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U.S. Department of Health and Human Services

Animal & Veterinary

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Closing Comments: Summary, concluding remarks, and next steps

SLIDE 1:

Summary and Next Steps

Stephen F. Sundlof, D.V.M., Ph.D.
Director
Center for Veterinary Medicine

SLIDE 2:

Summary- Session 2

  • General agreement that appropriate to be more conservative for drugs considered highly important in human medicine
    • Concern expressed as to how important will be defined
  • Interest in meeting with agency to discuss methodology for collecting needed drug use data

SLIDE 3:

Summary- Session 3

  • CVM should address complexities such as indirect transfer, environmental dissemination and multi-drug resistance
  • Threshold approach should focus on treatment failure and not split impact into enteric and systemic illness
  • There may be other impacts that should be considered as endpoints, such as potentiation of transmission
  • Should address variability of risk across population
  • Threshold approach should be science-based, while recognizing that societal concerns/ values are important in developing in risk management and risk communication strategies

Slide 4:

Summary- Session 4

  • Model too simple, must address complexities of all contributing risk factors
  • Agreement that there must be a mechanism to reassess and periodically update threshold
  • Need to evaluate whether developed model is applicable to other antimicrobials and bacteria
  • Need to develop criteria to determine whether threshold exceeded, and not just background fluctuation
  • Concerns expressed as to whether linear model appropriate

Slide 5:

Summary- Session 5 

  • Expert panel to assist CVM in evaluating NARMS data and recommend appropriate actions
  • Emphasize prudent use strategies
  • For commensals, restrict use in animals until human resistance trigger exceeded
  • Develop a model that can address all known risk factors and the impact of all risk management interventions
    • validate model

Slide 6:

Next Steps

  • Comments to be submitted to docket #00D-1677
    • by April 9, 2001
  • CVM will review comments from meeting and public docket and formulate next steps on thresholds

Slide 7:

Next Steps

  • Categorization
    • CVM and CDER has working group to categorize antimicrobials as to importance in human medicine
    • Plan to develop a draft guidance document
    • Timeframe: 2001
  • Microbiological Safety Assessment
    • Guidance document- overall data to be addressed
    • Timeframe: June 2001