HHS - 21 CFR PART 16
REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION
| Organization: | HHS |
| Publication Date: | 1 April 2015 |
| Status: | active |
| Page Count: | 8 |
scope:
The procedures in this part apply when:
(a) The Commissioner is considering any regulatory action, including a refusal to act, and concludes, as a matter of discretion, on the Commissioner's initiative or at the suggestion of any person, to offer an opportunity for a regulatory hearing to obtain additional information before making a decision or taking action.
(b) The act or a regulation provides a person with an opportunity for a hearing on a regulatory action, including proposed action, and the act or a regulation either specifically provides an opportunity for a regulatory hearing under this part or provides an opportunity for a hearing for which no procedures are specified by regulation. Listed below are the statutory and regulatory provisions under which regulatory hearings are available:
Document History
