StacksVerified U.S. regulatory reference

21 CFR §516.135

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov
  1. (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.
  2. (b)When a request for determination of eligibility for indexing is granted, FDA will notify the requestor in accordance with § 516.137.