Released for public comment: February X, 2011 

A PUBLIC HEALTH ACTION PLAN TO COMBAT ANTIMICROBIAL RESISTANCE 

Interagency Task Force on Antimicrobial Resistance 

Co-Chairs: 

Centers for Disease Control and Prevention 

Food and Drug Administration 

National Institutes of Health 

Participating Agencies: 

Agency for Healthcare Research and Quality 

Centers for Medicare and Medicaid Services 

Department of Agriculture 

Department of Defense 

Department of Veterans Affairs 

Environmental Protection Agency 

Health Resources and Services Administration 

Health and Human Services/ Office of the Assistant Secretary for Preparedness and Response
A PUBLIC HEALTH ACTION PLAN TO COMBAT ANTIMICROBIAL RESISTANCE 

2010 

TABLE OF CONTENTS 

Executive Summary ........................................................................................................................ 1

Introduction and Overview ............................................................................................................. 3

The Focus Areas ........................................................................................................................... 10

Focus Area I: Surveillance ........................................................................................................ 10

Focus Area II: Prevention and Control ..................................................................................... 18

Focus Area III: Research .......................................................................................................... 24

Focus Area IV: Product Development ...................................................................................... 27

Acronyms and Abbreviations ....................................................................................................... 30
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A Public Health Action Plan to Combat Antimicrobial Resistance 

Executive Summary 

The Interagency Task Force on Antimicrobial Resistance (hereafter referred to as the Task 

Force) was created in 1999 to coordinate the activities of federal agencies in addressing 

antimicrobiala resistance (AR) in recognition of the increasing importance of AR as a public 

health threat. The Task Force is co-chaired by the Centers for Disease Control and Prevention 

(CDC), the Food and Drug Administration (FDA), and the National Institutes of Health (NIH) 

and also includes the Agency for Healthcare Research and Quality (AHRQ), the Centers for 

Medicare and Medicaid Services (CMS), the Department of Agriculture (USDA), the 

Department of Defense (DoD), the Department of Veterans Affairs (VA), the Environmental 

Protection Agency (EPA), the Health Resources and Services Administration (HRSA), and the 

Department of Health and Human Services Office of the Assistant Secretary for Preparedness 

and Response (HHS/ASPR). 

In 2001, the Task Force developed an initial Action Plan, outlining specific issues, goals, and 

actions important for addressing the problem of AR. This document, entitled A Public Health 

Action Plan to Combat Antimicrobial Resistance, Part I: Domestic Issues, reflected a broadbased consensus of participating federal agencies, which was reached with individual input from 

state and local health agencies, universities, professional societies, pharmaceutical companies, 

healthcare delivery organizations, agricultural producers, consumer groups, and other members 

of the public. Continued collaboration with these partners has been vital to achieving successful 

implementation of the Action Plan. 

The 2010 Action Plan is based in part on individual input obtained at a consultants’ meeting held 

in Atlanta, Georgia, in December 2007. Present at the public meeting were consultants with 

wide-ranging expertise in areas such as human and veterinary medicine, pharmaceutical and 

diagnostics manufacturing, animal husbandry, clinical microbiology, epidemiology, infectious 

diseases and infection control, and state and local public health officials. 

The 2010 Action Plan includes action items organized into four focus areas: Surveillance, 

Prevention and Control, Research, and Product Development. Within each of these four areas, 

specific goals are listed. The focus areas and goals are as follows: 

I. Surveillance 

• Goal 1: Improve the detection, monitoring, and characterization of drug-resistant infections in 

humans and animals. 

• Goal 2: Better define, characterize, and measure the impact of antimicrobial drug use in 

humans and animals in the United States. 

 

a

 In this document, the term “antimicrobial” is used inclusively to refer to any agent (including an antibiotic) used to 

kill or inhibit the growth of microorganisms (bacteria, viruses, fungi, or parasites). This term generally applies to 

agents intended for healthcare, veterinary, and agricultural applications. 
- 2 - 

II. Prevention and Control 

• Goal 3: Develop, implement, and evaluate strategies to prevent the emergence, transmission, 

and persistence of drug-resistant microorganisms. 

• Goal 4: Develop, implement, and evaluate strategies to improve appropriate antimicrobial use. 

III. Research 

• Goal 5: Facilitate basic research on antimicrobial resistance. 

• Goal 6: Facilitate the translation of basic research findings into practical applications for the 

prevention, diagnosis and treatment of resistant infections. 

• Goal 7: Facilitate clinical research to improve the treatment and prevention of antimicrobial 

drug resistant infections. 

• Goal 8: Conduct and support epidemiological studies to identify key drivers of the emergence 

and spread of AR in various populations. 

IV. Product Development 

• Goal 9: Provide information on the status of antibacterial drug product development and 

clarify recommended clinical trial designs for antibacterial products. 

• Goal 10: Consider opportunities for international harmonization and means to update 

susceptibility testing information for human and animal use. 

• Goal 11: Encourage development of rapid diagnostic tests and vaccines. 

The Task Force will continue to facilitate coordination among agencies and monitor 

implementation of the plan. As with the 2001 Action Plan, the Task Force will continue to 

publish annual reports detailing how the plan is being implemented, solicit comments from the 

public, and if necessary, update the plan. 
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Introduction and Overview 

Background

In the 1940s, the widespread availability of penicillin and the subsequent discovery of 

streptomycin led to a dramatic reduction in illness and death from infectious diseases. However, 

bacteria and other disease-causing organisms — viruses, fungi, and parasites — have a 

remarkable ability to mutate and acquire resistance genes from other organisms and thereby 

develop resistance to antimicrobial drugs. When an antimicrobial drug is used, the selective 

pressure exerted by the drug favors the growth of organisms that are resistant to the drug's action. 

The extensive use of antimicrobial drugs has resulted in drug resistance that threatens to reverse 

the medical advances of the last half century. 

Drug-resistant pathogens are a growing menace to all people, regardless of age, gender, or 

socioeconomic background. They endanger people in affluent, industrial societies like the United 

States, as well as in less-developed nations. Examples of clinically important microbes that are 

rapidly developing resistance to available antimicrobials include bacteria that cause pneumonia, 

ear infections, and meningitis (e.g., Streptococcus pneumoniae), skin, bone, lung, and 

bloodstream infections (e.g., Staphylococcus aureus), urinary tract infections (e.g., Escherichia 

coli), foodborne infections (e.g., Salmonella or E. coli acquired from meat, eggs, nuts, fresh 

produce etc), and infections transmitted in healthcare settings (e.g., enterococci, Acinetobacter 

baumanii, Pseudomonas aeruginosa, and Klebsiella spp.). 

Antimicrobial resistance (AR) is not a new phenomenon; however, the current magnitude of the 

problem and the speed with which new resistance phenotypes have emerged elevates the public 

health significance of this issue. In addition, the scarcity of new antimicrobial agents limits 

treatment options, particularly for patients with infections caused by multidrug-resistant 

organisms. For example, surveillance data for S. pneumoniae, a common cause of bacterial 

respiratory tract infections, showed that 24 percent of isolates were not susceptible to penicillin. 

In addition, resistance to several other antibacterial drugs is common; 1.5 percent of isolates 

were resistant to cefotaxime (a "third generation" cephalosporin antibiotic), and resistance to the 

newer fluoroquinolone antimicrobials has already been reported.b

 Nearly all strains of 

Staphylococcus aureus in the United States are resistant to penicillin, and many are resistant to 

newer methicillin-related drugs. Vancomycin for many years has been the only uniformly 

effective treatment against these methicillin resistant strains, but over the last decade there have 

been reported strains of S. aureus with decreased susceptibility and isolates resistant to 

vancomycin. The public health burden of methicillin-resistant Staphylococcus aureus (MRSA) is 

staggering with over 90,000 invasive MRSA infections per year estimated in the U.S. 

population.c

 

b

 Active Bacterial Core Surveillance (ABCs) Report Emerging Infections Program Network Streptococcus 

pneumoniae, 2008 available at: http://www.cdc.gov/abcs/reports-findings/survreports/spneu08.pdf 

c

 Klevens RM, Morrison MA, Nadle J, Petit S, Gershman K, Ray S, Harrison LH, Lynfield R, Dumyati G, Townes 

JM, Craig AS, Zell ER, Fosheim GE, McDougal LK, Carey RB, Fridkin SK; Active Bacterial Core surveillance 

(ABCs) MRSA Investigators. Invasive methicillin-resistant Staphylococcus aureus infections in the United States. 

JAMA. 2007 Oct 17;298(15):1763-71. 
- 4 - 

Many other pathogens – including the bacteria that cause tuberculosis and gonorrhea, human 

immunodeficiency virus, the fungi that cause yeast infections, and the parasites that cause 

malaria – are also becoming resistant to standard therapies. For instance, CDC modified 

treatment recommendations for gonorrhea in 2007 due to increasing and widespread 

fluoroquinolone resistance in Neisseria gonorrhoeae.

d

 Even as we act to address the problem of 

AR, we lose quick and reliable treatment options for infections that have been a manageable 

problem in the United States since the 1940s. Drug choices for the treatment of common 

infections are becoming increasingly limited and expensive – and, in some cases, nonexistent. 

The unpredictable and fluid nature of AR is illustrated by the prevalence of resistant 

Acinetobacter baumannii among military personnel in and returning from conflict areas and the 

hospital outbreaks of Clostridium difficile and Acinetobacter baumannii.

e

Additionally, antimicrobials have been used extensively in livestock and poultry since their 

discovery for the treatment, control, and/or prevention of animal diseases, as well as for 

production purposes (e.g., to enhance growth, improve feed efficiency). In contrast to human 

medicine where treatment is customarily directed at the patient, entire groups of animals may be 

treated by the use of medicated feed and/or water. As a result of continued exposure to 

antimicrobials, the prevalence of resistant bacteria in the fecal flora of food animals may be 

relatively high. Determining the impact of these resistant bacteria on the management of human 

infections is an ongoing challenge as many classes of antimicrobials used in food-producing 

animals have analogues to human therapeutics and are therefore capable of selecting for similar 

resistance phenotypes. 

Risk

Drug-resistant infections may be acquired in healthcare settings (e.g., staphylococcal infections 

in intensive care units), in the community (e.g., pneumococci acquired from a classmate), and 

through the food supply (e.g., salmonella acquired from meat or eggs), both domestically and 

 

d

 Update to CDC’s Sexually Transmitted Diseases Treatment Guidelines, 2006: Fluoroquinolones No Longer 

Recommended for Treatment of Gonococcal Infections. MMWR 56(14);332-336. April 13, 2007. 

e

 Scott P, Deye G, Srinivasan A, Murray C, Moran K, Hulten E, Fishbain J, Craft D, Riddell S, Lindler L, Mancuso 

J, Milstrey E, Bautista CT, Patel J, Ewell A, Hamilton T, Gaddy C, Tenney M, Christopher G, Petersen K, Endy T, 

Petruccelli B.An outbreak of multidrug-resistant Acinetobacter baumannii-calcoaceticus complex infection in the 

US military health care system associated with military operations in Iraq. Clin Infect Dis. 2007 Jun

15;44(12):1577-84. Epub 2007 May 8. 

Jones A, Morgan D, Walsh A, Turton J, Livermore D, Pitt T, Green A, Gill M, Mortiboy D. Importation of

multidrug-resistant Acinetobacter spp infections with casualties from Iraq. Lancet Infect Dis. 2006 Jun;6(6):317-8. 

Moran KA, McAllister CK, Gray PJ Multidrug-resistant Acinetobacter extremity infections in soldiers. Davis KA,. 

Emerg Infect Dis. 2005 Aug;11(8):1218-24. 

Tan ET, Robertson CA, Brynildsen S, Bresnitz E, Tan C, McDonald C. Clostridium difficile-associated disease in 

New Jersey hospitals, 2000-2004. Emerg Infect Dis. 2007 Mar;13(3):498-500. 

Munoz-Price LS, Weinstein RA. Acinetobacter infection. N Engl J Med. 2008 Mar 20;358(12):1271-81. 
- 5 - 

overseas. While anyone may acquire a drug-resistant infection, certain people are at increased 

risk, e.g., patients in hospitals and children in daycare centers. However, resistant microbes are 

increasingly appearing in new settings. MRSA, which for 30 years was almost exclusively a 

problem in hospitals, is now occurring in the community.f

Costs

The costs of treating AR infections place a significant burden on society — a burden that is 

likely to grow larger as the number of cases of drug-resistant illness increases. Individuals 

infected with drug-resistant organisms are more likely to remain in the hospital for a longer time, 

and to have a poor prognosis.g In a 2008 study of antimicrobial resistant infections acquired in 

the hospital, the medical costs attributable to the infection ranged from $18,588 to $29,069 per 

patient, hospital stays were extended between 6.4 to 12.7 days, and the attributable mortality of 

the infection was 6.5%. Using the most conservative estimates, the total cost of resistant 

infections in the 188 patients from this study was $13.35 million dollars. These findings suggest 

that significant health and economic benefits are possible through efforts to reduce antimicrobial 

resistance and healthcare-associated infections. 

Solutions

AR will always be with us. The challenge before us is to transform this increasingly urgent threat 

into a manageable problem. In the past, the Institute of Medicine (IOM), the American Society 

for Microbiology, the World Health Organization (WHO), the Congressional Office of 

Technology Assessment, the Government Accountability Office, and other panels of 

distinguished experts have provided recommendations and options for government action to 

address the dangers posed by AR. In addition, a 2009 U.S.-EU Summit Declaration included a 

statement to establish a transatlantic task force on AR.h

 The experts agree that we need to 

improve surveillance for emerging AR problems, to prolong the useful life of antimicrobial 

drugs, to develop new drugs, and to utilize other measures, e.g., improved vaccines, diagnostics, 

and infection control measures to prevent and control AR. 

Despite the urgency of the problem, the achievement of these goals has not been simple or 

straightforward, and accomplishments to date have been insufficient. Monitoring, preventing, 

and controlling AR requires sustained effort, commitment, and collaboration among many 

groups in the public and private sectors, and involvement of the general public. It also requires 

support and leadership from the federal government and a willingness to address complex and 

sometimes controversial scientific, medical, and economic issues. 

 

f

 Klevens RM, Morrison MA, Nadle J, Petit S, Gershman K, Ray S, Harrison LH, Lynfield R, Dumyati G, Townes 

JM, Craig AS, Zell ER, Fosheim GE, McDougal LK, Carey RB, Fridkin SK; Active Bacterial Core surveillance 

(ABCs) MRSA Investigators. Invasive methicillin-resistant Staphylococcus aureus infections in the United States. 

JAMA. 2007 Oct 17;298(15):1763-71. 

g

 Roberts, RR, Hota B, Ahmad I, Scott RD II, Foster SD, Abbasi F, Schabowski S, Kampe LM, Ciavarella GG, 

Supino M, Naples J, Cordell R, Levy SB, Weinstein, RA. Hospital and societal costs of antimicrobial-resistant 

infections in a Chicago teaching hospital: implications for antibiotic stewardship. Clin. Infect. Dis. 2009; 49:1175-

84. 

h

 http://www.whitehouse.gov/the-press-office/us-eu-joint-declaration-and-annexes 
- 6 - 

Focus Areas

The 2010 Action Plan includes action items organized into four focus areas: Surveillance, 

Prevention and Control, Research, and Product Development. The Action Plan contains specific 

action items, projects and implementation steps. In addition to these, a selection of AR activities, 

in which the Task Force will actively engage within the next two years, are highlighted below.i

I. Surveillance

Unless AR problems are detected as they emerge and actions are taken quickly to contain them, 

the world may soon be faced with previously treatable diseases that have again become 

untreatable, as in the pre-antibiotic era. Identification of antimicrobial use information sources 

and integration of data with existing monitoring and surveillance systems will allow experts to 

quickly interpret trends and identify strategies to prevent or mitigate the development and/or 

spread of AR. 

The 2010 Action Plan incorporates several action items aimed at strengthening, expanding and 

coordinating existing national and international surveillance systems for antimicrobial-resistant 

microorganisms. Additional action items in this area focus on reviewing barriers to timely 

dissemination and updating of surveillance data and providing recommendations and best 

antimicrobial use practices. 

Over the next few years, CDC will address several action items in this focus area by continuing 

to expand and improve its surveillance systems that collect data on AR. For instance, the 

National Healthcare Safety Network (NHSN) is a surveillance system that provides healthcare 

facilities a way to track, analyze, and interpret data on healthcare-associated infections (HAIs), 

including those caused by antimicrobial-resistant pathogens. NHSN will be expanded to improve 

its capacity for collection and analysis of data on multidrug-resistant organisms (MDROs) and 

antimicrobial drug use. In addition to monitoring resistance in healthcare settings, CDC will 

maintain surveillance activities for pathogens affecting the general population through efforts 

such as the Emerging Infections Program (EIP), a population-based network of CDC and state 

health departments, the Gonococcal Isolate Surveillance Project, and the National Tuberculosis 

Surveillance System. Through the EIP program, CDC closely monitors invasive bacterial 

pathogens through Active Bacterial Core surveillance and tracks resistance among enteric 

pathogens through the National Antimicrobial Resistance Monitoring System. In addition to 

monitoring resistance among bacterial pathogens, CDC will continue to monitor resistance 

among non-bacterial pathogens such as influenza, malaria and human immunodeficiency virus, 

both domestically and internationally. 

II. Prevention and Control

The prevention and control of antimicrobial-resistant infections requires measures to promote the 

appropriate usejof antimicrobial agents and prevent the transmission of infections (whether drug-

 

i

 These highlighted activities are provided as illustrative examples and do not represent a comprehensive list. 

j

In this Action Plan, appropriate antimicrobial drug use is defined as use that maximizes therapeutic impact while 

minimizing toxicity and the development of resistance. In practice, this means prescribing antimicrobial therapy 
- 7 - 

resistant or not). While development of new antimicrobial agents and effective stewardship of 

existing agents are cornerstones of activities to protect the health of the nation in the face of 

expanding AR, successful prevention or elimination of resistance occurs with successful 

prevention or elimination of resistant microbes. Public health initiatives can be successful. For 

example, drug-resistant malaria is rampant in parts of the world, but malaria was effectively 

eliminated from the United States through mosquito control efforts. Antibiotic resistance in 

Haemophilus influenzae was the critical issue that determined antibiotic choice for virtually all 

invasive bacterial infections in young children in the United States as recently as 15 years ago, 

but following the introduction of Haemophilus infuenzae serotype b (HIB) vaccines this problem 

has nearly been eliminated. 

Other action items in this area focus on extending the useful life of antimicrobial drugs by 

encouraging appropriate use through educational efforts such as the Get Smart: Know When 

Antibiotics Work campaigns, preventing infection transmission through improved infection 

control methods and use of vaccines, and preventing and controlling emerging AR problems in 

agriculture, human and veterinary medicine. 

AR prevention and control activities that will be key over the next few years include several 

interagency collaborations focused on controlling and preventing MRSA infections within 

healthcare settings. Based upon the successful collaboration between the VA Pittsburgh 

Healthcare System and CDC that demonstrated a reduction of MRSA infections, the initiative 

was expanded into an additional 17 sites within the Veterans Health Administration (VHA). The 

successful prevention of MRSA at the local and regional levels led the VA to expand its MRSA 

Prevention Initiative, which is now a nationwide effort to reduce occurrence of healthcareassociated MRSA infection from developing while patients are in hospital. VA is also evaluating 

lessons learned from the MRSA Prevention Initiative to explore expanding this beyond just 

MRSA to other MDROs, including Clostridium difficile. 

Also continuing over the next few years is an interagency initiative to identify and help suppress 

the spread of MRSA and other related infections through an ongoing partnership between CDC 

and AHRQ. The two agencies are working together closely to identify gaps in the prevention, 

diagnosis, and treatment of MRSA and related infections across the healthcare system and to 

fund research, implementation, measurement, and evaluation practices that mitigate healthcare 

related infections. 

 

Several Task Force member agencies, including AHRQ, CDC, FDA, NIH, CMS and VA, are 

working to implement the 2008 HHS Action Plan to Prevent Health Care-Associated Infections 

(HAI)k

, which includes both Clostridium difficile and MRSA. By working to implement the HHS 

HAI Action Plan these agencies and partners will impact several areas and action items covered 

in this 2010 AR Action Plan. 

 

when and only when beneficial to a patient; targeting therapy to the desired pathogens; and using the appropriate 

agent, dose, and duration.

k

 The HHS Action Plan to Prevent Healthcare-Associated Infections is available on the HHS website at: 

http://www.hhs.gov/ophs/initiatives/hai/infection.html
- 8 - 

III. Research

Understanding the fundamental processes involved in AR within microbes and the resulting 

impact on humans, animals, and the environment forms an important basis for influencing and 

changing these processes and outcomes. Basic and clinical research provides the fundamental 

knowledge necessary to develop appropriate responses to the emergence and spread of AR in 

hospitals, communities, farms, and the food supply. Critical activities in this focus area include 

support of basic research to uncover new targets and new antimicrobials, investigations into the 

development of resistance and host-pathogen interactions, optimization of treatment for resistant 

pathogens, and translation of research findings into clinically useful products, such as novel 

approaches to detect, prevent, and treat antimicrobial-resistant infections.

In the next few years, NIH will engage in AR research activities that address several action items 

in this focus area. NIH is addressing the need for clinical trials aimed at identifying ways to 

reduce the use of antimicrobials with recent solicitations. Funded projects resulting from these 

solicitations include late-phase clinical trials to test the absolute need and optimal duration of 

treatment with off-patent antimicrobials for the following diseases 1) community-acquired 

methicillin-resistant Staphylococcus aureus (CA-MRSA) skin and soft tissue infections 2) 

urinary tract infections in children and 3) catheter-associated bloodstream infections. In 2010, 

NIH will fund additional targeted clinical trials to reduce the risk of AR focusing on one or more 

of the following disease areas: (1) acute otitis media; (2) pneumonia; (3) pulmonary tuberculosis; 

and (4) bacteremia. 

Recently renewed NIH activities in support of basic research include the Genomic Sequencing 

Centers for Infectious Diseases and the Bioinformatics Resource Centers for Infectious Diseases. 

The objective of the sequencing centers is to provide rapid and cost-efficient production of highquality genome sequences of microorganisms and invertebrate vectors of infectious diseases and 

to make the resulting genomic data rapidly and readily accessible to the broader scientific 

community through publicly accessible international databases. In addition, the sequencing 

centers will provide comparative genomics and genotyping services to examine genetic variation 

in populations and communities of human pathogens and also across the human genome to 

identify genetic associations with observable phenotypes in the pathogen and in the human host. 

The scope of the bioinformatics resource centers is to provide facilities, equipment, qualified 

personnel, and all necessary resources and services to collect, archive, update, integrate, and 

maintain genomics and other types of research data from human pathogens. In addition they 

provide the scientific community free access to resources for the query, analysis and display of 

such information through user friendly interfaces.

IV. Product Development

There is a critical need for new drugs, vaccines, and diagnostic tests to treat, prevent, and 

diagnose infections, including serious and life-threatening infections caused by drug-resistant 

bacteria. FDA is working on a study to better understand the trends over time in the development 

of new antibacterial drugs, the number of drugs approved, and reasons why development 

programs may not have achieved approval. 
- 9 - 

The 2010 Action Plan incorporates action items that will facilitate the development of vaccines 

and diagnostic tests for pathogens for which AR poses a significant problem for treatment or 

public health. 

FDA is working on a number of guidances on approaches to evaluating new antimicrobial 

products. Providing guidance can help by identifying recommended scientific approaches and 

also to identify areas where additional developmental work would be beneficial for the design 

and conduct of studies. Over the last few years, FDA has held several public workshops and/or 

Advisory Committee meetings to discuss clinical trial designs for evaluating antibacterial drugs. 

FDA has also published several guidance documents that describe recommended approaches 

regarding clinical trial designs.l

One particular example of the efforts to date is the work to refine clinical trial designs for 

studying antibacterial drugs for the treatment of hospital-acquired bacterial pneumonia (HABP) 

and ventilator-associated bacterial pneumonia (VABP). As part of these efforts, in 2009, FDA 

co-sponsored a public workshop with the Infectious Diseases Society of America, the American 

College of Chest Physicians, the Society of Critical Care Medicine, and the American Thoracic 

Society regarding scientific issues in clinical trial design for HABP and VABP. This public 

workshop provided information about, and gained perspective from, health care providers, 

academics, and industry on various aspects of antimicrobial drug development for HABP and 

VABP, including diagnosis, treatment, trial endpoints, and statistical issues in analysis of results 

of trials in HABP and VABP. 

In the next few years, FDA will engage in activities to address a number of the action items in 

the Product Development focus area. FDA will be working to provide clarity on recommended 

approaches for evaluating new medical products for bacterial disease through publishing 

guidance documents. FDA plans to publish guidance documents on recommended clinical trial 

designs for evaluating antibacterial drugs for conditions such as acute bacterial skin and skin 

structure infections and hospital-acquired and ventilator-associated bacterial pneumonia. In 

addition, FDA also plans to publish guidance for establishing performance for in vitro 

diagnostics assays for MRSA and vancomycin-resistant enterococci (VRE). These guidances 

will describe recommended approaches for developing new antimicrobial products for specific 

uses. 

The Biomedical Advanced Research Development Authority (BARDA), in the HHS Office of 

the Assistant Secretary for Preparedness and Responsem

 is designing and implementing programs 

that create partnerships between government and industry based on support and incentives that 

induce the commercial enterprises to address public health and biodefense priorities. 

 

l

Examples of recent guidance documents: Antibacterial Drug Products: Use of Noninferiority Studies to Support 

Approval (draft, October 2007), Acute Bacterial Sinusitis: Developing Antimicrobial Drugs for Treatment (draft, 

October 2007), Acute Bacterial Otitis Media: Developing Drugs for Treatment (draft, January 2008), Acute 

Bacterial Exacerbations of Chronic Bronchitis in Patients with Chronic Obstructive Pulmonary Disease: Developing 

Antimicrobial Drugs for Treatment (draft, August 2008), Community-Acquired Bacterial Pneumonia: Developing 

Drugs for Treatment (draft, March 2009), Non-Inferiority Clinical Trials (draft, March 2010) 

m

 See http://www.phe.gov/about/barda/Pages/default.aspx for more information on BARDA 
- 10 - 

BARDA is currently supporting the development of intravenous formulation of a next generation 

aminoglycoside antibiotic for the treatment of plague and tularemia, as well as ventilatorassociated pneumonia. BARDA is projecting an expansion of this program in the near-term by 

supporting the development of more novel antimicrobial candidates for the treatment and 

prevention of diseases caused by bacterial threat agents as well as diseases caused by clinically 

prevalent infectious diseases, including those that are AR. 

The Focus Areas 

Within each of the goals listed for each focus area are several action items that define topic areas 

for specific projects or implementation steps (numbered items). Wherever possible, action items 

are populated with specific projects or implementation steps (lettered items) to provide greater 

specificity for planned federal activities. The action items, projects, and implementation steps do 

not represent an exhaustive list of activities.n The expected completion dates for specific projects 

and implementation steps are indicated with a date. For example, (2011) means that the work is 

expected to be completed by the end of the 2011 calendar year. Some activities are ongoing and 

are indicated as such. Since project planning is itself an ongoing activity, these will be updated at 

least every 2 years. 

Focus Area I: Surveillance 

Overarching goals 

In order to develop and implement effective control strategies there must be 1) continuous or 

periodic monitoring of infections caused by AR microorganisms and 2) comprehensive 

knowledge of the use of antimicrobial agents across all sectors. 

Goal 1: Improve the detection, monitoring, and characterization of drug-resistant infections in 

humans and animals. 

1.1 Develop strategies to more accurately assess the burden of antimicrobial drug resistance 

in the community through the enhancement of existing systems including the EIP, and 

the Epidemiology and Laboratory Capacity (ELC) sites. 

 

a) Design, and implement (2010) a multi-site community-onset pneumonia etiology study 

among persons admitted with pneumonia and evaluate the specific role of antibacterial 

and antiviral resistance in determining outcomes associated with pneumonia (2011). 

 

n

 Because of the rapidly evolving nature of AR, there will likely be new or emerging challenges in antimicrobial 

resistance subsequent to the publication of this Action Plan. The Task Force is committed to identifying and 

responding to these issues as they arise. 
- 11 - 

b) Facilitate surveillance for resistant enteric bacteria by construction of a web interface for 

data entry and reporting results between state and federal participants in the National 

Antimicrobial Resistance Monitoring System (NARMS) (2012). 

c) Implement electronic tools to query resistance prevalence among enteric pathogens 

collected in NARMS (2015). 

d) Report regular summaries of antimicrobial resistance trends and mechanisms among 

foodborne bacterial pathogens on the NARMS website and in the literature (2011 and 

ongoing). 

e) Expand the Gonococcal Isolate Surveillance Project (GISP) to include a State public 

health laboratory for sentinel site reference susceptibility testing (2011) and initiate a 

CDC administered external quality assessment testing to ensure accurate testing at all 5 

sentinel sites (2012). 

f) Expand GISP to include surveillance to identify the emergence of cephalosporinresistant Neisseria gonorrheae by monitoring for gonorrhea cephalosporin treatment 

failures (2011). 

Coordinator: CDC; Collaborators: FDA, USDA, VA 

1.2 Develop strategies to more accurately assess the burden of antimicrobial resistance in 

healthcare settings through the enhancement of existing systems including NHSN, the 

EIP, and ELC sites. 

a) Expand NHSN to use electronically captured antimicrobial susceptibility data from 

participating facilities for reporting of resistance rates and trends; (have an expansion 

plan by 2010, pilot the plan in 2011, provide results of pilot in 2012, develop a webbased query for users in 2014 and provide ongoing periodic reports of the collected 

resistance data. 

b) Report regular summaries to provide national estimates of the resistance burden using 

data reported on HAIs to NHSN (2011 and ongoing). 

c) Evaluate the utility of electronic rules for identifying and reporting central line-associated 

bloodstream infections (2010), surgical site infections (2011), catheter-related urinary 

tract infections (2012), and ventilator-associated pneumonia (2011), including associated 

pathogens; and compare electronic algorithms with traditional manual surveillance by 

infection control professionals (CLABSIs 2011). 

g) Develop a system to collect representative sets of bacterial isolates to assess changes in 

resistance mechanisms or strains nationally and work with the Clinical and Laboratory 

Standards Institute (CLSI) to determine the impact of changes on antimicrobial 

susceptibility testing and reporting practices in the United States. 
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h) Collect convenience samples of bacterial and fungal isolates through the EIP to assess 

changes in antimicrobial-resistant pathogens such as MRSA (2011), Clostridium difficile

(2011), and selected gram-negative bacteria (2012), as well as community-associated 

pathogens such as S. pneumoniae, N. meningitidis, and Salmonella spp.; determine the 

feasibility of routine isolate submission for validation of antimicrobial susceptibility data 

submitted to NHSN (2012). 

i) Design (2010), pilot (2010) and implement (2011) a periodic national prevalence survey 

for healthcare-associated infections, including those caused by antimicrobial-resistant 

pathogens. 

Coordinator: CDC; Collaborator: VA 

1.3 Assess the presence of antimicrobial-resistant microorganisms, such as MRSA, 

Clostridium difficile, and vancomycin-resistant enterococci (VRE), among food animals, 

retail meats, and household environment in the United States. Assessment should include 

comparison of isolates from humans, environment, retail meats, and food animals. 

a) Design and implement a 1 year prevalence study of MRSA, VRE, and Clostridium 

difficile from retail meat (2011). 

b) Evaluate the quantity of Clostridium difficile recovered from retail meats in FoodNet sites 

(2010). 

c) Conduct a pilot study to evaluate Clostridium difficile environmental contamination in 

households of infected and non-infected patients (2010). 

d) Characterize and compare recovered food bacterial isolates with those associated with 

environmental assessments and human illness (2012).

 Coordinator: CDC; Collaborators: FDA, USDA

1.4 Identify patient populations colonized or infected with antimicrobial-resistant pathogens 

which may be important both for transmission of pathogens themselves and the transfer 

of resistance genes (e.g. vancomycin-resistant Staphylococcus aureus). Use this 

information to develop prevention strategies. 

a) Identify populations at risk for Clostridium difficile and MRSA infections based on data 

from population-based surveillance systems (2010). 

b) Conduct studies of colonization with antimicrobial-resistant S. pneumonia to determine 

the effects of antimicrobial use and pneumococcal vaccination on colonization (2012). 

Coordinator: CDC; Collaborator: NIH, VA 
- 13 - 

1.5 Strengthen and expand multi-state, national and international surveillance systems for 

antimicrobial-resistant microorganisms and ensure adequate sentinel surveillance for the 

emergence and spread of critical resistance phenotypes (e.g., penicillin-resistance in 

Group A Streptococcus, extensively drug-resistant tuberculosis (XDR TB), oseltamivirresistant influenza viruses), and strive for more timely dissemination of surveillance data. 

a) Increase the number and capacity of public health laboratories that routinely monitor for 

influenza antiviral resistance by developing new assays for rapid testing for antiviral 

resistance (2011) and developing web-based reporting systems (2012). 

 

b) Increase the capacity of state public health laboratories to identify antimicrobial-resistant 

organisms among cases of culture-negative clinical syndromes (e.g., meninigitis, 

empyema) using real-time polymerase chain reaction (PCR) for species-specific genes 

and markers of antimicrobial resistance (2013). 

c) Routinely evaluate isolates captured through ABCs with unusual resistance profiles (e.g., 

penicillin-resistant Group A or Group B Streptococcus, or vancomycin resistance among 

any of the Streptococcus pathogens) to identify resistance and characterize the molecular 

mechanisms (2010 and annually). 

d) Assess the impact of including fluoroquinolone susceptibility data to the national TB 

reporting system for enhanced detection of XDR TB (2010) 

e) Complete a pilot exercise to expand routine nationwide surveillance for MDR TB and 

determine whether this additional surveillance provides useful information that warrants 

broader implementation (2010). 

f) Organize, plan and conduct a NARMS public scientific meeting to highlight results and 

related AR research and solicit input from stakeholders and international partners on 

future enhancements and improvements (2010). 

Coordinator: CDC; Collaborators: DoD, FDA, USDA, VA

1.6 Work with public health associations, including Association of Public Health 

Laboratories (APHL) and Council of State and Territorial Epidemiologists (CSTE), to 

define minimal surveillance activities for AR for local, state, and regional health 

departments. Enhance the accurate detection and identification of AR by clinical and 

public health laboratories. 

a) Develop consensus definitions for outbreaks of antimicrobial-resistant pathogens that are 

reportable to health departments to optimize the detection, investigation and resolution of 

outbreaks (2011). 

b) Disseminate expert recommendations for effective state-based surveillance for multidrugresistant organisms related to healthcare-associated infections (2010). 
- 14 - 

c) Implement standard protocols for antimicrobial susceptibility testing through CDC’s ELC 

Program (2010 and ongoing). 

d) Develop and implement an antimicrobial susceptibility testing training program for 

public health laboratories (2012). 

e) Establish a web-based training program, updated annually, on laboratory detection of AR 

(pilot in 2013 and implement in 2014). 

 Coordinator: CDC 

1.7 Promote participation of microbiologists and local, state, and national public health 

workers in the design of systems to collect and disseminate AR data to appropriate endusers. Identify methods to assist laboratories in summarizing and disseminating AR data 

to appropriate end-users and provide methods for individual laboratories to compare their 

data with data in surrounding regions. 

a) Establish state-based surveillance networks utilizing NHSN to aggregate local-level data 

on healthcare-associated infections, multidrug-resistant organisms, and/or Clostridium 

difficile infections for targeted prevention interventions (2010-2011). 

b) Coordinate the collection of AR data for select veterinary bacterial pathogens by 

partnering with State veterinary diagnostic laboratories (2011). 

 Coordinator: CDC; Collaborators: FDA, USDA, VA 

1.8 Collaborate with surveillance systems in other parts of the world to build global 

surveillance of AR microorganisms. 

a) Establish liaisons with reference laboratories in countries without well-developed 

surveillance systems, both to improve the accuracy of global surveillance for resistance 

and to improve local use of the data (2010 and ongoing). 

b) Support and assist WHO on matters related to integrated surveillance of AR and 

containment of food-related AR through participation in the newly establish WHO 

Advisory Group on Integrated Surveillance of Antimicrobial Resistance (WHOAGISAR) (2010 and ongoing). 

• NARMS scientists from FDA, CDC and USDA will provide expert advice to the 

WHO-AGISAR steering committee through participation and information sharing 

(2010-2012). 

• Support laboratory capacity building activities in WHO member countries for AR 

monitoring by developing AR modules for Global Foodborne Infections Network 

training courses (2011-2012). 
- 15 - 

c) Develop collaborations with International Emerging Infections Program (IEIP) sites to 

improve surveillance systems for AR, facilitate prevention programs, and ensure 

appropriate responses to outbreaks of resistant organisms (2010 and ongoing). 

d) Collaborate with IEIP sites to expand surveillance systems to measure the burden of AR 

and the impact of infection control interventions in healthcare settings (2011). 

 Coordinator: CDC; Collaborators: DoD, FDA, USDA 

1.9 Develop national and international surveillance systems to monitor understudied areas, 

such as resistance in protozoan parasites (e.g. Plasmodium spp.) helminthes or 

understudied sexually transmitted diseases (e.g., T. pallidum, T. vaginalis, HSV), 

neglected tropical diseases, and resistance to disinfectants, sanitizers, and insecticides. 

a) Identify resistance mechanisms in Trichomonas and use this information to develop 

laboratory tests for detection of resistance (2012). 

b) Identify and characterize markers of artemisinin-based combination therapies (ACT) 

resistance in malaria for the purpose of developing new laboratory tests for surveillance 

(2012). 

c) Work with international partners to conduct in vivo/ in vitro studies to monitor the 

efficacy of anti-parasitic drugs (2013). 

d) Collect a repository of specimens with characterized antimalarial drug sensitivity patterns 

for the development of laboratory test development and quality control (2012). 

Laboratory tests will be used to expand surveillance. 

e) Work with international partners to improve laboratory capacity in endemic countries for 

the detection and surveillance of malaria drug- resistant parasites (2012). 

f) Evaluate current strategies for deploying insecticides for public health that reduce or 

minimize resistance and as necessary develop new strategies. (2012). 

Coordinator: CDC; Collaborator: DoD 

1.10 Assess the risk of AR emergence and spread in food borne pathogens due to 

environmental contamination by antimicrobial drug residues and pesticides in 

collaboration with the existing Pharmaceuticals in the Environment Subcommittee of the 

Office of Science and Technology Policy. 

Coordinator: FDA; Collaborator: EPA
- 16 - 

Goal 2: Better define, characterize, and measure the impact of antimicrobial use in humans and 

animals in the United States. 

2.1 Identify sources of antimicrobial use information in the United States for humans, 

animals, agriculture, aquaculture, and other sectors to establish baseline data on 

antimicrobial use. Develop a standard for collecting and reporting schemes for 

antimicrobial use data (comparable to “defined daily doses” in humans) that allow 

aggregation, reporting, and comparisons of trends across sectors. 

a) Gain access to and summarize de-identified data on antimicrobial use from market 

research companies, health maintenance organizations, federal healthcare systems, and 

other medical care systems in the United States to aid in quantifying antimicrobial use in 

humans and understanding geographical heterogeneity in antimicrobial use (2011). 

b) Perform a national antibiotic use point-prevalence survey - pilot survey to be completed 

by 2010 and full survey by 2012. 

c) Revise the Antibiotic Use and Resistance module of NHSN to accept electronic data on 

antibiotic use from healthcare facilities by 2011 and begin receiving data by 2012. 

d) Collect and publish animal antimicrobial drug distribution data through implementation 

of Section 105 of the Animal Drug User Fee Amendments of 2008 (2010). 

e) Collect data through the National Animal Health Monitoring System to produce 3 reports 

on antimicrobial use practices on livestock and poultry operations in the United States. 

These reports (shown below) will be produced by July 2011: 

• Food Safety Pathogens Isolated from U.S. Dairy Operations, 1996-2007 

• Antimicrobial Use and Resistance on Beef Cow-calf Operations in the U.S. 2007-08 

• Antimicrobial Use and Resistance Across Livestock and Poultry Operations - A 

compilation of data from the National Animal Health Monitoring System studies 

Coordinator: FDA, CDC; Collaborators: USDA, VA 

2.2 Develop mathematical models to guide studies of use and resistance in both humans and 

animals by collating existing data on correlations between antimicrobial use and 

antimicrobial resistance from studies in healthcare and veterinary institutions (e.g., 

cephalosporin use and prevalence of vancomycin-resistant enterococci) and community 

settings (e.g., fluoroquinolone use for respiratory tract infections and macrolide resistance 

in pneumococci). 

a) Compare retail pharmacy sales of outpatient oral antimicrobials to geographic differences 

in bacterial resistance (2011). 

Coordinator: CDC; Collaborators: NIH, USDA, VA 
- 17 - 

2.3 Implement systems to detect the development and spread of resistance in microorganisms 

during implementation of new programs that significantly impact antimicrobial drug use 

(e.g., pay-for-performance mandates on antibiotic timing for community-acquired 

pneumonia, guidelines for intrapartum prophylaxis to prevent neonatal group B 

streptococcocal disease, mass population-based treatment campaigns for trachoma or 

helminthic infections, or large studies of treating partners or contacts). 

a) Monitor the use of intrapartum antimicrobial prophylaxis for the prevention of neonatal 

group B streptococcal infections and the potential impact of prophylaxis on resistant 

cases of neonatal sepsis (2013). 

Coordinator: CDC 
- 18 - 

Focus Area II: Prevention and Control 

Overarching goals 

Federal agencies are strong advocates of prevention and control measures that will both decrease 

the development of new resistant microorganisms and stop the transmission of existing resistant 

microorganisms in healthcare institutions, communities, and agriculture. 

Goal 3. Develop, implement, and evaluate strategies to prevent the emergence, transmission, and 

persistence of drug-resistant microorganisms. 

3.1 Implement and evaluate the impact of community-based interventions, such as 

vaccination campaigns and the promotion of appropriate antibiotic use to reduce the 

spread of AR microorganisms, rates of disease, and antimicrobial use, and to improve 

patient outcomes. 

a) Estimate the effectiveness of pneumococcal and influenza vaccines on drug-resistant 

infections caused by those pathogens (2012). 

b) Evaluate factors that influence the prescribing practices of primary care physicians, 

including academic detailing and benchmark analysis (2011). 

Coordinator: CDC; Collaborators, DoD, VA 

3.2 Promote use of appropriate interventions, including checklists, to reduce the risk of 

infection associated with catheters and other devices and procedures in healthcare 

settings. 

a) Facilitate multicenter prevention collaborative focused on device and procedure-related 

infections in at least 20 states by 2012. 

b) Design and implement systems to measure healthcare processes that are linked to 

outcome data in order to measure the adherence of healthcare personnel to prevention 

measures. 

c) Correlation between adherence to best catheter insertion practices and CLABSI rates 

(2011). 

d) Revise and publish HICPAC guidance for prevention of catheter-associated bloodstream 

infections (2010). 

e) Revise and publish HICPAC guidance for prevention of surgical site infections (2011). 

Coordinator: CDC; Collaborators: AHRQ, VA 
- 19 - 

3.3 Identify and promote successful AR prevention and control programs in healthcare 

settings that utilize existing recommendations for preventing transmission of AR 

organisms. 

a) Establish state-based MDRO and Clostridium difficile prevention collaborative in at least 

10 states by 2011 and evaluate impact by 2013. 

b) Evaluate impact of the CMS-Quality Improvement Organization MRSA prevention 

initiative by 2012. 

c) Evaluate impact of the Department of Veterans Affairs National MRSA prevention 

initiative (2012). Explore the expansion of prevention initiatives to include other MDRO 

including Clostridium difficile and multidrug-resistant gram-negative pathogens (2010). 

d) Facilitate initiation of at least one regional, multi-center prevention collaborative in 

which acute and long-term care facilities address prevention of multi-drug resistant 

infections in a coordinated manner (2011). 

Coordinator: CDC; Collaborators: AHRQ, VA, CMS 

3.4 Evaluate the effectiveness of infection-control practices, products, and devices in 

healthcare facilities, including long-term healthcare and outpatient settings.

a) Expand CDC’s Prevention Epicenter Program to include academic centers, integrated 

health systems, and healthcare departments to support early translation of technical 

advances and epidemiologic knowledge into evidence-based recommendations (2011). 

b) Initiate studies that will assess the dynamics of contamination of the healthcare 

environment and the ability of cleaning and disinfection methods to reduce 

environmental contamination (2011). 

c) Evaluate the impact of state-based CDC-funded HAI prevention collaborative by 2013. 

d) Quantify the national impact of HAI prevention efforts by publishing annual national 

summary statistics (standardized infection ratio) of HAI data reported to CDC’s NHSN 

(2010 and ongoing). 

Coordinator: CDC; Collaborators: AHRQ, DoD, VA 

3.5 Identify factors that reduce transmission of drug-resistant pathogens, including infection 

control, in veterinary, agriculture and aquaculture settings, and formulate guidelines on 

“best practices.” 
- 20 - 

a) Identify critical control points on-farm for dairy production that will decrease 

antimicrobial resistant salmonellae (2011). Evaluate interventions in dairy production that 

will decrease antimicrobial resistant salmonellae (2012). 

b) Make available grant funds of up to $4 million through USDA’s National Integrated 

Food Safety Initiative to support systematic studies that identify intervention strategies 

for effective mitigation of AR throughout the food chain. Grant awards will be 

announced in June 2010. These 4-year grants will begin in 2010 and must be completed 

no later than 2015. 

c) Identify factors important for assuring that antimicrobial drugs are used judiciously in 

veterinary, agriculture and aquaculture environments (2010). 

Coordinators: FDA, USDA 

3.6 Promote research and development of processing technologies to minimize microbial 

contamination of food. 

a) Develop alternatives to current antimicrobial treatments and sanitizers for processing 

poultry carcasses (e.g. natural Generally Recognized as Safe [GRAS] products) (2011). 

Evaluate alternative sanitizers for poultry processing and their reduction of food 

pathogens (2012). 

b) Develop alternatives to current processing treatments for the reduction of Escherichia 

coli in beef (2011). Evaluate effectiveness of processing treatments (2012). 

c) Identify processing interventions to decrease antimicrobial-resistant microorganisms in 

eggs (2011). Evaluate alternative interventions in egg processing for reduction of 

antimicrobial-resistant microorganism (2012). 

Coordinator: USDA 

3.7 Expand public health education campaigns targeting food producers, food handlers, and 

the general public about food safety practices that reduce microbial contamination of 

food. 

a) Co-host the 2010 Food Safety Education Conference: USDA and NSF International will 

co-host a 3-day conference sponsored by HHS, FDA, CDC, and WHO. The conference is 

designed for attendees to share the most current research, learn best practices, and 

explore cutting-edge strategies for reducing foodborne illness. 

b) Launch new USDA Food Safety Mobile Program in spring 2010 as part of the Food 

Safety and Inspection Service’s ongoing consumer education campaign to reach 

consumers where they live. The USDA Food Safety Mobile will travel throughout the 

United States visiting local community events to educate consumers about food safety. 

The revamped program will offer consumers in-depth, interactive, hands-on 

demonstrations on the science of food safety based on the four Be Food Safe Campaign 

messages: Clean, Separate, Cook and Chill. The Mobile’s interactive learning stations are 

designed to improve consumer’s food safety awareness, knowledge, and behavior. 
- 21 - 

c) Host USDA Nutrition Month to include Food Safety Day on March 10, 2010 to increase 

consumer awareness about food safety. 

Coordinator: USDA 

3.8 Promote infection control education at all stages of training and practice for healthcare 

workers in human and veterinary medicine. 

a) Complete basic infection control curriculum for posting on the CDC website by 2011. 

b) Develop a plan for infection control education of veterinary medicine workers by 2011. 

 Coordinator: CDC; Collaborator: USDA, VA 

3.9 Develop interagency programs in collaboration with regulators, payers, professional 

societies and other stakeholders to promote effective hand hygiene strategies in 

communities and healthcare settings and to foster the use of biomedical devices and 

behaviors that prevent the transmission of infectious organisms in community settings. 

a) Develop a plan to collaborate with WHO on their hand hygiene promotion campaign 

(2010). 

b) In collaboration with academic partners, complete research studies that evaluate the 

impact of novel technologies for measuring hand hygiene adherence in the healthcare 

setting (2011). 

Coordinator: CDC; Collaborator: AHRQ, VA 

Goal 4: Develop, implement, and evaluate strategies to improve appropriate antimicrobial use. 

4.1 Identify factors and strategies that promote appropriate antimicrobial use (i.e., best 

practices) or discourage inappropriate use in all types of healthcare settings, including 

inpatient and outpatient facilities, clinics and offices. Facilitate the implementation of 

these strategies. 

a) Develop algorithms and reporting tools to facilitate local monitoring of antimicrobial use 

(design 2010, pilot 2011, and implement 2012) and resistance rates (develop 2010 and 

pilot 2011). 

b) Develop a “change package” for improving antimicrobial use in in-patient healthcare 

settings by 2010. 

c) Collaborate with a network of hospitals to identify patient-level indications for and 

factors associated with antibiotic use to help guide efforts on improving use by 2011. 
- 22 - 

d) Examine knowledge, attitudes, and behaviors of healthcare providers regarding adverse 

events and antimicrobial use (focus testing to be completed in 2010). 

e) Examine the impact of improved antimicrobial use on adverse events associated with 

antimicrobials, especially Clostridium difficile infections by 2011. 

f) Evaluate the benefits and potential unintended consequences of clinical guidelines and 

policies that bear on antimicrobial use and affect patient care, reimbursement, or other 

areas of medical practice (e.g., increased use of antimicrobial agents in emergency rooms 

for unconfirmed community-acquired pneumonia) (2012). 

Coordinator: CDC; Collaborators: AHRQ, FDA, VA 

4.2 Promote, implement, and evaluate guidelines for appropriate antimicrobial use in 

agricultural and veterinary settings. Specifically, 

a) Seek appropriate expert input to update specific aspects of guidance 152 (particularly the 

antimicrobial drug ranking in Appendix A of guidance) and publish revised draft 

guidance for public comment (2011). 

b) Publish and seek public comment on draft guidance outlining FDA’s current thinking on 

the judicious use of medically important antimicrobial drugs in food-producing animals 

(2010). 

c) Publish a revised order to prohibit certain extralabel uses of cephalosporin antimicrobial 

drugs in food producing animals due to AR concerns (2011). 

d) Survey orchards periodically for emerging resistance among agricultural bacterial plant 

pathogens (e.g., Erwinia amylovera, Pseudomonas syringae, and Xanthomonas 

campestris) to tetracycline, streptomycin, gentamicin, or other antimicrobial agents that 

may be used, such as kasugamycin. Monitoring is conducted to comply with pesticide use 

authorization. 

 Coordinators: CDC, FDA; Collaborators: EPA, USDA 

4.3 Promote the development of improved field-based methods to measure the quality of 

antimalarial drugs, given that poor quality drugs contribute to antimicrobial drug 

resistance. 

Coordinator: CDC 

4.4 Develop, implement, and evaluate treatment algorithms for management of common 

clinical syndromes frequently treated with antibiotics (e.g., ventilator-associated and 

community-acquired pneumonia, acute bronchitis and sinusitis, and asymptomatic 

bacteriuria and sexually transmitted diseases. 
- 23 - 

a) Update the Principles of Judicious Use of Antimicrobial Agents for Pediatric Upper 

Respiratory Infections and develop and disseminate academic detaining sheet with 

diagnosis and treatment algorithms (2012). 

b) Update the Guidelines for Appropriate Antibiotic Use for Treatment of Acute Respiratory 

Tract Infections in Adults and develop and disseminate academic detailing sheet with 

diagnosis and treatment algorithms (2014). 

Coordinator: CDC; Collaborator: NIH, VA 

 
- 24 - 

Focus Area III: Research 

Overarching goals 

Encourage, conduct and support basic and translational research to enhance our understanding of 

factors leading to the development of AR microorganisms, their transmission in various settings, 

and optimal modes of prevention, diagnosis and therapy. 

Goal 5: Facilitate basic research on AR. 

5.1 Conduct and support genetic, biochemical and structural studies of AR factors to enable 

the identification of novel drug, diagnostic and vaccine targets. 

Coordinator: NIH 

5.2 Investigate naturally occurring mechanisms of resistance, gene transfer, and hostpathogen interactions. 

Coordinators: CDC, NIH; Collaborators: FDA, USDA 

5.3 Investigate the role of biofilms in the development of resistant microorganisms and 

transfer of resistance genes among diverse genera of microorganisms. 

Coordinators: CDC, NIH; Collaborators: FDA, USDA 

5.4 Develop and make available genomics, metagenomic, bioinformatics, proteomics, 

structural biology, molecular imaging, and other emerging research technologies. Ensure 

that genomic, proteomic, and other related data sets are made publicly available rapidly 

through searchable public online databases and provide data analysis tools to assist 

researchers in using these resources. 

Coordinator: NIH; Collaborators: CDC, DoD, FDA, USDA 

5.5 Bring new researchers into the field by utilizing appropriate strategies such as training 

and research opportunities. 

Coordinators: CDC, NIH; Collaborator: FDA, VA 

Goal 6: Facilitate the translation of basic research findings into practical applications for the 

prevention, diagnosis and treatment of resistant infections. 
- 25 - 

6.1 Facilitate preclinical studies, including toxicology, pharmacokinetics, 

pharmacodynamics, and in vitro and in vivo activity of antimicrobial agents to inform the 

treatment of resistant pathogens. 

Coordinator: NIH; Collaborators: CDC, FDA, VA 

6.2 Encourage, support and conduct basic and clinical research on the development and use 

of vaccines and novel or alternative approaches for prevention and treatment of infections 

in human and veterinary medicine. 

Coordinators: NIH, USDA; Collaborators: CDC, DoD, FDA, VA 

6.3 Encourage, support and conduct research on the development of novel diagnostic 

technologies to rapidly distinguish among pathogens and their resistant subtypes at the 

point of care. 

Coordinator: NIH; Collaborator: VA 

6.4 Support development of novel broad spectrum antimicrobials with dual indications for 

community-acquired infections and biodefense threat agents. 

Coordinator:HHS/ASPR; Collaborator: NIH, CDC 

Goal 7: Facilitate clinical research to improve the treatment and prevention of AR infections. 

7.1 Conduct and support clinical research to evaluate the safety and efficacy of novel drugs 

and vaccines for pathogens where resistance threatens effective treatment. 

Coordinator: NIH; Collaborator: VA 

7.2 Design and implement studies focused on optimizing the dose and duration of 

antibacterial agents prescribed for treatment of community-acquired pneumonia, urinary 

tract infections, skin and soft-tissue infections, and other infectious illnesses. 

Coordinator: NIH; Collaborator: VA 
- 26 - 

Goal 8: Conduct and support epidemiological studies to identify key drivers of the emergence 

and spread of AR in various populations. 

8.1 Investigate the interplay among AR, colonization, and disease in acute, long-term care, 

and outpatient facilities. 

Coordinator: CDC; Collaborator: NIH, VA 

8.2 Support research on how prevalence data on antimicrobial resistance can be used to help 

guide treatment choices. For example, define geographic heterogeneity of resistance rates 

and determine impact of treatment decisions. 

a) Define appropriate methods for collection and distribution of information on prevalence 

of resistance to community physicians and veterinarians. 

Coordinator: CDC; Collaborators: FDA, USDA, VA 

8.3 Evaluate the utility of monitoring sentinel human populations (e.g., farm, abattoir, fruit 

and vegetable, and food processing plant workers) and persons in the general community 

for infection or colonization with resistant enteric bacteria to identify reservoirs of 

resistant organisms. 

a) Investigate risk factors for AR development in Salmonella and Campylobacter in food 

animals (2014). 

Coordinator: CDC; Collaborator: FDA, USDA 

8.4 Develop options to capture and record AR research for all federal agencies. 

Coordinators: CDC, NIH; Collaborators: AHRQ, EPA, FDA, USDA 
- 27 - 

Focus Area IV: Product Development 

Overarching goals 

Encourage the development of new antimicrobial products to improve our capacity to diagnose, 

prevent and treat infections, including infections caused by resistant microorganisms. 

Goal 9: Provide information on the status of antibacterial drug product development and clarify 

recommended clinical trial designs for antibacterial products. 

9.1 Examine trends over time for new drug applications for systemic antibacterial drugs. 

a) Perform pilot phase of study to evaluate trends over time for new drug applications for 

systemic antibacterial drugs (2010). Complete assessment of trends over time for new 

drug applications for systemic antibacterial drugs (2011) and publish findings (2012). 

 Coordinator: FDA 

9.2 Publish guidance documents for the following conditions describing recommended 

approaches on clinical trial designs for evaluating antibacterial drugs. 

a) Publish draft guidance on recommended approaches to clinical trial designs for 

evaluating antibacterial drugs for acute bacterial skin and skin structure infections (2010). 

Publish final guidance (2012). 

b) Publish draft guidance on recommended approaches to clinical trial designs for 

evaluating antibacterial drugs for hospital acquired and ventilator associated bacterial 

pneumonia (2010). Publish final guidance (2012). 

c) Publish updated guidance on recommended approaches to clinical trial designs for 

evaluating antibacterial drugs for community-acquired bacterial pneumonia. Publish 

updated draft guidance (2010) and final guidance (2012). 

Coordinator: FDA

9.3 Publish guidance documents for the following types of devices to provide 

recommendations regarding product development. 

a) Publish final guidance document on premarket notification [510(k)] submissions for 

medical devices that include antimicrobial agents (2012). 

b) Publish draft guidance for establishing performance for in vitro diagnostics assays for 

MRSA and VRE (2011). Publish final guidance (2012).

c) Publish draft guidance document for establishing performance for in vitro diagnostic 

assays for Clostridium difficile. Publish final guidance (2011). 

 Coordinator: FDA 
- 28 - 

9.4 Provide regulatory advice on recommended regulatory pathways for evaluating products 

that target unmet medical or veterinary needs including approaches to evaluating nontraditional products, e.g., cytokine, probiotics, and antimicrobial peptides (ongoing). 

 Coordinator: FDA; Collaborator: USDA 

9.5 Evaluate use of the Orphan Drug Act, or similar incentives, to encourage development 

and marketing of new antimicrobial agents for human medicine. 

a) Part 15 public hearing held April 28, 2008, on issues in AR and the Orphan Drug Act. 

 Coordinator: FDA 

9.6 Sponsor a study to evaluate incentives to promote the development of antibacterial drugs 

and rapid diagnostic tests (including antimicrobial susceptibility tests), including the 

impact of such strategies upon appropriate use of such products. 

 Coordinator: HHS/ASPE 

Goal 10: Consider opportunities for international harmonization and means to update 

susceptibility testing information for human and animal use. 

10.1 Pursue interagency collaborations to discuss international harmonization of standards and 

regulatory requirements for antimicrobial products (e.g., International Conference on 

Harmonization, International Cooperation on Harmonization of Technical Requirements 

for Registration of Veterinary Medical Products) (ongoing). 

 Coordinator: FDA 

10.2 Collaborate with relevant international organizations and use international expert 

consultations (e.g., the WHO, the World Organization on Animal Health, CLSI standards 

Institute, the European Committee on Antimicrobial Susceptibility Testing) to enhance 

product development (ongoing). 

 Coordinator: FDA; Collaborator: NIH 

10.3 Develop a strategy for periodic updating of susceptibility testing information for 

antimicrobial agents approved for use in humans and animals in the United States 

(ongoing). 

a) Participate in multi-laboratory method trial studies to develop standardized in vitro

antimicrobial susceptibility testing methods for veterinary pathogens where such tests are 

lacking (2010-2011) 

 Coordinators: CDC, FDA; Collaborator: USDA 

Goal 11: Encourage development of rapid diagnostic tests and vaccines. 
- 29 - 

11.1 Encourage development, testing, and evaluation of new rapid diagnostic methods for 

human and veterinary use to help guide antimicrobial therapy. Specifically, promote the 

development of tests for infections cause by fastidious (e.g. TB) or difficult to culture 

organisms (e.g. Treponema pallidum, the agent of syphilis) and rapid point-of-care 

diagnostics to identify patients with viral respiratory infections who do not need 

antimicrobial agents. 

a) Encourage improved diagnostic tests for resistant TB by conducting a FDA/CDC/NIH 

co-sponsored meeting to identify gaps in TB diagnostics and to explore models and 

strategies that may expedite the development of new diagnostics (2010). Work to 

develop, evaluate, and implement molecular tests for the detection of MDR-TB directly 

from pulmonary specimens (2012). 

b) Encourage development of rapid point-of-care tests to confirm diagnoses of possible 

bacterial respiratory infections including otitis media, sinusitis, and pneumonia and rapid 

point-of-care tests to identify pathogens associated with these infections (ongoing). 

c) Collaborate with partners to develop and evaluate rapid methods for identification and 

characterization of Clostridium difficile, MRSA, and other multidrug-resistant organisms 

for human, animal, and plant sources to support national surveillance efforts. 

Coordinators: CDC, FDA; Collaborators: NIH, USDA HHS/ASPR, VA 

11.2 Encourage development, testing, and evaluation of new vaccines for human pathogens 

for which AR poses a significant problem for treatment or public health. Specifically, 

a) Working with stakeholders, examine strategies to maximize the quality and the quantity 

of candidate vaccines for prevention of antimicrobial-resistant infections of public health 

significance (ongoing). 

b) Conduct research to facilitate development of vaccines for resistant pathogens such as 

Staphylococcus aureus, Mycobacterium tuberculosis, Clostridium difficile, enteric 

pathogens and Neisseria gonorrhoeae (ongoing). 

c) Conduct research to facilitate development of vaccines for viral respiratory infections that 

may contribute to increased antibiotic use due to subsequent or co-bacterial infections or 

inappropriate antibiotic use (ongoing). 

 Coordinator: FDA; Collaborators: CDC, NIH, VA 

11.3 Support advanced development of vaccines for resistant pathogens such as 

Staphylococcus aureus 

 Coordinator: HHS/ASPR 
- 30 - 

 

Acronyms and Abbreviations 

AHRQ Agency for Healthcare Research and Quality 

APHL Association of Public Health Laboratories 

AR Antimicrobial resistance 

ASPE Office of the Assistant Secretary for Planning and Evaluation 

ASPR Office of the Assistant Secretary for Preparedness and Response (HHS) 

BARDA Biomedical Advanced Research Development Authority 

CDC Centers for Disease Control and Prevention 

CLSI Clinical and Laboratory Standards Institute 

CMS Centers for Medicare and Medicaid Services 

CSTE Council of State and Territorial Epidemiologists 

DoD Department of Defense 

EPA Environmental Protection Agency 

FDA Food and Drug Administration 

HAI Healthcare-associated infection 

HAP Hospital-acquired pneumonia 

HHS Department of Health and Human Services 

HRSA Health Resources and Services Administration

IPEC Inpatient Evaluation Center 

MDRO Multidrug-resistant organism 

MRSA Methicillin-resistant Staphylococcus aureus

NHSN National Healthcare Safety Network 

NIH National Institutes of Health 

USDA United States Department of Agriculture 

VA Department of Veterans Affairs 

VAP Ventilator-associated pneumonia 

VHA Veterans Health Administration 

XDR TB Extensively drug-resistant tuberculosis