21 CFR 516.121
§ 516.121 Meetings.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 516.121, § 516.121 Meetings, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/87022
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.