21 CFR § 516.121 New Animal Drugs for Minor Use and Minor Species

§ 516.121 Meetings.

Current through Sep 8, 2026 · Read all of Part 516

(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.

← § 516.119 Permanent-resident U.S. agent for foreign requestors and holders.§ 516.123 Informal conferences regarding agency administrative actions. →