Refuse to file a request for determination of eligibility for indexing.

21 C.F.R. § 516.131
in effectEffective: 2024-07-01
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(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.

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