§ 516.153. Notification of decision regarding index listing.
96 words·~1 min read·
/us/cfr/t21/s§ 516.153·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Within 180 days after the filing of a request for addition of a new animal drug to the index, FDA shall grant or deny the request and notify the requestor of FDA's decision in writing.
(b)If FDA denies the request for addition of a new animal drug to the index, FDA shall provide due notice and an opportunity for an informal conference as described in § 516.123. A decision of FDA to deny a request to index a new animal drug following an informal conference shall constitute final agency action subject to judicial review.