21 C.F.R. § 1301.15

Additional information.

Last amended: 2016Year: 2026Length: 88 wordsOfficial source

Cite as 21 C.F.R. § 1301.15 (2026)

The Administrator may require an applicant to submit such documents or written statements of fact relevant to the application as he/she deems necessary to determine whether the application should be granted. The failure of the applicant to provide such documents or statements within a reasonable time after being requested to do so shall be deemed to be a waiver by the applicant of an opportunity to present such documents or facts for consideration by the Administrator in granting or denying the application. [62 FR 13948, Mar. 24, 1997]
21 C.F.R. § 1301.15: Additional information. | Justis AI