(a) If a request for addition to the index contains all of the information required by Sec. 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 Sec. 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.