(a) If a request for determination of eligibility for indexing contains all of the information required by §516.129, FDA shall file it, and the filing date shall be the date FDA receives the request.

(b) If a request for a determination of eligibility lacks any of the information required by §516.129, 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.