subsection (h)— 9 (A) in the heading, by striking ‘‘INFORMA- 10 TION RELATED TO’’; 11 (B) by striking ‘‘The Secretary’’ and in- 12 serting the following: 13 ‘‘(1) DISSEMINATION OF INFORMATION.—The 14 Secretary’’; and 15 (C) by adding at the end the following: 16 ‘‘(2) ENCOURAGING ANTIMICROBIAL STEWARD- 17 SHIP PROGRAMS.—The Secretary shall encourage 18 health care facilities to establish antimicrobial stew- 19 ardship programs that are consistent with docu- 20 ments issued by the Centers for Disease Control and 21 Prevention relating to the core elements of anti- 22 microbial stewardship programs. 23 ‘‘(3) DEFINITION OF ANTIMICROBIAL STEWARD- 24 SHIP.—For purposes of this section, the term ‘anti- 25 VerDate Sep 11 2014 04:19 Aug 07, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S2304.IS S2304 jbell on DSK3GLQ082PROD with BILLS 7 •S 2304 IS microbial stewardship’ means coordinated interven- 1 tions designed to improve and evaluate the appro- 2 priate use of antimicrobial agents, including pro- 3 moting the use of antimicrobial drugs only when 4 clinically indicated, and, when antimicrobial drugs 5 are clinically indicated, promoting the selection of 6 the optimal antimicrobial drug regimen, including 7 through factors such as dosage, duration of therapy, 8 and route of administration.’’; 9 (3) in subsection (m), by striking 10 ‘‘$40,000,000’’ and all that follows through the pe- 11 riod at the end and inserting ‘‘such sums as may be 12 necessary for each of fiscal years 2020 through 13 2026.’’; and 14 (4) by adding at the end the following: 15 ‘‘(n) ANNUAL REPORT ON IMPLEMENTING THE AC- 16 TION PLAN OBJECTIVES.—Not later than 1 year after the 17 date of the enactment of the Strategies to Address Anti- 18 biotic Resistance Act, and annually thereafter, the Sec- 19 retary, in cooperation with the Secretary of Agriculture, 20 the Secretary of Defense, and the task force described in 21 subsection (a), shall submit to the Committee on Health, 22 Education, Labor, and Pensions of the Senate and the 23 Committee on Energy and Commerce of the House of 24 Representatives, and make available on the websites of the 25 VerDate Sep 11 2014 04:19 Aug 07, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S2304.IS S2304 jbell on DSK3GLQ082PROD with BILLS 8 •S 2304 IS Department of Health and Human Services, the Depart- 1 ment of Agriculture, and the Department of Defense, a 2 report on the progress made in implementing the objec- 3 tives of the Action Plan.’’. 4 SEC. 3. ADDITIONAL STRATEGIES FOR COMBATING ANTI- 5 BIOTIC RESISTANCE. 6 Part B of title III of the Public Health Service Act 7 (42 U.S.C. 243 et seq.) is amended by inserting after sec- 8 tion 319E the following: 9 ‘‘SEC. 319E–1. SURVEILLANCE AND REPORTING OF ANTI- 10 BIOTIC USE AND RESISTANCE. 11 ‘‘(a) IN GENERAL.—The Secretary, acting through 12 the Director of the Centers for Disease Control and Pre- 13 vention, shall use the National Healthcare Safety Network 14 and other appropriate surveillance systems to assess— 15 ‘‘(1) appropriate conditions, outcomes, and 16 measures causally related to antibacterial resistance, 17 including types of infections, the causes for infec- 18 tions, and whether infections are acquired in a com- 19 munity or hospital setting, increased lengths of hos- 20 pital stay, increased costs, and rates of mortality; 21 and 22 ‘‘(2) changes in bacterial resistance to drugs in 23 relation to patient outcomes, including changes in 24 VerDate Sep 11 2014 04:19 Aug 07, 2019 Jkt 089200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S2304.IS S2304 jbell on DSK3GLQ082PROD with BILLS 9 •S 2304 IS percent resistance, prevalence of antibiotic-resistant 1 infections, and other such changes. 2 ‘‘(b) ANTIBIOTIC USE DATA.—The Secretary, acting 3 through the Director of the Centers for Disease Control 4 and Prevention, shall work with Federal agencies (includ- 5 ing the Department of Veterans Affairs, the Department 6 of Defense, and the Centers for Medicare & Medicaid 7 Services), private vendors, health care organizations, phar- 8 macy benefit managers, and other entities as appropriate 9 to obtain reliable and comparable human antibiotic drug 10 consumption data (including, as available and appropriate, 11 volume antibiotic distribution data and antibiotic use data, 12 including prescription data) by State or metropolitan 13 areas. 14 ‘‘(c) ANTIBIOTIC RESISTANCE TREND DATA.—The 15 Secretary, acting through the Director of the Centers for 16 Disease Control and Prevention, shall intensify and ex- 17 pand efforts to collect antibiotic resistance data and en- 18 courage adoption of the antibiotic resistance and use mod- 19 ule within the National Healthcare Safety Network among 20 all health care facilities across the continuum of care, in- 21 cluding, as appropriate, acute care hospitals, dialysis fa- 22 cilities, nursing homes, ambulatory surgical centers, and 23 other ambulatory health care settings in which anti- 24 microbial medications are routinely prescribed. The Sec- 25 VerDate Sep 11 2014 04:19 Aug 07, 2019 Jkt 089200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S2304.IS S2304 jbell on DSK3GLQ082PROD with BILLS 10 •S 2304 IS retary shall seek to collect such data from electronic medi- 1 cation administration reports and laboratory systems to 2 produce the reports described in subsection (d). 3 ‘‘(d) PUBLIC AVAILABILITY OF DATA.—The Sec- 4 retary, acting through the Director of the Centers for Dis- 5 ease Control and Prevention, shall, for the purposes of im- 6 proving the monitoring of important trends in patient out- 7 comes in relation to antibacterial resistance— 8 ‘‘(1) make the data derived from surveillance 9 under this section publicly available through reports 10 issued on a regular basis that is not less than annu- 11 ally; and 12 ‘‘(2) examine opportunities to make such data 13 available in near real time. 14 ‘‘SEC. 319E–2. DETECTING NETWORK OF ANTIBIOTIC RE- 15 SISTANCE REGIONAL LABORATORIES. 16 ‘‘(a) IN GENERAL.—The Secretary, acting through 17 the Director of the Centers for Disease Control and Pre- 18 vention, shall establish not less than 7 Antibiotic Resist- 19 ance Surveillance and Laboratory Network sites, building 20 upon the intramural and extramural programs and labora- 21 tories of the Centers for Disease Control and Prevention, 22 to intensify, strengthen, and expand the national capacity 23 to— 24 VerDate Sep 11 2014 04:19 Aug 07, 2019 Jkt 089200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S2304.IS S2304 jbell on DSK3GLQ082PROD with BILLS 11 •S 2304 IS ‘‘(1) monitor the emergence and changes in the 1 patterns of antibiotic-resistant bacteria; 2 ‘‘(2) describe, confirm, and, as necessary, facili- 3 tate a response to, local or regional outbreaks of re- 4 sistant bacteria; 5 ‘‘(3) assess and describe antibiotic resistance 6 patterns to inform public health and improve preven- 7 tion practices; 8 ‘‘(4) obtain isolates of pathogens, and in par- 9 ticular, bacteria that show new or atypical patterns 10 of resistance adversely affecting public health; 11 ‘‘(5) assist in studying the epidemiology of in- 12 fections from such pathogens; 13 ‘‘(6) evaluate commonly used antibiotic suscep- 14 tibility testing methods to improve the accuracy of 15 resistance testing and reporting; 16 ‘‘(7) as necessary, develop or evaluate novel di- 17 agnostic tests capable of detecting new or emerging 18 resistance in bacteria; 19 ‘‘(8) link data generated by regional laboratory 20 networks under existing public health surveillance 21 networks and relevant government agencies; and 22 ‘‘(9) provide laboratory assistance and reference 23 testing of antibiotic-resistant bacteria to enhance in- 24 VerDate Sep 11 2014 04:19 Aug 07, 2019 Jkt 089200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S2304.IS S2304 jbell on DSK3GLQ082PROD with BILLS 12 •S 2304 IS fection control and facilitate outbreak detection and 1 response in health care and community settings. 2 ‘‘(b) GEOGRAPHIC DISTRIBUTION.—The sites estab- 3 lished under subsection (a) shall be geographically distrib- 4 uted across the United States. 5 ‘‘(c) NONDUPLICATION OF CURR [Text truncated for display. 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