21 C.F.R. § 516.131

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

Last amended: 2016Year: 2026Length: 78 wordsSubsections: 2Official source

Cite as 21 C.F.R. § 516.131 (2026)

(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.
Cross-references to the CFR
516.129
21 C.F.R. § 516.131: Refuse to file a request for determination of eligibility for indexing. | Justis AI