§ 516.147. Refuse to file a request for addition to the index.
77 words·~1 min read·
/us/cfr/t21/s§ 516.147·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)If a request for addition to the index contains all of the information required by § 516.145(b), FDA shall file it, and the filing date shall be the date FDA receives the request.
(b)If a request for addition to the index lacks any of the information required by § 516.145, FDA will not file it, but will inform the requestor in writing within 30 days of receiving the request as to what information is lacking.