ML19221B312

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Veterinary Release Instruction Guidance
ML19221B312
Person / Time
Issue date: 08/09/2019
From: Irene Wu
NRC/NMSS/DMSST/MSEB
To:
WU I/415-1945
Shared Package
ML19221B309 List:
References
Download: ML19221B312 (1)


Text

Guidance for Veterinarians Preparing Release Instructions Literature reviews and estimates for dog-human interactions indicate that the typical interactions between treated osteoarthritic dog and their owners/caretakers result in up to 15 minutes per day on average of close contact (at a distance of 1 foot between the treated join and the caregivers center of torso) during interactions such as feeding, grooming, and petting. There is an additional up to 4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br /> of intermediate contact (at a distance of 3 feet between the treated joint and the caregivers center of torso) during interactions such as dog walking, and with the dog sitting or lying near a seating person.

There are situations where a person may spend significantly more time in close or intermediate contact with their treated dog. Examples of extended duration close contact may be behaviors such as holding the dog in their lap or next to them on the couch, extended daily grooming, or sleeping with the dog in their bed. Examples of extended duration intermediate contact may be behavior such as a dog that rests at the feet of an owner that works from home or is otherwise sedentary during the day or a dog that desires extensive affection such that it remains near its owners for long durations.

During the pre-screening process, the veterinary staff should interview the owner/caregivers asking open-ended questions to establish the normal behavior patterns for the dog to be treated and the nature of their typical interactions with the owner/caregiver. Each behavior pattern should be assigned a distance ( 1 ft, 3 ft, or greater than 3 ft between the treated join and the caregivers center of torso) and length of time per day. The average daily times at 1 ft and 3 feet should then be calculated. The table below provide release instruction durations for 4 broad categories of dog-human interactions based on duration of contact and distance regardless of the specific behaviors that drive those durations and distances.

All times should be rounded up and the and appropriate line should be chosen from the table below based on the selected category. The measured dose rate at a distance of 1 meter at release is then used to select the proper column for release instruction duration.

Release Instructions Duration (weeks)

Measured Dose Rate at Release (mR/h @ 1m) 0.5 0.4 0.3 0.2 0.1 0.05 Common Contact 2 2 2 2 2 2 Up to 15 min/day @ 1 ft and 4 hr/day @ 3 ft e.g., feeding, grooming, petting, dog walking, etc.

Extended Duration Close Contact 5 4 3 2 2 2 Up to 3 hr/day @ 1 ft and 4 hr/day @ 3 ft e.g., holding dog in lap or on the couch; extended grooming, etc.

Extended Duration Intermediate Contact 4 2 2 2 2 2 Up to 15 min/day @ 1 ft and 12 hr/day @ 3 ft e.g., dog rests at the feet of the caregiver, etc.

Prolonged Close and Intermediate Contact 8 7 6 5 3 2 Up to 11 hr/day @1 ft and 9 hr/day @ 3 ft e.g., dog sleeps in the caregiver's bed, etc.

All measured exposure rates should be rounded up to the next higher value in the table.