§ 516.131. Refuse to file a request for determination of eligibility for indexing.
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/us/cfr/t21/s§ 516.131·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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.