A PUBLIC HEALTH ACTION PLAN TO COMBAT ANTIMICROBIAL RESISTANCE

PART 1: DOMESTIC ISSUES

Interagency Task Force on Antimicrobial Resistance

Co-chairs:

Centers for Disease Control and Prevention

Food and Drug Administration

National Institutes of Health 

Agency for Healthcare Research and Quality

Health Care Financing Administration

Health Resources and Services Administration

Department of Agriculture

Department of Defense

Department of Veterans Affairs

Environmental Protection Agency
1

A PUBLIC HEALTH ACTION PLAN TO COMBAT ANTIMICROBIAL RESISTANCE

PART 1: DOMESTIC ISSUES

TABLE OF CONTENTS

Executive Summary Page 2

Top Priority Action Items Page 7

Introduction and Overview Page 9

The Focus Areas

I. Surveillance (Action Items 1-20) Page 13

II. Prevention and Control (Action Items 21-66) Page 20

III. Research (Action Items 67-78) Page 32

IV. Product Development (Action Items 79-84) Page 37

References Page 41
2

A Public Health Action Plan to Combat Antimicrobial Resistance 

Executive Summary

This Public Health Action Plan to Combat Antimicrobial Resistance (Action Plan) was developed 

by an interagency Task Force on Antimicrobial Resistance that was created in 1999. The Task Force 

is co-chaired by the Centers for Disease Control and Prevention, the Food and Drug Administration, 

and the National Institutes of Health and also includes the Agency for Healthcare Research and Quality, 

the Health Care Financing Administration, the Health Resources and Services Administration, the 

Department of Agriculture, the Department of Defense, the Department of Veterans Affairs, and the 

Environmental Protection Agency.

The Action Plan reflects a broad-based consensus of federal agencies on actions needed to address 

antimicrobiala resistance (AR). Input from state and local health agencies, universities, professional 

societies, pharmaceutical companies, health care delivery organizations, agricultural producers, 

consumer groups, and other members of the public was important in developing the plan. While some 

actions are already underway, complete implementation of this plan will require close collaboration with 

all of these partners,b a major objective of the process. The plan will be implemented incrementally, 

dependent on the availability of resources.

The Action Plan provides a blueprint for specific, coordinated federal actions to address the emerging 

threat of antimicrobial resistance. This document is Part I of the Action Plan, focusing on domestic 

issues. Since AR transcends national borders and requires a global approach to its prevention and 

control, Part II of the plan, to be developed subsequently, will identify actions that more specifically 

address international issues. The Action Plan, Part I (Domestic Issues), includes four focus areas: 

Surveillance, Prevention and Control, Research, and Product Development. A summary of the top 

priority goals and action items in each focus area follows. 

Surveillance

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

 

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 applies whether the agent is intended for human, veterinary or agricultural applications.

b

Implementation of this Action Plan requires working with a wide variety of partners, e.g. state and 

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

health care delivery organizations, insurers, agricultural producers, consumer groups, and the public. A 

wide variety of expertise is needed, e.g., from clinicians, consumers, pharmacists, microbiologists, 

epidemiologists, behavioral and social scientists, economists, health policy researchers, and others. 

Partners and expertise needed will vary with different action items.
3

world may soon be faced with previously treatable diseases that have again become untreatable, as in 

the pre-antibiotic era. Priority Goals and Action Items in this focus area address ways to:

• Develop and implement a coordinated national plan for AR surveillance;

• Ensure the availability of reliable drug susceptibility data for surveillance;

• Monitor patterns of antimicrobial drug use; and

• Monitor AR in agricultural settings to protect the public’s health by ensuring a safe food supply as 

well as animal and plant health.

A coordinated national surveillance plan for monitoring AR in microorganisms that pose a threat to 

public health will be developed and implemented. The plan will specify activities to be conducted at 

national, state, and local levels; define the roles of participants; promote the use of standardized 

methods; and provide for timely dissemination of data to interested parties, e.g., public health officials, 

clinicians, and researchers. Needed core capacities at state and local levels will be defined and 

supported. When possible, the plan will coordinate, integrate, and build on existing disease surveillance 

infrastructure. All surveillance activities will be conducted with respect for patient and institutional 

confidentiality.

The availability of reliable drug susceptibility data is essential for AR surveillance. The accuracy 

of AR detection and reporting will be improved through training and proficiency testing programs for 

diagnostic laboratories and by promoting and further refining standardized methods for detecting drug 

resistance in important pathogens, including bacteria, parasites, fungi, and viruses. Public and private 

sector partners will address barriers to AR testing and reporting, e.g., barriers due to changes in health 

care delivery.

A plan to monitor patterns of antimicrobial drug use will be developed and implemented as an 

important component of the national AR surveillance plan. This information is essential to interpret 

trends and variations in rates of AR, improve our understanding of the relationship between drug use 

and resistance, identify and anticipate gaps in availability of existing drugs, and identify interventions to 

prevent and control AR.

Improved surveillance for AR in agricultural settings will allow early detection of resistance trends 

in pathogens that pose a risk to animal and plant health, as well as in bacteria that enter the food supply. 

 Agricultural surveillance data will also help improve understanding of the relationship between 

antimicrobial drug and pesticide use and the emergence of drug resistance.

Prevention and Control

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

usec of antimicrobial drugs and prevent the transmission of infections (whether drug-resistant or not). 

 

c

In this Action Plan, appropriate antimicrobial drug use is defined as use that maximizes therapeutic 
4

Priority Goals and Action Items in this focus area address ways to:

• Extend the useful life of antimicrobial drugs through appropriate use policies that discourage overuse 

and misuse;

• Improve diagnostic testing practices;

• Prevent infection transmission through improved infection control methods and use of vaccines;

• Prevent and control emerging AR problems in agriculture, human and veterinary medicine; and

• Ensure that comprehensive programs to prevent and control AR involve a wide variety of 

nonfederal partners and the public so these programs become a part of routine practice nationwide.

Appropriate drug-use policies will be implemented through a public health education campaign on 

appropriate antimicrobial drug use as a national health priority. Other actions in support of appropriate 

drug use will include reducing inappropriate prescribing through development of clinical guidelines and 

computer-assisted decision support, considering regulatory changes, supporting other interventions 

promoting education and behavior change among clinicians, and informing consumers about the uses 

and limitations of antimicrobial drugs.

Improved diagnostic practices will be promoted by encouraging the use of rapid diagnostic methods 

to guide drug prescribing, facilitating direct consultation between clinicians and laboratory personnel with 

appropriate expertise and authority, and promoting the use of appropriate laboratory testing methods. 

Guidelines, training, and regulatory and reimbursement policies will be utilized to promote improved 

diagnostic practices.

Reduced rates of infection transmission will be addressed through public health campaigns that 

promote vaccination and hygienic practices such as hand washing, safe food handling, and other 

behaviors associated with prevention of infection transmission. Infection control in health care settings 

will be enhanced by developing new interventions based on rapid diagnosis, improved understanding of 

the factors that promote cross-infection, and modified medical devices or procedures that reduce the 

risk of infection.

The prevention and control of AR in agriculture and veterinary medicine requires 1) improved 

understanding of the risks and benefits of antimicrobial use and ways to prevent the emergence and 

spread of resistance; 2) development and implementation of principles for appropriate antimicrobial 

drug use in the production of food animals and plants; 3) improved animal husbandry and foodproduction practices to reduce the spread of infection; and 4) a regulatory framework to address the 

need for antimicrobial drug use in agriculture and veterinary medicine while ensuring that such use does 

not pose a risk to human health.

 

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 drug, dose, and duration.
5

Comprehensive, multifaceted programs involving a wide variety of nonfederal partners and the 

public are required to prevent and control AR. The AR Task Force agencies will ensure ongoing input 

from, review by, and collaboration with nonfederal partners. The appropriate agencies will support 

demonstration projects that use multiple interventions to prevent and control AR (e.g., through 

surveillance, appropriate drug use, optimized diagnostic testing, immunization practice, and infection 

control). The Task Force agencies will encourage the incorporation of effective programs into routine 

practice by implementing model programs in federal health care systems and promoting the inclusion of

AR prevention and control activities as part of quality assurance and accreditation standards for health 

care delivery nationwide.

Research

Understanding the fundamental processes involved in antimicrobial resistance 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 antimicrobial resistance emerging and 

spreading in hospitals, communities, farms, and the food supply. Priority Goals and Action Items in this 

focus area address ways to:

• Increase understanding of microbial physiology, ecology, genetics and mechanisms of resistance;

• Augment the existing research infrastructure to support a critical mass of researchers in AR and 

related fields; and

• Translate research findings into clinically useful products, such as novel approaches to detecting, 

preventing, and treating antimicrobial resistant infections.

Needs in the field of AR research will be identified and addressed through a government-wide 

program review with external input. Additional research is needed, for example, on the epidemiology of 

resistance genes; on mechanisms of AR emergence, acquisition, spread, and persistence; and on the 

effects of antibiotics used as agricultural growth promotants on microbes that live in animals, humans, 

plants, soil and water. Further study is also required to determine whether variations in drug use 

regimens may stimulate or reduce AR emergence and spread. Improved understanding of the causes of 

AR emergence will lead to the development of tools for reducing microbial resistance, as well as for 

predicting where AR problems are likely to arise.

A comprehensive research infrastructure will help ensure a critical mass of AR researchers who will 

interact, exchange information, and stimulate new discoveries. This aim will be achieved through the 

appropriate strategies and scientific conferences that promote research on AR. The AR Task Force 

agencies will work with the academic and industrial research communities to attract AR researchers, 

prioritize needs, identify key opportunities, and optimize the utilization of resources to address AR 

problems.
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The translation of research findings into innovative clinical products to treat, prevent, or 

diagnose drug-resistant infections is an area in which the federal government can play an important role, 

focusing on gaps not filled by the pharmaceutical industry or by other nongovernment groups. Special 

efforts will be placed on the identification, development and testing of rapid, inexpensive, point-of-care 

diagnostic methods to facilitate appropriate use of antimicrobials. The AR Task Force agencies will 

also encourage basic research and clinical testing of diagnostic methods, novel treatment approaches, 

new vaccines, and other prevention approaches for resistant infections.

Product Development

As antimicrobial drugs lose their effectiveness, new products must be developed to prevent, rapidly 

diagnose, and treat infections. The Priority Goals and Action Items in this focus area address ways to:

• Ensure that researchers and drug manufacturers are informed of current and projected gaps in the 

arsenal of antimicrobial drugs, vaccines, and diagnostics and of potential markets for these products 

(designated here as “AR products”);

• Stimulate the development of priority AR products for which market incentives are inadequate, 

while fostering their appropriate use; and

• Optimize the development and use of veterinary drugs and related agricultural products that reduce 

the transfer of resistance to pathogens that can infect humans.

Current and projected gaps in the arsenal of AR products and potential markets for these 

products will be reported to researchers and drug manufacturers through an interagency working group 

convened to identify and publicize priority public health needs.

The development of urgently needed AR products will be stimulated throughout the process from 

drug discovery through licensing. The regulatory process for AR products will continue to be 

streamlined, and incentives that promote the production and appropriate use of priority AR products 

can be evaluated in pilot programs that monitor costs and assess the return on the public investment.

The production of veterinary AR products that reduce the risk of development and transfer of 

resistance to drugs used in human clinical medicine will be expedited through a streamlined regulatory 

and approval process. As with drugs for the treatment of human infections, pilot programs can be 

initiated to evaluate incentives that encourage the development and appropriate use of priority products 

that meet critical animal and plant health needs.

Private and public partners will also evaluate ways to improve or reduce the agricultural use of particular 

antimicrobial drugs, as well as ways to prevent infection, such as the use of veterinary vaccines, changes 

in animal husbandry, and the use of competitive exclusion products (i.e., treatments that affect the 

intestinal flora of food animals).
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Top Priority Action Items to Combat Antimicrobial Resistance

(All 13 items have top priority, regardless of their order in the list)

Surveillance

• With partners, design and implement a national AR surveillance plan that defines national, regional, 

state, and local surveillance activities and the roles of clinical, reference, public health, and veterinary 

laboratories. The plan should be consistent with local and national surveillance methodology and 

infrastructure that currently exist or are being developed.

(Action Item #2)

• Develop and implement procedures for monitoring patterns of antimicrobial drug use in human 

medicine, agriculture, veterinary medicine, and consumer products.

(Action Item #5)

Prevention and Control

• Conduct a public health education campaign to promote appropriate antimicrobial use as a national 

health priority. 

(Action Item #25)

• In collaboration with many partners, develop and facilitate the implementation of educational and 

behavioral interventions that will assist clinicians in appropriate antimicrobial prescribing. 

(Action Item #26)

• Evaluate the effectiveness (including cost-effectiveness) of current and novel infection-control 

practices for health care and extended care settings and in the community. Promote adherence to 

practices proven to be effective. 

(Action Item #39)

• In consultation with stakeholders, refine and implement the proposed FDA framework for 

approving new antimicrobial drugs for use in food-animal production and, when appropriate, for reevaluating currently approved veterinary antimicrobial drugs.

(Action Item #58)

• Support demonstration projects to evaluate comprehensive strategies that use multiple interventions 

to promote appropriate drug use and reduce infection rates, in order to assess how interventions 

found effective in research studies can be applied routinely and most cost-effectively on a large 

scale.

(Action Item #63)

Research

• Provide the research community genomics and other powerful technologies to identify targets in 

critical areas for the development of new rapid diagnostics methodologies, novel therapeutics, 
8

and interventions to prevent the emergence and spread of resistant pathogens. 

(Action Item #70)

• In consultation with academia and the private sector, identify and conduct human clinical studies 

addressing AR issues of public health significance that are unlikely to be studied in the private 

sector (e.g., novel therapies, new treatment regimens, and other products and practices).

(Action Item #75)

• Identify, develop, test, and evaluate new rapid diagnostic methods for human and veterinary 

uses with partners, including academia and the private sector. Such methods should be 

accurate, affordable, and easily implemented in routine clinical settings (e.g., tests for resistance 

genes, point-of-care diagnostics for patients with respiratory infections and syndromes, and 

diagnostics for drug resistance in microbial pathogens, including in nonculture specimens).

(Action Item #76)

• Encourage basic and clinical research in support of the development and appropriate use of 

vaccines in human and veterinary medicine in partnership with academia and the private sector.

(Action Item #77)

Product Development

• Create an Interagency AR Product Development Working Group to identify and publicize 

priority public health needs in human and animal medicine for new AR products (e.g., innovative 

drugs, targeted spectrum antibiotics, point-of-care diagnostics, vaccines and other biologics, 

anti-infective medical devices, and disinfectants).

(Action Item #79)

• Identify ways (e.g. financial and/or other incentives or investments) to promote the development 

and/or appropriate use of priority AR products, such as novel compounds and approaches, for 

human and veterinary medicine for which market incentives are inadequate.

(Action Item #80)
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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 miracles 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 pneumoniae1), skin, bone, lung, and bloodstream infections (e.g., 

Staphylococcus aureus2,3), urinary tract infections (e.g., Escherichia coli4), foodborne infections (e.g., 

Salmonella5), and infections transmitted in health care settings (e.g., enterococci6 and Klebsiella spp.7).

For example, up to 30 percent of S. pneumoniae found in some areas of the United States are no 

longer susceptible to penicillin, and multidrug resistance is common. Approximately 11 percent of S. 

pneumoniae are resistant to “third generation” cephalosporin antibiotics, and resistance to the newest 

fluoroquinolone antimicrobials has already been reported.8 Nearly all strains of Staphylococcus aureus

in the United States are resistant to penicillin, and many are resistant to newer methicillin-related drugs.2

 Since 1997, strains of S. aureus with decreased susceptibility to vancomycin, for many years the only 

uniformly effective treatment, have been reported.9,10

Many other pathogens – including the bacteria that cause tuberculosis11 and gonorrhea,12 human 

immunodeficiency virus,13 the fungi that cause yeast infections,14 and the parasites that cause malaria15–

are also becoming resistant to standard therapies. If we do not act to address the problem of AR, we 

may lose quick and reliable treatment of infections that have been a manageable problem in the United 

States since the 1940s. Drug choices for the treatment of common infections will become increasingly 

limited and expensive – and, in some cases, nonexistent.

Risk

While anyone may acquire a drug-resistant infection, certain people are at increased risk, e.g., patients 

in hospitals and children in daycare centers. Drug-resistant infections may be acquired in health care 

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 overseas. However, resistant microbes are increasingly appearing in new 

settings. Methicillin-resistant S. aureus, which for 30 years with few exceptions was a problem only in 
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hospitals, is now occurring in the community.3,16

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 increase. Individuals infected with drug resistant 

organisms are more likely to require hospitalization, to remain in the hospital for a longer time, and to 

have a poor prognosis. For example, it has been estimated that the in-hospital cost of hospital-acquired 

infections caused by just six common kinds of resistant bacteria are at least $1.3 billion per year, in 

1992 dollars.17 This estimate does not include the costs of infections caused by other pathogens, the 

costs of lost workdays, post-hospital care, or resistant infections in the outpatient or extended care 

facility settings.

Solutions

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

manageable problem. Over the past ten years, the Institute of Medicine,18 the American Society for 

Microbiology,19 World Health Organization20 other panels of distinguished experts, the Congressional 

Office of Technology Assessment,17 and the General Accounting Office 21, 22 have provided 

recommendations and options for government action to address the dangers posed by AR. 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.

A Public Health Action Plan to Combat Antimicrobial Resistance

A Public Health Action Plan to Combat Antimicrobial Resistance provides a blueprint for specific, 

coordinated federal government actions to address this emerging threat. The plan builds upon reports 

prepared by expert panels in recent years. This document is Part I of the plan, focusing on domestic 

issues. However, AR transcends national borders and requires a global approach to its prevention and 

control. Part II of the plan, to be developed after the World Health Organization finalizes its Global 

Strategy for the Containment of Antimicrobial Resistance,23 will identify federal actions that more 

specifically address international issues with input from and in collaboration with WHO and additional 

partners. A National Action Plan to Combat Multi-drug Resistant Tuberculosis has been published 

previously.24

Plan Development
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This plan was developed by an Interagency Task Force on Antimicrobial Resistance that was created in 

1999. 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 Health Care Financing Administration 

(HCFA), the Health Resources and Services Administration (HRSA), the Department of Agriculture 

(USDA), the Department of Defense (DoD), the Department of Veterans Affairs (DVA), and the 

Environmental Protection Agency (EPA).

The plan is based in part on input obtained at a public meeting held in Atlanta, Georgia, in July 1999.25 

Present at the public meeting were consultants from a wide variety of groups, including state and local 

health agencies, universities, professional societies, pharmaceutical and biotechnology companies, health 

care delivery organizations, agricultural producers, consumer groups, and the public. A draft of the plan 

was released for public comment in June 2000, 26 and the plan was modified following consideration of 

comments received. 

Partnerships, Implementation, and Coordination

The plan reflects a broadly-based consensus of federal agencies on federal actions to combat AR. 

However, implementation of this plan will require collaboration with many partners.b More specific 

details of these collaborations will be developed by the agencies as the actions are implemented.

The plan will be implemented incrementally as resources become available. The agencies recognize that 

a number of the items may require either new statutory authority or changes in regulatory requirements. 

The extent to which such measures may be needed to implement a given action item will be considered 

by the agencies involved.

The plan includes a summary and a list of issues, goals, and action items addressing surveillance, 

prevention and control, research, and product development.d For each action item, coordinator and 

collaborator agencies/departments are specified. Contingent on available resources, the coordinators 

will assume the primary responsibility of carrying out the specified action items and the collaborators will 

assist and/or carry out part of the specified action. Additional agencies may become collaborators in 

the future. 

The Task Force identified 13 top priority action items. Approximate timelines were also identified for 

all action items; these timelines provide another indication of priority but also take into account 

prerequisites for certain items and the achievable pace of action on sometimes complex issues. 

Designation of top priorities and timelines was a difficult task given the realization that many items could 

be considered top priority and should ideally begin immediately. For action items with multiple 

 

dExcept where specified, these issues, goals, and action items apply to human AR issues and not to 

nonhuman (e.g., agricultural) issues. Agricultural issues refer to the production of animals and plants, as 

well as fish and other species (aquaculture).
12

component parts, the agencies involved will further develop priorities and timelines, with appropriate 

input from outside partners, as they implement the action item.

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

implementation of the plan. During the coming years, the Task Force will publish periodic reports 

detailing how the plan is being implemented, solicit comments from the public, – and if necessary, 

update the plan. Details of current agency activities regarding AR are beyond the scope of this 

document, but may be obtained by contacting the specific agencies. 
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The Focus Areas

I. Surveillance

Surveillance of AR is critical to providing early warning of emerging problems, monitoring changing 

patterns of resistance, and targeting and evaluating prevention and control measures.e Timely 

surveillance information is also necessary for assisting researchers in developing new drugs and for 

providing good patient care. For example, clinicians should be informed of drug resistance problems in 

their communities that may influence their prescribing decisions in order to help them avoid treatment 

failures. In addition, monitoring patterns of antimicrobial drug use is needed to interpret trends and 

variations in rates of AR, improve understanding of the relationship between drug use and resistance, 

identify and anticipate gaps in availability of existing drugs, and help identify preventive interventions.

At present, the United States lacks a coordinated national plan for AR surveillance. Creating a national 

plan requires collaboration with partners in the public and private sectors. Improved AR surveillance

depends on enhancing epidemiologic and laboratory capabilities at local, state, and national levels; using 

standardized and reliable laboratory testing methods; and enhancing use of informatics.

A. Issue: The United States lacks a coordinated national plan for surveillance of:

• AR emergence in organism-drug combinations of public health importance and

• Antimicrobial drug use in human and nonhuman settings.

1. Goal: Collaborate with appropriate partners to develop procedures and methods for 

surveillance of AR emergence in organism-drug combinations of public health 

importance.

a. Action Items

(1)Determine which organisms and susceptibility to specific antimicrobial drugs should be 

under surveillance and create a mechanism for periodic updating of this list.

Coordinators: CDC, FDA, USDA, EPA

Timeline: Initiated

(2) TOP PRIORITY ACTION ITEM - With partners, design and implement a national 

 

ePublic health surveillance is the ongoing, systematic collection, analysis, and interpretation of data for 

use in the planning, implementation, and evaluation of public health practice. Desirable qualities of any 

system include simplicity, flexibility, acceptability, sensitivity, and representativeness. A surveillance 

system also includes the timely dissemination of these data to persons who can undertake effective 

prevention and control activities, including clinicians, researchers, laboratorians, and public health 

personnel. (MMWR, Guidelines for Evaluating Surveillance Systems, May 6, 1988/37(S5); 118.)
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AR surveillance plan:

• Identify the components of a national AR surveillance plan and the roles of 

partners in its design and implementation.

Coordinator: CDC; Collaborators: DoD, DVA, FDA, USDA, HCFA

• Determine which surveillance activities should be conducted routinely at 

national, regional, state, or local levels and which may require specialized

projects.

Coordinators: CDC, FDA, USDA

• Define the roles of clinical, reference, public health, and veterinary laboratories 

at federal, state, and local levels in AR surveillance.

Coordinator: CDC; Collaborators: DoD, DVA, FDA, USDA, HCFA

• Improve coordination of AR surveillance systems at CDC, FDA, and USDA 

(e.g., identify components for integration).

Coordinators: CDC, FDA, USDA

• Consider the role of nongovernment funded surveillance and other data 

collection systems to augment a national surveillance plan.

Coordinators: CDC, FDA, USDA

• Ensure that the national AR surveillance plan is consistent with local and national 

surveillance methodology and infrastructure that currently exist or are being 

developed.

Coordinators: CDC, USDA, FDA

• Identify and assess practical surveillance strategies for components of the 

national plan by conducting pilot studies and demonstration projects. 

Coordinators: CDC, USDA, FDA

Timeline for entire action item 2: Begin within one to two years

(3) Develop standards and methodologies.

• Develop standards and methodologies for monitoring drug-resistant microbes in 

humans, animals, and plants as well as for monitoring drug-resistant microbes in 

food products and environmental samples.

Coordinators: CDC, UDSA, FDA, EPA

• Develop standardized laboratory methodologies and data elements that allow 

susceptibility test results and AR surveillance data to be compared across 

geographic jurisdictions.

Coordinators: CDC, USDA, FDA, EPA

• Explore the use of standardized definitions and methodology (Related Action 

Item: Surveillance #5) to create an electronic surveillance system health care 

institutions can use to compare AR data from other local facilities.

Coordinator: CDC; Collaborators: HCFA, DVA, DoD, HRSA

• Encourage development of local, regional, and national data systems that allow 

linking of microbiology, clinical and pharmaceutical data that would support 

local decision making for prevention and control of antimicrobial resistance and 
15

facilitate surveillance for antimicrobial resistance at all levels.

Coordinator: CDC; Collaborators: HCFA, DVA, DoD, HRSA

• Develop standards for reporting quantitative resistance data (e.g., minimal 

inhibitory concentrations or zone diameters) in ways that will detect decreased 

susceptibility. These standards are necessary because numerical AR test results 

reported nonquantitatively (e.g., as susceptible, intermediate, or resistant) as 

“susceptible” may mask an emerging AR problem, i.e, microbes with a small 

decrease in susceptibility may still be classified as susceptible.

Coordinators: CDC, USDA, FDA

• Assess how current policies on maintaining the confidentiality of medical and 

veterinary data collected for other purposes relate to procedures for gathering 

data on antimicrobial resistance. If necessary, develop a comprehensive 

national confidentiality policy on human and agricultural AR surveillance that 

includes both patient and institutional confidentiality, is consistent with 

confidentiality policies applied to other forms of surveillance and research data, 

and recognizes the differences in human and animal medicine and food 

production surveillance programs.

Coordinator: CDC; Collaborators: DVA, HCFA, DoD, FDA, USDA

Timeline for entire action item 3: Initiated

(4) Address additional surveillance issues unique to AR.

• Conduct post-marketing surveillance for the development of resistance to 

critical antimicrobial drugs. Surveillance should be linked to information on drug 

use, and criteria should be developed to allow a prompt response to a finding of 

increased resistance associated with a specific pattern of use (e.g., consumer 

and professional alerts, enhanced education, labeling changes, or restrictions on 

use depending on the extent of and reasons for emergence of resistance).

Coordinators: FDA, CDC, USDA

• Facilitate the collection of AR surveillance data on pathogens for which cultures 

are not routinely obtained, either because the infections are empirically treated 

without laboratory diagnosis or because they are diagnosed with nonculture 

tests.

Coordinator: CDC

• Enhance availability of isolates of drug-resistant microbes to researchers (e.g., 

via a network of collections with an accessible databank). 

Coordinator: CDC; Collaborator: NIH

Timeline for entire action item 4: Begin within one to two years
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2. Goal: Collaborate with appropriate partners to develop procedures and methods for 

nationwide surveillance of antimicrobial drug use in human and nonhuman settings.

a. Action Items

(5) TOP PRIORITY ACTION ITEM - Develop and implement procedures for 

monitoring antimicrobial use in human medicine, agriculture, veterinary medicine, and 

consumer products:

• Link human drug-use data to clinical information (e.g., diagnosis, severity of 

illness, and outcome).

• Link agricultural drug-use data to species and usage patterns.

• Assess potential effects of geographic variations in drug use on the incidence 

and prevalence of antimicrobial resistance.

• Incorporate appropriate confidentiality protections.

• Identify and anticipate gaps in availability of existing drugs. (Related Action 

Item: Product Development #79).

Coordinators: CDC, FDA, USDA; Collaborators: EPA, DVA, DoD

Timeline for entire action item 5: Begin within one to two years

(6) Identify and evaluate methods for collecting (e.g., optimal sampling methods) and 

disseminating the surveillance data on antimicrobial drug use:

• Identify inexpensive sources of drug use data (e.g., the National Ambulatory 

Medical Care Survey [NAMCS], the National Hospital Ambulatory Medical 

Care Survey [NHAMCS], and databases in some health care delivery systems 

and pharmacies) and evaluate their usefulness for surveillance purposes

Coordinators: CDC, FDA

• Consider ways that results of periodic drug use surveys could be made available 

to food animal producers and veterinarians to encourage participation in data 

collection

Coordinators: CDC, FDA, USDA

Timeline for entire action item 6: Begin within one to two years

(7) Work with accrediting agencies to address antimicrobial drug-use monitoring as part of 

quality assurance in health care delivery systems. (Related Action Item: Prevention 

and Control #64)

Coordinators: CDC, HCFA

Timeline: Begin within one to two years

B. Issue: Implementation of the national plan for AR surveillance will require:

• Reliable drug susceptibility data;

• Adequate capacity and resources at state and local health and agricultural 

agencies; and
17

• An accessible, centralized source of AR data.

1. Goal: Promote the consistent and appropriate use of reliable laboratory tests for 

antimicrobial drug susceptibility.

a. Action Items

(8) Ensure that clinical laboratories that provide data for AR surveillance purposes have 

access to and routinely participate in pertinent training and proficiency testing programs 

with good performance and indicate AR testing methodologies in their surveillance 

reports (e.g., specific automated methods or manual techniques).

Coordinator: CDC; Collaborator: HCFA

Timeline: Initiated

(9) Evaluate the performance of licensed, automated AR testing devices in the context of 

changing resistance patterns and update their labeling where appropriate (e.g., changes 

in quantitative resistance that may make a test result invalid).

Coordinators: FDA, CDC

Timeline: Initiated

(10) Working with partners,b including the National Committee for Clinical Laboratory 

Standards (NCCLS), further develop, refine, and promote standardized clinical, 

epidemiologic, and laboratory methods for documenting and assessing the significance 

of drug resistance among yeasts and moulds, parasites, and viruses

Coordinators: CDC, NIH, FDA, USDA, HCFA

Timeline: Initiated

(11) Identify ways to overcome economic, legal, and other barriers to appropriate AR 

testing and to the reporting of results (e.g., sufficient human resources, cost 

considerations, empiric treatment recommendations, managed-care practices, etc.). 

 (Related Action Item: Prevention and Control #34)

Coordinators: HCFA, HRSA, CDC, AHRQ

Timeline: Begin within one to two years

(12) Pursue legal mechanisms for manufacturers to provide otherwise unavailable drugs 

to government reference laboratories for the sole purpose of antimicrobial drug 

susceptibility testing (as part of surveillance) with the understanding that these drugs 

will not be used for drug discovery purposes.

Coordinator: CDC

Timeline: Begin within one to two years

2. Goal: Ensure that state and local health and agricultural agencies have the capacity to 
18

conduct surveillance of drug-resistant organisms of public health importance.

a. Action Items

(13) With state health and agriculture departments and other stakeholders, define needed 

core capacity (the minimum needed in human, laboratory, and electronic resources) 

at the state and local level to ensure that basic AR surveillance is conducted in these 

jurisdictions. As part of this effort, ensure that state public health and veterinary 

diagnostic laboratories maintain the capacity to test the drug-susceptibility patterns 

of resistant organisms of public health importance, especially for drugmicroorganism combinations for which testing methods are not routinely available at 

hospital and commercial laboratories.

Coordinators: CDC, USDA, FDA

Timeline: Begin within one to two years

(14) Provide resources to assist in meeting state and local core capacity needs for AR 

surveillance. Strive to provide consistent funding from year to year to state and 

local public health and veterinary diagnostic laboratories that meet quality assurance 

standards.

Coordinators: CDC, USDA

Timeline: Initiated

3. Goal: Disseminate surveillance data in a timely manner to public health officials, clinicians, 

and others who may make decisions based on an analysis of the data.

a. Action Items

(15) Provide an accessible, centralized source of AR data from major surveillance 

systems involving animal and human populations. In consultation with stakeholders, 

determine how to report AR data in a way that is valid and useful to interested 

parties (e.g., clinicians, public health officials, veterinarians, and researchers). 

Include sufficient detail in surveillance reports to permit local analysis and 

comparison with trends in drug use and medical and agricultural practices.

Coordinators: CDC, USDA, FDA, HCFA

Timeline: Begin within one to two years

(16) Provide health care system administrators and other decision makers with data on 

the impact of drug-resistant organisms (e.g., outcome, treatment costs) and on 

effective prevention and control measures.

Coordinators: CDC, AHRQ

Timeline: Begin within one to two years
19

C. Issue: Monitoring AR in agricultural settings is essential to ensure animal and plant health and a 

safe food supply.

1. Goal: Monitor AR in animal and plant pathogens and in bacteria that can be transmitted to 

humans through the food supply.

a. Action Items

(17) Expand and enhance coordination of surveillance for drug-resistance in enteric 

bacteria in sick and healthy humans and in sick and healthy animals on farms, at 

slaughter, and at retail. This effort includes:

• Expanding the National Antimicrobial Resistance Monitoring System: Enteric 

Bacteria (NARMS:EB);

• Comparing AR data on pathogenic and nonpathogenic organisms detected on 

farms (in sick and healthy animals), at slaughter, and in commercial food 

products; and

• Utilizing these data to monitor the transmission of resistant infections and assess 

the effectiveness of prevention measures

Coordinators: CDC, FDA, USDA

Timeline: Initiated

(18) Evaluate the usefulness 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.

Coordinators: CDC, USDA, FDA

Timeline: Begin within three to five years

(19) Conduct pilot studies to assess the extent of environmental contamination by 

antimicrobial drug residues and drug-resistant organisms that enter the soil or water 

from human and animal waste. If contamination is detected, conduct appropriate 

surveillance in waste, surface and ground water, and soil from agricultural areas in 

which waste is used for fertilizer, and conduct studies to determine potential impact 

on human and animal health. (Related Action Item: Prevention and Control #55)

Coordinators: EPA, CDC, USDA 

Timeline: Initiated

(20) Gather information on the relationship between antimicrobial pesticide and herbicide 

use and the emergence of drug-resistance by monitoring:

• The prevalence and incidence of drug-resistant organisms in agricultural areas 

where antimicrobial pesticides are used and areas where they are not used, and 

• The prevalence of colonization or infection with resistant bacteria in human or 

animal populations who live or work near orchards or who consume fruit 
20

products sprayed (or treated) with antimicrobial. pesticides (Related Action 

Item: Prevention and Control #62)

Coordinators: EPA, CDC, USDA

Timeline: Begin within three to five years

II. Prevention and Control

Prevention and control of drug-resistant infections require measures to promote the appropriate use of 

antimicrobial drugs and prevent infection transmission. The concept of appropriate use may be 

expressed in various other ways, e.g., good antimicrobial stewardship or judicious, prudent, or rational 

use. 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 drug, dose, and duration. Appropriate antimicrobial drug use 

should not be interpreted simply as reduced use because these drugs offer valuable benefits when used 

appropriately. It is overuse and misuse that must be decreased to reduce the selective pressure favoring 

the spread of resistance. 

Appropriate use can be facilitated in various ways, e.g., by promoting informed prescribing by clinicians, 

informing consumers about the proper use and limitations of antimicrobial drugs, and improving 

diagnostic techniques. The challenge facing public health organizations is to work with partners to 

identify effective methods of promoting appropriate antimicrobial drug use and to translate these 

interventions into routine medical practice.

Measures to prevent infection transmission, whether drug-resistant or not, are also very important in 

controlling AR. These measures include the appropriate use of vaccines and infection control, 

sanitation, hygiene measures, and other safe behaviors, e.g., safe sexual practices. Efforts to control 

drug-resistant infections must become part of everyday practice in health care settings across the nation, 

as well as in other settings (e.g., agriculture and veterinary medicine) in which antimicrobial drugs are 

used. Partners in many sectors of society and the general public will need to be involved in this effort.

A. Issue: Appropriate use of antimicrobial drugs can offer great benefits to patients, but overuse 

and misuse of these drugs can hasten the development of resistance and shorten the drug’s 

useful life.

1. Goal: Identify effective methods for promoting appropriate antimicrobial use.

a. Action Items

(21) Identify factors that promote or impede appropriate drug use in hospitals, extended 

care facilities, and outpatient settings in collaboration with partners.b

Coordinator: CDC; Collaborators: FDA, AHRQ, DVA, DoD
21

Timeline: Initiated

(22) Develop appropriate drug use policies and evaluate the impact (including on 

prescribing patterns, resistance rates, patient outcome, and cost) of implementing 

these policies in hospitals and other health care delivery settings. Identify ways to 

increase adherence to appropriate use policies proven to be beneficial in 

collaboration with partners.b

Coordinator: CDC; Collaborators: AHRQ, FDA, DVA, DoD, HCFA

Timeline: Initiated

(23) Evaluate the relationship between prescribing behavior and specific antimicrobial 

drug marketing and promotional practices. Assess the public health effects of these 

practices in collaboration with partners.b

Coordinators: CDC, FDA

Timeline: Begin within three to five years

(24) Help individual hospitals and health care systems analyze how the availability of AR 

data and computer-assisted decision support systems influences prescriber 

behavior, health outcomes, and costs. This plan may include the provision of 

computer software and the establishment of projects that involve the Medicare Peer 

Review Organizations (PROs).

Coordinator: CDC; Collaborators: HCFA, DVA, DoD

Timeline: Begin within three to five years

2. Goal: Promote appropriate antimicrobial use through educational and behavioral 

interventions found to be effective.

a. Action Items

(25) TOP PRIORITY ACTION ITEM - Conduct a public health education campaign 

to promote appropriate antimicrobial use as a national health priority. The 

campaign should involve many partners.b Elements of this campaign may include:

• Culturally appropriate educational and behavioral interventions implemented 

through community-based programs that target patients and selected 

populations and communities, such as daycare centers and schools;

• Strategies to improve patient adherence to appropriate therapies;

• A clearinghouse for educational materials (e.g., booklets and CD-ROM 

presentations) on appropriate drug use and AR prevention;

• A periodically updated priority list of drug-resistant microorganisms in humans 

and animals; and

• A glossary disseminated through CDC Website that defines technical words 

commonly used in discussions of AR issues.
22

Coordinators: CDC, FDA; Collaborators: USDA, HCFA

Timeline: Begin within one to two years

(26) TOP PRIORITY ACTION ITEM - In collaboration with many partners,b

develop and facilitate the implementation of educational and behavioral interventions 

that will assist clinicians in appropriate antimicrobial prescribing. Examples may 

include:

• Educational curricula and training modules for all prescribing clinicians, health 

professions students, trainees, and senior health care administrators as part of 

quality assurance programs;

• Clinical guidelines that address appropriate antimicrobial use;

• Informatics technology (e.g., computer-assisted decision support) to assist in 

point-of-care prescribing and patient outcome monitoring;

• Culturally appropriate materials and methods to help clinicians explain to 

patients the benefits and limitations of antimicrobial drugs and the importance of 

appropriate use of these drugs; and

• Material that could be included in licensing, board certification, and credentialing 

examinations.

Coordinators: CDC, FDA; Collaborators: DoD, DVA, HRSA, HCFA

Timeline: Initiated

3. Goal: Promote appropriate antimicrobial use through regulatory changes and public policy 

actions.

a. Action Items

(27) Explore ways to integrate appropriate use information into antimicrobial package 

inserts and promotional materials, to provide such information to patients with each 

prescription, and to provide clear guidance to industry to ensure that promotion of 

antimicrobials directed towards consumers encourages appropriate use and 

discourages inappropriate use. 

Coordinator: FDA; Collaborator: CDC

Timeline: Initiated

(28) Articulate factors that support the current approach of requiring prescription-only 

dispensing for all systemic (i.e., nontopical) antimicrobial drugs used in clinical 

medicine.

Coordinator: FDA; Collaborator: CDC

Timeline: Begin within one to two years

(29) Periodically review and update antimicrobial drug susceptibility information included in 

drug labeling, with input from stakeholders and other experts, e.g., the National 
23

Committee for Clinical Laboratory Standards (NCCLS) and CDC.

Coordinator: FDA 

Timeline: Begin within one to two years

(30) Convene an advisory panel or other expert group involving stakeholders and 

partnersb to consider issues related to resistant pathogens that cause serious 

infections for which available treatment options are very limited or nonexistent. 

Issues include:

• Criteria for designating such drug-pathogen combinations;

• Compiling and updating a list of such drug-pathogen combinations;

• Recommendations for diagnosis and management of patients with suspected or 

documented infection, including where appropriate that selected important drugs 

be preferentially used for the treatment of conditions associated with organisms 

that are resistant to other drugs;

• Publicizing and facilitating access to clinical trials or compassionate use of 

investigational therapies;

• Recommendations for preventing infection transmission;

• Recommendations for performance and reporting of susceptibility test results for 

selected important drugs by clinical laboratories including possibly that they be 

reported to clinicians only on request if an organism is sensitive to other 

appropriate drugs;

• Monitoring the use of selected important drugs, with consideration of changes in 

product labeling by FDA and in recommendations for use if increased resistance 

is detected; and

• Labeling by FDA of selected important drugs with the recommendation that 

they be preferentially used for the treatment of conditions associated with 

organisms that are resistant to other drugs. (Related Action Item: This item will 

also be considered in conjunction with Product Development #80.)

Coordinators: FDA, CDC

Timeline: Begin within one to two years

(31) Convene a working group to examine the impact of federal reimbursement policies 

for home parenteral antimicrobial treatment, appropriate antimicrobial use, and 

appropriate use of antimicrobial susceptibility testing. Where needed, the working 

group will make recommendations for modifying these policies.

Coordinator: HCFA; Collaborators: CDC, HRSA

Timeline: Begin within one to two years

(32) Develop and submit measures for appropriate antimicrobial use to the National 

Committee for Quality Assurance for inclusion in Health Plan Employer Data and 

Information Set (HEDIS), which provides comparative data on managed care 

organizations.
24

Coordinator: CDC; Collaborator: HCFA

Timeline: Initiated

B. Issue: Improved diagnostic practices can enhance antimicrobial use and patient care.

1. Goal: Identify and promote the widespread use of diagnostic testing and reporting 

strategies that effectively facilitate appropriate use of antimicrobial drugs in routine 

practice.

a. Action Items

(33) Evaluate the potential impact of improved diagnostic tests, including rapid point-ofcare tests on antimicrobial drug use and patient care, and assess their financial 

implications. Take into account tests that distinguish between bacterial and viral 

infections, tests that identify resistant pathogens, and tests that distinguish common 

clinical entities such as bacterial sinusitis and acute bacterial otitis media from 

illnesses with similar manifestations for which antimicrobials are not beneficial. 

(Related Action Item: Research #76)

Coordinators: CDC, FDA, NIH; Collaborators: DVA, DoD, 

Timeline: Begin within one to two years

(34) Identify economic and other barriers in the health care system (e.g., reimbursement 

policies by third-party payers, managed care practices, cost considerations, empiric 

treatment recommendations, etc.) to diagnostic testing that promotes appropriate 

use of antimicrobials. Develop recommendations that remove disincentives or 

promote incentives to such testing.

Coordinator: HCFA; Collaborators: CDC, HRSA; AHRQ

Timeline: Begin within three to five years

(35) In collaboration with professional societies, industry, health departments, and other 

stakeholders and partners,b develop guidelines for clinicians and clinical 

microbiology laboratories that address:

• Appropriate specimen collection;

• Performance, interpretation, and reporting of antimicrobial (including 

antibacterial, antifungal, antiviral, and antiparasitic) susceptibility tests performed 

on clinical specimens; and

• Use of in-office (point-of-care) tests for infection, including AR infections.

Coordinator: CDC; Collaborators: FDA, DoD, DVA, HCFA, HRSA

Timeline: Begin within three to five years

(36) In collaboration with professional societies, industry, health departments, and other 

stakeholders and partners,b develop guidelines that address the use of clinical 
25

microbiology laboratories for use by health care delivery organizations. The 

guidelines will:

• Promote access to clinical microbiology services by clinicians;

• Promote access to appropriate on-site microbiology services in acute care 

facilities;

• Allow physicians to submit specimens to clinical laboratories other than those 

designated by their health care delivery organization or the patient’s insurance 

company, with appropriate justifications; and

• Facilitate direct consultation between clinicians and laboratory personnel with 

appropriate expertise and authority.

Coordinator: CDC; Collaborator: HCFA for bullet 2.

Timeline: Begin within one to two years

(37) Promote the increased performance of direct examination of microbiological 

specimens (e.g., by Gram stain or other rapid method), in circumstances where 

appropriate, clinically relevant, and reliable information can be garnered, as a readily 

available point-of-care diagnostic test. This step will require working within the 

framework of the Clinical Laboratory Improvement Amendment (CLIA) regulations 

and involving medical education and health care delivery organizations.

Coordinator: CDC; Collaborator: HCFA

Timeline: Begin within one to two years

C. Issue: Preventing infection transmission through improved infection control, behaviors that 

prevent infection (e.g., safe sexual practices), and use of vaccines can help prevent the 

spread of antimicrobial resistance.

1. Goal: Identify ways to reduce disease transmission in health care settings and in the 

community.

a. Action Items

(38) Identify factors that promote transmission of drug-resistant pathogens in health care 

facilities, in extended care facilities, and in community settings including daycare 

centers and in the community at large. These may include characteristics of the 

facilities and of the populations that they serve.

Coordinator: CDC; Collaborators: DVA, DoD

Timeline: Initiated
26

(39) TOP PRIORITY ACTION ITEM - Evaluate the effectiveness (including costeffectiveness) of current and novel infection-control practices for health care and 

extended care settings and in the community. Promote adherence to practices 

proven to be effective.

Coordinator: CDC; Collaborators: DoD, DVA, HCFA, HRSA

Timeline: Initiated

(40) Evaluate the cost-effectiveness and impact on patient care and drug resistance of 

medical devices that incorporate anti-infective compounds to prevent infection (e.g., 

anti-infective urinary catheters and prosthetic heart valves). Where appropriate 

(e.g., shown to be effective and not induce resistance), encourage the clinical use of 

these devices. (Related Action Item: Product Development #82)

Coordinator: CDC; Collaborators: AHRQ, DoD, DVA, FDA, HRSA, 

HCFA

Timeline: Begin within three to five years

(41) Encourage the development and implementation of clinical alternatives to those 

invasive medical procedures and devices that increase the risk of infection in 

hospitals and other health care settings, e.g., substitution of transcutaneous 

monitoring of blood oxygen levels of indwelling catheters. 

Coordinator: CDC; Collaborators: FDA, DVA 

Timeline: Begin within three to five years

(42) Evaluate the benefits and risks of incorporating antimicrobial, disinfectant, or 

antiseptic chemicals into consumer products (e.g., soap, toys, kitchen utensils, 

clothes, paints, plastics, and film preservatives) and of applying disinfectants and 

sanitizers to hard, non-porous surfaces such as food-contact surfaces, hospital 

premises, bathrooms, etc. Consider whether they have any efficacy in reducing 

infection and/or may play a role in promoting drug resistance.

Coordinators: CDC, EPA; Collaborator: FDA

Timeline; Initiated

2. Goal: Promote infection control through behavioral and educational interventions.

a. Action Items

(43) Conduct a public health campaign to promote hand hygiene and other hygienic

practices, as well as other behaviors that prevent the transmission of infectious 

organisms, in collaboration with professional societies and stakeholders. This 

campaign may be coordinated with the public health education strategy to promote 

appropriate antimicrobial use described in Action Item #25: Prevention and 

Control. Components will include developing, evaluating, and facilitating the 
27

implementation of school-based and other programs that promote hand hygiene and 

other behaviors that prevent infection, building on previous campaigns (e.g., 

American Society of Microbiology’s Operation Clean Hands).27

Coordinator: CDC

Timeline: Begin within one to two years

(44) Facilitate and support the activities of infection control programs in health care 

settings as a component of medical care. Promote infection control education at all 

stages of training and practice for all health care workers who have contact with 

patients.

Coordinator: CDC; Collaborators: DVA, HCFA, DoD, HRSA

Timeline: Initiated

(45) Support ongoing public health education campaigns on food safety, such as FDA 

and USDA’s Fight Bac program,28 whose aims are to educate food producers, 

suppliers, retailers, and consumers about food safety practices that reduce 

foodborne infections (including AR infections).29

Coordinators: USDA, CDC, FDA

Timeline: Initiated

(46) Educate the public about the merits and safety of irradiation as one tool to reduce 

bacterial contamination of food.

Coordinator: CDC

Timeline: Begin within one to two years

3. Goal: Optimize the use of vaccines to prevent drug-resistant infections and reduce 

antibiotic use.

a. Action Items

(47) Support community-based programs that promote and facilitate availability of 

recommended vaccinations for adults and children.

Coordinator: CDC

Timeline: Initiated

(48) Identify vaccines useful in preventing drug-resistant infections and reducing 

antimicrobial drug use, and evaluate novel methods for improving coverage with 

these vaccines. For example: 

• Evaluate the risks and benefits of allowing certain vaccines for adults (e.g., for 

pneumococci and influenza virus) to be dispensed by pharmacists without 

prescription and

• Review and evaluate methods to promote administration of pneumococcal 
28

vaccines (e.g., offering vaccination when patients are discharged from the 

hospital), and encourage the use of methods found to be effective.

Coordinator: CDC; Collaborators: DVA, FDA, HCFA

Timeline: Begin within three to five years

D. Issue: Prevention and control of drug resistance in agriculture and veterinary medicine is 

important to promoting animal and plant health, as well as in preventing AR transmission 

to humans through the food supply or through contact with infected animals or the 

environment.

1. Goal: Improve understanding of the risks and benefits of antimicrobial use, and ways to 

prevent the emergence and spread of drug resistance, in agricultural and veterinary 

settings.

a. Action Items

(49) Evaluate the nature and magnitude of the impact of using various antimicrobial drugs 

as growth promotants in different species, using current animal husbandry practices. 

 Use this information to assist in risk-benefit assessments of such use.

Coordinator: USDA; Collaborators: CDC, FDA

Timeline: Begin within one to two years

(50) Conduct additional research to further define the effects of using various veterinary 

drugs on the emergence of resistant bacteria that infect or colonize food animals of 

different species, using various animal husbandry practices. Identify risk factors and 

preventive measures. Assess the associated risk of: 

• Transmission of AR infections to humans;

• Clinical disease in humans; and

• Transfer of resistance factors from animal flora to human flora.

Coordinators: CDC, USDA, FDA

Timeline: Initiated

(51) Conduct epidemiologic and laboratory studies to assess the risk of development 

and transfer of resistance related to the use of antimicrobial drugs in food and 

nonfood plants, and identify risk factors and potential preventive measures.

Coordinator: USDA; Collaborators: CDC, FDA, EPA

Timeline: Initiated

(52) Develop rapid tests for inspecting fresh commodities like fruit for evidence of 

contamination with bacteria that are resistant to antibiotics.

Coordinator: USDA; Collaborators: EPA, FDA, CDC

Timeline: Begin within one to two years
29

(53) Evaluate the effect of current food processing and distribution methods on the 

emergence and spread of drug-resistant organisms.

Coordinator: USDA; Collaborators: CDC, FDA

Timeline: Begin within one to two years

(54) Identify and evaluate new food pasteurization strategies.

Coordinator: USDA; Collaborators: FDA, CDC

Timeline: Begin within three to five years

(55) Assess the risk of AR emergence and spread due to environmental contamination 

by antimicrobial drugs or by resistant bacteria in animal and human waste. Collect 

information on whether environmental contamination by antimicrobial drugs can lead 

to the development of resistance in bacteria that live in the soil or in water. (Related 

Action Item: Surveillance #19)

Coordinators: USDA, CDC, EPA, FDA 

Timeline: Initiated

(56) Assess the impact of antimicrobial use in companion animals (pets) on colonization 

and infection with drug-resistant organisms in the animals and their human household 

contacts.

Coordinator: CDC

Timeline: Begin within three to five years

2. Goal: Promote appropriate antimicrobial use in agricultural and veterinary settings.

a. Action Items

(57) Work with veterinary and agricultural communities to help educate users of 

veterinary and agricultural antimicrobials about AR issues, and promote the 

implementation and evaluation of guidelines that address these issues:

• Appropriate antimicrobial use in agricultural and veterinary settings;

• Performance and interpretation of antimicrobial susceptibility tests performed on 

specimens from different species of animals; and

• Point-of-care tests for infection, including AR infections.

Coordinators: USDA, CDC, FDA; Collaborator: EPA

Timeline: Initiated

(58) TOP PRIORITY ACTION ITEM - In consultation with stakeholders, refine and 

implement the proposed FDA framework30 for approving new antimicrobial drugs 

for use in food-animal production and, when appropriate, for re-evaluating currently 

approved veterinary antimicrobial drugs. The proposed framework includes the 

following major steps:
30

• Categorize antimicrobial drugs according to their importance in human medicine.

Timeline: Initiated

• Develop an approach to the establishment of thresholds for drug resistance in 

selected pathogens.

Timeline: Initiated

• Revise requirements for the industry’s submission of drug use data.

Timeline: Initiated

• Develop procedures to assess microbial safety of antimicrobial drug use in 

food-producing animals.

Timeline: Initiated

In support of the concepts articulated in the framework document:

• Conduct risk assessments on the human health impact of using selected 

antimicrobials important in human medicine in food-producing animals

Timeline: Initiated

• Initiate appropriate steps to address any unacceptable human health impact, if 

identified by the risk assessments, for drugs categorized as being of critical 

importance in human medicine

Timeline: Begin within one to two years

Coordinator: FDA

(59) Strongly encourage involvement of veterinarians in decisions regarding the use of 

systemic antimicrobial drugs in animals, regardless of the distribution system through 

which the drug is obtained (e.g., regardless of whether a prescription is required to 

obtain the drug).

Coordinators: FDA, USDA

Timeline: Initiated

(60) Evaluate the potential impact of making all systemic veterinary antimicrobial drugs 

available by prescription only.

Coordinators: FDA, USDA

Timeline: Begin within three to five years

(61) Convene an expert group to consider how to incorporate AR issues into regulations 

governing the registration and use of antimicrobials and antibiotic pesticides. Invite 

external experts, stakeholders, and the public to provide input.

Coordinator: EPA

Timeline: Begin within one or two years
31

E. Issue: Efforts to prevent and control AR emergence and spread must be comprehensive and 

multifaceted, involve a wide variety of nonfederal partners and the public, and become a 

part of routine practice nationwide.

1. Goal: Ensure input from nonfederal experts on federal efforts to combat antimicrobial 

resistance.

a. Action Item

(62) Establish an ongoing mechanism to obtain periodic input from external experts on 

AR issues. This process will include ensuring input from stakeholders and partnersb

(e.g., state and local health agencies, the private sector, and the public) in 

developing and reviewing federal efforts to address antimicrobial resistance.

Coordinators: CDC, FDA, NIH; Collaborators: USDA, EPA, DoD, DVA, 

AHRQ, HRSA, HCFA

Timeline: Begin within one to two years

2. Goal: Develop and evaluate comprehensive demonstration programs to prevent and 

control AR.

a. Action Item

(63) TOP PRIORITY ACTION ITEM - Support demonstration projects to evaluate 

comprehensive strategies that use multiple interventions to promote appropriate 

drug use and reduce infection rates. These projects will include the following steps:

• Assess how interventions found effective in research studies can be applied 

routinely and most cost-effectively on a large scale;

• Evaluate the use of these programs in health care systems (federal and 

nonfederal), in the community, and in agricultural and veterinary settings; and

• Involve partnerships with local and state agencies, health care systems, 

professional societies, community organizations, schools, private industry, and 

the public.

Coordinator: CDC; Collaborators: FDA, DVA, DoD, HRSA, HCFA, 

Timeline: Initiated

3. Goal: Incorporate into routine clinical practice AR prevention strategies and programs that 

have been found to be beneficial in research and demonstration projects.

a. Action Items

(64) Utilize federal health care systems (e.g., DoD, DVA) as models for AR surveillance 

and prevention and control activities involving appropriate drug use, optimized 
32

diagnostic testing, infection control, and vaccination practice.

Coordinators: CDC, DVA, DoD, HCFA, HRSA

Timeline: Begin within three to five years

(65) For all health care systems for which federal funds are provided, identify and 

promote strategies to establish AR prevention and control activities as part of 

quality monitoring programs.

Coordinators: CDC, DVA, DoD, HCFA, HRSA

Timeline: Initiated

(66) Encourage nationally recognized accrediting agencies such as the National 

Committee for Quality Assurance (NCQA) and the Joint Commission on 

Accreditation of Healthcare Organizations (JCAHO) to include accreditation 

standards that promote efforts to prevent and control AR, including appropriate 

antimicrobial use, infection control, vaccine use, and diagnostic testing. These 

standards may draw on the findings of existing data and demonstration programs 

and AHRQ Evidence-Based Practice Centers.

Coordinator: CDC; Collaborators: HCFA, AHRQ

Timeline: Begin within one to two years

III. Research

Antimicrobial resistance is among the most challenging problems in microbiology, clinical medicine, and 

public health. Antimicrobial resistance is not one problem, but an overarching term for an array of 

problems inherent in the evolution of microbes and influenced by antimicrobial use. Basic and clinical 

research provides the fundamental knowledge necessary to develop appropriate responses to 

antimicrobial resistance emerging and spreading in hospitals, communities, farms, and the food supply. 

Major scientific accomplishments throughout the years have contributed much to the understanding of 

the fundamental biological processes of AR within microbes and the resulting impact on humans, 

animals, and the environment. This knowledge base provides us the opportunity to influence these 

processes and outcomes.

Because of its broad scope, the U.S. research community has a major contribution to make in meeting 

the goals the AR Task Force has set forth. The research and development of diagnostic tests, new 

antimicrobial agents, novel therapeutic products, and vaccines and other preventive approaches in 

response to AR is a multistep process that begins with basic research discoveries and ends with the 

availability and use of a new product or implementation of a process. Along this pathway three areas 

need to be addressed: the identification of gaps and needs in the molecular and cellular understanding of 

resistance, the infrastructure to support a robust research community, and a means for moving research 

findings into the development of new products.

The Interagency Task Force has worked with representatives from the public and private sector to 
33

identify important research needs in microbial physiology, ecology, genetics and mechanisms of 

resistance. Existing gaps in knowledge and understanding should be addressed to augment the federal 

and private sector response to the overall problem. Efforts are underway to build and enhance the field 

of AR research, through increased focus, recognition, and collaboration. The aim is to develop a 

research infrastructure to support a critical mass of AR researchers who will interact, exchange

information, and stimulate new discoveries. In order to move novel ideas arising in the research 

laboratory to useful products or approaches, support of the underlying infrastructure to study and test 

products and a mechanism to transition to industrial partners is necessary.

This effort will involve federal agencies that conduct, support and promote basic and clinical research in 

academia and industry and will involve prioritizing needs, identifying key opportunities, recruiting new 

investigators to the field, and making responsible use of resources to address AR problems.

A. Issue: Specific scientific gaps remain in the understanding of microbial physiology, ecology, 

genetics and mechanisms of resistance.

1.Goal: Identify gaps and address existing research needs and identify new ones.

a. Action Items

(67) Additional research, including high risk and high payoff research in nontraditional 

fields, is needed to enhance the understanding and assess the impact of:

• Mechanisms of AR emergence, acquisition, spread, persistence, and decline, 

with special regard to multidrug resistant organisms;

• Emergence and transfer of resistance genes among microorganisms in vivo, 

including epidemiologic factors;

• Microbial ecology and the role of normal flora as a repository of resistance 

factors, as well as the use of susceptible bacterial populations in the control of 

antimicrobial resistance;

• Effects of preventive, therapeutic, growth-promoting agents and residues of 

agents in the environment on the microbiota of animals, plants, soil, and aquatic 

environments;

• Host factors and immune modulators (e.g., cytokines) in clinical resistance to 

treatments for opportunistic infections;

• The determinants of colonization and infection with drug-resistant pathogens; 

and

• Variations in antimicrobial use patterns that may affect the emergence and 

spread of resistance and the outcome of treatment, such as:

o Differences in duration and dosage in the administration of antimicrobial 

agents;

o Prophylactic use of antimicrobial (including antibacterial and antifungal) 

agents;
34

o Drug combinations used to treat resistant organisms; and

o The rotation (cycling) of antimicrobial drugs and other similar changes in 

selection and use of drug classes.

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

Timeline: Initiated

(68) Conduct further government-wide assessments with external input on the scope and 

composition of AR research to identify research opportunities.

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

AHRQ, EPA, HCFA

Timeline: Initiated

B. Issue: The existing research infrastructure needs to ensure a critical mass of researchers in AR 

and related fields.

1. Goal: Augment the scientific research infrastructure.

a. Action Items

(69) Work with the appropriate peer review structures to ensure that the requisite 

expertise is applied to the review process to facilitate funding of quality AR 

research.

Coordinators: NIH, DVA, FDA

Timeline: Begin in one to two years

(70) TOP PRIORITY ACTION ITEM - Provide to the research community 

genomics and other powerful technologies to identify targets in critical areas for the 

development of new rapid diagnostics methodologies, novel therapeutics, and 

interventions to prevent the emergence and spread of resistant pathogens. 

Examples include tools such as microbial genome sequences, information on 

comparative genomics, DNA chip technology, informatics, and assistance in the 

application and use of these tools.

Coordinator: NIH; Collaborators: DoD, USDA, FDA

Timeline: Initiated

(71) Encourage sharing of AR data between industry and the research community, 

including genomics and other technologies.

Coordinator: NIH; Collaborators: DoD, USDA, FDA

Timeline: Begin in three to five years

2. Goal: Develop a critical mass of researchers in AR.
35

a. Action Items

(72) Bring new researchers into the field, by utilizing appropriate strategies such as 

training and research opportunities.

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

Timeline: Initiated

(73) Organize conferences that address research issues relating to AR.

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

Timeline: Initiated

C. Issue: Special efforts are needed to translate research findings into medically useful products 

for human and agricultural/veterinary use, such as novel antimicrobial therapeutics, 

diagnostic tests, vaccines and other tools for preventing AR emergence and spread.

1. Goal: Address the governmental role in translating novel ideas into new clinically relevant 

products, focusing on gaps not filled by pharmaceutical industry and other 

nongovernment groups.

a. Action Items

(74) Explore the need to encourage preclinical studies on the toxicology, 

pharmacokinetics, and pharmacodynamics of novel therapeutic agents for the 

treatment of multidrug-resistant pathogens and facilitate the transition of potential 

products from preclinical to clinical studies leading to development by industry of 

novel therapeutic agents.

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

Timeline: Begin within one to two years

(75) TOP PRIORITY ACTION ITEM - In consultation with academia and the 

private sector, identify and conduct human clinical studies addressing AR issues of 

public health significance that are unlikely to be studied in the private sector, such as:

• Novel therapies;

• Existing antimicrobials administered in treatment regimens and combinations that 

may not be included in approved indications and dosing schedules; and

• Other products and practices relevant to the control and treatment of 

antimicrobial-resistant pathogens including devices, diagnostics, antimicrobial 

soaps, disinfectants, etc.

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

Timeline: Begin within one to two years

2. Goal: Develop rapid, inexpensive, point-of-care diagnostic methods to facilitate 
36

appropriate use of antimicrobials.

a. Action Item

(76) TOP PRIORITY ACTION ITEM - Identify, develop, test, and evaluate new 

rapid diagnostic methods for human and veterinary uses with partners including 

academia and the private sector. Such methods should be accurate, affordable, and 

easily implemented in routine clinical settings and may include:

• Tests for resistance genes that are associated with drug resistance, including 

nonculture specimens;

• Rapid point-of-care diagnostics for patients with viral respiratory infections and 

clinical syndromes such as otitis media, sinusitis, and pneumonia; and

• Rapid methods for detecting drug resistance among fungi, parasites, viruses, and 

mycobacteria.

Coordinators: NIH, FDA; Collaborators: DoD, USDA, CDC, AHRQ, DVA

Timeline: Initiated

3. Goal: Develop new products and strategies to prevent and treat colonization and infection 

with resistant organisms in patients, prevent transmission of resistant infections in the 

community, and prevent AR emergence

a. Action Items

(77) TOP PRIORITY ACTION ITEM - Encourage basic and clinical research in 

support of the development and appropriate use of vaccines in human and 

veterinary medicine in partnership with academia and the private sector. Vaccines 

are needed to:

• Prevent viral infections that predispose patients to and are difficult to 

differentiate from bacterial infection and are presumptively treated with 

antibacterial agents (e.g., influenza virus);

• Prevent colonization, infection, and transmission of resistant organisms such as 

enterococci and staphylococci; and

• Prevent common bacterial infections (such as S. pneumoniae, nontypable 

Haemophilus influenzae) to reduce antibacterial use.

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

Timeline: Initiated

(78) Encourage basic and clinical research in support of novel approaches to preventing 

or treating infections with resistant organisms that occur in humans and animals by 

partnering with academia and the private sector. Novel approaches may include:

• Bacteriophage therapy;

• Active (vaccine) and passive (antibody, hyperimmune globulin) immunization;
37

• Host-derived antimicrobial agents;

• Nonantibiotic antimicrobials and nonchemical approaches with broad or 

nonspecific anti-infective activities (e.g., defending and nonspecific 

immunostimulants, such as defensins, ribozymes, etc.); and

• Microbial ecology (probiotics, direct fed microbials, etc.).

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

Timeline: Initiated

IV. Product Development

New products are not being developed rapidly enough to address increasing microbial resistance. 

Needed products include not only new classes of antimicrobials able to kill otherwise resistant 

organisms, but also vaccines and anti-infective devices with the potential to prevent infections as well as 

improved diagnostic tools to aid in appropriate use of therapeutics. With respect to antimicrobial drugs, 

each new agent represents a major investment by a pharmaceutical company, which must shepherd the 

product through pre-clinical studies and clinical testing, followed by large and expensive clinical trials. 

Pharmaceutical companies may be reluctant to invest extensive resources in the development of drugs, 

such as those antimicrobials targeted to resistant organisms, which are often given for short time periods 

to small numbers of patients. Manufacturers are similarly concerned that appropriate use policies may 

limit sales and profits. On the other hand, when a drug is used widely, allowing recovery of costs and 

profitability, resistance may develop more rapidly and shorten the useful life of the drug.

Due to these economic realities – as well as to scientific limitations and a lag in the perception of a need 

for new agents – very few novel antimicrobial drugs have reached the market for several years. A 

major aim of this interagency effort is to work with the private sector to explore and test innovative 

ways to address these issues. Approaches to be considered include providing incentives (and 

overcoming disincentives) to promote and assist the development of important products to address AR.

Product development is also a very important issue for veterinary medicine and agriculture. U.S. 

agencies and private sector partners must intensify efforts to encourage the development and use of 

veterinary drugs and agricultural practices that are unlikely to stimulate resistance to important human 

drugs or spread resistant pathogens to humans. Again, increased attention also needs to be turned to 

strategies to prevent infections of animals (e.g., vaccines, changes in husbandry) and to the improved 

use of existing and new products.

A. Issue: Researchers and drug manufacturers need to be better informed of current and 

projected gaps in the arsenal of antimicrobial drugs, vaccines, and diagnostics and of 

potential markets for these products.

1. Goal: Provide a systematic assessment of the current status and projected future needs for 

AR products.
38

a. Action Item

(79) TOP PRIORITY ACTION ITEM - Create an Interagency AR Product 

Development Working Group to identify and publicize priority public health needs in 

human and animal medicine for new AR products (e.g., innovative drugs, targeted 

spectrum antibiotics, point-of-care diagnostics, vaccines and other biologics, antiinfective medical devices, and disinfectants). The Working Group will take these 

steps:

• Obtain input from stakeholders, including pharmaceutical companies, 

physicians, epidemiologists, and microbiologists, on which products are needed;

• Involve experts in the nonmedical disciplines (e.g., engineering and remote 

sensing, etc.);

• Model future resistance trends, product needs, and potential markets 

(particularly for novel and narrow spectrum uses), taking into account AR 

surveillance data and numbers of patients at high risk of developing drug 

resistant infections (e.g., increases in immunocompromised patients);

• Evaluate current market incentives for the development of priority AR products 

(Related Action Item: Product Development #80);

• Reassess AR product priorities on a regular basis; 

• Evaluate the availability of currently approved, critical products where shortages 

or potential for shortages exists and develop an approach to ensure that the 

supply of such products is adequate to meet public health needs; and

• Communicate the information and priorities developed by the Workgroup to 

inform and allow coordination with planning and action efforts in research, 

prevention and control, and product development.

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

Timeline: Begin within one to two years

B. Issue: Existing market incentives and regulatory processes may be insufficient to stimulate the 

development of certain priority AR products while fostering their appropriate use.

1. Goal: Investigate and act upon potential approaches for stimulating and speeding the entire 

AR product development process, from drug discovery through licensing.

a. Action Items
39

(80) TOP PRIORITY ACTION ITEM - Identify ways (e.g. financial and/or other 

incentives or investments) to promote the development and/or appropriate use of 

priority AR products, such as novel compounds and approaches, for human and 

veterinary medicine for which market incentives are inadequate.

• This process should include consultation with outside stakeholders, economic 

consultants, and the AR Product Development Working Group (Related Action 

Item: Product Development #79).

• All such proposals will require careful economic modeling and analysis. New 

approaches should be used on a trial basis for appropriate time periods and the 

costs and benefits of incentives used in these pilot programs should be 

monitored to assess the return on the public investment.

• Similar incentives should be explored for ensuring adequate availability of 

existing products that meet critical public health needs but for which market 

incentives are inadequate to assure supply. (Related Action Item: Product 

Development #79).

Coordinators: FDA, CDC; Collaborators: USDA, AHRQ

Timeline: Begin within one to two years

(81) Consider, in consultation with academia and industry, whether government has a 

constructive role to play in discovery of drugs and other products targeted to 

address areas where market incentives are limited and unmet needs exist (e.g., 

novel antimicrobial drugs targeted to specific resistant organisms). (Related Action 

Items: Research Issue B)

• Such a role could utilize intramural, extramural or partnership type mechanisms. 

 Products developed under such mechanisms could be licensed commercially 

either with or without specific stipulations regarding use.

Coordinator: NIH; Collaborators: USDA, FDA, CDC

Timeline: Begin within three to five years

(82) Continue ongoing approaches that streamline the regulatory process, including 

clinical trials and enhanced pre-clinical studies (e.g., use of pharmacokinetics, and 

pharmacodynamics data) to help bring AR products (including drugs, vaccines, 

diagnostics and devices) to market as efficiently and rapidly as possible, while still 

assuring their safety and efficacy.

• This approach might involve use of an expedited process in which certain drugs 

are considered for approval, in accordance with Subpart E of the Investigational 

New Drug (IND) regulations. It might also involve defining new surrogate 

endpoints that indicate a meaningful response benefit over existing treatments for 

particular infections (e.g., HIV-1 RNA viral loads or CD4 counts as surrogate 

markers in the treatment of HIV/AIDS), in accordance with Subpart H of New 

Drug Application (NDA) regulations.

• In the case of approvals for anti-infective medical devices, AR concerns will be 
40

addressed during the pre-and post-licensing review, to ensure that these 

products reduce infection without engendering significant resistance.

• For products specifically targeted to serious or life-threatening AR infections, 

for which there are few therapeutic alternatives, develop approaches for more 

focused development programs that would streamline product availability. This 

should be done in consultation with all of the stakeholders in the process. 

Coordinator: FDA; Collaborator: USDA

Timeline: Initiated

C. Issue: The development and use of antimicrobial drugs and related products in agriculture and 

veterinary medicine should be optimized to reduce the development and transfer of 

resistance to pathogens that can infect humans.

1. Goal: Promote the development and use of new and existing AR products that reduce the 

risk of the development and transfer of antimicrobial resistance to humans, as well 

as new approaches to reducing agricultural and veterinary use of antimicrobial 

drugs.

a. Action Items

(83) In consultation with stakeholders and expert consultants, identify ways to promote 

the development of new and alternative veterinary treatments and the improved use 

of existing therapies that are unlikely to stimulate resistance to drugs in human 

medicine. This action will include consideration of the incentives and approaches 

listed in Action Items #80 (Product Development), #28 (Prevention and Control), 

and #78 (Research) and the implementation of pilot programs to stimulate the 

development of priority products that meet critical animal health needs. 

• Approaches for evaluation should include ways to improve and/or reduce the 

use of specific antimicrobial drugs, as well as ways to prevent infection, such as 

vaccines, changes in animal husbandry, and the use of competitive exclusion 

products (e.g., treatments that affect the intestinal flora of food animals).

Coordinators: FDA, USDA, NIH, CDC

Timeline: Begin within three to five years

(84) Streamline the regulatory and approval process for veterinary antimicrobial drugs 

and related products that are unlikely, now or in the future, to result in transfer of 

antimicrobial resistance to humans.

Coordinators: FDA, USDA 

Timeline: Begin within three to five years
41

References

1. Hofmann J, Cetron MS, Farley MM, et al. The prevalence of drug-resistant Streptococcus 

pneumoniae in Atlanta. N Engl J Med. 1995;333:481-6.

2. Panlilio AL, Culver DH, Gaynes RP, et al. Methicillin-resistant Staphylococcus aureus in U.S. 

hospitals, 1975-1991. Infect Control Hosp Epidemiol. 1992;13:582-6.

3. CDC. Four pediatric deaths from community-acquired methicillin-resistant Staphylococcus 

aureusBMinnesota and North Dakota, 1997-1999. MMWR. 1999;48:707-10.

4. Gupta K, Scholes D, Stamm WE. Increasing prevalence of antimicrobial resistance among 

uropathogens causing acute uncomplicated cystitis in women. JAMA. 1999;281:736-8.

5. Glynn MK, Bopp C, Dewitt W, et al. Emergence of multidrug-resistant Salmonella enterica

serotype typhimurium DT104 infections in the United States. N Engl J Med. 1998;338:1333-8.

6. Martone W. Spread of vancomycin-resistant enterococci: why did it happen in the United 

States? Infect Control Hosp Epidemiol 1998;19:539-45.

7. Wiener J, Quinn JP, Bradford PA, et al. Multiple antibiotic-resistant Klebsiella and 

Escherichia coli in nursing homes. JAMA 1999;281:517-23.

8. CDC. Active Bacterial Core Surveillance, unpublished data 1999. 

9. Hiramatsu K, Hanaki H, Ino T, Yabuta K, Oguri T, Tenover FC. Methicillin-resistant S 

Staphylococcus aureus clinical strain with reduced vancomycin susceptibility. J Antimicrob 

Chemother 1997;40:135-136.

10. Smith TL, Pearson ML, Wilcox KR, et al. Emergence of vancomycin resistance in 

Staphylococcus aureus. N Engl J Med. 1999;340:493-501.

11. Pablos-Mendez A, Raviglione MC, Laszlo A, et al. Global surveillance for antituberculous drug 

resistance, 1994-1997. N Engl J Med 1998;338:1641-9.

12. Fox KK, Knapp JS, Holmes KK, et al. Antimicrobial resistance in Neisseria gonorrhoeae in 

the United States, 1998-1994: the emergence of decreased susceptibility to the 

fluoroquinolones. J Infect Dis 1997;175:1396-403.

13. Wainberg MA, Friedland G. Public health implications of antiretroviral therapy and HIV drug 

resistance. JAMA 1998;279:1977-83.
42

14. Rex JH, Rinaldi MG, Pfaller MA. Resistance of Candida species to fluconazole. Antimicrob 

Agents Chemotherapy 1995;39:1-8.

15. White NJ. Drug resistance in malaria. Br Med Bull 1998;54:703-15.

16. Adcock PM, Pastor P, Medley F, et al. Methicillin-resistant Staphylococcus aureus in two 

child care centers. J Infect Dis 1998;178:577-80.

17. U.S. Congress, Office of Technology Assessment, Impacts of Antibiotic-Resistant Bacteria, 

OTA-H-629, Washington, DC: U.S. Government Printing Office, September 1995.

18. National Academy of Sciences, Institute of Medicine. Forum on Emerging Infections, 

Antimicrobial Resistance: Issues and Options [Workshop Report], Washington, DC, 1998.

19. American Society for Microbiology. Report of the ASM Task Force on Antibiotic Resistance, 

Washington, DC, 1995. 

20. World Health Organization. World Health Organization Report on Infectious Diseases 2000; 

Overcoming Antimicrobial Resistance. WHO/CDS/2000.2 Geneva 2000.

21. General Accounting Office, Antimicrobial Resistance: Data to assess public health threat from 

resistant bacteria are limited [GAO/HEHS/NSIAD/RCED-99-132], Washington, DC, April 

1999.

22. General Accounting Office, Food Safety: The agricultural use of antibiotics and its implications 

for human health [GAO/RCED-99-74], Washington, DC, April 1999.

23. World Health Organization. Draft Global Strategy for the Containment of Antimicrobial 

Resistance. Available on the Internet at <http://www.who.int/emc/amr.html.

24. Centers for Disease Control. A national action plan to combat multidrug resistant tuberculosis. 

MMWR 1992;41 (RR-11).

25. Department of Health and Human Services. Development of a Public Health Action Plan to 

Combat Antimicrobial Resistance. Federal Register 1999;64:34558.

26. Department of Health and Human Services. Draft Public Health Action Plan to Combat 

Antimicrobial Resistance. Federal Register 2000; 65:38832-3.

27. American Society for Microbiology. Clean Hands Campaign. Available on the Internet at 

<http://www.washup.org/>.
43

28. Partnership for Food Safety Education. Fight Bac! Available on the Internet at 

<http://www.fightbac.org/>. 

29. Department of Agriculture. U.S. Government Food Safety for Farm to Table: A National 

Food-Safety Initiative, A Report to the President, Washington, DC, May 1997.

30. Food and Drug Administration. A Proposed Framework for Evaluating and Assuring the 

Human Safety of the Microbial Effects of Antimicrobial New Animal Drugs Intended for Use in 

Food-producing Animals, Rockville, MD, February 1999.
Index to the Action Items

Terms below are listed according to the Action Items in which they may be found. These and other terms may also be 

found in the Executive Summary, Top Priority Action Items, and Introduction and Overview sections of the document.

accreditation 7, 66

Agency for Healthcare Research and Quality (AHRQ)

coordinator 11, 16

collaborator 21, 22, 34, 40, 62, 66, 68, 73, 76, 79, 80

agriculture 5, 13, 83, 84

animal and plant health 19, 83

animal husbandry 50, 83

farms 17, 18

see also food safety

AHRQ see Agency for Healthcare Research and Quality

American Society for Microbiology (ASM) 43

antimicrobial drugs

availability of 5, 12, 47, 60, 79, 80, 82

discovery of 12, 80-82

stimulating resistance 20, 55, 83

gaps in the arsenal of drugs 5, 74, 75, 79

monitoring patterns of drug use 3, 4, 5, 22, 67

overuse and misuse of see appropriate use

prescribing 22, 23, 59, 60

susceptibility of 3, 8-13, 29-31, 35, 37

antimicrobial resistance (AR)

communities, spread of AR in 63, 78

emergence of 3, 4, 20, 50, 51, 53, 55, 67, 70, 83-84

nonfederal partners 62, 63

the public, and 61-63

spread of 53, 55, 67, 70

appropriate use of antimicrobial drugs 21-27, 31-34, 43, 

57, 59, 63, 64, 66, 76, 80

promotion of 21, 22, 25, 26, 43, 63, 66, 80

ASM see American Society for Microbiology

bacteria 17, 18, 20, 33, 35, 46, 50, 52

behavioral change 24-26, 43

behavioral interventions see behavioral change 

CDC see Centers for Disease Control and Prevention

Centers for Disease Control and Prevention (CDC)

coordinator 1-26, 30-33, 35-48, 50, 55-57, 62-66, 68, 

79, 80, 83

collaborator 27, 28, 34, 49, 51-54, 67, 72, 73, 75-78, 

81

CLIA see Clinical Laboratory Improvement Amendments

clinical devices see medical devices and procedures

Clinical Laboratory Improvement Amendments (CLIA) 37

clinical trials 30, 35, 74, 75, 82

competitive exclusion products 83

computer-assisted decision support 24, 26

confidentiality 3, 5

consumer groups see consumers

consumer products 5, 42

consumers 27, 45

contamination

bacterial 46, 52

environmental 19, 55

see also environmental impact

core capacities 13, 14

cross-infection see infection

daycare centers 25, 38

demonstration projects 2, 63

Department of Defense (DoD)

coordinator 64, 65

collaborator 2, 3, 5, 21, 22, 24, 26, 33, 35, 38-40, 44, 

62, 63, 67, 68, 70-78

Department of Veterans Affairs (DVA)

coordinator 64, 65, 69

collaborator 2, 3, 5, 21, 22, 24, 26, 33, 35, 38-41, 44, 

48, 62, 63, 67, 68, 72-78

detection and reporting see surveillance

diagnosis 4, 5, 30

diagnostic tests and testing 13, 14, 33, 34, 37, 64, 66, 70, 

75, 76, 79, 82

disinfectants 42, 75, 79

DoD see Department of Defense

drugs see antimicrobial drugs

DVA see Department of Veterans Affairs

economics 11, 34, 80

electronic surveillance see surveillance

environmental impact 67

see also contamination environmental

Environmental Protection Agency (EPA)

coordinator 1, 3, 19, 20, 42, 55, 61

collaborator 5, 51, 52, 57, 62, 67, 68

EPA see Environmental Protection Agency

epidemiology 10, 51, 67, 79

extended care facilities 21, 38, 39

FDA see Food and Drug Administration

flu see influenza

Food and Drug Administration (FDA)

coordinator 1-6, 9, 10, 13, 15, 17, 18, 23, 25-30, 33, 

45, 50, 55, 57-60, 62, 68, 69, 72, 73, 76, 77, 79, 80, 

82-84

collaborator 2, 3, 21, 22, 35, 40-42, 48, 49, 51-54, 63, 

67, 70, 71, 74, 75, 78, 81

food safety 6, 17, 45, 46, 49-51, 53, 54, 58, 83

fungi 35, 67, 76

genetics see microbial genes and microbial genomics

growth promotants 49

guidelines, clinical 26, 35

HCFA see Healthcare Financing Administration

health care delivery 6, 7, 16, 22, 34, 36-42, 44, 63-65

hospitals 21, 22, 24, 41, 48

managed care 32, 34

state and local health agencies 13, 14, 62, 63

Healthcare Financing Administration (HCFA)

coordinator 7, 10, 11, 15, 31, 34, 64, 65

collaborator 2, 3, 8, 22, 24-26, 32, 35-37, 39, 40, 44, 

48, 62, 63, 66, 68

Health Plan Employer Data and Information Set (HEDIS) 

32

Health Resources and Services Administration (HRSA)

coordinator 11, 64, 65

collaborator 3, 26, 31, 34, 35, 39, 40, 44, 62, 63
HEDIS see Health Plan Employer Data and Information Set

HIV/AIDS 82

host factors 67

HRSA see Health Resources and Services Administration

hygienic practices 43

immunization see vaccine

infection

control 39, 44, 64, 66, 75

transmission 17, 30, 38, 43, 50, 77

influenza 48, 77

insurance 36

JCAHO see Joint Commission on Accreditation of 

Healthcare Organizations

Joint Commission on Accreditation of Healthcare 

Organizations (JCAHO) 66

labeling 4, 9, 29, 30

laboratories 2-4, 8-10, 12-14, 29, 30, 35, 36, 51

market incentives 34, 80, 81, 83

medical devices and procedures 40, 70

Medicare 24

microbial

ecology 67, 78

genes 67, 76

genomics 70

microbiologists 79

microbiology 35, 37, 43

mold see mould 

mould 10

National Committee for Clinical Laboratory Standards 

(NCCLS) 10, 29

National Committee for Quality Assurance (NCQA) 66

National Institutes of Health (NIH)

coordinator 10, 33, 62, 67-78, 81, 83

collaborator 4, 79

NCCLS see National Committee for Clinical Laboratory 

Standards

NCQA see National Committee for Quality Assurance

NIH see National Institutes of Health

nongovernment surveillance see surveillance

outcomes see patient outcomes

outpatient 21

package inserts 27

parasites 10, 35, 76

patient outcomes 5, 16, 22, 24, 26, 67

Peer Review Organizations (PROs) 24

pesticide use 20, 61

pharmaceutical companies 74, 79

pharmacies 6, 48

pharmacodynamics 74, 82 

pharmacokinetics 74, 82

pilot programs 80, 83

pilot studies 2, 19

pre-clinical studies 74, 82

Prevention and Control (Focus Area II) 21-66

Product Development (Focus Area IV) 79-84

products, new

antimicrobials 58, 74, 75, 78, 79, 82-84

vaccines 77, 78, 82, 83

proficiency testing programs 8

PROs see Peer Review Organizations

public health education campaign 25, 43, 45, 46

quality assurance 7, 14, 26

reimbursement 31, 34

regulations 61, 82

regulatory process 82, 84

reporting see Surveillance (Focus Area I)

Research (Focus Area III) 67-78

resistance mechanisms 67

Surveillance (Focus Area I) 1-20

surveillance

electronic 3

national plan 2

nongovernment 2

susceptibility data see antimicrobial drugs susceptibility 

Top Priority Action Items 2, 5, 25, 26, 39, 58, 63, 70, 75-

77, 79, 80

training programs 8, 26, 44, 72

treatment, novel 48, 70, 74, 75, 78-81

USDA see U.S. Department of Agriculture

U.S. Department of Agriculture (USDA)

coordinator 1-6, 10, 13-15, 17-20, 45, 49-55, 57, 59, 

60, 68, 79, 83, 84

collaborator 2, 3, 25, 62, 63, 67, 70-74, 76-78, 80-82

vaccination see vaccine

vaccine 47, 48, 64, 66, 77, 78, 79, 82, 83

veterinary medicine 2, 3, 5, 6, 13-15, 49-61, 63, 76, 77, 80, 

83, 84

viral infection see viruses

viruses 10, 33, 35, 76, 77, 82

yeast 10