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U.S. Department of Health and Human Services

Advisory Committees

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Agency Response

Agency Response

Jeffrey M. Gilbert, Ph.D.
Supervisory Microbiologist & Team Leader
Microbial Food Safety Team (HFV-157)

Center for Veterinary Medicine
U.S. Food & Drug Administration
Rockville, MD 

Agency Response - Slide 1

Slide 2

Integration of Outcomes of Individual Assessments

 

Release Exposure Consequence Risk Estimation 
Low
Medium
High 
Low
Medium
High 
Important
Highly Important
Critically Important 
Low
Medium
High 
Agency Response - Slide 2

Slide 3

Possible Risk Management Considerations

 

Approval conditions

Category of concern

Category 1

Category 2

Category 3

Marketing status
 

Rx

Rx/VFD

Rx/VFD/OTC

Extra-label use

No

Restricted in
some cases

Permitted

Extent of use

Low

Low, medium

Low, medium, high

Post-approval monitoring

NARMS

NARMS

NARMS

Advisory Committee

Yes

In certain cases

No

Agency Response - Slide 3