21 C.F.R. § 516.147

Current through May 31, 2024
Section 516.147 - Refuse to file a request for addition to the index
(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.

21 C.F.R. §516.147