21 C.F.R. § 516.135

Granting a request for determination of eligibility for indexing

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(a) FDA will grant the request for determination of eligibility for indexing if none of the reasons described in § 516.133 for denying such a request applies.

(b) When a request for determination of eligibility for indexing is granted, FDA will notify the requestor in accordance with § 516.137.