21 CFR §516.121
Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
- (a)A requestor or potential requestor is entitled to one or more meetings to discuss the requirements for indexing a new animal drug.
- (b)Requests for such meetings should be in writing, be addressed to the Director, OMUMS, specify the participants attending on behalf of the requestor or potential requestor, and contain a proposed agenda for the meeting.
- (c)Within 30 days of receiving a request for a meeting, FDA will attempt to schedule the meeting at a time agreeable to both FDA and the person making the request.