Next Steps

• These are proposed rules; there is no duty to comply with the rules now, but note:

  • The BT Act's access to records authority is in effect now; however, the Act does not provide a specific time period within which applicable records must be made available to FDA upon an appropriate request (Act says records must be made available at "reasonable times")

  • Administrative detention authority is in effect now. Until final regulations are published and in effect, 21 CFR Part 16 would apply to any detention proceedings.

Previous slide

Next slide

Back to first slide

View graphic version