I 

111TH CONGRESS 

1ST SESSION H. R. 2400 

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

antimicrobial resistance. 

IN THE HOUSE OF REPRESENTATIVES 

MAY 13, 2009 

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. 

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) The recent 2009 Influenza A: H1N1 virus 

11 (also known as ‘‘Swine Flu Virus’’) outbreak clearly 

12 illustrates why infectious diseases experts are con13 cerned about drug resistance; although the H1N1 

14 virus currently appears to be treatable by two class15 es of available antiviral drugs, it is resistant to other 

16 classes, and should the virus mutate and become re17 sistant to all classes, which is possible, we would be 

18 left extremely vulnerable. 

19 (4) Scientific evidence suggests that the devel20 opment of antimicrobial resistance in humans is not 

21 due only to use of antimicrobial drugs in humans, 

22 but also may be caused by the use of antimicrobial 

23 drugs in food-producing animals. 

24 (5) A study estimates that in 2005 more than 

25 94,000 invasive methicillin-resistant Staphylococcus 


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1 aureus (MRSA) infections occurred in the United 

2 States and more than 18,500 of these infections re3 sulted in death—7 times more than a decade earlier. 

4 (6) The recent 2009 Influenza A: H1N1 virus 

5 outbreak exacerbates concerns about MRSA and 

6 other bacteria that cause respiratory diseases given 

7 that, during the 1918 influenza pandemic, many 

8 thousands of deaths were caused by complications 

9 due to secondary bacterial infections and not by the 

10 influenza virus itself. 

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

12 bacterial infections in hospitals and approximately 

13 90,000 of these people die from these infections. 

14 (8) The current annual costs of antimicrobial15 resistant bacterial diseases are hard to quantify, but 

16 a 1995 report by the Office of Technology Assess17 ment, an agency of Congress, which looked at 6 dif18 ferent antimicrobial-resistant strains of bacteria, cal19 culated that the minimum nationwide hospital costs 

20 of just these strains of bacteria accounted for 

21 $1,300,000,000 annually in 1992 dollars 

22 ($1,870,000,000 in 2006 dollars). 

23 (9) A 1998 Institute of Medicine report esti24 mated the societal cost of resistance as between 

25 $4,000,000,000 to $5,000,000,000; many experts 


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1 argue the cost in 2009 may be close to 10 times 

2 greater. 

3 (10) The costs of antimicrobial-resistant infec4 tions in terms of lives lost and economically will only 

5 rise as antimicrobial resistance continues to spread. 

6 SEC. 3. ANTIMICROBIAL RESISTANCE TASK FORCE. 

7 (a) IN GENERAL.—Section 319E of the Public 

8 Health Service Act (42 U.S.C. 247d–5) is amended— 

9 (1) in subsection (a)— 

10 (A) in the subsection heading, by striking 

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

12 ‘‘ANTIMICROBIAL RESISTANCE OFFICE, TASK

13 FORCE, AND ADVISORY BOARD’’; 

14 (B) in paragraph (1)— 

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

16 enactment of this section’’ and inserting 

17 ‘‘as of September 30, 2006’’; and 

18 (ii) by adding at the end the fol19 lowing: ‘‘The Secretary shall, not later 

20 than 1 year after the date of enactment of 

21 the Strategies to Address Antimicrobial 

22 Resistance Act, establish an Antimicrobial 

23 Resistance Office in the Office of the Sec24 retary and appoint a director to that Of25 fice. The Secretary shall, not later than 1 


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1 year after the date of enactment of such 

2 Act, establish the Public Health Anti3 microbial Advisory Board as an advisory 

4 board to the Director of the Antimicrobial 

5 Resistance Office. The Director of the 

6 Antimicrobial Resistance Office shall serve 

7 as the Director of the task force. To avoid 

8 duplication and ensure that Federal re9 sources are used efficiently and effectively, 

10 the Director shall work in conjunction with 

11 the Federal agencies represented on the 

12 Task Force to coordinate all antimicrobial 

13 resistance activities undertaken and sup14 ported by the Federal Government, includ15 ing the activities and budgetary allocations 

16 of the Office, task force, and Public Health 

17 Antimicrobial Advisory Board.’’; 

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

19 follows: 

20 ‘‘(2) MEMBERS.— 

21 ‘‘(A) MEMBERS OF THE ANTIMICROBIAL

22 RESISTANCE TASK FORCE.—The task force de23 scribed in paragraph (1) shall be composed of 

24 representatives of such Federal agencies as the 


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1 Secretary determines necessary, including rep2 resentation of the following: 

3 ‘‘(i) The Antimicrobial Resistance Of4 fice. 

5 ‘‘(ii) The Assistant Secretary of Pre6 paredness and Response. 

7 ‘‘(iii) The Centers for Disease Control 

8 and Prevention. 

9 ‘‘(iv) The Food and Drug Administra10 tion. 

11 ‘‘(v) The National Institutes of 

12 Health. 

13 ‘‘(vi) The Agency for Healthcare Re14 search and Quality. 

15 ‘‘(vii) The Centers for Medicare & 

16 Medicaid Services. 

17 ‘‘(viii) The Health Resources and 

18 Services Administration. 

19 ‘‘(ix) The Department of Agriculture. 

20 ‘‘(x) The Department of Education. 

21 ‘‘(xi) The Department of Defense. 

22 ‘‘(xii) The Department of Veterans 

23 Affairs. 

24 ‘‘(xiii) The Environmental Protection 

25 Agency. 


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1 ‘‘(xiv) The Department of Homeland 

2 Security. 

3 ‘‘(xv) The United States Agency for 

4 International Development. 

5 ‘‘(B) MEMBERS OF THE PUBLIC HEALTH

6 ANTIMICROBIAL ADVISORY BOARD.— 

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

8 Antimicrobial Advisory Board shall be 

9 composed of 19 voting members, appointed 

10 by the Secretary. Such members shall in11 clude experts from the medical professions 

12 (including hospital and community-based 

13 physicians), pharmacy, public health, vet14 erinary, research, and international health 

15 communities, as well as one representative 

16 from a public interest group. 

17 ‘‘(ii) TERMS.—Each member ap18 pointed under clause (i) shall be appointed 

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

20 19 members first appointed— 

21 ‘‘(I) 6 shall be appointed for a 

22 term of 12 months; and 

23 ‘‘(II) 6 shall be appointed for a 

24 term of 2 years. 


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1 ‘‘(iii) CHAIR.—The Secretary shall ap2 point a Chair of the Public Health Anti3 microbial Advisory Board from among its 

4 members to lead and supervise the activi5 ties of the Advisory Board. 

6 ‘‘(iv) DISCLOSURE OF FINANCIAL IN7 TERESTS.—Prior to a meeting of the Pub8 lic Health Antimicrobial Advisory Board, 

9 each member of the Advisory Board shall 

10 disclose to the Secretary any potential, rel11 evant financial interests as defined under 

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

13 Code.’’; 

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

15 consultation with the task force described in 

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

17 through the Director of the Antimicrobial Re18 sistance Office and the Director of the Centers 

19 for Disease Control and Prevention, and in con20 sultation with’’; and 

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

22 follows: 

23 ‘‘(4) MEETINGS AND DUTIES.— 

24 ‘‘(A) ANTIMICROBIAL RESISTANCE OFFICE

25 RESISTANCE DUTIES.—The Director of the 


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1 Antimicrobial Resistance Office, working in 

2 conjunction with the Federal agencies that are 

3 represented on the task force described in para4 graph (1), shall issue an update to the Public 

5 Health Action Plan to Combat Antimicrobial 

6 Resistance within 18 months of the establish7 ment of the Office and biennial updates there8 after. The updates shall include enhanced plans 

9 for addressing antimicrobial resistance in the 

10 United States and internationally. The Director 

11 of the Office shall post on a website these up12 dates as well as summaries of all non-propri13 etary data the Task Force makes available. The 

14 Director of the Antimicrobial Resistance Office 

15 shall work in conjunction with the Federal 

16 agencies that are represented on the task force 

17 described in paragraph (1), and in consultation 

18 with the Public Health Antimicrobial Advisory 

19 Board, to— 

20 ‘‘(i) establish benchmarks for achiev21 ing the goals set forth in the action plan; 

22 ‘‘(ii) assess the ongoing, observed pat23 terns of emergence of antimicrobial resist24 ance, and their impact on clinical outcomes 


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1 in terms of how patients feel, function, or 

2 survive; 

3 ‘‘(iii) assess how antimicrobial prod4 ucts are being used in humans, animals, 

5 and plants, and the impact of such use in 

6 furthering the development of resistance 

7 and the implications thereof for patient 

8 safety and public health; 

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

10 infectious diseases with the greatest need 

11 for development of new point-of-care and 

12 other diagnostics, antimicrobial drugs, and 

13 vaccines, and in particular serious and life14 threatening bacterial diseases, for which 

15 there are few or no diagnostic or treatment 

16 options; 

17 ‘‘(v) recommend basic, clinical, epide18 miological, prevention, and translational 

19 research where additional federally sup20 ported studies may be beneficial; 

21 ‘‘(vi) recommend how to support anti22 microbial development through Food and 

23 Drug Administration activities, including 

24 through the agency’s Critical Path Initia25 tive; 


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1 ‘‘(vii) recommend how best to 

2 strengthen and link antimicrobial resist3 ance-related surveillance and prevention 

4 and control activities; and 

5 ‘‘(viii) collaborate with the Assistant 

6 Secretary for Preparedness and Response 

7 to ensure that strategies to address anti8 microbial-resistance are coordinated with 

9 initiatives aimed at pandemic influenza, in10 cluding the 2009 Influenza A: H1N1 virus 

11 and H1N1 Avian Influenza virus, severe 

12 acute respiratory syndrome, bioterrorism, 

13 and other emerging health threats. 

14 ‘‘(B) ANTIMICROBIAL RESISTANCE TASK

15 FORCE MEETINGS AND DUTIES.— 

16 ‘‘(i) MEETINGS.—The Antimicrobial 

17 Resistance Task Force shall convene peri18 odically as the Director of the Anti19 microbial Resistance Task Force deter20 mines to be appropriate, but not fewer 

21 than twice a year, to consider issues relat22 ing to antimicrobial resistance. 

23 ‘‘(ii) PUBLIC HEALTH ACTION

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

25 force described in paragraph (1) shall have 


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1 a meeting to review, discuss, and further 

2 develop the Public Health Action Plan to 

3 Combat Antimicrobial Resistance issued by 

4 the interagency task force on antimicrobial 

5 resistance in 2001. Among other issues, 

6 the task force may discuss and review, 

7 based on current need or concern— 

8 ‘‘(I) antimicrobial clinical suscep9 tibility concentrations proposed, estab10 lished, or updated by the Food and 

11 Drug Administration; 

12 ‘‘(II) data obtained by govern13 ment agencies and, as possible, by pri14 vate sources on emerging anti15 microbial resistance related to clinical 

16 outcomes in terms of how patients 

17 function, feel, or survive as well as 

18 data related to how antimicrobial 

19 drugs may have been used inappropri20 ately; 

21 ‘‘(III) surveillance data and pre22 vention and control activities regard23 ing emerging antimicrobial resistance 

24 from reliable sources including the 

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1 vention, the Food and Drug Adminis2 tration, the Department of Defense, 

3 the Department of Veterans Affairs, 

4 the Department of Agriculture, the 

5 Environmental Protection Agency, 

6 and as feasible from private sources 

7 and international bodies; 

8 ‘‘(IV) data on the amount of 

9 antimicrobial products used in hu10 mans, animals, and plants from reli11 able sources including data from the 

12 Centers for Disease Control and Pre13 vention, the Food and Drug Adminis14 tration, the Environmental Protection 

15 Agency, the Department of Veterans 

16 Affairs, the Centers for Medicare & 

17 Medicaid Services, the Department of 

18 Homeland Security, and the Depart19 ment of Agriculture, and as feasible 

20 from private sources and international 

21 bodies; 

22 ‘‘(V) the impact of antimicrobial 

23 resistance on human health resulting 

24 from the approval of antimicrobial 

25 drugs for use in humans or animals 


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1 (including consideration of and rec2 ommendations on potential manage3 ment plans to limit and reduce the 

4 negative impacts of such resistance on 

5 human health); 

6 ‘‘(VI) reports of federally sup7 ported antimicrobial resistance re8 search and antimicrobial drug devel9 opment research activities (including 

10 clinical, epidemiological, prevention, 

11 and translational research) obtained 

12 from Federal agencies, as well as re13 ports of research sponsored by other 

14 countries, industry, and non-govern15 mental organizations; 

16 ‘‘(VII) reports on efforts by the 

17 Food and Drug Administration to de18 velop policies and guidances which en19 courage antimicrobial drug develop20 ment and appropriate use while main21 taining high standards for safety and 

22 effectiveness; 

23 ‘‘(VIII) health plan employer 

24 data and information set (HEDIS) 


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1 measures pertaining to appropriate 

2 use of antimicrobial drugs; and 

3 ‘‘(IX) other data and issues the 

4 task force described in paragraph (1) 

5 identifies as relevant to the issue of 

6 antimicrobial resistance. 

7 ‘‘(iii) PENDING APPLICATIONS.—The 

8 Food and Drug Administration may con9 sult with the Director of the Antimicrobial 

10 Resistance Office concerning the pending 

11 application of any antimicrobial drug appli12 cation submitted to the Secretary under 

13 section 505 or 512 of the Federal Food, 

14 Drug, and Cosmetic Act or the Public 

15 Health Service Act. 

16 ‘‘(C) PUBLIC HEALTH ANTIMICROBIAL AD17 VISORY BOARD MEETINGS AND DUTIES.— 

18 ‘‘(i) MEETINGS.—The Public Health 

19 Antimicrobial Advisory Board shall meet 

20 as the Chair of the Public Health Anti21 microbial Advisory Board determines to be 

22 appropriate, preferably in conjunction with 

23 meetings of the Antimicrobial Resistance 

24 Task Force, but not fewer than 2 times 

25 each year. 


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1 ‘‘(ii) RECOMMENDATIONS.—The Pub2 lic Health Antimicrobial Advisory Board 

3 shall make recommendations to the Sec4 retary, and the Antimicrobial Resistance 

5 Office, regarding— 

6 ‘‘(I) ways to encourage the avail7 ability of an adequate supply of safe 

8 and effective antimicrobial products; 

9 ‘‘(II) research priorities and 

10 other measures (such as antimicrobial 

11 drug resistance management plans) to 

12 enhance the safety and efficacy of 

13 antimicrobial products; 

14 ‘‘(III) how best to implement and 

15 update the goals of the Public Health 

16 Action Plan to Combat Antimicrobial 

17 Resistance; 

18 ‘‘(IV) incentives necessary to es19 tablish uniform mechanisms and data 

20 sets for State and local reporting of 

21 resistance data; 

22 ‘‘(V) the adequacy of existing 

23 surveillance systems to collect anti24 microbial resistance data and how 


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1 best to improve the collection, report2 ing, and analysis of such data; 

3 ‘‘(VI) the development of a na4 tional plan for the collection and anal5 ysis of isolates of resistant pathogens, 

6 including establishing priorities as to 

7 which isolates should be collected; 

8 ‘‘(VII) the implementation and 

9 evaluation of interventions to promote 

10 appropriate antimicrobial drug use in 

11 both inpatient and outpatient settings; 

12 and 

13 ‘‘(VIII) areas for government, 

14 nongovernment, and international co15 operation to strengthen implementa16 tion of the Public Health Action Plan 

17 to Combat Antimicrobial Resistance. 

18 ‘‘(D) AVAILABILITY OF INFORMATION.— 

19 The Antimicrobial Resistance Office shall en20 sure that all information shall be made avail21 able to the public on the website described in 

22 subparagraph (A) consistent with section 8 of 

23 the Strategies to Address Antimicrobial Resist24 ance Act.’’; 


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1 (2) by amending subsection (b) to read as fol2 lows: 

3 ‘‘(b) ANTIMICROBIAL RESISTANCE STRATEGIC RE4 SEARCH PLAN.—The Secretary, acting through the Direc5 tor of the Antimicrobial Resistance Office, the Director 

6 of the Centers for Disease Control and Prevention, and 

7 the Director of the National Institutes of Health, and in 

8 consultation with other Federal agencies and the Public 

9 Health Antimicrobial Advisory Board, shall develop an 

10 antimicrobial resistance strategic research plan that 

11 strengthens existing epidemiological, interventional, clin12 ical, behavioral, translational, and basic research efforts 

13 to advance the understanding of— 

14 ‘‘(1) the development, implementation, and effi15 cacy of interventions to prevent and control the 

16 emergence and transmission of antimicrobial resist17 ance; 

18 ‘‘(2) how best to optimize antimicrobial effec19 tiveness while limiting the emergence of resistance, 

20 including addressing issues related to duration of 

21 therapy, effectiveness of therapy in self-resolving dis22 eases, and determining populations most likely to 

23 benefit from antimicrobial drugs; 

24 ‘‘(3) the extent to which the use of anti25 microbial products in humans, animals, plants, and 


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1 other uses accelerates development and transmission 

2 of antimicrobial resistance; 

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

4 (including defining the disease, diagnosis, severity, 

5 and the time course of illness); 

6 ‘‘(5) the development of new therapeutics, in7 cluding antimicrobial drugs, biologics, and devices 

8 against resistant pathogens, and in particular dis9 eases for which few or no therapeutics are in devel10 opment; 

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

12 diagnostics to identify patients with infectious dis13 ease and identify the exact cause of infectious dis14 eases syndromes, particularly with respect to the de15 tection of pathogens resistant to antimicrobial drugs; 

16 ‘‘(7) the epidemiology, pathogenesis, mecha17 nisms, and genetics of antimicrobial resistance; and 

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

19 DNA analysis, or other comparative analysis of pri20 ority pathogens (as determined by the Public Health 

21 Antimicrobial Advisory Board), in collaboration with 

22 the Department of Defense and the Joint Genome 

23 Institute of the Department of Energy.’’; 

24 (3) in subsection (c)— 


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1 (A) by inserting ‘‘acting through the Di2 rector of the Antimicrobial Resistance Office,’’ 

3 after ‘‘The Secretary,’’; and 

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

5 described in subsection (a),’’; 

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

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

8 Secretary’’; and 

9 (5) in subsection (e)— 

10 (A) in paragraph (1), by inserting ‘‘, act11 ing through the Director of the Antimicrobial 

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

13 (B) in paragraph (3), by inserting ‘‘, act14 ing through the Antimicrobial Resistance Of15 fice,’’ after ‘‘The Secretary’’; and 

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

17 ‘‘(4) PREFERENCE IN MAKING AWARDS.—In 

18 making awards under paragraph (1), the Secretary 

19 shall give preference to eligible entities that will use 

20 grant funds to establish demonstration projects to 

21 assess the scope of the antimicrobial resistance prob22 lem and the level of appropriate and inappropriate 

23 use of antimicrobial drugs especially related to self24 resolving infections, including the validation of mod25 els that may lead to the development of quality 


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1 measures for health care providers prescribing anti2 microbial drugs.’’. 

3 (b) ENSURE ACCESS TO ANTIMICROBIAL DATA AND

4 RESEARCH.—The Director of the Antimicrobial Resist5 ance Office shall work with the agencies represented on 

6 the Antimicrobial Resistance Task Force to identify rel7 evant data and formats, and mechanisms for commu8 nicating such data to the Antimicrobial Resistance Office 

9 and Antimicrobial Resistance Task Force and, in a man10 ner consistent with section 8 of this Act, with the Public 

11 Health Antimicrobial Advisory Board and the public, in12 cluding relevant data obtained by the agencies through 

13 contracts with other organizations, including— 

14 (1) use and clinical outcomes data on patients 

15 receiving antimicrobial drugs for the treatment, pre16 vention, or diagnosis of infection or infectious dis17 eases; 

18 (2) surveillance data regarding emerging anti19 microbial drug resistance; 

20 (3) susceptibility data related to antimicrobial 

21 drug use; 

22 (4) data related to the amount of antimicrobial 

23 products used in humans, animals, and plants; 

24 (5) data from federally funded research in25 tended to support antimicrobial drug development; 


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1 (6) data demonstrating the impact of research, 

2 surveillance, and prevention and control initiatives in 

3 understanding and controlling antimicrobial resist4 ance; and 

5 (7) data regarding implementation and evalua6 tion of interventions to improve antimicrobial drug 

7 prescribing practices. 

8 SEC. 4. COLLECTION OF ANTIMICROBIAL DRUG DATA. 

9 (a) SUBMISSION OF HUMAN AND ANIMAL DRUG DIS10 TRIBUTION DATA.—Chapter V of the Federal Food, Drug, 

11 and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by 

12 inserting after section 512 the following: 

13 ‘‘SEC. 512A. SUBMISSION OF HUMAN AND ANIMAL DRUG 

14 DISTRIBUTION DATA. 

15 ‘‘(a) IN GENERAL.—Notwithstanding any other pro16 vision of law, the Secretary shall require that each sponsor 

17 of a human antimicrobial drug product which is approved 

18 under section 505 (including section 505(j)) and sold or 

19 distributed in the United States, submit antimicrobial 

20 drug sales and distribution data. Such data shall be— 

21 ‘‘(1) submitted not later than 60 days after the 

22 beginning of the subsequent calendar year; 

23 ‘‘(2) reported on the calendar year and seg24 regated by month; 


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1 ‘‘(3) in such format, and utilize any such unit 

2 of measure, as the Secretary by regulation deems 

3 necessary and appropriate to ensure the reported 

4 data is comparable and reliable; and 

5 ‘‘(4) made available to the Antimicrobial Resist6 ance Office and the Antimicrobial Resistance Task 

7 Force. 

8 ‘‘(b) CONFIDENTIALITY.—To protect proprietary 

9 commercial information, officials who serve in the Anti10 microbial Resistance Office and on the Antimicrobial Re11 sistance Task Force shall sign a confidentiality agreement 

12 prior to reviewing any such data to which access is granted 

13 under subsection (a)(4).’’. 

14 (b) SUBMISSION OF ANIMAL SALES AND DISTRIBU15 TION DATA.—Section 512(l)(3) (21 U.S.C. 360b(l)(3)) is 

16 amended— 

17 (1) in subparagraph (C)— 

18 (A) in clause (ii), by deleting ‘‘and’’ at the 

19 end; 

20 (B) in clause (iii), by striking the period at 

21 the end and inserting ‘‘; and’’; and 

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

23 ‘‘(iv) contain any such additional in24 formation, be in such format, and utilize 

25 any such unit of measure as the Secretary 


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1 by regulation deems necessary and appro2 priate to ensure the reported data is com3 parable and reliable.’’; and 

4 (2) in subparagraph (D), by striking ‘‘may’’ 

5 and inserting ‘‘shall’’. 

6 (c) DATA FROM ADDITIONAL SOURCES.— 

7 (1) IN GENERAL.—The Secretary, acting 

8 through the Director of the Antimicrobial Resistance 

9 Office, shall explore opportunities to secure from pri10 vate vendors and health care organizations reliable 

11 and comparable animal and human antimicrobial 

12 drug consumption data (volume antimicrobial dis13 tribution data and antimicrobial use, including pre14 scription data) by State or metropolitan area, as 

15 necessary, to supplement the antimicrobial drug con16 sumption data to be collected under this section for 

17 the purpose of demonstrating how the consumption 

18 of antimicrobial drugs for human and animal uses 

19 may affect the development of resistance over time 

20 and within geographic locations and to institute pre21 ventive interventions. 

22 (2) NEGOTIATIONS.—The Director of the Anti23 microbial Resistance Office may enter into negotia24 tions with private vendors and health care organiza25 tions to determine acceptable scope and parameters 


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1 for summaries of antimicrobial drug consumption 

2 data that is collected under this section publicly 

3 available for research purposes. 

4 (3) OTHER MEANS TO SECURE DATA.—If the 

5 Director of the Antimicrobial Resistance Office is 

6 not able to secure sufficient supplemental anti7 microbial drug consumption data for human and 

8 animal uses through private vendors and health care 

9 organizations as provided for in this section, the 

10 Secretary shall consider other means to secure such 

11 consumption data, including through the conduct of 

12 surveys about how antimicrobial drugs are used in 

13 various settings. 

14 (d) COLLECTION OF ANTIMICROBIAL PRESCRIPTION

15 DATA.— 

16 (1) CLINICAL OUTCOMES DATA.—The Director 

17 of the Antimicrobial Resistance Office, the Under 

18 Secretary for Health of the Department of Veterans 

19 Affairs, and the Administrator of the Centers for 

20 Medicare & Medicaid Services shall work together to 

21 collect and analyze relevant drug utilization data 

22 and clinical outcomes data, as determined relevant 

23 by the Director of the Antimicrobial Resistance Of24 fice, on patients who receive services funded by such 

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1 microbial agents for the treatment or prevention of 

2 infection or infectious diseases. 

3 (2) ORGANIZATION.—Any data collected under 

4 paragraph (1) shall be organized by— 

5 (A) indication (including results of diag6 nostic studies when available); 

7 (B) dosage; 

8 (C) route of administration; 

9 (D) duration; 

10 (E) age of the patient; and 

11 (F) geographic region. 

12 (3) INTERVENTIONS AND ANALYSIS.—The 

13 Under Secretary for Health of the Department of 

14 Veterans Affairs, the Administrator of the Centers 

15 for Medicare & Medicaid Services, and the Director 

16 of the Antimicrobial Resistance Office shall work to17 gether to identify and report upon interventions that 

18 prevent and control the development of antimicrobial 

19 resistance and to include within such reports, where 

20 appropriate, an analysis of the following— 

21 (A) intra- and extra-label antimicrobial 

22 use; 

23 (B) where challenges to appropriate use re24 main; 


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1 (C) trends and variations in antimicrobial 

2 resistance rates; and 

3 (D) the relationship between drug use and 

4 resistance. 

5 (e) PUBLIC AVAILABILITY OF DATA.—The Director 

6 of the Antimicrobial Resistance Office shall make sum7 maries of the data received under this section publicly 

8 available and ensure that such summaries are updated and 

9 published, in a manner consistent with section 8, at least 

10 once annually on the website described in section 

11 319E(a)(4)(A) of the Public Health Service Act (42 

12 U.S.C. 247d–5(a)(4)(A)) in order to support epidemiologic 

13 and microbiologic research. 

14 SEC. 5. ANTIMICROBIAL RESISTANCE SURVEILLANCE AND 

15 RESEARCH NETWORK. 

16 (a) IN GENERAL.—The Secretary, through the Direc17 tor of the Centers for Disease Control and Prevention and 

18 the Director of the National Institutes of Health, shall es19 tablish at least 10 Antimicrobial Resistance Surveillance 

20 and Research Network sites to strengthen the national ca21 pacity to— 

22 (1) describe and confirm regional outbreaks 

23 through surveillance of locally available clinical 

24 specimens; 


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1 (2) assess, integrate, and address local and na2 tional antimicrobial resistance patterns; 

3 (3) facilitate research on prevention, control, 

4 and treatment of resistant organisms; and 

5 (4) serve as a clinical trials network for opti6 mizing antimicrobial drug effectiveness. 

7 (b) GEOGRAPHIC DISTRIBUTION.—The sites estab8 lished under subsection (a) shall be geographically distrib9 uted across the United States. 

10 (c) NONDUPLICATION OF CURRENT NATIONAL CA11 PACITY.—The sites established under subsection (a) may 

12 be based in academic centers, health departments, and ex13 isting surveillance sites. 

14 (d) RESPONSIBILITIES.—The Network of sites estab15 lished under subsection (a) shall— 

16 (1) monitor the emergence and changes in the 

17 patterns of antimicrobial resistant pathogens in indi18 viduals; 

19 (2) study the molecular epidemiology of such 

20 pathogens; 

21 (3) evaluate the efficacy of new and existing 

22 interventions to prevent or limit the emergence of 

23 antimicrobial resistance throughout the geographic 

24 region of the site; 


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1 (4) provide to the Centers for Disease Control 

2 and Prevention isolates of resistant pathogens, and 

3 in particular, pathogens that show new or atypical 

4 patterns of resistance adversely affecting public 

5 health; 

6 (5) conduct clinical research to develop natural 

7 histories of infectious disease and to study duration 

8 of antimicrobial use related to resistance develop9 ment, among other things; 

10 (6) assess the feasibility, cost-effectiveness, and 

11 appropriateness of surveillance and screening pro12 grams in differing health care and institutional set13 tings, such as schools; and 

14 (7) evaluate current treatment protocols and 

15 make appropriate recommendations on best practices 

16 for treating drug resistant infections. 

17 (e) COORDINATION.—The sites established under 

18 subsection (a) shall share data and cooperate with the 

19 Centers for Disease Control and Prevention and the Na20 tional Institutes of Health. 

21 (f) DATA ACCESS.—The Director of the Centers for 

22 Disease Control and Prevention and the Director of the 

23 National Institutes of Health shall ensure that summary 

24 reports of data obtained by the Antimicrobial Resistance 

25 Surveillance and Research Network sites are made availVerDate Nov 24 2008 05:13 May 15, 2009 Jkt 079200 PO 00000 Frm 00029 Fmt 6652 Sfmt 6201 E:\BILLS\H2400.IH H2400

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1 able to the Antimicrobial Resistance Task Force and, in 

2 a manner consistent with section 8 of this Act, with the 

3 Public Health Antimicrobial Advisory Board and the pub4 lic, for review on an ongoing basis . 

5 SEC. 6. SUPPLEMENT NOT SUPPLANT. 

6 Section 319E(f) of the Public Health Service Act (42 

7 U.S.C. 247d–5(f)) is amended to read as follows: 

8 ‘‘(f) SUPPLEMENT NOT SUPPLANT.—Funds appro9 priated under this section shall be used to supplement and 

10 not supplant other Federal, State, and local public funds 

11 provided for activities under this section, including funds 

12 appropriated for the Centers for Disease Control and Pre13 vention and the National Institutes of Health.’’. 

14 SEC. 7. AUTHORIZATION OF APPROPRIATIONS. 

15 Section 319E(g) of the Public Health Service Act (42 

16 U.S.C. 247d–5(g)) is amended to read as follows: 

17 ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.— 

18 ‘‘(1) AUTHORIZATION.—There are authorized to 

19 be appropriated to carry out this section (other than 

20 subsection (b)) $45,000,000 for fiscal year 2010, 

21 $65,000,000 for fiscal year 2011, and $120,000,000 

22 for fiscal years 2012 through 2014. 

23 ‘‘(2) ALLOCATION.—Of the amount appro24 priated to carry out this section for a fiscal year, not 

25 less than one-third of such amount shall be made 


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1 available for activities of the Centers for Disease 

2 Control and Prevention under subsections (a)(3)(B) 

3 and (c), of which an appropriate amount shall be al4 located to educational programs under subsection (c) 

5 dedicated to the reduction of inappropriate anti6 microbial use.’’. 

7 SEC. 8. PROTECTION OF CONFIDENTIAL AND NATIONAL SE8 CURITY INFORMATION. 

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

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

11 disclosure of trade secrets, confidential commercial infor12 mation, or material inconsistent with national security 

13 that is obtained by any person under this Act. 

Æ 


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