Regulation Text
(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.
Authority
21 U.S.C. 360ccc-1,360ccc-2,371.