A PUBLIC HEALTH ACTION PLAN TO COMBAT ANTIMICROBIAL 

RESISTANCE

2012 Update

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 Health

Health and Human Services/ Office of the Assistant Secretary for Preparedness and Response
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Preface

This 2012 update of the 2011 revision of the A Public Health Action Plan to Combat 

Antimicrobial Resistance, provides a listing of projects that the Federal Agencies in the 

Interagency Task Force on Antimicrobial Resistance are pursuing or planning to pursue in an 

effort to respond to the complex and pressing topic of antimicrobial resistance. The past decade 

has seen extraordinary change in the microbiology and epidemiology of antimicrobial-resistant 

microbes and subsequent changes in treatment and patient outcomes. The Task Force is taking 

further strides to ensure that the Action Plan remains current and relevant as the agencies 

continue to look towards the future by taking the following steps:

 Actions, the numbered items that follow each goal, will be reviewed biennially by the Task 

Force beginning in 2013. New actions will be added as needed and existing actions may be 

modified or deleted in response to progress or changes that occur in the future with regard to 

antimicrobial resistance. This will allow the Action Plan to be updated over time and will

help all Task Force agencies to continue to collaborate most effectively in achieving Action 

Plan goals. 

 Implementation steps or projects, the lettered items that follow action items, are being 

revised annually. In this first annual update, new projects have been added, and some 

existing projects have been modified in response to intervening events. Completed projects 

have been moved to an Appendix, and their outcomes will be cross-referenced to the yearly 

progress report for the year during which the project was completed. For example, projects 

completed in 2011 are listed in Appendix A: Retired Projects and Implementation Steps. The 

outcomes of these projects can be found in the 2011 Progress Towards Implementation of: A 

Public Health Action Plan To Combat Antimicrobial Resistance.

The Task Force and all participating Federal agencies continue to stress the importance of good 

communication with the many stakeholders who share the Task Force’s goals of preventing and 

controlling antimicrobial resistant infections. The Task Force remains committed to continuing 

communication with the public and health professionals, since antimicrobial resistance so 

profoundly affects public health and clinical medicine. Among these efforts is the 2012 annual 

public meeting of the Task Force, scheduled for November 15. Given the public health 

consequences of AR and its ever-changing nature, the Task Force will continue to address the 

issue of antimicrobial resistance in this and future versions of the Action Plan. 
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A Public Health Action Plan to Combat Antimicrobial Resistance 

Table of Contents

Executive Summary........................................................................................................................ 3

Introduction and Overview ......................................................................................................... 5

The Focus Areas ........................................................................................................................... 13

Focus Area I: Surveillance........................................................................................................ 13

Focus Area II: Prevention and Control ..................................................................................... 22

Focus Area III: Research .......................................................................................................... 29

Focus Area IV: Product Development...................................................................................... 32

Acronyms and Abbreviations ....................................................................................................... 35

Appendix A: Retired Projects and Implementation Steps............................................................ 36
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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 

antimicrobialaresistance (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), the 

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

and Response (HHS/ASPR), and the Office of the Assistant Secretary for Health (HHS/OASH).

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.

In 2011, the Action Plan was revised 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, and infectious diseases and infection control, and state and local public health

officials. 

This 2012 update reflects changes since the 2011 Action Plan. The 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.

 

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

humans and animals in the United States. 

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 has been done since 2001, the Task Force will continue to 

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

public, and 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 seventy years. 

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

immunodeficiency virus (HIV), the fungi that cause yeast infections, and the parasites that cause 

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

treatment recommendations for gonorrhea in 2007 due to increasing and widespread 

fluoroquinolone resistance in Neisseria gonorrhoeae.

d

Since 2007, the emergence of N. 

gonorrhoeae with increasing MICs of cephalosporins has the potential to make some cases of 

disease untreatable.e The unpredictable and fluid nature of AR is also illustrated by the 

prevalence of resistant Acinetobacter baumannii among military personnel in and returning from 

conflict areas and in hospital outbreaks in civilian U.S. hospitals.f Drug choices for the treatment 

of other infections are becoming increasingly limited and expensive, and, in some cases, 

nonexistent.

Since their discovery, antimicrobials have been used extensively in livestock and poultry 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 can be relatively high. The impact of 

increases in resistant bacteria in food animals on the management of human infections is an 

ongoing concern 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., gram-negative 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 

around the world. 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 

 

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 Bolan GA, Sparling PF, Wasserheit JN. The emerging threat of untreatable gonococcal infection. N Engl J Med. 

2012 Feb 9;366(6):485-7.

f

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 

U.S. 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. 

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

persons.

g

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 poorer prognoses.

h

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 resistant 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, the American Society for 

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

Assessment, the Government Accountability Office, the Infectious Disease Society of America, 

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.iThe 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 interventions) to prevent and control AR. 

The problem is urgent, the achievement of these goals has not been simple or straightforward, 

and accomplishments to date, while notable, 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 continuing 

support and leadership from Federal and state governments and a willingness to address complex 

and sometimes controversial scientific, medical, and economic issues.

Focus Areas

 

g 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.

h 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.

i

http://www.whitehouse.gov/the-press-office/us-eu-joint-declaration-and-annexes
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The Action Plan includes action items organized into four focus areas: Surveillance, Prevention 

and Control, Research, and Product Development. Each focus area contains specific action items, 

projects and implementation steps. In addition to these, a selection of AR activities, in which the 

Task Force is actively engaging, is highlighted below.j

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. Early detection of new and emerging resistance, ongoing 

monitoring of resistant infections, and information on antimicrobial use will allow experts to 

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

of AR.

The 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 addressing barriers to timely 

dissemination and updating of surveillance data and gathering information on 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 is expanding 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 is

maintaining 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, National Antimicrobial Resistance Monitoring System (NARMS), 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. In partnership, FDA, USDA, and CDC track resistance among 

enteric pathogens through NARMS. On-farm pilot projects were initiated in 2011 to test the 

feasibility of expanding NARMS to include a preharvest component to the sampling design. In 

addition to monitoring resistance among bacterial pathogens, CDC continues to monitor 

resistance among non-bacterial pathogens such as influenza, malaria, and HIV, both domestically

and internationally.

II. Prevention and Control

 

j These highlighted activities are provided as illustrative examples and do not represent a comprehensive list.
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The prevention and control of antimicrobial-resistant infections requires measures to prevent the 

transmission of resistant microorganisms and promote the appropriate usekof antimicrobial 

agents. 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 of resistance occurs by reducing the size of the populations of 

resistant microorganisms in humans, animals, and the environment. 

Preventing infections with resistant strains of a microorganism can also be accomplished by 

preventing or eliminating all infections caused by that microorganism. For example, drugresistant 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 threat that dictated 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. 

Action items in this area address 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 infectionsl within 

healthcare settings. Based upon the successful prevention initiative involving the VA Pittsburgh 

Healthcare System and CDC demonstrating a reduction of MRSA infections, that initiative was 

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

VHA’s MRSA Prevention Initiative is now a nationwide effort to reduce healthcare-associated 

MRSA infection in hospital patients. VHA is also evaluating lessons learned from the MRSA 

Prevention Initiative to explore initiatives directed at other MDROs as well as 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 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.

 

k

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 

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

agent, dose, and duration.

l

Jain, R., S.M. Kralovic, et al. (2011). “Veterans Affairs Initiative to Prevent Methicillin-Resistant Staphylococcus 

aureus Infections.” New England Journal of Medicine 364(15): 1419-1430.
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Several Task Force member agencies, including AHRQ, CDC, FDA, NIH, CMS, and VA are 

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

(HAI)m, which includes reduction targets for 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 2012 AR Action Plan.

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 provide 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.

NIH continues to engage in AR research activities that address multiple action items in this focus 

area. In addition to an extensive investigator-initiated grants portfolio, NIH supports the basic 

research activities of 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 high-quality 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 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 bioinformatics resource 

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

display of such information through user-friendly interfaces. 

NIH currently supports clinical trials aimed at identifying ways to reduce the use of licensed 

antibacterials in both community and healthcare settings. These trials focus on areas of greatest 

antimicrobial drug exposure, such as pneumonia, otitis media, skin and soft tissue infection, and

bacteremia, and employ strategies to reduce use, such as shorter courses of antimicrobial 

treatment; using antimicrobials only where indicated; different dosages/frequencies to achieve 

desirable in vivo efficacy; validation of the key components of multi-drug therapy; and optimal 

use of off-patent antimicrobials to prevent the emergence of resistance.

IV. Product Development

 

m 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
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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.

The 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.n

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.

 

n

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

the Assistant Secretary for Preparedness and Responseois designing and implementing programs 

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

induce commercial enterprises to address public health and biodefense priorities.

BARDA is currently supporting the development of an intravenous formulation of a nextgeneration aminoglycoside antibiotic for the treatment of plague and tularemia, as well as 

ventilator-associated pneumonia. In 2012, BARDA established an additional partnership for the 

development of a next generation tetracycline antibiotic for the treatment of anthrax, plague, and 

tularemia, as well as community-acquired bacterial 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 antimicrobial resistant. 

 

o

See http://www.phe.gov/about/barda/Pages/default.aspx for more information on BARDA
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The Focus Areas

Following 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.pThe expected completion dates for specific 

projects and implementation steps are indicated with a date. For example, (2012) means that the 

work is expected to be completed by the end of the 2012 calendar year. Some activities are 

ongoing and are indicated as such. Project lists will be updated annually, and actions will be 

updated every two 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 Emerging 

Infections Program (EIP) and the Epidemiology and Laboratory Capacity (ELC) sites.

a) Completed: See Appendix A.

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 (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 CDC-

 

p 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.
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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 cephalosporin-resistant 

Neisseria gonorrheae by monitoring for gonorrhea cephalosporin treatment failures 

(2011). Data analysis and report will be completed in 2014.

g) NEW: The U.S. Army's Multidrug-resistant organism Repository and Surveillance 

Network (MRSN) at the Walter Reed Army Institute of Research in Silver Spring, MD 

will enhance efforts to extend its surveillance network to monitor the DoD beneficiary

community worldwide (ongoing).

h) NEW: Conduct and report results of susceptibility testing of representative bacterial 

isolates from enteric disease outbreaks (ongoing).

i) NEW: Link data in NARMS to data in other enteric disease surveillance systems to better 

understand and characterize the burden of resistant enteric infections and to identify risk 

factors for acquiring these infections (ongoing).

j) NEW: Determine food, water, and other sources for resistant versus susceptible enteric 

infections (ongoing).

k) NEW: Identify sources of resistant enteric infections among travelers returning to the 

United States (ongoing).

l) NEW: Determine the prevalence of antimicrobial resistance among enteric organisms of 

livestock on farms (ongoing).

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

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; pilot expansion plan in

2011-2012, provide results of pilot in 2012, develop a web-based 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 (ongoing).

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

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

infections (2012), and ventilator-associated pneumonia (2012), including associated 
- 15 -

pathogens; and compare electronic algorithms with traditional manual surveillance by

infection control professionals (CLABSIs 2011).

d) 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. 

e) Collect convenience samples of bacterial and fungal isolates through the EIP to assess 

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

difficile (ongoing), and selected gram-negative bacteria (ongoing), as well as communityassociated 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 (ongoing). 

f) Implement (2011) and analyze (ongoing) a periodic national prevalence survey for 

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

pathogens.

g) NEW: The U.S. Army's Multidrug-resistant organism Repository and Surveillance 

Network (MRSN) at the Walter Reed Army Institute of Research in Silver Spring, MD 

will assess existing and new PCR and other technologies to more accurately monitor the 

burden of antimicrobial resistance in the global Military Health System and support 

infection control programs (2012).

h) NEW: Develop analytic tools in NHSN for State Department of Health (and any group 

user) to evaluate summary resistance of reported HAIs by group (i.e., state) allowing 

regional and state-level comparisons of HAI-related summary data (2013); report on 

geographic variability in resistance rates among HAIs in U.S. by 2013.

Coordinator: CDC; Collaborator: VA, DoD

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

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) Completed: See Appendix A.

b) Completed: See Appendix A.

c) Completed: See Appendix A.

d) Completed: See Appendix A.
- 16 -

e) NEW: Assess the prevalence of C. difficile in livestock on farms throughout the United 

States (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 C. difficile and MRSA infections based on data from 

population-based surveillance systems (2013).

b) Conduct (2012) and analyze (2013) studies of colonization with antimicrobial-resistant S. 

pneumoniae to determine the effects of antimicrobial use and pneumococcal vaccination 

on colonization.

c) NEW: The U.S. Army's Multidrug-resistant organism Repository and Surveillance 

Network (MRSN) at the Walter Reed Army Institute of Research in Silver Spring, MD 

will track the occurrence of multidrug resistant organisms in Military Health System 

(MHS) facilities and assess movement of these organisms in the MHS and interactions 

between these organisms (ongoing).

d) NEW: The U.S. Army's Multidrug-resistant organism Repository and Surveillance 

Network (MRSN) at the Walter Reed Army Institute of Research in Silver Spring, MD 

will conduct surveillance for and assess multidrug resistant organism in military working 

dogs (ongoing).

Coordinator: CDC; Collaborator: NIH, VA, DoD

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, multidrug-resistant and extensively drug-resistant tuberculosis

[XDR TB], oseltamivir-resistant 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). 
- 17 -

c) Routinely evaluate and monitor 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 and genetic mechanisms (ongoing).

d) Completed: See Appendix A.

e) Completed: See Appendix A.

f) Completed: See Appendix A.

g) NEW: Evaluate state-based laboratory surveillance and associated public health response 

for MDROs using established meaningful use criteria for electronic laboratory reporting 

(ELR) in states that have made CREs notifiable; assess considerations for integration 

with NHSN (2015).

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 (ongoing). 

b) Completed: See Appendix A.

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

Program (ongoing).

d) Completed: See Appendix A.

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

(pilot in 2013 and implement in 2014).

f) NEW: In anticipation of the shift to culture-independent testing, catalog and prioritize 

resistance genes and other relevant genetic elements that can help predict clinical 

resistance in particular enteric pathogens and develop sentinel approaches for monitoring 

this resistance in the population (2014).

Coordinator: CDC
- 18 -

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 C. difficile

infections for targeted prevention interventions (ongoing).

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

partnering with state veterinary diagnostic laboratories (2011).

c) NEW: Assess the feasibility of collecting data on selected animal pathogens through state 

veterinary diagnostic laboratories and other private entities (2012).

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 (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) (ongoing).

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

WHO-AGISAR steering committee through participation and information sharing 

(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).

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 (ongoing).

d) Collaborate with IEIP sites to expand surveillance systems (2011) to measure the burden 

of AR and the impact of infection control interventions in healthcare settings and conduct 

carriage studies (2014) in the community setting.
- 19 -

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, Herpes 

simplex), 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).

g) NEW: Conduct studies to assess the efficacy of transmission blocking interventions to 

reduce spread of resistant P. falciparum strains (2012-2014).

h) NEW: Work with host nationals to identify asymptomatic carriers of drug resistant P. 

falciparum via active case detection (ongoing).

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

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

animals in the United States. 
- 20 -

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 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 (ongoing).

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) Completed: See Appendix A.

e) Completed: See Appendix A.

f) NEW: Pilot (2012) and implement (2013-2014) national prevalence survey of appropriate 

antimicrobial use utilizing tools developed in 4.1a, and utilize infrastructure in 2.1b.

g) NEW: Conduct national studies to determine antimicrobial use practices in livestock and 

poultry populations throughout the United States through the USDA:APHIS National 

Animal Health Monitoring System (ongoing). 

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 veterinary and human healthcare settings (e.g., 

cephalosporin use and prevalence of vancomycin-resistant enterococci in intensive care 

units) and community settings (e.g., fluoroquinolone use for respiratory tract infections 

and macrolide resistance in pneumococci). 

a) Completed: See Appendix A.

b) NEW: Explore metagenomic approaches to understand ecology of resistance 

determinants in enteric organisms (2015).

c) NEW: Compare the relationship between antibiotic prescribing and C. difficile disease 

rates (2013). 
- 21 -

d) NEW: Compare the relationship between antibiotic use and invasive S. pneumonia in the 

era of expanded-valent pneumococcal conjugate vaccines (2013).

Coordinator: CDC; Collaborators: USDA, VA

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
- 22 -

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 (2013).

b) Completed: See Appendix A.

c) NEW: Evaluate the impact of electronic clinical decision support on prescribing practices 

in ambulatory care settings (2014).

d) NEW: Provide support to state health departments to implement appropriate antibiotic 

use campaigns and interventions and evaluate their impact (ongoing).

e) NEW: Coordinate the annual health observance Get Smart About Antibiotics Week in 

collaboration with state and local health departments, international health agencies, 

professional organizations, and private corporations to increase awareness about 

antibiotic resistance and improve antibiotic use (ongoing).

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) Completed: See Appendix A.

c) Completed: See Appendix A.
- 23 -

d) Completed: See Appendix A.

e) Completed: See Appendix A.

Coordinator: CDC; Collaborators: AHRQ, VA

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 C. difficile prevention collaborative in at least 10 states 

by 2011 and evaluate impact by 2013.

b) Completed: See Appendix A.

c) Completed: See Appendix A.

d) Completed: See Appendix A.

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) Completed: See Appendix A.

b) Initiate studies (2011), collect and process samples (2012), and analyze data (2013) to 

establish standardized methods and baseline levels of contamination of healthcare 

environmental surfaces. These standardized methods and baselines will be used by

industry and other partners to evaluate the dynamics of contamination and in 

demonstrating the ability of cleaning and disinfection methods to reduce transmission of 

AR pathogens.

c) Evaluate the impact of state-based CDC-funded HAI prevention collaboratives 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 

(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 (ongoing).

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).
- 24 -

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. These 4-year grants began in 

2010 and will be completed no later than 2015. 

c) Completed: See Appendix A.

d) NEW: A systems approach will be employed to understand and characterize the hostpathogen interactions that are manipulated in food animals using novel therapeutic 

approaches with BT peptides (immunomodulators) and CpG oligonucleotides without 

engendering antimicrobial resistance (2013-2015).

e) NEW: ARS researchers at College Station, TX, showed that day-old birds of an 

immunologically efficient genetic line of chickens were much more resistant to 

colonization by Salmonella enteritidis than were birds of a less immunologically efficient 

line. These researchers demonstrated that certain enzymes in the birds (protein kinases) 

and the relevant signaling pathways did in fact contribute to the pathogen resistance 

patterns exhibited in the different bird lines. The work is important because it has 

identified key regulatory points that can be targeted in genetic selection for pathogenresistant and possibly even pathogen-immune commercial poultry (2015).

f) NEW: ARS researchers in Ames, IA, have identified a gene (poxA) in Salmonella 

typhimurium that, when mutated, dramatically reduces the ability of the bacterium to 

survive numerous stress conditions as well as antibiotic and chemical exposures. 

Furthermore, the gene mutation decreased the ability of S. typhimurium to colonize the 

pig. As this genetic system is critical for the ability of the salmonellae to cause disease 

and resist antibiotics, it offers a novel target mechanism for intervention development 

against salmonellae (possible vaccine) (2013).

g) NEW: Conduct workshop to solicit input from stakeholders on insights into the issues 

and information gaps that exist in the areas of antimicrobial use and resistance 

monitoring, practices to support judicious antimicrobial use, alternatives to antibiotics, 

and the discovery of new antimicrobials (2012).

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).
- 25 -

b) Develop alternatives to current processing treatments for the reduction of E. 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) Completed: See Appendix A.

b) Completed: See Appendix A.

c) Completed: See Appendix A.

d) NEW: Launched the Food Safety Families Campaign (developed by USDA, FDA, CDC, 

and the Ad Council) in English and Spanish, to target parents and caregivers of young 

children (2011). The launch news release reached over 26 million people while broadcast 

coverage reached 13 million. In FY 2012, a Thanksgiving media tour with the Under 

Secretary for Food Safety generated more than 190 TV and radio segments nationwide, 

reaching 20.3 million people. Continue to expand campaign outreach (2012).

e) NEW: Develop three consumer applications for smartphones to reach consumers with the 

latest, most up-to-date food safety information (2012).

f) NEW: Through the internet and other mechanisms, educate food producers, food 

handlers, and the general public about the major sources and ecology of resistant and 

susceptible bacterial enteric infections in humans (2014).

g) NEW: Educate consumers about food safety through the USDA Food Safety Discovery

Zone, launched in 2010, which travels throughout the United States visiting community 

events (ongoing).

h) NEW: Conduct food safety education events in Washington D.C. for National Nutrition 

Month (ongoing).

Coordinator: USDA, FDA, CDC

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

workers in human and veterinary medicine. 

a) Completed: See Appendix A.

b) Completed: See Appendix A.
- 26 -

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) Completed: See Appendix A.

b) Completed: See Appendix A.

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 

(pilot 2011 and implement 2012) and resistance rates (pilot 2011).

b) Completed: See Appendix A. 

c) Completed: See Appendix A. 

d) Completed: See Appendix A.

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

antimicrobials, especially C. difficile infections by 2011. Two manuscripts will be 

developed in 2012.

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

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

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

for unconfirmed community-acquired pneumonia) (2014).

g) NEW: Explore feasibility of correlating outpatient antimicrobial use with incidence of 

community-based C. difficile infection to inform efforts at reducing infection through 

community-based stewardship (2013).

h) NEW: Examine knowledge, attitudes and behaviors of healthcare providers regarding 

antibiotic choice (2013).
- 27 -

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 (2011-2012).

b) Completed: See Appendix A.

c) Completed: See Appendix A.

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.

e) NEW: Develop or update educational materials on the judicious use of antimicrobial 

agents in food animals and make those materials available to veterinarians, veterinary

students, and food animal producers (2014).

f) NEW: Implement and maintain an education module on judicious antimicrobial use for 

veterinarians through the USDA: APHIS National Veterinary Accreditation Program 

(ongoing).

Coordinators: FDA; Collaborators: CDC, USDA, EPA

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). 

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 (2013).
- 28 -

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
- 29 -

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

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

prevention, diagnosis and treatment of resistant infections.

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
- 30 -

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

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

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

community and hospital acquired infections and biodefense threat agents. 

Coordinator: ASPR/BARDA; 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

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

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. 

b) NEW: Develop capacity in developing countries to conduct genomic and bioinformaticsbased molecular epidemiological studies to inform public health drug resistance 

containment and elimination efforts (ongoing).
- 31 -

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
- 32 -

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; 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 guidance on recommended approaches to clinical trial designs for evaluating

antibacterial drugs for acute bacterial skin and skin structure infections (2012).

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

antibacterial drugs for hospital-acquired and ventilator-associated bacterial pneumonia 

(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 (2011) 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 C. difficile. Publish final guidance (2011).

Coordinator: FDA

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). 
- 33 -

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) Completed: See Appendix A.

Coordinator: FDA

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

for human use and rapid diagnostic tests (including antimicrobial susceptibility tests), 

including the impact of such strategies upon appropriate use of such products. Prepare a 

report for publication describing the study results (2012).

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

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 (2011).

Coordinators: CDC, FDA; Collaborator: USDA

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

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 
- 34 -

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 to 

identify pathogens associated with these infections (ongoing).

c) Completed: See Appendix A.

Coordinators: CDC, FDA; Collaborators: NIH, USDA, 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. 

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, C. 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 Completed: See Appendix A.
- 35 -

Acronyms and Abbreviations

AHRQ Agency for Healthcare Research and Quality

APHL Association of Public Health Laboratories

AR Antimicrobial resistance

ASH Office of the Assistant Secretary for Health (HHS)

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
- 36 -

Appendix A: Retired Projects and Implementation Steps

This Appendix lists all projects and implementation steps that the Task Force retired from the 

2012 Action Plan. 

Project 

Number 

and Letter

Project Description Reason for 

Retirement

1.1a Implement 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).

Completed

See 2011 Annual 

Progress Report

1.3a Design and implement a 1 year prevalence study of MRSA, 

VRE, and C. difficile from retail meat (2011).

Completed

See 2011 Annual 

Progress Report

1.3b Evaluate the quantity of C. difficile recovered from retail 

meats in FoodNet sites.

Completed

See 2011 Annual 

Progress Report

1.3c Evaluate the quantity of C. difficile recovered from retail 

meats in FoodNet sites.

Completed

See 2009 – 2010 

Annual Progress 

Report

1.3d Conduct a pilot study to evaluate C. difficile environmental 

contamination in households of infected and non-infected 

patients.

Completed

See 2011 Annual 

Progress Report

1.5d Assess the impact of including data on susceptibility to 

multiple fluoroquinolones and injectable agents 

(aminoglycosides and capreomycin) to the national TB 

reporting system for enhanced detection of XDR TB.

Completed

See 2009 – 2010 

Annual Progress 

Report

1.5e Complete a pilot exercise to expand routine nationwide 

surveillance for MDR TB to include additional drugs and 

determine whether this additional surveillance provides useful 

information that warrants broader implementation.

Completed

See 2009 – 2010 

Annual Progress 

Report

1.5f 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.

Completed

See 2011 Annual 

Progress Report

1.6b Disseminate expert recommendations for effective state-based 

surveillance for multidrug-resistant organisms related to 

healthcare-associated infections.

Completed

See 2011 Annual 

Progress Report

1.6d Develop and implement an antimicrobial susceptibility testing 

training program for public health laboratories (2012).

Completed

See 2009 – 2010 

Annual Progress 

Report
- 37 -

2.1d Collect and publish annual reports on animal antimicrobial 

drug distribution data through implementation of Section 105 

of the Animal Drug User Fee Amendments of 2008 (2010 and 

ongoing).

Completed

See 2011 Annual 

Progress Report

2.1e 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

Completed

See 2011 Annual 

Progress Report

2.2a Compare retail pharmacy sales of outpatient oral 

antimicrobials to geographic differences in bacterial 

resistance (2011).

Completed

See 2011 Annual 

Progress Report

3.1b Evaluate factors that influence the prescribing practices of 

primary care physicians, including academic detailing and 

benchmark analysis (2011).

Completed

See 2011 Annual 

Progress Report

3.2b 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.

Completed

See 2011 Annual 

Progress Report

3.2c Correlation between adherence to best catheter insertion 

practices and CLABSI rates (2011).

Completed

See 2011 Annual 

Progress Report

3.2d Revise and publish HICPAC guidance for prevention of 

catheter-associated bloodstream infections.

Completed

See 2011 Annual 

Progress Report

3.2e Revise and publish HICPAC guidance for prevention of 

surgical site infections (2011).

Completed

See 2011 Annual 

Progress Report

3.3b Evaluate impact of the CMS-Quality Improvement 

Organization MRSA prevention initiative by 2012.

Completed

See 2011 Annual 

Progress Report

3.3c Evaluate impact of the Department of Veterans Affairs 

National MRSA prevention initiative (2012). Explore the 

expansion of prevention initiatives to include other MDRO 

including C. difficile and multidrug-resistant gram-negative 

pathogens.

Completed

See 2011 Annual 

Progress Report

3.3d Facilitate initiation of at least one regional, multi-center 

prevention collaborative in which acute and long-term care

Completed

See 2011 Annual 
- 38 -

facilities address prevention of multi-drug resistant infections 

in a coordinated manner (2011).

Progress Report

3.4a 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).

Completed

See 2011 Annual 

Progress Report

3.5c Identify factors important for assuring that antimicrobial 

drugs are used judiciously in veterinary, agriculture and 

aquaculture environments.

Completed

See 2011 Annual 

Progress Report

3.7a 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.

Completed

See 2009 – 2010 

Annual Progress 

Report

3.7b 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 

Completed 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.

Completed

See 2011 Annual 

Progress Report

3.7c Host USDA Nutrition Month to include Food Safety Day on 

March 10, 2010 to increase consumer awareness about food 

safety.

Completed

See 2011 Annual 

Progress Report

3.8a Complete basic infection control curriculum for posting on 

the CDC website by 2011.

Completed

See 2009 – 2010 

Annual Progress 

Report

3.8b Develop a plan for infection control education of veterinary

medicine workers by 2011.

Completed

See 2009 – 2010 

Annual Progress 

Report

3.9a Develop a plan to collaborate with WHO on their hand 

hygiene promotion campaign.

Completed

See 2011 Annual 

Progress Report

3.9b 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).

Completed

See 2011 Annual 

Progress Report
- 39 -

4.1b Develop a “change package” for improving antimicrobial use 

in in-patient healthcare settings.

Completed

See 2011 Annual 

Progress Report

4.1c Collaborate with a network of hospitals to identify patientlevel indications for and factors associated with antibiotic use 

to help guide efforts on improving use by 2011.

Completed

See 2011 Annual 

Progress Report

4.1d Examine knowledge, attitudes, and behaviors of healthcare 

providers regarding adverse events and antimicrobial use.

Completed

See 2011 Annual 

Progress Report

4.2 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.

Completed

See 2009 – 2010 

Annual Progress 

Report

4.2c Publish a revised order to prohibit certain extralabel uses of 

cephalosporin antimicrobial drugs in food producing animals 

due to AR concerns (2011).

Completed

See 2011 Annual 

Progress Report

9.5a Part 15 public hearing held April 28, 2008, on issues in AR 

and the Orphan Drug Act.

Completed

See 2009 – 2010 

Annual Progress 

Report

11.1c 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).

Completed

See 2009-2010 

Annual Progress 

Report

11.3 Support advanced development of vaccines for resistant 

pathogens such as Staphylococcus aureus.

Work was not 

initiated and 

determined to be 

beyond the 

current scope of 

work at BARDA