II 

115TH CONGRESS 

2D SESSION S. 2469 

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 

FEBRUARY 28, 2018 

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. FINDINGS. 

7 Congress makes the following findings: 

8 (1) Antibiotic resistance is one of the greatest 

9 threats to human health worldwide, necessitating in10 creased prevention efforts, antimicrobial stewardship 


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1 programs and surveillance programs, and research 

2 and development of new antibiotics and rapid 

3 diagnostics. 

4 (2) Since the discovery of antibiotic drugs, 

5 these powerful drugs have saved millions of lives and 

6 allowed for incredible medical progress. However, 

7 antibiotic resistance is accelerated by over- and inap8 propriate use of antibiotic drugs by which bacteria, 

9 through mutation and other mechanisms, can de10 velop resistance to antibiotic drugs. 

11 (3) Antibiotic-resistant infections significantly 

12 complicate a wide variety of complex medical serv13 ices, including chemotherapy to treat cancer, solid 

14 organ and bone marrow transplants, joint replace15 ments and other surgeries, and care of preterm in16 fants and other immunocompromised individuals. 

17 (4) According to the Centers for Disease Con18 trol and Prevention, each year in the United States 

19 at least 2,000,000 people become infected with bac20 teria that are resistant to antibiotics and at least 

21 23,000 people die as a result of antibiotic-resistant 

22 infections. Many more people die from other condi23 tions that were complicated by an antibiotic-resistant 

24 infection. 


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1 (5) According to a 2015 report from the New 

2 England Journal of Medicine, Clostridium difficile 

3 infects approximately 500,000 patients in the United 

4 States each year, resulting in almost 30,000 deaths 

5 and an estimated $4,800,000,000 in excess health 

6 care costs each year. Clostridium difficile infections 

7 are most common as a result of over-prescribing 

8 antibiotics, and antibiotic-resistant strains of Clos9 tridium difficile are on the rise. 

10 (6) The Centers for Disease Control and Pre11 vention estimate that the annual impact of anti12 biotic-resistant infections on the United States econ13 omy is more than $20,000,000,000 in excess direct 

14 health care costs. Additional costs to the United 

15 States economy for lost productivity from antibiotic16 resistant infections may be as great as 

17 $35,000,000,000 per year. 

18 (7) Data from the Centers for Disease Control 

19 and Prevention indicate that at least 30 percent of 

20 antibiotic drugs used in hospitals are unnecessary or 

21 prescribed incorrectly. Similarly, the Centers for 

22 Disease Control and Prevention estimate that ap23 proximately 30 percent of antibiotic drugs prescribed 

24 in outpatient clinics are unnecessary and that ap25 proximately 40 percent of orders for antibiotic drugs 


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1 in nursing homes lacked important prescribing infor2 mation. Thus, improvements in prescribing antibiotic 

3 drugs are necessary across health care settings. 

4 (8) The National Action Plan for Combating 

5 Antibiotic-Resistant Bacteria, published in March 

6 2015, in response to Executive Order 13676 of Sep7 tember 18, 2014 (79 Fed. Reg. 56931; relating to 

8 combating antibiotic-resistant bacteria), outlines the 

9 domestic and international efforts to be conducted 

10 by the United States to prevent, detect, and control 

11 illness and death related to infections caused by an12 tibiotic-resistant bacteria. 

13 SEC. 3. COMBATING ANTIMICROBIAL RESISTANCE. 

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

15 U.S.C. 247d–5) is amended— 

16 (1) in subsection (a)— 

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

18 by striking ‘‘and coordinate Federal programs 

19 relating to antimicrobial resistance’’ and insert20 ing ‘‘relating to antimicrobial resistance, coordi21 nate Federal programs relating to antimicrobial 

22 resistance, and implement the objectives of the 

23 National Action Plan for Combating Antibiotic24 Resistant Bacteria, published in March 2015 in 

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1 tember 18, 2014 (79 Fed. Reg. 56931; relating 

2 to combating antibiotic-resistant bacteria) (re3 ferred to in this section as the ‘Action Plan’)’’; 

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

5 follows: 

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

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

8 by the Secretary of Health and Human Services, the 

9 Secretary of Agriculture, and the Secretary of De10 fense, and shall be composed of representatives of 

11 relevant Federal agencies and such executive depart12 ments, agencies, or offices as the co-chairs may des13 ignate.’’; 

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

15 follows: 

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

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

18 public meeting to assess progress and obstacles to 

19 implementing the objectives of the Action Plan. The 

20 task force may discuss and review based on need or 

21 concern the following (among other issues): 

22 ‘‘(A) Federal activities to slow the emer23 gence of antimicrobial-resistant bacteria and 

24 prevent the spread of resistant infections. Such 

25 activities may include optimal use of vaccines 


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1 and other infection control measures to prevent 

2 infections, implementation of health care poli3 cies and antimicrobial stewardship programs 

4 that improve patient outcomes, regional efforts 

5 to control transmission across community and 

6 health care settings, and public awareness cam7 paigns. 

8 ‘‘(B) Federal activities to strengthen na9 tional One-Health surveillance efforts, which 

10 are efforts addressing the interactions between 

11 human, animal, and environmental health, to 

12 combat antibiotic resistance. One-Health sur13 veillance efforts to combat antibiotic resistance 

14 may include enhanced data sharing and coordi15 nation of surveillance and laboratory systems 

16 across human and animal settings, and en17 hanced monitoring of sales, usage, resistance, 

18 and management practices of antibiotic drugs 

19 along the food-production chain. Such surveil20 lance and laboratory systems may include the 

21 National Healthcare Safety Network, the 

22 Emerging Infections Program, the National 

23 Antimicrobial Resistance Monitoring System, 

24 the National Animal Health Monitoring Sys25 tem, the National Animal Health Laboratory 


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1 Network, the Veterinary Laboratory Investiga2 tion and Response Network, and the Antibiotic 

3 Resistance Laboratory Network. 

4 ‘‘(C) Federal efforts to advance the devel5 opment and use of rapid and innovative diag6 nostic tests for identification and characteriza7 tion of antibiotic-resistant bacteria. Such efforts 

8 may include development of new diagnostic 

9 tests and expansion of their availability and use 

10 to improve treatment, infection control, and 

11 outbreak response. 

12 ‘‘(D) Federal efforts to accelerate basic 

13 and applied research and development for new 

14 antibiotic drugs, other therapeutics, prevention 

15 efforts, and vaccines. Such efforts may include 

16 support for basic and applied research, provi17 sion of scientific services and guidance to re18 searchers, and fostering of public-private part19 nerships. 

20 ‘‘(E) Federal efforts to improve inter21 national collaboration and capacities for anti22 biotic-resistance prevention, surveillance, and 

23 control and antibiotic research and develop24 ment. Such efforts may include collaborations 

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1 culture, the World Health Organization, the 

2 Food and Agriculture Organization, the World 

3 Organization for Animal Health, and other mul4 tinational organizations.’’; and 

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

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

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

8 permitted by law, shall— 

9 ‘‘(A) provide the Advisory Council defined 

10 in section 319E–1(a) with such information as 

11 may be required for carrying out the functions 

12 of such Advisory Council, including information 

13 on progress in advancing the Action Plan, meet14 ing minutes, and other key information of the 

15 task force; and 

16 ‘‘(B) ensure that all information described 

17 in subparagraph (A) is made available on the 

18 websites of the Department of Health and 

19 Human Services, the Department of Agri20 culture, and the Department of Defense.’’; 

21 (2) in subsection (h)— 

22 (A) in the heading, by striking ‘‘INFORMA23 TION RELATED TO’’; 

24 (B) by striking ‘‘The Secretary’’ and in25 serting the following: 


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

2 Secretary’’; and 

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

4 ‘‘(2) ENCOURAGING ANTIMICROBIAL STEWARD5 SHIP PROGRAMS.—The Secretary shall encourage 

6 health care facilities to establish antimicrobial stew7 ardship programs that are consistent with docu8 ments issued by the Centers for Disease Control and 

9 Prevention relating to the core elements of anti10 microbial stewardship programs. 

11 ‘‘(3) DEFINITION OF ANTIMICROBIAL STEWARD12 SHIP.—For purposes of this section, the term ‘anti13 microbial stewardship’ means coordinated interven14 tions designed to improve and evaluate the appro15 priate use of antimicrobial agents, including pro16 moting the use of antimicrobial drugs only when 

17 clinically indicated, and, when antimicrobial drugs 

18 are clinically indicated, promoting the selection of 

19 the optimal antimicrobial drug regimen, including 

20 through factors such as dosage, duration of therapy, 

21 and route of administration.’’; 

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

23 ‘‘$40,000,000’’ and all that follows through the pe24 riod at the end and inserting ‘‘such sums as may be 


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1 necessary for each of fiscal years 2018 through 

2 2024.’’; and 

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

4 ‘‘(n) ANNUAL REPORT ON IMPLEMENTING THE AC5 TION PLAN OBJECTIVES.—Not later than 1 year after the 

6 date of the enactment of the Strategies to Address Anti7 biotic Resistance Act, and annually thereafter, the Sec8 retary, in cooperation with the Secretary of Agriculture, 

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

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

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

12 Committee on Energy and Commerce of the House of 

13 Representatives, and make available on the websites of the 

14 Department of Health and Human Services, the Depart15 ment of Agriculture, and the Department of Defense, a 

16 report on the progress made in implementing the objec17 tives of the Action Plan.’’. 

18 SEC. 4. ADDITIONAL STRATEGIES FOR COMBATING ANTI19 BIOTIC RESISTANCE. 

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

21 (42 U.S.C. 243 et seq.) is amended by inserting after sec22 tion 319E the following: 

23 ‘‘SEC. 319E–1. PRESIDENTIAL ADVISORY COUNCIL ON COM24 BATING ANTIBIOTIC-RESISTANT BACTERIA. 

25 ‘‘(a) DEFINITIONS.—In this section: 


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1 ‘‘(1) ACTION PLAN.—The term ‘Action Plan’ 

2 means the Action Plan described in section 

3 319E(a)(1). 

4 ‘‘(2) ADVISORY COUNCIL.—The term ‘Advisory 

5 Council’ means the Presidential Advisory Council on 

6 Combating Antibiotic-Resistant Bacteria established 

7 by Executive Order 13676 of September 18, 2014 

8 (79 Fed. Reg. 56931; relating to combating anti9 biotic-resistant bacteria). 

10 ‘‘(3) NATIONAL STRATEGY.—The term ‘Na11 tional Strategy’ means the National Strategy for 

12 Combating Antibiotic-Resistant Bacteria issued by 

13 the White House in September 2014, and any subse14 quent update to such strategy or a successor strat15 egy. 

16 ‘‘(b) ADVISORY COUNCIL.—The Advisory Council 

17 shall provide advice, information, and recommendations to 

18 the Secretary regarding programs and policies intended to 

19 support and evaluate the implementation of Executive 

20 Order 13676 of September 18, 2014 (79 Fed. Reg. 56931; 

21 relating to combating antibiotic-resistant bacteria), includ22 ing the National Strategy, and the Action Plan. 

23 ‘‘(c) MEETINGS AND DUTIES.— 

24 ‘‘(1) MEETINGS.—The Advisory Council shall 

25 meet as the Chair determines appropriate but not 


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1 less than twice per year, and, to the extent prac2 ticable, in conjunction with meetings of the task 

3 force described in section 319E. 

4 ‘‘(2) RECOMMENDATIONS.—The Advisory Coun5 cil shall make recommendations to the Secretary, in 

6 consultation with the Secretary of Agriculture and 

7 the Secretary of Defense, regarding programs and 

8 policies intended to— 

9 ‘‘(A) preserve the effectiveness of anti10 biotics by optimizing their use; 

11 ‘‘(B) advance research to develop improved 

12 methods for combating antibiotic resistance and 

13 conducting antimicrobial stewardship, as de14 fined in section 319E(h)(3); 

15 ‘‘(C) strengthen surveillance of antibiotic16 resistant bacterial infections; 

17 ‘‘(D) prevent the transmission of anti18 biotic-resistant bacterial infections; 

19 ‘‘(E) advance the development of rapid 

20 point-of-care and agricultural diagnostics; 

21 ‘‘(F) further research on new treatments 

22 for bacterial infections; 

23 ‘‘(G) develop alternatives to antibiotics for 

24 animal health purposes; 


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1 ‘‘(H) maximize the dissemination of up-to2 date information on the appropriate and proper 

3 use of antibiotics to the general public and 

4 human and animal health care providers; and 

5 ‘‘(I) improve international coordination of 

6 efforts to combat antibiotic resistance. 

7 ‘‘SEC. 319E–2. SURVEILLANCE AND REPORTING OF ANTI8 BIOTIC USE AND RESISTANCE. 

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

10 the Director of the Centers for Disease Control and Pre11 vention, shall use the National Healthcare Safety Network 

12 and other appropriate surveillance systems to assess— 

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

14 measures causally related to antibacterial resistance, 

15 including types of infections, the causes for infec16 tions, and whether infections are acquired in a com17 munity or hospital setting, increased lengths of hos18 pital stay, increased costs, and rates of mortality; 

19 and 

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

21 relation to patient outcomes, including changes in 

22 percent resistance, prevalence of antibiotic-resistant 

23 infections, and other such changes. 

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

25 through the Director of the Centers for Disease Control 


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1 and Prevention, shall work with Federal agencies (includ2 ing the Department of Veterans Affairs, the Department 

3 of Defense, and the Centers for Medicare & Medicaid 

4 Services), private vendors, health care organizations, phar5 macy benefit managers, and other entities as appropriate 

6 to obtain reliable and comparable human antibiotic drug 

7 consumption data (including, as available and appropriate, 

8 volume antibiotic distribution data and antibiotic use data, 

9 including prescription data) by State or metropolitan 

10 areas. 

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

12 Secretary, acting through the Director of the Centers for 

13 Disease Control and Prevention, shall intensify and ex14 pand efforts to collect antibiotic resistance data and en15 courage adoption of the antibiotic resistance and use mod16 ule within the National Healthcare Safety Network among 

17 all health care facilities across the continuum of care, in18 cluding, as appropriate, acute care hospitals, dialysis fa19 cilities, nursing homes, and ambulatory surgical centers. 

20 The Secretary shall seek to collect such data from elec21 tronic medication administration reports and laboratory 

22 systems to produce the reports described in subsection (d). 

23 ‘‘(d) PUBLIC AVAILABILITY OF DATA.—The Sec24 retary, acting through the Director of the Centers for Dis25 ease Control and Prevention, shall, for the purposes of imVerDate Sep 11 2014 02:03 Mar 06, 2018 Jkt 079200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6201 E:\BILLS\S2469.IS S2469

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1 proving the monitoring of important trends in patient out2 comes in relation to antibacterial resistance— 

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

4 under this section publicly available through reports 

5 issued on a regular basis that is not less than annu6 ally; and 

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

8 available in near real time. 

9 ‘‘SEC. 319E–3. DETECTING NETWORK OF ANTIBIOTIC RE10 SISTANCE REGIONAL LABORATORIES. 

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

12 the Director of the Centers for Disease Control and Pre13 vention, shall establish not less than 7 Antibiotic Resist14 ance Surveillance and Laboratory Network sites, building 

15 upon the intramural and extramural programs and labora16 tories of the Centers for Disease Control and Prevention, 

17 to intensify, strengthen, and expand the national capacity 

18 to— 

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

20 patterns of antibiotic-resistant bacteria; 

21 ‘‘(2) describe, confirm, and, as necessary, facili22 tate a response to, local or regional outbreaks of re23 sistant bacteria; 


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1 ‘‘(3) assess and describe antibiotic resistance 

2 patterns to inform public health and improve preven3 tion practices; 

4 ‘‘(4) obtain isolates of pathogens, and in par5 ticular, bacteria that show new or atypical patterns 

6 of resistance adversely affecting public health; 

7 ‘‘(5) assist in studying the epidemiology of in8 fections from such pathogens; 

9 ‘‘(6) evaluate commonly used antibiotic suscep10 tibility testing methods to improve the accuracy of 

11 resistance testing and reporting; 

12 ‘‘(7) as necessary, develop or evaluate novel di13 agnostic tests capable of detecting new or emerging 

14 resistance in bacteria; 

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

16 networks under existing public health surveillance 

17 networks and relevant government agencies; and 

18 ‘‘(9) provide laboratory assistance and reference 

19 testing of antibiotic-resistant bacteria to enhance in20 fection control and facilitate outbreak detection and 

21 response in health care and community settings. 

22 ‘‘(b) GEOGRAPHIC DISTRIBUTION.—The sites estab23 lished under subsection (a) shall be geographically distrib24 uted across the United States. 


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1 ‘‘(c) NONDUPLICATION OF CURRENT NATIONAL CA2 PACITY.—The sites established under subsection (a) may 

3 be based in academic centers, health departments, and ex4 isting surveillance and laboratory sites. 

5 ‘‘SEC. 319E–4. CLINICAL TRIALS NETWORK ON ANTI6 BACTERIAL RESISTANCE. 

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

8 the Director of the National Institute of Allergy and Infec9 tious Diseases, shall maintain a Clinical Trials Network 

10 on Antibacterial Resistance to enhance, strengthen, and 

11 expand research on clinical science, antibacterial and diag12 nostic development, and optimal usage strategies with re13 spect to addressing antibacterial resistance. Such Network 

14 shall, at a minimum— 

15 ‘‘(1) facilitate research to better understand re16 sistance mechanisms and how to prevent, control, 

17 and treat resistant organisms; 

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

19 antibiotics diagnostics, and evaluate and optimize 

20 the usage of such antibiotics diagnostics; 

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

22 histories of resistant infectious diseases; 

23 ‘‘(4) examine patient outcomes with currently 

24 available antibiotic therapy and validate and improve 

25 upon biomarkers and other surrogate endpoints; and 


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

2 cessation of antibiotic therapy for treatment efficacy 

3 and the effect on development of resistance. 

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

5 are authorized to be appropriated to carry out this section 

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

7 2018 through 2024. 

8 ‘‘SEC. 319E–5. REGIONAL PREVENTION COLLABORATIVE EF9 FORTS. 

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

11 the Director of the Centers for Disease Control and Pre12 vention, shall work with State and local health depart13 ments to support the expansion of collaborative efforts by 

14 groups of health care facilities that focus on preventing 

15 the spread of antibiotic-resistant bacteria that pose a seri16 ous threat to public health, and that are designed to inter17 rupt and prevent the transmission of significant antibiotic18 resistant pathogens being transmitted across health care 

19 settings in a geographic region. Such collaborative efforts 

20 shall— 

21 ‘‘(1) identify significant drug resistant patho22 gens being transmitted across health care settings 

23 locally; 

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

25 interrupt the transmission of antibiotic-resistant 


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1 strains of bacteria and prevent the infections caused 

2 by such bacteria, including evidence-based trans3 mission prevention guidelines, rigorous hand-hygiene 

4 protocols, and infection control and prevention meas5 ures; 

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

7 adherence to such measures; 

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

9 the extent possible, on hospital readmissions in 

10 health care facilities across the continuum of care, 

11 rates of health care associated infections, or any 

12 other relevant measures that characterize the health 

13 or economic impact of the collaborative efforts; and 

14 ‘‘(5) provide recommendations for improved 

15 outcomes and compliance with such measures. 

16 ‘‘(b) PREVENTION EPICENTERS.— 

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

18 through the Director of the Centers for Disease 

19 Control and Prevention, may intensify and expand 

20 academic public health partnerships through the 

21 Prevention Epicenters Program to provide the re22 gional prevention collaboration efforts described in 

23 subsection (a) with tools, strategies, and evidence24 based interventions. 


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1 ‘‘(2) EVALUATIONS AND RESEARCH.—The Di2 rector of the Centers for Disease Control and Pre3 vention and the epicenters participating in the Pre4 vention Epicenters Program shall work with entities, 

5 including the entities participating in the regional 

6 prevention collaborative efforts, to— 

7 ‘‘(A) evaluate new and existing interven8 tions to prevent or limit infection rates in 

9 health care facilities across the continuum of 

10 care and in community settings; 

11 ‘‘(B) facilitate public health research on 

12 the prevention and control of resistant orga13 nisms; and 

14 ‘‘(C) assess the feasibility, cost-effective15 ness, and appropriateness of surveillance and 

16 prevention programs in differing health care 

17 and institutional settings. 

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

19 acting through the Director of the Centers for Disease 

20 Control and Prevention, shall use the evaluations, re21 search, and assessments described in subsection (b) to cre22 ate and disseminate educational materials focused on in23 fection prevention and control for use in health care facili24 ties across the continuum of care and in community set25 tings.’’. 


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1 SEC. 5. PROTECTION OF CONFIDENTIAL AND NATIONAL SE2 CURITY INFORMATION. 

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

4 shall not be construed to permit the disclosure of any 

5 trade secret, confidential commercial information, or ma6 terial inconsistent with national security, that is otherwise 

7 prohibited by law. 

Æ 


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