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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Strategies To Address 

5 Antibiotic Resistance Act’’ or the ‘‘STAAR Act’’. 

6 SEC. 2. COMBATING ANTIMICROBIAL RESISTANCE. 

7 Section 319E of the Public Health Service Act (42 

8 U.S.C. 247d–5) is amended— 

9 (1) in subsection (a)— 


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1 (A) in paragraph (1), in the first sentence, 

2 by striking ‘‘and coordinate Federal programs 

3 relating to antimicrobial resistance’’ and insert4 ing ‘‘relating to antimicrobial resistance, coordi5 nate Federal programs relating to antimicrobial 

6 resistance, and implement the objectives of the 

7 National Action Plan for Combating Antibiotic8 Resistant Bacteria, published in March 2015 in 

9 response to Executive Order 13676 of Sep10 tember 18, 2014 (79 Fed. Reg. 56931; relating 

11 to combating antibiotic-resistant bacteria) (re12 ferred to in this section as the ‘Action Plan’)’’; 

13 (B) by amending paragraph (2) to read as 

14 follows: 

15 ‘‘(2) MEMBERS OF TASK FORCE.—The task 

16 force described in paragraph (1) shall be co-chaired 

17 by the Secretary of Health and Human Services, the 

18 Secretary of Agriculture, and the Secretary of De19 fense, and shall be composed of representatives of 

20 relevant Federal agencies and such executive depart21 ments, agencies, or offices as the co-chairs may des22 ignate.’’; 

23 (C) by amending paragraph (4) to read as 

24 follows: 


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1 ‘‘(4) MEETINGS.—At least twice a year, the 

2 task force described in paragraph (1) shall have a 

3 public meeting to assess progress and obstacles to 

4 implementing the objectives of the Action Plan. The 

5 task force may discuss and review based on need or 

6 concern the following (among other issues): 

7 ‘‘(A) Federal activities to slow the emer8 gence of antimicrobial-resistant bacteria and 

9 prevent the spread of resistant infections. Such 

10 activities may include optimal use of vaccines 

11 and other infection control measures to prevent 

12 infections, implementation of health care poli13 cies and antimicrobial stewardship programs 

14 that improve patient outcomes, regional efforts 

15 to control transmission across community and 

16 health care settings, and public awareness cam17 paigns. 

18 ‘‘(B) Federal activities to strengthen na19 tional One-Health surveillance efforts, which 

20 are efforts addressing the interactions between 

21 human, animal, and environmental health, to 

22 combat antibiotic resistance. One-Health sur23 veillance efforts to combat antibiotic resistance 

24 may include enhanced data sharing and coordi25 nation of surveillance and laboratory systems 


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1 across human and animal settings, and en2 hanced monitoring of sales, usage, resistance, 

3 and management practices of antibiotic drugs 

4 along the food-production chain. Such surveil5 lance and laboratory systems may include the 

6 National Healthcare Safety Network, the 

7 Emerging Infections Program, the National 

8 Antimicrobial Resistance Monitoring System, 

9 the National Animal Health Monitoring Sys10 tem, the National Animal Health Laboratory 

11 Network, the Veterinary Laboratory Investiga12 tion and Response Network, and the Antibiotic 

13 Resistance Laboratory Network. 

14 ‘‘(C) Federal efforts to advance the devel15 opment and use of rapid and innovative diag16 nostic tests for identification and characteriza17 tion of antibiotic-resistant bacteria. Such efforts 

18 may include development of new diagnostic 

19 tests and expansion of their availability and use 

20 to improve treatment, infection control, and 

21 outbreak response. 

22 ‘‘(D) Federal efforts to accelerate basic 

23 and applied research and development for new 

24 antibiotic drugs, other therapeutics, prevention 

25 efforts, and vaccines. Such efforts may include 


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1 support for basic and applied research, provi2 sion of scientific services and guidance to re3 searchers, and fostering of public-private part4 nerships. 

5 ‘‘(E) Federal efforts to improve inter6 national collaboration and capacities for anti7 biotic-resistance prevention, surveillance, and 

8 control and antibiotic research and develop9 ment. Such efforts may include collaborations 

10 with foreign ministries of health and agri11 culture, the World Health Organization, the 

12 Food and Agriculture Organization, the World 

13 Organization for Animal Health, and other mul14 tinational organizations.’’; and 

15 (D) by adding at the end the following: 

16 ‘‘(5) AVAILABILITY OF INFORMATION.—The 

17 task force described in paragraph (1), to the extent 

18 permitted by law, shall— 

19 ‘‘(A) provide the Presidential Advisory 

20 Council on Combating Antibiotic-Resistant Bac21 teria described in section 505 of the Pandemic 

22 and All-Hazards Preparedness and Advancing 

23 Innovation Act of 2019 with such information 

24 as may be required for carrying out the func25 tions of such Advisory Council, including inforVerDate Sep 11 2014 04:19 Aug 07, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S2304.IS S2304

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1 mation on progress in advancing the Action 

2 Plan, meeting minutes, and other key informa3 tion of the task force; and 

4 ‘‘(B) ensure that all information described 

5 in subparagraph (A) is made available on the 

6 websites of the Department of Health and 

7 Human Services, the Department of Agri8 culture, and the Department of Defense.’’; 

9 (2) in subsection (h)— 

10 (A) in the heading, by striking ‘‘INFORMA11 TION RELATED TO’’; 

12 (B) by striking ‘‘The Secretary’’ and in13 serting the following: 

14 ‘‘(1) DISSEMINATION OF INFORMATION.—The 

15 Secretary’’; and 

16 (C) by adding at the end the following: 

17 ‘‘(2) ENCOURAGING ANTIMICROBIAL STEWARD18 SHIP PROGRAMS.—The Secretary shall encourage 

19 health care facilities to establish antimicrobial stew20 ardship programs that are consistent with docu21 ments issued by the Centers for Disease Control and 

22 Prevention relating to the core elements of anti23 microbial stewardship programs. 

24 ‘‘(3) DEFINITION OF ANTIMICROBIAL STEWARD25 SHIP.—For purposes of this section, the term ‘antiVerDate Sep 11 2014 04:19 Aug 07, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S2304.IS S2304

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1 microbial stewardship’ means coordinated interven2 tions designed to improve and evaluate the appro3 priate use of antimicrobial agents, including pro4 moting the use of antimicrobial drugs only when 

5 clinically indicated, and, when antimicrobial drugs 

6 are clinically indicated, promoting the selection of 

7 the optimal antimicrobial drug regimen, including 

8 through factors such as dosage, duration of therapy, 

9 and route of administration.’’; 

10 (3) in subsection (m), by striking 

11 ‘‘$40,000,000’’ and all that follows through the pe12 riod at the end and inserting ‘‘such sums as may be 

13 necessary for each of fiscal years 2020 through 

14 2026.’’; and 

15 (4) by adding at the end the following: 

16 ‘‘(n) ANNUAL REPORT ON IMPLEMENTING THE AC17 TION PLAN OBJECTIVES.—Not later than 1 year after the 

18 date of the enactment of the Strategies to Address Anti19 biotic Resistance Act, and annually thereafter, the Sec20 retary, in cooperation with the Secretary of Agriculture, 

21 the Secretary of Defense, and the task force described in 

22 subsection (a), shall submit to the Committee on Health, 

23 Education, Labor, and Pensions of the Senate and the 

24 Committee on Energy and Commerce of the House of 

25 Representatives, and make available on the websites of the 


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1 Department of Health and Human Services, the Depart2 ment of Agriculture, and the Department of Defense, a 

3 report on the progress made in implementing the objec4 tives of the Action Plan.’’. 

5 SEC. 3. ADDITIONAL STRATEGIES FOR COMBATING ANTI6 BIOTIC RESISTANCE. 

7 Part B of title III of the Public Health Service Act 

8 (42 U.S.C. 243 et seq.) is amended by inserting after sec9 tion 319E the following: 

10 ‘‘SEC. 319E–1. SURVEILLANCE AND REPORTING OF ANTI11 BIOTIC USE AND RESISTANCE. 

12 ‘‘(a) IN GENERAL.—The Secretary, acting through 

13 the Director of the Centers for Disease Control and Pre14 vention, shall use the National Healthcare Safety Network 

15 and other appropriate surveillance systems to assess— 

16 ‘‘(1) appropriate conditions, outcomes, and 

17 measures causally related to antibacterial resistance, 

18 including types of infections, the causes for infec19 tions, and whether infections are acquired in a com20 munity or hospital setting, increased lengths of hos21 pital stay, increased costs, and rates of mortality; 

22 and 

23 ‘‘(2) changes in bacterial resistance to drugs in 

24 relation to patient outcomes, including changes in 


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1 percent resistance, prevalence of antibiotic-resistant 

2 infections, and other such changes. 

3 ‘‘(b) ANTIBIOTIC USE DATA.—The Secretary, acting 

4 through the Director of the Centers for Disease Control 

5 and Prevention, shall work with Federal agencies (includ6 ing the Department of Veterans Affairs, the Department 

7 of Defense, and the Centers for Medicare & Medicaid 

8 Services), private vendors, health care organizations, phar9 macy benefit managers, and other entities as appropriate 

10 to obtain reliable and comparable human antibiotic drug 

11 consumption data (including, as available and appropriate, 

12 volume antibiotic distribution data and antibiotic use data, 

13 including prescription data) by State or metropolitan 

14 areas. 

15 ‘‘(c) ANTIBIOTIC RESISTANCE TREND DATA.—The 

16 Secretary, acting through the Director of the Centers for 

17 Disease Control and Prevention, shall intensify and ex18 pand efforts to collect antibiotic resistance data and en19 courage adoption of the antibiotic resistance and use mod20 ule within the National Healthcare Safety Network among 

21 all health care facilities across the continuum of care, in22 cluding, as appropriate, acute care hospitals, dialysis fa23 cilities, nursing homes, ambulatory surgical centers, and 

24 other ambulatory health care settings in which anti25 microbial medications are routinely prescribed. The SecVerDate Sep 11 2014 04:19 Aug 07, 2019 Jkt 089200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S2304.IS S2304

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1 retary shall seek to collect such data from electronic medi2 cation administration reports and laboratory systems to 

3 produce the reports described in subsection (d). 

4 ‘‘(d) PUBLIC AVAILABILITY OF DATA.—The Sec5 retary, acting through the Director of the Centers for Dis6 ease Control and Prevention, shall, for the purposes of im7 proving the monitoring of important trends in patient out8 comes in relation to antibacterial resistance— 

9 ‘‘(1) make the data derived from surveillance 

10 under this section publicly available through reports 

11 issued on a regular basis that is not less than annu12 ally; and 

13 ‘‘(2) examine opportunities to make such data 

14 available in near real time. 

15 ‘‘SEC. 319E–2. DETECTING NETWORK OF ANTIBIOTIC RE16 SISTANCE REGIONAL LABORATORIES. 

17 ‘‘(a) IN GENERAL.—The Secretary, acting through 

18 the Director of the Centers for Disease Control and Pre19 vention, shall establish not less than 7 Antibiotic Resist20 ance Surveillance and Laboratory Network sites, building 

21 upon the intramural and extramural programs and labora22 tories of the Centers for Disease Control and Prevention, 

23 to intensify, strengthen, and expand the national capacity 

24 to— 


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1 ‘‘(1) monitor the emergence and changes in the 

2 patterns of antibiotic-resistant bacteria; 

3 ‘‘(2) describe, confirm, and, as necessary, facili4 tate a response to, local or regional outbreaks of re5 sistant bacteria; 

6 ‘‘(3) assess and describe antibiotic resistance 

7 patterns to inform public health and improve preven8 tion practices; 

9 ‘‘(4) obtain isolates of pathogens, and in par10 ticular, bacteria that show new or atypical patterns 

11 of resistance adversely affecting public health; 

12 ‘‘(5) assist in studying the epidemiology of in13 fections from such pathogens; 

14 ‘‘(6) evaluate commonly used antibiotic suscep15 tibility testing methods to improve the accuracy of 

16 resistance testing and reporting; 

17 ‘‘(7) as necessary, develop or evaluate novel di18 agnostic tests capable of detecting new or emerging 

19 resistance in bacteria; 

20 ‘‘(8) link data generated by regional laboratory 

21 networks under existing public health surveillance 

22 networks and relevant government agencies; and 

23 ‘‘(9) provide laboratory assistance and reference 

24 testing of antibiotic-resistant bacteria to enhance inVerDate Sep 11 2014 04:19 Aug 07, 2019 Jkt 089200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S2304.IS S2304

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1 fection control and facilitate outbreak detection and 

2 response in health care and community settings. 

3 ‘‘(b) GEOGRAPHIC DISTRIBUTION.—The sites estab4 lished under subsection (a) shall be geographically distrib5 uted across the United States. 

6 ‘‘(c) NONDUPLICATION OF CURRENT NATIONAL CA7 PACITY.—The sites established under subsection (a) may 

8 be based in academic centers, health departments, and ex9 isting surveillance and laboratory sites. 

10 ‘‘SEC. 319E–3. CLINICAL TRIALS NETWORK ON ANTI11 BACTERIAL RESISTANCE. 

12 ‘‘(a) IN GENERAL.—The Secretary, acting through 

13 the Director of the National Institute of Allergy and Infec14 tious Diseases, shall maintain a Clinical Trials Network 

15 on Antibacterial Resistance to enhance, strengthen, and 

16 expand research on clinical science, antibacterial and diag17 nostic development, and optimal usage strategies with re18 spect to addressing antibacterial resistance. Such Network 

19 shall, at a minimum— 

20 ‘‘(1) facilitate research to better understand re21 sistance mechanisms and how to prevent, control, 

22 and treat resistant organisms; 

23 ‘‘(2) advance clinical trial efforts to develop 

24 antibiotics diagnostics, and evaluate and optimize 

25 the usage of such antibiotics diagnostics; 


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1 ‘‘(3) conduct clinical research to develop natural 

2 histories of resistant infectious diseases; 

3 ‘‘(4) examine patient outcomes with currently 

4 available antibiotic therapy and validate and improve 

5 upon biomarkers and other surrogate endpoints; and 

6 ‘‘(5) study shorter treatment duration and early 

7 cessation of antibiotic therapy for treatment efficacy 

8 and the effect on development of resistance. 

9 ‘‘(b) AUTHORIZATION OF APPROPRIATIONS.—There 

10 are authorized to be appropriated to carry out this section 

11 such sums as may be necessary for each of fiscal years 

12 2020 through 2026. 

13 ‘‘SEC. 319E–4. REGIONAL PREVENTION COLLABORATIVE EF14 FORTS. 

15 ‘‘(a) IN GENERAL.—The Secretary, acting through 

16 the Director of the Centers for Disease Control and Pre17 vention, shall work with State and local health depart18 ments to support the expansion of collaborative efforts by 

19 groups of health care facilities that focus on preventing 

20 the spread of antibiotic-resistant bacteria that pose a seri21 ous threat to public health, and that are designed to inter22 rupt and prevent the transmission of significant antibiotic23 resistant pathogens being transmitted across health care 

24 settings in a geographic region. Such collaborative efforts 

25 shall— 


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1 ‘‘(1) identify significant drug resistant patho2 gens being transmitted across health care settings 

3 locally; 

4 ‘‘(2) implement evidence-based interventions to 

5 interrupt the transmission of antibiotic-resistant 

6 strains of bacteria and prevent the infections caused 

7 by such bacteria, including evidence-based trans8 mission prevention guidelines, rigorous hand-hygiene 

9 protocols, and infection control and prevention meas10 ures; 

11 ‘‘(3) assess compliance and identify barriers to 

12 adherence to such measures; 

13 ‘‘(4) evaluate the impact of such measures, to 

14 the extent possible, on hospital readmissions in 

15 health care facilities across the continuum of care, 

16 rates of health care associated infections, or any 

17 other relevant measures that characterize the health 

18 or economic impact of the collaborative efforts; and 

19 ‘‘(5) provide recommendations for improved 

20 outcomes and compliance with such measures. 

21 ‘‘(b) PREVENTION EPICENTERS.— 

22 ‘‘(1) EXPANSION.—The Secretary, acting 

23 through the Director of the Centers for Disease 

24 Control and Prevention, may intensify and expand 

25 academic public health partnerships through the 


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1 Prevention Epicenters Program to provide the re2 gional prevention collaboration efforts described in 

3 subsection (a) with tools, strategies, and evidence4 based interventions. 

5 ‘‘(2) EVALUATIONS AND RESEARCH.—The Di6 rector of the Centers for Disease Control and Pre7 vention and the epicenters participating in the Pre8 vention Epicenters Program shall work with entities, 

9 including the entities participating in the regional 

10 prevention collaborative efforts, to— 

11 ‘‘(A) evaluate new and existing interven12 tions to prevent or limit infection rates in 

13 health care facilities across the continuum of 

14 care and in community settings; 

15 ‘‘(B) facilitate public health research on 

16 the prevention and control of resistant orga17 nisms; and 

18 ‘‘(C) assess the feasibility, cost-effective19 ness, and appropriateness of surveillance and 

20 prevention programs in differing health care 

21 and institutional settings. 

22 ‘‘(c) EDUCATIONAL MATERIALS.—The Secretary, 

23 acting through the Director of the Centers for Disease 

24 Control and Prevention, shall use the evaluations, re25 search, and assessments described in subsection (b) to creVerDate Sep 11 2014 04:19 Aug 07, 2019 Jkt 089200 PO 00000 Frm 00015 Fmt 6652 Sfmt 6201 E:\BILLS\S2304.IS S2304

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1 ate and disseminate educational materials focused on in2 fection prevention and control for use in health care facili3 ties across the continuum of care and in community set4 tings.’’. 

5 SEC. 4. PROTECTION OF CONFIDENTIAL AND NATIONAL SE6 CURITY INFORMATION. 

7 This Act, and the amendments made by this Act, 

8 shall not be construed to permit the disclosure of any 

9 trade secret, confidential commercial information, or ma10 terial inconsistent with national security, that is otherwise 

11 prohibited by law. 

Æ 


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