I 

113TH CONGRESS 

1ST SESSION H. R. 2285 

To amend the Public Health Service Act to enhance efforts to address 

antimicrobial resistance, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JUNE 6, 2013 

Mr. MATHESON introduced the following bill; which was referred to the 

Committee on Energy and Commerce 

A BILL 

To amend the Public Health Service Act to enhance efforts 

to address antimicrobial 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 Antimicrobial Resistance Act’’. 

6 SEC. 2. FINDINGS. 

7 The Congress finds as follows: 

8 (1) The advent of the antibiotic era has saved 

9 millions of lives and allowed for incredible medical 

10 progress; however, the increased use and overuse of 


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1 antimicrobial drugs have correlated with increased 

2 rates of antimicrobial resistance. 

3 (2) Through mutation as well as other mecha4 nisms, bacteria and other infectious disease-causing 

5 organisms—viruses, fungi, and parasites—develop 

6 resistance to antimicrobial drugs over time. The 

7 more antimicrobial drugs are used, whether appro8 priately or inappropriately, the more this contributes 

9 to the development of antimicrobial resistance. 

10 (3) Scientific evidence suggests that the devel11 opment of antimicrobial resistance in humans is not 

12 due only to use of antimicrobial drugs in humans, 

13 but also may be caused by the use of antimicrobial 

14 drugs in food-producing animals. 

15 (4) A study estimates that in 2005 more than 

16 94,000 invasive methicillin-resistant Staphylococcus 

17 aureus (MRSA) bacterial infections occurred in the 

18 United States and more than 18,500 of these infec19 tions resulted in death—7 times more than a decade 

20 earlier. 

21 (5) The 2009 Influenza A: H1N1 virus out22 break, and the yearly seasonal influenza outbreaks, 

23 exacerbate concerns about antiviral resistance given 

24 that so few antivirals are available to treat influenza 

25 as well as secondary bacterial infections due to 


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1 MRSA, antibiotic-resistant Streptococcus pneu2 monia, and other bacteria that cause respiratory dis3 eases. Given that, during the 1918 influenza pan4 demic, many thousands of deaths were caused by 

5 complications due to secondary bacterial infections 

6 and not by the influenza virus itself. 

7 (6) Each year, nearly 2,000,000 people contract 

8 bacterial infections in hospitals and approximately 

9 90,000 of these people die from these infections. 

10 Many of these infections are resistant to one or 

11 more commonly used antibiotics. 

12 (7) A 2012 study conducted at Columbia Uni13 versity (‘‘Clinical Infectious Disease’’, September 

14 2012) found that each antibiotic-resistant infection 

15 cost, on average, over $15,000 more to treat than 

16 susceptible infections. 

17 (8) The costs of antimicrobial-resistant infec18 tions in terms of lives lost and the economy will only 

19 rise as antimicrobial resistance continues to spread. 

20 SEC. 3. ANTIMICROBIAL RESISTANCE TASK FORCE. 

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

22 U.S.C. 247d–5) is amended— 

23 (1) in subsection (a)— 

24 (A) in the subsection heading, by striking 

25 ‘‘TASK FORCE’’ and inserting the following: 


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1 ‘‘ANTIMICROBIAL RESISTANCE OFFICE, TASK

2 FORCE, AND ADVISORY BOARD’’; 

3 (B) in paragraph (1)— 

4 (i) by striking ‘‘as of the date of the 

5 enactment of this section’’ and inserting 

6 ‘‘as of September 30, 2006’’; and 

7 (ii) by adding at the end the fol8 lowing: ‘‘The Secretary shall, not later 

9 than 1 year after the date of enactment of 

10 the Strategies to Address Antimicrobial 

11 Resistance Act, direct the Assistant Sec12 retary of Health to establish an Anti13 microbial Resistance Office and appoint a 

14 director to that Office. The Secretary shall, 

15 not later than 1 year after the date of en16 actment of such Act, establish the Public 

17 Health Antimicrobial Advisory Board as an 

18 advisory board to the Director of the Anti19 microbial Resistance Office. The Director 

20 of the Antimicrobial Resistance Office shall 

21 serve as the Director of the Antimicrobial 

22 Resistance Task Force. To avoid duplica23 tion and ensure that Federal resources are 

24 used efficiently and effectively, the Direc25 tor shall work in conjunction with the FedVerDate Mar 15 2010 04:52 Jun 12, 2013 Jkt 029200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H2285.IH H2285

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1 eral agencies represented on the Task 

2 Force to coordinate all antimicrobial resist3 ance activities undertaken and supported 

4 by the Federal Government, including the 

5 activities and budgetary allocations of the 

6 Office, Task Force, and Public Health 

7 Antimicrobial Advisory Board.’’; 

8 (C) by amending paragraph (2) to read as 

9 follows: 

10 ‘‘(2) MEMBERS.— 

11 ‘‘(A) MEMBERS OF THE ANTIMICROBIAL

12 RESISTANCE TASK FORCE.—The task force de13 scribed in paragraph (1) shall be composed of 

14 representatives of such Federal agencies as the 

15 Secretary determines necessary, including rep16 resentation of the following: 

17 ‘‘(i) The Antimicrobial Resistance Of18 fice. 

19 ‘‘(ii) The Assistant Secretary for Pre20 paredness and Response. 

21 ‘‘(iii) The Biomedical Advanced Re22 search and Development Authority. 

23 ‘‘(iv) The Centers for Disease Control 

24 and Prevention. 


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1 ‘‘(v) The Food and Drug Administra2 tion. 

3 ‘‘(vi) The National Institutes of 

4 Health. 

5 ‘‘(vii) The Agency for Healthcare Re6 search and Quality. 

7 ‘‘(viii) The Centers for Medicare & 

8 Medicaid Services. 

9 ‘‘(ix) The Health Resources and Serv10 ices Administration. 

11 ‘‘(x) The Department of Agriculture. 

12 ‘‘(xi) The Department of Education. 

13 ‘‘(xii) The Department of Defense. 

14 ‘‘(xiii) The Department of Veterans 

15 Affairs. 

16 ‘‘(xiv) The Environmental Protection 

17 Agency. 

18 ‘‘(xv) The Department of Homeland 

19 Security. 

20 ‘‘(xvi) The United States Agency for 

21 International Development. 

22 ‘‘(B) MEMBERS OF THE PUBLIC HEALTH

23 ANTIMICROBIAL ADVISORY BOARD.— 

24 ‘‘(i) IN GENERAL.—The Public Health 

25 Antimicrobial Advisory Board shall be 


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1 composed of 19 voting members, appointed 

2 by the Secretary. Such members shall in3 clude experts from the medical professions 

4 (including hospital and community-based 

5 physicians), pharmacy, public health, vet6 erinary, research, and international health 

7 communities, as well as one representative 

8 from a public interest group. 

9 ‘‘(ii) TERMS.—Each member ap10 pointed under clause (i) shall be appointed 

11 for a term of 3 years, except that of the 

12 19 members first appointed— 

13 ‘‘(I) 6 shall be appointed for a 

14 term of 12 months; and 

15 ‘‘(II) 6 shall be appointed for a 

16 term of 2 years. 

17 ‘‘(iii) CHAIR.—The Secretary shall ap18 point a Chair of the Public Health Anti19 microbial Advisory Board from among its 

20 members to lead and supervise the activi21 ties of the Advisory Board. 

22 ‘‘(iv) DISCLOSURE OF FINANCIAL IN23 TERESTS.—Prior to a meeting of the Pub24 lic Health Antimicrobial Advisory Board, 

25 each member of the Advisory Board shall 


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1 disclose to the Secretary any potential, rel2 evant financial interests as defined under 

3 section 208(a) of title 18, United States 

4 Code.’’; 

5 (D) in paragraph (3)(B), by striking ‘‘in 

6 consultation with the task force described in 

7 paragraph (1) and’’ and inserting ‘‘acting 

8 through the Director of the Antimicrobial Re9 sistance Office and the Director of the Centers 

10 for Disease Control and Prevention, and in con11 sultation with’’; and 

12 (E) by amending paragraph (4) to read as 

13 follows: 

14 ‘‘(4) MEETINGS AND DUTIES.— 

15 ‘‘(A) ANTIMICROBIAL RESISTANCE OFFICE

16 DUTIES.—The Director of the Antimicrobial 

17 Resistance Office, working in conjunction with 

18 the Federal agencies that are represented on 

19 the task force described in paragraph (1), shall 

20 issue an update to the Public Health Action 

21 Plan to Combat Antimicrobial Resistance within 

22 1 year of the establishment of the Office and 

23 annually thereafter. The updates shall include 

24 enhanced plans for addressing antimicrobial re25 sistance in the United States and internationVerDate Mar 15 2010 04:52 Jun 12, 2013 Jkt 029200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H2285.IH H2285

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1 ally. The Director of the Office shall post on a 

2 website these updates as well as summaries of 

3 all non-proprietary data the Task Force makes 

4 available. The Director of the Antimicrobial Re5 sistance Office shall work in conjunction with 

6 the Federal agencies that are represented on 

7 the task force described in paragraph (1), and 

8 in consultation with the Public Health Anti9 microbial Advisory Board, to— 

10 ‘‘(i) establish benchmarks for achiev11 ing the goals set forth in the action plan; 

12 ‘‘(ii) assess the ongoing, observed pat13 terns of emergence of antimicrobial resist14 ance, and their impact on clinical outcomes 

15 in terms of how patients feel, function, or 

16 survive; 

17 ‘‘(iii) assess how antimicrobial prod18 ucts are being used in humans, animals, 

19 plants, and the environment and the risks 

20 and benefits of those uses in furthering the 

21 development of resistance and the implica22 tions thereof for patient safety and public 

23 health; 

24 ‘‘(iv) establish a priority list of human 

25 infectious diseases with the greatest need 


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1 for development of new point-of-care and 

2 other diagnostics, antimicrobial drugs, and 

3 vaccines, and in particular serious and life4 threatening resistant infections, for which 

5 there are few or no diagnostic, treatment, 

6 or prevention options; 

7 ‘‘(v) recommend basic, clinical, epide8 miological, prevention, and translational 

9 research where additional federally sup10 ported studies may be beneficial; 

11 ‘‘(vi) recommend how to support anti12 microbial development through Food and 

13 Drug Administration activities, including 

14 through the agency’s Critical Path Initia15 tive and the Reagan-Udall Foundation; 

16 ‘‘(vii) recommend how best to 

17 strengthen and link antimicrobial resist18 ance-related surveillance and prevention 

19 and control activities; and 

20 ‘‘(viii) collaborate with the Assistant 

21 Secretary for Preparedness and Response 

22 to ensure that strategies to address anti23 microbial-resistance are coordinated with 

24 initiatives aimed at pandemic influenza, seVerDate Mar 15 2010 04:52 Jun 12, 2013 Jkt 029200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H2285.IH H2285

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1 vere acute respiratory syndrome, and bio2 terrorism. 

3 ‘‘(B) ANTIMICROBIAL RESISTANCE TASK

4 FORCE MEETINGS AND DUTIES.— 

5 ‘‘(i) MEETINGS.—The Antimicrobial 

6 Resistance Task Force shall convene peri7 odically as the Director of the Anti8 microbial Resistance Task Force deter9 mines to be appropriate, but not fewer 

10 than twice a year, to consider issues relat11 ing to antimicrobial resistance. 

12 ‘‘(ii) PUBLIC HEALTH ACTION

13 PLAN.—At least twice a year, the task 

14 force described in paragraph (1) shall have 

15 a meeting to review, discuss, and further 

16 develop the Public Health Action Plan to 

17 Combat Antimicrobial Resistance first 

18 issued by the interagency task force on 

19 antimicrobial resistance in 2001. Among 

20 other issues, the task force may discuss 

21 and review, based on current need or con22 cern— 

23 ‘‘(I) antimicrobial clinical suscep24 tibility concentrations proposed, estabVerDate Mar 15 2010 04:52 Jun 12, 2013 Jkt 029200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H2285.IH H2285

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1 lished, or updated by the Food and 

2 Drug Administration; 

3 ‘‘(II) data obtained by govern4 ment agencies and, as possible, by pri5 vate sources on emerging anti6 microbial resistance related to clinical 

7 outcomes as well as data related to 

8 how antimicrobial drugs may have 

9 been used inappropriately; 

10 ‘‘(III) surveillance data and pre11 vention and control activities regard12 ing emerging antimicrobial resistance 

13 from reliable sources including the 

14 Centers for Disease Control and Pre15 vention, the Food and Drug Adminis16 tration, the Department of Defense, 

17 the Department of Veterans Affairs, 

18 the Department of Agriculture, the 

19 Environmental Protection Agency, 

20 and as feasible from private sources 

21 and international bodies; 

22 ‘‘(IV) data on the amount of 

23 antimicrobial products used in hu24 mans, animals, plants, and the envi25 ronment from reliable sources, includVerDate Mar 15 2010 04:52 Jun 12, 2013 Jkt 029200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\H2285.IH H2285

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1 ing data from the Centers for Disease 

2 Control and Prevention, the Food and 

3 Drug Administration, the Environ4 mental Protection Agency, the De5 partment of Veterans Affairs, the 

6 Centers for Medicare & Medicaid 

7 Services, the Department of Home8 land Security, and the Department of 

9 Agriculture, and as feasible from pri10 vate sources and international bodies; 

11 ‘‘(V) the impact of antimicrobial 

12 resistance on human health resulting 

13 from the approval of antimicrobial 

14 drugs for use in humans, animals, or 

15 plants (including consideration of and 

16 recommendations on potential man17 agement plans to limit and reduce the 

18 negative impacts of such resistance on 

19 human health and consideration of 

20 the benefits to animal health and food 

21 safety); 

22 ‘‘(VI) reports of federally sup23 ported antimicrobial resistance re24 search and antimicrobial drug, related 

25 diagnostics, and vaccine development 


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1 for antimicrobial resistant infections 

2 (such as methicillin-resistant Staphy3 lococcus aureus (MRSA)) and other 

4 research activities (including clinical, 

5 epidemiological, prevention, and trans6 lational research) obtained from Fed7 eral agencies, as well as reports of re8 search sponsored by other countries, 

9 industry, and non-governmental orga10 nizations; 

11 ‘‘(VII) reports on efforts by the 

12 Food and Drug Administration to de13 velop policies and guidance which en14 courage antimicrobial drug, related 

15 diagnostics, and vaccine development 

16 and appropriate use while maintaining 

17 high standards for safety and effec18 tiveness; 

19 ‘‘(VIII) quality measures, which 

20 may include health plan employer 

21 data and information set (HEDIS) 

22 measures, pertaining to appropriate 

23 use of antimicrobial drugs; and 

24 ‘‘(IX) other data and issues the 

25 task force described in paragraph (1) 


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1 identifies as relevant to the issue of 

2 antimicrobial resistance. 

3 ‘‘(iii) PENDING APPLICATIONS.—The 

4 Food and Drug Administration may con5 sult with the Director of the Antimicrobial 

6 Resistance Office concerning the pending 

7 application of any antimicrobial drug appli8 cation submitted to the Secretary under 

9 section 505 or 512 of the Federal Food, 

10 Drug, and Cosmetic Act or the Public 

11 Health Service Act. 

12 ‘‘(C) PUBLIC HEALTH ANTIMICROBIAL AD13 VISORY BOARD MEETINGS AND DUTIES.— 

14 ‘‘(i) MEETINGS.—The Public Health 

15 Antimicrobial Advisory Board shall meet 

16 as the Chair of the Public Health Anti17 microbial Advisory Board determines to be 

18 appropriate, preferably in conjunction with 

19 meetings of the Antimicrobial Resistance 

20 Task Force, but not fewer than 2 times 

21 each year. 

22 ‘‘(ii) RECOMMENDATIONS.—The Pub23 lic Health Antimicrobial Advisory Board 

24 shall make recommendations to the SecVerDate Mar 15 2010 04:52 Jun 12, 2013 Jkt 029200 PO 00000 Frm 00015 Fmt 6652 Sfmt 6201 E:\BILLS\H2285.IH H2285

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1 retary, and the Antimicrobial Resistance 

2 Office, regarding— 

3 ‘‘(I) ways to encourage the avail4 ability of an adequate supply of safe 

5 and effective antimicrobial products, 

6 related diagnostics, and vaccines; 

7 ‘‘(II) research priorities and 

8 other measures (such as antimicrobial 

9 drug resistance management plans) to 

10 enhance the safety and efficacy of 

11 antimicrobial products; 

12 ‘‘(III) how best to implement and 

13 update the goals of the Public Health 

14 Action Plan to Combat Antimicrobial 

15 Resistance; 

16 ‘‘(IV) incentives necessary to es17 tablish uniform mechanisms (which 

18 could include electronic surveillance 

19 systems) and data sets for State and 

20 local reporting of resistance; 

21 ‘‘(V) the adequacy of existing 

22 United States antimicrobial resistance 

23 and use surveillance; 

24 ‘‘(VI) the development of a na25 tional plan for the collection and analVerDate Mar 15 2010 04:52 Jun 12, 2013 Jkt 029200 PO 00000 Frm 00016 Fmt 6652 Sfmt 6201 E:\BILLS\H2285.IH H2285

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1 ysis of isolates of resistant pathogens, 

2 including establishing priorities as to 

3 which isolates should be collected; and 

4 ‘‘(VII) areas for government, 

5 nongovernment, and international co6 operation to strengthen implementa7 tion of the Public Health Action Plan 

8 to Combat Antimicrobial Resistance. 

9 ‘‘(D) AVAILABILITY OF INFORMATION.— 

10 The Antimicrobial Resistance Office shall en11 sure that all information shall be made avail12 able to the public on the website described in 

13 subparagraph (A) consistent with section 9 of 

14 the Strategies to Address Antimicrobial Resist15 ance Act.’’; 

16 (2) by amending subsection (b) to read as fol17 lows: 

18 ‘‘(b) ANTIMICROBIAL RESISTANCE STRATEGIC RE19 SEARCH PLAN.—The Secretary, acting through the Direc20 tor of the National Institutes of Health, working in con21 sultation with the Director of the Centers for Disease Con22 trol and Prevention, the Assistant Secretary for Prepared23 ness and Response, the Director of the Biomedical Ad24 vanced Research and Development Authority, the Director 

25 of the Antimicrobial Resistance Office, the Public Health 


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1 Antimicrobial Advisory Board, and other non-government 

2 experts, including representatives from professional soci3 eties and the pharmaceutical, vaccine, and medical device 

4 industries, and other Federal agencies shall develop a 

5 blue-ribbon antimicrobial resistance strategic research 

6 plan that strengthens existing epidemiological, inter7 ventional, clinical, behavioral, translational, and basic re8 search efforts to advance the understanding of— 

9 ‘‘(1) the development, implementation, and effi10 cacy of interventions to prevent and control the 

11 emergence and transmission of antimicrobial resist12 ance; 

13 ‘‘(2) how best to optimize antimicrobial effec14 tiveness while limiting the emergence of resistance, 

15 including addressing issues related to duration of 

16 therapy, effectiveness of therapy in self-resolving dis17 eases, and determining populations most likely to 

18 benefit from antimicrobial drugs; 

19 ‘‘(3) the extent to which specific uses of anti20 microbial products in humans, animals, plants, and 

21 other uses accelerates development and transmission 

22 of antimicrobial resistance; 

23 ‘‘(4) the natural histories of infectious diseases 

24 (including defining the disease, diagnosis, severity, 

25 and the time course of illness); 


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1 ‘‘(5) the development of new therapeutics, in2 cluding antimicrobial drugs, biologics, and devices 

3 against resistant pathogens, and in particular dis4 eases for which few or no therapeutics are in devel5 opment; 

6 ‘‘(6) the development and testing of medical 

7 diagnostics to identify patients with infectious dis8 ease and identify the exact cause of infectious dis9 eases syndromes, particularly with respect to the de10 tection of pathogens resistant to antimicrobial drugs; 

11 ‘‘(7) the epidemiology, pathogenesis, mecha12 nisms, and genetics of antimicrobial resistance; and 

13 ‘‘(8) the sequencing of the genomes, or other 

14 DNA analysis, or other comparative analysis of pri15 ority pathogens (as determined by the Public Health 

16 Antimicrobial Advisory Board), in collaboration with 

17 the Department of Defense and the Joint Genome 

18 Institute of the Department of Energy.’’; 

19 (3) in subsection (c)— 

20 (A) by inserting ‘‘acting through the Di21 rector of the Antimicrobial Resistance Office,’’ 

22 after ‘‘The Secretary,’’; and 

23 (B) by striking ‘‘members of the task force 

24 described in subsection (a),’’; 


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1 (4) in subsection (d)(1), by inserting ‘‘, through 

2 the Antimicrobial Resistance Office,’’ after ‘‘The 

3 Secretary’’; 

4 (5) in subsection (e)— 

5 (A) by amending the subsection heading to 

6 read as follows: ‘‘IMPROVING UPTAKE AND

7 MEASUREMENT OF ANTIMICROBIAL STEWARD8 SHIP’’; 

9 (B) in paragraph (1)— 

10 (i) by inserting ‘‘, acting through the 

11 Director of the Antimicrobial Resistance 

12 Office,’’ after ‘‘The Secretary’’; and 

13 (ii) by striking ‘‘judicious use of anti14 microbial drugs or control the spread of 

15 antimicrobial-resistant pathogens’’ and in16 serting ‘‘the uptake and measurement of 

17 antimicrobial stewardship programs in the 

18 Nation’s health care facilities’’; 

19 (C) in paragraph (2), by striking ‘‘labora20 tory’’; 

21 (D) in paragraph (3), by inserting ‘‘, act22 ing through the Antimicrobial Resistance Of23 fice,’’ after ‘‘The Secretary’’; and 

24 (E) by adding at the end the following new 

25 paragraphs: 


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1 ‘‘(4) DEFINITION OF ANTIMICROBIAL STEWARD2 SHIP.—For purposes of this subsection and Act, 

3 ‘antimicrobial stewardship’ means coordinated inter4 ventions designed to improve and measure the ap5 propriate use of antimicrobial agents, including pro6 moting the use of antimicrobials only when clinically 

7 indicated, and, when antimicrobials are indicated, 

8 promoting the selection of the optimal antimicrobial 

9 drug regimen including dosing, duration of therapy, 

10 and route of administration. 

11 ‘‘(5) PREFERENCE IN MAKING AWARDS.—In 

12 making awards under paragraph (1), the Secretary 

13 shall give preference to eligible entities that will use 

14 grant funds to establish demonstration projects that 

15 lead to the development of quality measures for 

16 health care providers prescribing antimicrobial 

17 drugs.’’; 

18 (6) by redesignating subsections (f) and (g) as 

19 subsections (i) and (j), respectively; and 

20 (7) by inserting after subsection (e) the fol21 lowing new subsections: 

22 ‘‘(f) APPROPRIATE ANTIMICROBIAL USE.—The Sec23 retary, acting through the Director of the Centers for Dis24 ease Control and Prevention, shall take such additional ac25 tions as follows: 


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1 ‘‘(1) To pilot and test health care quality meas2 ures to help providers, facilities, and health systems 

3 measure and benchmark appropriate antimicrobial 

4 use. As appropriate, the Director shall work with 

5 standard setting organizations (such as the National 

6 Quality Forum, the Joint Commission, and the Na7 tional Committee for Quality Assurance) to deter8 mine if any such measure is suitable for national 

9 quality reporting efforts. 

10 ‘‘(2) To develop methods to help providers, fa11 cilities, and health systems measure and improve ap12 propriate antimicrobial use, including methods and 

13 tools to assess the change in antimicrobial use, the 

14 impact on antibiotic resistance and adverse effects 

15 (such as Clostridium difficile infections), and the 

16 economic impact and cost savings of antimicrobial 

17 stewardship programs. 

18 ‘‘(g) COLLECTION OF HUMAN ANTIMICROBIAL CON19 SUMPTION AND RESISTANCE TREND DATA.— 

20 ‘‘(1) ANTIMICROBIAL USE DATA.—The Director 

21 of the Centers for Disease Control and Prevention 

22 shall work with private vendors, health care organi23 zations, pharmacy benefit managers, and other enti24 ties to obtain reliable and comparable human anti25 microbial drug consumption data (including volume 


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1 antimicrobial distribution data and antimicrobial 

2 use, including prescription data) by State or metro3 politan area. 

4 ‘‘(2) ANTIMICROBIAL RESISTANCE TREND

5 DATA.—The Director of the Centers for Disease 

6 Control and Prevention shall intensify and expand 

7 their efforts to collect antimicrobial resistance data 

8 including through the establishment of an Anti9 microbial Resistance Surveillance and Laboratory 

10 Network, established in section 4 of the Strategies 

11 to Address Antimicrobial Resistance Act, and devel12 opment of a fully automated antimicrobial resistance 

13 and use module within the National Healthcare 

14 Safety Network. The Director shall seek to collect 

15 data from electronic medication administration re16 ports (eMAR) and laboratory systems to produce 

17 regular reports on antimicrobial resistance patterns 

18 and antimicrobial use. 

19 ‘‘(3) MEANINGFUL USE REPORTING.—The Of20 fice of the National Coordinator for Health Informa21 tion Technology shall work with the Director of the 

22 Centers for Disease Control and Prevention to deter23 mine how best antimicrobial use, susceptibility, and 

24 resistance data can be incorporated into meaningful 

25 use reporting. 


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1 ‘‘(4) REPORT.—Not later than 2 years after the 

2 date of the enactment of the Strategies to Address 

3 Antimicrobial Resistance Act, and every two years 

4 thereafter, the Director of the Centers for Disease 

5 Control and Prevention shall submit to the Com6 mittee on Energy and Commerce of the House of 

7 Representatives and the Committee on Health, Edu8 cation, Labor and Pensions of the Senate and make 

9 available on the agency’s website a report summa10 rizing key trends and major issues related to anti11 microbial resistance and use in the United States. 

12 Each such report shall include the most relevant and 

13 up-to-date data available from the infectious diseases 

14 and surveillance programs of the Centers for Disease 

15 Control and Prevention. Each such report shall— 

16 ‘‘(A) outline major issues and threats in 

17 antimicrobial resistance facing the United 

18 States; 

19 ‘‘(B) provide data on the incidence, preva20 lence, morbidity, mortality, and general societal 

21 burden, including economic, of antimicrobial re22 sistant pathogens; 

23 ‘‘(C) provide updates on resistance pat24 terns and antimicrobials use data and potential 

25 impacts on human health and patient safety; 


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1 ‘‘(D) articulate activities of the Centers for 

2 Disease Control and Prevention targeted toward 

3 measuring and preventing the spread of drug 

4 resistant pathogens; 

5 ‘‘(E) describe any international develop6 ments that may impact antimicrobial resistance 

7 in the United States; and 

8 ‘‘(F) identify the major gaps that the Na9 tion faces in the areas of antimicrobial resist10 ance surveillance, prevention, use, and anti11 microbial stewardship. 

12 ‘‘(h) ENSURE ACCESS TO ANTIMICROBIAL RESIST13 ANCE DATA AND RESEARCH.—The Director of the Anti14 microbial Resistance Office shall work with the Federal 

15 agencies represented on the Antimicrobial Resistance 

16 Task Force to identify relevant data and formats, and 

17 mechanisms for communicating such data to the Anti18 microbial Resistance Office and Antimicrobial Resistance 

19 Task Force and, in a manner consistent with section 9 

20 of the Strategies to Address Antimicrobial Resistance Act, 

21 with the Public Health Antimicrobial Advisory Board and 

22 the public, including relevant data obtained by the agen23 cies through contracts with other organizations, includ24 ing— 


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1 ‘‘(1) use and clinical outcomes data on patients 

2 receiving antimicrobial drugs for the treatment, pre3 vention, or diagnosis of infection or infectious dis4 eases; 

5 ‘‘(2) surveillance data regarding emerging anti6 microbial drug resistance and existing resistance 

7 patterns; 

8 ‘‘(3) susceptibility data related to antimicrobial 

9 drug use; 

10 ‘‘(4) data related to the amount of anti11 microbial products used in humans, animals, plants, 

12 and the environment; 

13 ‘‘(5) data from federally funded research in14 tended to support antimicrobial drug, vaccine, and 

15 related diagnostics development; 

16 ‘‘(6) data demonstrating the impact of research, 

17 surveillance, and prevention and control initiatives in 

18 understanding and controlling antimicrobial resist19 ance; and 

20 ‘‘(7) data regarding implementation and evalua21 tion of interventions to improve antimicrobial drug 

22 prescribing practices.’’. 


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1 SEC. 4. ANTIMICROBIAL RESISTANCE SURVEILLANCE AND 

2 LABORATORY NETWORK. 

3 (a) IN GENERAL.—The Secretary of Health and 

4 Human Services, acting through the Director of the Cen5 ters for Disease Control, shall establish at least 10 Anti6 microbial Resistance Surveillance and Laboratory Net7 work sites, building upon the intramural and extramural 

8 programs and laboratories of the Centers for Disease Con9 trol and Prevention, to intensify, strengthen, and expand 

10 the national capacity to— 

11 (1) monitor the emergence and changes in the 

12 patterns of antimicrobial resistant pathogens; 

13 (2) describe, confirm, and as necessary facili14 tate a response to local or regional outbreaks of re15 sistant pathogens; 

16 (3) assess and describe antimicrobial resistance 

17 patterns to inform public health and improve preven18 tion practices; 

19 (4) obtain isolates of pathogens, and in par20 ticular, pathogens that show new or atypical pat21 terns of resistance adversely affecting public health; 

22 (5) study the epidemiology of infections from 

23 such pathogens; 

24 (6) evaluate commonly used antimicrobial sus25 ceptibility testing methods to improve the accuracy 

26 of resistance testing and reporting; and 


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1 (7) as necessary, develop novel diagnostic tests 

2 capable of detecting new or emerging resistance in 

3 pathogens. 

4 (b) GEOGRAPHIC DISTRIBUTION.—The sites estab5 lished under subsection (a) shall be geographically distrib6 uted across the United States. 

7 (c) NONDUPLICATION OF CURRENT NATIONAL CA8 PACITY.—The sites established under subsection (a) may 

9 be based in academic centers, health departments, and ex10 isting surveillance and laboratory sites. 

11 SEC. 5. CLINICAL TRIALS NETWORK ON ANTIBACTERIAL 

12 RESISTANCE. 

13 (a) IN GENERAL.—The Secretary, acting through the 

14 Director of the National Institute of Allergy and Infec15 tious Diseases, shall establish a Clinical Trials Network 

16 on Antibacterial Resistance to enhance, strengthen, and 

17 expand research on clinical science, antibacterial and diag18 nostic development, and optimal usage strategies, and 

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 anti24 microbial therapies, vaccines and diagnostics, and 

25 evaluate and optimize their usage; 


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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 antimicrobial therapy and validate and im5 prove upon biomarkers and other surrogate end6 points; and 

7 (5) study shorter treatment duration and early 

8 cessation of antimicrobial therapy for treatment effi9 cacy and effect on development of resistance. 

10 (b) LEADERSHIP GROUP FOR A CLINICAL RESEARCH

11 NETWORK ON ANTIBACTERIAL RESISTANCE.—The Sec12 retary, acting through the Director of the National Insti13 tute of Allergy and Infectious Diseases, shall establish a 

14 Leadership Group for the Clinical Research Network on 

15 Antibacterial Resistance described in subsection (a) to de16 velop and implement a comprehensive clinical research 

17 agenda to address antibacterial resistance that takes into 

18 consideration the recommendations contained in the Stra19 tegic Research Plan on Antimicrobial Resistance devel20 oped in accordance with section 319E of the Public Health 

21 Service Act. The Leadership Group shall provide support 

22 for the following components— 

23 (1) scientific leadership and operations; 

24 (2) network laboratories; and 

25 (3) statistical and data management. 


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1 (c) APPROPRIATIONS.—There are authorized to be 

2 appropriated from the existing budget of the National In3 stitute of Allergy and Infectious Diseases, $100,000,000 

4 annually for each of fiscal years 2014 through 2020 to 

5 carry out this section. 

6 SEC. 6. REGIONAL PREVENTION COLLABORATIVES. 

7 The Secretary, acting through the Director of the 

8 Centers for Disease Control and Prevention, shall work 

9 with State health departments to support regional preven10 tion collaboratives designed to interrupt and prevent the 

11 transmission of significant antibiotic resistant pathogens 

12 being transmitted across health care settings in a geo13 graphic region. Such regional prevention collaboratives 

14 shall work to— 

15 (1) identify significant drug resistant pathogens 

16 being transmitted across health care settings locally; 

17 (2) implement evidence-based interventions to 

18 interrupt and prevent the transmission of such 

19 pathogens; and 

20 (3) evaluate the impact of such measures on 

21 hospital readmissions, transitions of care, rates of 

22 health care associated infections, or any other rel23 evant measures that characterize the health or eco24 nomic impact of the collaboratives. 


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1 SEC. 7. PREVENTION EPICENTERS. 

2 To provide the regional prevention collaboratives es3 tablished under section 6 with tools, strategies, and evi4 dence-based interventions, the Director of the Centers for 

5 Disease Control and Prevention may intensify and expand 

6 academic public health partnerships through the work of 

7 the Prevention Epicenters Program of the Centers of Dis8 ease Control and Prevention. The Centers for Disease 

9 Control and Prevention and the epicenters participating 

10 in such program shall work with the regional prevention 

11 collaboratives to— 

12 (1) evaluate new and existing interventions to 

13 prevent or limit the emergence of antimicrobial re14 sistance throughout the geographic region of the 

15 collaboratives; 

16 (2) facilitate public health research on the pre17 vention and control of resistant organisms; and 

18 (3) assess the feasibility, cost-effectiveness, and 

19 appropriateness of surveillance and prevention pro20 grams in differing health care and institutional set21 tings. 

22 SEC. 8. CONTINUATION OF CURRENT PROGRAMS. 

23 Subsection (j) of section 319E of the Public Health 

24 Service Act (42 U.S.C. 247d–5), as redesignated by sec25 tion 3(6), is amended by inserting ‘‘and for each of the 

26 fiscal years 2014 through 2018’’ after ‘‘2006’’. 


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1 SEC. 9. PROTECTION OF CONFIDENTIAL AND NATIONAL SE2 CURITY INFORMATION. 

3 Except as otherwise required by law, this Act (and 

4 the amendments made by this Act) shall not permit public 

5 disclosure of trade secrets, confidential commercial infor6 mation, or material inconsistent with national security 

7 that is obtained by any person under this Act (or amend8 ments made by this Act). 

Æ 


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